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TIZANIDINE 4 MG TABLETS

Active substance(s): TIZANIDINE / TIZANIDINE HYDROCHLORIDE

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• beta blockers e.g. atenolol, propranolol (used to
lower blood pressure and slow the heart rate)
Package Leaflet: Information for the user
• digoxin (used to treat congestive heart failure
and problems with heart rhythm)
Read all of this leaflet carefully before you start
taking this medicine because it contains important • sleeping tablets, e.g. temazepam
• the contraceptive pill
information for you.
• any other medicines which, when taken with
• Keep this leaflet. You may need to read it again.
Tizanidine, might affect your heart's rhythm:
• If you have any further questions, ask your doctor
check with your doctor or pharmacist.
or pharmacist.
• This medicine has been prescribed for you only.
Please tell your doctor or pharmacist if you are
Do not pass it on to others. It may harm them,
taking or have recently taken any other medicines,
even if their signs of illness are the same as yours. including medicines obtained without a
• If you get any side effects, talk to your doctor or
prescription.
pharmacist. This includes any possible side
Tizanidine contains lactose
effects not listed in this leaflet. See section 4.
• Patients who are intolerant to lactose should
What is in this leaflet
note that Tizanidine tablets contain a small
1. What Tizanidine is and what it is used for
amount of lactose. If you have been told by your
2. What you need to know before you take Tizanidine
doctor that you have an intolerance to some
3. How to take Tizanidine
sugars, contact your doctor before taking this
4. Possible side effects
medicine.
5. How to store Tizanidine
Tizanidine with food and drink
6. Contents of the pack and other information
• DO NOT drink alcohol while taking Tizanidine, as
What Tizanidine is and what it is used for
it may make the sedative effect of Tizanidine
worse.
Tizanidine belongs to a group of drugs called
Pregnancy and breast-feeding
skeletal muscle relaxants.
• if you are pregnant or planning to become
Tizanidine is used to relieve the stiffness and
pregnant ask your doctor for advice before
restriction of muscles resulting from multiple
taking this medicine
sclerosis, injury or diseases of the spinal cord.
• it is not recommended to take Tizanidine tablets
while breast-feeding.

Tizanidine 2 mg or 4 mg Tablets

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What you need to know before you take
Tizanidine

Do not take Tizanidine:
• if you are allergic to tizanidine hydrochloride 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’)
• if you have rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
Warnings and precautions
Talk to your doctor before you start to take this
medicine if you:
• have kidney problems
• have liver problems.
Other medicines and Tizanidine
Talk to your doctor if you are taking any of the
following:
• any medicine that may affect the heart’s normal
rhythm
• 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
• rofecoxib (a painkiller)
• ticlopidine (to prevent blood clots)
• any medicine to treat high blood pressure
including diuretics (water tablets)

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Driving and using machines
• Tizanidine may cause drowsiness, dizziness and
decreased blood pressure. If you are affected,
DO NOT drive or operate machinery.

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How to take Tizanidine

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The tablets should be swallowed preferably with a
drink of water. The recommended dose is:
• Adults:
Your doctor will usually start your treatment with
a dose of one 2 mg tablet taken once a day.
Your doctor will gradually increase the number
of tablets you take, and spread them out over the
day into three or four doses. The exact dose will
be set by your doctor according to your
response to treatment.
Your total dose should not be more than 36 mg a
day.
• Elderly:
Your doctor will decide if you should take
Tizanidine.
• Children (under 18 years):
Tizanidine is not recommended for use in children.
• Patients with kidney problems:
Treatment should be started with 2 mg once
daily. Your doctor will advise you on how to
increase your dose.

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If you take more Tizanidine than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause dizziness, low blood
pressure, feeling sick, being sick, pin-point pupils,
breathing problems, coma, restlessness, and
sleepiness.
Please take this leaflet, any remaining tablets, and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Tizanidine
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Tizanidine
DO NOT stop taking your medicine without talking
to your doctor first even if you feel better.
Treatment with Tizanidine tablets should be stopped
gradually, especially if you have been taking a high
dose or with other blood pressure lowering
medicine. Stopping treatment suddenly may cause
an increase in heart rate and high blood pressure.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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Not known (frequency cannot be estimated from
the available data):
• confusional state
• stomach pain
• vomiting
• itching
• blurred speech
• allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible 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 30°C. Do not transfer to another
container.
Do not use this medicine after the expiry date that
is stated on the carton. 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.

Possible side effect
Contents of the pack and other information

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

What Tizanidine tablets contain:
• The active substance is tizanidine hydrochloride
• The other ingredients are lactose anhydrous,
cellulose microcrystalline, stearic acid and silica
colloidal anhydrous.

Stop taking the tablets and tell your doctor
immediately or go to the casualty department at
your nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing; skin What Tizanidine tablets look like and contents of
the pack:
rash or hives).
• Tizanidine tablets are white to off-white,
This is a very serious side effect. You may need
biconvex, round tablets
urgent medical attention or hospitalisation.
• The 2 mg tablets are debossed ‘T2’ on one side
Other side effects include:
and have a scoreline on the reverse
• The 4 mg tablets are debossed ‘T4’ on one side
Common (may affect up to 1 in 10 people):
and divided into quarters by scorelines on the
• drowsiness, tiredness, dizziness
reverse
• reduction in blood pressure, decrease in heart rate
• The 2 mg tablets are available in pack sizes of 15,
• dry mouth.
20, 30, 50, 100, 120 and 500
Rare (may affect up to 1 in 1,000 people):
• The 4 mg tablets are available in pack sizes of 20,
• hallucinations (hearing or seeing things that are
30, 50, 100, 120, 200 and 500.
not real)
Not all pack sizes may be marketed.
• difficulty in sleeping
Marketing Authorisation Holder and Manufacturer
• feeling sick, stomach upsets
• changes in the function of the liver - it may be
Marketing Authorisation Holder
necessary to have blood tests to monitor this
TEVA UK Limited, Eastbourne, BN22 9AG.
• muscle weakness.
Very rare (may affect up to 1 in 10,000 people):
• yellowing of the eyes or skin and/or production
of dark urine, which may be caused by
inflammation of the liver. Tell your doctor
immediately if you experience this side effect
• liver failure.

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
H-4042 Debrecen,Pallagi ut 13,Hungary
This leaflet was last revised: 05/2016
PL 00289/0648-0649
63675-ZA

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Version 3.2

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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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