Laxose (Lactulose Solution BP) 3.35g/5ml Oral Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Lactulose

Commercializzato da:

Pinewood Laboratories Ltd

Codice ATC:

A06AD; A06AD11

INN (Nome Internazionale):

Lactulose

Dosaggio:

3.35 g/5ml

Forma farmaceutica:

Oral solution

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Osmotically acting laxatives; lactulose

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

1996-05-07

Foglio illustrativo

FOR THE RELIEF OF CONSTIPATION
500 ML
BALLYMACARBRY, CO. TIPPERARY.
LACTULOSE SOLUTION BP
3.35 G/5 ML ORAL SOLUTION
P
PATIENT
Adults & adolescents
Children, 7 - 14 years
Children, 1 - 6 years
Infants under 1 year
STARTING
DOSE DAILY
15 - 45 ml
15 ml
5 - 10 ml
Up to 5 ml
FOR ORAL ADMINISTRATION. EACH 5 ML OF
LAXOSE™ CONTAINS: 3.35 g of Lactulose.
Also includes Lactose, Galactose and Fructose.
CONSTIPATION:
HEPATIC ENCEPHALOPATHY (hepatic coma):
Initially 30 - 45 ml three to four times daily.
Read the package leaftlet before use.
Use as directed by your doctor or pharmacist.
The action of Laxose may take 2 - 3 days
to show results hence it is important to take
the medicine regularly as directed.
Keep out of the sight and reach of children.
Do not store above 25˚C. Do not freeze.
PA Holder: Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel, Co. Tipperary,
Ireland.
PA 281/79/1 23LL05176PW
FOR THE RELIEF OF CONSTIPATION
500 ML
BALLYMACARBRY, CO. TIPPERARY.
LACTULOSE SOLUTION BP
3.35 G/5 ML ORAL SOLUTION
P
PATIENT
Adults & adolescents
Children, 7 - 14 years
Children, 1 - 6 years
Infants under 1 year
STARTING
DOSE DAILY
15 - 45 ml
15 ml
5 - 10 ml
Up to 5 ml
FOR ORAL ADMINISTRATION. EACH 5 ML OF
LAXOSE™ CONTAINS: 3.35 g of Lactulose.
Also includes Lactose, Galactose and Fructose.
CONSTIPATION:
HEPATIC ENCEPHALOPATHY (hepatic coma):
Initially 30 - 45 ml three to four times daily.
Read the package leaftlet before use.
Use as directed by your doctor or pharmacist.
The action of Laxose may take 2 - 3 days
to show results hence it is important to take
the medicine regularly as directed.
Keep out of the sight and reach of children.
Do not store above 25˚C. Do not freeze.
PA Holder: Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel, Co. Tipperary,
Ireland.
PA 281/79/1 23LL05176PW
25˚C. Do not freeze. Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help
to protect the environment.
6. CONTENTS OF THE PACK AND OT

Scheda tecnica

Health Products Regulatory Authority
09 June 2022
CRN00CY5T
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxose (Lactulose Solution BP) 3.35g/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains 3.35 g lactulose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear to almost clear pale yellow oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of hepatic encephalopathy (HE).
In the treatment of constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lactulose solution may be administered diluted or undiluted.
A single dose of lactulose should be swallowed in one and should not
be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of
the patient. In case of a single daily dose, this should be
taken at the same time e.g. during breakfast. During the therapy with
laxatives it is recommended to drink sufficient amounts
of fluids (1.5 – 2 litres, equal to 6-8 glasses) during the day.
DOSING IN CONSTIPATION
Lactulose may be given as a single daily dose or in two divided doses.
After a few days the starting dosage may be adjusted to the
maintenance dose based upon treatment response.
Several days (2-3 days) of treatment may be needed before treatment
effect occurs.
Starting dose daily
Maintenance dose daily
Adults and adolescents
15 - 45 ml
15 – 30 ml
Children (7-14 years)
15 ml
10 – 15 ml
Children (1-6 years)
5 - 10 ml
5 – 10 ml
Infants under 1 year
Up to 5 ml
Up to 5 ml
Health Products Regulatory Authority
09 June 2022
CRN00CY5T
Page 2 of 6
DOSING IN HEPATIC ENCEPHALOPATHY HE (FOR ADULTS ONLY)
Starting Dose
Maintenance Dose
3 to 4 times daily 30-45 ml
Starting dose may be adjusted to the maintenance dose to achieve 2 –
3 soft stools per day
PAEDIATRIC POPULATION
The safety and efficacy in children (newborn to 18 years of age) with
HE have not been established. No data is available.
ELDERLY PATIENTS A