Lactulose 3.335 g/5 ml oral solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Lactulose

可用日期:

Bristol Laboratories Limited

ATC代码:

A06AD; A06AD11

INN（国际名称）:

Lactulose

剂量:

3.335 g/5ml

药物剂型:

Oral solution

处方类型:

Product not subject to medical prescription

治疗领域:

Osmotically acting laxatives; lactulose

授权状态:

Not marketed

授权日期:

2016-10-28

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACTULOSE 3.335 G/5 ML ORAL SOLUTION
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 your doctor if you do not feel
better or if you feel worse after several days.
WHAT IS IN THIS LEAFLET
1.
What this medicine is and what it is used for
2.
What you need to know before you take this
medicine
3.
How to take this medicine
4.
Possible side effects
Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this
medicine if you suffer from any medical conditions or
illnesses, in particular:
•
if you suffer from unexplained tummy ache
•
if you are unable to digest milk sugar (lactose)
•
if you have diabetes
You should not take this medicine if you suffer from:
•
galactose or fructose intolerance
coma). This is also known as a 'hepatic coma'.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS
MEDICINE
DO NOT TAKE THIS MEDICINE IF:
•
You are allergic to lactulose or any of the other
ingredients of this medicine (listed in section 6)
•
You have a rare problem called 'galactosaemia'
(a severe genetic disorder where you cannot
digest galactose)
•
You have a blockage caused by anything else
but normal constipation, digestive perforation or
risk of digestive perforation.
TAKING OTHER MEDICINES
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines.
LACTULOSE WITH FOOD AND DRINK
Lactulose ca

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose 3.335 g/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains Lactulose 3.335 g.
Excipients with known effect: Also contains small amounts of lactose,
galactose, fructose, tagatose or epilactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, viscous liquid, colourless or pale brownish yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.) For the treatment of constipation.
2.) For the treatment of hepatic encephalopathy (HE): treatment and
prevention of hepatic coma or precoma
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lactulose solution may be administered diluted or undiluted. Each
dose may if necessary be taken with water or
fruit juices, etc.
Each 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 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.
_Lactulose oral solution in bottles:_
STARTING DOSE DAILY
MAINTENANCE
DOSE
DAILY
Adults and adolescents
15-45 ml, corresponding
to 10-30 g lactulose
15-30
ml,
corresponding to
10-20 g lactulose
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