Cimetidine 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Tillomed Laboratories Ltd

ATC code:

A02BA01

INN (International Name):

Cimetidine

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100; GTIN: 5024655000920

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg cimetidine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A pale green, elliptic, convex, scored film-coated tablet with an
approximate
size of 8mm x 16mm, coded CIM 400 on one side
The score line is not intended for breaking the tablet
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
or
benign
gastric
ulceration,
including
that
associated
with
non-steroidal
anti-inflammatory
agents,
recurrent
and
stomal
ulceration.
Reflux
eosophagitis
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.
Zollinger-Ellison
syndrome. Prophylaxis of stress ulceration in seriously acutely ill
patients.
Prophylaxis of acid aspiration syndrome and 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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)
_ADULTS _
For patients with duodenal or benign gastric ulceration, a single
daily dose of
800 mg at bedtime is recommended. Otherwise the usual dosage is 400 mg
twice a day with breakfast and at bedtime. Other effective regimens
are 200
mg three times a day