Tizanidine 4 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 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Tizanidine is and what it is used for
2. Before you take Tizanidine
3. How to take Tizanidine
4. Possible side effects
5. How to store Tizanidine
6. Further 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. BEFORE YOU TAKE TIZANIDINE Do not take Tizanidine 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', below)
Take special care with Tizanidine
Check with your doctor before taking Tizanidine if you:
• Have kidney problems
• Have heart problems such as coronary artery disease
• Have liver problems.
Taking other medicines
Tizanidine must not be taken at the same time as fluvoxamine (to treat depression) or ciprofloxacin (an antibiotic) (see 'Do not take Tizanidine if you', above).
Please tell you 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 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.
Taking Tizanidine with food and drink
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
If it not recommended to take Tizanidine during pregnancy or while are 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 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.
Important information about some of the ingredients in your medicine:
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.
3. HOW TO TAKE TIZANIDINE
Always take Tizanidine 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 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 usual 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.
Children and adolescents (under 18 years):
Tizanidine is not recommended for use in children and adolescents.
Patients with kidney problems:
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.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tizanidine can cause side effects, although not everybody gets them. The following side effects have been reported:
Common (affecting fewer than one person in 10 but more than one person in 100):
• 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 (affecting fewer than one person in 1,000 but more than one person in 10,000):
• 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 (affecting fewer than one person 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
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 Tizanidine out of the reach and sight of children. Do not use Tizanidine after the expiry date shown on the outer packaging. Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no loger required. These measures will help protect the environment.
6. FURTHER INFORMATION
What Tizanidine contains:
• The active ingredient is tizanidine. Each tablet contains 2 mg or 4 mg of tizanidine (as hydrochloride).
• 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 scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
• 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 approved: March 2015