Dulcolax Pico Liquid 5 mg/5 ml, oral solution

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Sodium picosulfate

থেকে পাওয়া:

Sanofi-Aventis Ireland Limited T/A SANOFI

এটিসি কোড:

A06AB; A06AB08

INN (International Name):

Sodium picosulfate

ডোজ:

5 mg/5ml

ফার্মাসিউটিকাল ফর্ম:

Oral solution

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

Therapeutic area:

Contact laxatives; sodium picosulfate

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1975-08-31

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
DULCOLAX
® PICO LIQUID 5MG/5ML ORAL SOLUTION
(sodium picosulfate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Always take Dulcolax
Pico Liquid exactly as
described in this leaflet or as your doctor or pharmacist has 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 five days.
WHAT IS IN THIS LEAFLET:
1. What Dulcolax Pico Liquid is and what it is used for
2. What you need to know before you take Dulcolax Pico Liquid
3. How to take Dulcolax Pico Liquid
4. Possible side effects
5. How to store Dulcolax Pico Liquid
6. Contents of the pack and other information
1.
WHAT DULCOLAX PICO LIQUID IS AND WHAT IT IS USED FOR
Dulcolax Pico Liquid contains a medicine called sodium picosulfate.
This belongs to a group of
medicines called laxatives.
Dulcolax Pico Liquid is used for relief of constipation. This medicine
does not help with weight
loss. Dulcolax Pico Liquid gently stimulates the muscles of the bowel
(large intestine). This
brings predictable, overnight relief from constipation, helping to
return the body to its natural
rhythm.
WHAT IS CONSTIPATION?
Normal and regular bowel movement is important for most people.
However, what is “normal
and regular” varies from person to person. Some may have a bowel
movement every day, others
less often. Whatever it is like for you, it is best that your bowel
movement has a regular pattern.

Constipation is an occasional problem for some people. For others, it
may happen more
often

It happens when the normal muscle actions in the bowel (large
intestine) slow down.
This can mean that material is no

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
14 June 2021
CRN00C66P
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dulcolax Pico Liquid 5 mg/5 ml, oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution containing 5 mg of sodium picosulfate (as monohydrate)
in each 5 ml.
Excipients:
Methyl Parahydroxybenzoate (E218) 2.5 mg / 5 ml
Propyl Parahydroxybenzoate (E216) 0.5 mg / 5 ml
Ethanol 96% 250 mg / 5 ml
Excipient with known effect: Each 5 ml dose contains 1.18 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless to yellowish or slightly yellowish-brown, slightly
viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term management of constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The following dosages are recommended to be taken at night to produce
evacuation the following morning.
It is recommended to start with the lowest dose. The dose may be
adjusted up to the maximum recommended dose to
produce regular stools. The maximum recommended daily dose should not
be exceeded.
Adults and children over 10 years of age:
One to two 5 ml spoonfuls (5-10 mg) per day.
Children under 10 years of age:
Not to be taken by children under 10 years of age without medical
advice.
Children aged 4-10 years:
Half to one 5 ml spoonful (2.5-5 mg) per day.
Children aged 2-4 years:
The recommended dosage is 0.25 mg per kilogram body weight per day (1
ml of Dulcolax Pico Liquid contains 1 mg sodium
picosulfate).
<
In the management of constipation, once regularity has been restarted
dosage should be reduced and can usually be stopped.
Diluent: Can be diluted with purified water.
4.3 CONTRAINDICATIONS
DULCOLAX PICO is contraindicated in patients with:
Health Products Regulatory Authority
14 June 2021
CRN00C66P
Page 2 of 5

Ileus or intestinal obstruction

Severe painful and/or feverish acute abdominal conditions (e.g.
appendicitis) potentially associated with nausea
and vomiting