Tizanidine 4mg Tablets
Tizanidine 2mg and 4mg tablets
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet:
1. What Tizanidine tablets are and what they are used for
2. What you need to know before you take Tizanidine tablets
3. How to take Tizanidine tablets
4. Possible side effects
5. How to store Tizanidine tablets
6. Contents of the pack and other information
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.
2. What you need to know before you take Tizanidine tablets
Do not take Tizanidine tablets:
• 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 tablets’, below).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tizanidine tablets:
• if you have kidney problems
• if you have heart problems such as coronary artery disease
• if you have liver problems.
Other medicines and Tizanidine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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’, above).
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.
Tizanidine tablets with food, drink and alcohol
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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.
Tizanidine tablets contain lactose
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 tablets
Always take this medicine exactly as your doctor 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 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.
Use in 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.
The 4 mg tablet can be divided into equal doses
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 a double dose to make up for a forgotten tablet.
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 medicine, ask your doctor, pharmacist or nurse.
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 10 people):
• 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 (may affect up to 1 in 1000 people):
• Hallucinations
• Sleep disorders including difficulty in sleeping
• 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 (may affect up to 1 in 10,000 people):
• 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 the available data):
• Allergic reactions
• Blurred speech
• Stomach pain
• Vomiting
• Itching, rash
• Abnormal heart rhythms
• Headache, abnormal movements
• Difficulty focusing the eyes
• Loss of appetite
• Anxiety, confusion
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 tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.
Do not throw away any medicines 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 tablets contain
• The active substance is tizanidine. Each tablet contains 2mg or 4mg of tizanidine (as hydrochloride).
• The other ingredients are lactose anhydrous, cellulose microcrystalline, stearic acid and silica colloidal anhydrous.
What Tizanidine tablets look like and 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
This leaflet was last revised December 2015
If you would like a leaflet with larger text, please contact 01271 385257.