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Lansoprazole 15 mg & 30 mg

gastro-resistant tablets 120 x 520 mm - Times New Roman 9 pt.

LANSOPRAZOLE 15 mg & 30 mg GASTRO-RESISTANT CAPSULES

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 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 Lansoprazole capsules are and what they are used for

2.    Before you take Lansoprazole capsules

3.    How to take Lansoprazole capsules

4.    Possible side effects

5.    How to store Lansoprazole capsules

6.    Further information

1. WHAT LANSOPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR

The active ingredient in Lansoprazole 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 lansoprazole 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 treatment (NSAID treatment is used against pain or inflammation)

-    Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed lansoprazole for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor’s instructions for taking your medicine.

2. BEFORE YOU TAKE LANSOPRAZOLE CAPSULES

Do not take Lansoprazole capsules

-    if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole capsules.

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

Take special care with Lansoprazole 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 lansoprazole has been associated with a small increase in infectious diarrhoea.

If your doctor has given you lansoprazole 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 lansoprazole 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 Lansoprazole capsules, 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 prescription.

In particular tell your doctor if you are taking medicines containing any of the following active substances as lansoprazole 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 (Hypericumperforatum) (used to treat mild depression)

Taking lansoprazole with food and drink

For the best results from your medicines you should take lansoprazole at least 30 minutes before food.

Pregnancy and breast-feeding

If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before taking this medicine.

Driving and using machines

Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking lansoprazole. If you experience side effects like these you should take caution as your ability to react may be decreased.

You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections.

Read all the information in this leaflet for guidance.

Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

Important information about some of the ingredients of Lansoprazole capsules

Lansoprazole capsules contain 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 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 lansoprazole once a day, try to take it at the same time each day. You may get best results if you take lansoprazole first thing in the morning.

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

The dose of lansoprazole depends on your condition. The usual doses of lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.

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 together with 250-500 mg clarithromycin and 1000 mg amoxicillin

-    30 mg lansoprazole together with 250 mg clarithromycin and 400-500 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.

Lansoprazole capsules should not be given to children.

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 capsules than prescribed

If you take more lansoprazole than you have been told to, seek medical advice quickly.

If you forget to take Lansoprazole capsules

If you forget to take a dose, take it as soon as you 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 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 or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, lansoprazole can cause side effects, although not

everybody gets them.

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

-    fracture of the hip, wrist or spine (if lansoprazole is used in high doses and over a long period of time).

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

-    inflammation of the liver (may be seen as yellow skin or eyes)

-    breast swelling in males, impotence

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

-    angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties in breathing.

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

patients):

-    severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure

-    inflammation of your mouth (stomatitis)

-    colitis (bowel inflammation)

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

-    very severe skin reactions with reddening, blistering, severe inflammation and skin loss.

-    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 capsules 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 CAPSULES

Keep out of the reach and sight of children.

Do not store above 25° C. Keep the bottle tightly closed to protect from moisture.

Do not use Lansoprazole capsules after the expiry date which is stated on the pack. 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 15 mg & 30 mg capsules contain

-    The active substance is lansoprazole. Each capsule contains 15 mg or 30 mg of lansoprazole.

-    The other ingredients are: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), metacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethylcitrate (E-1505), sugar spheres (sucrose and maize starch), gelatin and black ink (shellac and black iron oxide (E-172)).

What Lansoprazole capsules look like and contents of the pack

The capsules are white coloured and imprinted with LAN 15 and LAN 30 for Lansoprazole 15 mg capsules and Lansoprazole 30 mg capsules, respectively.

Both, 15 mg and 30 mg capsules come in bottle packs of 28 and 56 capsules.

Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder is:

Distriquimica, S.A.

Avda. Mare de Deu de Montserrat, 221 08041 Barcelona, Spain

The Manufacturer is:

Laboratorios Dr. Esteve, S.A.

Sant Marti, s/n, Poligono Industrial La Roca,

08107, Martorelles, Barcelona, Spain.

This leaflet was last approved in May 2012.

MU1952-12-3