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Dicycloverine Hydrochloride 20mg Tablets

Document: leaflet MAH GENERIC_PL 20046-0286 change

PATIENT INFORMATION LEAFLET DICYCLOVERINE HYDROCHLORIDE 10MG&20MG TABLETS

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 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


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


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.


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


3. HOW TO TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS


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.


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

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

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.

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._


4. POSSIBLE SIDE EFFECTS


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.

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. HOWTO 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.

•    Store your tablets in the original package. 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 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

Focus Pharmaceuticals Limited,

Capital House, 85 King William Street London, EC4N 7BL, UK

Manufacturer

Primegen Limited,

Unit 15 Moorcroft Harlington Road,

Uxbridge, UB8 3HD UK

This leaflet was prepared in December 2015.


103634-35/LF/332/02