ANVERSO:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole 15 mg gastro-resistant capsules Lansoprazole 30 mg gastro-resistant capsules

(Lansoprazole)

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, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Lansoprazole gastro-resistant capsules are and what they are used fori

2.    Before you take Lansoprazole gastro-resistant capsules

3.    How to take Lansoprazole gastro-resistant capsules

4.    Possible side effects

5.    How to store Lansoprazole gastro-resistant capsules

6.    Further information

1.    WHAT LANSOPRAZOLE GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR

The active ingredient in Lansoprazole gastro-resistant capsules is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.

Your doctor may prescribe this medicine for the following indications:

-    Treatment of duodenal and stomach ulcer

-    Treatment of inflammation in your oesophagus (reflux oesophagitis)

-    Prevention of reflux oesophagitis

-    Treatment of heartburn and acid regurgitation

-    Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy

-    Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID (Non-Steroidal Anti-inflammatory Drugs) treatment (NSAlD treatment is used against pain or inflammation)

-    Treatment of Zollinger-Ellison syndrome.

2.    BEFORE YOU TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES Do not take Lansoprazole gastro-resistant capsules:

-    if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this medicine (see section 6 Further information)

-    if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Take special care with Lansoprazole gastro-resistant capsules

Please tell your doctor if you have serious liver disease. The doctor may have to adjust your dosage.

Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.

If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as this medicine has been associated with a small increase in infectious diarrhoea.

If your doctor has given you this medicine in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat ' your pain or rheumatic disease: please also read the package leaflets of these medicines carefully.

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

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular tell your doctor if you are taking medicines containing any of the following active substances as Lansoprazole may affect the way these drugs work:

-    ketoconazole, itraconazole, rifampicin (used to treat infections)

-    digoxin (used to treat heart problems)

-    theophylline (used to treat asthma)

-    tacrolimus (used to prevent transplant rejection)

-    fluvoxamine (used to treat depression and other psychiatric diseases)

-    antacids (used to treat heartburn or acid regurgitation)

-    sucralfate (used for healing ulcers)

-    St John's wort (Hypericum perforatum) (used to treat mild depression) Taking Lansoprazole gastro-resistant capsules with food and drink

For the best results from your medicines you should take Lansoprazole gastro-resistant capsules at least 30 minutes before food.

Pregnancy and breast-feeding

This medicine is not recommended during pregnancy. It is thought that Lansoprazole may cross into breast milk and therefore your doctor will consider the benefits of breast feeding your baby against continuing treatment with Lansoprazole capsules. Please speak to your doctor for further advice if you are pregnant, become pregnant or wish to breastfeed your baby if you are taking this medicine

Driving and using machines

Side effects such as dizziness, vertigo, tiredness and problems with vision sometimes occur in patients taking Lasoprazole capsules. If you are affected, you must not drive or operate machinery, as your ability to react may be decreased. Please discuss with your doctor or pharmacist if you are unsure about anything.

Important information about some of the ingredients of Lansoprazole gastro-resistant capsules

Lansoprazole gastro-resistant capsules contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES

Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine. Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly.

If you are taking this medicine once a day, try to take it at the same time each day. You may get best results if you take this medicine first thing in the morning.

If you are taking this medicine twice a day, you should have the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole gastro-resistant capsules depends on your condition. The usual doses for adults are given below. Your doctor will sometimes prescribe you a different to those stated below. Please check with your doctor or pharmacist if you are unsure about the dose.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor.

Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks Treatment of stomach ulcer: one 30 mg capsule every day for 4 weeks

Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks

Long-term prevention of reflux oesophagitis: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.

Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days.

The recommended combinations of antibiotics are:

-    30 mg Lansoprazole gastro-resistant capsules together with 250-500 mg clarithromycin and 1000 mg amoxicillin

-    30 mg Lansoprazole gastro-resistant capsules together with 250 mg clarithromycin and 400500 mg metronidazole

If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose.

