Antepsin 1 g Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sucralfate

Available from:

Chugai Pharma France

ATC code:

A02BX; A02BX02

INN (International Name):

Sucralfate

Dosage:

1 gram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); sucralfate

Authorization status:

Not marketed

Authorization date:

2000-03-31

Patient Information leaflet

1.3.1 Spc, Labelling and Package Leaflet -
UK and IE proposed leaflet
INN_: _lenograstim
_ _
Proposed – Dec 2018
CONFIDENTIAL
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GRANOCYTE 13 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION IN A PRE-
FILLED SYRINGE
GRANOCYTE 34 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION IN A PRE-
FILLED SYRINGE
Lenograstim
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 Granocyte is and what it is used for
2. What you need to know before you take Granocyte
3. How to take Granocyte
4. Possible side effects
5. How to store Granocyte
6. Contents of the pack and other information
1. WHAT GRANOCYTE IS AND WHAT IT IS USED FOR
The name of your medicine is Granocyte, powder and solvent for
injection/infusion (called Granocyte
in this leaflet). Granocyte contains a medicine called lenograstim.
This belongs to a group of medicines
called cytokines.
Granocyte works by helping your body to make more of the blood cells
which fight infection.
• These blood cells are made in your bone marrow.
• Granocyte encourages your bone marrow to make more cells called
‘blood stem cells’.
• It then helps turn these young blood cells into fully working
blood cells.
• In particular, it helps produce more white blood cells called
neutrophils. Neutrophils are
important in fighting infections.
GRANOCYTE IS USED:
• AFTER CANCER TREATMENT, IF THE LEVEL OF YOUR WHITE BLOOD CELLS IS
TOO LOW (CALLED ‘NEUTROPENIA’)
Some tre

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2019
CRN008QYF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antepsin 1g Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 gram of sucralfate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Biconvex, oblong, white tablets with a dividing score on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antepsin is indicated in adults and adolescents over 14 years old for
the treatment of duodenal ulcer, gastric ulcer, chronic
gastritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Duodenal ulcer, gastric ulcer, chronic gastritis:_
Adults: The usual dose is 2 grams twice daily to be taken on rising
and at bedtime, or 1 gram 4 times a day to be taken 1 hour
before meals and at bedtime. Maximum daily dose: 8 grams.For ease of
administration, Antepsin Tablets may be dispersed in
10-15 ml of water.
Four to six weeks’ treatment is usually needed for ulcer healing,
but up to twelve weeks may be necessary in resistant cases.
Antacids may be used as required for relief of pain, but should not be
taken half an hour before or after Antepsin.
Elderly:There are no special dosage requirements for elderly patients
but, as with all medicines, the lowest effective dose
should be used.
Paediatric population:
The safety and efficacy of Antepsin in children under 14 years of age
has not been established.
Currently available data are described in section 5.1 but no
recommendation on posology can be made.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product should only be used with caution in patients with renal
dysfunction, due to the possibility of increased aluminium
absorption.
Sucralfate is not recommended for use in individuals on dialysis.
Health Pr