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Read all of this leaflet carefully before you start takingthis medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Ranitidine Tablets are and what they are used for

2.    Before you take Ranitidine Tablets

3.    Howto take Ranitidine Tablets

4.    Possible side effects

5.    Howto store Ranitidine Tablets

6.    Further Information

1.    What Ranitidine Tablets are and what they are used for

Ranitidine is one of a group of medicines known as H2 antagonists. These drugs reduce the amount of acid produced in yourstomach.

Your doctor may have prescribed Ranitidine Tablets for:

•    The treatment and prevention of ulcer disease of the stomach and duodenum (the part of the gut the stomach empties into).

•    The treatment of ulcers associated with infection by the germ Helicobacter pylori when used with antibiotics.

•    The prevention of ulcer disease associated with drugs used to treat arthritis (non-steroidal antiinflammatory drugs NSAIDs).

•    The treatment of ulcers that can occur after operations.

•    To prevent ulcers from bleeding in seriously ill patients or patients known to have ulcers that bleed.

•    The treatment of an inflamed gullet (oesophagitis) that can occur because of acid reflux from the stomach into the gullet.

•    Other problems associated with excess acid in the stomach such as chronic indigestion, dyspepsia or heartburn.

•    The management ofZollinger-Ellison Syndrome (a disease of the pancreas which causes excess acid production in the stomach and can cause ulceration of the stomach, duodenum, gut and gullet).

•    Patients at risk of inhaling acid from the stomach into the lungs particularly before operations requiring a general anaesthetic and in women during labour.

For children

• Short term treatment of peptic ulcer

•    Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

2.    Before you take Ranitidine Tablets

Do not take Ranitidine Tablets:

•    If you are allergic to the active ingredient ranitidine or any of the other ingredients of Ranitidine Tablets.

Take special care with Ranitidine Tablets:

Ranitidine may hide the symptoms of stomach cancer, especially in middle-aged or older patients or those whose symptoms have just changed. Your doctor will check to make sure you do not have this condition before you start yourtablets.

•    If you have kidney, liver or heart damage or disease. Your doctor may reduce your dose if your kidneys do not work properly.

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.

This is because Ranitidine can affect the way some other medicines work. Also some other medicines can affect the way Ranitidine works.

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

•    Non steroidal Anti-inflammatory (NSAID) medicines, for pain and inflammation.

•    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, forthinning of your blood.

•    glipizide, for lowering blood glucose.

•    atazanavir or delaviridine, for treating HIV infection.

•    gefitnib, for lung cancer

•    ketoconazole, an anti fungal medicine, some times used for treating thrush.

Midazolam is amedicine that may be given to you just before you have an operation. Tell the doctor you are taking Ranitidine before your operation in case he or she wants to give you midazolam.

If you are not sure if any of the above apply to you, talk toyour doctor or pharmacist before taking Ranitidine. Taking Ranitidine Tablets with food and drink:

Swallow the tablets whole with a glass of water. You may take your medicine with or without a meal.

Pregnancy and Breastfeeding:

Tell your doctor if you are, thinkyou might be pregnant or planning to become pregnant or are breast-feeding.

Driving and using machines:

Ranitidine Tablets may occasionally cause dizziness or blurred vision. If affected do not drive or operate machinery.

Important information about some of the ingredients of Ranitidine Tablets:

Ifyou are allergic to the active ingredient ranitidine or any of the other ingredients, do not take these tablets. Contact your doctor or pharmacist for further advice.

3. Howto take Ranitidine Tablets

Always take Ranitidine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou arenotsure.

Ranitidine Tablets should be taken by mouth. Swallow yourtablets with a glass of water.

Treatment will usually be given for at least 4 weeks (up to 12 weeks for oesophagitis).

The usual doses for this medicine are given below:

Adults and children over 12 years General - Either I50mg twice daily (morning and night) or 300mg at night. This may then be reduced to a maintenance dose of I50mg at night.

Prevent ulcers - (including those associated with NSAIDs) I50mg twice daily. Serious ulcers may require 300mg twice daily.

Prevent ulcers bleeding - I50mg twice daily. Oesophageal reflux (heart burn) - I50mg twice daily or300mgatnight.

Oesophagitis (inflammation) - I50mg twice daily or 300mg at night. Long term treatment I50mg twice daily. If oesophagitis is severe dosage may be increased to I50mgfourtimes daily.

Chronic indigestion - I50mgtwice daily.

