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ZANAFLEX 4 MG TABLETS

Active substance(s): TIZANIDINE HYDROCHLORIDE

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Date: 2016.06.03
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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZANAFLEX 2mg tablets
ZANAFLEX 4mg tablets
Tizanidine

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 or pharmacist.
• 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 of pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

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1. What ZANAFLEX is and what it is used for.
2. What you need to know before you take ZANAFLEX.
3. How to take ZANAFLEX.
4. Possible side effects.
5. How to store ZANAFLEX.
6. Contents of the pack and other information.
1. What ZANAFLEX is and what it is used for
The name of this medicine is ZANAFLEX. The active ingredient is
tizanidine hydrochloride which belongs to a group of medicines
called muscle relaxants.
ZANAFLEX is used to relax muscles which have become stiff due to
multiple sclerosis or other diseases affecting the spinal cord.
2. What you need to know before you use ZANAFLEX

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Do not take ZANAFLEX:

• if you are allergic to tizanidine hydrochloride or any of the other ingredients in ZANAFLEX.
• if you have liver problems.
• if you are taking a medicine called fluvoxamine or ciprofloxacin.

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What is in this leaflet:

Warnings and precautions

Talk to your doctor or pharmacist before taking ZANAFLEX:
• if you have kidney problems

Children and the Elderly

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Other medicines and ZANAFLEX

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ZANAFLEX is not suitable for children or the elderly.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes
medicines obtained without a prescription.
This is especially important if you are taking any of the following:
• The oral contraceptive pill
• Antibiotics called norfloxacin, enoxacin or rifampicin.
• Ticlopine to thin the blood.
• Cimetidine for stomach ulcers.
• Medicines which may make you drowsy e.g. sedatives (such as diazepam or temazepam), baclofen or
antihistamines.
• Medicines for high blood pressure (e.g. water tablets, beta-blockers or clonidine).
• Medicines for abnormal heart rhythms e.g. digoxin, amiodarone, mexiletine or propafenone.
• Medicines that could affect the electrical rhythm of your heart (QT prolongation, for example amitriptyline and
azithromycin).

Taking ZANAFLEX 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 ZANAFLEX for it
to work properly.

ZANAFLEX with drink

Alcohol may increase the chance of you feeling drowsy or experiencing side effects while taking ZANAFLEX. You
should not drink alcohol with ZANAFLEX, consult your doctor before taking alcohol with ZANAFLEX.

Pregnancy and breast-feeding

Driving and using machines
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LEAFLET

ZANAFLEX can sometimes cause blurred vision, drowsiness or dizziness in some people. If you are affected you
should not drive or operate machinery.

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Zanaflex 2mg/4mg Tabs ALL CeUK V3

ZANAFLEX is not recommended for use during 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 before taking this medicine.

ZANAFLEX contains Lactose

ZANAFLEX contains Lactose which is a type of sugar. If you have been told you have an intolerance to some sugars
contact your doctor before taking this medicine.
3. How to use ZANAFLEX
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will usually start treatment with one 2 mg tablet once a day, but may instruct you to gradually increase the
number of tablets you take and spread them out over the day. The exact does will depend on your response to the tablets.
The total dose should not exceed 36 mg.
In patients with kidney disease the dose may be increased more slowly and you may need blood tests to check on
your kidneys.

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If you take more ZANAFLEX than you should

If you take too much ZANAFLEX you should 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.

If you forget to take ZANAFLEX

If you forget to take your dose in the morning you should take it as soon as you remember unless it is nearly time for
your next dose. Do not take a double dose to make up for a forgotten one.

If you stop taking ZANAFLEX:

The following side effects have been observed when patients stop taking ZANAFLEX suddenly after a long period of
time, especially in patients on a high dose of ZANAFLEX or patients who take ZANAFLEX with drugs used to lower
blood pressure: high blood pressure, increased heart rate (which may result in headache, blurred vision). Talk to your
doctor before stopping treatment with ZANAFLEX.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Stop taking Zanaflex and tell your doctor immediately if you experience:
• any signs of liver damage, such as dark urine or yellowing of the eyes or skin
• signs of an allergic reaction, such as swelling of the face, lips or tongue, sudden wheezing (which can cause great
difficulty in breathing); itching or nettle rash.

Other side effects

Very common: may affect more than 1 in 10 people
• Drowsiness, feeling tired, weak muscles
• Dry mouth, stomach problems
• Dizziness
Common: may affect up to 1 in 10 people
• Difficulty in sleeping or problems whilst sleeping
• Low blood pressure
• Feeling sick
• Abnormal liver tests (this may be found on a blood test)
Uncommon: may affect up to 1 in 100 people
• Slower heart rate
• Stomach pain
• Vomiting
• Itching
• Blurred speech
Not known: frequency cannot be estimated from the available data
• Hallucinations
• Feeling confused
• Vertigo (a feeling of dizziness or spinning)
• Loss of consciousness
• Inflammation of the liver
• a feeling of weakness
• Blurred vision.

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 ZANAFLEX
Keep out of the sight and reach of children.
Keep the tablets in the pack.
Do not use this medicine after the expiry date which is stated on the pack.
There are no special precautions for storage
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information

What ZANAFLEX contains

Each ZANAFLEX 2 mg tablet contains 2 mg of tizanidine (as hydrochloride) as the active ingredient.
Each ZANAFLEX 4 mg tablet contains 4 mg of tizanidine (as hydrochloride) as the active ingredient.
It also contains colloidal anhydrous silica, stearic acid, microcrystalline cellulose and lactose anhydrous as the
inactive ingredients.

What ZANAFLEX looks like and contents of the pack

ZANALFEX is supplied as white, round tablets marked with “A”and “592” (for the 2 mg tablets) or “A” and “594”
(for the 4 mg tablets).
The tablets come in blister strips of 20 tablets and each packet contains 6 blister strips to give a packet size of 120
tablets.

Marketing Authorisation Holder

Cephalon UK Limited,
Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX, UK

Manufacturer

Almac Pharma Services
Seagoe Industrial Estate, Craigavon,
County Armagh, BT63 5UA, UK
This leaflet was last revised in 05/2016
ZANAFLEX is a registered trademark of Cephalon, Inc., or its affiliates.
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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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