Molluscum Contagiosum Medications

Definition of Molluscum Contagiosum: A viral skin infection that causes raised pearl-like papules or nodules on the skin.

Drugs associated with Molluscum Contagiosum

The following drugs and medications are in some way related to, or used in the treatment of Molluscum Contagiosum. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Molluscum Contagiosum

Medical Encyclopedia:

• Molluscum contagiosum

Harvard Health Guide:

• Symptoms and treatment for Molluscum Contagiosum

Drug List:

Aldara

UlcerGard

Dosage Form: FOR ANIMAL USE ONLY
UlcerGard®

(omeprazole) Oral Paste for Horses

PREVENTS STOMACH ULCERS BY REDUCING ACID PRODUCTION

Stomach ulcers are more common in horses than once believed. Studies have demonstrated stomach ulcers in over 90% of racehorses and 60% of performance horses in various disciplines. Horses secrete acid in their stomach 24 hours a day. Horses on grass pasture or eating large quantities of roughage infrequently develop stomach ulcers. Horses without continual access to roughage or in rigorous training are at greater risk of stomach ulceration due to the effects of acid on the stomach lining. The additional stresses of traveling, competition, stall confinement, and strenuous exercise can also contribute to the development of stomach ulcers in horses.

UlcerGard works to prevent stomach ulcers in horses. The active ingredient in UlcerGard, omeprazole has been extensively tested for safety and effectiveness. It works by reducing the production of acid in the horse's stomach. To help horses maintain optimal gastric health, it is recommended that UlcerGard be administered during stressful events or activities that may induce stomach ulcers. Such conditions may include: training, racing, showing, traveling, stall confinement, and competition.

DIRECTIONS FOR USE

Each syringe contains 4 individual daily doses for horses weighing 600-1200 lbs. Please refer to the following dosage chart for help in determining the correct dose for your horse.

UlcerGard® DOSAGE CHART

HORSE WEIGHT	DOSE*
* Duration of 8 or 28 days
Less than 600 lbs	Consult a veterinarian
600-1200 lbs	1 dose per day
over 1200 lbs	2 doses once per day

SYRINGE INSTRUCTIONS

1)

To set the syringe plunger, unlock the dose ring by rotating ¼ turn and slide the dose ring along the plunger shaft so that the side nearest the barrel is set at the appropriate daily dose marking.

2)

Rotate ¼ turn to lock ring before dosing.

3)

Make sure horse's mouth contains no feed before administration.

4)

Remove syringe tip cover.

5)

Insert syringe into the corner of the horse's mouth.

6)

Depress the plunger until it stops at the dose ring.

• The entire dose should be deposited on the back of the tongue or deep in the cheek pouch.


• Horses should be observed briefly to assure no part of the dose is lost or rejected.


• If any of the dose is lost, re-dosing is recommended.


• Replace cap if any unused doses remain in the syringe.

ACTIVE INGREDIENT

omeprazole

USES

For the prevention of gastric ulcers in horses.

DOSAGE

The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. When given once daily during the stressful period, UlcerGard has been shown to effectively prevent stomach ulcers in horses. This effect was tested in horses exposed to stressful conditions for either 8 or 28 days.

Warning

Not for use in humans. Keep this and all medications out of the reach of children. In case of ingestion by humans, contact a physician. Do not use in horses intended for human consumption. To obtain product information call 1-877-MERIAL-E.

INFORMATION FOR HORSE OWNERS

• UlcerGard is intended for use in healthy horses. If you notice any signs of illness prior to or during the use of this product, consult your veterinarian for appropriate diagnosis and treatment recommendations.


• UlcerGard may be used in horses that weigh at least 600 lbs. The effectiveness of UlcerGard in the prevention of gastric ulcers in foals and weanlings has not been evaluated.


• UlcerGard may be used safely in breeding stallions. Safety in pregnant mares has not been determined.


• Once daily administration of UlcerGard is recommended in horses exposed to stressful conditions which may include: training, racing, showing, traveling, stall confinement, and competition.


