Ranitidine 300mg Tablets
PATIENT INFORMATION LEAFLET
Ranitidine Hydrochloride 150mg and 300mg Film-Coated Tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, please ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
J What Ranitidine is and what it is used for M Possible side effects
2 What you need to know before you take Ranitidine O How to store Ranitidine
3 How to take Ranitidine □
What Ranitidine is and what it is used for
Ranitidine may interfere with the actions of other medicines, in particular the following:
Ranitidine belongs to a group of medicines called H2 antagonists, which reduce the amount of acid in your stomach.
■ Medicines for thinning the blood (anticoagulants), such as warfarin
■ Procainamide, used to control an irregular or rapid heart rate
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 Anti-Inflammatory drugs (NSAIDs),(see 'Other medicines and Ranitidine” section)
■ Prevent ulcers in the upper part of the intestine (duodenal ulcer) which may be caused by Non-Steroidal Anti-Inflammatory Drugs (NsAIDs) including aspirin (see "Other medicines and Ranitidine” section) especially in patients with a history of peptic ulcer disease
■ Treat ulcers in the upper part of the intestine (duodenal ulcer) associated with the bacterial infection Helicobacter pylori
■ 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 and relieve symptoms of inflammation of the food pipe (oesophagus), caused by stomach acid which flows back into the food pipe (oesophageal reflux disease). Ranitidine is also used in the long term management of healed inflammation of the food pipe (oesophagitis)
■ Treat long lasting (chronic) episodes of indigestion (dyspepsia), which are related to meals or disturbs sleep but not associated with the above listed conditions
■ Prevent ulcers (known as stress ulcers) from bleeding in seriously ill patients
■ Prevent ulcers in the stomach (gastric ulcer) or upper part of the intestine (duodenal ulcer) from bleeding again
■ Prevent damage to the lungs caused by breathing in stomach fluids (acid aspiration, Mendelson's syndrome) whilst under anaesthetic or in women during childbirth
Children aged 3 - 18 years
■ Treat (short term) ulcers in the stomach (gastric ulcer) or upper part of the intestine (duodenal ulcer)
■ Treat and relieve symptoms of inflammation of the food pipe (oesophagus), caused by stomach acid which flows back into the food pipe (Gastro-Oesophageal Reflux Disease - GORD)
[2 What you need to know before you take Ranitidine
Do not take if:
■ You are allergic to Ranitidine, other H2 antagonists or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other Information”)
Warnings and precautions
Talk to your doctor before taking Ranitidine if:
■ You are over 40 years of age and recently had indigestion (dyspepsia) 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 "How to take Ranitidine”)
■ You have a history of short lived attacks of porphyria (a group of rare inherited or acquired disorders where there is a problem with the production of haem (used to make haemoglobin in red blood cells) within the body). Your doctor may advise you not to take Ranitidine
■ You are taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). You should see your doctor regularly, in particular if you are older or you have a history of ulcers
■ You are older, have long term lung disease, diabetes or have a weakened immune system. You may have an increased risk of developing inflammation of the lungs (pneumonia) whilst taking Ranitidine
Other medicines and Ranitidine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
In particular tell your doctor or pharmacist if you are taking the following:
■ Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), often used to treat arthritis or as pain relievers e.g. indometacin, aspirin
Ranitidine 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
Ranitidine 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 oesophagus, stomach, or small intestine)
Taking Ranitidine with food
Ranitidine can be taken with or without food.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Ranitidine should only be used if considered essential by your doctor.
Breast-feeding
If you are breast-feeding, the use of Ranitidine should be avoided unless essential as Ranitidine is passed into breast milk.
Driving and using machines
There are no reports of Ranitidine interfering with the ability to drive or operate machinery.
Ranitidine contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
How to 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.
■ These tablets are to be taken orally.
■ The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Adults (including older people)
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):
■ The usual dose is 150mg twice a day or a single dose of 300mg at night.
■ 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 bacterial infection 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 Ranitidine should continue for a further two weeks.
Gastro-Oesophageal Reflux Disease - GORD:
■ The usual dose is 150mg twice a day or 300mg at bedtime for up to eight weeks or, if required 12 weeks.
Continued....
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