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PATIENT INFORMATION LEAFLET

Ranitil 150mg Tablets & Ranitil 300mg Tablets

(Ranitidine Hydrochloride)

[1 What Ranitil Tablets are and what they are used for

Ranitil belongs to a group of medicines called H2 antagonists, which reduce the amount of acid in your stomach.

You may have been given ranitidine previously by your doctor under a different brand name. However the effect of the Ranitil will be the same.

This medicine is used to:

■    treat ulcers in the stomach (gastric ulcer) or upper part of the intestine (duodenal ulcer), including those associated with non-steroidal antiinflammatory medicines (NSAIDs), often used to treat arthritis and as pain killers (see 'Taking other medicines)

■    prevent ulcers which may be caused by nonsteroidal anti-inflammatory drugs (NSAIDs)

(see above and 'Taking other medicines)

■    treat ulcers in the upper part of the intestine (duodenal ulcer) associated with the bacteria Helicobacter pylori when used with antibiotics

■    treat ulcers which develop after an operation

■    treat a rare disorder which causes excessive production of acid in the stomach due to increased levels of the hormone gastrin (Zollinger-Ellison syndrome)

■    treat inflammation of the food pipe (oesophagus), caused by stomach acid which flows back into the food pipe (oesophageal reflux disease). The most common symptom is heartburn. Ranitil is also used in the long term management of healed inflammation of the food pipe (oesophagitis)

■    treat long lasting (chronic) episodes of indigestion, which are related to meals or disturbs sleep but not associated with the preceding conditions

■    prevent ulcers (known as stress ulcers) from bleeding in seriously ill patients

■    prevent ulcers in the stomach and upper part of the intestine (peptic ulcer) from bleeding again

■    prevent damage to the lungs caused by breathing in stomach fluids (acid aspiration) whilst under anaesthetic or in women during childbirth

Children aged 3 - 18 years

■    treat (short term) ulcers in the stomach and upper part of the intestine (peptic ulcer)

■    treat stomach acid which flows back into the food pipe (oesophagus) (gastro-oesophageal reflux disease- GORD)

[2 Before taking Ranitil Tablets

Do not take if:

■    you are allergic to ranitidine or any of the other ingredients (listed in Further Information on the back page) An allergic reaction can include a rash, itching or shortness of breath

Take special care

Talk to your doctor before taking if:

■    you are over 40 and recently had indigestion for the first time or your symptoms have changed

■    you have severe kidney problems. The dose of this medicine will need to be adjusted (see section 3)

■    you have a history of short lived attacks of a rare illness called porphyria. Your doctor may advise you not to take Ranitil

■    you are or think you may be pregnant

■    you are breast feeding

■    you are taking non-steroidal anti-inflammatory drugs (NSAIDs). You should see your doctor regularly, in particular if elderly or you have a history of ulcers

■    you are elderly, have long term lung disease, diabetes or have a weakened immune system caused by certain diseases or treatments. You may have an increased risk of developing inflammation of the lungs (pneumonia) whilst taking Ranitil

Taking other medicines

Tell your doctor or pharmacist about any medicines

you are taking or have recently taken, even those

bought without a prescription.

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

■    Non-steroidal anti-inflammatories (NSAIDs), often used to treat arthritis or as pain killers e.g. indometacin, aspirin

Ranitil may interfere with the actions of other medicines, in particular the following:

■    Medicines for thinning the blood (anticoagulants), such as warfarin

■    Procainamide, used to control an irregular or rapid heart rate

Ranitil may increase the absorption of the following:

■    Triazolam, used to treat difficulty in sleeping

■    Midazolam, usually used to sedate patients before surgery

■    Glipizide, used for diabetes

Ranitil may decrease the absorption of the following:

■    Ketoconazole, used to treat skin and fungal infections

■    Atazanavir and delaviridine, used to treat HIV infection

■    Gefitnib (used as a cancer treatment)

■    Sucralfate used to treat ulcers of the esophagus, stomach, or small intestine

Pregnancy and Breast-feeding

If you are pregnant, planning to become pregnant or you are breast-feeding, talk to your doctor before taking this medicine. Ranitil should only be used if considered essential by your doctor.

