24mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

RANITIDINE 75MG FILM-COATED TABLETS

Read all of this leaflet carefully because it contains important information for you.

•    This medicine is available without prescription; however you still need to take it carefully to get the best results from it.

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

•    Ask your pharmacist if you need more information or advice

•    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 this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further Information

1. What this medicine is and what it is used for

The active ingredient ranitidine belongs to a group of medicines called ‘H2-blockers’. This medicine works by preventing your stomach from producing too much acid. This medicine treats indigestion and heartburn for up to 12 hours. One of the most common causes of indigestion and heartburn is excess acid in the stomach.

This medicine can be indicated for the prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink.

2. Before you take this medicine

Do not take these tablets if you:

•    have ever had an allergic reaction to Ranitidine or to any of the other ingredients (listed in section 6)

•    are under 16 years.

Ask your doctor before you take this medicine:

•    if you have kidney or liver problems

•    if you have porphyria (too much of pigment called porphyrin which may discolour the urine)

•    if you have unintended weight loss associated with acid indigestion

•    if you are middle-aged or older with new or recently changed indigestion symptoms

•    if you have persistent stomach pain

•    if you are under regular medical supervision

•    if you are elderly

•    if you have breathing problems

•    if you have a weak immune system

•    if you suffer from diabetes.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as they may interact with this medicine.

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

•    Non-steroidal anti-inflammatory drugs (NSAIDs) e.g., Aspirin, Ibuprofen for pain and inflammation especially in elderly.

•    lidocaine, a local anaesthetic

•    propranolol, procainamide or n-acetylprocainamide, for heart problems

•    diazepam, for worry or anxiety problems

•    phenytoin, for epilepsy

•    theophylline,    for breathing    problems    (asthma)

•    warfarin, for    thinning your    blood

•    glipizide, for    diabetes

•    ketoconazole, for fungal infections

•    sucralfate, for ulcers

•    atazanavir or delaviridine, for treating HIV infection

•    gefitnib, for lung cancer

•    triazolam or    midazolam, for insomnia.

If you are not sure if any of the above applies to you, talk to

your doctor or pharmacist before taking Ranitidine.

Pregnancy and breast-feeding

•    If you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets or are breast-feeding, ask your doctor or pharmacist before taking this medicine.

3. How to take this medicine

Adults (including elderly) and children 16 years of age

and older:

•    Swallow one tablet, whole with a drink of water as soon as you have the symptoms.

•    If symptoms persist for more than one hour, take another tablet.

•    For prevention of acid indigestion, indigestion,

hyperacidity and heartburn associated with consuming food and drink, swallow one tablet with water, half to onehour beforehand    g

•    Do no take more than four tablets in 24 hours.

•    Do not take for longer than 2 weeks at a time.

Do not give to children under 16 years of age.

If your symptoms get worse or persist after two weeks of treatment, please consult your doctor.

If you take more number of tablets than you should

•    Contact your nearest hospital casualty (A&E) or your doctor immediately.

•    Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

_4. Possible side effects_

Like all medicines, Ranitidine 75mg Tablets can cause side effects although not everybody gets them.

Stop taking this medicine and tell your doctor immediately if you experience:

•    Allergic reactions which may include developing an itchy rash, swelling of the eyelids, face or lips (with or without a lumpy skin rash elsewhere on the body), unexplained fever, difficulty breathing, dizziness (especially on standing up) and chest pain or tightness.

•    Unexplained bruising or bleeding, sore throat, mouth ulcers, fever, extreme paleness, weakness or exhaustion. These can be signs of blood disorders such as anaemia, low white blood cells, low platelet count, suppressed bone marrow or reduction in agranulocytes (a type of white blood cell).

Tell your doctor if you get any of the following side effects:

Very Rare (affects less than 1 in 10,000 people)

•    Confusion, depression, drowsiness or hallucinations

•    Headache, dizziness or sudden, jerky movements

•    Changes in heart rhythm

•    Inflammation of your blood vessels

•    Sudden inflammation of your pancreas (you may get severe stomach pain) or diarrhoea

•    Inflammation your liver which may cause one or more of the following: feeling or being sick, fever, itching, yellowing of the skin and eyes, dark coloured urine. This can cause changes to your liver function tests

•    Hair loss, blurred vision

•    Aches and pains in your muscles and joints

•    Sudden inflammation of your kidneys

•    Impotence

•    Swollen, tender or leaking breasts

Uncommon (affects less than 1 in 100 people)

•    Stomach pain, constipation, feeling sick (nausea)

•    Increase of serum creatine in the blood (kidney function test)

If any of the side effects become serious, or if you

notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

_5. How to store this medicine_

•    Keep the medicines in a safe place where children cannot see or reach it.

•    Store below 25°C. Store in the original package in order to protect from light.

•    Do not take your tablets after the expiry date marked on the pack.

•    If you have any leftover tablets then take them back to your pharmacist for safe disposal.

_6. Further Information_

What Ranitidine Tablet contains:

•    Each tablet contains 75mg of the active substance, ranitidine hydrochloride

•    The other ingredients are: microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (E171)

What the Ranitidine Tablet looks like and contents of the pack

•    Tablets are white to almost white, circular, biconvex, film coated tablets embossed with “BL” on one side and “75” on the other side.

•    Ranitidine tablets are available in packs of 24 tablets. Marketing Authorisation Holder

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Ranitidine 75mg Film-Coated tablets, PL 17907/0247 This leaflet was last revised in December 2011

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