AXID 150 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-12-2016
Summary of Product characteristics
(SPC)
01-12-2016
Active ingredient:
NIZATIDINE
Available from:
Flynn Pharma Ltd
ATC code:
A02BA04
INN (International Name):
NIZATIDINE
Dosage:
150 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
H2-receptor antagonists
Authorization status:
Authorised
Authorization date:
2005-08-12
Patient Information leaflet
Package leaflet: Information for the user
AXID 150MG
CAPSULES
Nizatidine
The name of your medicine is Axid 150mg
capsules, which will be referred to as Axid
capsules throughout this document.
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
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Keep this leaflet. You may need to
read it again.
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If you have any further questions, ask your
doctor or pharmacist.
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This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illnesss
are the same as yours.
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If you get any side effects, talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Axid capsules are and
what they are used for
2. What you need to know before you take
Axid capsules
3. How to take Axid capsules
4. Possible side effects
5. How to store Axid capsules
6. Contents of the pack and other information
1
WHAT AXID CAPSULES ARE AND
WHAT THEY ARE USED FOR
Axid capsules contain the active ingredient
nizatidine, which is one of a group of
medicines known as H2 receptor antagonists.
This medicine is intended for use in adults.
Axid capsules are used to reduce gastric acid
(a digestive acid produced by the stomach).
This helps to treat the following conditions:
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Duodenal ulcer (the duodenum is the part
of the intestine leaving the stomach)
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Non-cancerous (benign) stomach
(gastric) ulcer
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To prevent the return of a duodenal or
benign gastric ulcer
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Gastric and/or duodenal ulcer caused by
a type of painkiller such as ibuprofen
(a non-steroidal anti-inflammatory drug).
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AXID CAPSULES
DO NOT TAKE AXID CAPSULES IF
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you are allergic (hypersensitive) to
nizatidine, H2 receptor antagonists (other
similar drugs) or any of the other ingredients
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Axid 150 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg Nizatidine
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Hard gelatin capsule with dark yellow caps and pale yellow bodies coded FLYNN 3144, containing an off-white
granular powder.
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 and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs
Axid capsules are intended for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _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.
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.
For the prevention of duodenal and/or benign gastric ulcer recurrence (prophylactic maintenance therapy) the
recommended daily dose is 150mg in the evening. Patients should be kept under regular
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