CIMETIDINE 200MG TABLETS BP

Active substance: CIMETIDINE

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PACKAGE LEAFLET – INFORMATION
FOR THE USER

Cimetidine 200mg Tablets
Cimetidine 400mg Tablets
Cimetidine 800mg Tablets

• Improve absorption of food and reduce
fluid loss in short bowel syndrome.
• Reduce the breakdown of pancreatic
enzyme supplements in patients with
pancreatic problems.
• Excess acid in the stomach caused by
a tumour in the pancreas (ZollingerEllison syndrome).

(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. 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 are Cimetidine Tablets and what
are they used for
2. Before you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Further information

1. WHAT ARE CIMETIDINE
TABLETS AND WHAT ARE
THEY USED FOR
Cimetidine belongs to a group of
medicines called Histamine H2 receptor
antagonists and is used as an anti-ulcer
drug. It works by reducing the amount of
acid in your stomach.
Cimetidine is used to treat and relieve the
following conditions:
• Ulcers in the stomach (gastric ulcer)
and in upper part of the intestine
(duodenum ulcer).
• Recurrent or stomach ulcers (ulcers
that keep coming back or which have
occurred following stomach surgery).
• Ulcers in the stomach or duodenum
which may be caused by non-steroidal
anti-inflammatory drugs (NSAIDs, often
used to reduce pain, fever and
inflammation).
• Acid from the stomach escaping into
the
food
pipe
causing
pain,
inflammation
and
heartburn
(oesophageal reflux).
• Persistent heartburn and stomach pain.
• Upper abdominal pain particularly after
meals.
• Prevention of internal bleeding from
ulcers caused by stress in seriously ill
patients.
• For patients at risk of acid inhalation
before general anaesthesia particularly
pregnant
women
during
labour
(Mendelson's syndrome).

2. BEFORE YOU TAKE
CIMETIDINE TABLETS
Do not take cimetidine tablets:
• if you are hypersensitive (allergic) to
Cimetidine or to any of the tablet
ingredients (see section 6).
Take special care with Cimetidine
Tablets
Before taking Cimetidine Tablets, tell
your doctor if:
• you suffer from kidney problems or
from gastric cancer.
• you are suffering from liver problems.
• you have a history of peptic ulcer,
particularly if you are taking a non
steroidal
anti-inflammatory
drug
(NSAIDs) e.g. aspirin, ibuprofen,
naproxen, diclofenac.
• you are middle aged or over, with new
or recently changed indigestion
symptoms (e.g. Stomach pain or
discomfort, heartburn), other causes of
your symptoms such as stomach
cancer, should be excluded.
Taking other medicines:
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other
medicines,
including
those
medicines obtained without a prescription.
In particular, tell your doctor if you are
taking any of the following:
• Anticoagulants (thin the blood) ( e.g.
warfarin)
• Anticonvulsants (prevent fits) (e.g.
phenytoin, diazepam)
• Bronchodilators
(for
breathing
difficulties) (e.g. theophylline)
• Immunosuppresants (to prevent organ
rejection
or
rheumatism)
(e.g.
ciclosporin).
• Medicines that cause a fall in blood cell
count.
• Antifungals (used to treat fungal
infections)
(e.g.
ketoconazole,
itraconazole or posaconazole)
• Heart medicines (e.g. diltiazem,
nifedipine,
lidocaine,
propranolol,
metoprolol, procainamide or quinidine)
• Antidiabetics (lowers glucose levels in
the blood) (e.g. metformin or glipizide)
• Anti-cancer drugs (treatment of cancer
or tumor) (e.g. carmustine, fluorouracil,
epirubicin, or therapies such as
radiation)
• Strong pain killers (e.g. morphine).
• Tricyclic antidepressants (used to treat
depression) (e.g. amitriptyline).

• Antiretroviral drug (used
HIV/AIDs) (e.g. atazanavir)
• Tacrolimus for eczema

to

treat

Pregnancy and breast-feeding
It is preferable to avoid the use of
Cimetidine Tablets during pregnancy
unless it is essential. Tell your doctor if
you are pregnant or planning to become
pregnant.
Do not take Cimetidine Tablets during
breast feeding because cimetidine is
excreted in breast milk and can be
harmful for your child.
Ask your doctor or pharmacist for advice
before taking any other medicine.
Driving and using machines
Cimetidine tablets will not affect your
ability to drive or to use machinery.
Important information about some of
the ingredients of Cimetidine Tablets:
Cimetidine Tablet contains Lactose
monohydrate – If you have been told by
your doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicine.

