NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
OMEPRAZOLE WINTHROP® 20MG
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Omeprazole Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of you taking Omeprazole Winthrop against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What Omeprazole Winthrop is used for
The name of your medicine is Omeprazole Winthrop. It contains the active ingredient omeprazole.
Omeprazole Winthrop is used to treat the following conditions:
Omeprazole Winthrop is used to treat reflux oesophagitis (reflux disease) and to help stop it coming back or relapsing. Reflux can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause heartburn, a burning sensation in the chest rising up to the throat.
Treatment and prevention of peptic ulcers
Omeprazole Winthrop is used to help heal peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. This can be caused in part by too much acid being made in the stomach. Omeprazole Winthrop is also used to help stop gastric and duodenal ulcers from coming back.
Combination therapy for the treatment of peptic ulcers associated with Helicobacter pylori infection
Helicobacter pylori is a bacteria that often occurs in the stomach together with peptic ulcers. It is important to kill Helicobacter pylori to let your peptic ulcer heal. Omeprazole Winthrop is usually combined with two antibiotics to help kill this bacteria. However, it is possible that the antibiotics might not always be able to kill Helicobacter pylori.
Treatment and prevention of peptic ulcers associated with non-steroidal anti inflammatory drugs (NSAIDs)
Non-steroidal anti-inflammatory drugs are used to relieve pain, swelling and other symptoms of inflammation, including arthritis and joint pain. Some peptic ulcers are caused by taking these NSAIDs. Omeprazole Winthrop is used to treat and help prevent ulcers developing which are associated with long term NSAID use.
Omeprazole Winthrop is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.
Your doctor may have prescribed Omeprazole Winthrop for another reason.
Ask your doctor if you have any questions about why Omeprazole Winthrop was prescribed for you.
How Omeprazole Winthrop works
Omeprazole Winthrop belongs to a group of medicines called proton pump inhibitors (PPIs).
It works by decreasing the amount of acid made by the stomach, to give relief from symptoms and allow healing to take place. This does not stop food being digested in the normal way.
There is no evidence that Omeprazole Winthrop is addictive.
Before you take it
When you must not take it
Do not take Omeprazole Winthrop if:
you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description
Symptoms of an allergic reaction may include skin rash, fever, wheezing or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
it is past its expiry date or the packaging appears to have been tampered with
you are pregnant or breastfeeding, unless permitted by your doctor
It is not yet known if it is safe for you to take Omeprazole Winthrop while you are pregnant. It may affect your developing baby. It is also not yet known if Omeprazole Winthrop passes into breast milk if you are breastfeeding.
Ask your doctor about the risks and benefits involved in taking Omeprazole Winthrop while pregnant or breastfeeding.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any other medicines, especially if they are in the same drug class as omeprazole (proton pump inhibitors) eg esomeprazole, lansoprazole, pantoprazole and rabeprazole
any other substances, including foods, preservatives or dyes
Also tell your doctor if you have or have had any problems with your liver or any other medical conditions.
Taking other medicines
Do not take Omeprazole Winthrop if you are taking the following medicine:
cilostazol, a medicine used to treat intermittent claudication.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you take any of the following:
clarithromycin (Klacid), used to treat bacterial infections
diazepam (Valium), used as sedative or to treat anxiety
ketoconazole (Nizoral), itraconazole (Sporanox) or voriconazole (Vfend), used to treat fungal infections
phenytoin (Dilantin), used to treat epilepsy or fits
atazanavir (Reyataz) and nelfinavir (Viracept), used to treat viral infections such as HIV
erlotinib or related medicines used to treat cancer
tacrolimus (Prograf), used as immunosuppressant, adjunct to liver or kidney transplantation
St. John’s wort, used to treat anxiety, stress, nervous tension and some other conditions
warfarin (Coumadin, Marevan) and clopidogrel (Plavix), used to prevent blood clots
These medicines may be affected by Omeprazole Winthrop, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
How to take it
The dosage recommendation and duration of treatment will be determined for your specific condition by your doctor.
Follow your doctor’s instructions about how and when to take Omeprazole Winthrop carefully.
They may differ from the information contained in this leaflet.
For adults, the usual dose is one Omeprazole Winthrop tablet (20mg omeprazole) per day. The dose may vary from 10mg to 40mg a day depending on the condition you are being treated for and how severe it is.
