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1. Lansoprazole 30mg Gastro-Resistant Capsules Hard
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PACKAGE LEAFLET: INFORMATION FOR THE USER Lansoprazole 15mg Gastro-Resistant Capsules, Hard Lansoprazole 30mg Gastro-Resistant Capsules, Hard

(Referred to as Lansoprazole Gastro-Resistant Capsules in the remainder of the leaflet)

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

-    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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

In this leaflet:

1.    What Lansoprazole Gastro-Resistant Capsules are and what they are used for

2.    What you need to know 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.    Contents of the pack and other information

1. What Lansoprazole Gastro-Resistant Capsules are and what they are used for

The name of your medicine is Lansoprazole Gastro-Resistant Capsules, Hard.

The active ingredient in your medicine is lansoprazole. Lansoprazole belongs to a group of medicines called proton-pump inhibitors (PPIs), which are used to lower the amount of acid that your stomach produces.

Lansoprazole Gastro-Resistant Capsules are used:

•    to treat ulcers in the stomach or the upper part of the gut (duodenum)

•    to treat and relieve the symptoms of a condition where acid and food from the stomach escapes into your food pipe (reflux oesophagitis) and to prevent this condition from coming back

•    to treat stomach and duodenal ulcers caused by medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and to stop you getting an ulcer while you are taking an NSAID

•    to treat an infection caused by Helicobacter pylori. This is a bacterial infection which can cause inflammation of the stomach and can also cause ulcers

•    to treat problems in your gut (pancreas and/or intestine) caused by your stomach producing too much acid (Zollinger-Ellison syndrome).

2. What you need to know before you take Lansoprazole Gastro-Resistant Capsules

Do not take Lansoprazole Gastro-Resistant Capsules if you:

•    are allergic (hypersensitive) to lansoprazole or to any of the other ingredients in this medicine (listed in section 6)

•    are taking a medicine called atazanavir (used to treat HIV).

Talk to your doctor before taking Lansoprazole Gastro-Resistant Capsules if you:

•    have liver problems

•    are currently receiving treatment for infections in the stomach or intestine

•    are taking antibiotics

•    know you are going to be treated with this medicine for more than a year.

Taking other medicines

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

The following medicines can affect or can be affected by Lansoprazole Gastro-Resistant Capsules:

•    ketoconazole, itraconazole, and rifampicin, used to treat various types of infection

•    fluvoxamine, used to treat depression and other psychiatric problems

•    tacrolimus, used to prevent transplant rejection

•    digoxin, used to treat various heart conditions

•    theophyllin, used to treat asthma

•    St John's wort, used to treat mild depression.

•    Methotrexate, used to treat a number of conditions including cancer, arthritis and psoriasis

Take Lansoprazole Gastro-Resistant Capsules at least an hour before or after you take the following medicines:

•    antacids, used to treat indigestion or heartburn

•    sucralfate, used to treat intestinal ulcers or gastritis.

Taking Lansoprazole Gastro-Resistant Capsules with food and drink

Taking Lansoprazole Gastro-Resistant Capsules with food can reduce its effect. Take this medicine before meals.

Take your medicine in the morning before eating. If you are taking the medicine twice a day, take the second dose in the evening before you eat.

Pregnancy and breast-feeding

Do not take Lansoprazole Gastro-Resistant Capsules if you are pregnant, think you may be pregnant or are planning to get pregnant.

If you are breastfeeding check with your doctor before taking this medicine. Your doctor will decide if you should take it.

Ask your doctor for advice before taking any medicine.

Driving and using machinery

You may feel dizzy, sleepy, or have problems with your eyesight whilst taking Lansoprazole Gastro-Resistant Capsules. If this happens do not drive, use tools or machines until you feel normal.

Important information about some of the ingredients of Lansoprazole Gastro-Resistant Capsules

This medicine 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.

Lansoprazole15mg Gastro-Resistant Capsules contain carmoisine (E122) and tartrazine (E102), which may cause allergic reactions.

3. How to take Lansoprazole Gastro-Resistant Capsules

Always take Lansoprazole Gastro-Resistant Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Lansoprazole Gastro-Resistant Capsules at least 30 minutes before meals. Take your medicine in the morning before eating. If you are taking the medicine twice a day, take the second dose in the evening before you eat.

Swallow the capsules whole or empty the capsules and swallow the contents with a glass of water (do not crush or chew the capsules/contents of the capsule).

Your doctor will decide the right dose and duration of treatment for you. This information will be on the pharmacist's label.

Adults

This medicine may be given to you in different doses depending on the illness being treated.

The usual doses for adults are:

•    ulcers in the upper part of the gut (duodenal ulcers): 30mg once daily for two weeks. Your doctor may then decide you need to take the medicine for another two weeks

•    ulcers in the stomach (gastric ulcers): 30mg once daily for four weeks. Your doctor may then decide you need to take the medicine for another four weeks

•    treatment and relief of symptoms of a condition where acid and food from the stomach escapes into the food pipe (reflux oesophagitis): 15mg or 30mg once daily for four weeks.

•    prevention of reflux oesophagitis: 15mg once daily, which may be increased to 30mg

•    treatment of gastric and duodenal ulcers caused by an NSAID: 30mg once daily for four weeks. Your doctor may then decide you need to take the medicine for another four weeks

•    Prevention of an ulcer while taking an NSAID: 15mg or 30mg once daily.

