Famotidine 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Famotidine

Available from:

Arrow Generics Ltd

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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Famotidine 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains famotidine 20 mg.
Excipient with known effect: Each tablet contains 1.99mg of lactose
(as lactose
monohydrate).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White, oblong, biconvex tablet, scored on one side
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duodenal and benign gastric ulcers which have been confirmed by
radiological or
endoscopic examination.
Zollinger-Ellison syndrome
Reflux oesophagitis confirmed by endoscopy, including curative
treatment of erosion
or ulcer associated with reflux oesophagitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Duodenal ulcer._
Initiation of treatment: The recommended dose is 40 mg of famotidine
per day at
bedtime. The treatment should be continued for 4-8 weeks, but it may
be discontinued
even earlier if it is found by endoscopic examination that the ulcer
has healed. In most
cases the ulcer will heal with this treatment within four weeks.
Treatment should be
continued for another four weeks in patients whose ulcer has not
healed completely
within four weeks.
Maintenance treatment: In prophylactic treatment of recurrent ulcer it
is
recommended that famotidine therapy be continued with a dose of 20 mg
per day at
bedtime.
_Non-malignant gastric ulcer._
The recommended dose is 40 mg per day at bedtime. The treatment is
continued for 4-
8 weeks, but a shorter course of treatment is adequate if an
endoscopic examination
shows that the ulcer is healed.
_Zollinger-Ellison syndrome._
If the patient has not previously received drugs to reduce the
secretion of acid, the
treatment is introduced by giving 20 mg of famotidine every 6 hours.
The dosage
should be adjusted according to the patient's needs and it should be
continued as long
as it is clinically indicated. Dail