Cimetidine 800mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
11-10-2018

ingredients actius:

Cimetidine

Disponible des:

Phoenix Healthcare Distribution 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

Informació per a l'usuari

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
CIMETIDINE 200 MG, 400 MG & 800 MG TABLETS
(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 only. Do not pass it on to
others.
It may harm them, even if their symptoms 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. 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
The name of your medicine is Cimetidine Tablets. It contains the
active ingredient
called Cimetidine. Cimetidine belongs to a group of medicines called
Histamine
H2 - receptor antagonists and is used as anti-ulcer drug. It works by
reducing the
amount of acid in your stomach.
The tablets are 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
•
Prevent 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)
                                
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Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 800mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cimetidine tablets contain 800mg of the active ingredient Cimetidine
USP
3
PHARMACEUTICAL FORM
Tablet.
Cimetidine 800 mg Tablets are green elliptical film coated tablets
coded CIM
on one side and 800 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
                                
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