Dulcolax Pico Perles 2.5 mg Capsules, soft

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Sodium picosulfate
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
A06AB; A06AB08
INN (International Name):
Sodium picosulfate
Dosage:
2.5 milligram(s)
Pharmaceutical form:
Capsule, soft
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Contact laxatives; sodium picosulfate
Authorization status:
Not marketed
Authorization number:
PA0540/183/001
Authorization date:
1999-04-01

Read the complete document

D5a/E/PIL/20s/50s/IA dated Jan 2019

Package Leaflet: Information for the user

Dulcolax

Pico Perles

[picture of 4 x capsules]

2.5 mg capsules

sodium picosulfate

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. You need to take DULCOLAX PICO

PERLES as instructed in this leaflet to get the best results from it.

Keep this leaflet. You may need to read it again

Ask your pharmacist if you need more information or advice

You must contact your pharmacist or doctor if your symptoms worsen or do not

improve after five days treatment

If a side effect occurs and gets troublesome, or seems serious to you, or if you

experience any side effect not listed in this leaflet, please tell your pharmacist or

doctor

In this leaflet:

What DULCOLAX PICO PERLES are and what they are used for

Before you take DULCOLAX PICO PERLES

How to take DULCOLAX PICO PERLES

Possible side effects

How to store DULCOLAX PICO PERLES

Further information

1. WHAT DULCOLAX PICO PERLES ARE AND WHAT THEY ARE USED FOR

DULCOLAX PICO PERLES contain a medicine called sodium picosulfate. This

belongs to a group of medicines called laxatives

DULCOLAX PICO PERLES are used for relief of constipation

DULCOLAX PICO PERLES gently stimulate 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 not easily eliminated from the body

D5a/E/PIL/20s/50s/IA dated Jan 2019

The cause of constipation is often not known. It can be associated with:

Sudden change of diet

A diet with not enough fibre

Loss of ‘tone’ of the bowel muscles in older people

Pregnancy

Medicines such as morphine or codeine

Having to stay in bed for a long time

Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated

and heavy or generally “off colour”. Sometimes it causes headaches.

These healthy tips are recommended to try to prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

2. BEFORE YOU TAKE DULCOLAX PICO PERLES

Do not take DULCOLAX PICO PERLES if:

You are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients

in the product (listed in Section 6: Further information)

You have severe dehydration

You have a bowel condition called “ileus” (blockage in the intestine)

You have a serious abdominal condition such as appendicitis

You have severe abdominal pain with nausea and vomiting and/or fever

You have a blocked bowel (intestinal obstruction)

You have inflammation of the bowel (small or large intestine)

Do not take this medicine if any of the above applies to you. If you are not sure, talk to

your pharmacist or doctor before taking this medicine.

Taking other medicines

Please tell your pharmacist or doctor if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription. This includes herbal

medicines. This is because DULCOLAX PICO PERLES can affect the way some other

medicines work. Also, some other medicines can affect the way DULCOLAX PICO

PERLES works.

In particular, tell your pharmacist or doctor if you are taking:

Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide)

Steroid medicines such as prednisolone

Antibiotics – used for infections

Before taking DULCOLAX PICO PERLES tell your pharmacist or doctor if you are not

sure if any of the above applies to you.

D5a/E/PIL/20s/50s/IA dated Jan 2019

Pregnancy and breast-feeding

Talk to your pharmacist or doctor before taking DULCOLAX PICO PERLES if you are

pregnant, planning to become pregnant or are breast-feeding.

3. HOW TO TAKE DULCOLAX PICO PERLES

If this medicine is from your doctor or pharmacist, do exactly as they have told you.

Otherwise, follow the instructions below. If you do not understand the instructions, or if

you are not sure, ask your pharmacist or doctor.

As with all laxatives, DULCOLAX PICO PERLES should not be taken every day for

more than five days. If you need laxatives every day, or if you have abdominal

pain which does not go away, you should see your doctor.

How much to take

Adults and children over 10 years

Take two to four capsules (5 mg to 10 mg) at night

When your bowel regularity has returned to normal, the dose can usually be stopped

Children aged between 4 and 10 years

DULCOLAX PICO PERLES should only be given to children between the ages of 4 and

10 if recommended by a doctor. The usual dose for children is:

Give one to two capsules (2.5 mg to 5 mg) at night

Children under 4 years

DULCOLAX PICO PERLES is not recommended for children under 4 years.

