1007112 vi_En:_ 2/11/09 7:35 AM Page 1 IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Pr Sandoz® Omeprazole Omeprazole Capsules This leaflet is part III of a three-part “Product Monograph” published when Sandoz Omeprazole was approved for sale in Canada and is designed specifically for consumers. This leaflet is a summary and will not tell you everything about Sandoz Omeprazole. Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION WHAT IS SANDOZ OMEPRAZOLE USED FOR AND HOW DOES IT WORK? Sandoz Omeprazole is the brand name for a drug called omeprazole. The most common uses of Sandoz Omeprazole are: 앫 for ulcers caused by your medicine for pain and joint problems (NSAIDassociated gastric and duodenal ulcers), and; 앫 for the symptoms of gastroesophageal reflux disease such as: a burning sensation rising from the chest towards the neck (heartburn) and flow of bitter/sour juice into the mouth (regurgitation); and 앫 reflux esophagitis (tissue damage caused by stomach contents flowing back up the food pipe); and 앫 for stomach ulcers or for duodenal ulcers (not caused by H. pylori ). Sandoz Omeprazole may also be used in rare conditions like “Zollinger-Ellison syndrome”, where the stomach produces large amounts of acid. Sandoz Omeprazole works by reducing the amount of acid made in your stomach. This helps in treating acid-related stomach problems (not caused by H. pylori ). Your doctor will have explained why you are being treated with Sandoz Omeprazole and will have told you what dose to take. Follow those directions carefully. They may differ from the information contained in this leaflet. WHEN SANDOZ OMEPRA0ZOLE SHOULD NOT BE USED? If you are allergic to omeprazole or any other ingredients in Sandoz Omeprazole (see WHAT IS IN SANDOZ OMEPRAZOLE?) WHAT IS IN SANDOZ OMEPRAZOLE? Each Sandoz Omeprazole capsule contains omeprazole as the active ingredient. In addition, it contains the following nonmedicinal ingredients (listed in alphabetical order): Carrageenan, croscarmellose sodium, dibutyl sebacate, hypromellose (HPMC), hypromellose phthalate (HPMCP), iron oxide red, lactose anhydrous, lowsubstituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 80, potassium chloride, povidone, talc, titanium dioxide, water. Check with your doctor or pharmacist if you think you might be allergic to any of the nonmedicinal substances which may be present in Sandoz Omeprazole. WARNINGS AND PRECAUTIONS BEFORE you use Sandoz Omeprazole talk to your doctor or pharmacist: 앫 About all health problems you have now or have had in the past. 앫 About severe liver problems you have now or have had in the past. 앫 About other medicines you take, including ones you can buy without a prescription. 앫 If you are pregnant, plan to become pregnant or are breast feeding. clotting (warfarin or other vitamin K blockers), for HIV treatment (atazanavir) and in transplant patients (tacrolimus). PROPER USE OF THIS MEDICATION Take all doses of Sandoz Omeprazole, as recommended by your doctor, even when you feel well. Daily doses are needed to help damaged areas heal. In general, the recommended dose for treating disease is 10 to 40 mg once a day for 2 to 8 weeks. Your doctor may recommend that you continue taking Sandoz Omeprazole 10 to 40 mg to control symptoms of reflux disease or to prevent reflux esophagitis from coming back, or Sandoz Omeprazole 20 mg to prevent ulcers from returning while you continue to take your medicine for pain and joint problems. Take Sandoz Omeprazole until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if Sandoz Omeprazole is stopped too soon. Sandoz Omeprazole needs to be taken for the full duration of treatment to help correct acid problems. If you miss a dose of Sandoz Omeprazole and remember within 12 hours, take it as soon as possible. Then go back to your regular schedule. However, if more than 12 hours have passed when you remember, do not take the missed tablet. Just take your next dose on time. Sandoz Omeprazole may be taken with food or on an empty stomach. Overdose: In case of an overdose, contact your doctor, hospital emergency department or regional Poison Control Centre. However, no severe symptoms have been seen in patients who have taken doses up to 400 mg. SIDE EFFECTS AND WHAT TO DO ABOUT THEM Like any medication, Sandoz Omeprazole may cause side effects in some people. Side effects that do occur are usually mild and go away a short time after starting Sandoz Omeprazole. Talk with your doctor if you suffer from any of these effects or if you get any other unusual or unexpected symptoms. These side effects may not be caused by Sandoz Omeprazole in your case, but only a doctor can assess this. Common side effects that may occur (frequency of greater than or equal to 1 in 100 