TIZANIDINE 2MG TABLETS

Active substance: TIZANIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TIZANIDINE 2 mg
TABLETS
TIZANIDINE 4 mg
TABLETS
(tizanidine hydrochloride)

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.
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 tizanidine
hydrochloride, 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 trauma affecting the brain or
spinal cord.
2. What you need to know before you
take Tizanidine
Do not take Tizanidine:
• if you are allergic to tizanidine
hydrochloride or to 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 might take
any other medicines.
Do not take Tizanidine if you are already
taking any of the following:
• fluvoxamine (for depression)
• ciprofloxacin (an antibiotic)
Tell your doctor or pharmacist if you are
taking any of the following medicines as
they may interact with Tizanidine:
• the oral contraceptive pill
• antibiotics called norfloxacin, enoxacin,
or pefloxacin or rifampicin
• ticlopidine (to prevent blood clots)
• cimetidine (for indigestion and stomach
ulcers)

• any medicine with a sedative effect such
as sleeping pills or medicines for anxiety
e.g. such as diazepam or temazepam),
baclofen or antihistamines
• medicines for high blood pressure,
including diuretics (water tablets),
beta-blockers (e.g. atenolol,
propranolol) or clonidine
• medicine to treat abnormal heart
rhythms e.g. digoxin, procainamide
amiodarone, mexiletine or propafenone
• any other medicine that could effect the
rhythm of your heart (QT prolongation,
for example amitriptyline and
azithromycin) - check with your
doctor or pharmacist
• rofecoxib (a painkiller)
Taking Tizanidine if you are a smoker
You should also tell your doctor if you are
a smoker as this may mean you require a
higher dose of Tizanidine for it to work
properly.
Tizanidine with food and alcohol
You may take your tablets with or
without food. Alcohol may increase the
chance of you feeling drowsy or
experiencing side effects while taking
Tizanidine. You should not drink alcohol
with Tizanidine. Consult your doctor
before taking alcohol with Tizanidine.
Pregnancy and breast-feeding
Tizanidine is not recommended for use
during pregnancy and breast-feeding. If
you are pregnant, think you may be
pregnant, are planning to become
pregnant, or are breast-feeding, tell your
doctor or pharmacist before you take this
medicine.
Driving and using machines
Do not drive or operate machinery or
equipment if you have blurred vision, feel
drowsy or dizzy whilst taking Tizanidine.
Tizanidine tablets contain lactose
This medicine contains lactose. If you
have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking this
medicine.
3. How to take Tizanidine
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
The recommended dose is:
Adults: 2 mg Tizanidine (one 2 mg tablet)
taken once a day.
If needed, every 3 or 4 days, your doctor
may increase the dose by 2 mg of
Tizanidine. You should take larger doses
of Tizanidine as 3 or 4 divided doses
during the day. The exact dose will
depend on your response to the tablets.
The maximum daily dose is 36 mg of
Tizanidine.
Use in children: Tizanidine should not be
given to children.
Elderly: If you are elderly you should not
take Tizanidine unless your doctor tells
you otherwise.
Kidney problems: In patients with kidney
disease the dose may be increased more
slowly and you may need blood tests to
check on your kidneys.
Method of administration
Swallow the tablets with a drink of water.
You may take the tablets with or without
food.

LT1325AE

If you take more Tizanidine than you
should
If you accidentally take too many tablets,
contact your doctor or nearest hospital
emergency department immediately for
advice. Take the packet and this leaflet
with you so that the doctor will know
what you have taken. Symptoms of
overdose may include nausea, vomiting,
low blood pressure, dizziness,
contraction of the pupil of the eye,
respiratory distress, coma, restlessness,
abnormal heartbeat or sleepiness.
If you forget to take Tizanidine
Unless it is nearly time for your next dose,
take it as soon as you remember.
Otherwise, if you miss a dose do not take
a double dose to make up for a forgotten
tablet.
If you stop taking Tizanidine
Do not stop or change your treatment
before talking to your doctor (See section
4 ‘Possible side effects’).
If you have any further questions on the
use of this medicine, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
You should tell your doctor immediately
if you experience signs of liver damage
such as yellowing of the eyes or skin
and/or production of dark urine, or signs
of an allergic reaction such as swelling of
the face, lips or tongue, sudden
wheezing, itching or nettle rash.
Other side effects include:
Very common (may affect more than 1
in 10 people)
• drowsiness, feeling tired
• weak muscles
• dry mouth, stomach upset
• dizziness
Common (may affect up to 1 in 10
people)
• difficulty in sleeping or problems whilst
sleeping
• a drop in blood pressure causing you to
feel lightheaded or feel dizzy on
standing up
• feeling sick
• abnormal liver tests (this may be found
on a blood test)
• slow heart beat
Rare (may affect up to 1 in 1.000
people)
• hallucinations (more likely if you are
taking other drugs which may
themselves cause hallucinations e.g.
antidepressants)
Very Rare (may affect up to 1 in 10.000
people)
• inflammation of the liver
Not known (frequency cannot be
estimated from the available data)
• confusion
• vertigo (a feeling of dizziness or
spinning)
• loss of consciousness
• feeling of weakness
• blurred vision

• high blood pressure
• increased heart rate, which may result in
headache
Talk to your doctor before stopping
treatment with Tizandine.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5.How to store Tizanidine
Keep this medicine out of the sight and
reach of children.
Do not store above 25 ˚C.
Keep the tablets in the pack and do not
use this medicine after the expiry date
which is stated on the carton after EXP.
The expiry date refers to the last day of
that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.
6. Contents of the pack and other
information
What Tizanidine 2 mg and 4 mg Tablets
contain
The active substance is tizanidine
hydrochloride. Each 2 mg tablet contains
2 mg tizanidine (as hydrochloride). Each
4 mg tablet contains 4 mg tizanidine (as
hydrochloride).
The other ingredients are: colloidal
anhydrous silica, stearic acid,
microcrystalline cellulose and anhydrous
lactose.
What Tizanidine looks like and contents
of the pack
Tizanidine 2 mg Tablets are white, and
marked “TI” and “2” on either side of a
bisecting score on one side and “G” on
the other.
Tizanidine 4 mg Tablets are white and
marked “TI” and “4” on one side and a
quadrasecting score on the other side.
Tizanidine Tablets are available in: Blister
strips of plastic/aluminium foil in a carton
in packs of 15, 30, 50 and 120; or in Plastic
containers with polyethylene caps in
packs of 15, 30, 50 and 120
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Gerard Laboratories Ltd,
35-36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland

If you stop taking Tizanidine
The following side effects have been
observed when patients stop taking
Tizanidine tablets suddenly, especially if
you have been taking Tizanidine tablets
for a long time, been taking a high dose
or if you are taking drugs to lower your
blood pressure:

This leaflet was last revised in: 01/2014

LT1325AE 10005243

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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