Driving and using machines

There are no reports of Ranitil interfering with the ability to drive or operate machinery.

Important information about some of the ingredients of this medicine:

This medicine contains lactose: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

|3| How to take Ranitil Tablets

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure. The doses stated below are guidelines only.

■ Ranitil Tablets are to be taken orally with a glass of water

Adults (including the elderly) and adolescents 12 years and over

The usual dosage is 150mg twice a day, taken in the morning and evening.

Ulcers in the stomach (gastric ulcer) or upper part of the intestine (duodenal ulcer):

As an alternative to the usual dose, your doctor may decide to give a single bedtime dose of 300mg

In most cases gastric and duodenal ulcers will heal within four weeks. If this is not the case your doctor will most likely extend the course for a further four weeks.

Post operative ulcers:

The usual dosage is 150mg twice a day. In most cases, post operative ulcers will heal within four weeks.

Ulcers associated with taking NSAID medicines:

The usual dosage is 150mg twice a day. Treatment may last eight weeks.

To prevent NSAID associated ulcers:

The usual dose is 150mg twice a day with NSAID therapy.

Ulcers in the upper part of the intestine (duodenal ulcer) associated with the bacteria Helicobacter pylori:

The usual dosage is 150mg twice a day or 300mg at bedtime. This may be given with the antibiotics amoxicillin 750mg (three times a day) and metronidazole 500mg (three times a day) for a duration of two weeks. Treatment with Ranitil should continue for a further two weeks.

Continued....

Inflammation of the food pipe (oesophagus), caused by stomach acid flowing back into the food pipe (oesophageal reflux disease):

The usual dose is 150mg twice a day or 300mg at bedtime for up to eight weeks or, if required 12 weeks.

For more severe inflammation of the oesophagus your doctor may increase the dose up to 150mg four times a day for up to twelve weeks.

For healed oesophagitis, the usual dose is 150mg twice a day.

Excessive production of acid in the stomach due to increased levels of gastrin (Zollinger-Ellison syndrome):

The usual starting dose is 150mg three times a day. Depending on how you respond your doctor may increase this up to 6g a day.

Chronic indigestion:

The usual dose is 150mg twice a day for up to six weeks.

To prevent stress ulcers from bleeding (in seriously ill patients) or ulcers in the stomach and upper part of the intestine (peptic ulcer) from bleeding again:

The usual dose is 150mg twice a day.

To prevent breathing in stomach fluids (acid aspiration) under anaesthetic:

150mg may be given two hours before the induction of a general an anaesthetic and also 150mg the previous night.

To prevent breathing in stomach fluids (acid aspiration) at the start of labour:

150mg may be given followed a further 150mg at 6-hourly intervals.

Patients with severe kidney problems:

Your doctor will reduce your dose if you suffer from severe kidney problems. The usual dose is 150mg tablet given at bedtime for 4-8 weeks.

Duration of treatment:

Even if you feel better, your doctor may decide to continue your treatment with Ranitidine Tablets in order to prevent the pain and discomfort returning. It is important that you keep taking your medicine for as long as you are told to. Do not stop taking the tablets, continue with the full course of treatment that has been prescribed for you.

Children (3 to 11 years):

Ulcers in the stomach and upper part of the intestine (peptic ulcers)

Short term treatment - the usual dose is 4mg/kg to 8mg/kg twice a day, up to a maximum of 300mg Ranitil daily, for 4 weeks.

For patients with complete healing, another 4 weeks or treatment may be required.

Stomach acid which flows back into the food pipe (gastro-oesophageal reflux disease - GORD)

the usual dose is 5mg/kg to 10mg/kg twice a day, up to a maximum of 600mg)

If you take more Ranitil than you should (overdose):

Taking more than it says on the label is unlikely to be dangerous, unless a lot of tablets are taken at once.

