Peptimep 20 g Tablets

PEPTIMEP contains esomeprazole, which is part of a group of medicines called proton pump inhibitors, which reduces the amount of acid produced in your stomach. PEPTIMEP is used to treat the following conditions:

• Gastro-oesophageal reflux disease (GORD): A condition where acid from your stomach escapes into the oesophagus (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. PEPTIMEP is also used in the long term, after your oesophagus has healed, to prevent relapse.
• Stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). PEPTIMEP can also be used to stop such stomach ulcers from forming if you are taking NSAIDs.
• Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called Helicobacter pylori. Your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. PEPTIMEP is also used to prevent relapse of such ulcers.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison Syndrome).

Do not take PEPTIMEP:

• If you are hypersensitive (allergic) to esomeprazole, substituted benzimidazoles or any of the other ingredients of PEPTIMEP (see section 6).
• If you are taking medicines containing atazanavir and nelfinavir (used to treat HIV infection).

Warnings and Precautions

Take special care with PEPTIMEP:

• If you suddenly lose weight, are vomiting regularly, experience heartburn, have blood in your faeces or if you are vomiting blood, as further tests are required to eliminate the possibility of cancer before you start taking PEPTIMEP.
• If you have a liver problem. You should discuss this with your doctor, as he/she may wish to reduce the dose.
• Inflammation of the kidneys has been observed in patients taking proton pump inhibitors such as PEPTIMEP which, if not treated correctly, could lead to kidney failure. Your doctor will monitor your kidney function and regularly check your urine for the presence of blood or proteins. Tell you doctor if you notice that you are producing less urine than usual, or if you think there is blood in your urine.
• You may experience diarrhoea or stomach problems while taking PEPTIMEP.
• False-negative results may occur if you are having a urea breath test done to test for a stomach infection caused by a bacteria known as Helicobacter pylori.
• You may experience an increase in gastrointestinal bacterial infections because PEPTIMEP reduces the acidity of your stomach.
• If you are taking vitamin B12 and minerals, since PEPTIMEP may reduce their absorption into your body. This should be considered if you have reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.
• If you are taking PEPTIMEP regularly, you may have an increased risk of getting bone fractures, and certain types of infections, such as pneumonia (lung infection) and infection with a bacteria called Clostridium difficile which causes diarrhoea.
• If you are taking warfarin (a medicine used to thin your blood), your doctor should regularly monitor your blood clotting levels.
• If you have been prescribed PEPTIMEP “on demand” you should contact your doctor if your symptoms continue or change in character.
• If you are taking PEPTIMEP for long periods of time, or if you are also taking digoxin (used for various heart conditions) or water tablets (diuretics), you may experience symptoms such as tiredness, muscle spasms, confusion, fits/seizures, dizziness and changes in the way your heart beats, due to a condition known as hypomagnesaemia (very low levels of magnesium in your blood). Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor should regularly monitor your magnesium levels while taking PEPTIMEP.
• If you are taking clopidogrel (an antiplatelet medicine used to reduce the risk of heart disease and stroke in those at high risk).
• If you get a lesion (ulcer or abscess) 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 PEPTIMEP. You should also mention any other ill-effect like pain in your joints.
• If you are due to have a specific blood test (Chromogranin A) since PEPTIMEP may interfere with the test results.

Children and adolescents

The safety and efficacy of PEPTIMEP in children younger than 12 years of age has not been established.

Other medicines and PEPTIMEP

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). The following medicines may cause an interaction when used in combination with PEPTIMEP:

• Do not take PEPTIMEP if you are taking atazanavir or nelfinavir (used to treat HIV infection) (see Do not take PEPTIMEP).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat certain types of cancer).
• Saquinavir (used to treat HIV infection).
• Diazepam (used to treat anxiety, panic attacks, muscle spasms or seizures).
• Citalopram, imipramine, clomipramine or St. John’s wort (used to treat depression).
• Phenytoin (used to treat epilepsy (fits/seizures)). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking PEPTIMEP.
• Warfarin (used to thin your blood). Your doctor will need to monitor you when you start or stop taking PEPTIMEP.
• Digoxin (used to treat heart problems).
• Clarithromycin or rifampicin and amoxicillin (used in the treatment of bacterial infections) as well as PEPTIMEP to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
• Rifampicin (medicine used to treat tuberculosis).
• Methotrexate (used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis). If you are taking a high dose of methotrexate, your doctor may temporarily stop your PEPTIMEP treatment.
• Tacrolimus (used as an immunosuppressant to enable your body to accept a transplanted organ).
• Clopidogrel (an antiplatelet medicine used to reduce the risk of heart disease and stroke in patients at high risk).
• Cilostazol (medicines used for intermittent claudication, a condition where leg pain is caused by poor circulation).
• Cisapride (medicines used for indigestion, heartburn and to speed up stomach emptying).

Do not share medicines prescribed for you with any other person. Always take PEPTIMEP exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.

