Somac Tablets (20mg or 40mg on Prescription)

Generic Name: Pantoprazole
Product Name: Somac Tablets (20mg or 40mg on Prescription)

Indication

Somac tablets are used to treat the following symptoms and conditions in adults:

1. Relieving symptoms and healing gastrointestinal wounds caused by excessive gastric acid productionassociated with:
   • Duodenal ulcer;
   • Gastric ulcer;
   • Reflux oesophagitis;
   • Gastrointestinal lesions which have been treated with H₂ receptor antagonist medication, but which have failed to heal;
   • Zollinger-Ellison syndrome.
2. Stopping the return of symptoms of reflux oesophagitis in individuals who have previously had moderate–severe symptoms of reflux, but have been successfully treated;
3. Eradication ofthe bacteria Helicobacter pylori. In these cases, antibiotics should also be taken;
4. Relief of symptoms of gastro-oesophageal reflux disease (GORD);
5. Prevention of gastrointestinal lesions and dyspepsia caused by long term treatment with non-selective non-steroidal anti-inflammatory drugs (NSAIDs).

Somac tablets can also be used to treat children older than five years of age, but should not be used for more than 8 weeks. For children, Somac tablets are used to treat:

1. Symptomatic GORD; and
2. Reflux oesophagitis.

Somac is available in several different forms. For more information on other available forms, see Somac Granules (40mg on Prescription), Somac Injection and Somac Heartburn Relief (Over-the-Counter).

Action

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.

Dose advice

Dose information

The doctor who prescribed Somac tablets will tell you how much medication to take and how often.

Somac tablets should be swallowed whole. They should not be crushed or chewed.

Contraindications

Somac tablets should not be taken in certain situations. Your doctor will discuss alternatives that will be more suitable for you. Do not take Somac tablets if you have:

• Allergies to any of the medication’s components;
• Cirrhosis;
• Moderate to severe liver failure;
• Moderate to severe kidney failure;
• Are currently taking atazanavir.

Precautions

Some circumstances need special consideration before taking Somac tablets. Tell your doctor if you have any of the following:

• Significant unintentional weight loss;
• Recurrent vomiting;
• Difficulty swallowing;
• Vomiting blood;
• Anaemia;
• Black ‘tarry’ stools;
• Suspected or confirmed gastric ulcer;
• Cyanocobalamin (vitamin B12) deficiency or risk of deficiency.

Use in children

The use of Somac tablets in children under five years of age has not been studied. Do not give Somac tablets to a child under five years of age.

Use in pregnancy

Somac tablets are a Pregnancy Category B3 medication. The safety of use during pregnancy has not been established. Somac tablets should not be used if you are pregnant or planning to become pregnant.

Use while breastfeeding

Somac tablets should not be used if you are breastfeeding or planning to breastfeed.

Schedule

Somac tablets 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 tablets.

Common side effects are those which occur in more than 1% of patients given Somac tablets. These include:

• Fatigue;
• Asthenia;
• Increased sweating;
• Headache;
• Diarrhoea;
• 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 tablets are considered uncommon. Patients do not necessarily experience any of these side effects, so do not become alarmed by this list:

• Dizziness;
• 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 tablets. These include:

• Fever;
• Anaphylactic reactions including anaphylactic shock and peripheral oedema;
• Hypertension;
• 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);
• Anaemia;
• Sepsis.

Very rare side effects occur in less than 0.01% of people given Somac tablets. They include:

• Chest pain;
• Hot flushes;
• Circulatory collapse;
• Reduced movement;
• Speech disorder;
• Faecal discolouration;
• Increased saliva;
• Tinnitus;
• Increased liver enzymes;
• Hepatic failure;
• Cholestatic hepatitis;
• Bilirubinaemia;
• Jaundice;
• Hypertriglyceridaemia;
• Muscle pain;
• Pain, including skeletal pain;
• Interstitial nephritis;
• Thrombocytopaenia;
• Increased bleeding;
• Anxiety;
• Leukopaenia;
• Breathlessness;
• Angioedema;
• Urticaria;
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Lyell’s syndrome and photosensitivity;
• Changes to sense of smell and taste;
• Flushing;
• Conjunctivitis.

If you experience any of the listed side effects, or any other symptoms which appear abnormal or unusual, please tell your doctor.

References

1. Product Information: Somac. North Ryde, NSW: Nycomed Pty Ltd; 19 February 2009.
2. Pantoprazole [online]. Adelaide, SA: Australian Medicines Handbook; July 2009 [cited 24 April 2009]. Available from: [URL Link]

For further information talk to your doctor.