RANITIDINE 150MG FILM-COATED TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

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RANITIDINE 150MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this
medicine. Even if you have used this medicine or a similar product
before, you should read this leaflet carefully as the information
may have changed.
• 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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further 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 clear 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’

Ranitidine 150 mg
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240 x 120 mm
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• 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 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”.

2. Before you take this medicine
Do not take these tablets without consulting your doctor if you:
• Have ever been told you are allergic to ranitidine or to any of the
other ingredients (these are listed in Section 6,)
If you are not sure, talk to your doctor or pharmacist before taking
Ranitidine.
Take special care with this medicine
Check with 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
• 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
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before using this medicine.
Taking other medicines
Please tell you doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
that you buy 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 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 delaviridine, 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 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 applies to you, talk to your
doctor or pharmacist before taking ranitidine.
Pregnancy and breast-feeding
• If you 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 Ranitidine 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine 150 mg
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4. Possible side effects
Like all medicines, Ranitidine can cause side effects, although not
everybody gets them.
The following side effects may happen with this medicine
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. These are very rare but may include developing
an itchy rash, swelling of the eyelids, face or lips (with or without
a lumpy skin rash elsewhere on the body), unexplained fever,
difficulty breathing, dizziness (especially on standing up) and
chest pain or tightness.
• Unexplained bruising or bleeding, sore throat, mouth ulcers,
fever, extreme paleness, weakness or exhaustion. These can
be signs of blood disorders such as anaemia, low white blood
cells, platelet count, suppressed bone marrow or reduction in
agranulocytes (a type of white blood cell)
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)
• Confusion, depression, drowsiness or hallucinations
• Headache, dizziness or sudden, jerky movements
• Changes in heart rhythm
• Inflammation of your blood vessels (vasculitis)
• Sudden inflammation of your pancreas (you may get severe
stomach pain) or diarrhoea
• Inflammation your liver which may cause one or more of the
following: feeling or being sick, fever, itching, yellowing of the
skin and eyes, dark coloured urine.
• Hair loss, blurred vision
• Aches and pains in your muscles and joints
• Sudden inflammation of your kidneys
• Impotence
• Swollen, tender or leaking breasts
Uncommon (affects less than 1 in 100 people)
• Stomach pain, constipation, feeling sick (nausea)
• Increase of serum creatine in the blood (kidney function test)

Rare (affects up to 1 in 1,000 people):
• skin rash
• increase of serum creatine in the blood (kidney function test)
• changes to liver function
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.

5. How to store this medicine
• Keep the medicines in a safe place where children cannot see or
reach it.
• Do not store above 250C. Store in the original package in order
to protect from light.
• Do not take your tablets after the expiry date marked on the pack.
• If you have any leftover tablets then take them back to your
pharmacist for safe disposal.

6. Further Information
What Ranitidine Tablet contains:
• Each tablet contains 150mg of the active substance, ranitidine
hydrochloride
• The other ingredients are: microcrystalline cellulose, magnesium
stearate, hypromellose and titanium dioxide (E171)
What the Ranitidine Tablet looks like and contents of the pack
• Tablets are white to almost white, circular, biconvex, film coated
tablets embossed with “BL” on one side and “150” on the other
side.
• Ranitidine tablets are available in packs of 30, 60 or 100 tablets.
Manufacturer and Marketing Authorisation Holder
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
This leaflet was last revised in November 2013
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,
V1 07-11-13 D0
email) above.
IXXXXX

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.
Treatment of heartburn due to too much acid:
The usual dose is 2.5 mg for each kg of body weight,twice 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 it, 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 of taking the tablets you should start to feel much
better. Do not stop taking the tablets without talking to your doctor or
pharmacist first, 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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