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment:

one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment:

one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.

Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules every day to start with, then depending on how you respond to Lansoprazole the dose that your doctor decides is best for you.

This medicine should not be given to children, especially in children below one year of age.

Take your medicine exactly as your doctor has told you. You should check with your doctor if you are not sure how to take your medicine.

If you take more Lansoprazole gastro-resistant capsules than prescribed

If you take more Lansoprazole gastro-resistant capsules than you have been told to, seek medical advice quickly

If you forget to take Lansoprazole gastro-resistant capsules

If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Lansoprazole gastro-resistant capsules

Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lansoprazole gastro-resistant capsules can cause side effects, although not everybody gets them.

Stop taking lansoprazole and see your doctor or go to a hospital straightaway if you experience any of the following:

-    inflammation of the liver (symptoms include tiredness, fever, yellowing of your skin or whites of your eyes)

-    Severe hypersensitive reactions - symptoms include shock, fever, rash, swelling, fall in blood pressure

-    Angioedema - symptoms include, swelling of hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.

-    severe skin reactions

•    Stevens -Johnson syndrome - symptoms include blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms, high temperature)

•    toxic epidermal necrolysis (symptoms include, severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body & urticaria-nettle rash)

-    reduction in white blood cells (symptoms include - fevers and frequent infections)

Taking a proton pump inhibitor like Lansoprazole, 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).

The following side effects are common (occur in more than 1 in 100 patients):

-    headache, dizziness

-    diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat

-    skin rash, itching

-    changes in liver function test values

-    tiredness.

The following side effects are uncommon (occur in less than 1 in 100 patients):

-    depression

-    joint or muscle pain

-    fluid retention or swelling

-    changes in blood cell counts.

The following side effects are rare (occur in less than 1 in 1000 patients):

-    fever

-    restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo

-    a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)

-    skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating

-    sensitivity to light

-    hair loss

-    feelings of ants creeping over the skin (paresthesiae), trembling

-    anaemia (paleness)

-    kidney problems

-    pancreatitis

-    breast swelling in males, impotence

-    candidiasis (fungal infection, may affect skin or the mucosa)

The following side effects are very rare (occur in less than 1 in 10000 patients):

-    inflammation of your mouth (stomatitis)

-    colitis (bowel inflammation)

-    changes in test values such as sodium, cholesterol and triglyceride levels

-    very rarely Lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).

Frequency not known:

If you are on Lansoprazole 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, 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.

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

5.    HOW TO STORE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES

•    Keep out of the reach and sight of children.

•    Do not store above 25°C. Store in the original package in order to protect from moisture.

•    Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Lansoprazole gastro-resistant capsules contains

-    The active substance is lansoprazole

-    The other ingredients are:

Capsule content: Sugar spheres (sucrose and maize starch), Sodium laurilsulphate, Meglumine, Mannitol (E421), Hypromellose, Macrogol, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Dispersion 30%

Capsule shell: Gelatin, Titanium dioxide (E171)

Capsule shell of 15 mg also contains: Quinoline yellow (E104)

What Lansoprazole gastro-resistant capsules look like and contents of the pack

Lansoprazole 15mg gastro-resistant capsules are opaque yellow cap and body capsules.

Lansoprazole 30mg gastro-resistant capsules are opaque white cap and body capsules.

These gastro-resistant capsules are available in blister packs containing 7, 14, 28, 56 or 98 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:

Bristol Laboratories Limited.

Unit 3, canalside, Northbridge Road Berkhamsted, Herts, HP4 1EG United Kingdom

Telephone: 0044 (0) 1442 200922 Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

The manufacturer is:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara), Spain

Lansoprazole 15mg gastro-resistant capsules; PL 17907/0333 Lansoprazole 30mg gastro-resistant capsules; PL 17907/0334

This leaflet was last revised in May 2012

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.

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