DUPHALAC DRY POWDER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbott Laboratories S.A. (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

POWDER

Composition:

EACH 10,0 g POWDER CONTAINS LACTULOSE 10,0 g

Authorization status:

Registered

Authorization date:

1996-03-05

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
DUPHALAC DRY, 10 G POWDER FOR ORAL SOLUTION
Contains sugar: 10 g lactose
_READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU _
DUPHALAC DRY is available without a doctor’s prescription, for you
to treat a mild illness.
Nevertheless, you still need to use DUPHALAC DRY carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share DUPHALAC DRY with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
3 days._ _
WHAT IS IN THIS LEAFLET
1. What DUPHALAC DRY is and what it is used for
2. What you need to know before you use DUPHALAC DRY
3. How to use DUPHALAC DRY
4. Possible side effects
5. How to store DUPHALAC DRY
6. Contents of the pack and other information
1.
WHAT DUPHALAC DRY IS AND WHAT IT IS USED FOR
DUPHALAC DRY 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.
DUPHALAC DRY is used to treat the symptoms of constipation (infrequent
bowel
movements, hard and dry stools). DUPHALAC DRY is indicated in adults
and in children and
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adolescents aged 1 to 18 years.
Lactulose is used to treat portal systemic encephalopathy (a liver
disease causing confusion,
tremor, decreased level of consciousness).
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 DUPHALAC DRY
DO NOT TAKE DUPHALAC DRY:
•
if are hypersensitive (allergic) to lactulose;
•
if you suffer from galactosaemia (a severe genetic disorder where you
cannot digest
galactose);
•
if you have a blockage in your bowel (apart from normal constipation).
WARNINGS AND PRECAUTIONS
Special care should be taken with DUPHALAC DRY.
Talk to your doctor or pharmacist before taking DUPHALAC DRY

Summary of Product characteristics

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PROFESSIONAL INFORMATION
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
DUPHALAC DRY
10 g of Duphalac Dry contains 10 g lactulose
Crystalline powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 g of DUPHALAC DRY contains 10 g lactulose
(4-0-ᵦ-D-galactopyranosyl-D-fructofuranose) (a
maximum of 0,25 g galactose and 0,2 g lactulose).
For the full list of excipients, see section 6 .1.
DUPHALAC DRY contains residues from the route of production with known
effect, see section
4.4.
3.
PHARMACEUTICAL FORM
A white to slightly yellow coloured crystalline powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A)
CONSTIPATION
Particularly when associated with laxative habituation or for those
patients in whom
constipation presents a special problem, e.g. children, obstetric and
post-surgical patients.
B)
PORTAL SYSTEMIC ENCEPHALOPATHY
Hepatic coma or precoma stages where hyperammonaemia is present.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
A)
CONSTIPATION
The dosage for constipation can be varied according to the individual
response, but the
following serves as a guide.
Starting dose (3 days) gram
per day
Maintenance dose gram per
day
Adults
10-30 g
10-20 g
Children 7-14 years
10 g
10 g
Children 1-6 years
5-10 g
5-10 g
If there is no response within 48 hours the dosage can be increased
and if diarrhoea
occurs dosage should be decreased.
Since DUPHALAC DRY exerts its effect when it reaches the colon it may
take 1-2 days
before normal defaecation occurs.
B)
PORTAL SYSTEMIC ENCEPHALOPATHY
Starting dose 20-35 g three times a day.
Maintenance dose has to be adjusted to the individual response.
DUPHALAC DRY can be taken with breakfast cereals, or drinks such as
tea, coffee, fruit juice or
milk.
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4.3 CONTRAINDICATIONS
Hypersensitivity to lactulose (see section 6.1)
Galactosaemia including patients on a galactose-free diet.
Patients with intestinal obstruction.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In case of insufficient therapeutic effect after several days
consultation of