24mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

_Ranicalm® 75MG 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.

2. Before you take this medicine Do not take these tablets without consulting your doctor if you:

•    have ever been told you are allergic to ranitidine or to any of the other ingredients (these are listed in Section 6, Further Information)

•    are under 16 years

Take special care with this medicine

Check with your doctor or pharmacist before taking your medicine if :

•    you have difficulty swallowing

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

•    you have unintended weight loss

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

•    you have persistent stomach pain

•    you have kidney or liver problems

•    you are under regular medical supervision

•    you have had a peptic ulcer

•    you are elderly

•    you have breathing problems

•    you have a weak immune system

•    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 (NSAID) medicines, for pain and inflammation e.g. ibuprofen or aspirin

•    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

•    atazanavir or delaviridine, for treating HIV infection

•    triazolam, for insomnia

•    gefitnib, for lung cancer

•    ketoconazole, an anti-fungal medicine sometimes used for treating thrush

Midazolam is a medicine that may be given to you just before you have an operation. Tell your doctor you are taking ranitidine before your operation in case he or she wants to give you midazolam.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ranicalm®. Pregnancy and breast-feeding

•    Talk to your doctor before taking Ranicalm® if you are pregnant, trying to become pregnant or are breast feeding.

_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. Do not take more than two tablets in 24 hours.

•    Do not use for more than 6 days

•    Do not buy a second packet of tablets without speaking to your doctor or pharmacist

•    Do not take more than the recommended dose.

•    Do not give to children under 16 years of age.

If you take too many tablets

•    Contact your nearest hospital casualty (A&E) or your g

doctor immediately.    s

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|    4. Possible side effects    1

Like all medicines, Ranitidine can have side effects, but they

are rare.

STOP TAKING this medicine and tell your doctor immediately

if you suffer from any of the following:

•    Allergic reactions. These are very rare but 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, platelet count, suppressed bone marrow or reduction in agranulocytes (a type of white blood cell)

The following side effects may occur. Tell your doctor if you

get them:

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)

Rare (affects up to 1 in 1,000 people)

•    skin rash

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

•    changes to liver function

If any of the side effects becomes serious, or if you notice any side effects is 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.

•    Do not store above 25⁰C. 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 Ranicalm® 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 Ranicalm^® 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.

•    Ranicalm® tablets are available in packs of 6 and 12 tablets.

Manufacturer and 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

Ranicalm® 75mg Film-Coated tablets, PL 17907/0028 This leaflet was last revised in September 2014 To request a copy of this leaflet in Braille, large print or audio then please contact the licence holder at the address (or telephone, fax, email) above.

V1 09-09-2014 DO

SAME SIZE ARTWORK

240 x 120 mm

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