Tizanidine 2mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Tizanidine hydrochloride

থেকে পাওয়া:

Niche Generics Ltd

এটিসি কোড:

M03BX02

INN (International Name):

Tizanidine hydrochloride

ডোজ:

2mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 10020200; GTIN: 5060020123207

তথ্য লিফলেট

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.
■
Your medicine is used to relieve the
stiffness and restriction of muscles
resulting from multiple sclerosis,
injury or diseases of the spinal cord.
2.WHAT YOU NEED TO KNOW
BEFORE YOU TAKE TIZANIDINE
DO NOT TAKE TIZANIDINE:
■
If you are allergic to tizanidine or to
any of the ingredients of this medicine
(listed in section 6)
■
if you have severely impaired liver
function
■
if you are taking medicines such as
fluvoxamine (for depression) or
ciprofloxacin (an antibiotic) (see also
'Other medicines and Tizanidine'
below)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking Tizanidine:
■
if you have kidney problems. In this
situation your doctor may adjust your
dose
■
if you have heart problems such as
coronary artery disease. Regular
clinical laboratory and ECG monitoring
is recommended during treatment
with tizanidine
■
if you have liver problems. Liver
function tests should be monitored
monthly for the first four months of
treatment in all patients and in those
who develop symptoms suggestive of
liver dysfunction or where jaundice
occurs
■
if you have low blood pressure
CHILDREN AND ADOLESCENTS
Tizanidine is not recommended for use
in children and adolescents.
OTHER MEDICINES AND TIZANIDINE
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This is
especially important if you are taking
any of the following;
■
Any medicine to treat an abnormal
heart rhythm, such as amiodarone,
mexiletine or propafenone
■
Cimetidine (for indigestion and
digestive ulcers)
■
Some antibiotics known as
fluoroquinolones, such as enoxacin,
pefloxacin or norfloxacin
■
Rofeco

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tizanidine 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
2 mg tizanidine (as 2.288 mg tizanidine hydrochloride)
Excipient with known effect: 100 mg of lactose, anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Tizanidine tablets are white, round tablets.
Tizanidine 2 mg tablets are marked ‘N 62’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 optimum therapeutic response is
generally achieved
with a daily dose of between 12 and 24 mg, administered in 3 or 4
equally spaced
doses. Single doses should not exceed 12 mg. The total daily dose
should not exceed
36 mg.
Adverse events (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.
Discontinuing therapy
If therapy needs to be discontinued, particularly in patients who have
been receiving
high doses for long periods, the dose should be decreased slowly (see
section 4.4).
Elderly
Experience in the elderly is limited and use of tizanidine is not
recommended unless
the benefit of treatment clearly outweighs the risk. Pharmacokinetic
data suggest t