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DICYCLOVERINE ORAL SOLUTION

Active substance(s): DICYCLOVERINE HYDROCHLORIDE / DICYCLOVERINE HYDROCHLORIDE / DICYCLOVERINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

DICYCLOVERINE 10MG/5ML
ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
THE LEAFLET CONTAINS INFORMATION ON:
1. What Dicycloverine Oral Solution is and what it is used for.
2. Before you take Dicycloverine Oral Solution
3. How to take Dicycloverine Oral Solution
4. Possible side effects
5. How to store Dicycloverine Oral Solution
6. Further Information
1. WHAT DICYCLOVERINE ORAL SOLUTION IS AND
WHAT IT IS USED FOR?
Dicycloverine hydrochloride, the active ingredient of Dicycloverine Oral
Solution is one of a group of medicines called anticholinergic
antispasmodics. It is used to relieve painful bowel cramps. The
anticholinergic action helps to relax the muscles of the intestine and relieve
the painful symptoms.

103565/LF/332/02

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Dicycloverine Oral
Solution
120 ml
Leaflet
103565
UK
Indoco Remedies
1
29/08/2016
PAT
PR 6296

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

130 x 320 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

28/09/2016
9 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

2. BEFORE YOU TAKE DICYCLOVERINE ORAL SOLUTION
You should not take Dicycloverine Oral Solution until you are sure it is safe for
you to do so.
Do not give or take Dicycloverine Oral Solution
• If you are allergic to dicycloverine hydrochloride or any other ingredients in
the products
• To babies under 6 months old as it may be dangerous for them.
Take special care with Dicycloverine Oral Solution
Do not take Dicycloverine Oral Solution without discussing with your doctor if
you:
• are pregnant or think that you may be pregnant
• are breast-feeding
• have glaucoma (an eye condition involving increased pressure with in the
eye and resulting in poor vision)
• have an enlarged prostate gland (this causes difficulty in passing urine)
• have a hiatus hernia (a condition with symptoms such as acid and food
regurgitation and heartburn).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines including medicines obtained with out a prescription.
Taking Dicycloverine Oral Solution with food or drink
Dicycloverine Oral Solution may be taken before or after meals.
Pregnancy or breast-feeding
The safety of dicycloverine hydrochloride for use during pregnancy has not
been fully established. Hence, it should be taken only if there is a clear need
for it.
As it has not been established that dicycloverine does not pass in the breast
milk, it should be used with caution in lactating mothers.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
The effects of dicycloverine hydrochloride on the ability to drive and operate
machinery have not been established. Hence do not drive or use machinery
when you are on Dicycloverine Oral Solution unless you are sure your
judgement and co-ordination are not affected.
Important information about some of the ingredients of Dicycloverine
Oral Solution
Dicycloverine Oral Solution contains sucrose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
3. HOW TO TAKE DICYCLOVERINE ORAL SOLUTION
Always take Dicycloverine Oral Solution exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

Signature ...................................................................
Name .........................................................................
Date ...........................................................................

PAGE 1 OF 2

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Adults and Children over 12 years old
One to Two 5ml spoonfuls three times a day. Your doctor will tell you which
dose to use.
Children aged 2 - 12 years old
One 5ml spoonful three times a day.
The above doses may be taken before or after meals.
Children aged 6 months - 2 years old
Half to One 5ml spoonful three or four times a day. This should be given 15
minutes before feeding. Do not give more than four 5ml spoonfuls in any one
day.
If you take more Dicycloverine Oral Solution than you should
It is important to stick to the dose on the label of the medicine. If you or
someone else takes too much medicine, contact your doctor or nearest
hospital emergency department immediately. Always take any medicine left
over with you and also the box, as this will allow easier identification of the
medicine.
If you forget to take Dicycloverine Oral Solution
If you forget to take a dose, take it as soon as you remember. If it is almost
time for your next dose do not take a double dose to make up for a forgotten
dose, just carry on as before.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dicyloverine Oral Solution can cause side effects although
not everybody gets them.
Some people may feel dizzy, thirsty or have a dry mouth.
Rarely the following may occur:
- drowsiness/tiredness
- blurred vision
- constipation
- sickness or lack of appetite
- headache
- rash
- difficulty in passing urine.

103565/LF/332/02

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Dicycloverine Oral
Solution
120 ml
Leaflet
103565
UK
Indoco Remedies
1
29/08/2016
PAT
PR 6296

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

130 x 320 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

28/09/2016
9 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature ...................................................................
Name .........................................................................

If you experience any of the above problems or any other unwanted effects,
tell your doctor or pharmacist.
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 Yellow Card Scheme at:www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE DICYCLOVERINE ORAL SOLUTION
• Keep out of the reach and sight of children.
• Do not use Dicycloverine Oral Solution after the expiry date, which is
stated on the label and carton. The expiry date refers to the last day of the
month.
• Store your medicine in the original container. Do not store above 25°C.
• Store away from heat and direct sunlight.
• 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 Dicycloverine Oral Solution contains?
The name of this medicine is Dicycloverine Oral Solution.
The active substance in your oral solution is dicycloverine hydrochloride.
Each 5ml Spoonful contains 10mg of the active ingredient dicycloverine
hydrochloride respectively. Other ingredients include Sodium benzoate,
Sucrose, Citric acid monohydrate, Sodium citrate, Flavour Cherry-ST4545/25,
Flavour Raspberry-AF-2283, Flavour Vanilla-AF-2268 and Flavour BlackcurrantAF-2285.
What Dicycloverine Oral Solution looks like and contents of the pack
Dicycloverine Oral solution is a Pale yellow coloured, clear, flavoured
Solution. Each Bottle contains 120ml of Solution.
Marketing Authorisation Holder
The Marketing Authorisation holder of this oral solution is Focus
Pharmaceuticals Limited, Capital House, 85 King William Street, London
EC4N 7BL UK
Manufacturer
Mercury Pharmaceuticals Ltd,
Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was prepared in October 2016.
103565/LF/332/02

Date ...........................................................................

PAGE 2 OF 2

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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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