Famotidine 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Famotidine

Available from:

DE Pharmaceuticals

ATC code:

A02BA03

INN (International Name):

Famotidine

Dosage:

20mg

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

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FAMOTIDINE 20 MG FILM-COATED TABLETS
FAMOTIDINE 40 MG FILM-COATED TABLETS
famotidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Famotidine is and what it is used for
2.
What you need to know before you take Famotidine
3.
How to take Famotidine
4.
Possible side effects
5.
How to store Famotidine
6.
Contents of the pack and other information
1.
WHAT FAMOTIDINE IS AND WHAT IT IS USED FOR
Famotidine belongs to a group of medicines called histamine (H
2
) antagonists or anti-ulcer
medicines. These anti-ulcer medicines control the levels of acid in
the stomach. Famotidine
can lower the amount of acid you produce in your stomach.
Famotidine can be used for the following:
•
To help treat non-cancerous stomach ulcers and ulcers in the first
part of your
intestine (duodenal ulcers)
•
To help prevent the return of ulcers in the first part of the
intestine
•
To help treat Zollinger-Ellison syndrome (with a condition caused by
too
much stomach acid)
•
To help treat acid reflux (burning pain caused by stomach acid
escaping back
up the food pipe) and the symptoms of an inflamed food pipe
(oesophagitis)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMOTIDINE
DO NOT TAKE FAMOTIDINE IF:
•
you are allergic to famotidine or any of the ingredients of this
medicine (listed
in section 6) or to any other medicines called H
2
antagonists
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Famotidine if:
•
you have kid

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Famotidine 20 mg Film Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg famotidine
Excipient with known effect:
Each tablet contains 3.42 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablet
White, film coated, D shaped, biconvex tablets marked with ‘G’ on
one side
and ‘FD/20’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Famotidine tablets are indicated for the following conditions;
Duodenal ulcers
Prevention of relapses of duodenal ulceration
Benign gastric ulcers
Zollinger-Ellison syndrome
Symptomatic treatment of mild to moderate reflux oesophagitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2
_Adults _
Duodenal ulcers – The initial recommended dose is 40 mg of
famotidine to be taken at
night.
Healing
generally
occurs
in
most
patients
within
4
weeks.
This
period,
however, may be shortened if an endoscopic examination reveals that
the ulcer has
healed. However, in those patients whose ulcers have not healed within
this 4 week
period, treatment should continue for a further 4 weeks.
Prevention of relapses of duodenal ulceration – To prevent ulcers
from reoccurring
the recommended dose is_ _20 mg of famotidine to_ _be taken at night.
Benign gastric ulcers – The recommended dose of 40 mg of famotidine
to be taken at
night. Treatment should continue for between 4-8 weeks unless earlier
healing is
revealed by endoscopy.
Zollinger-Ellison syndrome – Patients who are not receiving any
antisecretory therapy
should be started on a dose of 20 mg of famotidine every 6 hours. The
dosage should
then be adjusted to individual response. Doses up to 800 mg daily have
been used up
to one year without the development of significant adverse effects or
tachyphylaxis.
If the desired inhibition of acid secretion cannot be attained with a
daily dosage of
800 mg, alternative treatment should be considered to regulate acid