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DICYCLOVERINE ORAL SOLUTION

Active substance(s): DICYCLOVERINE HYDROCHLORIDE

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DICYCLOVERINE 10MG/5ML ORAL SOLUTION
PATIENT INFORMATION LEAFLET
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.
2.
3.
4.
5.
6.

What Dicycloverine Oral Solution is and what it is used for.
Before you take Dicycloverine Oral Solution
How to take Dicycloverine Oral Solution
Possible side effects
How to store Dicycloverine Oral Solution
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.
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. Dicycloverine Oral Solution
may be harmful to the teeth.
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.
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

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.
 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 tablet 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 raspberryAF-2283, flavour vanilla-AF-2268, flavour blackcurrant-AF-2285 and purified water.
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
PRIMEGEN Limited, Unit 15 Moorcroft Harlington Road, Uxbridge, UB8 3HD United Kingdom
This leaflet was prepared in January 2016

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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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