Lactulose 10g/15ml oral solution 15ml sachets sugar free unflavoured

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Lactulose

Disponibbli minn:

Esteve Pharmaceuticals Ltd

Kodiċi ATC:

A06AD11

INN (Isem Internazzjonali):

Lactulose

Dożaġġ:

666.667mg/1ml

Għamla farmaċewtika:

Oral solution

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 01060400; GTIN: 5015664500815

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
LACTULOSE 10 G/15 ML ORAL SOLUTION SACHETS
LACTULOSE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Lactulose is and what it is used for
2.
What you need to know before you take Lactulose
3.
How to take Lactulose
4.
Possible side effects
5.
How to store Lactulose
6.
Contents of the pack and other further Information
1. WHAT LACTULOSE IS AND WHAT IT IS USED FOR
Lactulose 10 g/15 ml oral solution sachets contain a laxative called
lactulose. It makes the stool
softer and easier to pass, by drawing water into the bowel. It is not
absorbed into your body.
Lactulose is indicated in adults and in children and adolescents aged
7 to 18 years.
For children below 7 years, other dosage forms are available.
Lactulose is used to treat the symptoms of constipation.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE
DO NOT TAKE LACTULOSE:
-
if you are allergic to lactulose or any of the other ingredients of
this medicine (listed in section 6).
-
if you suffer from galactosaemia (a severe genetic disorder where you
cannot digest galactose),
acute inflammatory bowel disease (like Crohn's disease or ulcerative
colitis), blockage in your
bowel (apart from normal constipation), digestive perforation or risk
of digestive perforation or
unexplained abdominal pain.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lactulose.
Pl

Karatteristiċi tal-prodott

OBJECT 1
LACTULOSE 10 G / 15 ML ORAL SOLUTION SACHETS
Summary of Product Characteristics Updated 25-Jan-2017 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Laevolac 10 g/15 ml oral solution
Lactulose 10 g/15 ml oral solution sachets
2. Qualitative and quantitative composition
One sachet (15 ml) contains 10 g lactulose (as lactulose liquid).
3. Pharmaceutical form
Oral solution
Clear colourless to pale brownish yellow, viscous solution
4. Clinical particulars
4.1 Therapeutic indications
• Symptomatic treatment of constipation
Laevolac is indicated in adults and in children and adolescents aged 7
to 18 years. For children below 7
years, other dosage forms are available.
4.2 Posology and method of administration
Posology
Laevolac may be administered diluted or undiluted. The dose should be
titrated according to the clinical
response. Lactulose may be given as a single daily dose or in two to
three divided doses.
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. The starting dose can be
adjusted after adequate treatment effect individually (maintenance
dose). Several days (2-3 days) of
treatment may be needed in some patients before adequate treatment
effect occurs. In case of single daily
dose, this should be taken at the same time of the day, e.g. during
breakfast. During the therapy with
laxatives it is recommended to drink sufficient amounts of fluids
(1.5-2 l/day, equal to 6-8 glasses).
If diarrhoea occurs, the dosing regimen should be reduced.
The duration of treatment has to be adopted according to the symptoms.
Starting dose
Maintenance dose
Adults
15-45 ml daily
1-3 sachets,
15-30 ml daily
1-2 sachets,
corresponding to
10-30 g lactulose
corresponding to 10-
20 g lactulose
Older people
In elderly patients no special dosage recommendations exist.
Patients with renal or hepatic impairment
In patients with renal or hepatic insufficiency no