Dicycloverine 20mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Dicycloverine hydrochloride

Disponible depuis:

Phoenix Healthcare Distribution Ltd

Code ATC:

A03AA07

DCI (Dénomination commune internationale):

Dicycloverine hydrochloride

Dosage:

20mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 01020000

Notice patient

Pharma
Code
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DICYCLOVERINE HYDROCHLORIDE
10MG & 20MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Tablets are and what they are used
for
2.
What you need to know before you take Dicycloverine Hydrochloride
Tablets
3.
How to take Dicycloverine Hydrochloride Tablets
4.
Possible side effects
5.
How to store Dicycloverine Hydrochloride Tablets
6.
Contents of the pack and other information
1. WHAT ARE DICYCLOVERINE HYDROCHLORIDE TABLETS AND WHAT
ARE THEY USED FOR
Dicycloverine hydrochloride, the active ingredient of Dicycloverine
hydrochloride
Tablets is one of a group of medicines called anticholinergic
antispasmodics. It is
used to relieve painful bowel cramps. The anticholinergic action helps
to relax the
muscles of the intestine and relieve the painful symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICYCLOVERINE
HYDROCHLORIDE TABLETS
You should not take Dicycloverine Hydrochloride Tablets until you are
sure it is safe
for you to do so.
DO NOT TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS
•
If you are allergic to dicycloverine hydrochloride or any other
ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Dicycloverine
Hydrochloride Tablets if
you:
•
are pregnant or think that you may be pregnant
•
are breast-feeding
•
have glaucoma (an eye condition involving increased pressure within
the eye and
resulting in poor vision)
•
ha

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dicycloverine hydrochloride 20mg
Excipient(s) with known effect
Each tablet contains 101.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round flat bevelled edged tablets with ‘20’
embossed on one side
and scoring on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Smooth
muscle
antispasmodic
primarily
indicated
for
treatment
of
functional
conditions involving smooth muscle spasm of the gastrointestinal
tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults:_ 10-20mg three times daily before or after meals.
_Children (2-12 years):_ 10mg three times daily.
Method of administration
Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Known idiosyncrasy to dicycloverine hydrochloride
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Products containing dicycloverine hydrochloride should be used with
caution in any
patient with or suspected of having glaucoma or prostatic hypertrophy.
Use with care
in
patients
with
hiatus
hernia
associated
with
reflux
oesophagitis
because
anticholinergic drugs may aggravate the condition.
Patients
with
rare
hereditary
problems
of
galactose
intolerance,
total
lactase
deficiency or glucose-galactose malabsorption should not take this
medicine.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Epidemiological studies in pregnant women with products containing
dicycloverine
hydrochloride
(at
doses
up
to
40mg/day)
have
not
shown
that
dicycloverine
hydrochloride increases the risk of foetal abnormalities if
administered during the
first trimester of pregnancy. Reproduction studies have been performed
in rats and
rabbits at doses of up t