Somac Consumer Medicine Information

Pantoprazole sodium sesquihydrate

20mg and 40mg tablets

What is in this leaflet

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 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 need to read it again.

What Somac is used for

Ulcers

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.

Your doctor may also prescribe a course of antibiotics for you. 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 can also be used to prevent ulcers in patients taking certain pain medicines called non-steroidal anti-inflammatory drugs.

Reflux disease

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.

Zollinger-Ellison syndrome

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.

How Somac works

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.

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.

There is no evidence that Somac is addictive.

This medicine is available only with a doctor's prescription.

Before you take Somac

When you must not take it

Do not take Somac if:

  1. you have an allergy to:
    • Somac
    • Any of the ingredients listed at the end of this leaflet
    Symptoms of an allergic reaction include itchiness and rash, swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.
  2. you have severe liver disease or cirrhosis

Do not take Somac if the packaging is torn or shows signs of tampering.

Do not take Somac after the expiry date, printed on the pack, has passed.

Do not take Somac in combination with antibiotics if:

  • you are allergic to any of the antibiotics your doctor may prescribe with Somac
  • you have severe liver or kidney disease

If you are not sure whether you should start taking Somac or Somac in combination with antibiotics, talk to your doctor.

Before you start to take it

You must tell your doctor if

  • you intend to become pregnant or intend to breastfeed.

Taking other medicines

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 drugs whose activity depends 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.

How to take Somac

How much to take

Depending on your medical condition, the usual dose is one 20mg or one 40mg tablet each day. However, if your doctor also prescribes antibiotics with Somac, the dose of Somac is two 40mg tablets per day, morning and evening with or without food for 7 days.

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.

How and when to take it

Swallow your tablets whole with a little water with or without food.

If you are taking antibiotics in combination with Somac therapy, follow the instructions for the use of each drug carefully.

Do not crush or chew the tablets. Somac tablets 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.

How long to take it

Your doctor will tell you how long to take your tablets.

If you forget to take it

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.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (telephone 03 474 7000 ) for advice, 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.

While you are taking Somac

Things you must do

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.

Things you must not do

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.

Side effects

Check with 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 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 to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • headache
  • diarrhoea
  • skin problems such as itchiness and rash
  • nausea
  • stomach pain
  • excessive gas in the stomach or bowel
  • dizziness
  • swelling of the legs
  • fever
  • depression
  • blurred vision
  • muscle pain

Other side effects not listed above may occur in some people. Tell your doctor if you notice anything 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 anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Somac

Storage

Keep your tablets in their blister pack or bottle until it is time to take them. If you take the tablet out of the blister pack or bottle they may not keep well.

Keep Somac tablets in a cool dry place where the temperature stays below 30C.

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.

Disposal

If your doctor tells you to stop taking Somac or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Somac is available as a 20mg and 40mg tablet. The tablets are yellow and oval shaped and have an acid-resistant coating called an enteric coating.

Somac 20mg tablets are available in blister packs of 30 tablets.
Somac 40mg tablets are available in blister packs of 30 tablets.

Ingredients

The active ingredient in Somac tablets is pantoprazole sodium sesquihydrate. Somac 20mg tablets contain the equivalent of 20mg of pantoprazole and the 40mg tablets contain the equivalent of 40mg of pantoprazole.

Somac tablets also contain sodium carbonate, mannitol, crospovidone, povidone, calcium stearate, hypromellose, titanium dioxide, iron oxide yellow (CI 77492), propylene glycol, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulphate and triethyl citrate.

Somac tablets do not contain gluten, lactose, sucrose, tartrazine or other azo dyes.

This leaflet was prepared in June 2002