Spasmomen 40mg film-coated Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

OTILONIUM BROMIDE

Предлага се от:

A. Menarini Industrie Farmaceutiche Riunite S.r.L. Via Sette Santi 3, 50131, Florence, Italy

АТС код:

A03AB06

INN (Международно Name):

OTILONIUM BROMIDE 40 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

OTILONIUM BROMIDE 40 mg

Вид предписание :

POM

Терапевтична област:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Статус Оторизация:

Authorised

Дата Оторизация:

2006-05-30

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPASMOMEN
®
40 MG FILM-COATED TABLETS
Otilonium bromide
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 SPASMOMEN is and what it is used for
2.
What you need to know before you take SPASMOMEN
3.
How to take SPASMOMEN
4.
Possible side effects
5.
How to store SPASMOMEN
6.
Contents of the pack and other information
1.
WHAT SPASMOMEN IS AND WHAT IT IS USED FOR
SPASMOMEN tablets contain 40 mg of otilonium bromide which belongs to
a group of medicines called
“synthetic anticholinergics”.
SPASMOMEN has a selective and intense antispasmodic action on the
smooth muscle of the digestive tract
and is therefore indicated in all hyperkinetic or spastic states which
may exist in various locations and may
also vary in cause and extent and are attributable to a pathological
contraction of the fibrocells of the smooth
muscle.
If used at the recommended therapeutic dose, the medicine causes no
side effects whatsoever and, in
particular, does not precipitate atropine-like effects.
SPASMOMEN is used to treat irritable bowel and painful, spastic states
of the distal enteric tract in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPASMOMEN
_ _
DO NOT TAKE SPASMOMEN:
-
if you are allergic to Otilonium or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking SPASMOMEN.
The medicine must be used with caution in patients with glaucoma,
prostatic hypertrophy, pyloric stenosis.
Keep out o

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_SPASMOMEN 40 MG – FILM-COATED TABLETS _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of otilonium bromide.
Excipient(s) with known effect: approximately 28 mg of lactose
monohydrate per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White to almost-white round shaped, biconvex film-coated tablets of
5.4 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irritable
Bowel
Syndrome
(IBS);
relief
of
abdominal
pain,
distension
and
motility
disorders
characterised by smooth muscle spasm.
Spasmomen is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 Tablet 2-3 times a day, according to the physician's judgement.
Special populations
_ _
_ _
_Patients with hepatic or renal impairment _
Dose adjustment is not necessary (see section 5.2).
_Elderly _
Dose adjustment is not necessary.
_Paediatric population _
Clinical data on the use of otilonium bromide 40 mg coated tablets in
paediatric patients below 18
years is limited, therefore this medicinal product is not recommended
for use in this population.
Method of administration
Oral administration.
Tablets should be swallowed whole, with a glass of water, preferably
20 minutes before meal.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
To be used with caution in subjects with glaucoma, prostatic
hypertrophy and pyloric stenosis.
This
medicinal
product
contains
lactose.
Patients
with
rare
hereditary
problems
of
galactose
intolerance,
total
lactase
deficiency
or
glucose-galactose
malabsorption
should
not
take
this
medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially
‘sodium-free'.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies of otilonium bromide with other product