Dicycloverine Oral Solution

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Dicycloverine Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information

• If you are allergic to dicycloverine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• To babies under 6 months old as it may be dangerous for them.

Talk to your doctor or pharmacist before taking Dicycloverine Oral Solution if you:

• are pregnant or think that you may be pregnant
• are breast-feeding
• have glaucoma (an eye condition involving increased pressure within 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).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Dicycloverine Oral Solution may be taken before or after meals.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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.

Breast-feeding

As it has not been established that dicycloverine does not pass in the breast milk, it should be used with caution in lactating mothers.

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.

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 medicinal product.

Contains 2.33 g (5ml) and 4.67 g (10ml) of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains 0.25 mg of sodium benzoate in each 1ml.

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.

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 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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 Blackcurrant-AF-2285.

Dicycloverine Oral solution is a Pale yellow coloured, clear, flavoured Solution. Each Bottle contains 120ml of Solution.