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DICYCLOVERINE HYDROCHLORIDE 20MG TABLETS

Active substance(s): DICYCLOVERINE HYDROCHLORIDE

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Fonts: Vectora Light & Vectora Black

Colours:  Black

Size: 150mm x 320mm

DICYCLOVERINE HYDROCHLORIDE
10MG & 20MG TABLETS

2. BEFORE YOU TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS
You should not take Dicycloverine Hydrochloride Tablets until you are sure it is safe for you to
do so.
Do not take Dicycloverine Hydrochloride Tablets
• If you are allergic to dicycloverine hydrochloride or any other ingredients in the products.
Take special care with Dicycloverine Hydrochloride Tablets
Do not take Dicycloverine Hydrochloride Tablets 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 Hydrochloride Tablets with food or drink
Dicycloverine Hydrochloride Tablets 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
Hydrochloride Tablets unless you are sure your judgement and co-ordination are not affected.
Important information about some of the ingredients of Dicycloverine
Hydrochloride Tablets
Dicycloverine Hydrochloride Tablets contain Lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicine

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Version: 1
Strength: 10mg / 20mg

Dicycloverine hydrochloride, the active ingredient of Dicycloverine hydrochloride Tablets 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.

Arta Creative Solutions Ltd
Suite1 Interlinks House
81c Church Road
London NW4 4DP

Date: 19.08.15

1. WHAT ARE DICYCLOVERINE HYDROCHLORIDE TABLETS AND WHAT ARE THEY
USED FOR?

Product: Dicycloverine HCl Tabs PIL Page 1

THE LEAFLET CONTAINS INFORMATION ON:
1. What Dicycloverine Hydrochloride Tablets are and what they are used for.
2. Before you take Dicycloverine Hydrochloride Tablets
3. How to take Dicycloverine Hydrochloride Tablets
4. Possible side effects
5. How to store Dicycloverine Hydrochloride Tablets
6. Further Information

PL Number: 20046/0285-6

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.

Client: Focus Pharmaceuticals Limited

PATIENT INFORMATION LEAFLET

Fonts: Vectora Light & Vectora Black

Colours:  Black

Always take Dicycloverine Hydrochloride Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

Size: 150mm x 320mm

3. HOW TO TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS

Adults and Children over 12 years old
10mg to 20mg three times a day. Your doctor will tell you which dose to use.
Children aged 2 - 12 years old
10mg three times a day

5. HOW TO STORE DICYCLOVERINE HYDROCHLORIDE TABLETS
• Keep out of the reach and sight of children.
• Do not use Dicycloverine Hydrochloride Tablets after the expiry date, which is stated on the
label and carton. The expiry date refers to the last day of the month.
• 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 Hydrochloride Tablets contain
The name of this medicine is Dicycloverine Hydrochloride 10mg or 20mg Tablets.
The active substance in your tablet is dicycloverine hydrochloride. Each tablet contains 10mg
or 20mg of dicycloverine hydrochloride respectively. Other ingredients include Lactose
monohydrate, maize starch, povidone K-30, colloidal anhydrous silica, talc and magnesium
stearate.
What Dicycloverine Hydrochloride Tablets look like and contents of the pack
Dicycloverine Hydrochloride 10mg Tablets are white to off-white, round flat bevelled edged
tablets with ‘10’ embossed on one side.
Dicycloverine Hydrochloride 20mg Tablets are white to off-white, round flat bevelled edged
tablets with ‘20’ embossed on one side and scoring on the other.
Dicycloverine Hydrochloride 10mg Tablets are supplied in blisters of 100 tablets.
Dicycloverine Hydrochloride 20mg Tablets are supplied in blisters of 84 tablets.
Marketing Authorisation Holder & Manufacturer
The Marketing Authorisation holder and manufacturer of these tablets is Focus Pharmaceuticals
Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom.
This leaflet was prepared in 08/2015

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www.artacreative.com
Arta Creative Solutions Ltd
Suite1 Interlinks House
81c Church Road
London NW4 4DP

If you experience any of the above problems or any other unwanted effects, tell your doctor or
pharmacist.

Version: 1

Rarely the following may occur:
- drowsiness/tiredness
- blurred vision
- constipation
- sickness or lack of appetite
- headache
- rash
- difficulty in passing urine

Strength: 10mg / 20mg

Like all medicines, Dicyloverine Hydrochloride Tablets can cause side effects although not
everybody gets them. Some people may feel dizzy or thirsty or have a dry mouth.

Date: 19.08.15

4. POSSIBLE SIDE EFFECTS

Product: Dicycloverine HCl Tabs PIL Page 2

If you forget to take Dicycloverine Hydrochloride Tablets
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.

PL Number: 20046/0285-6

If you take more Dicycloverine Hydrochloride Tablets than you should
It is important to stick to the dose on the label of the medicine. If you or someone else swallows
several of these tablets all together, contact your doctor or nearest hospital emergency
department immediately. Always take any tablets left over with you and also the box, as this will
allow easier identification of the tablets.

Client: Focus Pharmaceuticals Limited

Take your tablets with water. Tablets may be taken before or after meals.

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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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