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Ranitidine 75mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 39484-0047 change

230 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

RANITIDINE 75 mg FILM COATED TABLETS

(Ranitidine hydrochloride)

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 Ranitidine 75 mg film coated tablets carfully 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, of if you notice any side effects not listed in this leaflet, please tell your doctor or

pharmacist.    _

In this leaflet:

1.    What Ranitidine 75 mg film coated tablets are and what they are used for

2.    Before you take Ranitidine 75 mg film coated tablets

3.    How to take Ranitidine 75 mg film coated tablets

4.    Possible side effects

5.    How to store Ranitidine 75 mg film coated tablets

6.    Further information

1. WHAT RANITIDINE 75 mg FILM COATED TABLETS ARE AND WHAT THEY ARE USED FOR


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Ranitidine 75 mg tablets are used to treat and prevent indigestion and heartburn for up to 12 hours. The name of your medicine is Ranitidine 75 mg film coated tablets. It contains the active ingredient called Ranitidine Hydrochloride.

Ranitidine belongs to a group of medicines called H2-antagonists. It works by preventing your stomach from producing too much acid and its effects last for up to 12 hours.

The tablets are used to relieve the burning sensation in the stomach and chest caused by heartburn, indigestion, acid indigestion and hyperacidity (too much acid).


•    are under regular medical supervision for other reasons

•    are suffering from any other illness or taking medications either prescribed by a physician or prescribed by yourself

•    have lost weight unintentionally linked with symptoms of indigestion

•    are middle-aged or elderly with new or recently changed symptoms of indigestion

•    are taking non-steroidal anti-inflammatory painkillers (NSAIDs, such as Aspirin)

•    have the rare condition called porphyria

•    are pregnant, or intend to become pregnant

•    are breast-feeding or intend to breast-feed

•    if you have a weak Immune system

Please tell your doctor or pharmacist if you are taking or

have recently taken any other medicines, including

medicines obtained without a prescription.


2. BEFORE YOU TAKE RANITIDINE 75 mg FILM COATED TABLETS


3. HOW TO TAKE RANITIDINE 75 mg FILM COATED TABLETS


Do not take Ranitidine 75 mg film coated tablets if you have an allergy to Ranitidine or to any of the ingredients listed at the end of this leaflet.


Swallow one tablet (75 mg of Ranitidine) whole with water as soon as symptoms appear.

If symptoms are not controlled or return within one hour, swallow another tablet.


If you are not sure whether you should start taking Ranitidine 75 mg film coated tablets, talk to your doctor.

Ranitidine 75 mg film coated tablets is not recommended for children under 16 years old.

You must tell your doctor or pharmacist if you:

•    have been told by a doctor that you have an ulcer in the stomach or small intestine (lower part of your stomach)

•    have kidney and/or liver problems

For prevention of heartburn associated with consuming food and drink, indigestion, acid indigestion and hyperacidity (too much acid), swallow one tablet with water, half to one hour beforehand.

Do not take more than two tablets (150 mg of Raniditine) in 24 hours.

Medical attention should be sought if symptoms worsen. Do not take tablets for more than 14 days without the advice of a pharmacist or doctor.

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5. HOW TO STORE RANITIDINE 75 mg FILM COATED TABLETS


6. FURTHER INFORMATION


If you forget to take Ranitidine 75 mg film coated tablets:

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

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

If you take more Ranitidine 75 mg film coated tablets than you should:

Immediate medical advice should be sought in the event of taking too many tablets or an overdose, even if you feel well.

4. POSSIBLE SIDE EFFECTS

Like all medicines Ranitidine 75 mg film coated tablets 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 while blood cells, low platelet count, suppressed bone marrow or reduction in agranulocytes (a type of while blood cell).

Check with your doctor as soon as possible if any of these side effects are noticed:

Rare

•    Headache

•    Dizziness

•    Changes to blood counts (causing tiredness, bruising, fever or frequent infections)

•    Diarrhoea

•    Nausea

•    Muscle and joint pains

•    Jaundice or yellowing of the skin

•    Abnormally low blood pressure

•    Acute pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back)

•    Highly or excessively sensitive reactions like an itchy skin eruption

•    Rare cases of hepatitis, with or without jaundice (which are usually reversible)

•    Vasculitis (inflammation of blood vessels) or a rash related to vasculitis, inflammation of the kidney which can cause swollen ankles or high blood pressure.

•    Breast enlargement

•    Erectile dysfunction (impotence) in men

•    Severe headache, confusion, hallucinations or depression (mainly in elderly or severely ill patients)

•    Swollen, tender or leaking breasts.

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.

Keep out of the reach and sight of children.

Store in the original pack. Do not store above 25°C.

Do not take Ranitidine 75 mg film coated tablets after the expiry date (EXP) printed on the pack. The expiry date refers to the last day of that month.

If you have any Ranitidine 75 mg film coated tablets left, return them to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is in Ranitidine 75 mg film coated tablets?

Each tablet contains 75 mg Raniditine as Ranitidine Hydrochloride.

The tablet also contains Microcrystalline Cellulose, Povidone, Magnesium Stearate, Hypromellose, Talc, Macrogol 6000, Methacrylic acid copolymer and the colouring agent E171.

Ranitidine 75 mg film coated tablets are white to off-white, round biconvex film coated tablets with a break line on one side and the imprint ‘‘R75” on the other side.

Pack sizes: 5, 6, 10, 12. Not all pack sizes may be marketed.

MA Holder: Fourrts(UK) Pharmacare Ltd.,

30, Chaul End Lane, Luton, Bedfordshire,

LU4 8EZ, UK.

This leaflet was last revised in 02/2013

Very rare

•    Visual disturbances

•    Changes in heart rate (faster or slower)

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