SPASMEX 30

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

TROSPIUM CHLORIDE

Dostopno od:

TEC-O-PHARM-LIBRA LTD

Koda artikla:

A03DA06

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

TROSPIUM CHLORIDE 30 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

DR. PFLEGER ARZNEIMITTEL GMBH, GERMANY

Terapevtska skupina:

TROSPIUM AND ANALGESICS

Terapevtsko območje:

TROSPIUM AND ANALGESICS

Terapevtske indikacije:

For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence.

Datum dovoljenje:

2014-11-30

Navodilo za uporabo

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is sold with a doctor’s prescription only
SPASMEX
®
15
SPASMEX
®
30
ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet of Spasmex 15 contains: Trospium chloride 15 mg
Each tablet of Spasmex 30 contains: Trospium chloride 30 mg
THIS MEDICINE CONTAINS LACTOSE. For further information, see section
6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, refer to
the doctor or pharmacist. This medicine has been prescribed for you
only. Do not
pass it on to others. It may harm them even if it seems to you that
their medical
condition is similar.
THIS MEDICINE IS INTENDED FOR ADULTS AND ADOLESCENTS OVER 12 YEARS
OLD.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is used for the treatment of impaired function of the
urinary bladder,
accompanied by urgency and/or frequency and/or urinary incontinence.
THERAPEUTIC GROUP: Anticholinergic, Antimuscarinic.
2. BEFORE USING THE MEDICINE X DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or any of the
other ingredients
of this medicine (see section 6 – "further information").
You suffer from:
•
urinary retention (urination is less frequent than usual).
•
narrow-angle glaucoma.
•
arrhythmia (increased and irregular heartbeat).
•
myasthenia gravis.
•
severe chronic inflammatory bowel disease (Crohn’s disease,
ulcerative colitis).
•
toxic megacolon.
•
renal disease requiring dialysis (Creatinine clearance < 10
ml/min/1.73 m
2
).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
!
BEFORE STARTING THE TREATMENT WITH SPASMEX TELL THE DOCTOR IF YOU
SUFFER OR
HAVE SUFFERED IN THE PAST FROM:
•
An obstruction in the digestive system (e.g. due to narrowing of the
pylorus - pyloric
stenosis).
•
Urine outflow obstruction or disturbance that may cause residual
urine.
•
Hiatus hernia with an inflammation of the esophagus.
•
Dis

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
SPASMEX
® 30
mg film-coated tablets
SPASMEX
® 15
mg film-coated tablets.
1.
N
AME OF THE MEDICINAL PRODUCT
Spasmex
®
30 film-coated tablets
Spasmex
®
15 film-coated tablets
2.
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet of Spasmex 30 contains 30 mg trospium chloride.
1 film-coated tablet of Spasmex 15 contains 15 mg trospium chloride.
Excipients with known effect: 1 film-coated tablet contains 100
mg lactose-monohydrate
For the complete list of excipients see chapter 6.1.
3.
P
HARMACEUTICAL FORM
Film-coated tablet.
Spasmex 30: White, round, biconvex film-coated tablets with a special
score line (“SNAP-TAB”) on
one side. The tablet may be divided into two equal doses.
Spasmex 15: White, round, biconvex film-coated tablets,
special score line (“SNAP-TAB”) on one side
and the stamp “0” on the other side.
4.
C
LINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of vegetative bladder dysfunction accompanied by
urgency and/or frequency and/or
urinary incontinence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
15 mg (one tablet of Spasmex 15 or half a tablet of Spasmex 30) should
be taken three times a day, or
30 mg in the morning (two tablets of Spasmex 15 or one tablet of
Spasmex 30) and 15 mg in the
evening.
Patients with reduced kidney function
In patients with severely impaired renal function (Creatinine
clearance between 10 and 30 ml/ min/
1.73 m
2
) a daily dose of 15 mg should not be exceeded.
Patients with reduced liver function
Dose adjustment does not appear necessary in patients with a mild to
moderate impairment in liver
function (Child-Pugh 5-6 or 7-9) (see section 5.2 Pharmacokinetic
properties).
Studies for patients with severe liver dysfunction (Child-Pugh > 10;
class C) have not been carried
out meaning that treatment cannot be recommended in these cases.
Use in children
Treatment in children under 12 years old is not recommended as no data
exist.
Mode and duration of treatment
The film-coated tablets should be swallowed wh