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Ranzac 75mg Tablets

Document: leaflet MAH BRAND_PL 20338-0020 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

RANZAC 75 mg TABLETS (Ranitidine 75 mg 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 Ranzac 75 mg Tablets 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 get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Ranzac 75 mg Tablets

3.    How to take Ranzac 75 mg T ablets

4.    Possible side effects

5.    How to store Ranzac 75 mg Tablets

6.    Further information

1.    WHAT RANZAC 75 mg TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Ranzac 75 mg 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).

2.    BEFORE YOU TAKE RANZAC 75 mg TABLETS

Do not take Ranzac 75 mg Tablets: if you have an allergy to Ranitidine or to any of the ingredients listed at the end of this leaflet.

If you are not sure whether you should start taking Ranzac 75 mg Tablets, talk to your doctor.

Ranzac 75 mg 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

•    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 especially the elderly (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

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    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

•    glipizide, for lowering blood glucose

•    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 the doctor you are taking Ranzac before your operation in case he or she wants to give you midazolam.

3.    HOW TO TAKE RANZAC 75 mg TABLETS

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

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

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 four tablets (75 mg of Ranzac) in 24 hours.

Medical attention should be sought if symptoms worsen.

Do not take tablets for more than 6 days without the advice of a pharmacist or doctor.

If you take more Ranzac 75 mg 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, Ranzac 75 mg Tablets can cause side effects, although not everybody gets them.

You must stop taking the tablets and tell your doctor immediately, if your chest suddenly feels tight and you start to wheeze or get a skin rash or swelling of the face, lips, throat and eyelids.

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

•    Headache

•    Dizziness

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

•    Diarrhoea

•    Constipation

•    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)

Very rare

•    Visual disturbances (blurred vision)

•    Changes in heart rate (faster or slower)

•    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)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE RANZAC 75 mg TABLETS

Keep out of the reach and sight of children.

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

Do not take Ranzac 75 mg 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 Ranzac 75 mg 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.

6.    FURTHER INFORMATION What is in Ranzac 75 mg Tablets?

Each tablet contains 75 mg Ranitidine as Ranitidine Hydrochloride.

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

Ranzac 75 mg 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.

Marketing Authorisation Holder:

OTC Concepts Ltd 2 Park Street Woburn Bedfordshire MK17 9PG

Manufacturer:

Rx Farma Ltd Colonial Way, Watford Herts, WD24 4YR, UK.

This leaflet was last revised in May 2015