CIMETIDINE 400 MG FILM-COATED TABLETS

Active substance: CIMETIDINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CIMETIDINE 200mg, 400mg & 800mg
FILM-COATED TABLETS
(Cimetidine)
Read all of this leaflet carefully before
you start taking this medicine.
• 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.
In this leaflet:
1. What Cimetidine Tablets are and
what they are used for
2. What you need to know before
you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Contents of the pack and other
information

1. What Cimetidine Tablets are and
what they are used for
The name of your medicine is Cimetidine
film-coated Tablets referred to as Cimetidine
Tablets in the leaflet. It contains the active
ingredient called Cimetidine.
Cimetidine tablets contain cimetidine which
is a histamine H2 antagonist. It helps to
reduce the natural production of acid in the
stomach.
They are used to treat and relieve:
• the symptoms of peptic ulcers which
occur in the stomach or intestine (gut)
• oesophageal reflux disease which can be
caused when food and acid from the
stomach washes back into the food pipe
(oesophagus). This can cause a burning
feeling in the chest known as heartburn
• a rare condition called Zollinger-Ellison
syndrome when the stomach produces
very large amounts of acid.
This medicine may also be prescribed for a
range of other medical conditions where a
reduction of acid production in the stomach
is needed, or to protect your stomach from
other medicines (such as non-steroidal antiinflammatories).

2. What you need to know before you
take Cimetidine Tablets
Do not take Cimetidine Tablets if you:
• have an allergy to cimetidine, or any of
the other ingredients (See Section 6)
Warnings and precautions
Before taking the tablets, tell your doctor if
you:
• have a kidney problem
• have a blood disease
• have had a peptic ulcer and are also taking
a non-steroidal anti-inflammatory drug
(NSAID), (e.g. ibuprofen)
• are pregnant or planning a pregnancy
• are breast-feeding.
Other medicines and Cimetidine
Tablets

doctor or pharmacist if you are taking
medicines which:
• control epilepsy (e.g. phenytoin). Your
doctor will monitor you.
• thin the blood (e.g. warfarin). Your doctor
will monitor you
• treat
breathing
problems
(e.g.
theophylline)
• may cause your blood cell count to
change (e.g. antibiotics)
• treat fungal (yeast) infections (e.g.
ketoconazole, itraconazole,
posaconazole)
• treat diabetes (e.g. glipizide, metformin)
• treat anxiety (e.g.diazepam)
• treat depression, called tricyclic
antidepressants (e.g.amitriptylline)
• lower blood pressure or treat heart
conditions (e.g. metoprolol, propranolol,
nifedipine, diltiazem, procainamide)
• numb the body such as anaesthetics used in
hospital (e.g. lidocaine)
• are strong pain relievers (e.g.morphine)
• suppress the immune system (e.g.
ciclosporin, tacrolimus)
• treat HIV/AIDS (e.g. atazanavir)
• treat tumours or cancer (e.g. carmustine,
fluorouracil, epirubicin), or if you are having
radiation therapy.
Pregnancy, breast-feeding and fertility
DO NOT take Cimetidine tablets if you are
pregnant, planning to become pregnant or
breast-feeding unless advised to by your
doctor.
Ask your doctor for advice before taking any
medicine.
Driving and using machines
Cimetidine tablets are unlikely to affect your
ability to operate machinery or to drive.

3. How to take Cimetidine Tablets
Always take Cimetidine tablets exactly as your
doctor has told you and always read the label.
Your doctor will decide on the appropriate
dose to suit your condition. Ask your doctor
or pharmacist if you are not sure.
• Swallow the tablets whole with a drink of
water. Take the tablets with meals or at
bedtime as advised by your doctor.
Doses
Adults and the elderly: the usual dose is
400 mg twice a day with breakfast, and at
bedtime.
Your doctor will tell you the correct dose
depending on your condition.
The maximum dose is 2400 mg a day.
Children: your doctor will decide on the dose
according to your child’s body weight.
The usual length of treatment is at least four
weeks though this may be longer in some
conditions. Your doctor will advise you.
If you take more Cimetidine Tablets than
you should
1. Tell your doctor, pharmacist or nearest
hospital casualty department immediately.
2. Take the container and any remaining tablets
with you so that people can see what
you have taken.
3. Do this even if you feel well.

