Riva-Esomeprazole DR: Uses, Side Effects and Dosage

What the medication is used for:

In adults, Riva-ESOMEPRAZOLE DR is used for the treatment of acid-related disorders such as:

• reflux esophagitis (tissue damage caused by stomach

  content flowing back up the food pipe) and symptoms of gastroesophageal reflux disease (GERD) in patients with reflux esophagitis

• duodenal ulcers caused by infection with a bacterium

  called Helicobacter pylori in combination with other antibiotics, and to help reduce the risk of these ulcers from coming back

• the symptoms of nonerosive reflux disease (NERD),

  which are not related to tissue damage within the food pipe, such as: a burning feeling rising from the chest towards the neck (heartburn) and the flow of bitter/sour juice into the mouth (regurgitation)

• rare pathological hypersecretory conditions, including

  “Zollinger-Ellison syndrome”, which cause the stomach to produce large amounts of acid.

Riva-ESOMEPRAZOLE DR is also used to heal and/or reduce the risk of ulcers that can be caused by medication you may be taking for pain or joint problems such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) or acetylsalicylic acid (i.e. Aspirin®).

In children (12- 17 years of age), Riva-ESOMEPRAZOLE DR is used for the treatment of acid-related disorders such as:

• reflux esophagitis (tissue damage caused by stomach

  content flowing back up the food pipe) and symptoms of gastroesophageal reflux disease (GERD) in patients with reflux esophagitis;

• the symptoms of nonerosive reflux disease (NERD),

  which are not related to tissue damage within the food pipe, such as: a burning feeling rising from the chest towards the neck (heartburn) and the flow of bitter/sour juice into the mouth (regurgitation).

What it does:

Riva-ESOMEPRAZOLE DR works by causing less acid

to be made in your stomach.

When it should not be used:

If you are allergic to the active ingredient esomeprazole or any of the other ingredients of Riva-ESOMEPRAZOLE DR (see What the important nonmedicinal ingredients are). If you think you may be allergic, ask your doctor for advice.

What the medicinal ingredient is:

Riva-ESOMEPRAZOLE DR contains esomeprazole magnesium dihydrate as the active ingredient.

What the important nonmedicinal ingredients are:

Each Riva-ESOMEPRAZOLE DR capsule contains the active ingredient esomeprazole magnesium dihydrate and the following non-medicinal ingredients (listed in alphabetical order): diacetylated monoglycerides, dimethicone emulsion 35%, hydroxypropyl methylcellulose 603, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, stearoyl macrogolglycerides, sugar spheres, talc, triethyl citrate. The capsule shell is composed of gelatin, yellow iron oxide and titanium dioxide. The black ink is composed of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong Ammonia.

Check with your doctor or pharmacist if you think you may be allergic to any of the above ingredients.

What dosage forms it comes in:

Riva-ESOMEPRAZOLE DR 20 mg capsules come in bottles that contain 90 capsules and in blister packages that contain 30 capsules. Riva-ESOMEPRAZOLE DR 40 mg capsules come in bottles that contain 90 capsules and in blister packages that contain 30 capsules.

WARNINGS AND PRECAUTIONS

BEFORE or DURING your use of Riva-ESOMEPRAZOLE DR talk to your doctor or pharmacist about:

• symptoms that may be a sign of a more serious problem in your stomach or intestine such as: trouble swallowing, unplanned weight loss, vomiting blood or food, or black (blood-stained) stools

• if you are pregnant or trying to become pregnant

• if you are allergic to esomeprazole or any other ingredients or components of the container
• if you have health problems now or have had any in the past
• other medications you take, including ones you can buy without a prescription.

INTERACTIONS WITH THIS MEDICATION

Blood levels of some drugs may be influenced if Riva-ESOMEPRAZOLE DR is taken at the same time as drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), drugs to speed up stomach emptying (cisapride*), poor circulation in the legs (cilostazol*), heart problems (digoxin), treatment for tuberculosis (rifampin), St John’s Wort (Hypericum performatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class). However, none of these interactions have been shown to change the effectiveness of esomeprazole magnesium or the other drug.

Drugs used for blood clotting (warfarin or coumarin derivatives) have been reported to interact with esomeprazole magnesium. Speak to your doctor or pharmacist if you are taking any of these drugs.

Riva-ESOMEPRAZOLE DR may decrease the effectiveness of some drugs used for HIV treatment; atazanavir and nelfinavir should not be used with Riva-ESOMEPRAZOLE DR.

If you are taking a high dose of methotrexate (a drug used in high doses to treat cancer), Riva-ESOMEPRAZOLE DR may need to be temporarily withdrawn.

