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PACKAGE LEAFLET: INFORMATION FOR THE USER • ^any ^{medicine with} a ^{sedative effect suc}h

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)

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)

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.

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f you take more Tizanidine than you should

f you accidentally take too many tablets, ontact your doctor or nearest hospital mergency 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, ow blood pressure, dizziness,

:ontraction of the pupil of the eye, respiratory distress, coma, restlessness, abnormal heartbeat or sleepiness.

f 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.

f you stop taking Tizanidine

Do not stop or change your treatment before talking to your doctor (See section 4 'Possible side effects').

f you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

ike all medicines, this medicine can cause side effects, although not verybody gets them.

You should tell your doctor immediately f 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 n 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

f 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 or a long time, been taking a high dose or if you are taking drugs to lower your blood pressure:

•    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

This leaflet was last revised in: 01/2014

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