Cimetidine 800mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Cimetidine

Disponible des:

Accord-UK Ltd

Codi ATC:

A02BA01

Designació comuna internacional (DCI):

Cimetidine

Dosis:

800mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01030100; GTIN: 5060149310175

Informació per a l'usuari

PACKAGE LEAFLET –
INFORMATION FOR THE USER
Cimetidine 200mg
Tablets
Cimetidine 400mg
Tablets
Cimetidine 800mg
Tablets
(CIMETIDINE)
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.
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
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 (Men

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 800mg Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIMETIDINE 800 MG TABLETS
Each film coated tablet contains 800 mg cimetidine
Excipient: each tablet contains 37 mg of Lactose monohydrate, 0.76 mg
of
sodium
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Plane green coloured, capsule-shaped, biconvex, film coated tablet,
debossed
“CE” on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H
2
-receptor antagonist which rapidly inhibits both
basal and stimulated gastric secretion of acid and reduces pepsin
output.
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
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
gastrointestinal 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 by any route should not normally exceed 2.4g.
Dosage
should
be
reduced
in
patients
with
impaired
renal
function
(see
Special
warnings and precautions for use)
Posology
ADULTS:
Oral: The usual dosage is 400mg twice a day, with breakfast and at
bedtime. For
patients with duodenal or benign g