ZANAFLEX 2 MG TABLETS

Active substance: TIZANIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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(Tizanidine)
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Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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Product Name
Market
Component
No. of Colours
Profile
Dimensions

Zanaflex
UK/Ireland
LEAFLET
1 (One)
9407400
245 x 148 mm
(folded 31 x 148 mm)
Barcode
N/A
Pharmacode
20213
Material No.
PX2021/3
Packaging supp. Almac
Date
11 Jun 2012

In
1.
2.
3.
4.
5.
6.

this leaflet:
What ZANAFLEX is and what it is used for.
Before you use ZANAFLEX.
How to use ZANAFLEX.
Possible side effects.
How to store ZANAFLEX.
Further 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.

ARK Pharma Graphics Ltd
Crown House Business Centre, Home Gardens,
Dartford, Kent, DA1 1DZ.
Tel +44(0)1322 424656
V4.01.2011

2. BEFORE YOU TAKE ZANAFLEX
Do not take ZANAFLEX if you:
- Are allergic (hypersensitive) to tizanidine hydrochloride or any of the other ingredients in ZANAFLEX.
- Have liver problems.
- Are taking a medicine called fluvoxamine or ciprofloxacin.
ZANAFLEX is not suitable for children or the elderly.
Take special care with ZANAFLEX if you have:
- An intolerance to certain sugars (lactose and cellulose).
- Kidney problems.
If any of the above apply to you, you should speak to your doctor before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines,
including 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.
• Ticlopidine 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.
Taking ZANAFLEX with food and 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
ZANAFLEX is not recommended for use during pregnancy and breast-feeding. If you are pregnant,
think you might be pregnant, are planning to become pregnant, or are breast-feeding tell your doctor or
pharmacist before you take this medicine.
Driving and operating machinery
ZANAFLEX can sometimes cause blurred vision, drowsiness or dizziness in some people. If you are
affected you should not drive or operate machinery.
Important information about some of the ingredients of ZANAFLEX
ZANAFLEX contains lactose and cellulose which are types of sugars. If you have been told you have
an intolerance to some sugars contact your doctor before taking this medicine.

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9407400
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H 245 x W 148 mm
H 1.22 x W 5.82 “
H 31 x W 148 mm
Zanaflex
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01
25 Jul 09

0003-20ZanaflexPIL.indd

Profile Key

ARK 004

All Over Varnish Unless Marked

Cephalon Job No.:

0003/20

02

Iteration No.:

Black

100%

95%

50%

5%

Product Name
Market
Component
No. of Colours
Profile
Dimensions

Zanaflex
UK/Ireland
LEAFLET
1 (One)
9407400
245 x 148 mm
(folded 31 x 148 mm)
Barcode
N/A
Pharmacode
20213
Material No.
PX2021/3
Packaging supp. Almac
Date
11 Jun 2012
ARK Pharma Graphics Ltd
Crown House Business Centre, Home Gardens,
Dartford, Kent, DA1 1DZ.
Tel +44(0)1322 424656
V4.01.2011

Artwork Approval Signature Box
ARK

Site Packaging

Regulatory UK

Regulatory Ireland

Commercial

Medical

Packaging Ctrl.

TEXT SIZE
The Smallest Body
text on this A/W is:

8 pt
TINT VALUES
N/A
OFF-PACK PHARMACODE
Number: 20213

First Bar

3. HOW TO TAKE ZANAFLEX
Always take your medicine exactly as your doctor has told you. You should 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 dose 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.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ZANAFLEX can cause side effects, although not everyone gets them.
You should tell your doctor immediately if you experience signs of liver damage such as dark urine
or yellowing of the eyes or skin 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 side effects (affecting more than 1 in 10 patients)
• Drowsiness, feeling tired, weak muscles
• Dry mouth, stomach problems
• Dizziness
Common side effects (affecting 1 to 10 patients in 100)
• Difficulty in sleeping or problems whilst sleeping
• Low blood pressure
• Feeling sick
• Abnormal liver tests (this may be found on a blood test)
Uncommon side effects (affecting 1 to 10 patients in 1000)
• Slower heart rate
The following side effects have also been reported with the use of ZANAFLEX but it is not known how
often they occur: Hallucinations, feeling confused, vertigo (a feeling of dizziness or spinning), loss of
consciousness, inflammation of the liver, a feeling of weakness and blurred vision.
If any of the side effects become serious or you notice any side effects which are not listed in this
leaflet, please tell your doctor or pharmacist.
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.
5. HOW TO STORE ZANAFLEX
Keep out of the reach and sight of children.
Keep the tablets in the pack and do not use after the expiry date stated on the pack. There are no
special precautions for storage
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures help protect the environment.
6. FURTHER 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
ZANAFLEX 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
Manufacturer
Cephalon UK Limited,
Almac Pharma Services,
Ridings Point, Whistler Drive, Castleford,
Seagoe Industrial Estate, Craigavon,
West Yorkshire, WF10 5HX, UK
County Armagh, BT63 5UA, UK
This leaflet was last revised in 03/2012
ZANAFLEX is a registered trademark of Cephalon, Inc., or its affiliates.

0003/20

PX2021/3

Non Print
Area

Varnish Free
Area

Fold

Perforation

Profile Name:
Component:
Style:
Dimensions:
Folded Size:
Product:
Markets:
Version:
Date:

9407400
PIL
N/A
H 9.64 x W 5.82 “
H 245 x W 148 mm
H 1.22 x W 5.82 “
H 31 x W 148 mm
Zanaflex
N/A
01
25 Jul 09

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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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