Dicycloverine hydrochloride 10mg/5ml Oral Solution

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

DICYCLOVERINE HYDROCHLORIDE

Disponibil de la:

Syri Pharma Limited t/a Thame Laboratories

Codul ATC:

A03AA; A03AA07

INN (nume internaţional):

DICYCLOVERINE HYDROCHLORIDE

Dozare:

10 mg/5ml

Forma farmaceutică:

Oral solution

Zonă Terapeutică:

Synthetic anticholinergics, esters with tertiary amino group; dicycloverine

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2015-01-30

Prospect

VAR/IB-021/RFI/Day 20-27
1.3.1 Package leaflet
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 a medicine called dicycloverine hydrochloride.
This belongs to a
group of medicines called antispasmodics.
WHAT DICYCLOVERINE IS USED FOR:

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 hydrochloride 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

The person being given this medicine

Caracteristicilor produsului

Health Products Regulatory Authority
02 December 2020
CRN009X3F
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine hydrochloride 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dicycloverine Hydrochloride Oral Solution contains the active
ingredient, dicycloverine hydrochloride.
Each 5ml solution contains 10mg dicycloverine hydrochloride.
Excipients with known effect:
Each 5ml solution contains 14.735mg of propylene glycol (E1520), 4mg
of sodium benzoate and 3.696g of mixture of fructose,
glucose and sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, light yellow to yellow solution with a strawberry flavour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dicycloverine Hydrochloride is a smooth muscle antispasmodic primarily
indicated
for treatment of functional conditions involving smooth muscle spasm
of the gastrointestinal tract. The commonest of
these are irritable colon (mucouscolitis, spastic colon).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
One to two 5ml spoonfuls (10-20mg) three times daily before or after
meals.
Children (2-12 years):
One 5ml spoonful (10mg) three times daily.
Children (6 months - 2 years)
5-10mg three or four times daily 15 minutes before feeds. Do not
exceed a daily dose of 40mg.
Dicycloverine Hydrochloride is contraindicated in children under 6
months of age (see sections 4.3 and 4.4).
METHOD OF ADMINISTRATION:
For oral administration.
If it is necessary to dilute Dicycloverine Hydrochloride Oral
Solution, this may be done using syrup or if diluted immediately
prior to use with water.
4.3 CONTRAINDICATIONS
Hypersensitivity to dicycloverine hydrochloride or any of the
excipients listed in section 6.1.
Known idiosyncrasy to dicycloverine hydrochloride.
Infants under 6 months of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
02 December 2020
CRN009X3F
Page 2 of 4
Products containing dicycloverine hydrochloride should be used with