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KEEP ALL MEDICATION OUT OF THE REACH OF CHILDREN

BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULY. This leaflet contains a summary of the Information about your medicine, Ranitidine Tablets BP.

Your medicine is in the form of a coated tablet. There are two strengths of Ranitidine Tablets BP available, 150 mg (marked "G" on one side and "00" over "30" on the other) and 300 mg (marked "G" on one side and "0031" ON THE OTHER). One 150 mg tablet contains 168 mg Ranitidine Hydrochloride equivalent to 150 mg Ranitidine. Whilst one 300 mg tablet contains 336 mg Ranitidine Hydrochloride equivalent to 300 mg Ranitidine. Each tablet also contains microcrystalline cellulose and magnesium stearate and the 300 mg tablet also contains croscarmellose sodium. The coating contains methylhydroxypropyl cellulose, titanium dioxide (E171), polydextrose, triethyl citrate and polyethylene glycol.

Ranitidine Tablets BP 150 mg are available in blisters packs of 60 tablets and Ranitidine Tablets BP 300 mg in blister packs of 30 tablets.

Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL.

Ranitidine belongs to a group of medicines called H₂ antagonists. These medicines work by reducing the amount of acid in the stomach.

For adults (including the elderly) Ranitidine is used to:

-    heal and prevent ulcers in the stomach or the part of the gut it empties into, the duodenum

-    prevent ulcers from bleeding

-    heal and prevent problems caused by acid in the food pipe (oesophagus) or to much acid in the stomach, which can cause pain or discomfort known as "indigestion", "dyspepsia" or "heartburn"

-    prevent ulcers, which can be a side effect of some medicines used to treat arthritis especially in women during labour

-    clear up infection with the germ Helicobacter pylori when used with antibiotics

For children (3 to 18 years) Ranitidine is used to:

•    heal ulcers in the stomach, or the part of the gut it empties into (the duodenum)

•    heal and stop problems caused by acid in the food pipe (oeosophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as "indigestion", "dyspepsia" or "heartburn".

If you are not sure why you are taking these tablets ask your doctor.

You must tell your doctor before taking your medicine if:

-    you have taken a medicine containing Ranitidine before and suffered an unusual or allergic reaction

-    you are pregnant, intend to become pregnant or are breast feeding

-    you suffer from kidney disease

-    you have a rare condition called porphyria

Do not take these tablets if you may be allergic to any of the ingredients especially microcrystalline cellulose.

After a few days you should feel much better but do not stop taking the tablets or the pain and discomfort may return. If you are taking Ranitidine Tablets BP with non-steroidal antiinflammatory drugs (NSAID) your doctor will check your condition regularly.

Swallow the tablet whole with a drink of water.

ADULTS

The usual dosage is either one Ranitidine Tablet BP 150 mg in the morning and one tablet in the evening, or for some conditions one Ranitidine Tablet BP 300 mg at bedtime. Depending on your symptoms, your doctor may wish to prescribe a dose of 300 mg twice daily.

If you have the germ Helicobacter pylori the doctor will also prescribe antibiotics to be taken for two weeks whilst taking Ranitidine tablets BP, relief of your symptoms will usually be rapid. The treatment should last for at least 4 weeks and up to 8 weeks. Most ulcers will have healed by this time. If you have oesophagitis treatment may last for up to 12 weeks and your doctor may prescribe Ranitidine Tablets BP 150 mg four times daily. After your ulcer has healed, your doctor may prescribe a maintenance dose of 150 mg at bedtime, especially if you have had an ulcer return.

To prevent the breathing in of acid from the stomach during general anaesthesia a dose of 150 mg Ranitidine may be given the evening before the operation and 150 mg two hours before the anaesthetic. Or during labour, a dose of 150 mg Ranitidine may be given every six hours.

CHILDREN

For children 12 years and over the adult dosage is given.

For children over 30 kg in weight and from 3 to 11 years:

Your doctor will work out the right dose for you based on your child's weight Treatment of stomach or duodenal (small intestine) ulcers:

The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks.

Treatment of heartburn due to too much acid:

The usual dose is 2.5mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart.

If you forget to take a dose:

If you forget to take a dose take is as soon as you remember. If it is almost time for your next dose though, do not double the dose just carry on as before.

If you take too much:

It is important to stick to the dose on the label of your medicine. Taking more medication than this is unlikely to be dangerous unless many tablets are taken at once. In that case, do not delay, contact your doctor or hospital emergency department immediately.

CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?

Along with its needed effects, a medicine may cause unwanted effects. Most people taking this medicine find it causes them no problems. A few people may be allergic to some medicines; if any of the following side effects come on soon after taking these tablets, stop the tablets and tell your doctor immediately; . sudden wheeziness or tightness of the chest . swelling of the eyelids, face or lips; with or without a lumpy skin rash ("hives") anywhere on the body . unexplained fever . feeling faint, especially on standing up.

Also check with your doctor as soon as possible if any of these uncommon side effects are noticed: Rare . skin rash (red spots) . nausea (feeling sick), loss of appetite with or without jaundice (yellow colour of skin and whites of the eyes) . confusion . slow or irregular heart beat . unusual tiredness, shortness of breath, or tendency to infections, or bruising, which can be caused by upsets to "blood counts" . severe stomach pain rarely caused by inflamed pancreas.

Also check with your doctor at your next visit if any of these side effects are noticed: Uncommon . headache . dizziness. Rare . pains in muscles or joints . feelings of depression . hallucinations . breast tenderness and/or enlargement in men.

Sometimes if your doctor has prescribed antibiotics with Ranitidine, these can cause diarrhoea.

The side-effects seen in children treated for Indigestion, Heartburn or Dyspepsia are similar to those in adults. There is limited information available about the long-term effects.

If you should suffer from any of these unwanted effects or any undesired effect please tell your pharmacist or doctor.

DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE CARTON. REMEMBER this medicine was prescribed by your doctor for you. DO NOT give it to others.

It may harm them. Store out of reach of children.

Store below 25⁰C in a dry place. Protect from heat and moisture.

Date of Revision: October 2013