During episodic dosing of Riva-ESOMEPRAZOLE DR when needed, your response to potential drug interactions may change as compared to daily dosing during the entire, initial treatment period.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

* not marketed in Canada

PROPER USE OF THIS MEDICATION

Administration:

Riva-ESOMEPRAZOLE DR may be taken with food or on an empty stomach.

Capsules:

The capsules should be swallowed whole with sufficient water. DO NOT open, divide, crush or chew the capsules. Do NOT open the capsules to sprinkle on food or beverages.

Usual dose:

Adults

Take all doses of Riva-ESOMEPRAZOLE DR as directed by your doctor. Do so even when you feel well. In some cases, daily doses are needed to control your pain and symptoms and to help damaged areas heal. The suggested dose for treating acute disease is 20 to 40 mg once a day for 2 to 8 weeks. Your doctor may suggest that you continue taking Riva-ESOMEPRAZOLE DR 20 mg each day. This is to keep your

symptoms from coming back.

Follow the directions given to you by your doctor. They may differ from the information contained in this leaflet.

Riva-ESOMEPRAZOLE DR may be used together with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori. This also helps to reduce the risk of these ulcers from coming back. Your prescription may say esomeprazole magnesium 1-2-3 A. This tells the pharmacist to give you three different drugs (Riva-ESOMEPRAZOLE DR and two antibiotics). The pharmacist should also give you information on the two antibiotics that will be used in combination with Riva-ESOMEPRAZOLE DR.

If you receive Riva-ESOMEPRAZOLE DR plus antibiotic drugs, take all three drugs twice each day. Do so at the correct time each day for one week. This will ensure they work properly. Studies have shown that patients who take their drugs as prescribed, have better ulcer healing rates and greater success getting rid of their Helicobacter pylori infection.

It is important to take Riva-ESOMEPRAZOLE DR until your doctor tells you to stop. This is true even if you start to feel better in a few days. Riva-ESOMEPRAZOLE DR needs to be taken for the full treatment duration to help correct acid problems.

Maintenance Treatment of NERD (on-demand) dose After initial treatment of NERD, your doctor may suggest that you take Riva-ESOMEPRAZOLE DR 20 mg once daily, as needed, if symptoms of heartburn and regurgitation return periodically. Contact your doctor if your symptoms get worse, persist or if new symptoms arise.

Children (12 – 17 years of age)

Take all doses of Riva-ESOMEPRAZOLE DR as directed by your doctor. Do so even when you/your child feels well. Riva-ESOMEPRAZOLE DR needs to be taken for the full treatment duration to help correct acid problems.

Follow the directions given to you by your doctor. They may differ from the information contained in this leaflet.

The suggested dose for treating acute disease is 20 or 40 mg once a day for 2 to 8 weeks.

Overdose

Missed Dose:

If you/your child miss a dose of Riva-ESOMEPRAZOLE In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

DR, and remember within 12 hours, take the capsule as soon as possible. Then go back to the regular schedule. If more than 12 hours have passed, do not take the missed dose. Do not double the dose. Just take the next dose on time.

Like any drug, Riva-ESOMEPRAZOLE DR may cause side effects in some people. Side effects that may occur are usually mild. They usually go away a short time after starting Riva-ESOMEPRAZOLE DR. These side effects may not be caused by Riva-ESOMEPRAZOLE DR in your case, but only a doctor can assess this. If these become bothersome (or exceed 1-2 days), discuss with your doctor:

Common: nausea, stomach upset, diarrhea, headache

Uncommon: dry mouth, dizziness, insomnia, feeling of burning/prickliness/numbing, swelling of extremities, feeling sleepy, vertigo

Rare: taste disorders, nervousness, hair loss, increased sweating

Treatment in combination with antibiotics:

If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by a bacterial infection (Clostridium difficile). If this happens call your doctor or pharmacist immediately and stop taking the drug combination.

If you experience any bothersome or unusual effects while using Riva-ESOMEPRAZOLE DR, check with your doctor or pharmacist.

^Θ These would only be seen if a blood test was taken.

HOW TO STORE IT

• Keep all capsules sealed in the blister strips until it is time for a dose. If you do not, moisture from the air may damage the drug.
• Keep Riva-ESOMEPRAZOLE DR well out of reach of children.

• Keep Riva-ESOMEPRAZOLE DR at room temperature

  (15-25°C).

• Do not keep Riva-ESOMEPRAZOLE DR in the bathroom medicine cabinet or other warm, moist places.
• Do not use Riva-ESOMEPRAZOLE DR after the expiry date marked on the pack.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting:

Laboratoire Riva Inc.

By telephone: 1-888-550-6060

By post: Laboratoire Riva Inc.

6111 Royalmount, # 100

Montreal, QC H4P 2T4

ASPIRIN^® is a registered trademark of Bayer AG, used under license.

Last revised: May 16, 2012