Cimetidine 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Viatris UK Healthcare 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 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine Ph Eur 400 mg.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Pale green, oblong, film-coated tablet embossed with the company logo
on one
face and the code ‘275’ on the reverse, or plain on one side and
embossed with
‘275’ or ‘CIM 400’ or ‘CIMET 400’ on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H2-receptor antagonist which rapidly
inhibits both
basal and stimulated gastric secretion of acid and reduces pepsin
output.
Cimetidine is 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, and other conditions
where reduction of gastric acid by cimetidine has been shown to be
beneficial.
2.
In the treatment of persistent dyspeptic symptoms with or without
ulceration, particularly meal-related upper abdominal pain, including
such
symptoms associated with non-steroidal anti-inflammatory agents.
3.
In the prophylaxis of gastro-intestinal haemorrhage from stress
ulceration
in critically 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
Posology
The total daily dose should not normally exceed 2.4g. 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 sing