patients): • Headache, diarrhea, constipation, abdominal pain, nausea/vomiting, and excess gas in stomach (flatulence). Uncommon side effects that may occur (frequency of greater than or equal to 1 in 1000 patients, but less than 1 in 100 patients): • Dizziness, sensation of movements of one’s self or of one’s surroundings (vertigo), difficulty sleeping, feeling sleepy, sensation of burning/ prickling/numbness, skin reactions (such as skin rash, dermatitis, itchy skin and/or hives) and feeling ill. Before taking Sandoz Omeprazole tell your doctor if you are currently taking other medications. Rare side effects that may occur (frequency of less than 1 in 1000 patients): • Dry mouth, inflammation in the mouth, gastrointestinal fungal infection, kidney and liver problems (i.e. inflammation of kidney, inflammation of liver with or without jaundice, impaired liver function), blood disorders (reduced number of cells in the blood, low blood sodium), sore joints and muscles, muscular weakness, development of breast in males, sensitivity to sunlight, severe skin reaction, hair loss, hypersensitive (allergic) reactions (such as swelling of tissues, fever, discomfort/tightness in chest and anaphylactic shock), increased sweating, blurred vision, and taste disorders. If you already have severe liver disease, you may experience disorientation/aggression/confusion/decreased consciousness. If you are very ill, you may feel confused, nervous, depressed or may hallucinate. Drug effects may be influenced if Sandoz Omeprazole is taken at the same time as some other drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), blood Other unwanted effects which cannot be predicted may occur in rare cases. If you experience any bothersome or unusual effects while using Sandoz Omeprazole, check with your doctor or pharmacist right away. If you experience symptoms that may indicate a more serious stomach or intestinal problem, you should contact your doctor immediately. Such symptoms may include any of the following: difficulty swallowing, unintentional weight loss, vomiting blood or food, or black (blood-stained) stools or other situations, which cannot be predicted, that may arise. INTERACTIONS WITH THIS MEDICATION 1007112 vi_En:_ 2/11/09 7:35 AM Page 2 SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom/effect Talk with your doctor or pharmacist Only if In all severe cases Uncommon Skin reactions (such as skin rash, dermatitis, itchy skin and/or hives) ✔ Rare Inflammation in the mouth ✔ Gastrointestinal fungal infection ✔ Jaundice (yellowing of the skin and the whites of the eyes) Blood disorders (reduced number of cells in the blood, low blood sodium) ✔ Sore joints and muscles ✔ Muscular weakness ✔ Development of breast in males ✔ Sensitivity to sunlight ✔ Severe skin reaction Allergic reaction (such as swelling of tissues, fever, discomfort/tightness in chest and anaphylactic shock) Blurred vision Hallucination ✔ Depression ✔ Confusion and nervousness ✔ Decreased consciousness ✔ Aggression ✔ Disorientation ✔ Stop taking drug and call your doctor or pharmacist MORE INFORMATION This document, plus the full product monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062 or by written request at: 145 Jules-Léger, Boucherville (QC) Canada J4B 7K8 or by e-mail at: [email protected] This leaflet was prepared by Sandoz Canada Inc. ✔ ✔ ✔ ✔ This is not a complete list of side effects. For any unexpected effects while taking Sandoz Omeprazole, contact your doctor or pharmacist. HOW TO STORE IT Remember to keep Sandoz Omeprazole well out of reach of children. Sandoz Omeprazole should be stored between 15 and 30°C, in tightly closed and moisture resistant containers. Do not keep Sandoz Omeprazole in the bathroom medicine cabinet or other warm, moist places. Keep all capsules in their container until it is time for a dose. If you do not, moisture from the air may damage the capsules. Do not use Sandoz Omeprazole after the expiry date indicated on the label. Keep out of reach of children. REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by: Toll-free telephone: 1-866-234-2345 Toll-free fax: 1-866-678-6789 Online: www.healthcanada.gc.ca/medeffect By email: [email protected] By regular mail: Canada Vigilance National Office Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate Health Products and Food Branch Health Canada Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Should you require information related to the management of the side effect, please contact your healthcare provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice. ® Registered trademark used under license by Sandoz Canada Inc. Sandoz Canada Inc. QC, Canada J4B 7K8 [email protected] □ ? 1-800-361-3062 Last Revised: November 18, 2008 1007112 vi