• UlcerGard is intended for use only in the prevention of gastric ulcers in healthy horses. Clinical signs of gastric ulcers may include: decreased appetite, recurrent colic, intermittent loose stools or diarrhea, poor hair coat, poor body condition or poor performance. These signs may also be associated with other diseases as well as existing gastric ulcers. If your horse is exhibiting one or more of these signs, consult your veterinarian for diagnosis and treatment.

STORAGE INFORMATION

Store at 68°F-77°F (20-25°C). Excursions between 59°F-86°F (15-30°C) are permitted.

CUSTOMER ASSISTANCE AND WEB SITE

For more information, please call 1-877-MERIAL-E or visit our web site: www.UlcerGard.com.

®UlcerGard is a registered trademark of the AstraZeneca Group of Companies.

©2010 Merial. All rights reserved.

US Patent:

4255431 and 5708017

1900/01 - Rev. 03-2010

Marketed by: Merial LLC,

Duluth, GA 30096-4640, U.S.A.

Made in Brazil

PRINCIPAL DISPLAY PANEL - 6 Syringe Carton

UlcerGard®

(omeprazole) Oral Paste for Horses

NADA 141-227, Approved by FDA

For the prevention of gastric ulcers in horses

Once-a-Day Dosing with a well-accepted paste

6 PACK - 24 Total Doses

Contains 6 Syringes (4 Doses Each)

MERIAL

UlcerGard  omeprazole  paste

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-9719 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength omeprazole (omeprazole) omeprazole 370 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score      Shape Size Flavor CINNAMON Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-9719-1 1 SYRINGE In 1 CARTON contains a SYRINGE, PLASTIC 1 6.15 g In 1 SYRINGE, PLASTIC This package is contained within the CARTON (50604-9719-1) 2 50604-9719-2 6 SYRINGE In 1 CARTON contains a SYRINGE, PLASTIC 2 6.15 g In 1 SYRINGE, PLASTIC This package is contained within the CARTON (50604-9719-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141227	02/18/2004

Labeler - Merial Limited (034393582)

Revised: 06/2010Merial Limited

Urecholine

Generic Name: bethanechol (Oral route, Subcutaneous route)

be-THAN-e-kol

Commonly used brand name(s)

In the U.S.

• Urecholine

Available Dosage Forms:

• Tablet


• Solution


• Elixir

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Cholinergic

Uses For Urecholine

Bethanechol is taken to treat certain disorders of the urinary tract or bladder. It helps to cause urination and emptying of the bladder. Bethanechol may also be used for other conditions as determined by your doctor.

Bethanechol is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, bethanechol is used in certain patients with the following medical conditions:

• Certain stomach problems


• Gastroesophageal reflux (caused by acid in the stomach washing back up into the esophagus)


• Megacolon (an abnormally large or dilated colon)

Before Using Urecholine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of bethanechol in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of bethanechol in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betel Nut

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy or


• Heart or blood vessel disease or


• Intestinal blockage or


• Low blood pressure or


• Parkinson's disease or


• Recent bladder or intestinal surgery or


• Stomach ulcer or other stomach problems or


• Urinary tract blockage or difficult urination—Bethanechol may make these conditions worse

• High blood pressure—Bethanechol may cause a rapid fall in blood pressure

• Overactive thyroid—Bethanechol may further increase the chance of heart problems

Proper Use of Urecholine

Take this medicine on an empty stomach (either 1 hour before or 2 hours after meals) to lessen the possibility of nausea and vomiting, unless otherwise directed by your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• To empty the bladder:
  
  • For oral dosage form (tablets):
    
    • Adults—25 to 50 milligrams (mg) three or four times a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.6 mg per kilogram (kg) (0.27 mg per pound) of body weight a day. This dose is divided into smaller doses and taken three or four times a day.
    
    
  
  
  • For injection dosage form:
    
    • Adults—5 mg injected under the skin three or four times a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.2 mg per kg (0.09 mg per pound) of body weight a day. This dose is divided into smaller doses, which are injected under the skin three or four times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Urecholine

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help lessen this problem.

