Cimetidine 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Sandoz Ltd

ATC code:

A02BA01

INN (International Name):

Cimetidine

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100

Patient Information leaflet

CIMETIDINE 200MG, 400MG AND 800MG 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, pharmacist or
nurse
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cimetidine is and what it is used for
2. What you need to know before you take Cimetidine
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6. Contents of the pack and other information
1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR
The name of your medicine is Cimetidine 200mg Tablets Cimetidine 400mg
Tablets or Cimetidine
800mg Tablets (all called Cimetidine in this leaflet). Cimetidine
belongs to a group of medicines called
“H2 antagonists”.
Cimetidine works by lowering the amount of acid in your stomach. It
can be used for the following:
•
To treat or prevent ulcers in your stomach and duodenum (the part of
the gut the
stomach empties into)
•
An inflamed food pipe (oesophagitis) where stomach acid has travelled
up into your food
pipe (acid reflux disease)
•
To prevent ulcers from bleeding in seriously ill people
•
The management of Zollinger-Ellison Syndrome. This is a problem with
your pancreas where
too much acid in the stomach can cause ulcers in your stomach,
duodenum, gut and food
pipe
•
The management of short bowel syndrome. This is where some parts of
your bowel either do
not work or have been removed
•
If your pancreas does not work and you are taking enzyme supplements
to help you digest
your food
•
For people at risk of breathing in acid from their stomach
(aspiration). This might happen
during an operation with a general anaesthetic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cimetidine tablets contain 200mg of the active ingredient Cimetidine
USP
3
PHARMACEUTICAL FORM
Tablet.
Cimetidine 200 mg Tablets are green round film coated tablets coded
CIM on
one side and 200 on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H2-receptor antagonist which rapidly
inhibits both basal
and stimulated gastric secretion of acid and reduces pepsin output.
Cimetidine is indicated in the treatment duodenal and benign gastric
ulceration
including that associated with non-steroidal inflammatory agents
recurrent and stomal
ulceration, oesophageal reflux disease and other conditions where
reduction of
gastric acid by Cimetidine has been shown to be beneficial: persistent
dyspeptic
symptoms with or without ulceration, particularly meal-related upper
abdominal pain,
including such symptoms associated with non-steroidal
anti-inflammatory agents; the
prophylaxis of gastro-intestinal haemorrhage from stress ulceration in
seriously ill
patients; before general anaesthesia in patients thought to be at risk
of acid aspiration
(Mendelson’s) syndrome, particularly obstetric patients during
labour; to reduce
malabsorption and fluid loss in the short bowel syndrome; and in
pancreatic
insufficiency to reduce degradation of enzyme supplements. Cimetidine
is also
recommended in the management of the Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The total daily dose should not normally exceed 2.4g. Dosage should be
reduced in
patients with impaired renal function (see section 4.4).
Adults:
The usual dosage is 400 mg twice a day with breakfast and at bedtime.
Alternatively
for patients with duodenal or benign gastric ulceration, a single
daily dose of 800 mg
at bedtime can be used. Other effective regimens are 200 mg three
times a day with
meals and 400 mg at bedtime (1.0 g/day) and, if inadequate, 400mg four
times a day
(1 .6g