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TIZANIDINE 4MG TABLETS

Active substance(s): TIZANIDINE HYDROCHLORIDE

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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

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Talk to your doctor or pharmacist before
taking Tizanidine:
• if you have kidney problems.
• if you have liver problems.

• 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, amiodarone,
mexiletine or propafenone)
• any other medicine that could
affect the rhythm of your heart (QT
prolongation, e.g. amitriptyline and
azithromycin) - check with your doctor
or pharmacist
Taking Tizanidine if you are a smoker
You should also tell your doctor if you
are a smoker as your doctor may need to
change your dose.
Tizanidine with alcohol
You should not drink alcohol with
Tizanidine. Alcohol may increase
the chance of you feeling drowsy or
experiencing side effects while taking
Tizanidine. Consult your doctor before
taking Tizanidine with alcohol.
Pregnancy and breast-feeding
Tizanidine should not be used during
pregnancy or breast-feeding. If you are
pregnant or breast-feeding, think you
may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery if you
have blurred vision, feel drowsy or dizzy
whilst taking Tizanidine.
Tizanidine tablets contain 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.
Swallow the tablets with a drink of water.
You may take the tablets with or
without food.
The score line is only there to help you
break the tablet if you have difficulty
swallowing it whole.
Use in adults: The recommended dose is
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 and adolescents:
Tizanidine should not be given to children
or adolescents under 18 years old.

Your doctor will decide if you need
blood tests to check that your liver is
working properly.

Elderly: If you are elderly you should not
take Tizanidine unless your doctor tells
you otherwise.

Other medicines and Tizanidine

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.

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 affect the way Tizanidine works
or makes side effects more likely:
• the oral contraceptive pill
• antibiotics called norfloxacin, enoxacin,
pefloxacin or rifampicin
• ticlopidine (to prevent blood clots)
• cimetidine (for indigestion and
stomach ulcers)
• any medicine with a sedative effect
such as sleeping pills, medicines for
anxiety (e.g. diazepam or temazepam),
other muscle relaxants ( e.g. baclofen)
or antihistamines (e.g. chlorphenamine)

If you take more Tizanidine
than you should
If you accidentally take too many
tablets, contact your doctor or go to the
nearest hospital emergency department
immediately. Take the packet and
this leaflet with you so that the doctor
will know what you have taken. Signs
of overdose may include feeling sick
(nausea), being sick (vomiting), low blood
pressure, dizziness, a decrease in the
size of the pupils of the eye, breathing
problems, 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. Do not
take a double dose to make up
for a forgotten dose.
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Package leaflet: Information for the patient

If you stop taking Tizanidine
Do not stop or change your treatment
before talking to your doctor. Your doctor
will gradually reduce your dose and
regularly check your blood pressure to
prevent signs of withdrawal.
The following side effects have been
observed if you stop taking tizanidine
suddenly, especially if you have been
taking tizanidine for a long time, been
taking a high dose or if you are taking
medicines to lower your blood pressure:
• high blood pressure
• increased heart rate, which may result
in blurred vision or headache
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
or go to the nearest hospital emergency
department if you experience signs of any
of the following:
Very rare (may affect up to 1 in
10,000 people)
• liver damage, such as yellowing of the
eyes or skin, abdominal pain, tiredness,
fever, pale stools and/or dark urine
Not known (cannot be estimated from
the available data)
• an allergic reaction, such as swelling of
the face, lips, tongue or throat, sudden
wheezing, difficulty swallowing or
breathing itching or nettle rash (hives)
• convulsions (fits)
Other side effects include:
Very common (may affect more than
1 in 10 people)
• drowsiness, feeling tired
• weak muscles
• dry mouth, problems with your gut
• dizziness
Common (may affect up to 1 in
10 people)
• difficulty falling asleep or other
sleeping problems
• a drop in blood pressure causing you
to feel lightheaded or feel dizzy
• feeling sick (nausea)
• increase in levels of liver enzymes in
the blood (this may be seen with a
blood test)
• slow heart beat
Rare (may affect up to 1 in 1,000 people)
• seeing, hearing or feeling things
that are not real (hallucinations).
More likely if you are taking other
drugs which may themselves cause
hallucinations e.g. antidepressants
Not known (cannot be estimated from
the available data)
• confusion
• vertigo (a feeling of dizziness
or spinning)
• loss of consciousness
• feeling of unusual weakness
• blurred vision
• signs of withdrawal (see section 3,
'If you stop taking Tizanidine')
• stomach pain, vomiting
• itching
• blurred speech

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.
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 contains
The active substance is tizanidine. 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 (see section 2 'Tizanidine contains
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 score
line on one side and 'G' on the other.
Tizanidine 4 mg Tablets are white and
marked 'TI' and '4' on one side and a
cross-shaped score line on the other side.
Tizanidine tablets are available in blister
strips of plastic/aluminium foil in a carton
or in plastic containers with plastic 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
Generics [UK] Limited
Station Close, Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom

This leaflet was last revised in
12/2015

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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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