Urecholine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare - more common with the injection

• Shortness of breath, wheezing, or tightness in chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare - more common with the injection

• Belching


• blurred vision or change in near or distance vision


• diarrhea


• dizziness or lightheadedness


• feeling faint


• frequent urge to urinate


• headache


• increased watering of mouth or sweating


• nausea or vomiting


• redness or flushing of skin or feeling of warmth


• seizures


• sleeplessness, nervousness, or jitters


• stomach discomfort or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Urecholine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Urecholine resources

• Urecholine Side Effects (in more detail)
• Urecholine Use in Pregnancy & Breastfeeding
• Drug Images
• Urecholine Drug Interactions
• Urecholine Support Group
• 0 Reviews for Urecholine - Add your own review/rating

• Urecholine Prescribing Information (FDA)


• Urecholine MedFacts Consumer Leaflet (Wolters Kluwer)


• Urecholine Concise Consumer Information (Cerner Multum)


• Urecholine Monograph (AHFS DI)


• Bethanechol Prescribing Information (FDA)

Compare Urecholine with other medications

• Abdominal Distension
• GERD
• Urinary Retention

Cyclosporine Capsules

Pronunciation: SYE-kloe-SPOR-een
Generic Name: Cyclosporine
Brand Name: Examples include Gengraf and Neoral

Cyclosporine Capsules suppresses the immune system, which may increase your risk of developing an infection or cancer. In kidney, liver, or heart transplant patients, Cyclosporine Capsules may be used along with other medicines that suppress the immune system. Using these medicines together may further increase your risk of developing an infection or a certain type of cancer (lymphoma).

Cyclosporine Capsules cannot be switched with other forms of cyclosporine (eg, Sandimmune) without your doctor's approval. If you are taking Cyclosporine Capsules for a transplant or for rheumatoid arthritis, lab tests may be performed to monitor your progress or to check for side effects, such as toxicity.

If you are using Cyclosporine Capsules for psoriasis and you are also using certain other forms of treatment (eg, psoralen ultraviolet A [PUVA] or ultraviolet B [UVB] therapy, medicines that suppress the immune system, coal tar, radiation therapy), you may be at an increased risk of developing skin cancer.

Cyclosporine Capsules may cause high blood pressure or kidney problems. This risk may be increased with high doses or prolonged use of Cyclosporine Capsules. Kidney function tests may be performed while you are taking Cyclosporine Capsules to check for side effects.

Cyclosporine Capsules is used for:

Preventing the rejection of organ transplants (kidney, liver, and heart). Cyclosporine Capsules is also used to treat psoriasis and rheumatoid arthritis in certain patients. It may also be used for other conditions as determined by your doctor.

Cyclosporine Capsules is an immunosuppressant. Exactly how Cyclosporine Capsules works is not known, but it may block certain white blood cells (lymphocytes).

Do NOT use Cyclosporine Capsules if:

• you are allergic to any ingredient in Cyclosporine Capsules


• you are taking bosentan, disulfiram, fluorouracil, metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)


• you have psoriasis or rheumatoid arthritis and also have kidney problems, uncontrolled high blood pressure, or cancer


• you are using other therapies for psoriasis (eg, PUVA or UVB therapy, methotrexate or other medicines that suppress the immune system, coal tar, radiation therapy)


• you are going to be vaccinated with a live vaccine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cyclosporine Capsules:

Some medical conditions may interact with Cyclosporine Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; or problems absorbing food or medicine; or have had a recent vaccination


• if your diet contains a lot of potassium


• if you have a history of seizures


• if you are having phototherapy for psoriasis, or are having radiation treatment

Some MEDICINES MAY INTERACT with Cyclosporine Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Many prescription and nonprescription medicines (eg, used for infections, inflammation, allergic reactions, asthma, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) may interact with Cyclosporine Capsules. They may increase the risk of side effects or decrease the effectiveness of this or other medicines


• Potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• Bosentan because the risk of its side effects and toxic effects may be increased by Cyclosporine Capsules


• Disulfiram , fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur


• Orlistat because it may decrease Cyclosporine Capsules's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyclosporine Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cyclosporine Capsules:

Use Cyclosporine Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cyclosporine Capsules on a regular schedule with regard to food and time of day.


