Generic Name: Pantoprazole sodium sesquihydrate
Product Name: Somac Granules (40mg on Prescription)
Somac 40 mg granules are used to treat people who have difficulty swallowing Somac tablets.
They are used to treat the following symptoms and conditions in adults:
- Relieving symptoms and healing gastrointestinal wounds caused by excessive gastric acid productionassociated with:
- Stopping the return of symptoms of reflux oesophagitis in individuals who have previously had moderate to severe symptoms of reflux, but have been successfully treated;
- Eradication of the bacteria Helicobacter pylori. In these cases, antibiotics should also be taken.
Somac granules can also be used to treat children aged 5–17 years, but should not be used for more than 8 weeks. For children, they are used to treat:
- Symptomatic gastro-oesophageal reflux disease (GORD); and
- Reflux oesophagitis.
Somac is available in several different forms. For more information on other available forms, see Somac Tablets (20mg or 40mg on Prescription), Somac Injection and Somac Heartburn Relief (Over-the-Counter).
The active ingredient in Somac 40 mg tablets is pantoprazole, which belongs to a group of medications known as proton pump inhibitors. These medications control an enzyme called H+/K+-ATPase which produces gastric acid in the parietal cells of the stomach. By controlling this enzyme, pantoprazole decreases the amount of acid produced by the stomach. When acid production is controlled, symptoms like acid reflux and stomach lesions caused by excessive acid production are also controlled.
The doctor who prescribed Somac 40 mg granules will tell you how much medication to take and how often.
Take Somac 40 mg granules on an empty stomach, about 30 minutes before a meal. To prepare the granules for consumption, mix them with apple sauce, apple juice, orange juice or water as follows:
- Administration with juice or water:
- Open the sachet of Somac granules.
- Sprinkle the granules into a cup containing 15–30 mL of water or apple or orange juice.
- Drink the solution immediately.
- Rinse the cup with a further 15–30 mL of juice or water to dissolve any remaining granules, and drink the solution again.
- Administration with apple sauce:
- Mix the granules with one teaspoon of apple sauce.
- Consume the mixture within 10 minutes of preparation.
Somac 40 mg granules can also be administered through a gastric tube (i.e. a tube inserted directly into the stomach to feed a patient who is unable to take food by mouth). For patients who are in hospital and feeding with a tube, a doctor may administer Somac 40 mg granules via the tube.
Somac granules should not be used in certain situations. Your doctor will discuss alternatives that will be more suitable for you. Do not take Somac granules if you have:
- Allergies to any of the medication’s components;
- Moderate to severe liver failure;
- Moderate to severe kidney failure;
- Are currently taking atazanavir.
Some circumstances need special consideration before taking Somac granules. Tell your doctor if you have any of the following:
- Significant unintentional weight loss;
- Recurrent vomiting;
- Vomiting blood;
- Black ‘tarry’ stools;
- Suspected or confirmed gastric ulcer;
- Cyanocobalamin (vitamin B12) deficiency or risk of deficiency.
Use in children
The use of Somac granules in children under five years of age has not been studied. Do not give Somac granules to a child under five years of age.
Use in pregnancy
Somac granules are a Pregnancy Category B3 medication. The safety of use during pregnancy has not been established. Somac granules should not be used if you are pregnant or planning to become pregnant.
Use in lactation
Somac granules have not been established as safe for use during lactation. Somac granules should not be used if you are breastfeeding or planning to breastfeed.
Somac 40 mg granules are Schedule 4 – prescription only medication.1
Common side effects
All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on Somac granules.
Common side effects are those which occur in more than 1% of patients given Somac granules. These include:
- Increased sweating;
- Severe belching;
- Constipation or flatulence;
- Dry mouth;
- Upper abdominal pain;
- Metallic taste.
Uncommon side effects
Side effects which occur in less than 1% of patients given Somac granules are considered uncommon. Patients do not necessarily experience any of these side effects, so do not become alarmed by this list:
- Nausea and vomiting;
- Allergic skin reactions, including pruritus and skin rash;
- Blurred vision.
Rare side effects occur in less than 0.1% of patients given Somac granules. These include:
- Anaphylactic reactions including anaphylactic shock and peripheral oedema;
- Rectal disorder;
- Colonic polyp;
- Joint pain;
- Psychiatric disorders, including depression, hallucination, disorientation and confusion. These conditions are particularly likely in patients who have previously experienced psychiatric disorders, and those who are already suffering from a psychiatric disorder may find that their symptoms become worse. Psychiatric disorders are also more common in patients who have an increased risk for these conditions (e.g. patients who have direct relatives who have a psychiatric condition);
Very rare side effects occur in less than 0.01% of people given Somac granules. They include:
- Chest pain;
- Hot flushes;
- Circulatory collapse;
- Reduced movement;
- Speech disorder;
- Faecal discolouration;
- Increased saliva;
- Increased liver enzymes;
- Hepatic failure;
- Cholestatic hepatitis;
- Muscle pain;
- Pain, including skeletal pain;
- Interstitial nephritis;
- Increased bleeding;
- Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Lyell’s syndrome and photosensitivity;
- Changes to sense of smell and taste;
If you experience any of the listed side effects, or any other symptoms which appear abnormal or unusual, please tell your doctor.
- Product Information: Somac. North Ryde, NSW: Nycomed Pty Ltd; 19 February 2009.
For further information talk to your doctor.