Some medicines may be affected by
Cimetidine tablets or they may affect how
well Cimetidine tablets will work. Tell your

If you stop taking Cimetidine Tablets
If you stop your treatment too soon, your
symptoms may come back.
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Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription, and herbal
preparations.

If you forget to take Cimetidine Tablets
If you forget to take a dose take it as soon as
you remember, but if it is almost time for
your next dose, skip the missed dose and
continue as usual.
Do not take a double dose to make up for a
forgotten dose.

You may feel better after a few days, but you
should keep taking your medicine until the
prescribed course is finished.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Cimetidine tablets can cause
side effects, although not everybody gets
them. Do not be alarmed by this list of
possible side effects. You may not experience
any of them.
STOP taking the tablets and seek medical
help immediately if you have any of the
following allergic reactions:
• difficulty breathing or swallowing, swelling
of the face, lips, tongue or throat, severe
itching of the skin, with a red rash or raised
lumps.
Seek immediate medical attention if you
have any of the following symptoms:
• unusual bleeding or bruising; or fever,
sore throat, mouth ulcers, repeated
infections or infections that will not go
away. This may be due to changes in your
blood red spots on the skin which may be
painful to touch, joint pain, swollen lymph
glands
• yellowing of your skin or eyes, pale faeces
and dark urine, unexplained persistent
nausea, stomach problems, loss of appetite
or unusual tiredness. This may be due to
liver changes, confusion, hallucinations,
depression
• in men: enlarged breasts, trouble getting or
keeping an erection
• unexpected secretion of breast milk in men
or women
• pain behind the ribs radiating towards the
back, often worse when lying down, nausea,
vomiting, fever. This may be due to
inflammation of the pancreas
• unusually slow or fast heartbeat, irregular
heartbeat and fainting
• fever, rash, nausea, aches and pains, change
in colour of urine, passing more or less urine
than usual or passing urine at night. These
problems may indicate kidney changes
• aching or weak muscles, or aching joints.

circular, biconvex, film-coated tablets,
embossed with ‘BL’ on one side and “200”
on the reverse.
They are available in packs of 50, 60, 84,
100, 250, 500, 120 & 5000.*
• Cimetidine 400 mg Tablets are pale green,
oblong, film-coated tablets, embossed with
‘BL’ on one side and “400” on the reverse
They are available in packs of 50, 56, 60,
100, 250, 500, 2500 & 5000.*
• Cimetidine 800 mg Tablets are pale green,
oval, film-coated tablets, embossed with
‘BL’ on one side and “800” on the reverse.
They are available in packs of 28, 30, 50,
100, 250 & 500.*
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Name and address:
Bristol Laboratories Ltd
Unit-3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG, UK.
Telephone: 0044(0)1442 200922
Fax:
0044(0)1442 873717
Email:
info@bristol-labs.co.uk
Cimetidine 200mg Film-Coated Tablets;
PL 17907/0357
Cimetidine 400mg Film-Coated Tablets;
PL 17907/0358
Cimetidine 800mg Film-Coated Tablets;
PL 17907/0359
This leaflet was last revised in
October 2012
To request a copy of this leaflet in Braille,
large print or audio format, contact the
licence holder at the address (or telephone,
fax, email) above.

Tell your doctor if you get any of the
following side effects:
• diarrhoea
• dizziness
• tiredness
• mild skin rash
• headache
• hair loss.
Side effects with Cimetidine tablets are usually
mild and do not last long.
If any of the side effects get troublesome, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Cimetidine Tablets
• Keep out of the sight and reach of children.
• Do not use Cimetidine Tablets after the
expiry date (EXP) which is stated on the
pack. The expiry date refers to the last day
of that month.
• Do not store above 250C.
• Do not throw away any medicines via waste
water 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 Cimetidine tablets look like and
contents of the pack
• Cimetidine 200 mg Tablets are pale green,

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What Cimetidine Tablets contain
The active ingredient is cimetidine (200 mg,
400 mg or 800 mg).
The other ingredients are:
starch, povidone, sodium starch glycollate,
magnesium stearate, purified water and
opadry oy-8839 (E104, E132, E171, E172)

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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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