• Do not eat grapefruit or drink grapefruit juice while you use Cyclosporine Capsules.


• If you also take sirolimus, do not take it within 4 hours after taking Cyclosporine Capsules. Check with your doctor if you have questions.


• If you miss a dose of Cyclosporine Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyclosporine Capsules.

Important safety information:

• Cyclosporine Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Cyclosporine Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not switch to another doseform or change brands of Cyclosporine Capsules without talking to your doctor. Products made by other companies may not work as well for you.


• Cyclosporine Capsules may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cyclosporine Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.


• Cyclosporine Capsules may lower the ability of your body to fight infection and may increase the risk of severe infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.


• Some people treated with Cyclosporine Capsules have developed severe kidney problems associated with the BK virus infection. Tell your doctor right away if you notice symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Cyclosporine Capsules. Talk with your doctor before you receive any vaccine.


• Cyclosporine Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Tell your doctor or dentist that you take Cyclosporine Capsules before you receive any medical or dental care, emergency care, or surgery.


• Patients who are being treated for psoriasis will need to have careful skin and physical examinations, including blood pressure measurements, before starting this medication.


• Diabetes patients - Cyclosporine Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including kidney and liver function; cyclosporine levels; and blood pressure, lipids, and electrolytes, may be performed while you use Cyclosporine Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cyclosporine Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: Cyclosporine Capsules may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cyclosporine Capsules while you are pregnant. Cyclosporine Capsules is found in breast milk. Do not breast-feed while taking Cyclosporine Capsules.

Possible side effects of Cyclosporine Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; burning sensation; coughing; dizziness; flushing; headache; increased hair growth; nausea; runny nose; sleeplessness; stomach discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; change in the appearance of a mole; chest pain; confusion; dark urine; diarrhea; fast or irregular heartbeat; gum disease or overgrowth; increased or decreased urination; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; symptoms of infection (eg, chills, cough, fever, painful urination, sore throat); tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cyclosporine Capsules:

Store Cyclosporine Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyclosporine Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Cyclosporine Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Cyclosporine Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cyclosporine Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cyclosporine resources

• Cyclosporine Dosage
• Cyclosporine Use in Pregnancy & Breastfeeding
• Drug Images
• Cyclosporine Drug Interactions
• Cyclosporine Support Group
• 5 Reviews for Cyclosporine - Add your own review/rating

Compare Cyclosporine with other medications

• Cogan's Syndrome
• Crohn's Disease
• Evan's Syndrome
• Focal Segmental Glomerulosclerosis
• Graft-versus-host disease
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Bowel Disease
• Nephrotic Syndrome
• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal
• Pemphigoid
• Pemphigus
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Ulcerative Colitis
• Ulcerative Colitis, Active

Lipodystrophy Medications

Definition of Lipodystrophy:

Lipodystrophy is a condition characterized by abnormal or degenerative conditions of the body's adipose tissue.

Drugs associated with Lipodystrophy

The following drugs and medications are in some way related to, or used in the treatment of Lipodystrophy. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Egrifta

Uta

Generic Name: hyoscyamine, methenamine, methylene blue, and phenyl salicylate (HYE oh SYE a meen, meth EN a meen, METH il een BLUE, FEEN il sa LIS il ate)

Brand Names: Darpaz, Hyophen, Phosenamine, Phosphasal, Prosed/DS, Urelle, Uribel, Uro Blue, Ustell, Uta, UTICAP, Utira, Utira-C

What is Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.

Phenyl salicylate is a mild pain reliever.

The combination of hyoscyamine, methenamine, methylene blue, and phenyl salicylate is used to treat bladder irritation (pain, burning, inflammation) caused by urinary tract infection. This medication is also used to prevent bladder discomfort during a medical procedure.

Hyoscyamine, methenamine, methylene blue, and phenyl salicylate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

Before taking this medication, tell your doctor if you have any type of heart problem (congestive heart failure, coronary heart disease, a heart valve or heart rhythm disorder), glaucoma, an enlarged prostate, bladder obstruction, myasthenia gravis, a stomach ulcer or obstruction, or if you are allergic to belladonna (Donnatal and others).

Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before taking Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  heart disease;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  coronary heart disease;

  
  


• 
  

  a heart valve disorder;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an enlarged prostate or bladder obstruction;

  
  


• 
  

  myasthenia gravis;

  
  


• 
  

  an ulcer or obstruction in your stomach; or

  
  


• 
  

  if you are allergic to belladonna (Donnatal and others).

  
  

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate should not be given to a child younger than 7 years old. Older adults may be more likely to have side effects from this medication.

How should I take Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Hyoscyamine, methenamine, methylene blue, and phenyl salicylate is usually taken 4 times daily. Follow your doctor's instructions.

Do not crush, chew, or break an enteric coated pill. Swallow it whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or rapid pulse.

What should I avoid while taking Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.

If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate) side effects

Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, blurred vision, fast heart rate;

  
  


• 
  

  agitation, confusion, feeling restless or excited;

  
  


• 
  

  painful or difficult urination; or

  
  


• 
  

  feeling short of breath.

  
  

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Uta (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use, especially:

• 
  

  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  homatropine (Hycodan, Tussigon);

  
  


• 
  

  methantheline;

  
  


• 
  

  neostigmine (Prostigmin) or pyridostigmine (Mestinon);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  
  


• 
  

  medicines to treat symptoms of Alzheimer's disease such as donepezil (Aricept), galantamine (Razadyne), memantine (Namenda), rivastigmine (Exelon), or tacrine (Cognex);

  
  


• 
  

  narcotic pain medication such as codeine (Tylenol #3, Cheratuss, Guaiatuss), fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid), methadone (Dolophine, Methadose), morphine (Avinza, Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Endocet, Percocet), propoxyphene (Darvocet, Propacet), and others;

  
  


• 
  

  sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);

  
  


• 
  

  sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or

  
  


• 
  

  ulcer or irritable bowel medications such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Hyomax), mepenzolate (Cantil), or propantheline (Pro Banthine).

  
  

This list is not complete and there are many other drugs that can interact with hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Uta resources

• Uta Side Effects (in more detail)
• Uta Use in Pregnancy & Breastfeeding
• Uta Drug Interactions
• 3 Reviews for Uta - Add your own review/rating

• Uta MedFacts Consumer Leaflet (Wolters Kluwer)


• Darcalma Prescribing Information (FDA)


• Darpaz Prescribing Information (FDA)


• Phosenamine Prescribing Information (FDA)


• Phosphasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Phosphasal Prescribing Information (FDA)


• Prosed EC Advanced Consumer (Micromedex) - Includes Dosage Information


• Prosed/DS MedFacts Consumer Leaflet (Wolters Kluwer)


• Urelle Prescribing Information (FDA)


• Uribel Prescribing Information (FDA)


• Urimax Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Urised MedFacts Consumer Leaflet (Wolters Kluwer)


• Uritact-EC Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ustell Prescribing Information (FDA)

Compare Uta with other medications

• Urinary Tract Infection

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

See also: Uta side effects (in more detail)

Simvastatin 80mg Tablets

Simvastatin 80mg Tablets

Read all of this leaflet carefully before you start taking this medicine

• 
  Keep this leaflet. You may need to read it again
  


• 
  If you have any further questions, ask your doctor or pharmacist
  


• 
  This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
  


• 
  If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  

In this leaflet:

• 1. What Simvastatin 80mg is and what it is used for


• 2. Before you take Simvastatin 80mg


• 3. How to take Simvastatin 80mg


• 4. Possible side effects


• 5. How to store Simvastatin 80mg


• 6. Further information

What Simvastatin 80Mg Is And What It Is Used For

Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins.

Simvastatin is used along with diet if you have:

• a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)


• a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.


• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

Before You Take Simvastatin 80Mg

Do not take Simvastatin 80mg:

• if you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of the tablet


• if you have liver problems or a continuous high level of certain liver enzymes (serum transaminases)


• if you are pregnant or breast-feeding


• if you are taking the following medicines (see also the section “Taking other medicines” below):


• certain antifungals (ketoconazole or itraconazole)


• certain medicines for the treatment of AIDS (HIV-protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir)


• certain antibiotics (erythromycin, clarithromycin or telithromycin)


• the antidepressant nefazodone

Take special care with Simvastatin 80mg:

• Tell your doctor about all your medical conditions including allergies.


