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Lansoprazole 30 Mg Gastro-Resistant Capsules

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Document: leaflet ACTAVIS_PL 01656-0006 change

Lansoprazole 15mg and 30mg Gastro-resitstant Capsules


•    Read this entire leaflet carefully before you start taking this medicine.

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

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

. This medicine has been prescribed for you personally and you should NOT pass it on to others. It may harm them, even if their symptoms are the same as yours.


In this leaflet

1 .What b In Lansoprazole Gastro-reslstant Capsules?

2.    What is your medicine used for?

3.    Before you take Lansoprazole Gastro-reslstant Capsules

4.    Howto take Lansoprazole Gastro-resistant Capsules

5.    Possible side effects

6.    Storing your Lansoprazole Gastro-reslstant Capsules

1.    WHAT IS IN LANSOPRAZOLE GASTRO-RESISTANT CAPSULES?

Your doctor has prescribed Lansoprazole Gastro-reslstant Capsules. Your medicine is available In 2 strengths:

•    Lansoprazole 1 Smg Gastro-reslstant Capsules: Each hard, white/red-brownish gelatin capsule contains ISmg of lansoprazole as the active ingredient The capsules are filled with white to light brown or lightly pink enteric-coated pellets.

•    Lansoprazole 30mg Gastro-reslstant Capsules: Each hard, white gelatin capsule contains 30mg of lansoprazole as the active ingredient. The capsules are filled with white to light brown or lightly pink enteric-coated pellets.

Both strengths also contain the following Inactive Ingredients: sugar spheres (consisting of sucrose and maize starch), povidone, disodium hydrogen phosphate dihydrate, sodium laurilsulphate, methacryfic acid-ethyl acrylate copolymer (1:1), ta k, macrogoi, titanium dioxide and polysorbate 80.The capsule shell for both strengths also contains the following inactive Ingredients: gelatin and titanium dioxide.The 1 Smg capsule shell also contains red Iron oxide (El 72).

Both strengths are available In plastic containers containing 14,28,56 or 98 hard capsules and in blisters containing 14,28,49,

56 or 98 hard capsules.The plastic containers also contain one or two silica gel desiccant capsules.

Marketing Authorisation Holden

Krka, d. d. Novo mesto, SmarjeSka cesta 6,8501

Novo Mesto, Slovenia.

Manufacturer

Krka, d. d. Novo mesto, SmarjeSka cesta 6,8501 Novo Mesto, Slovenia.

Distributed by:

Actavls, Barnstaple, EX32 8NS, UK

2.    WHAT IS YOUR MEDICINE USED FOR? Lansoprazole belongs to a group of medicines called proton pump Inhibitors which reduce the amount of add that your stomach makes.

Lansoprazole Gastro-reslstant Capsules are

given to:

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•    Heal the ulcers In your stomach (duodenal or gastric), verified by endoscopy or radiography

•    Heal your oesophagus (gullet) If it has become damaged or inflamed (reflux oesophagitis)

. Treat the excessive production of acid in your stomach (Zolllnger-Ellison syndrome)

3.    BEFORE YOU TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES

Do not take this medicine If:

•    You are allergic to lansoprazole or to any of the Ingredients listed above

Please talk to your doctor before taking Lansoprazole Gastro-reslstant Capsules If:

•    You suffer from liver problems

•    You are pregnant, planning to become pregnant or breast-feeding

You should always tell your doctor about any medicines you are taking.This Includes any medicines you have bought for yourself, as well as those prescribed for you by a doctor. Some medicines may interact with Lansoprazole Gastro-reslstant Capsules. These Include:

•    Fluvoxamine (a medicine used In depression)

•    Ketoconazole or itraconazole (medicines used In fungal infections)

•    Protease Inhibitors (medicines used for the treatment of patients with HIV Infection)

•    Macrolldes (a group of antibiotics used to treat a wide range of bacterial infections)

•    Dig ox) n (a medicine used In the treatment of certain heart conditions)

•    Tacrolimus (a medicine used in organ transplantation)

•    Carbamazepine or phenytoln (medicines used In the treatment of epilepsy)

•    Warfarin (a medicine used to thin the blood)

•    Theophylline (a medicine used to treat breathing problems due to asthma or chronic bronchitis)

. Antacids (medicines used for indigestion)

•    Sucralfate (a medicine used in the treatment of ulcers)

Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding do not take Lansoprazole Gastro-reslstant Capsules.

Driving and using machines

You may feel tired or dizzy after taking this

medicine. If this happens, do not drive or use

machinery.

This product 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.

