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RANITIDINE 75 MG FILM-COATED TABLETS

Active substance(s): RANITIDINE HYDROCHLORIDE

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Package leaflet: Information leaflet for the user
Ranitidine 75mg Film-coated Tablets
ranitidine

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 14
days.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

1.

What Ranitidine is and what it is used for
What you need to know before you take Ranitidine
How to take Ranitidine
Possible side effects
How to store Ranitidine
Contents of the pack and other information.

What Ranitidine is and what it is used for

Ranitidine is 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 ‘H 2 blocker’. It works by preventing your stomach from producing too much acid.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2.

What you need to know before you take Ranitidine

Do not take Ranitidine
• if you are allergic to ranitidine or any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ranitidine
• you are suffering from any other illness or taking medicines either prescribed by your
doctor or have been taking on your own
• if you have kidney or liver problems
• if you have porphyria (too much of the pigment called porphyrin which may discolor
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.
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 advice is
even more important if you are elderly and have history of peptic ulcer.
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 0.31mg 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.

3.
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 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 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.

Ranitidine tablets are not recommended for children under 16 years of age.
If you take more Ranitidine than you should:
Contact your doctor or casualty department.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4.

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.

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

5.

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 carton, after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

6.

Contents of the pack and other information

What Ranitidine 75mg Film-coated Tablets contains
-

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 Film-coated 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.
Blisters in packs containing 6, 7, 10, 12, 20, 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
20 Balderton Street,
London, W1K 6TL
United Kingdom
Manufacturer:
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co. Tipperary,
Ireland

This leaflet was last revised in November 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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