Ranitidine 300mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ranitidine I50mg and 300mg Tablets
Ranitidine Hydrochloride
Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist or nurse .
• This medicine has been prescribed for you only. Do not pass it on to 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:
1. What Ranitidine Tablets are and what they are used for
2. What you need to know before you take Ranitidine Tablets
3. How to take Ranitidine Tablets
4. Possible side effects
5. How to store Ranitidine Tablets
6. Contents of the pack and other 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 ofacid produced in your stomach.
For adults (including the elderly) Ranitidine is used for:
• The treatment and prevention of ulcer disease ofthe stomach and duodenum (the part ofthe gut the stomach empties into).
• The treatment of ulcers associated with infection by the germ Helicobacterpylori when used with antibiotics.
• The prevention of ulcer disease associated with drugs used to treat arthritis (nonsteroidal anti-inflammatory 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 managementofZollinger-Ellison Syndrome (a disease ofthe pancreas which causes excess acid production in the stomach and can cause ulceration ofthe 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 (3to 18 years) Ranitidine is used to:
• heal ulcers in the stomach, or part of the gut it empties into (duodenum)
• heal and stop problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both ofthese can cause pain or discomfort sometimes known as 'indigestion1, 'dyspepsia' or 'heartburn'.
2. What you need to know before you take Ranitidine Tablets
Do nottake Ranitidine Tablets:
• If you are allergic to the active ingredient ranitidine or any of the other ingredients of Ranitidine Tablets (listed in section 6)
Warnings and precautions
Checkwith your doctor or pharmacist before taking your medicine if:
• you have stomach cancer
• you have kidney problems. You will need to take a different amount of Ranitidine Tablets.
• You have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (NSAID) medicines
• you have a rare condition called acute porphyria
• you are over 65 years old
• you have lung disease
• you are diabetic
• you have any problems with your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
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Other medicines and Ranitidine tablets:
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.
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 ofthe 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, for thinning 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 a medicine 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 to your 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 Breast-feeding:
Ifyou are pregnant, might become pregnant or are breast-feeding, you should not take this medicine unless your doctor advises it is essential.
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 ofthe other ingredients, do not take these tablets. Contact your doctor or pharmacist for further advice.
3. How to take Ranitidine Tablets
Always take this medicine exactly as your doctor has told you. Checkwith your doctor or pharmacist ifyou are not sure.
Ranitidine Tablets should be taken by mouth. Swallow your tablets 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 I50mgtwice 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. Preventulcersbleeding - I50mgtwicedaily. Oesophageal reflux (heart burn) - I50mg twice daily or 300mg at night.
Oesophagitis (inflammation) - I50mg twice daily or 300mg at night. Long term treatment I50mg twice daily. If oesophagitis is severe dosage may be increased to I50mg four times daily.
Chronic indigestion - I50mg twice daily. Zollinger- Ellison Syndrome - I50mgthree times daily increased if necessary up to 6g daily in divided doses.
Mendelson's Syndrome - I50mgtwo hours before general anaesthetic and also I50mg the evening before the operation.
In childbirth - I50mg at start of labour, then I50mg at 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 ofyour kidney problems
Children from 3toll 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 dayforadurationof4weeks. Forthose patients with incomplete healing, another 4 weeks oftherapy 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. Ifyou take too many or someone else accidentally takes your medicine contact your doctor, pharmacist or nearest hospital straight away.
Take the medicine pack or any remaining medicine with you so that the doctor knows what you have taken.
If you forget to take Ranitidine Tablets:
Tryto take Ranitidine Tablets as prescribed. However, if you miss a dose take another as soon as you remember and the next dose atthe usual time. Do not take a double dose to make up for a forgotten dose.
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 this medicine, askyour doctor or pharmacist.
4. Possible Side Effects:
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may happen with this medicine.
The safety of ranitidine has been assessed in children aged 0tol6 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.
Stop taking Ranitidine tablets and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:
Allergic reactions, the signs may include:
• Chest pain, shortness of breath, wheezing or difficulty in breathing
• Unexplained fever and feel faint (especially on standing)
• Rash.hivesoritchingoftheskin.
• Swelling of your face, lips, tongue or other parts ofthe body.
• Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests.
• Severe stomach pain, this may be a sign of something called 'pancreatitis'
• A slow or irregular heartbeat.
Ifyou experience any ofthese side effects stop taking the tablets and contact your doctor immediately.
Check with your doctor at your next visit if you notice any of the following:
Uncommon (may affect up tolinlOO people):
• Stomach pain
• Constipation
• Feeling sick (nausea)
Rare (may affect up tolinlOOO people):
• Skin rash.
Rare side effects that may show up in your blood tests:
• Increase of serum creatinine in the blood (kidney function test)
• Changes to liver function
Checkwith your doctor as soon as possible if you notice any ofthe following:
Very rare (may affect up tolinl0,000 people):
• Inflammationofthekidneys
• Your liver can become swollen. This can lead to: nausea (feeling sick), or vomiting (being sick), loss of appetite or generally feeling unwell, itching, fever, yellowing ofthe skin and eyes or 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
• Headache (sometimes severe)
• Feeling dizzy or having blurred vision
• Your small blood vessels can become swollen (known as 'vasculitis') Signs ofthis can include: a rash, swollen joints or kidney problems
• Diarrhoea
• Feeling depressed, confused, seeing or hearing unexplained things (hallucinations)
• Your 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety ofthis medicine
5. How to store Ranitidine Tablets:
Keep out of the sight and reach 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 ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protectthe environment.
6. Contents of the pack and other information
What Ranitidine Tablets contain:
The active substance in this medicine is called ranitidine hydrochloride and is available as I50mg and 300mg strengths.
The I50mg tablets 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 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 'I' either side of score line. The 300mg tablets are oblong in shape and are marked with 'R' and 'J' either side ofthe score line.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 ORP, UK
PL 20395/0007 PL 20395/0008
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This leaflet was last revised in May 2015.