DICYCLOVERINE HYDROCHLORIDE 10 MG / 5ML ORAL SOLUTION - patient leaflet, side effects, dosage

What Dicycloverine Hydrochloride Oral Solution looks like and contents of the pack

Dicycloverine Hydrochloride Oral solution is a clear colourless liquid, with fruity odour. Each Bottle contains 120ml of Solution.

Marketing Authorisation Holder and Manufacturer:

NO

NOUme Noumed House, Shoppenhangers Road Maidenhead, Berkshire, SL6 2RB. UK

This leaflet was last revised in September 2018

Other sources of information:

To listen to or request a copy of this leaflet in braille, large print or audio please call, 020 33998960 (UK only)

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Product name:

DICYCLOVERINE HYDROCHLORIDE 10MG/5ML ORAL SOLUTION

Reference number: PL 44041/0091

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DICYCLOVERINE HYDROCHLORIDE 10MG/5ML ORAL SOLUTION

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

• 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.

What is in this leaflet:

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

• 2. What you need to know before you take Dicycloverine Hydrochloride Oral Solution

• 3. How to take Dicycloverine Hydrochloride Oral Solution

• 4. Possible side effects

• 5. How to store Dicycloverine Hydrochloride Oral Solution

• 6. Contents of the pack and other information

1. what dicycloverine hydrochloride oral solution is and what it is used for

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

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.

2. what you need to know before you take dicycloverine hydrochloride oral solution

Do not give or take Dicycloverine Hydrochloride Oral Solution

• If you are allergic (hypersensitive) to dicycloverine hydrochloride or any other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• To babies under 6 months old as it may be dangerous for them.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dicycloverine Hydrochloride Oral Solution.

Warnings and precautions

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

• You are pregnant or think that you may be pregnant
• You are breast-feeding
• You have glaucoma (an eye condition involving increased pressure within the eye and resulting in poor vision)

• You have an enlarged prostate gland (this causes difficulty in passing urine)
• You have a hiatus hernia (where part of your stomach pushes through the diaphragm)

Other medicines and Dicycloverine Hydrochloride Oral Solution

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines.

Dicycloverine Hydrochloride Oral Solution with food or drink

Dicycloverine Hydrochloride Oral Solution may be taken before or after meals.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 hydrochloride 10mg/5ml Oral Solution.

Important information about some of the ingredients of Dicycloverine hydrochloride 10mg/5mg Oral Solution This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

3. how to take dicycloverine hydrochloride oral solution

Always take Dicycloverine Hydrochloride Oral Solution exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and Children over 12 years old

One to Two 5ml doses (10–20mg) three times a day. Your doctor will tell you which dose to use. Take oral solution before or after meals.

Children aged 2 – 12 years old

One 5ml dose (10mg) three times a day.

Take oral solution before or after meals.

Children aged 6 months – 2 years old

Half to one 5ml dose (5–10mg) three or four times a day. This should be given 15 minutes before feeds.

Do not give more than four 5ml doses (40mg) in a 24 hour period. This medicine may be diluted. If this is done, take the oral solution immediately after dilution.

If you take more Dicycloverine Hydrochloride 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. 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. 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 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 because you feel better. If you stop, your cramps or pain may come back.

4. possible side effects

Like all medicines, Dicyloverine 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:

• Dry mouth or thirst
• Feeling dizzy
• Feeling tired or sleepy
• Blurred eyesight
• Rash
• Loss of appetite (anorexia)
• Feeling sick (nausea) or being sick (vomiting)
• Constipation
• Headache
• Difficulty or pain on passing water (urine).

5. how to store dicycloverine hydrochloride oral solution

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Dicycloverine Hydrochloride Oral Solution contains The name of this medicine is Dicycloverine Hydrochloride 10mg/5ml Oral Solution.

The active substance in your oral solution is dicycloverine hydrochloride.

Each 5ml contains 10mg of the active ingredient dicycloverine hydrochloride respectively. Other ingredients include Sodium benzoate (E211), Sucralose, Citric acid monohydrate, Chery Flavour, Raspberry Flavour, Vanilla Flavour, Blackcurrant Flavour, purified water.

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Signature of RA:

Noumed Life Sciences				Title: Art Work Approval Form
Product	DICYCLOVERINE 10MG/5ML ORAL SOLUTION – S/L – English – PIL			Specification:
Customer	NOUMED LIFE SCIENCES LIMITED, UK
Reason for Issue				Colours:	Single – Black
				Dimensions:	190 × 240 mm (Open size)
Related FG Codes	130XXXX Pharmacode No		XXXX
				No. Of Folds (Only for PIL)		Artwork made to		100%
Item Code	121XXXX-V1 (WOA) Layout No.: NA
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