4.    HOWTO TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES

The label on the carton will tell you how many capsules you should take and when. Follow your doctor's advice.The capsules are for oral use and should be swallowed with a glass of water, preferably at the same time each day, in the morning, before a meaL Do not crush or chew the capsules.

For the treatment of duodenal ulcers:

The recommended dose is 30mg once a day for two weeks, if your ulcers haven't healed within this time, your doctor will continue your treatment for another two weeks.

For the treatment of gastric ulcers:

The recommended dose Is 30mg once a day for

continued-


&actavis

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t 0044 1271 311400 1 0044 1271 311449 @ artworkstJdio@acTavts.co.j Kr/n 0044 1771 ^77411

Lansoprazole Capsules 15mg & 30mg - UK

item no: KRKPL006

dimensions: 148x297

colours/plates

k print proof no: 7

pharmacode: 1924

1. black

origination date: 27-03-07

design repeat (single)

MOCK UP ONLY

originated by: BW

web:

revision date: 21 -06-07

revised by: BW

1



four weeks. If your ulcers haven't healed within this time, your doctor will continue your treatment for another four weeks.

For the treatment of reflux oesophagitis:

The recommended dose Is 30mg once a day for four weeks. If your condition hasn't Improved within this time, your doctor wilt continue your treatment for another four weeks.

For the prophylaxis of reflux oesophagitis:

The recommended dose Is 15mg once a day for as long as your doctor decides. Your doctor may increase your dose to 30mg once a day.

For the treatment of excessive production of add In your stomach (ZoMnger-EHkon syndrome):

The recommended Initial dose Is 60mg once a day for as long as your doctor decides. The maximum dally dose Is 180mg twice a day  (morning and evening).

If you suffer from liver problems:

~==    Your doctor will prescribe a lower dose and

SjS Increase It If necessary.

Lansoprazole Gastro-resistant Capsules should not be given to children.

What If you mbs a dose?

If you forget to take a dose, take It as soon as you remember. Then go on as before. Do not take two doses at the same time.

What if you have taken too many capsules?

If you accidentally take more capsules than you should, contact your nearest casualty department or tell your doctor/pharmacist immediately.Take this leaflet and any left-over capsules with you, so the doctor knows what you have taken.

5. POSSIBLE SIDE EFFECTS Like all medicines, Lansoprazole Gastro-resistant Capsules can cause side effects in some patients.

Common side effects: feeling sick and/or being sick, diarrhoea, stomach ache, constipation, wind, heartburn, rash, itching, eczema, hives, headache, dizziness and tiredness.

Uncommon side effects: increase in liver enzyme levels.

Rare side effects: dry mouth or throat inflammation of the tongue; inflammation of the pancreas (pancreatitb), inflammation of the oesophagus, hair loss, restlessness, sleeping problems, drowsiness, depression, hallucinations, confusion, vertigo,tremors, pins and needles, inflammation of the liver (hepatitis), yellowing of the skin and/or eyes, kidney problems, anaemia (a low red cell count), low white cell count (the blood cells that fight Infection) and platelet count (the blood cells which helpthe blood clot), swelling ankles, Irregular heartbeat chest pain, muscle and joint pain, changes In the way things taste, blurred vision,fever, Increased sweating and Impotence

Very rare side effects: colitis (acute or chronic inflammation of the membrane lining the large bowel), inflammation of the mouth, black tongue, breast enlargement In men, production of milk, generally feeling unwell. Increase In cholesterol and triglyceride levels.

Allergic reactions have occurred to patients taking this medicine. If you experience any sudden wheeziness, tightness in the chest difficulty swallowing, swelling of eyelids, face or lips, a skin rash such as red spots or hives (skin lumps) or Itching, please talk to your doctor immediately.

If you suffer from any of these side effects or any other side effects not mentioned in this leaflet please talk to your doctor.

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6. STORING YOUR LANSOPRAZOLE G ASTRO-RESISTANT CAPSULES Do not store above 2S*C Store In the original package. Keep the container tightly closed. In order to protect from moisture.

Discard within 3 months of first opening the container.

Do not use Lansoprazole Castro-resistant Capsules after the expiry date shown on the container label or carton.

This leaflet was approved: March 2007



^actavis

Acta vis. Barnstaple. EX32 8NS. UK


^actav/s

t 0044 1271 311400 f 0044 1271 311449 @ artworks! jdio@actavis.co.ji isrln nrua 1771

Lansoprazole Capsules 15mg & 30mg - UK

item no: KRKPL006

dimensions: 148x297

colours/plates

k print proof no: 7

pharmacode: 1924

1. black

origination date: 27-03-07

design repeat (single)

MOCK UP ONLY

originated by: BW

web:

revision dare: 21-06-07

revised by: BW

__