Ranitidine 300mg Film-Coated Tablets
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Package Leaflet: Information for the user
Ranitidine 150mg Film-Coated Tablets _Ranitidine 300mg Film-Coated Tablets_
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.
• 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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Conlenls of the pack and other information_
1. What this medicine is and what it is used for
The active ingredient Ranitidine belongs to a group of medicines called H2 -receptor antagonists. It lowers the amount of acid in your stomach.
For adults (including the elderly) Ranitidine is used to:
• heal and stop ulcers in the stomach, or the part of the gut it empties into (the duodenum)
• help dear up infection in your stomach, when taken with antibiotic medicines (medicines taken to treat germs)
• stop stomach ulcers when they are a side effect of some medicines
• stop ulcers from bleeding
• improve problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as 'indigestion', 'dyspepsia' or 'heartburn'
• stop acid coming up from the stomach while under anaesthetic during an operation.
For children (3 to 18 years) Ranitidine is used to:
• heal ulcers in the stomach, of the part of the gut it empties into (the duodenum)
• heal and stop problems caused by add in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as "indigestion", “dyspepsia" or “heartburn".
| 2. What you need to know before you take this medicine | Do not take this medicine:
• if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
• you have stomach cancer
• you have kidney problems. You will need to take a different amountof ranitidine
• you have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (NSAID) medicines e.g. ibuprofen and aspirin
• you have a rare condition called acute porphyria (too much of the pigment called porphyrin which may discolour the urine)
• you are over 65 years of age
• you have lung disease
• you are diabetic
• you have any problems with your immune system
Ifyou are notsure ifany ofthe above apply to you, talktoyour doctor or pharmacist before using this medicine.
Taking other medicines
Tell your doctor or pharmacistifyou are taking, have recently taken or might take any other medicines.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Non-steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation e.g. ibuprofen and aspirin
• 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 your blood
• glipizide, for lowering blood glucose
• atazanavir or delavirdine, for treating HIV infection
• midazolam or triazolam, for insomnia
• gefitnib, 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 you have an operation. Tell your doctor if you are taking ranitidine, before your operation in case he or she wants to give you midazolam.
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.
• Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.
| 3. How to take this medicine |
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow each tablet whole with a glass of water.
The usual dose for an adult (including the elderly) and children (12 years and over) is either:
• 150 mg in the morning and 150 mg in the evening, or
• 300 mg at bedtime.
Your exact dose will depend on your particular stomach condition, your doctor will tell you the dose you should take.
Children over 30 kg of weight and from 3 to 11 years:
Your doctor will work out the right dose for you based on your child's weight. Treatment of stomach or duodenal (small intestine) ulcers:
The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks.
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Ranitidine Insert
SAME SIZE ARTWORK
240 x 120 mm
Front
Treatment of heartburn due to too much acid:
The usual dose is 2.5 mg for each kg of body weight, Iwice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart.
If you take more Ranitidine than you should
Ranitidine is not normally harmful if you take more than you should, unless you take many tablets at once. If this applies to you (or someone else taking this medicine), you should go to your nearest hospital casualty department 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
• If you forget a dose, take it as soon as you remember, unless it is nearly time for your next dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Ranitidine
After a few days oftaking the tablets you should start to feel much better. Do not stop taking the tablets without talking to your doctor or pharmacistfirst, otherwise the original pain and discomfort may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ranitidine 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: rash, itching or hives on the skin, swelling ofyour 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
• 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
Check with your doctor as soon as possible if you notice any of the following: Uncommon (may affect up to 1 in 100 people)
• stomach pain, constipation, feeling sick (nausea)
Rare (may affect up to 1 in 1,000 people)
• skin rash
• increase of serum creatinine in the blood (kidney function test)
• changes to liver function
Very rare (may affect up to 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 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
• your joints 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 feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine
• flushing or marks on your skin that look like targets
• unexplained hair loss
• diarrhoea
• impotence
• breast tenderness and/or breast enlargement
• breast discharge Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet You can also report side effects directfyvia 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.
| 5. How to store this medicine |
• Keep this medicine out of the sight and reach of children.
• Do not store above 250C. Store in the original package.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information |
What this medicine contains
• Each tablet contains 150mg or 300mg of the active substance, ranitidine hydrochloride
• The other ingredients are: microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (E171).
What this medicine looks like and contents of the pack
• 150mg: White to almostwhite, round, biconvex, film-coated tablets embossed with "BL" on one side and ”150' on the other side.
• 300mg: White to almostwhite, oblong, biconvex, film-coated tablets embossed with "B" and "L" on either side of the breakline on one side and "300' on the other.
• Ranitidine tablets are available in packs of 30, 60 or 100 tablets. Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
Name and address: Bristol Laboratories Ltd, Unit 3, Canalside,
Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Ranitidine 150mg Film-Coated tablets; PL 17907/0029
Ranitidine 300mg Film-Coated tablets; PL 17907/0030
This leaflet was last revised in April 2015
To request a copy of this leaflet in Braille, large print or audio then please contact
the licence holder at the address (or telephone, fax, email) above.
V2 01-04-15 D0 2
Ranitidine Insert
SAME SIZE ARTWORK
240 x 120 mm
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