What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 39307/0019 .

Dicycloverine Hydrochloride 10mg/5ml Oral Solution

Package leaflet: Information for the user

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.

The name of your medicine is Dicycloverine Hydrochloride 10mg/5ml Oral Solution but it will be referred as Dicycloverine throughout this leaflet.

What is in this leaflet?

1. What Dicycloverine is and what it is used for
2. What you need to know before you take Dicycloverine
3. How to take Dicycloverine
4. Possible side effects
5. How to store Dicycloverine
6. Contents of the pack and other information

1. What Dicycloverine is and what it is used for

Dicycloverine contains the active substance dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics.

Dicycloverine is used to treat:

  • Cramps
  • Pain in the stomach or intestine (gut)
  • Stomach or intestine (gut) problems – such as irritable bowel.

How Dicycloverine works

Dicycloverine 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

Do not take Dicycloverine if:

  • You are allergic (hypersensitive) to dicycloverine or any of the 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

Warnings and precautions

Talk to your doctor or pharmacist before taking Dicycloverine if you have or have had any of the following conditions:

  • You have glaucoma (signs include painful eyes with blurred vision)
  • You have an enlarged prostate
  • 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 any of the above apply to you, talk to your doctor or pharmacist.

Children

Do not give this medicine to children under 6 months of age

Other medicines and Dicycloverine

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

Dicycloverine should not be taken at the same time as other medicines. This is because Dicycloverine can affect the way other medicines work.

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.

Dicycloverine contains:

Invert syrup:

Dicycloverine contains 3.696g of a mixture of fructose, glucose and sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus. Dicycloverine may be harmful to the teeth, if the product is used for two weeks or more.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. How to take Dicycloverine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Doses

The recommended dose is:

Adults

  • 5-10ml (10-20mg) three times each day
  • Take the solution before or after meals

Children aged 2 to 12 years

  • 5ml (10mg) three times each day
  • Take the solution before or after meals

Children aged 6 months to 2 years

  • 2.5-5ml (5-10mg) three or four times each day
  • Give 15 minutes before feeds
  • Do not give more than 20ml (40mg) in a 24 hour period

Method of administration:

  • Use the 2.5-5ml double-ended spoon supplied in the pack (see below) to measure the required dose.
  • Swallow the solution.
  • Wash the spoon with clean water after taking every dose.

Double-ended Spoon

If you take more Dicycloverine than you should

Talk to your doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you, this is so that the doctor knows what you have taken.

Symptoms of overdose may include: headache, feeling dizzy, feeling sick, dry mouth or difficulty in swallowing, blurred eyesight and hot dry skin.

If you forget to take Dicycloverine

If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dicycloverine

Keep taking this medicine until your doctor tells you to stop. Do not stop taking Dicycloverine just because you feel better

If you stop taking the medicine too soon, your cramps or pain may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Dicycloverine and contact your doctor immediately if you develop the following symptoms:

  • 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 gets serious or lasts longer than a few days:

  • 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)

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 system at www.mhra.gov.uk/yellowcard.

By Reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dicycloverine

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date, which is printed on the carton and bottle after ‘Exp’. The expiry date refers to the last day of that month.
  • This medicinal product does not require any special storage conditions.
  • Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dicycloverine contains

The active substance is dicycloverine hydrochloride.

Each 5ml solution contains 10mg dicycloverine hydrochloride.

The other ingredients are citric acid monohydrate (E330), sucralose (E955), invert syrup (contains glucose, sucrose and fructose), sodium benzoate (E211), strawberry flavour (contains propylene glycol (E1520) and natural flavouring substances) and purified water.

What Dicycloverine looks like and contents of the pack

Dicycloverine is a clear, light yellow to yellow oral solution with a strawberry flavour. It is supplied in an amber glass bottle with a tamper-evident child-resistant plastic screw cap.

The pack also contains a 2.5-5ml double ended spoon.

Dicycloverine is supplied in bottles containing 100ml, 120ml and 300ml solution.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Syri Limited t/a Thame
Laboratories
Unit 4
Bradfield Road
Ruislip
Middlesex
HA4 0NU
UK

POM

This leaflet was revised in 12/2014.

The name of the product in member states

UK and IE

Dicycloverine Hydrochloride 10mg/5ml Oral Solution.

PIL/UK/MFG095/02/v1