Tizanidine 4mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Tizanidine hydrochloride

Prieinama:

Actavis UK Ltd

ATC kodas:

M03BX02

INN (Tarptautinis Pavadinimas):

Tizanidine hydrochloride

Dozė:

4mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 10020200; GTIN: 5012617018618

Pakuotės lapelis

AAAE5293
Tizanidine Hydrochloride 2mg & 4mg 120 Tablets PIL - UK
item no: AAAE5293
print proof no: 2
origination date: 06.11.12
originated by: SA
revision date: 15.11.12
revised by: sa
dimensions: 145 x 480
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 06.11.12
supplier: Niche Generics Ltd
technically app. date: 07.11.12
min pt size:
TECHNICAL APPROVAL
TIZANIDINE 2MG AND 4MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass
it on to others. It may harm
them, even if their symptoms
are the same as yours.
•
If any of the side effects get
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1
WHAT TIZANIDINE TABLETS ARE
AND WHAT THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6
FURTHER INFORMATION
1
WHAT TIZANIDINE TABLETS
ARE AND WHAT THEY ARE
USED FOR
Tizanidine tablets belong 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
BEFORE YOU TAKE
DO NOT TAKE TIZANIDINE
TABLETS IF YOU
• are ALLERGIC (hypersensitive)
to tizanidine or to any of the
ingredients in your medicine
• have SEVERELY IMPAIRED LIVER
function
• are taking medicines such as
FLUVOXAMINE (for depression)
or CIPROFLOXACIN (an
antibiotic) (see also ‘Taking
other medicines’)
TAKE SPECIAL CARE WITH
TIZANIDINE TABLETS
Check with your doctor before
taking Tizanidine tablets if you
have:
• KIDNEY problems
• HEART problems such as
coronary artery disease
• LIVER problems.
TAKING OTHER MEDICINES
Tizanidine tablets must not
be taken at the same time
as fluvoxamine (to treat
depression) or ciprof

Prekės savybės

OBJECT 1
TIZANIDINE 4MG TABLETS
Summary of Product Characteristics Updated 17-Mar-2016 | Accord-UK Ltd
1. Name of the medicinal product
Tizanidine 4mg Tablets
2. Qualitative and quantitative composition
Each 4mg tablet contains:
4 mg tizanidine (as 4.576mg tizanidine hydrochloride)
Excipient with known effect: 200mg of lactose, anhydrous
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Tizanidine Tablets are white, round tablets.
Tizanidine 4 mg Tablets are scored and marked 'N 63' on the other
side.
The 4mg tablet can be divided into equal doses.
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 2mg increasing by 2mg
increments at no less than half-weekly
intervals. The optimum therapeutic response is generally achieved with
a daily dose of between 12 and
24mg, administered in 3 or 4 equally spaced doses. Single doses should
not exceed 12mg. The total daily
dose should not exceed 36mg.
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