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DULCOLAX PICO PERLES 2.5 MG SOFT CAPSULES

Active substance: SODIUM PICOSULPHATE MONOHYDRATE

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4677012211-011

Package Leaflet: Information for the user

abcd
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:
1. What DULCOLAX PICO PERLES are and
what they are used for
2. Before you take DULCOLAX PICO PERLES
3. How to take DULCOLAX PICO PERLES
4. Possible side effects
5. How to store DULCOLAX PICO PERLES
6. 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
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.
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.

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
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
What DULCOLAX PICO PERLES look like
and contents of the pack
DULCOLAX PICO PERLES are small, pearlshaped soft gelatin capsules. They are
available in packs of 20, or larger packs of
50 (available only from pharmacies).
Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Consumer Healthcare,
Ellesfield Avenue, Bracknell, Berkshire,
RG12 8YS, United Kingdom.
Batch release is carried out by:

Very common side effects (affects 1 in 10
people or more)
• Diarrhoea

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim, Germany.

Common side effects (affects less than 1
in 10 people)
• Abdominal discomfort, cramps or pain

This leaflet was revised in July 2014.

Uncommon side effects (affects less than
1 in 100 people)
• Nausea
• Vomiting
• Dizziness

©Boehringer Ingelheim Limited 2014

® Registered trademark

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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.

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