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The product codes for this leaflet are: PL30306/0236, PL30306/0237

 

Tizanidine 2mg and 4mg Tablets

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

Tizanidine 2mg and 4mg tablets

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.

In this leaflet:

1 What Tizanidine tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

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1 What Tizanidine tablets are and what they are used for

Tizanidine tablets belong to a group of medicines called skeletal muscle relaxants.

Your medicine is used to relieve the stiffness and restriction of muscles resulting from multiple sclerosis, injury or diseases of the spinal cord.

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2 Before you take

Do not take Tizanidine tablets if you

  • are allergic (hypersensitive) to tizanidine or to any of the ingredients in your medicine
  • have severely impaired liver function
  • are taking medicines such as fluvoxamine (for depression) or ciprofloxacin (an antibiotic) (see also ‘Taking other medicines’)

Take special care with Tizanidine tablets

Check with your doctor before taking Tizanidine tablets if you have:

  • kidney problems
  • heart problems such as coronary artery disease
  • liver problems.

Taking other medicines

Tizanidine tablets must not be taken at the same time as fluvoxamine (to treat depression) or ciprofloxacin (an antibiotic) (see ‘Do not take Tizanidine tablets if you’).

Please tell your doctor or pharmacist if you are taking

  • 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)
  • the contraceptive pill. You may respond to a lower dose of Tizanidine tablets if you are taking the pill.
  • ticlopidine (to prevent blood clots)
  • any medicine to treat high blood pressure, including diuretics (water tablets)
  • beta blockers, e.g. atenolol, propranolol
  • digoxin (used to treat congestive heart failure and problems with heart rhythm)
  • any sedatives (sleeping pills or medicines for anxiety)
  • any other medicines which, when taken with Tizanidine, might affect your heart's rhythm: check with your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.

Taking Tizanidine tablets with food and drink

Tizanidine tablets can be taken independently of meals. Alcohol may increase the sedative effect of Tizanidine tablets. It is not recommended to drink alcohol while taking Tizanidine tablets.

Pregnancy and breast feeding

Tizanidine tablets are not recommended for use during pregnancy and breast-feeding. Tell your doctor if you think you may be pregnant, and ask your doctor for advice before taking any medicine.

Driving and using machines

Tizanidine tablets may cause drowsiness or dizziness (see ‘4. Possible side effects’). If you are affected do not drive or operate machinery.

Important information about one of the ingredients in Tizanidine tablets

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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3 How to take

Always take Tizanidine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dosage instructions are given below

Adults:

Your doctor will usually start you on a single dose of 2mg which will then be gradually increased. Your dose should not be increased more often than every three to four days. As the dose is increased your doctor will advise you to spread the dose out to three or four times a day.

The usual daily dose is between 12mg and 24mg. The maximum daily dose is 36mg.

Elderly:

Your doctor will decide if you should take Tizanidine tablets.

Children and adolescents (under 18 years):

Tizanidine tablets are not recommended for use in children and adolescents

Patients with kidney problems:

Treatment should be started with 2mg once daily. Your doctor will advise you on how to increase your dose.

Method of administration:

Tizanidine tablets are for oral use. The tablets should be swallowed with a glass of water.

If you take more Tizanidine tablets 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.

Overdose may cause nausea, vomiting, low blood pressure, a slow or abnormal heart beat, dizziness, small pupils, difficulty breathing, coma, restlessness or sleepiness.

If you forget to take Tizanidine tablets

If you forget to take one or more of your tablets, be sure to take only your usual number of tablets at the time of your next dose. Do not take any extra tablets.

If you stop taking Tizanidine tablets

Do not stop taking Tizanidine tablets unless your doctor tells you to. Treatment with Tizanidine tablets should be stopped gradually, especially if you have been taking a high dose, unless your doctor has told you otherwise. Stopping treatment suddenly may cause effects such as an increase in heart rate and high blood pressure.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4 Possible side effects

Like all medicines, Tizanidine tablets can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common (affects 1 to 10 users in 100):

  • Drowsiness, tiredness, dizziness
  • Reduction in blood pressure
  • Increase of blood pressure when stopping the treatment suddenly
  • Dry mouth
  • Decrease or increase in heart rate.

Rare (affects 1 to 10 users in 10,000):

  • Hallucinations
  • Sleep disorders including difficulty in sleeping
  • Allergic reactions (itching, rash)
  • Nausea, stomach upsets
  • Changes in the function of the liver - it may be necessary to have blood tests to monitor this
  • Muscle weakness.

Very rare (affects less than one user in 10,000):

  • Inflammation of the liver (hepatitis) or liver failure, which may lead to yellowing of the eyes or skin and/or production of dark urine. Consult your doctor immediately if this occurs.

Other side effects (frequency unknown):

  • Abnormal heart rhythms
  • Headache, abnormal movements
  • Difficulty focusing the eyes
  • Loss of appetite
  • Anxiety, confusion

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5 How to store

Keep Tizanidine tablets out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Tizanidine tablets after the expiry date shown on the outer packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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6 Further information

What Tizanidine tablets contain

  • The active ingredient is tizanidine. Each tablet contains 2mg or 4mg of tizanidine (as hydrochloride).
  • Other ingredients are lactose anhydrous, cellulose microcrystalline, stearic acid and silica colloidal anhydrous.

What Tizanidine tablets look like and the contents of the pack

  • Tizanidine tablets are supplied in white, round tablets.
  • Tizanidine tablets 2mg are marked ‘N 62’ on one side.
  • Tizanidine tablets 4mg are grooved on one side and marked ‘N 63’ on the other side.
  • The tablets are available in pack sizes of 10, 28, 30, 34, 60, 84, 90, 91, 98, 100, 105 and 120 tablets.
  • Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Manufacturer

Niche Generics Limited
The Cam Centre
Wilbury Way
Hitchin
Hertfordshire
SG4 OTW
United Kingdom
Niche Generics Limited
Unit 5
151 Baldoyle Industrial Estate
Dublin 13
Ireland
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This leaflet was last revised November 2012

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis
Barnstaple
EX32 8NS
UK

AAAE5293


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