Ranitidine Tablets 150mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _ _ _ _ n nogen Pharmal
'Read all of this leaflet carefully before you start faking this medicine because it contains important information for you.
L Keep this leaflet. You may need to read it I again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
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only. Do not pass it on to others. It may harm them, even if their signs of illness are the same I as yours.
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or pharmacist or nurse. 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 i 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 Tablets belong to a group of medicines palled H2-receptorantagonists which act to decrease the natural production of acid in the ptomach.
Ranitidine Tablets have been prescribed to treat ^ny of the following:
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I (duodenal ulcer) including those associated I with infections caused by Helicobacterpylori.
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pipe causing pain, inflammation and heartburn (oesophageal reflux disease)
I in the pancreas (Zollinger-Ellison syndrome)
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be caused by non-steroidal anti-inflammatory medicines (NSAIDs) which are used to treat pain, fever and inflammation
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acid and secretions is considered beneficial I e.g. for indigestion symptoms (e.g. stomach i pain or discomfort, heartburn), which are related to meals and disturbed sleep
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, damage to the lungs in patients at risk of ' breathing in stomach fluid during surgery.
Children (3-18years):
|* Peptic ulcers
• Oesophageal reflux disease (see above)
For dosage see Section 3 How to take i Ranitidine Tablets.
possible causes of your symptoms (such as stomach cancer) should be investigated before taking or continuing to take Ranitidine Tablets
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• Are diabetic
• Have any problems with your immune system.
Other medicines and Ranitidine Tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription and herbal medicines. This is because Ranitidine Tablets can affect the way some other medicines can work. Also some other medicines can affect the way Ranitidine Tablets work.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Lidocaine, a local anaesthetic
• Propranolol, procainamide or n-acetylprocainamide, for heart problems
• Diazepam, for worry or anxiety problems
• Phenytoin,forepilepsy
• Theophylline, for breathing problems (asthma)
• Warfarin, for thinning your blood
• Glipizide, for lowering blood glucose
• Atazanavir or delaviridine, for treating HIV infection
• Triazolam, for insomnia
• Gefitinib, for lung cancer
• Ketoconazole, an anti-fungal medicine, sometimes used for treating thrush.
Midazolam is a medicine that may be given to you just before an operation. Tell the doctor you are taking Ranitidine Tablets before your operation in case he or she wants to give you Midazolam.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breast-feeding. You should not take this medicine unless your doctor advises it is essential.
Driving and using machines
These tablets can cause some people to feel dizzy or drowsy. If you are affected do not drive or operate machinery.
3. HOW TO TAKE RANITIDINE TABLETS
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIDINE TABLETS
Do not take Ranitidine Tablets:
I or any of the other ingredients of Ranitidine Tablets.
Warnings and precautions
[Talk to your doctor, or pharmacist or nurse before taking Ranitidine Tablets if you:
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I kidney disease •
are elderly and are taking a non-steroidal antiinflammatory drug (NSAID) e.g. aspirin, ibuprofen, naproxen, diclofenac
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I changed indigestion symptoms e.g stomach i pain or discomfort, heartburn - because other
Always take Ranitidine Tablets exactly as your doctor has instructed you. You should checkwith your doctor or pharmacist if you are unsure.
The usual dosage is 150mg twice daily. As an alternative, 300mg can be taken as a single dose at bedtime.
Elderly:
The normal adult dosage may be used unless the patient has kidney problems.
Patients with duodenal ulcers associated with NSAID treatment: 150mg twice daily during NSAID treatment.
Patients with duodenal ulcers associated with Helicobacter pylori:
The usual dose ofranitidine 150mg should be given togetherwith amoxicillin 750mg three times daily and metronidazole 500mg three times daily for a period of two weeks. Ranitidine should then be continued for two weeks.
Patients with oesophageal reflux disease:
150mg twice daily or 300mg at bedtime for 8to12 weeks. The dose may be increased by your doctor. Ranitidine is not recommended for long term treatment of patients with unhealed oesophagitis.
Patients with Zollinger-Ellison syndrome:
Initially 150mg three times daily. The dose may be increased up to 6000mg daily.
Prevention of Mendelson's syndrome:
|150mg two hours before induction ofanaesthesia can be given to patients at risk from acid Aspiration. An additional dose of 150mg given the night before anaesthesia is desirable.
