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Antepsin 1g

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Document: leaflet MAH BRAND_PL 12185-0008 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antepsin 1g TABLETS

sucralfate

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, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Antepsin Tablets are and what they are used for

2.    What you need to know before you take Antepsin Tablets

3.    How to take Antepsin Tablets

4.    Possible side effects

5.    How to store Antepsin Tablets

6.    Contents of the pack and other information

1. What Antepsin Tablets are and what they are used for

The name of your medicine is Antepsin 1 g Tablets (called Antepsin Tablets in this leaflet). Antepsin Tablets contain a medicine called sucralfate. This belongs to a group of medicines called “Ulcer-healing” medicines. It works by forming a protective barrier over a stomach ulcer and helps stop further irritation caused by stomach acid.

Antepsin Tablets are used to treat:

•    Stomach ulcers

•    Ulcers in your bowel

•    Inflammation of your stomach lining

2. What you need to know before you take Antepsin Tablets

Do not take Antepsin Tablets:

•    If you are allergic (hypersensitive) to sucralfate

or any of the other ingredients of Antepsin Tablets (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    If you are on dialysis for kidney problems

Do not take this medicine if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before taking Antepsin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Antepsin Tablets if:

•    You are pregnant, trying to become pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)

•    You have kidney problems

•    You find it difficult to swallow

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Antepsin Tablets.

Other medicines and Antepsin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Antepsin Tablets can affect the way some other medicines work. Also some other medicines can affect the way Antepsin Tablets works.

In particular, before taking Antepsin Tablets, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines containing citrates

•    Medicines containing aluminium

•    Medicines for stomach ulcers such as cimetidine or ranitidine

•    Medicines for infection (antibiotics) such as tetracycline, ciprofloxacin or norfloxacin

•    Sulpiride -used for mental health problems (psychotic episodes)

•    Digoxin-used for heart problems

•    Phenytoin-used for fits (epilepsy)

•    Warfarin-used for blood clots

•    Theophylline-used for asthma or other breathing problems

•    Levothyroxine-used for thyroid problems

•    Quinidine-used for heart problems

•    Ketaconazole-used for fungal infections

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Antepsin Tablets.

If you are taking any other medicine, leave a two hour gap between taking Antepsin Tablets and the other medicine. For “antacid” medicines, the gap needs to be at least half an hour.

Antepsin Tablets with food and drink

If you are being fed by a tube into your stomach, Antepsin Tablets should be given at least one hour before or after a feed.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if:

•    You are pregnant, might become pregnant or think you might be pregnant

•    You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you might be pregnant.

Driving and using machines

Antepsin Tablets may make you feel dizzy or drowsy. If you feel dizzy or drowsy, do not drive or use tools or machines while taking this medicine.

3. How to take Antepsin Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is either:

•    Two tablets after waking up in the morning and two tablets at bedtime

or

•    One tablet four times a day. Doses should be taken before meals and at bedtime

Taking this medicine

•    Take this medicine by mouth

•    Tablets can be swallowed whole, or if preferred, they can be dispersed in 10 to 15 mL of water before taking

•    This medicine is usually taken for 4 to 6 weeks, but may be taken for up to 12 weeks if necessary

•    The maximum dose in a day is eight tablets

Use in children

Antepsin Tablets are not suitable for children under 14 years old.

If you take more Antepsin Tablets than you should

If you take more Antepsin Tablets than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Antepsin Tablets

•    If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose

•    Do not take a double dose to make up for a forgotten dose

If you stop taking Antepsin Tablets

Do not stop taking Antepsin Tablets without talking to your doctor.

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

4. Possible side effects

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

Stop taking Antepsin Tablets and tell your doctor straight away if:

•    You have an allergic reaction. The signs include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell a doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

•    Constipation or diarrhoea

•    Indigestion, stomach ache or wind

•    Being sick (vomiting) or feeling sick (nausea)

•    Feeling dizzy, drowsy or being unsteady on your feet

•    Back pain

•    Dry mouth

•    Headache

•    Itching

Antepsin Tablets may cause a blockage in the digestive tract of seriously ill patients in hospital.

This is a rare side effect.

Antepsin Tablets may cause aluminium to build up in your body. This can cause changes in your bones such as thinning or softening, impairment of your brain or problems with your blood.

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.

Reporting of side effects

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

You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

UK - Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland - HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2.

Tel: +353 1 6764971. Fax: +353 1 6762517.

Website: www.hpra.ie E-mail: medsafety@hpra.ie

5. How to store Antepsin Tablets

Keep this medicine out of the sight and reach of children.

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

Store your medicine below 25 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Antepsin Tablets contain

•    Antepsin Tablets contain 1 g per tablet of the active substance sucralfate

•    The other ingredients contained in the Antepsin Tablets are macrogol 6000, microcrystalline cellulose, calcium carmellose and magnesium stearate

What Antepsin Tablets looks like and contents of the pack

Antepsin Tablets are oblong and white. The tablets are packed in blisters of 10 tablets with 5 blister strips in a carton.

Marketing Authorisation Holder

Chugai Pharma UK Ltd., Mulliner House, Flanders Road, Turnham Green, London W4 1NN, U.K.

Manufacturer

Merck, S.L., Poligono Merck, E-08100 Mollet del Valles, Barcelona, Spain.

This leaflet was last revised in:

July 2015

1235751-1