Esomeprazol

• For heartburn
• For acid reflux and stomach ulcers
• Swallow tablet whole
• Not suitable for children under 12 years of age

Esomeprazole is a stomach acid inhibitor. This medicine acts in the stomach to decrease the production of stomach acid to relieve stomach problems such as acid reflux.

Esomeprazole is used to treat:

• Gastro-oesophageal reflux disease (GORD).
• Ulcers in the stomach or upper part of the gut (intestine) caused by bacteria or the use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).

Always take this medicine exactly as your doctor has told you. The general guidelines for use are:

• Esomeprazole can be taken with or without food.
• The tablets should be taken with a drink of water.
• Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach.
• People who have difficulty swallowing can disperse the tablets in half a glass of water. Wait for the tablet to dissolve completely. Drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it. The solid pieces contain the medicine – do not chew or crush them.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general guidelines for use are listed below.

Adults and adolescents aged 12 years and above

To treat gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your food pipe (oesophagus) has been slightly damaged, the recommended dose is one 40-mg tablet once a day for four weeks. Your doctor may tell you to take the same dose for a further four weeks if your gullet has not yet healed.
• The recommended dose once the oesophagus has healed is one 20-mg tablet once a day.
• If your oesophagus has not been damaged, the recommended dose is one 20-mg tablet once a day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20-mg tablet a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

• The recommended dose is one Esomeprazole 20-mg tablet twice a day for one week. Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs:

• Adults aged 18 and above: the recommended dose is one Esomeprazole 20-mg tablet once a day for four to eight weeks.

To prevent stomach ulcers if you are taking NSAIDs:

• Adults aged 18 and above: the recommended dose is one Esomeprazole 20-mg tablet, once a day.

For more information on the dosage, see the package leaflet.

Alcohol/driving

This medicine does not interact with alcohol or impair your ability to drive safely.

If you take more Esomeprazole than you should or miss a dose

If you take more Esomeprazole tablets than you were told to, consult your doctor or pharmacist.

If you forget to take your dose on time, you may take it as soon as you remember to, unless it is almost time for your next scheduled dose. Do not take a double dose to make up for a forgotten dose.

Esomeprazole is not suitable for everyone. Do not use this medicine if:

• You are allergic to esomeprazole or any of the other ingredients in this medicine, or to the group of medicines called benzimidazoles, which includes other proton pump inhibitor medicines (e.g., omeprazole, pantoprazole or lansoprazole).
• You are taking a medicine containing nelfinavir (used to treat HIV infection).

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking this medicine if:

• You have severe liver or kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esomeprazole.
• You are due to have a specific blood test (Chromogranin A).

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole. Remember to also mention any other ill-effects like pain in your joints.

Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking this medicine or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).

If you have been prescribed Esomeprazole on an as-needed basis, you should contact your doctor if your symptoms continue or change in character.

Taking Esomeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Pregnancy and breastfeeding

Consult a doctor on the use of Esomeprazole if you are pregnant.

You should not take Esomeprazole if you are breastfeeding.

Other medicines and Esomeprazole

Esomeprazole may interact with some medicines.

• Do not take Esomeprazole if you are taking a medicine containing nelfinavir (used to treat HIV).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain caused by an insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Esomeprazole treatment.
• Tacrolimus (used to reduce the immune response, helping to prevent rejection of organ transplant).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Esomeprazole include:

Common (may affect up to 1 in 10 people):

• Headache.
• Stomach or intestinal problems.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as pins and needles, feeling sleepy.
• Spinning feeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, urticaria and itchy skin.
• Fracture of the hip, wrist or spine (if Esomeprazole is used in high doses and over long duration).

See the package leaflet for a complete list of side effects. Consult a doctor if you experience side effects, also if the side effects are not listed on the package leaflet. Get emergency medical help if you have signs of a severe allergic reaction (see the package leaflet).

The active substance in Esomeprazole Apotex 20/40 mg gastro-resistant tablets is esomeprazole. Each tablet contains 20 mg or 40 mg esomeprazole (as magnesium dihydrate). The other ingredients are:

• Tablet core: mannitol (E421), microcrystalline cellulose, sodium laurilsulfate, hydroxypropyl cellulose, talc (E553b), metacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, propylene glycol, triethyl citrate, polysorbate 80, glycerol monostearate 40-55, colloidal anhydrous, hypromellose, magnesium stearate, calcium hydrogen phosphate dihydrate, crospovidone.
• Τablet coating: hypromellose 15cP (E464), titanium dioxide (E171), polydextrose, talc, medium-chain triglycerides, iron oxide yellow (E172), iron oxide red (E172).

The manufacturer Esomeprazole Apotex 20/40 mg gastro-resistant tablets is:

Apotex Europe B.V. Archimedesweg 2
2333 CN Leiden
The Netherlands

Read the package leaflet before use. The official package leaflet of Esomeprazole Apotex 20/40 mg gastro-resistant tablets is available for download here.