•    treatment of an infection caused by Helicobacter pylori: 30mg twice a day for one week in combination with antibiotics

•    problems in the gut (pancreas and/or intestine) caused by your stomach producing too much acid (Zollinger-Ellison Syndrome): your treatment may begin with a dose of 60mg taken once daily. Your doctor may decide to increase the daily dose up to a maximum of 180mg to stop your illness coming back.

Patients with liver problems

Your doctor may reduce your dose if you have moderate or severe liver problems.

Elderly patients

Your doctor may decide to change your dose, but it should not be more than a maximum daily amount of 30mg.

Children

Lansoprazole Gastro-Resistant Capsules are not recommended for use in children.

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If you take more Lansoprazole Gastro-Resistant Capsules than you should

Tell your doctor or go to your nearest hospital straight away. Remember to take with you any Lansoprazole Gastro-Resistant Capsules that are left and this leaflet. This is so the doctor knows what you have taken.

The symptoms of an overdose are not known. However, you may suffer from one of the side effects listed in section 4 (Possible side effects).

If you forget to take Lansoprazole Gastro-Resistant Capsules

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you have any further questions on the use of Lansoprazole Gastro-Resistant Capsules, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazole Gastro-Resistant Capsules can cause side effects, although not everybody gets them. The following side effects may be experienced:

Very rare (affecting less than 1 in 10,000 patients)

•    a severe form of allergic reaction (anaphylactic/anaphylactoid reaction). Symptoms of a severe allergic reaction include rash, swelling of the face and difficulty breathing.

If you experience any severe allergic reaction, contact your doctor or nearest hospital casualty department immediately.

Other very rare side effects are:

•    a very severe form of allergic skin reaction causing blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome and toxic epidermal necrolysis)

•    abdominal pain and diarrhoea

•    sore mouth

•    increase in your blood cholesterol and fat levels

•    low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma.

Rare (affecting at least 1 in 10,000 but less than 1 in 1000 patients)

•    itchy pink/red rash (erythema multiforme)

•    being more sensitive to the sun than usual

•    changes in the way things taste, or mouth infections

•    inflammation of your tongue (glossitis)

•    red spots under the skin, red or purple discolouration of the skin

•    hair loss

•    restlessness, difficulty sleeping, sleepiness, strange sounds or visions (hallucinations), feeling confused

•    feeling of extreme dizziness

•    shaking

•    liver problems including yellowing of your skin or whites of your eyes (jaundice)

•    swelling of the ankles, feet or fingers

•    tingling or numbness in the hands or feet (“pins and needles”)

•    kidney problems

•    severe stomach pain which may reach through to the back. This could be a sign of pancreatitis

•    blurred vision

•    swelling of one or both breasts in men

•    fever

•    sweating

•    feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia

•    loss of appetite

•    being unable to achieve an erection (impotence).

Uncommon (affecting at least 1 in 1000 but less than 1 in 100 patients)

•    changes to various types of blood cells (shown in blood tests)

•    feeling depressed

•    pain in your muscles or joints.

Common (affecting at least 1 in 100 but less than 1 in 10 patients)

•    feeling sick or being sick

•    wind, diarrhoea, stomach pain, difficulty in passing stools/constipation

•    feeling dizzy, headache, feeling tired

•    dry mouth or throat

•    changes in the way your liver works

•    itching or skin rash

•    hives.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

•    Do not store above 25°C.

•    Store in the original packaging in order to protect from moisture.

•    Do not take Lansoprazole Gastro-Resistant Capsules after

the expiry date stated on the packaging. The expiry date refers to the last day of the 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 protect the environment.

6. Contents of the pack and other information

What Lansoprazole Gastro-Resistant Capsules contain

The active ingredient is lansoprazole.

Each Lansoprazole 15mg Gastro-Resistant Capsule, Hard contains 15mg of lansoprazole.

Each Lansoprazole 30mg Gastro-Resistant Capsule, Hard contains 30mg of lansoprazole.

The other ingredients are: sugar spheres, opadry clear {hypromellose (E464), talc (E553b), Macrogol (PEG 400 and 6000)}, magnesium carbonate light (E504), hypromellose, Macrogol (PEG 6000), sucrose, purified talc (E553b), methacrylic acid-ethyl acrylate copolymer, titanium dioxide (E171), polysorbate 80, and colloidal anhydrous silica.

Capsule shell:

Body: gelatin, titanium dioxide (E171), purified water

Cap: gelatin, titanium dioxide (E171), purified water. Lansoprazole 15mg Gastro-Resistant Capsules, Hard also contain carmoisine (E122), tartrazine (E102) and brilliant blue (E133) in the capsule shells.

Capsule shell printing ink:

shellac (E904), dehydrated alcohol, isopropyl

alcohol, butyl alcohol, propylene glycol (E1520),

strong ammonium solution, iron oxide black

(E172), potassium hydroxide (E525), and

purified.water.

What Lansoprazole Gastro-Resistant Capsules look like and the contents of the pack

Lansoprazole 15mg Gastro-Resistant Capsules, Hard are white /red-brownish gelatin gastro-resistant capsules imprinted with ‘W760' in black ink, filled with white, off-white to bluish pellets.

Lansoprazole 30mg Gastro-Resistant Capsules, Hard are white gelatin gastro-resistant capsule imprinted with W761' in black ink, filled with white, off-white to bluish pellets.

Both strengths of capsules are available in aluminium blister strips, in pack sizes of 14, 28, 49, 56 and 98 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: July 2014 106038/2

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5. How to store Lansoprazole Gastro-Resistant Capsules

Keep out of the reach and sight of children.