Ranitidine 150mg Tablets
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• Breast enlargement in men
• Impotence (inability to attain or sustain an erection for the performance of a sexual act)
• Reversible mental confusion
• Headache
• Dizziness
• Erythema multiforme (a red rash caused by hypersensitivity to a drug or disease or other allergen)
• Blood count changes (leucopenia (abnormally low number of white blood cells in the circulating blood), thrombocytopenia (abnormally small number of platelets in the blood))
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store Ranitidine Tablets
Keep out of the reach and sight of children.
Store tablets in the original package and do not use after the expiry date stated on the label. 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.
If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
6. Further information
What Ranitidine Tablets contain
Active substance is ranitidine hydrochloride equivalent to ranitidine 150mg or 300mg.
The other ingredients are microcrystalline cellulose, hypromellose, croscarm-ellose sodium, castor oil, colloidal anhydrous silica, purified talc, magnesium stearate, ferric oxide yellow (El 72) and titanium dioxide (El 71). (see section 2 Important information about some of the ingredients of ranitidine tablets)
What Ranitidine Tablets look like and contents of the pack
Ranitidine Tablets are round, film-coated, creamish yellow tablets. The 150mg and 300mg tablets are embossed with "MR150" or "MR300".
The ranitidine tablets are available in blister sheets of 5, 7, 8, 10, 14, 15,
1 6, 20, 24, 28, 30, 32, 40, 45, 48, 50, 56, 60, 64, 72, 75, 80, 88, 90, 96, 98, 100, 105, 112, 120 and 150 tablets (not all pack sizes may be marketed).
This leaflet was last approved in March 2010
| POM |
Ranitidine 150mg: PL No.: 21880/0091 Ranitidine 300mg: PL No.: 21880/0092
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK.
E-mail : info@medreich.co.uk 121XXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER Ranitidine 150mg Tablets Ranitidine 300mg Tablets
(ranitidine hydrochloride)
Read all of this leaflet carefully before you start taking this 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 this leaflet, please tell your doctor.
In this leaflet:
1. What Ranitidine Tablets are and what they are used for
2. Before you take Ranitidine Tablets
3. How to take Ranitidine Tablets
4. Possible side effects
5. How to store Ranitidine Tablets
6. Further information
1. What Ranitidine Tablets are and what they are used for
Ranitidine Tablets belong to a group of medicines called "H2-antagonists". They reduce the amount of acid in your stomach and are used to treat:
• ulcers in the stomach or first part of the small intestine (duodenum)
• problems caused by acid in the food passage (reflux oesophagitis)
• Zollinger-Ellison syndrome and ulcers caused by serious illnesses.
2. Before you take Ranitidine Tablets
Do not take Ranitidine Tablets if you have:
• an allergy (hypersensitivity) to ranitidine or any of the other ingredients
in the product ("see section 4 'possible side effects' "), ("see Section 6 'What Ranitidine Tablets contain' ")
• porphyria (a rare inherited metabolism disorder which causes abdominal pains).
Take special care with Ranitidine Tablets
Speak to your doctor before taking Ranitidine Tablets if you have:
• a history of stomach cancer in your family
• kidney problems.
Please be aware that Ranitidine Tablets may give a false result for liver function tests.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following as they may not work effectively if taking Ranitidine:
• ketoconazole (an antifungal agent)
• Drugs used for HIV: Atazanavir, Delaviridine
• Gefitnib (drug used in the treatment of certain types of cancer)
• Drugs which induce sleep (Triazolam, Midazolam)
• Theophylline (used in the treatment of astma)
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• Lidocaine (local anesthetic)
• Phenytoin (treatment of epilepsy)
• Propanolol (treatment of hylosents)
• glipizide (used to treat diabetes)
• theophylline (used in the treatment of asthma)
• procainamide (for irregular heartbeat)
• Blood thining agent: Warfarin
Taking Ranitidine Tablets with food and drink
Adsorption is not significantly impaired by food or antacids
Pregnancy and Breast Feeding
Ask your doctor for advice before taking Ranitidine Tablets if you are pregnant, planning to become pregnant or are breast-feeding.
Important information about some of the ingredients of Ranitidine Tablets
These tablets contain Castor Oil- May cause stomach upsets and diarrhoea.
3. How to take Ranitidine Tablets
Ranitidine Tablets should be swallowed whole with a glass of water.
Always take Ranitidine Tablets exactly as your doctor has told you. The usual doses are as follows:
Adults
Treatment of stomach or duodenal ulcers:
Take one 150mg tablet twice a day, one in the morning and one in the evening OR one 300mg tablet at bedtime.
For maintenance, the usual dose is 1 50mg at bedtime.
Recommended duration of treatment is 4 to 8 weeks Treatment of reflux oesophagitis:
Take one 150mg tablet twice a day OR one 300mg tablet at bedtime.
In severe oesophagitis, take one 150mg tablet four times a day for a maximum of 12 weeks.
Zollinger-Ellison syndrome:
Take one 150mg tablet three times a day. This may be increased as necessary Patients with Kidney disease:
Your doctor may prescribe a lower dosage and will tell you how long to take the tablets for. The dose is usually 150mg at night for 4-8 weeks but will depend on the type and severity of your disease. If healing has not occurred, take 150 mg twice daily, followed by 150mg at night for maintenance.
Elderly
In patients with normal renal function, the doses of Ranitidine Tablets are the same as for younger adults.
Children
The recommended oral dose for the treatment of peptic ulcer is 4 mg/kg/day to 8mg/kg/day administered as two divided doses, to a maximum dose of 300 mg ranitidine per day.
121XXXX
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If you take more Ranitidine Tablets than you should
If you or someone else swallows more tablets than they should, contact a doctor or the nearest hospital emergency department immediately, taking any remaining tablets and the box if possible.
If you forget to take Ranitidine Tablets
If you miss a dose, take your dose as soon as you can, then carry on as before. Do not take an extra dose to make up for the forgotten one.
If you stop taking Ranitidine Tablets
Take Ranitidine Tablets as directed for as long as your doctor has told you. Do not stop taking them, even if you feel better, because your symptoms may return.
If you have any further questions on the use of th is product, ask your doctor or pharmacist.
4. Possible side effects
Like all other medicines, Ranitidine Tablets can cause side effects, although not everybody gets them.
You may suffer an allergic reaction; 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 in the chest
• Swelling on 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
The following have also been reported:
Rare Side Effects:
• Liver inflammation, which might cause one or more of the following:
• Nausea: (feeling sick)
• Vomiting: (being sick)
• Loss of appetite
• Generally feeling unwell
• Fever
• Itching
• Yellowing of the skin and eyes
• Dark coloured urine
• Unusual tiredness, shortness of breath or tendeacy to infections or bruising which can be caused by upsets to "blood counts"
Very Rare Side Effect
• Anaphylactic Shock (severe allergic reaction)
• Slow or irregular heart beat
• Severe stomach pain cause by inflamed pancreas
• Diarrhoea
• Feeling of depression
• Hallucinations
• Blurred Vision reversible
• Pains in muscles or joints
• Uncontrolled movements, inflammation of blood vessels (vasculitis)
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