Iln obstetric patients during labour, 150mg dose should be given at 6 hourly intervals. Patients needing emergency anaesthesia should be given a |non-particulate antacid, while maintaining standard precautions for the prevention of inhalation of gastric contents.
ko prevent stress ulceration (in seriously ill patients) and to prevent ulcers from bleeding:
^hen oral administration is appropriate 150mg twice daily may be given.
Patients with kidney problems:
Il50mg at bedtime for 4to8 weeks, as a maintenance dose, if necessary, if the ulcer has not healed after treatment, 150mg [twice daily should be taken. If necessary, followed by a maintenance treatment of 150mg at night.
Children 12 years and over:
For children 12 years and over after the adult plosage is given.
|Children 3 -11 years orweighing more than 30 kg:
fvour doctor will work out the correct dose based on
Check with your doctor as soon as possible if you notice any of the following:
Very rare (affects less than 1 in 10,000
people)
• 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 i likely to bruise or get an infection
• Feeling depressed, confused, seeing or hearing unexplained things (hallucinations)
• Headache (sometimes severe)
• Feeling dizzy or having blurred vision
• Yourjoints or muscles are painful or swollen or you cannot control their movement
• Your small blood vessels can become swollen (known as vasculitis). Signs of this can include a rash, swollen joints or kidney problems
• Your liver can become swollen. This can lead to nausea (feeling sick) or vomiting (being sick), loss of appetite or generally felling unwell, itching, fever, yellowing ofthe skin and eyes or dark coloured urine
• Flushing or marks on your skin that look like targets
• Unexplained hair loss
• Impotence
• Breast tenderness and/or breast enlargement
• Breast discharge
• Increase of serum creatinine in the blood (kidney function test)
• Changes to liver function
• Diarrhoea.
[Oesophageal reflux disease: 5mg/kg to 10mg/kg/day administered in two divided doses up |to a maximum of600mg (this is likely to apply to heavier children or adolescents with severe Symptoms).
Ifyou take more Ranitidine Tablets than you should
This medicine is to be taken at regular intervals, as determined by the doctor. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor jimmediately. Take your tablet pack with you.
[Ifyou stop taking Ranitidine Tablets
You may feel better after a few days, but you Should keep taking your tablets until the prescribed course is finished. Your symptoms may come back if you stop your treatment too soon.
ifyou forget to take Ranitidine Tablets
|lf you have forgotten to take a dose, leave out that dose completely. Take your next dose at the Inormal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.
Reporting ofside effects
Ifyou 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 of this medicine.
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Do not store above 25°C. Store in the original package.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment. Keep out of the sight and reach of children.
What Ranitidine Tablets contain:
Ranitidine Tablets 150mg and 300mg contain the active substance ranitidine hydrochloride 150mg and 300mg respectively.
|Like all medicines, Ranitidine Tablets can cause side effects. Although not everybody gets them.
Stop taking Ranitidine Tablets and see a doctor immediately, ifyou notice any ofthe following perious side effects, you may need urgent medical treatment:
|* Rash, itching or hives on the skin
• Swelling of your face, lips, tongue or other parts of the body
• Chest pain, shortness of breath, wheezing or 1 having trouble breathing
[• Unexplained fever and feeling faint, especially when standing up
|* 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 a condition called 'pancreatitis'
[• A slow or irregular heart beat.
|Check with your doctor at your next visit if you
notice any of the following:
Uncommon (affects less than 1 in 100 people) p Stomach pain
• Constipation
|* Feeling sick (nausea).
iRare (affects up to1in 1,000 people) m Skin rash.
The other ingredients are:- Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, talc, macrogol 6000, polymethacrylate.
What Ranitidine Tablets look like and contents of the pack:
Ranitidine 150mg Tablets: Circular biconvex, white to yellowish film coated tablets with R1 debossed on one side.
Ranitidine 300mg Tablets: Oblong, white to yellowish film coated tablets with R2 debossed on one side.
Ranitidine 150mg and 300mg Tablets are packed in blister strips in packsizes of: 7, 14, 15, 20, 21, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 240. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacture
Delta Ltd
Reykja Vikurvegi 78 IS-220 Hafnarfjordur Iceland