Tizanidine 2 Mg Tablets
Package leaflet: Information for the user
[Tizanidine 2 mg Tablets]
[Tizanidine 4 mg Tablets]
Tizanidine
Read all of this leaflet carefully before you start taking this medicinebecause 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 sign of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist . This includes any possible side effects not listed in this leaflet. See section 4.
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
• Tizanidine belongs 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.
2. What you need to know before you take Tizanidine Do not take Tizanidine:
• if you are allergic to tizanidine or any of the other ingredients of this medicine(listed in section 6)
• if you have severely impaired liver function.
• if you are taking medicines such as fluvoxamine (for depression) or ciprofloxacin (an antibiotic) (see also 'Other medicines and Tizanidine', below)
Warning and precautions
Talk to your doctor or pharmacist before taking Tizanidine :
• if you have kidney problems
• if you have heart problems such as coronary artery disease
• if you have liver problems.
Other medicines and Tizanide
Tizanidine must not be taken at the same time as fluvoxamine (to treat depression) or ciprofloxacin (an antibiotic) (see 'Do not take Tizanidine', above).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• 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 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), e.g. temazepam
• any other medicines which, when taken with Tizanidine, might affect your heart's rhythm: check with your doctor or pharmacist.
Tizanidine with food and drink and alcohol
Tizanidine can be taken independently of meals. Alcohol may increase the sedative effect of Tizanidine. It is recommended not to drink alcohol while taking Tizanidine.
Pregnancy and breast-feeding
It is not recommended to take Tizanidine during pregnancy or whilst breast feeding. . If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Tizanidine may cause drowsiness or dizziness (see '4. Possible side effects'). Alcohol and sedatives may increase this effect. If you are affected do not drive or operate machinery.
Tizanide contain 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.
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 usual dosage instructions are given below:
Adults
Your doctor will usually start you on a single dose of 2 mg 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 recommended daily dose is between 12 and 24 mg,. The maximum daily dose is 36 mg.
Elderly
Your doctor will decide if you should take Tizanidine.
Use in children and adolescents
Tizanidine is not recommended for use in children and adolescents.
Renal impairment
Treatment should be started with 2 mg once daily. Your doctor will advise you on how to increase your dose.
Method of administration
Tizanidine Teva is for oral use. The tablets should be swallowed with a glass of water.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Tizanidine 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
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
Do not stop taking Tizanidine unless your doctor tells you to. Treatment with Tizanidine 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines,this medicine can cause side effects, although not everybody gets them. The following side effects have been reported:
Common (may affect up to 1 in 10people):
• Drowsiness, tiredness, dizziness
• Reduction in blood pressure
• Increase of blood pressure when stopping the treatment suddenly
• Dry mouth, nausea, stomach upsets
• Decrease or increase in heart rate.
Rare (may affect up to 1 in 1,000 people):
• Hallucinations
• Sleep disorders including difficulty in sleeping
• Allergic reactions (itching, rash)
• Changes in the function of the liver - it may be necessary to have blood tests to monitor this
• Muscle weakness.
Very rare (may affect up to 1 in 10,000people):
• 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.
Not known (frequency cannot be estimated from available data):
• Allergic reactions
• Itching
• Stomach pain
• Vomiting
• Blurred speech
• Abnormal heart rhythms
• Headache, abnormal movements
• Difficulty focusing the eyes
• Loss of appetite
• Anxiety
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tizanidine
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the outer packaging. Do not store above 30°C.
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 protect the environment.
6. Contents of the pack and other information What Tizanidine contains
• The active substance is tizanidine. Each tablet contains 2 mg or 4 mg of tizanidine (as hydrochloride).
• The other ingredients are lactose anhydrous, cellulose microcrystalline, stearic acid and silica colloidal anhydrous.
What Tizanidine looks like and the contents of the pack
• Tizanidine 2 mg Tablets: White to off-white, biconvex, round tablets, 6 mm diameter, debossed “T2” on one side and scoreline on the other.
• Tizanidine 4 mg Tablets: White to off-white, biconvex, round tablets, 9 mm diameter, debossed “T4” on one side and quadrisected by scorelines on the other.
• The 2 mg tablets are available in pack sizes of 15, 20, 30, 50, 100, 120 & 500.
• The 4 mg tablets are available in pack sizes of 20, 30, 50, 100, 120, 200 & 500.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Ltd
Brampton Road, Hampden Park Eastbourne, BN22 9AG England
This medicinal product is authorised in the Member States of the EEA under the following names:
Tizanidine 2 mg Tablets, PL 00289/0650 Tizanidine 4 mg Tablets, PL 00289/0651
This leaflet was last revised in: February 2016