Cimetidine 400mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Cimetidine

Disponible des:

Ennogen Pharma Ltd

Codi ATC:

A02BA01

Designació comuna internacional (DCI):

Cimetidine

Dosis:

400mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01030100; GTIN: 5060313370066

Informació per a l'usuari

may be affected by Cimetidine or they may affect how well
Cimetidine will work.
In particular tell your doctor if you are taking any of the
following:
!
Anticoagulants to thin your blood e.g. warfarin. Your
doctor will monitor you
!
Anticonvulsants to prevent fits e.g. phenytoin. Your doctor
will monitor you
!
Bronchodilators for breathing difficulties e.g. theophylline
!
Anti-arrhythmics to slow heart rate e.g. lidocaine,
propranolol
!
Antidepressants to treat anxiety or depression e.g.
diazepam, amitriptyline
!
Immunosuppressants to prevent organ rejection or
rheumatism (e.g. ciclosporin)
!
Medicines that cause a fall in blood cell count
!
Antifungals used to treat fungal infections (e.g.
ketoconazole, itraconazole or posaconazole)
!
Antidiabetics to lower glucose levels in the blood (e.g.
metformin or glipizide)
!
Anti-cancer drugs for the treatment of
cancer or tumors (e.g. carmustine,
fluorouracil, epirubicin, or therapies such as
radiation)
!
Strong pain killers (e.g. morphine)
!
Antiretroviral drugs to treat HIV/AIDS (e.g
atazanavir)
!
Tacrolimus used to treat eczema
!
Medicines to treat heart problems e.g.
diltiazem, procainamide, metoprolol,
nifedipine.
PREGNANCY AND BREASTFEEDING
DO NOT take Cimetidine if you are pregnant, planning to
become pregnant or breast-feeding unless advised to by your
doctor.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any medicine.
DRIVING AND USING MACHINES
These tablets can cause some people to feel dizzy or drowsy.
If you are affected do not drive or operate machinery.
EXCIPIENT INFORMATION ABOUT CIMETIDINE TABLETS
This medicine contains less than 1mmol of sodium per tablet,
that is to say essentially 'sodium free'.
3.
HOW TO TAKE CIMETIDINE TABLETS
Always take Cimetidine Tablets exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure.
The usual dosage is 400mg to 1600mg cimetidine per day.
Take twice a day with bre

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine Tablets BP 400mg.
SUMMARY OF PRODUCT CHARACTERISTICS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg cimetidine BP.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pale green, oblong, film coated tablets, embossed with C2 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine Tablets are indicated for the following.
a) The treatment of duodenal and benign gastric ulceration, and
oesophageal reflux
disease.
b) The treatment of persistent dyspeptic symptoms with or without
ulceration,
particularly meal-related upper abdominal pain.
c) The prophylaxis of gastro-intestinal haemorrhage from stress
ulceration in
seriously ill patients.
d) Before general anaesthesia in patients thought to be at risk of
acid aspiration
(Mendelson’s) syndrome, particularly obstetric patients during
labour.
e) To reduce malabsorption and fluid loss in short bowel syndrome.
f) To reduce degradation of enzyme supplements in pancreatic
insufficiency.
g) In the management of Zollinger-Ellison syndrome.
SUMMARY OF PRODUCT CHARACTERISTICS
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 (see section 4.4).
Posology
Adults: the usual dosage is 400mg twice a day with breakfast and at
bedtime.
Alternatively, for patients with duodenal or benign gastric
ulceration, a single daily
dose
of 800mg
at
bedtime
is
recommended. Other
effective
regimens
are
200mg, 3 times
a
day
with
meals
and
400mg
at
bedtime
(1.0g/day)
and,
if
inadequate, 400mg, 4 times a day (1.6g/day), also with meals and at
bedtime.
Treatment should be given initially for at least 4 weeks (6 weeks in
benign
gastric ulcer) even if symptomatic relief has been achieved sooner.
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