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Consumer Medicine Information
This leaflet answers some common questions about SOMAC. 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 risks of you taking SOMAC against the benefits this medicine is expected to have for you.
Use SOMAC as directed and follow the advice given in the leaflet.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
The name of your medicine is SOMAC. It contains the active ingredient called pantoprazole.
SOMAC is used to treat and help heal duodenal and gastric 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.
These can be caused in part by too much acid being made in the stomach.
Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. When SOMAC is taken with antibiotics the combination therapy will kill the Helicobacter pylori and let your ulcer heal.
SOMAC may also be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (inflammation of the joints).
SOMAC is also used to treat reflux oesophagitis or reflux disease. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus.
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
SOMAC is also used to prevent reflux oesophagitis from coming back.
SOMAC is 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 SOMAC for another reason. Ask your doctor if you have any questions about why SOMAC has been prescribed for you.
SOMAC belongs to a group of medicines called proton pump inhibitors (PPIs).
SOMAC works by decreasing the amount of acid the stomach makes to give relief from the symptoms and allow healing to take place.
There is no evidence that SOMAC is addictive.
This medicine is available only with a doctor’s prescription.
Do not take SOMAC if:
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not take SOMAC if the packaging is torn or shows signs of tampering.
Do not take SOMAC after the expiry date (EXP) printed on the pack has passed.
Do not take SOMAC in combination with antibiotics or any other medicine if:
Do not take SOMAC in combination with atazanavir (an anti-viral medication).
SOMAC should not be given to children under 5 years of age. There is insufficient data concerning the safety and effectiveness of SOMAC in children under 5 years of age.
If you are not sure whether you should start taking SOMAC alone, or SOMAC in combination with antibiotics, talk to your doctor.
You must tell your doctor if:
Your doctor will discuss the risks and benefits of taking SOMAC during pregnancy or while breast-feeding.
If you have not told your doctor about any of the above, tell them before you take SOMAC.
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by SOMAC, or may affect how well it works. These may include medicines used to prevent blood clots (anticoagulants), atazanavir (an anti-viral medication) and medicines whose activity depend on the acidity of the stomach e.g. ketoconazole.
You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
The usual dose is 40 mg per day.
However, if your doctor also prescribes antibiotics in combination with SOMAC for the treatment of duodenal ulcers, the dose of SOMAC is 80 mg per day. The first 40 mg dose should be taken in the morning and the second should be taken before the evening meal for 7 days.
Your doctor will prescribe the dose that is right for you.
In children over 5 years of age the dose of SOMAC for reflux oesophagitis or reflux disease is based on weight and may be 20 mg or 40 mg, depending on the condition being treated. SOMAC should not be taken for longer than 8 weeks.
The dose and frequency of SOMAC that your doctor prescribes for you depends on your medical condition. Your doctor may change the dose as your condition changes.
Swallow your tablets whole with a little water with or without food.
SOMAC 40mg Granules are intended for people who have difficulty swallowing tablets including those who require a nasogastric tube.
If you are using SOMAC 40 mg Granules, take half hour before a meal without chewing or crushing the granules. Take the granules in apple juice, orange juice or water as follows:
You can also take the granules in applesauce as follows:
If you are taking other medicines, like antibiotics, in combination with SOMAC therapy, follow the instructions for the use of each medicine carefully.
Do not crush or chew the tablets or granules. SOMAC tablets and granules have a special coating to protect them from the acidic contents of your stomach. For SOMAC to work effectively, this coating must not be broken.
Your doctor will tell you how long to take your tablets or granules.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor or Poisons Information Centre for advice – the telephone number in Australia is 13 11 26 and in New Zealand is 0800 POISON or 0800 764 766 – or go to Accident and Emergency (Casualty) at your nearest hospital, if you think that you or anyone else may have taken too much SOMAC. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.
Use SOMAC exactly as your doctor has prescribed.
Tell your doctor immediately if you become pregnant while you are taking SOMAC.
Tell all doctors, dentists and pharmacists who are treating you that you are taking SOMAC.
If you take SOMAC for a long period of time, e.g. over 1 year, you will need to see your doctor regularly so that he/she can monitor your condition.
Tell your doctor if you do not feel better while taking SOMAC. Your doctor may recommend further examination.
Do not give SOMAC to anyone else, even if they have the same symptoms as you.
Do not use SOMAC to treat any other complaints unless your doctor tells you to.
Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.
Tell your doctor as soon as possible if you have any problems while taking SOMAC, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet. Like other medicines, SOMAC can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
These are the more common side effects of SOMAC. Some of these side effects may be due to the combination of other medicines you are taking with SOMAC.
Tell your doctor immediately if you notice any of the following:
These may be serious side effects and you may need urgent medical attention. Serious side effects are rare.
Other side effects not listed above may occur in some people. Tell your doctor if you notice anything that is making you feel unwell when you are taking, or soon after you have finished taking SOMAC.
Ask your doctor or pharmacist if you do not understand some of the information in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Keep your tablets in their blister or granules in their sachet pack until it is time to take them. If you take the tablets or granules out of the blister or sachet pack they may not keep well.
Keep SOMAC in a cool dry place where the temperature stays below 25°C.
Do not store SOMAC or any other medicines in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep SOMAC 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 tells you to stop taking SOMAC or if the tablets or granules have passed their expiry date, ask your pharmacist what to do with any tablets or granules that are left over.
SOMAC is available as 20 mg and 40 mg tablets, and 40 mg granules. The tablets and granules have an acid-resistant coating called an enteric coating.
The 20 mg tablets are yellow and oval shaped, marked with ‘P20’ on one side.
The 40 mg tablets are yellow and oval shaped, marked with ‘P40’ on one side.
The 40 mg granules are pale yellowish to dark brownish in colour.
SOMAC 40 mg tablets are available in blister packs of 5 and 30 tablets.
SOMAC 20 mg tablets are available in blister packs of 30 tablets.
SOMAC 40mg granules are available in single aluminium foil sachets in packs of 5 and 30 sachets.
The active ingredient in SOMAC is pantoprazole.
SOMAC 40 mg tablets contain the equivalent of 40 mg pantoprazole and SOMAC 20 mg tablets contain the equivalent of 20 mg pantoprazole.
SOMAC tablets also contain sodium carbonate anhydrous, mannitol, crospovidone, povidone, calcium stearate, hypromellose, titanium dioxide, iron oxide yellow (CI 77492), propylene glycol, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate and printing ink.
SOMAC 40 mg granules contain the equivalent of 40 mg pantoprazole.
SOMAC granules also contain microcrystalline cellulose,
sodium carbonate anhydrous, crospovidone, hypromellose, polysorbate 80, povidone, titanium dioxide, iron oxide yellow
(CI 77492), methacrylic acid copolymer, triethyl citrate, and purified talc.
SOMAC tablets or granules do not contain gluten, lactose, sucrose, tartrazine or other azo dyes.
SOMAC is made by Nycomed GmbH, Germany and supplied in Australia by:
Nycomed Pty Ltd
2-4 Lyonpark Road
North Ryde NSW 2113 Australia
For medical enquiries, call (AUST) 1800 675 957
40 mg - AUST R 69792
20 mg - AUST R 70829
40 mg – AUST R 148005
® Registered trademark of Nycomed GmbH.
This leaflet was revised in February 2009.
Published by MIMS/myDr June 2009