If you take more DULCOLAX PICO PERLES than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital

straight away. Take the medicine pack with you. This is so the doctor knows what you

have taken.

If you have any questions on the use of this product, ask your pharmacist or doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, DULCOLAX PICO PERLES can cause side effects, although not

everybody gets them. The following side effects may happen with this medicine:

Isolated events (some side effects are so rare that it is not known how many

people may be affected)

Syncope (feeling faint)

Allergic reaction

Skin reactions (rash, itching)

If you have a severe allergic reaction, stop taking this medicine and see a doctor straight

away. The signs may include: a rash, swelling of your skin, mouth and face which may

cause swallowing or breathing problems.

D5a/E/PIL/20s/50s/IA dated Jan 2019

Very common side effects (affect 1 in 10 people or more)

Diarrhoea

Common side effects (affect less than 1 in 10 people)

Abdominal discomfort, cramps or pain

Uncommon side effects (affect less than 1 in 100 people)

Nausea

Vomiting

Dizziness

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via

the national reporting system (see details below):

HPRA Pharmacovigilance

Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this

medicine.

5. HOW TO STORE DULCOLAX PICO PERLES

Keep this medicine out of the sight and reach of children

Do not take DULCOLAX PICO PERLES after the expiry date which is stated on the

carton or bottle label after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C

Keep the bottle within the outer carton in order to protect from light

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. FURTHER INFORMATION

What DULCOLAX PICO PERLES contain

Each capsule contains 2.5 mg of sodium picosulfate (present as monohydrate) as

the active ingredient

The other ingredients are: propylene glycol, macrogol 400, gelatin, glycerol and

purified water

D5a/E/PIL/20s/50s/IA dated Jan 2019

What DULCOLAX PICO PERLES look like and contents of the pack

DULCOLAX PICO PERLES are small, pearl-shaped soft gelatin capsules. They are

available in packs of 20 and 50 capsules.

The Marketing Authorisation is held by:

sanofi-aventis Ireland Ltd.

T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

Batch release is carried out by:

CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd

(CHINOIN Private Co. Ltd.)

Veresegyház site

Lévai utca 5,

Veresegyház, 2112

Hungary

This leaflet was revised in January 2019.

® Registered trade mark

Read the complete document

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dulcolax Pico Perles 2.5 mg Capsules, soft

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains 2.5 mg sodium picosulfate as Sodium Picosulfate Monohydrate.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, soft

Round, colourless, clear capsule.

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

Two to four capsules (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

One to two capsules (2.5 - 5 mg) per day.

Children under 4 years of age

Not recommended for children under 4 years of age.

Once regularity has been restarted, dosage should be reduced and can usually be stopped.

The capsules should be swallowed with adequate fluid.

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4.3 Contraindications

DULCOLAX PICO is contraindicated in patients with:

Ileus or intestinal obstruction

Severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea

and vomiting

Acute inflammatory bowel diseases

Severe dehydration

Known hypersensitivity to sodium picosulfate or any other component of the product

Rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4).

4.4 Special warnings and precautions for use

As with all laxatives, Dulcolax Pico Perles should not be taken on a continuous daily basis for more than five days

without investigating the cause of constipation.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

Dizziness and/or syncope have been reported in patients who have taken products in the DULCOLAX or DULCOLAX

PICO ranges. The details available for these cases suggest that the events would be consistent with defaecation syncope

(or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the

constipation, and not necessarily to the administration of sodium picosulfate itself.

Dulcolax Pico Perles should not be taken by children under 10 years without medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive

doses of Dulcolax Pico Perles are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

Concurrent administration of antibiotics may reduce the laxative action of this product.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women.

Long experience has shown no evidence of

undesirable or damaging effects during pregnancy.

Lactation

Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-

methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Nevertheless, as with all medicines, DULCOLAX PICO should not be taken in pregnancy, especially the first trimester,

and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical

advice.

Fertility

No studies on the effect on human fertility have been conducted. Non-clinical studies did not reveal any effect on

fertility (see section 5.3).

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4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

However, patients should be advised that due to a vasovagal response (for example, due to abdominal spasm), dizziness

and /or syncope may be experienced. If patients experience abdominal spasm they should avoid potentially hazardous

tasks such as driving or operating machinery.