For children (one year or older), the dose depends on the body weight. For children 10kg to 20kg, the dose is 10mg omeprazole per day. This dose may be increased to 20mg if required. For children more than 20kg the dose is 20mg per day. This dose may be increased to 40mg if required.
Omeprazole Winthrop tablets must be SWALLOWED WHOLE with a glass of water. IF THE TABLETS ARE BROKEN, CRUSHED OR CHEWED, THEY WILL NOT WORK PROPERLY.
Take Omeprazole Winthrop at the same time each day. It can be taken with or without food.
A 10mg dose is not available from this brand. For any 10mg doses that may be required, alternative brands are available.
Symptoms will be relieved rapidly in most patients, and healing usually takes place within four weeks.
If your symptoms return, tell your doctor. If you have been treated for Helicobacter pylori, the antibiotics might not have killed the bacteria, and you will have to be treated again.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
Do not take a double dose to make up for the dose you have missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for hints.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Omeprazole Winthrop.
Do this even if there are no signs of discomfort or poisoning.
Symptoms of overdosage may include nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache.
While you are taking it
Things you must do
Always follow your doctor’s instructions carefully.
Tell your doctor if you become pregnant while taking Omeprazole Winthrop.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Omeprazole Winthrop.
Things you must not do
Do not stop taking Omeprazole Winthrop without your doctor’s permission.
Do not use Omeprazole Winthrop to treat any other complaint unless your doctor says so.
Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Omeprazole Winthrop affects you.
Things that may help your condition
Some self-help measures suggested below may help your condition.
Talk to your doctor or pharmacist about these measures and for more information.
your doctor may advise you to limit your alcohol intake.
Aspirin and similar medicines used to treat arthritis, period pain or headaches –
these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist can suggest other medicines you can take.
your doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach.
Eating habits –
eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
your doctor may advise you to stop smoking or at least cut down.
if you are overweight, your doctor may suggest losing some weight to help your condition.
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Omeprazole Winthrop.
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
These are the more common side effects of Omeprazole Winthrop. Mostly, these are mild and short-lived.
Tell your doctor immediately if you notice any of the following:
changes in sleep patterns
frequent signs of infection such as fever, severe chills, sore throat or mouth ulcers
increased bruising, or bleeding more easily than normal
increase in breast size (males)
agitation, confusion, mood changes or hallucinations
muscle pain or weakness, joint pain
sleepiness or drowsiness
“pins and needles” (tingling or numbness) in the hands or feet
signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite.
These may be serious side effects of Omeprazole Winthrop. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, stop taking Omeprazole Winthrop and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
swelling of the limbs, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, itchy rash or hives.
These are the symptoms of an allergic reaction.
redness, blistering and peeling of the skin, accompanied by fever, chills and aching muscles
ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that is making you fell unwell.
Other side effects not listed above may also occur in some people.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor if you notice any other effects.
Some health problems or complications may arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
ongoing stomach pain or indigestion during treatment with Omeprazole Winthrop
passing black or blood-stained motions
vomiting blood or food
unexpected weight loss
Ask your doctor or pharmacist to answer any questions you may have.
After taking it
Keep Omeprazole Winthrop in the original packaging until you need to take it.
If you take the tablets out of the box or the blister pack they may not keep well.
Keep the medicine in a cool, dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or in a windowsill.
Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking Omeprazole Winthrop, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.
Return any unused or out of date medicine to your pharmacist.
What it looks like
Omeprazole Winthrop 20mg: White round tablets. Available in blisters of 30 tablets.
Each Omeprazole Winthrop tablet contains 20mg of omeprazole.
Each Omeprazole Winthrop tablet also contains arginine, betadex, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer, triethyl citrate, purified talc, lactose, hypromellose, titanium dioxide and macrogol 4000.
Omeprazole Winthrop is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No.: 1800 818 806
Omeprazole Winthrop is supplied in New Zealand by:
sanofi-aventis new zealand limited
Auckland, New Zealand
Freecall No.: 0800 283 684
This leaflet was prepared in October 2012.
Australian Register Number(s)
Omeprazole Winthrop 20mg enteric-coated tablets: AUST R 117205
® Registered Trademark
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