Dicycloverine 10mg/5ml oral solution

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Dicycloverine hydrochloride

Saadav alates:

Thame Laboratories Ltd

ATC kood:

A03AA07

INN (Rahvusvaheline Nimetus):

Dicycloverine hydrochloride

Annus:

2mg/1ml

Ravimvorm:

Oral solution

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01020000; GTIN: 5055935100023 5055935100030 5055935100047

Infovoldik

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
inc
ludes 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.
CO
NTENTS OF THE PACK AND
OTHER INFORMATION
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
musc
le
contractions (spasms). In doing this,
it relieves cramps, pain, bloating,
wind and discomfort.
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 ‘hia

Toote omadused

OBJECT 1
DICYCLOVERINE HYDROCHLORIDE 10MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 02-Feb-2018 | Thame
Laboratories
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 solutioncontains 14.735mg of propylene glycol (E1520) and
3.696gof 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 (mucous colitis, spastic colon).
4.2 Posology and method of administration
Adults
5-10ml (10 - 20mg) three times daily before or after meals.
Children (2-12 years):
5ml (10mg) three times daily.
Children (6 months - 2 years)
2.5-5ml (5 - 10mg) three or four times daily, 15 minutes before feeds.
Do not exceed a daily dose of 20ml (40mg).
Children (0 – 6 months)
Do not give this medicine to children under 6 months of age
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
4.3 Contraindications
Known idiosyncrasy to dicycloverine hydrochloride.
Infants under 6 months of age.
This medicine contains invert sugar. Patients with rare hereditary
problems of fructose intolerance or
glucose galactose malabsorption should not take this medicine.
This medicine contains 3.696g of a mixture of fructose, glucose and
sucrose per dose (5ml). This should
be taken in