Cimetidine 400mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Cimetidine

Предлага се от:

Bristol Laboratories Ltd

АТС код:

A02BA01

INN (Международно Name):

Cimetidine

дозиране:

400mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01030100; GTIN: 5060013943560

Листовка

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

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine 400mg
For excipients see 6.1
3
PHARMACEUTICAL FORM
Film coated tablets.
_Appearance_:
Pale green, oval biconvex, film coated tablet- with “CIM 400” on
one side and
breakline 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 anaesthesia 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.
_ _
Treatment should be given initially for at least four weeks (six weeks
in
benign gastric ulcer). Most ulcers will have healed by that stage, but
those
which have not will usually do so after a further course of treatment.
Treatment may be continued for longer periods in those patients who
may
benefit from reduction of gastric secre