Document: leaflet MAH GENERIC_PL 17780-0564 change

• leaflet MAH GENERIC_PL 17780-0564
• leaflet MAH GENERIC_PL 20117-0255
• leaflet MAH GENERIC_PL 39307-0019

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start taking this medicine

•    Keep this leaflet. You may need to read it again

•    If you haveanyfurtherquestions.askyour doctor or pharmacist

•    This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same asyours

•    If any of the side effects getsserious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Dicycloverine hydrochloride Oral Solution is and what it is used for

2.    Before you take Dicycloverine hydrochloride Oral Solution

3.    Howto take Dicycloverine hydrochloride Oral Solution

4.    Possible side effects

5.    Howtostore Dicycloverine hydrochloride Oral Solution

6.    Furtherinformation

1. What Dicycloverine hydrochloride Oral Solution is and what it is used for

What Dicycloverine hydrochloride Oral Solution is

Dicycloverine hydrochloride Oral Solution contains a medicine called dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics.

What Dicycloverine hydrochloride Oral Solution is used for:

•    Cramps

•    Pain in the stomach or intestine (gut)

•    Stomach or intestine (gut) problems - such as irritable bowel.

How Dicycloverine hydrochloride Oral Solution works

Dicycloverine hydrochloride Oral Solution works by relaxing the muscles in your stomach and gut (intestine). It stops sudden muscle contractions (spasms). In doing this, it relieves cramps, pain, bloating, wind and discomfort.

hydrochloride Oral Solution

Do not take Dicycloverine hydrochloride Oral Solution if:

You are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients in Dicycloverine hydrochloride Oral Solution (see Section 6: Further information) Signs of an allergic reaction include: a rash, swallowingor breathing problems, swelling of your lips, face, throat or tongue

x The person being given this medicine is under 6 months of age Do not take this medicine if anyof the above apply to you. If you are not sure, talkto your doctor or pharmacist before taking Dicycloverine hydrochloride Oral Solution.

Take special care with Dicycloverine hydrochloride Oral Solution Check with your doctor or pharmacist before taking your medicine if:

^A You have glaucoma (signs include painful eyes with blurred vision)

^A You havean enlarged prostate ^A You have indigestion or heart burn caused by a ‘hiatus hernia’ (where part of your stomach pushes through the diaphragm)

If you are not sure if anyof the above apply to you, talkto your doctor or pharmacist before taking Dicycloverine hydrochloride Oral Solution.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recentlytaken any other medicines. This includes medicines you buy without a prescription, including herbal medicines.

Dicycloverine hydrochloride Oral Solution should not be taken at the same time as other medicines. This is because Dicycloverine hydrochloride Oral Solution can affect the way other medicines work. Also some medicines can affect the way Dicycloverine hydrochloride Oral Solution works. Pregnancy and breast-feeding Talk to your doctor or pharmacist before taking this medicine if:

•    You are pregnant, might become pregnant, or think you may be pregnant

•    You are breast-feeding or planning to breast-feed

Important information about some of the ingredients of Dicycloverine hydrochloride Oral Solution

Dicycloverine hydrochloride Oral Solution contains 3.97g per 5ml dose of a mixture of glucose, fructose and sucrose. This should be taken into account in patients with diabetes mellitus. Dicycloverine hydrochloride Oral Solution may be harmful to the teeth.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

3. How to take Dicycloverine hydrochloride

Taking this medicine

•    Takethismedicinebymouth

•    This medicine may be diluted. If this is done, take the oral solution immediately after dilution

How much to take

The usual dose is:

Adults

• One to two 5ml spoonfuls (10-20mg) three timeseachday

meals

Drug Product: Dicycloverine hydrochloride 10mg-5ml oral solution

Name of Document: 1.3.2 Mock-up-leaflet

Children aged 2 to 12 years

•    One 5ml spoonful (10mg) three times each day

•    Take the oral solution before or after meals Children aged 6 months to 2 years

•    Half to one 5ml spoonful (5-10mg) three or four times each day

•    Give 15 minutes before feeds

•    Do not give more than four 5ml spoonfuls (40mg) in a 24 hour period

If you take more Dicycloverine hydrochloride Oral Solution than you should

Talk to your doctor or go to a hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have taken. The following effects may happen: headache, feeling dizzy, feeling sick, dry mouth or difficulty in swallowing, blurred eyesight and hot dry skin.

If you forget to take Dicycloverine hydrochloride Oral Solution

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

If you stop taking Dicycloverine hydrochloride Oral Solution Keep taking Dicycloverine hydrochloride Oral Solution until your doctor tells you to stop. Do not stop taking Dicycloverine hydrochloride Oral Solution just becauseyou feel better. If you stop, your cramps or pain may come back.

4. Possible side effects

Like all medicines, Dicycloverine hydrochloride Oral Solution can cause side effects, although not everybody gets them.

Stop taking Dicycloverine hydrochloride Oral Solution and see a doctor or go to a hospital straight away if;

•    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:

•    Drymouthorthirst

•    Feeling dizzy

•    Feelingtired orsleepy

•    Blurred eyesight

•    Rash

•    Loss of appetite (anorexia)

•    Feeling sick (nausea) or being sick (vomiting)

•    Constipation

•    Headache

•    Difficulty or pain on passing water (urine) Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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/vellowcard.

By reporting side effectsyou can help provide more information on the safety of this medicine.

5. How to store Dicycloverine hydrochloride Oral Solution

Keep this medicine in a safe place where children cannot see or reach it

Do not use Dicycloverine hydrochloride Oral Solution after the expiry date which is stated on bottle label or carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep your medicine in the amber glass bottle as supplied. Do not store it in any other containers.

Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information

What Dicycloverine hydrochloride Oral Solution contains

•    Each 5ml of oral solution containslOmg of the active substance, dicycloverine hydrochloride

•    The other ingredients are: invert syrup medium, citric acid monohydrate (E211), sodium benzoate, raspberry flavour, cherry flavour (contains ethanol), blackcurrent essence (contains ethanol), vanilla essence (contains ethanol) and purified water

What Dicycloverine hydrochloride Oral Solution looks like and contents of the pack Dicycloverine hydrochloride Oral Solution is a colourless liquid with a raspberry flavour. Supplied in 120ml or 500ml amber glass bottles. Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer

MarketingAuthorisation Holder Zentiva, One Onslow Street, Guildford, Surrey,

GU1 4YS, UK Manufacturer

Patheon FranceSA, Boulevard deChamparet, BP448, 38300 Bourgoin-Jallieu, France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in February 2014 © Zentiva 2014

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