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Ranitidine 75mg Tablets Bp

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PACKAGE LEAFLET: INFORMATION FOR THE USER

RANITIDINE INDIGESTION RELIEF AND PREVENTION 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 carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again

•    Askyour pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 14 days.

•    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.

In this leaflet:

1.    What Ranitidine is and what it is used for.

2.    Before you take Ranitidine.

3.    How to take Ranitidine.

4.    Possible side effects.

5.    Howto store Ranitidine.

6.    Further information.

1 .WHAT RANITIDINE IS AND WHAT IT IS USED FOR

Ranitidine belongs to a group of medicines called histamine H2 antagonists. It reduces the amount of acid in the stomach to relieve symptoms of stomach upsets such as:

•    heartburn

•    indigestion

•    acid indigestion

•    excess acid.

It can also be taken to prevent these symptoms before consuming certain types of food or drink.

2. BEFORE YOU TAKE RANITIDINE

Do not take Ranitidine If:

•    you are allergic (hypersensitive) to ranitidine hydrochloride or any of the other ingredients of this medicine.

Take special care with Ranitidine - You should tell your doctor before taking this medicine if:

•    you have a liver or kidney problem

•    you have a rare inherited disease of the blood called porphyria

•    you have experienced unintended weight loss and have the symptoms of excess acid at the same time

•    you are middle aged or elderly and have experienced new or recently changed symptoms of excess acid.

Ranitidine may hide the symptoms of other diseases. Before initiation of ranitidine treatment your doctor may carry out an endoscopy to diagnose your condition and/or exclude other diseases.

If you are elderly, have chronic lung disease, diabetes or a weak immune system, you may be at greater risk of pneumonia.

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, or the following:

•    Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) e.g. aspirin, ibuprofen, naproxen (for any condition)

•    the antibiotics cefuroxime, amoxicillin and metronidazole

•    sucralfate (for duodenal ulcers), warfarin (to prevent blood clots), procainamide, N-acetylprocainamide (for heart problems), triazolam, midazolam (to help you sleep), glipizide (for diabetes), ketoconazole (for fungal infections), atazanavir, delavirdine (to treat HIV), gefitinib (for the treatment of cancer).

Pregnancy and breast-feeding

Ranitidine can enter your baby's blood if taken when you are pregnant and is found in human breast milk if taken when you are breast-feeding. Ranitidine should only be taken when you are pregnant or breast-feeding if it is absolutely necessary. If you are pregnant or breast-feeding askyour doctor or pharmacist for advice before taking Ranitidine.

Driving and using machines

Ranitidine should not affect your ability to drive or use machines.

Important information about some of the ingredients of Ranitidine

These tablets contain the colourant sunset yellow (El 10) which may cause allergic reactions.

3. HOWTO TAKE RANITIDINE

Always take Ranitidine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water.

The usual dose is:

Adults including the elderly Treatment of heartburn, indigestion, acid indigestion and excess acid

One tablet as soon as you have the symptoms. If symptoms persist for more than one hour or return, take another tablet.

Prevention of acid indigestion, indigestion, excess acid and heartburn

One tablet, half to one hour before eating or drinking.

The maximum dose is four tablets in any 24 hour period in divided doses. Do not take Ranitidine for more than 2 weeks continuously unless advised by your doctor.

If you have kidney problems your doctor may change your dosage.    LT1421AB

Children

Ranitidine is not recommended for children under 16 years of age.

If you take more Ranitidine than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Ranitidine

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ranitidine

Speakto your doctor first before you stop taking this medicine.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ranitidine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Stop taking Ranitidine and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:

•    allergic reactions, the signs may include:

*    rash, itching or hives on the skin

*    swelling of your face, lips, tongue or other parts of the body

*    chest pain, shortness of breath, wheezing or having trouble breathing - unexplained fever and feeling faint, especially when standing up.

•    kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests

•    severe stomach pain, this may be a sign of something called 'pancreatitis'

•    a slow or irregular heartbeat.

Check with your doctor at your next visit if you notice any of the following:

Uncommon (affect less than 1 in 100 people):

•    diarrhoea, nausea, constipation, stomach pain.

Rare (affect less than 1 in 1,000 people):

•    flushing or marks on your skin that look like targets

•    unexplained hair loss

•    false results in blood tests called 'liver function tests'

•    a rash on its own.

Check with your doctor as soon as possible if you notice any of the following:

Very rare (affect less than 1 in 10,000 people):

•    breast discharge, breast tenderness and/or breast enlargement in men

•    headache (sometimes severe)

•    feeling dizzy

•    having blurred vision which is reversible

•    there can be changes in the level of certain substances in your blood. This can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infection

•    feeling confused, depression, seeing or hearing unexplained things (hallucinations).This is reversible and is more likely to happen in very ill or elderly patients

•    your joints or muscles are painful or swollen or you cannot control their movement

•    your small blood vessels can become swollen (known as 'vasculitis'). Signs of this can include: a rash, swollen joints or kidney problems

•    your liver can become swollen.This can lead to: nausea (feeling sick) or vomiting (being sick), loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine

•    impotence which is normally reversible and should get better once you stop taking the medicine.

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

5.    HOWTO STORE RANITIDINE

Keep out of the reach and sight of children. Do not use Ranitidine after the expiry date which is stated on the carton after'EXP'. The expiry date refers to the last day of that month. Store in the original package, at a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Ranitidine contains

The active substance is ranitidine hydrochloride.

Each tablet contains 85 mg of ranitidine hydrochloride (equivalent to 75 mg of ranitidine). The other ingredients are microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (El 71), polydextrose, triethyl citrate, polyethylene glycol, sunset yellow (El 10) and iron oxideyellow (El 72).

What Ranitidine looks like and contents of the pack

Tablets are peach, round, biconvex, film-coated, and marked '75' on one side and 'G' on the reverse. Ranitidine is available in blister packs of 6,12,24 or 48 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Generics [UK] Ltd t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Manufacturer: McDermott Laboratories Ltd (t/a Gerard Laboratories), 35/36 Baldoyle Indsutrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last

approved in: 06/10/2011    LT1421AB 10002884

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