Zollinger- Ellison Syndrome - I50mg three times daily increased if necessary up to 6g daily in divided doses.

Mendelson's Syndrome - I50mg two hours before general anaesthetic and also I50mg the evening before the operation.

In childbirth - I50mg at start of labour, then I50mgat 6 hourly intervals as required.

Severe kidney problems - I50mg at night for 4-8 weeks, although your doctor may prescribe a different dose depending on the severity of your kidney problems

Children from 3 to II years and over 30 kg of weight:

•    Peptic Ulcer Acute Treatment: 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.

Gastro-Oesophageal Reflux:    5 mg/kg/day to 10

mg/kg/day administered as two divided doses in a maximum dose of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).

Safety and efficacy in new-born patients has not been established.

Elderly

It is particularly important to take your medicine exactly as directed by your doctor.

If you take more Ranitidine Tablets than you should:

Taking too many tablets at once may make you feel unwell. If you take too many or someone else accidentally takes your medicine contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take Ranitidine Tablets:

Try to take Ranitidine Tablets as prescribed. However, if you miss a dose take another as soon as you remember and the next dose at the usual time. Never take two doses at the same time.

If you stop taking Ranitidine Tablets:

Do not stop taking Ranitidine Tablets without first discussing it with your doctor.

If you have any further questions on the use of Ranitidine Tablets askyour doctor or pharmacist.

4. Possible Side Effects:

Like all medicines, Ranitidine Tablets can cause side effects, although not everyone gets them.

The safety of ranitidine has been assessed in children aged 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults. There are limited long term safety data available, in particular regarding growth and development.

Some patients find they are allergic (hypersensitive) to ranitidine. This may occur after one dose:-

•    Difficulty in breathing (including sudden wheeziness ortightness of the chest).

•    Fever or feel faint (especially on standing).

•    Skin rash or hives, swollen or lumpy skin (including eyelids, face and lips).

If you experience any of these side effects stop taking the tablets and contact your doctor immediately.

Uncommon (affects I in 100 people):

The following may occasionally occur particularly when you first start taking the tablets.

•    Headache

•    Dizziness

•    Muscle and joint pain

• Swelling or discomfort of the breasts in men

•    Chest pain

•    having blurred vision.

•    Skin rash

You should contact your doctor if these are troublesome or continue.

Rare (affects up to I in 1000 people):

•    Slow or irregular heartbeat.

•    Unusual tiredness.

•    Loss of appetite.

•    Changes in blood cells, resulting in you bruise easily, have more nose bleeds, sore throats or infections.

•    Involuntary movements (usually reversible).

•    Changes to liver function.

•    Diarrhoea has been reported when ranitidine is taken with antibiotics such as amoxicillin and metronidazole.

•    Inflammation of the blood vessels.

•    Headaches, sometimes severe.

If you have any of the above side effects you should contact your doctor or pharmacist.

Very rare (affects less than I in 10,000 people):

•    Inflammation ofthe kidneys.

•    Inflammation of the liver and jaundice (causing yellowing of the skin and eyes and dark coloured urine).

•    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 depressed, confused, seeing or hearing unexplained things (hallucinations).

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

•    flushing or marks on your skin that look like targets.

•    unexplained hair loss.

•    impotence

•    breast tenderness and/or breast enlargement.

•    breast discharge.

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

5.    Howto store Ranitidine Tablets:

Keep out ofthe reach and sight of children.

Keep in the original packaging.

Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

6.    Further information

What Ranitidine Tablets contain:

The active substance in this medicine is called ranitidine hydrochloride and is available as I50mg and 300mg strengths.

The I50mgtablets contain I50mg ranitidine.

The 300mg tablets contain 300mg ranitidine.

The other ingredients are; Croscarmellose sodium, magnesium stearate, microcrystalline cellulose (E460), basic butylated methacrylate copolymer, hypromellose, Macrogol, purified talc, titanium dioxide (EI7I).

What Ranitidine Tablets look like and contents of the pack:

Both the I50mg and 300mg tablets are film coated and white to yellowish in colour.

Ranitidine tablets are available in blister packs of 30 and 60 tablets.

The I50mg tablets are circular in shape, and marked with 'R' and Teithersideof score line.

The 300mg tablets are oblong in shape and are marked with 'R' and 'J'eitherside ofthe score line.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 0RP, UK

PL 20395/0007 PL 20395/0008

|POM|

This leaflet was last revised in March 2014.