Cimetidine 400mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Cimetidine

제공처:

IVAX Pharmaceuticals UK Ltd

ATC 코드:

A02BA01

INN (International Name):

Cimetidine

복용량:

400mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 01030100

환자 정보 전단

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.
PL 15184/1640 Cimetidine 400mg
Tablets
Leaflet revision date: 27/03/19
Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: [phone] to
obtain the leaflet in a
format suitable for you
5. HOW TO STORE CIMETIDINE TABLETS
•
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
•
Do not store above 25°C.
•
Store in the original package.
•
Do not take Cimetidine Tablets after the expiry
date which is stated on the carton. The expiry
date refers to the last day of that month.
•
If your medicine becomes discoloured or shows
any other signs of deterioration consult your
pharmacist who will tell you what to do.
•
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT CIMETIDINE TABLETS CONTAIN
•
Each film-coated tablet contains 400mg of
cimetidine
•
The other ingredients are lactose monohydrate,
maize starch, povidone K30, sodium starch
glycollate (Type A), colloidal anhydrous silica,
magnesium Stearate, hypromellose (E464),
titanium dioxide (E171), macrogol 400,
quinoline yellow aluminium lake (E104),
yellow iron oxide (E172) and indigo carmine.
WHAT CIMETIDINE TABLETS LOOKS LIKE AND
CONTENTS OF THE PACK
Cimetidine Tablets are green capsule-shaped,
biconvex, film coated tablet debossed CD on one
side and plain on the other side.
Each pack contains 60 film-coated tablets.
MANUFACTURER AND LICENCE HOLDER
This medicine is manufactured by Accord
Healthcare Limited, Sage House, 319, Pinner
Road, North Harrow, Middlesex, HA1 4HF, UK and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
• Ac

제품 특성 요약

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, oblong, film-coated tablet embossed with ‘PV’on one
face and the
‘CIM 400’ on the reverse.
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 tablets are indicated for the following:
1.
In the treatment of duodenal and benign gastric ulceration, including
that
associated with non-steroidal anti-inflammatory agents, recurrent and
stomal
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 gastro-intestinal 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 a day 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