Ranitidine 300mg Film-Coated Tablets
Very rare side effects (experienced by less than 1 in 10,000 patients)
• Blood count changes, which could cause you to have an increased risk of infection, or have a tendency to bruise or bleed more easily
• Feeling confused, seeing or hearing unexplained things (hallucinations)
• Headache, nausea, dizziness or blurred vision
• Your small blood vessels can become swollen (known as Vasculitis'). Signs of this can include a rash, swollen joints or kidney problems
• Diarrhoea or constipation
• Flushing or marks on your skin that look like targets
• Unexplained hair loss
• Painful or swollen joints or muscles
• Difficulty controlling muscles
• Impotence
• Breast tenderness, enlargement or discharge.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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: http://www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.
5. HOWTO STORE RANITIDINE TABLETS
Do not store above 25°C.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton and blister foil. 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ranitidine tablets contain
The active substance is ranitidine hydrochloride (150mg or 300mg).
The other ingredients are microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (El71).
What Ranitidine tablets look like and contents of the pack
Ranitidine 150mg Tablets are white, round and film coated with a "K" logo on one side and 150 on the other. Ranitidine 300mg Tablets are white, elongated and film coated with a "K" logo, a score line and 300 on one face and plain on the other.
Ranitidine 150 mg and 300 mg film-coated tablets come in packs of 60 and 30 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder, manufacturer and distributor is Medreich PLC, Warwick House, Plane Tree Crescent, Feltham, TW13 7HF
PL No.: 21880/0023 & 21880/0024
This package leaflet was last revised in March 2013.
POM
©
121XXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
RANITIDINE
150 mg and 300 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please 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 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
This medicine contains Ranitidine. This is known as a histamine H2 antagonist.
It works by reducing the natural production of acid in the stomach.
Ranitidine tablets are used in adults (including the elderly):
• to heal and prevent ulcers in the stomach or, the part it empties into, the duodenum;
• to clear up infections with the germ Helicobacter pylori when used with antibiotics;
• to prevent ulcers from bleeding;
• to heal and prevent problems caused by acid in the gullet (oesophagus) or too much acid in the stomach, which can cause pain or discomfort, sometimes known as "indigestion, dyspepsia or heartburn";
• to prevent ulcers, which can be a side effect of some medicines used to treat arthritis;
• before surgical operations, to prevent acid coming up from the stomach during the anaesthetic.
Ranitidine tablets are used in children aged 3 to 18 years:
• for the short term treatment of peptic ulcer
• to heal and prevent problems caused by acid in the gullet (oesophagus) or too much acid in the stomach, which can cause pain or discomfort, sometimes known as "indigestion, dyspepsia or heartburn";
If you are not sure why you are taking tablets ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIDINE TABLETS
Do not take these tablets if:
• you are hypersensitive (allergic) to ranitidine or any of the other ingredients of Ranitidine film-coated tablets. See section 6 for ingredients.
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if:
• stomach cancer could be responsible for your symptoms. Your doctor will tell you if you can rule this out
• you have a kidney problem
• you have a blood disease
• you have had a stomach ulcer or a duodenal ulcer in the past
• you have a rare illness called porphyria
© -
L
121XXXX
• you have breathing or heart problems
• you have weak immune system
• you suffer from diabetes
• you are taking non-steroidal anti-inflammatories (NSAIDs) e.g., Indometacin, aspirin. This is particularly important in the elderly or those with a history of ulcers. You may require regular supervision.
• you are middle aged or older and have new or recently changed heartburn or indigestion symptoms
If any of these points apply to you, do not take this medicine until you have talked to your doctor. You may need to be given a different medicine or the dose may need to be changed.
Other medicines and Ranitidine tablets:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
This is because Ranitidine tablets can affect the way some other medicines 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:
• Blood thinning medicines e.g. warfarin
• Glipizide, for lowering blood glucose
• Sucralfate, for treatment of peptic ulcer
• Atazanavir or delaviridine, for treating HIV infection
• Triazolam, for sleep problems
• Gefitnib, for lung cancer
• Ketoconazole, an anti fungal medicine.
• Midazolam is a medicine that may be given to you just before you have an operation.
• Procainamide or N-acetylprocainamide, used to treat irregular heartbeat Tell the doctor you are taking ranitidine tablets before your operation in case he or she wants to give you midazolam.
Ranitidine Tablets with food and drink
Ranitidine tablets may be taken before or after meals as instructed by your doctor.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine. Ranitidine should only be used during pregnancy and breast-feeding if considered essential.
Driving and using machines:
Ranitidine tablets have no known effects on the ability to drive or operate machinery. However, when taking Ranitidine tablets you may experience dizziness or drowsiness, confusion and a blurred vision. If you experience any of these side effects, you should consult your doctor before attempting these activities.
3. HOW TO TAKE RANITIDINE TABLETS
Ranitidine tablets should be taken as directed by your doctor.
The tablets should be swallowed whole with a glass of water. Do not break Ranitidine 300mg tablets in half.
Adults (including the elderly) and adolescents (12 years and over)
Depending on the condition you are being treated for, the usual dosage
may be 150mg or 300mg once daily or 150mg twice daily
Your doctor will tell you how long you have to take the tablets for.
Children (3 to 11 years and over 30 kg of weight):
The heal and prevent ulcers in the stomach or the part it empties into the duodenum:
©
The recommend oral dose is 4 mg per kg of body weight per day to 8 mg per kg of body weight per day administered as two divided doses to a maximum of 300 mg Ranitidine per day.
To heal and prevent problems caused by acid in the gullet (oesophagus): The recommend oral dose is 5 mg per kg of body weight per day to 10 mg per kg of body weight per day administered as two divided doses to a maximum of 600 mg Ranitidine per day.
Important points to remember
• Your doctor may reduce your dose when you start to feel better.
• Doctors sometimes prescribe different doses to those described above. If this applies to you, you should discuss it with your doctor if you have not already done so.
• The pharmacist's label on your pack will tell you how much you must take and when to take it. Please read the label carefully.
• Do not take more than your doctor has recommended.
• If you have the impression that the effect of Ranitidine film-coated tablets is too strong or too weak, talk to your doctor or pharmacist.
• It is important that you keep taking the medicine until you finish the full course of treatment prescribed.
If you take more Ranitidine film-coated tablets than you should:
You should only take the dose that your doctor or pharmacist has told you. If you have taken too much tell your doctor or hospital casualty department straight away. Take your tablet pack with you.
If you forget to take Ranitidine film-coated tablets:
Do not take a double dose to make up for forgotten individual doses. Take your next dose at the normal time.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine tablets can cause side effects, although not everybody gets them.
Serious Allergic Reactions
If you experience any of these reactions, stop taking the medicine and seek medical help immediately:
• 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 having trouble breathing.
• Unexplained fever and feeling faint, especially when standing up.
Other Serious Side Effects
• Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests.
• Hepatitis (swollen liver). This can lead to feeling sick or being sick, loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine.
• Pancreatitis, which can lead to severe abdominal pain, nausea, and fever.
If you experience any of the above side effects tell your doctor IMMEDIATELY or go to a casualty department at your nearest hospital.
Other Possible side effects:
Rare side effects (experienced by between 1 in 1000 and 1 in 10000 patients)
• Liver enzyme increases which may have an effect on some medical tests
• Rise in plasma creatinine which may show up in kidney function tests
• Skin rash
(3
r