PACKAGE LEAFLET:

INFORMATION LEAFLET FOR THE USER

Ranitidine 75 mg Tablets

(ranitidine)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to take Ranitidine 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better

or if you feel worse after 6 days._

What is in this leaflet

1.    What Ranitidine is and what it is used for

2.    What you need to know before you take Ranitidine

3.    How to take Ranitidine

4.    Possible side effects

5.    How to store Ranitidine

6.    Contents of the pack and other information

□ WHAT RANITIDINE IS AND WHAT IT IS USED FOR

Ranitidine is used to treat indigestion and heartburn for up to 12 hours. The stomach produces acid which helps 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.

□ WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIDINE

Do not take Ranitidine

• If you are allergic to ranitidine or to any of the other ingredients of this medicine (listed in section 6).

• If you are under 16 years.

Warnings and precautions

Talk to your doctor of pharmacist before taking Ranitidine

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

• if you have unintended weight loss • if you are middle-aged or older with new or recently changed indigestion symptoms • if you have persistent stomach pain • if you have kidney or liver problems • if you are under regular medical supervision

•    if you have had a peptic ulcer

•    if you are elderly

•    if you have breathing problems

•    if you have a weak immune system

•    if you suffer from diabetes

Children

Ranitidine tablets are not recommended for children under 16 years of age.

Other medicines and Ranitidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

This particularly applies to any of the following:

-    medicines to prevent blood clotting, such as warfarin

-    non-steroidal anti-inflammatory painkillers (aspirin or ibuprofen). This advise is even more important if you are elderly

Ranitidine with food and drink

Ranitidine should be swallowed whole with a glass of water.

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 or pharmacist for advice before taking this medicine.

Ranitidine 75mg tablets contain sodium and castor oil

This medicinal product contains 0.31 mg of sodium (salt) per dose. This should be taken into consideration by patients on a controlled sodium (salt) diet. The tablets also contain castor oil. This may cause stomach upset and diarrhea.

FI HOW TO TAKE RANITIDINE

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 16 years and overt

Swallow one tablet, with a drink of water, as soon as you have 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 these tablets to children under 16 years of age.

If you take more Ranitidine than you should:

Contact your doctor or casualty department.

If you forget to take Ranitidine

Take it as soon as you remember then continue as before. If it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take a double dose to make up for a forgotten dose.

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

Q POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects although not everybody gets them.

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 granulocytes (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 pain in your muscles and joints

•    Sudden inflammation of your kidneys

•    Blood in your urine or changes in the normal amount of urine

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

•    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.

El HOW TO STORE RANITIDINE

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

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

Keep the blister in the outer carton in order to protect from light. Do not store above 25°C.

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

□ CONTENTS OF THE PACK AND OTHER INFORMATION

What Ranitidine 75mg tablets contain

- The active substance is ranitidine. Each film-coated tablet contains 83.75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient.

- The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and talc. Film-coating on the tablets contain: castor oil & Opadry OY-S-54902 Pink which contains hypromellose, talc, titanium dioxide (E171) and red ferric oxide (E172). The Printing ink contains Opacode S-1 -17823 Black (containing shellac, Isopropyl alcohol, Iron oxide black, N-Butyl alcohol, Propylene glycol and Ammonium Hydroxide 28%).

What Ranitidine 75mg tablets look like and contents of the pack

Ranitidine 75mg tablets are light pink, round, biconvex, film coated tablets printed with “75” in black edible ink on one side.

Ranitidine 75mg tablets are available in packs containing 6,10,12,20,24 or 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ranbaxy (UK) Limited,

Building 4, Chiswick Park, 5 66 Chiswick High Road,

London, W4 5YE,

United Kingdom.    fS

O

Manufacturer:    £■

Ranbaxy Ireland Limited,

Spafield, Cork Road,

Cashel, Co. Tipperary,

Ireland.

This leaflet was last revised in May 2016.

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