Tagamet 800mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Chemidex Pharma Ltd

ATC code:

A02BA01

INN (International Name):

Cimetidine

Dosage:

800mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100; GTIN: 5050204100216

Patient Information leaflet

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 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. See section 4.
Package leaflet: Information for the user
Tagamet
800 mg tablets
cimetidine
What is in this leaflet
1. What Tagamet tablets are and what they are used for
2. What you need to know before you take Tagamet
tablets
3. How to take Tagamet tablets
4. Possible side effects
5. How to store Tagamet tablets
6. Contents of the pack and other information
1. What Tagamet tablets are and what
they are used for
Tagamet tablets contain cimetidine which is a histamine
H
2
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
anti-inflammatories).
2. What you need to know before you take
Tagamet tablets
Do not take Tagamet tablets:
• if you are allergic to cimetidine or to any of the other
ingredients of this medicine (listed in section 6).
If this applies to you, speak to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tagamet 800mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine 800 mg.
Excipients with known effect: contains sodium 1.5 mg.
For the full list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pale green, oval, film-coated tablet engraved with Tagamet on one face
and
800 on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tagamet is a histamine H
2
-receptor antagonist which rapidly inhibits both
basal and stimulated gastric secretion of acid and reduces pepsin
output.
Tagamet
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
and other
conditions where reduction of gastric acid by Tagamet 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
gastrointestinal haemorrhage from stress ulceration in critically 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.
Tagamet
is
also
recommended
in
the
management
of
Zollinger-Ellision
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).
Posology
_Adults:_ For patients with duodenal or benign gastric ulceration a
single dose of 800
mg at bedtime is recommended. Otherwise the usual dose is 400 mg twice
a day with
breakfast and at bedtime. Other effective regimens are 200 mg three
times a day with
meals and 400 mg at b