TIZANIDINE 4MG 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)

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 TAKE
TIZANIDINE

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

Always take this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse have
told you. Check with your doctor, pharmacist or nurse
if you are not sure.

Tizanidine with food and alcohol
You may take your tablets with or without food. Do
not drink alcohol whilst taking Tizanidine.

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.

Pregnancy and 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.

If you stop taking Tizanidine
Do not stop or change your treatment before talking
to your doctor (See Section 4 'Possible side effects').

Do not take Tizanidine during your pregnancy, unless
your doctor tells you otherwise.
Tizanidine is not recommended for use while
breast-feeding as Tizandine may reach your baby
through the breast milk, therefore you should contact
your doctor before breast-feeding.
Driving and using machines
Do not drive or operate machinery or equipment if
you 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.

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. 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 have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS

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 maximum daily dose is 36 mg of
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Tizanidine.

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.
More common side effects are:
• feeling drowsy or tired
• dizziness
• dry mouth
• feeling sick
• stomach upset
• slowing of the heartbeat
• a drop in blood pressure causing you to feel
lightheaded or feel dizzy on standing up (or a loss of
consciousness).
Other side effects include:
• sleeplessness
• hallucinations (more likely if you are taking other
drugs which may themselves cause hallucinations
e.g. antidepressants)

• confusion
• allergic reactions such as itching or rash
• liver problems
• muscle weakness.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side effects
not listed in this leaflet.
If you stop taking Tizanidine
Treatment with Tizanidine tablets should be stopped
gradually, 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. Stopping treatment suddenly may cause
effects such as high blood pressure and an increase in
heart rate. Talk to your doctor before stopping
treatment with Tizandine.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
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 of 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 4mg Tablets contain
The active substance is tizanidine. Each 2 mg tablet
contains 2 mg tizanidine. Each 4 mg tablet contains
4 mg tizanidine.
The other ingredients are: colloidal anhydrous silica,
stearic acid, microcrystalline cellulose and anhydrous
lactose.
What Tizanidine looks like and contents of the pack
Tizanidine Tablets 2 mg are white, and marked 'TI' and
'2' on either side of a bisecting score on one side and
'G' on the other.
Tizanidine Tablets 4 mg 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.

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Warnings and precautions
If any of the conditions or illnesses listed below
applies to you, or if you have suffered from any of
them in the past, you must ask your doctor before
you start to take Tizanidine.
• if you have kidney disease
• if you have heart problems such as coronary artery
disease
• if you have liver problems.

Kidney problems: You may be more sensitive to the
effects of Tizanidine. The recommended starting dose
is 2 mg of Tizanidine once a day. If needed, your
doctor may slowly increase your dose by 2 mg while
closely monitoring your kidney problem.

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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 disease
• if you are taking medicines such as fluvoxamine (for
depression) or ciprofloxacin (an antibiotic) (See
'Taking other medicines').

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

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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.

Use in children: Tizanidine should not be given to
children.

Other medicines and Tizanidine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• medicines for high blood pressure, including
diuretics (water tablets)
• medicine to treat irregular heart rhythms
e.g. procainamide, amiodarone, mexiletine or
propafenone
• digoxin (a medicine used to treat congestive heart
failure and problems with heart rhythm)
• oral contraceptive pill
• any medicine with a sedative effect such as sleeping
pills or medicines for anxiety
• antibiotics known as fluoroquinolones, such as
norfloxacin, enoxacin or pefloxacin
• ticlopidine (to prevent blood clots)
• cimetidine (for indigestion and digestive ulcers)
• rofecoxib (a painkiller)
• beta blockers, e.g. atenolol, propanolol
• any other medicine that could effect the rhythm of
your heart, check with your doctor or pharmacist.
• fluvoxamine (for depression)
• ciprofloxacin (an antibiotic).

Marketing Authorisation Holder and Manufacturer
Mylan, Potters Bar, Herts, EN6 1TL, United Kingdom.
This leaflet was last revised
in: 03/2012

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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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