Nizatidine 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nizatidine

Available from:

Kent Pharma (UK) Ltd

ATC code:

A02BA04

INN (International Name):

Nizatidine

Dosage:

150mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100

Patient Information leaflet

NIZATIDINE 150 MG & 300 MG CAPSULES
(Nizatidine) PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Nizatidine Capsules are and what
they are used for
2. What you need to know before you take
Nizatidine Capsules
3. How to take Nizatidine Capsules
4. Possible side effects
5. How to store Nizatidine Capsules
6. Contents of the pack and other
information
1. WHAT NIZATIDINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
Nizatidine belongs to a group of medicines
called histamine H2-receptor antagonists,
which reduce acidity in your stomach.
Nizatidine Capsules are used to
•
TREAT NON CANCEROUS STOMACH AND
DUODENAL ULCERS (ulcers at the top of
the small intestine)
•
PROTECT HEALED ULCERS in the intestines
•
TREAT A TYPE OF HEARTBURN called 'reflux
oesophagitis' (irritation of the
oesophagus, the tube that takes food
and liquids into your stomach)
•
PREVENT ULCERS which may be caused by
NSAID (NON-STEROIDAL
ANTI-INFLAMMATORY DRUG) treatment i.e.
ibuprofen, diclofenac - often used to treat
arthritis.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NIZATIDINE CAPSULES
DO NOT TAKE THIS MEDICINE and speak to
your doctor if you have ever had an allergic
reaction to:
-
Nizatidine, or any of the other ingredients
of this medicine (listed under Section 6)
-
have taken a similar anti-ulcer medicine
before and you suffered an unusual or
allergic reaction. An allergic reaction may
include rash, itching, difficulty breathing
or swelling of the face, lips, throat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nizatidine 150mg capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nizatidine 150mg
Excipients with known effect: Propylene glycol and sunset yellow FCF
(E 110).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, Hard
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following diseases where reduction of gastric
acid is
indicated:
Duodenal ulcer
Benign gastric ulcer
Prevention of duodenal or benign gastric ulcer recurrence
Gastric oesophageal reflux disease (including erosions, ulcerations
and associated
heartburn)
Gastric and/or duodenal ulcer associated with concomitant use of
non-steroidal anti-
inflammatory drugs
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
For oral administration.
Posology
_Adults: _
_1._
_ _
For treatment of duodenal ulcer, the recommended daily dose is 300mg
in the
evening. Treatment should continue for four weeks, although this
period may be
reduced if healing is confirmed earlier by endoscopy. Most ulcers will
heal within
four weeks, but if complete ulcer healing has not occurred after four
weeks therapy,
patients should continue therapy for a further four weeks.
_2._
_ _
For the treatment of benign gastric ulcer, the recommended daily dose
is 300mg in
the evening for four or, if necessary, eight weeks. Prior to treatment
with
nizatidine, care should be taken to exclude the possibility of gastric
cancer.
If preferred, the 300mg daily dose for the treatment of duodenal or
benign gastric
ulcer may be given as two divided doses of 150mg in the morning and
evening.
_3._
_ _
For the prevention of duodenal or benign gastric ulcer recurrence
(prophylactic
maintenance therapy), the recommended daily dose is 150mg in the
evening.
_4._
_ _
For the treatment of gastric oesophageal reflux disease, the
recommended dosage is
from 150mg twice daily, up to 300mg twice daily. Therapy for up to 12
weeks is
indicated for erosions and ulcerations, and associated