Pill Identifier App

DULCOLAX PICO LIQUID 5 MG / 5 ML ORAL SOLUTION

Active substance: SODIUM PICOSULFATE

View full screen / Print PDF » Download PDF ⇩

Transcript


437713/GB/2

Pico Liquid

5mg / 5ml 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
• 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.
• 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 not easily eliminated from the body
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

ABCD

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 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.
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.
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.
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.

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 breastfeeding women, children and high risk groups such as
those with liver disease or epilepsy.
DULCOLAX PICO Liquid contains the preservatives methyl
parahydroxybenzoate, propyl parahydroxybenzoate and
the colouring agent sunset yellow (E110). 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.
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.
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
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
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, aroma tutti
frutti (flavouring), saccharin sodium, colouring sunset
yellow (E110), 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 Regello (FI), Italy
This leaflet was revised in August 2014.

®Registered trade mark
© Copyright Boehringer Ingelheim Limited 2014

ABCD

437713/GB/2

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
(web5)