Skip to Content

DULCOLAX PICO LIQUID 5 MG / 5 ML ORAL SOLUTION

Active substance(s): SODIUM PICOSULFATE

View full screen / Print PDF » Download PDF ⇩
Transcript
437524/GB/1

Pico Liquid
5 mg/5 ml oral solution
sodium picosulfate
Package leaflet: Information for the user 
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 Liquid 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:
1. What Dulcolax Pico Liquid is and what it is used for
2. 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. Further information

1. What Dulcolax Pico Liquid is and what it
is used for

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 Liquid
Do not take Dulcolax Pico Liquid 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 and large
intestine)
Do not take Dulcolax Pico Liquid if any of the above
applies to you. If you are not sure, talk to your pharmacist
or doctor before taking this medicine.

• 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 dependable, overnight
relief from constipation, helping to return the body to its
natural rhythm.

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 Liquid can
affect the way some other medicines work. Also, some
other medicines can affect the way Dulcolax Pico Liquid
works.

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.

In particular, tell your doctor or pharmacist if you are taking:
• Water tablets (diuretics) such as bendrofluazide or
furosemide (frusemide)
• Steroid medicines such as prednisolone
• Antibiotics – used for infections
If you are not sure if any of the above applies to you, talk to
your pharmacist or doctor before taking Dulcolax Pico Liquid.

• 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

Pregnancy and breast-feeding
Talk to your pharmacist or doctor before taking Dulcolax
Pico Liquid if you are pregnant, planning to become
pregnant or are breast-feeding.

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.

Important information about some of the ingredients
in Dulcolax Pico Liquid
Dulcolax Pico Liquid contains 5.9% ethanol (alcohol), which
is up to 480 mg per dose. This is equivalent to 12 ml beer or
5 ml wine per dose. This may be harmful for people with a
drink problem (alcoholism). This should also be taken into
account in pregnant or breast-feeding women, children and
high risk groups such as those with liver disease or epilepsy.
Dulcolax Pico Liquid contains the preservatives methyl
parahydroxybenzoate and propyl parahydroxybenzoate.
These ingredients may cause allergic reactions, which may
not happen after the first dose. The signs may include: a
rash, swelling of your skin, mouth and face which may
cause swallowing or breathing problems.

abcd

Mandatory in

File information

TD

Printfile

Issue date of TD:

15.05.2015

Yes

Yes

PPM SKU:

P036786

No

Yes

PPM SKU version: 

001

No

Yes

Issue date of artwork:

17.07.2015

No

Yes

Print colors:

PAN 357

No

Yes

Mat. No. Pack. Site:

437524/GB/1

No

Yes

Min. font size:

8pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

= 8 mm

= 1,5 mm

= 10 mm

= 2 mm

= 1,5 mm

= 72 mm

Technical colors
Free area

Additional Requirements of Packaging Site
Dimensions: mm 160 x 305

= 0,5 mm
= 2 mm

= 9 mm

Technical information

BI-Diecut-Legendcase

CONTROL CODE

PITCH CODE

Gluepoints

= 1 mm

3. How to take Dulcolax Pico Liquid
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 you are not sure, ask your pharmacist or
doctor.
As with all laxatives, Dulcolax Pico Liquid should not
be taken every day for long periods. 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
• One to two 5 ml spoonfuls 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 Liquid should only be given to children
under 10 if recommended by a doctor.
The usual dose for a child is:
• Half to one 5 ml spoonful at night
Children under 4 years
The dose will depend on the weight of your child: 0.25 ml
for each kilogram of the child’s body weight.
If you take more Dulcolax Pico Liquid 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.

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 (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Dulcolax Pico Liquid
• Keep this medicine out of the sight and reach of children
• Do not take Dulcolax Pico Liquid after the expiry date
which is stated on the carton and bottle label after EXP.
The expiry date refers to the last day of that month
• Keep the bottle within the outer carton
• 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
4. Possible side effects
Like all medicines, Dulcolax Pico Liquid 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.
Very common side effects (affects 1 in 10 people or
more)
• Diarrhoea
Common side effects (affects less than 1 in 10 people)
• Abdominal discomfort, cramps or pain
Uncommon side effects (affects less than 1 in 100
people)
• Nausea
• Vomiting
• Dizziness

What Dulcolax Pico Liquid contains
• Each 5 ml contains 5 mg of sodium picosulfate (present
as sodium picosulfate monohydrate) as the active
ingredient
• The other ingredients are: carmellose sodium, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), glycerol, tutti frutti flavour, saccharin sodium,
ethanol, sodium hydroxide (for pH adjustment) and water
What Dulcolax Pico Liquid looks like and contents of
the pack
Dulcolax Pico Liquid is a clear, yellowish-orange, slightly
viscous fruit flavoured solution. It is available in packs of
30 ml, 100 ml and 300 ml.
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berkshire,
RG12 8YS, United Kingdom.
Dulcolax Pico Liquid is manufactured at:
Istituto De Angeli S.r.l.
Località Prulli n. 103/c
50066 Reggello (FI), Italy
This leaflet was revised in July 2015.
®Registered trade mark
© Copyright Boehringer Ingelheim Limited 2015

abcd

437524/GB/1

437525/GB/1

Pico Liquid
5 mg/5 ml oral solution
sodium picosulfate
Package leaflet: Information for the user 
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 Liquid 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:
1. What Dulcolax Pico Liquid is and what it is used for
2. 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. Further information

1. What Dulcolax Pico Liquid is and what it
is used for

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 Liquid
Do not take Dulcolax Pico Liquid 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 and large
intestine)
Do not take Dulcolax Pico Liquid if any of the above
applies to you. If you are not sure, talk to your pharmacist
or doctor before taking this medicine.

