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Package leaflet: Information for the patient

Ranitidine 75 mg Tablets

Ranitidine Hydrochloride

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 effects not listed in this leaflet.

What is in this leaflet

1.    What Ranitidine 75 mg Tablets are and what they are used for

2.    What you need to know before you take Ranitidine 75 mg Tablets

3.    How to take Ranitidine 75 mg Tablets

4.    Possible side effects

5.    How to store Ranitidine 75 mg Tablets

6.    Contents of the pack and other information

1.    What Ranitidine 75 mg Tablets are and what they are used for

Ranitidine 75 mg Tablets are used to treat and prevent indigestion and heartburn for up to 12 hours. The stomach produces acid which helps to digest food. Sometimes your stomach produces too much acid which can cause indigestion and heartburn.

The active ingredient is ranitidine hydrochloride which is a medicine called an ‘H2-blocker’. It works by preventing your stomach from producing too much acid.

2.    What you need to know before you take Ranitidine 75 mg Tablets Do not take Ranitidine 75 mg Tablets:

-    if you have ever had an allergic reaction to ranitidine or to any of the other ingredients of this medicine (listed in section 6).

-    if you 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 the 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.

Other medicines and Ranitidine 75 mg Tablets

Talk to your doctor or pharmacist before taking Ranitidine 75 mg Tablets if you are taking any other medicines, including those obtained without a prescription; particularly medicines to prevent blood clotting, such as warfarin, and non-steroidal anti-inflammatory painkillers (e.g. aspirin or ibuprofen). This advice is even more important if you are elderly.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

3. How to take Ranitidine 75 mg Tablets

Adults and children aged 16 years and over:

Swallow 1 tablet, with a drink of water, as soon as you have symptoms.

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

To prevent your symptoms, you can take 1 tablet half an hour to an hour before eating or drinking.

-    Do not take more than 4 tablets in 24 hours

-    Do not take for longer than 2 weeks at a time

-    Do not take more than the recommended dose.

If you take more Ranitidine 75 mg Tablets than you should

Contact your doctor or casualty department

4. Possible side effects

Like all medicines, this medicine can cause side effects, but they are rare.

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

-    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, low 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.

-    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.

-    Stomach pain, constipation, feeling sick (nausea).

-    Inflammation of 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.

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

-    Blood in you urine or changes in the normal amount of urine.

-    Impotence

-    Swollen, tender or leaking breasts.

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 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.

5. How to store Ranitidine 75 mg 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 label. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information What Ranitidine 75 mg Tablets contain

-    The active substance is ranitidine hydrochloride 84 mg (equivalent to Ranitidine 75 mg)

-    The other ingredients are microcrystalline cellulose, polyvidone, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), talc, macrogol 6000 and methacrylic acid copolymer.

Cartons contain push through double foil blister strips. The strips are packed in cartons that contain 5, 6, 10 or 12 tablets.

Marketing Authorisation Holder and Manufacturer

M&A Pharmachem Ltd, Wigan Road, Westhoughton, Bolton, Lancashire, BL5 2AL

This leaflet was last revised in May 2015

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