This leaflet is part III of a three-part “Product Monograph”... clotting (warfarin or other vitamin K blockers), for HIV treatment...

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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
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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:
medinfo@sandoz.com
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: CanadaVigilance@hc-sc.gc.ca
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
medinfo@sandoz.com
□
? 1-800-361-3062
Last Revised: November 18, 2008
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