3. HOW TO TAKE CIMETIDINE
TABLETS
Always take Cimetidine Tablets
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
For oral administration only.
The maximum daily dose of 2.4g (i.e.
2,400mg) should not be exceeded.
Dosage should be reduced in patients
with kidney problems. Treatment should
be given for at least 4 weeks (duodenal
ulceration), 6 weeks (benign gastric
ulceration) and 8 weeks (ulcer associated
with
continued
non
steroidal
anti-inflammatory drug). If the ulcer has
not healed, your doctor may recommend
another course.
Adults:
(Usual dose)
The usual dose is 400mg twice a day at
breakfast and at bedtime or one 200mg
tablet three times a day with meals
followed by 400mg at bedtime. If
inadequate 400mg four times a day with
meals and at bedtime.
Your doctor will decide the right dose for
you, depending on your condition.
Elderly:
As per adults dosage, unless you have
serious kidney problems.
Children over 1 year of age:
“Your doctor will decide the right dose,
depending on your child’s weight.”

If you take more Cimetidine tablets
than you should
If you or someone else swallows several
of these tablets all together, or you think a
child has swallowed any of these tablets,
contact your doctor or pharmacist or
hospital
emergency
department
immediately. Always take any tablets left
over with you, also the box and leaflet as
this will allow easier identification of the
tablets.
If you forget to take Cimetidine tablets
If you forget to take a dose, take it as
soon as you remember. If it is almost time
for your next dose, do not take the missed
dose and just carry on as before. Do not
take a double dose to make up for a
forgotten dose.
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 can cause
side-effects, although not everybody gets
them.
Very rarely allergic reactions might occur.
If any of the following symptoms occur
soon after taking your tablets, stop
taking your tablets and tell your doctor
immediately.
• Rash
• itching or hives on the skin
• swelling of the face, or other parts of
the body
• shortness of breath, wheezing or
trouble breathing.
Some male patients may notice enlarging
of the breasts. Very rarely male or female
patients may experience unexpected
secretion of breast milk. Contact your
doctor if these occurs.
The most common side effects are
diarrhoea, headache, dizziness, rash or
tiredness, muscle pain, joint pain, which
are usually mild and do not last long.
Other effects occurring rarely are:
• hair loss
• mouth ulcers, infections of the throat
• fever
• kidney problems (symptoms may
include changes in the amount of urine
passed and its colour, nausea,
vomiting, confusion, fever and rash)
• confusion (usually in the elderly or ill
patients)
• A rare type of anaemia in which the red
and white blood cells and platelets are
all reduced in number (symptoms might
include tiredness, being short of breath,
looking pale, frequent infections,
bruising more easily or nose bleeds)
• liver inflammation, which might cause
one of the following: nausea (feeling
sick), vomiting (being sick), loss of







appetite, feeling generally unwell,
fever, itching, yellowing of the skin and
eyes and dark coloured urine
slowing
of
heartbeat,
irregular
heartbeat or fainting
trouble getting or keeping an erection
(impotence)
feelings of sadness, depression
hallucinations - seeing/feeling/hearing
things that are not there.
inflammation of the pancreas (sudden
onset of abdominal pain, nausea and
vomiting)

All these side effects should disappear
when treatment is stopped.
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
CIMETIDINE TABLETS
Do not store above 25°C. Store in the
original package. Keep the container
tightly closed.
Keep out of the reach and sight of
children.
Do not use your tablets after the expiry
date stated on the label or carton.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Cimetidine Tablet contains?
The Active substance in your tablet is
Cimetidine.
The Other ingredients are Lactose
Monohydrate, Maize Starch, Magnesium
Stearate (E572), Povidone K30, Sodium
Starch Glycollate, Colloidal anhydrous
silica, Hypromellose (E464) Titanium
Dioxide (E171), Quinoline Yellow (E104),
Iron Oxide Yellow (E172), Indigo Carmine
(E132), Polyethylene glycol 400 (see
section 2 for Important information about
some of the ingredients of Cimetidine
tablets).
What Cimetidine Tablet looks like and
contents of the pack?
Cimetidine 200mg Tablets are pale green
coloured, round, biconvex, film coated,
debossed with 'CC' on one side and plain
on other side.
Cimetidine 400mg Tablets are pale green
coloured, capsule shaped, biconvex, film
coated, debossed with 'CD' on one side
and plain on other side.

Cimetidine 800mg Tablets are pale green
coloured, capsule shaped, biconvex, film
coated, debossed with 'CE' on one side
and plain on other side.
They are available in container packs of
100, 250, 500 and 1000 tablets and are
also available in blister packs of 60,120
(200mg), 30, 60 (400mg) and 30 (800mg)
tablets.
(Not all pack sizes may be marketed).
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
This leaflet was last approved in
{02/2010}

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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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