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PACKAGE LEAFLET: INFORMATION FOR THE USER LOSEC® MUPS® 20MG TABLETS

(omeprazole magnesium)

The name of your medicine is Losec MUPS 20mg Tablets, but will be referred to as Losec throughout the remainder of this leaflet.

This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Losec is and what it is used for

2.    Before you take Losec

3.    How to take Losec

4.    Possible side effects

5.    How to store Losec

6.    Further information

Losec contains the active substance omeprazole. It belongs to a

group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid that your stomach produces.

Losec is used to treat the following conditions:

In adults:

•    'Gastro-oesophageal reflux disease' (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

•    Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).

•    Ulcers which are infected with bacteria called ‘Helicobacter pylori'. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

•    Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs.

•    Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and > 10 kg

• ‘Gastro-oesophageal reflux disease' (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age • Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Losec

•    If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec.

•    If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).

•    If you are taking a medicine containing nelfinavir (for HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Losec.

Take special care with Losec

Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Losec 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).

•    You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.

•    You have severe liver problems.

If you take Losec on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Taking a proton pump inhibitor like Losec, 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).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Losec can affect the way some medicines work and some medicines can have an effect on Losec.

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

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

•    Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).

•    Digoxin (used to treat heart problems).

•    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 Losec.

•    Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Losec.

•    Rifampicin (used to treat tuberculosis).

•    Atazanavir (used to treat HIV infections).

•    Tacrolimus (in cases of organ transplantation).

•    St John's wort (Hypericum perforatum) (used to treat mild depression).

•    Cilostazol (used to treat intermittent claudication).

•    Saquinavir (used to treat HIV infection).

•    Clopidogrel (used to prevent blood clots (thrombi)).

•    Erlotinib (used to treat cancer).

•    Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your Losec treatment.

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

Taking Losec with food and drink

You can take your tablets with food or on an empty stomach. Pregnancy and breast-feeding

Before taking Losec, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Losec during this time.

Your doctor will decide whether you can take Losec if you are breastfeeding.

Driving and using machines

Losec is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

Important information about some of the ingredients of Losec

Losec contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Losec exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition and how old you are.

The usual doses are given below.

Adults:

To treat symptoms of GORD such as heartburn and acid regurgitation:

•    If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.

•    The usual dose once the gullet has healed is 10 mg once a day.

•    If your gullet has not been damaged, the usual dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

•    The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.

•    If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

•    The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.

•    If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

•    The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

•    The usual dose is 20 mg once a day for 4 to 8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

•    The usual dose is 20 mg once a day.

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

•    The usual dose is 20 mg Losec twice a day for one week.

•    Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

•    The usual dose is 60 mg daily.

•    Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Children:

To treat symptoms of GORD such as heartburn and acid regurgitation:

•    Children over 1 year of age and with a body weight of more than 10 kg may take Losec. The dose for children is based on the child's weight and the doctor will decide the correct dose.

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

•    Children aged over 4 years may take Losec. The dose for children is based on the child's weight and the doctor will decide the correct dose.

•    Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

•    It is recommended that you take your tablets in the morning.

•    You can take your tablets with food or on an empty stomach.

•    Swallow your tablets whole with half a glass 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.

What to do if you or your child have trouble swallowing the tablets

•    If you or your child have trouble swallowing the tablets:

-    Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.

-    Always stir the mixture just before drinking (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.

-    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. Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush them.

If you take more Losec than you should

If you take more Losec than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Losec

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Like all medicines, Losec can cause side effects, although not everybody gets them.

•    An infection called “thrush” which can affect the gut and is caused by a fungus.

•    Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.

•    Hair loss (alopecia).

•    Skin rash on exposure to sunshine.

•    Joint pains (arthralgia) or muscle pains (myalgia).

•    Severe kidney problems (interstitial nephritis).

•    Increased sweating.

•    Inflammation in the gut (leading to diarrhoea).

Very rare side effects

•    Changes in blood count including agranulocytosis (lack of white blood cells)

•    Aggression.

•    Seeing, feeling or hearing things that are not there (hallucinations).

•    Severe liver problems leading to liver failure and inflammation of the brain.

•    Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

•    Muscle weakness.

•    Enlarged breasts in men.

•    Hypomagnesaemia.

Not known

•    If you are on Losec for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Losec may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.