• Tell your doctor if you drink large amounts of alcohol


• Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you.


• Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.


• Your doctor should do a blood test before you start taking Simvastatin. This is to check how well your liver is working.


• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of Simvastatin and is greater in certain patients. Tell your doctor if any of the following applies to you:

• you consume large amounts of alcohol


• kidney problems


• thyroid problems


• you are more than 70 years old


• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates


• you or close family members have a hereditary muscle disorder.

Taking other medicines

It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin 80mg:”)

Please note that the following statements may also apply to products you took some time ago or may take at some time in the future.

The risk of muscle problems can be greater if simvastatin is taken with the following medicines: (some of these have already been listed in the above section “Do not take the tablets”)

• Fibrates (other cholesterol-lowering medicines, such as gemfibrozil, bezafibrate); the simvastatin dose should not exceed 10mg daily


• Ciclosporin (drug used to suppress the immune system); the simvastatin dose should not exceed 10mg daily


• Certain antifungals (such as itraconazole or ketoconazole)


• The antibiotics erythromycin, clarithromycin and telithromycin


• Certain medicines for the treatment of AIDS (HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir)


• Danazol (medicine used to treat endometriosis and breast cysts in women) the simvastatin dose should not exceed 10mg daily


• The antidepressant nefazodone


• Amiodarone, a medicine used for irregular heart beat; the simvastatin dose should not exceed 20mg daily


• Verapamil and diltiazem (medicine used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions); if you take verapamil, the dose of simvastatin should not exceed 20mg daily. If you take dilitazem, the dose of simvastatin should not exceed 40mg daily, unless your doctor considers that the clinical effects is likely to outweigh the increased risk of muscle problems


• Fusidic acid as a tablet or infusion (a medicine used to treat bacterial infections)

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

• medicines to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).


• fenofibrate (another medicine for lowering cholesterol).


• niacin (another medicine for lowering cholesterol).

Taking Simvastatin 80mg with food and drink

Grapefruit juice contains one or more components which may increase the amount of simvastatin in the blood. Therefore, you should not drink grapefruit juice as it could increase the risk of muscle damage.

Pregnancy and breast-feeding

Do not take simvastatin if you are pregnant, trying to become pregnant or suspect you may be pregnant, as the safety in pregnant women has not been established. If you become pregnant while using simvastatin, you must stop taking the tablets immediately and contact your doctor.

No data on the excretion of simvastatin in breast milk are available. Because many medicinal products are excreted in human milk and because of the potential for serious side effects, you must not breast-feed your infant while taking simvastatin.

Children

Simvastatin is not recommended for use in children.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin has no effect or only a negligible effect on the ability to drive or use machines. However, there have been rare cases of dizziness reported in patients taking simvastatin tablets (see section 4 “Possible side effects”). Do not drive vehicles or operate machines that require attention if you experience this side effect.

Important information about some of the ingredients of Simvastatin 80mg

Amongst other ingredients, Simvastatin 80mg tablets contain lactose monohydrate. If your doctor has told you that you cannot tolerate certain sugars, contact your doctor before taking this medicine.

How To Take Simvastatin 80Mg?

Always take your tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Take the tablets either on an empty stomach or after a meal.

Before starting your treatment with Simvastatin 80mg you should be on a diet to lower your cholesterol and should keep on this diet while you are taking Simvastatin 80mg.

The usual dose is 5mg to 80mg simvastatin per day as a single dose in the evening. If needed, your doctor can increase the dose at intervals of at least 4 weeks to a maximum of 80mg per day as a single dose in the evening. The dose of 80mg is only recommended in patients with very high cholesterol levels and high-risk cardiovascular complications.

