Cimetidine 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Dowelhurst 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

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 Tablets 400 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine 400 mg
Also contains lactose, for a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Capsule shaped pale green film-coated tablet with the Chatfield logo
on one
side and ‘CIMET 400’ imprinted on the other
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 and benign
gastric
ulceration, including that associated with non-steroidal
anti-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
gastrointestinal haemorrhage from stress ulceration in seriously ill
patients;
before general anesthesia 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 by any route should not normally exceed 2.4 g.
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 is recommended. Other effective regimes are 200 mg three
times a day