Tizanidine 4mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Tizanidine hydrochloride

から入手可能:

Viatris UK Healthcare Ltd

ATCコード:

M03BX02

INN（国際名）:

Tizanidine hydrochloride

投薬量:

4mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 10020200; GTIN: 5016695461014

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIZANIDINE 2 MG
TABLETS
TIZANIDINE 4 MG
TABLETS
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, pharmacist or nurse.
•
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, pharmacist or nurse.
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
Your tablets contain the active
substance tizanidine, which belongs
to a group of medicines called muscle
relaxants. Tizanidine acts on your central
nervous system and can help to relieve
painful muscle spasms and cramping
and tightness of muscle due to multiple
sclerosis or other disease or injury
affecting the spinal cord.
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 you have severe liver problems
•
if you are taking medicines such
as fluvoxamine (for depression)
or ciprofloxacin (an antibiotic) (See
'
Other medicines and Tizanidine
'
)
Tizanidine is not suitable for children or
the elderly.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Tizanidine:
•
if you have kidney problems.
•
if you have liver problems.
Your doctor will decide if you need
blood tests to check that your liver is
working properly.
OTHER MEDICINES AND TIZANIDINE
Tell your doctor or pharmacist if you are
taking, have recently taken or

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tizanidine 4mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of tizanidine (as hydrochloride).
Excipient with known effect:
Each tablet contains 48.024 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, 9 mm flat bevel edged tablet marked with “TI” and “4”
on one side and a
quadrasecting score line on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tizanidine is indicated in adults for the treatment of spasticity
associated with
multiple sclerosis, or with spinal cord injury or disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The effect of tizanidine on spasticity is maximal within 2-3 hours of
dosing and it has
a relatively short duration of action. The timing and frequency of
dosing should
therefore be tailored to the individual, and Tizanidine should be
given in divided
doses, up to 3-4 times daily, depending on the patient's needs. There
is considerable
variation in response between patients so careful titration is
necessary. Care should be
taken not to exceed the dose producing the desired therapeutic effect.
It is usual to
start with a single dose of 2 mg increasing by 2 mg increments at no
less than half-
weekly intervals.
The total daily dose should not exceed 36 mg, although it is usually
not necessary to
exceed 24 mg daily. Secondary pharmacological effects (see section
4.8) may occur at
therapeutic doses but these can be minimised by slow titration so that
in the large
majority of patients they are not a limiting factor.
_ _
_Elderly patients_
Experience with the use of tizanidine in the elderly is limited,
therefore use is not
recommended in elderly patients unless the benefit of treatment
clearly outweighs the
risk.
Pharmacokinetic data suggest that renal clearance in the elderly may
be decreased by
up to three