Your doctor will decide the appropriate dose for you and when you should take your tablets. This will depend on why you need to lower your cholesterol (see also section 1 “What Simvastatin 80mg is and what it is used for”):

Adults

• 
  To lower cholesterol and triglycerides in the blood (Hypercholesterolaemia), a usual starting dose is 10-20mg as a single dose in the evening. If a stronger effect is needed, the starting dose can be 20-40mg as a single dose in the evening. Your doctor can decide to increase the dose as mentioned above.


• 
  To lower inherited high levels of cholesterol in your blood (homozygous familial hypercholesterolemia), the recommended dose is 40mg as a single dose in the evening, or 80mg per day in 3 divided doses: 20mg in the morning, 20mg in the afternoon and 40mg in the evening.


• 
  To reduce the risk of coronary heart disease, the usual dose is 20-40mg as a single dose in the evening. Your doctor can decide to increase the dose as mentioned above.

If you have moderate kidney problems your dose will not have to be adjusted. If you have severe kidney problems your doctor may prescribe a lower dose, which will not be more than 10mg per day.

If your doctor has prescribed a bile acid sequestrant (another medicine for lowering cholesterol such as colestyramine) along with Simvastatin 80mg, you should take Simvastatin 80mg at least two hours before or four hours after taking the bile acid sequestrant.

Children and adolescents

Efficacy and safety of use in children have not been established.

Elderly

No dosage adjustment is necessary.

Duration of treatment:

You will have to take simvastatin over a long period of time. Your doctor will tell you how long you need to take simvastatin.

If you have the impression that the effect of simvastatin is too strong or too weak, talk to your doctor or pharmacist.

If you take more Simvastatin 80mg than you should

Although no specific information about simvastatin overdose is available, any medication taken in excess can have serious consequences. If you take too many tablets by mistake, contact a doctor or pharmacist immediately.

If you forget to take Simvastatin 80mg

If you realise you have forgotten to take a dose soon after its due time, take it as soon as possible. However, if it is almost time to take the next dose, omit the forgotten dose and take the next one when it is due. Ask your doctor or pharmacist in case of doubt.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Simvastatin 80mg

If you suddenly stop taking this medicine, your cholesterol may rise again. It is therefore important that you consult a doctor before stopping treatment. He/she can tell you if you can stop and the best way to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Simvastatin 80mg can cause side effects, although not everybody will have them.

The following term is used to describe how often side effects have been reported:

Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.


• hypersensitivity (allergic) reactions including:


• swelling of the face, tongue and throat which may cause difficulty in breathing


• severe muscle pain usually in the shoulders and hips


• rash with weakness of limbs and neck muscles


• pain or inflammation of the joints


• inflammation of the blood vessels


• unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing


• shortness of breath and feeling unwell


• lupus-like disease picture (including rash, joint disorders, and effects on blood cells)


• inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare)


• inflammation of the pancreas often with severe abdominal pain.

The following side effects have also been reported rarely:

• low red blood cell count (anaemia)


• numbness or weakness of the arms and legs


• headache, tingling sensation, dizziness


• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)


• rash, itching, hair loss


• weakness.

Laboratory values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Simvastatin 80Mg

Keep out of the reach and sight of children.

Store the tablets in the original package in order to protect from light and moisture.

Do not store above 30°C.

Do not use the tablets after the ¨do not use after¨ or ¨expiry¨. date stated on the packaging. The first 2 digits denote the month, the last digits the year.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Simvastatin 80mg contains:

• The active substance is: Simvastatin, 80mg per tablet


• The other ingredients are:

Tablet core: Lactose monohydrate, cellulose microcrystalline (E460), pregelatinised maize starch, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b).
Film-coating: Hypromellose (E464), red iron oxide (E172), triethylcitrate (E1505), titanium dioxide (E171), talc (E553b), povidone K-30.

Product appearance and pack size

Simvastatin 80mg is a dark pink-coloured , oblong, film-coated tablet, scored on one side. The tablets can be divided into equal halves.

The tablets are packed in blisters in a carton box, containing 10, 20, 28, 30, 40, 50, 56, 60, 98 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturers

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande No.2

2710-089 Sintra

Portugal

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Distributor

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in: October 2009

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