Tizagelan 2 mg tabletten

País: Holanda

Língua: holandês

Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes ativos:

TIZANIDINEHYDROCHLORIDE 2,29 mg/stuk SAMENSTELLING overeenkomend met ; TIZANIDINE 2 mg/stuk

DCI (Denominação Comum Internacional):

TIZANIDINEHYDROCHLORIDE 2,29 mg/stuk SAMENSTELLING overeenkomend met ; TIZANIDINE 2 mg/stuk

Forma farmacêutica:

Tablet

Composição:

LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROSE ; STEARINEZUUR (E 570) ; ZETMEEL, GEPREGELATINEERD

Via de administração:

Oraal gebruik

Data de autorização:

1900-01-01

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIZAGELAN 2 MG TABLETTEN
TIZAGELAN 4 MG TABLETTEN
tizanidine
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 [Tizanidine] is and what it is used for
2.
What you need to know before you take [Tizanidine]
3.
How to take [Tizanidine]
4.
Possible side effects
5.
How to store [Tizanidine]
6.
Contents of the pack and other information
1.
WHAT [TIZANIDINE] IS AND WHAT IT IS USED FOR
[Tizanidine] belongs to a group of medicines called skeletal muscle
relaxants.
Tizanidine] can be prescribed by your doctor for muscle cramps caused
by certain conditions of
the spine or as a result of surgery on the musculoskeletal system (for
example vertebrae or hip
joint).
[Tizanidine] can also be prescribed for muscle cramps as a result of
disorders of the nervous
system, such as multiple sclerosis and after a stroke.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [TIZANIDINE]
DO NOT TAKE [TIZANIDINE],
-
if you are allergic to tizanidine or any of the other ingredients of
this medicine (listed in
section 6).
-
if your liver function is severely impaired.
-
if
you
are
taking
certain
medicines
such
as
fluvoxamine
(to
treat
depressions)
or
ciprofloxacin (an antibiotic) (see also ‘Other medicines and
[Tizanidine]’).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking [Tizanidine],
-
if you have a severe kidney disease. You may require a lower dose.
-
if you have heart problems such as coronary artery disease.
-
if you have liver problems. Maybe your doctor will check your li

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Tizagelan 2 mg tabletten
Tizagelan 4 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Tizanidine] 2 mg tablets
Each tablet contains 2 mg tizanidine (as 2.29 mg tizanidine
hydrochloride).
Excipients with known effect:
Each tablet contains 106.79 mg lactose monohydrate and 11.76 mg
sucrose.
[Tizanidine] 4 mg tablets
Each tablet contains 4 mg tizanidine (as 4.57 mg tizanidine
hydrochloride).
Excipients with known effect:
Each tablet contains 104.51 mg lactose monohydrate and 11.76 mg
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
[Tizanidine] 2 mg tablets
White to yellowish coloured, round and biconvex tablet, with a break
score on one side
and
with a diameter of about 8 mm.
The tablet can be divided into equal doses.
[Tizanidine] 4 mg tablets
White to yellowish coloured, round and biconvex tablet, with a cross
break score on one side
and with a diameter of about 8 mm.
The tablet can be divided into equal doses, either halves or quarts.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPASMS OF THE SKELETAL MUSCLES
-
associated with static and functional disorders of the spine (cervical
and lumbar
syndromes)
-
after surgical interventions on the musculoskeletal system, e.g.
herniated disc or joint
disorders of the hip.
SPASTICITY DUE TO NEUROLOGICAL DISORDERS, such as
-
multiple sclerosis, chronic myelopathy, degenerative spinal cord
disease,
cerebrovascular accidents and cerebral palsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
[Tizanidine] has a narrow therapeutic index and a high inter-patient
variability in tizanidine
plasma concentrations. Therefore, it is important to adjust the dose
individually.
A low starting dose of 2 mg three times daily can reduce the risk of
side effects. The dose
should be increased gradually and with caution according to the
individual patient’s need and
the therapeutic response.
Posology
SPASMS OF THE SKELETAL MUSCLES
The recommended dose is 2-4 mg 3 times daily.
In