4.8 Undesirable effects

Adverse events have been ranked under headings of frequency using the following convention: Very common (

1/10);

common (

1/100, < 1/10); uncommon (

1/1000, <1/100); rare (

1/10000, <1/1000); very rare (<1/10000);

not known – cannot be estimated from the available data.

Immune system disorders

Not known:

Hypersensitivity

Nervous system disorders

Uncommon: Dizziness

Not known: Syncope

Dizziness and syncope occurring after taking sodium picosulfate appear to be consistent with a vasovagal response (for

example, due to abdominal spasm, defaecation).

Gastrointestinal disorders

Very common: Diarrhoea

Common: Abdominal discomfort, abdominal pain, abdominal cramps.

Uncommon: Nausea, vomiting.

Skin and subcutaneous tissue disorders

Not known: Skin reactions

such as angioedema

, drug eruption

, rash

, pruritus

*This adverse event

has been observed in post-marketing experience. With 95% certainty, the frequency category is

not greater than uncommon, but might be lower. A precise frequency estimation is not possible as the adverse event did

not occur in a clinical trial database of 1020 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Symptoms:

If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other

electrolytes can occur.

Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of DULCOLAX

PICO range considerably higher than those recommended for the routine management of constipation.

Laxatives when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary

hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to

hypokalaemia have also been described in association with chronic laxative abuse.

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Therapy:

Within a short time of ingestion, absorption can be minimised or prevented by inducing vomiting or by gastric

lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in

the elderly and the young.

Administration of antispasmodics may be of some value.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Laxative

ATC code: A06AB08

Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the

colon, has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Stimulation of the

mucosa of the large intestine results in colonic peristalsis, with promotion of accumulation of water, and consequently

electrolytes, in the colonic lumen. This results in a stimulation of defaecation, reduction of transit time and softening of

the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help

to restore the “call to stool” although its clinical relevance remains to be established.

As a laxative that acts on the colon, sodium picosulfate specifically stimulates the natural evacuation process in the

lower region of the gastrointestinal tract. Therefore, sodium picosulfate is ineffective in altering the disgestion or

absorption of calories or essential nutrients in the small intestine.

5.2 Pharmacokinetic properties

Absorption and Distribution

After oral ingestion, sodium picosulfate reaches the colon without any appreciable absorption. Therefore, enterohepatic

circulation is avoided.

Biotransformation

Sodium picosulfate is converted into the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM),

via bacterial cleavage in the distal segment of the intestine.

Elimination

Following conversion, only small amounts of BHPM are absorbed and are almost completely conjugated in the

intestinal wall and the liver to form the inactive BHPM glucuronide. After oral administration of 10 mg sodium

picosulfate 10.4% of the total dose was excreted as BHPM glucuronide in urine after 48 hours. In general, urinary

excretion decreases when higher doses of sodium picosulfate are being administered.

Pharmacokinetic/Pharmacodynamic relationship(s)

Consequently, the onset of action of the preparation is usually between 6 - 12 hours, which is determined by the release

of the active substance (BHPM).

There is no direct or inverse relationship between the laxative effect and plasma levels of the active moiety.

5.3 Preclinical safety data

Sodium picosulfate was investigated for teratogenicity (Segment II) in rats (1, 10, 1000 and 10000 mg/kg) and rabbits

(1, 10 and 1000 mg/kg) following oral dosing. Maternal toxic dose levels causing severe diarrhoea were associated

with embryotoxicity (increase of early resorptions) without any teratogenic effects or adverse effects on the

reproductive performance of the offspring. Fertility and general embryonic development (Segment I) as well as pre-and

postnatal development (Segment III) of rats were not impaired by oral doses of 1, 10 and 100 mg/kg.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol

Macrogol 400

Gelatin

Glycerol

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Keep the bottle within the outer carton, in order to protect from light.

6.5 Nature and contents of container

Type III colourless glass bottles with polypropylene screw caps or child resistant polypropylene screw caps.

Pack sizes 20, 24, 30, 40 or 50 capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

Any unused product should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Ireland Ltd

T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0540/183/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1999

Date of last renewal: 01 April 2009

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10 DATE OF REVISION OF THE TEXT

August 2017

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