Cimetidine 800mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Cimetidine

Διαθέσιμο από:

Dexcel-Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

A02BA01

INN (Διεθνής Όνομα):

Cimetidine

Δοσολογία:

800mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01030100; GTIN: 5033847000198

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
CIMETIDINE 200MG, 400MG AND 800MG TABLETS
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 FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.

THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO
OTHERS. IT
MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS.

IF ANY SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECT NOT
LISTED IN
THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
1. What Cimetidine is and what it is used for
2. Before you take Cimetidine.
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6.
Further information
1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR
The name of your medicine is Cimetidine Tablets. Cimetidine belongs to
a group of
medicines known as histamine H 2 receptor agonists. They work by
reducing the
amount of acid produced by your stomach (gastric acid). Acid plays a
part in ulcer
disease and the uncomfortable condition known as heartburn. Reducing
the amount of
acid produced can help ulcers to heal and give relief where gastric
acid is causing
discomfort.
Cimetidine Tablets are used to:

Treat and relieve the symptoms of stomach/duodenal ulcers

Treat and relieve Zollinger-Ellison syndrome (excessive secretion of
acid by
the stomach)

Treat and relieve ulceration of the oesophagus (gullet) caused by
reflux of
gastric juices

Prevent the recurrence of stomach/duodenal ulcers.

Treat or prevent ulcers caused by medicines such as non-steroidal
anti-
inflammatory drugs (NSAIDs), which are used to treat conditions such
as
arthritis. If you are taking this type of medicine, your doctor may
prescribe
Cimetidine Tablets for you to try to keep you free of ulcers.

Improve absorption of food and reduce fluid loss in short bowel
syndrome

Prevent acid coming up the oesophagus (gullet) before an anaesthetic
2. BEFORE YOU TAKE CIMETIDINE
DO NOT TAKE CIMETIDINE IF Y

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 800mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine 800mg
For excipients see 6.1.
3
PHARMACEUTICAL FORM
Film coated tablets.
_Appearance:_
Pale green, oval, film coated tablet, plain on one side and embossed
‘CIM
800’ on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine tablets are indicated for the following:
1.
In the treatment of duodenal and benign gastric ulceration, recurrent
and stomach ulceration and oesophageal reflux disease.
2.
In the treatment of persistent dyspeptic symptoms with or without
ulceration, particularly meal-related upper abdominal pain.
3.
In
the
prophylaxis
of
gastrointestinal
haemorrhage
from
stress
ulceration in seriously ill patients.
4.
Before general anaethesia in patients thought to be at risk of acid
aspiration
(Mendelson’s)
syndrome,
particularly
obstetric
patients
during labour.
5.
To reduce malabsorption and fluid loss in short bowel syndrome.
6.
To
reduce
degradation
of
enzyme
supplements
in
pancreatic
insufficiency.
7.
In the management of 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.
_Adults:_ The usual dosage is 400mg twice daily with breakfast and at
bedtime.
For patients with duodenal or benign gastric ulceration, a single
daily dose of
800mg at bedtime is recommended. Other effective regimens are 200mg
three
times a day with meals and 400mg at bedtime (1.0g/day) and, if
inadequate,
400mg four times a day (1.6g/day) also with meals and at bedtime.
Symptomatic relief is usually rapid. Treatment should be given
initially for at
least four weeks (six weeks in benign gastric ulcer, eight weeks in
ulcer
associated with continued use of non-steroidal anti-inflammatory
agents).
Most ulcers will have healed by that stage, but those which have not
will
usually do so after a further course of tr