Antepsin 1 g/5 ml Oral Suspension

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 g/5ml

Pharmaceutical form:

Oral suspension

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/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains 1 gram sucralfate.
Each 5ml dose also contains sodium propyl hydroxybenzoate (E217) 2.0mg
and sodium methyl hydroxybenzoate (E219) 3.75mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White to off-white viscous suspension with an odour of
aniseed/caramel.
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, and the prophylaxis of gastrointestinal haemorrhage from
stress ulceration in seriously ill patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Antepsin must not be administered intravenously.
_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.
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.
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.
Elderly: see below
_Prophylaxis of gastrointestinal haemorrhage from stress ulceration:_
Adults: The usual dose is 1 gram six times a day.A maximum dose of 8
grams daily should not be exceeded.Antacids may be
used as required for relief of pain, but should not be taken half an
hour before or after Antepsin.
Paediatric population
The safety and efficacy of Antepsin in children under 14 years of age
has no