In that case, phone your doctor or go to your nearest accident and emergency department straight away.

If you forget to take this medicine:

Take another dose as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose.

|4 Possible side effects

Like all medicines, Ranitil can cause side effects, although not everybody gets them.

If you have an allergic reaction to this medicine see a doctor immediately.

An allergic reaction may include:

■    itching rash (urticaria)

■    swelling of the throat or face

■    fever

■    difficulty breathing, wheezing or dizziness

■    low blood pressure (symptoms may include feeling faint, especially on standing up)

■    chest pain

If you get the following side effects, you should see your doctor as soon as possible.

Uncommon side effects (affecting less than 1 in 100 treated patients)

■    abdominal pain, diarrhoea,constipation,nausea (these symptoms usually improve during continued treatment

Rare side effects (affecting less then 1 in 1000 treated patients)

■    abnormal liver test results

■    skin rash

■    increase in creatinine levels(detected through a blood test)

Very rare side effects (affecting less than 1 in 10,000 treated patients)

■    blood disorders, which can cause weakness, or increase the risk of bruising, bleeding and infections

■    reduced heart rate or heart block

■    inflammation of the pancreas, which can cause severe pain in the abdomen and back

■    headache (sometimes severe)

■    dizziness

■    slower heart beat

■    inflammation of blood vessels, often with skin rash

■    feeling sick or loss of appetite, with or without jaundice (yellowing colour of skin and white of eyes). This may be due to hepatitis

■    blistering of the skin

■    loss of hair

■    joint or muscle pain

■    kidney problems (symptoms may include a change in the amount of urine passed and its colour, nausea, vomiting, confusion, fever and rash)

■    in men, breast tenderness or enlargement or sexual impotence

■    abnormal production of breast milk(in men and women)

The following very rare side effects usually stop once

you stop taking this medicine

■    feeling confused, depressed or seeing or hearing things that are not real (mostly in severely ill and elderly patients)

■    blurred vision (reversible)

■    uncontrolled movements

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

If you have taken all the medicine and still feel unwell, or if you have not taken all the medicine but feel worse, tell your doctor.

Children aged 0 - 16 years

Assessment of the safety of Ranitidine in children aged 0 - 16 years with acid-related disease, showed that it is generally well tolerated. Any side effects were similar to those for adults.

However, there is only limited long term safety data available, in particular regarding growth and development.

How to store Ranitil Tablets

Looking after your medicine

■    Keep out of the reach and sight of children.

■    Do not store above 25°C.

■    Store in the original container.

■    Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

■    If it is out of date or you no longer want it, take it back to the pharmacy.

■    Do not use Ranitil Tablets if you notice anything wrong with the medicine. Talk 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.

Further information

What Ranitil Tablets contains

The active substance is Ranitidine Hydrochloride. Ranitil 150mg Tablets contain 150mg ranitidine and Ranitil 300mg Tablets contain 300mg ranitidine

The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maize starch, sodium starch glycollate (Type A), magnesium stearate, colloidal anhydrous silica, titanium dioxide (E171), lactose monohydrate, hypromellose and macrogol 4000.

What Ranitil Tablets look like and the contents of the pack

Ranitil 150mg Tablets are round, white film-coated tablets with a score mark on one side.

They are available in pack sizes of 20, 50, 60 or 100 tablets.

Ranitil 300mg Tablets are oblong, white film coated tablets with a score mark on both sides.

They are available in pack sizes of 20, 30, 50 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd 3 Howard Road,

Eaton Socon,

St. Neots Cambridgeshire,

PE19 8ET,

UK

Product Licence Numbers:

Ranitil 150mg Tablets - PL 11311/0138 Ranitil 300mg Tablets - PL 11311/0139

Date of last revision:

June 2010

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