Swallow your tablets whole 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. It is important not to damage the pellets. If you have trouble swallowing the tablets, put them into a glass of still (non-fizzy) water. Do not use any other liquids. Stir until the tablets break up (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking it. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them. If you cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Use in adults:

To treat heartburn caused by gastro-oesophageal reflux disease (GORD): The usual dose is 40 mg once daily for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet (food pipe) has not yet healed. The usual dose is 20 mg once daily to prevent a relapse after your gullet has healed. If your gullet has not yet been damaged, the usual dose is 20 mg once daily. Once the condition is under control, your doctor may tell you to take your PEPTIMEP tablets as and when you need it.

To prevent stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs): The usual dose is 20 mg or 40 mg once daily.

To treat ulcers caused by Helicobacter pylori infection and to stop them from coming back: The usual dose is 20 mg twice daily (every 12 hours) for 7 days. Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin for you to take with your PEPTIMEP.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome): The usual dose is 40 mg twice a day. Your doctor will adjust the dose depending on your needs and will also decide how long you need to take PEPTIMEP.

Use in adolescents aged 12 – 18 years:

To treat heartburn caused by gastro-oesophageal reflux disease (GORD): If your doctor has found that your gullet (food pipe) has been damaged, the usual dose is 40 mg once a day for 4 weeks. If your symptoms have not resolved and your gullet has not yet healed, your doctor may tell you to take the same dose for a further 4 weeks. The usual dose once your gullet has healed is 20 mg once a day to prevent a relapse. If your gullet has not been damaged, the usual dose is 20 mg once a day. If your symptoms have not resolved within 4 weeks of taking PEPTIMEP, you should consult your doctor to discuss further treatment options. If you have severe liver problems, your doctor may give you a lower dose.

If you have the impression that the effect of PEPTIMEP is too strong or too weak, tell your doctor or pharmacist.

Children

PEPTIMEP is not recommended for children less than 12 years old.

If you take more PEPTIMEP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and the rest of the remaining tablets with you so the doctor will know what you have taken.

If you forget to take PEPTIMEP

If you have missed your dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take PEPTIMEP at the next regularly scheduled time. Do not take a double dose to make up for forgotten individual doses.

PEPTIMEP can have side effects. Not all side effects reported for PEPTIMEP are included in this leaflet. Should your general health worsens, or if you experience any untoward effects while taking PEPTIMEP, please consult your healthcare provider for advice.

If any of the following happens, stop taking PEPTIMEP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to PEPTIMEP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Dangerously low levels of white blood cells, red blood cells or blood platelets when your blood is tested, which can cause you to feel ill and be at high risk of infection.
• Yellowing of your skin and whites of the eyes, also called hepatitis or jaundice, due to liver problems.
• Angina (chest pains)
• Changes in the way your heart beats (beating slower or faster than normal)
• Pancreatitis (causing pain in the stomach area radiating to your back, nausea, vomiting, fever, high blood pressure and fast heartbeat)
• Toxins affecting your brain due to liver failure (causing drowsiness, confusion, lack of concentration, changes in your personality or coma)
• Severe skin disorders causing peeling and blistering skin rashes, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) and subacute cutaneous lupus erythematosus (SCLE)
• Kidney problems (you may notice a decrease in urine, blood in urine or experience water retention), inflammation of your kidneys (which could lead to kidney failure).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Stomach pain, nausea (feeling sick), vomiting (being sick), diarrhoea, constipation, gas or indigestion
• Rash.

Less frequent side effects:

• Unusual bruising or bleeding
• Difficulty sleeping (insomnia)
• Drowsiness
• Feeling agitated, confused, depressed or aggressive
• Sensing or seeing things that are not real (hallucinations)
• Dizziness
• Tingling, burning or numb sensation of your skin
• Blurred vision or problems with your eyes
• Ringing sound in your ears (tinnitus)
• A spinning or whirling sensation (vertigo)
• Lung infections, sinusitis (blocked or runny nose) or coughing
• Dry mouth or taste disturbances
• Inflammation (redness and swelling) inside your mouth, on your cheeks, under your tongue or on your palate
• Stomach polyps (masses of cells on the lining of your stomach). Symptoms may include pain or tenderness when you press your stomach, nausea, blood in stool
• Overgrowth of fungi in your stomach (causing stomach pain, nausea, vomiting, fever and chills)
• Increases in the amount of liver enzymes in your blood when tests are done
• Itchy, dry skin, or a rash on swollen, reddened skin, sensitivity of your skin to light
• Hives or blistering of the skin
• Increased sweating
• Hair loss
• Joint pain, back pain or muscle pain
• Muscle weakness
• Fracture of the hip, wrist or spine
• Enlargement of breast tissues in men
• Impotence (difficulty to get or maintain an erection)
• Fever
• Swelling of the hands, feet or ankles due to fluid build-up (peripheral oedema)
• General feeling of discomfort or tiredness
• Too little sodium in your blood (causing headache, confusion, seizures, weakness or restlessness)
• Too little magnesium in your blood (causing changes in your heartbeat, high blood pressure, tremor, jerking, seizures or hallucinations). Low blood magnesium may result in low blood calcium and/or low blood potassium.

Side effects of unknown frequency:

Inflammation of the colon (large intestine) that can cause watery diarrhoea and cramping. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store at or below 25 °C.
• Store in the original package in order to protect from light and moisture.
• Keep the blister strips in the outer carton until required for use.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the label or the carton.
• Return all unused tablets to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems.