Cimetidine 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

DE Pharmaceuticals

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 Tablets 200mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Cimetidine USP.
3.
PHARMACEUTICAL FORM
Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is indicated in the treatment of duodenal and benign
gastric
ulceration, including that associated with non-steroidal
anti-inflammatory
agents, recurrent and stomal ulceration, oesophageal reflux disease.
It is also
indicated for 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
For oral administration only.
Adults
The usual adult dose is 400mg twice a day with breakfast and at
bedtime.
Alternatively patients with duodenal or benign gastric ulceration may
be
treated with a single dose of 800mg at bedtime. Regimes of 200mg
thrice
daily with meals and 400mg at night or, if inadequate, 400mg four
times daily
with meals and at bedtime may also be used. Symptomatic relief is
usually
rapid. Treatment should be given for 6 weeks in benign gastric ulcers,
and for
8 weeks in ulcers associated with continued non-steroidal
anti-inflammatory
agents.
The maintenance dose for patients who would benefit from reduction of
gastric secretion and in patients with benign peptic ulcer disease is
400mg at
bedtime. A