• 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 dependable, overnight
relief from constipation, helping to return the body to its
natural rhythm.

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 Liquid can
affect the way some other medicines work. Also, some
other medicines can affect the way Dulcolax Pico Liquid
works.

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.

In particular, tell your doctor or pharmacist if you are taking:
• Water tablets (diuretics) such as bendrofluazide or
furosemide (frusemide)
• Steroid medicines such as prednisolone
• Antibiotics – used for infections
If you are not sure if any of the above applies to you, talk to
your pharmacist or doctor before taking Dulcolax Pico Liquid.

• 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

Pregnancy and breast-feeding
Talk to your pharmacist or doctor before taking Dulcolax
Pico Liquid if you are pregnant, planning to become
pregnant or are breast-feeding.

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.

Important information about some of the ingredients
in Dulcolax Pico Liquid
Dulcolax Pico Liquid contains 5.9% ethanol (alcohol), which
is up to 480 mg per dose. This is equivalent to 12 ml beer or
5 ml wine per dose. This may be harmful for people with a
drink problem (alcoholism). This should also be taken into
account in pregnant or breast-feeding women, children and
high risk groups such as those with liver disease or epilepsy.
Dulcolax Pico Liquid contains the preservatives methyl
parahydroxybenzoate and propyl parahydroxybenzoate.
These ingredients may cause allergic reactions, which may
not happen after the first dose. The signs may include: a
rash, swelling of your skin, mouth and face which may
cause swallowing or breathing problems.

abcd

Mandatory in

File information

TD

Printfile

Issue date of TD:

21.05.2015

Yes

Yes

PPM SKU:

P036789

No

Yes

PPM SKU version: 

001

No

Yes

Issue date of artwork:

17.07.2015

No

Yes

Print colors:

PAN 357

No

Yes

Technical information
Control code

PITCH CODE

= 0,35 mm
2 mm

Mat. No. Pack. Site:

437525/GB/1

Min. font size:

8pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

No

Yes
= 1 mm

= 10 mm

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

5 mm

1 mm

= 0,65 mm

Technical colors
BI-Diecut-Legendcase

Free area

= 9 mm

Gluepoints
= 46,5 mm

Additional Requirements of Packaging Site
Dimensions: mm 160 x 305 folded 160 x 36

= 2 mm

3. How to take Dulcolax Pico Liquid
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 you are not sure, ask your pharmacist or
doctor.
As with all laxatives, Dulcolax Pico Liquid should not
be taken every day for long periods. 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
• One to two 5 ml spoonfuls 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 Liquid should only be given to children
under 10 if recommended by a doctor.
The usual dose for a child is:
• Half to one 5 ml spoonful at night
Children under 4 years
The dose will depend on the weight of your child: 0.25 ml
for each kilogram of the child’s body weight.
If you take more Dulcolax Pico Liquid 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.

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 (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Dulcolax Pico Liquid
• Keep this medicine out of the sight and reach of children
• Do not take Dulcolax Pico Liquid after the expiry date
which is stated on the carton and bottle label after EXP.
The expiry date refers to the last day of that month
• Keep the bottle within the outer carton
• 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
4. Possible side effects
Like all medicines, Dulcolax Pico Liquid 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.
Very common side effects (affects 1 in 10 people or
more)
• Diarrhoea
Common side effects (affects less than 1 in 10 people)
• Abdominal discomfort, cramps or pain
Uncommon side effects (affects less than 1 in 100
people)
• Nausea
• Vomiting
• Dizziness

What Dulcolax Pico Liquid contains
• Each 5 ml contains 5 mg of sodium picosulfate (present
as sodium picosulfate monohydrate) as the active
ingredient
• The other ingredients are: carmellose sodium, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), glycerol, tutti frutti flavour, saccharin sodium,
ethanol, sodium hydroxide (for pH adjustment) and water
What Dulcolax Pico Liquid looks like and contents of
the pack
Dulcolax Pico Liquid is a clear, yellowish-orange, slightly
viscous fruit flavoured solution. It is available in packs of
30 ml, 100 ml and 300 ml.
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berkshire,
RG12 8YS, United Kingdom.
Dulcolax Pico Liquid is manufactured at:
Istituto De Angeli S.r.l.
Località Prulli n. 103/c
50066 Reggello (FI), Italy
This leaflet was revised in July 2015.
®Registered trade mark
© Copyright Boehringer Ingelheim Limited 2015

abcd

437525/GB/1

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide