Tizanidine 2mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Tizanidine 2mg and 4mg 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet
1. What Tizanidine Tablets are and what they are used for
2. Before you take Tizanidine Tablets
3. How to take Tizanidine Tablets
4. Possible side effects
5. How to store Tizanidine Tablets
6. Further information
1 .What Tizanidine Tablets are and what they are used foi
Tizanidine Tablets contain tizanidine, which is a muscle relaxant.
Tizanidine 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 Tablets
Do NOT take Tizanidine Tablets if you:
• are allergic to tizanidine or any of the other ingredients (see Section 6).
• have serious problems with your liver.
• are taking medicines containing fluvoxamine or ciprofloxacin.
Take special care:
• you may require a lower dose if you have kidney disease.
• tizanidine may affect liver function, so your liver function may be monitored especially if you develop symptoms such as unexplained nausea, tiredness,anorexia or yellow colouration of the skin and eyes.
• If you have heart problems such as coronary artery disease: regular clinical laboratory and ECG monitoring is recommended during treatment with tizanidine.
Taking other medicines
Please tell your doctor or pharmacist before taking Tizanidine Tablets if you are taking or have recently taken any other medicines, including those bought without a prescription and herbal remedies.
Tizanidine should be used cautiously if you:
• are already taking medicines for high blood pressure, beta blockers, or asthma, or diuretics or digoxin, because tizanidine may further lower your blood pressure.
• are taking medicines known to affect normal heart rhythm, such as amiodarone, mexiletine, propafenone, cimetidine, enoxacin, norfloxacin,pefloxacin,rofecoxib and ticlopidine, and some anti malarial or antifungal medicines.
• use alcohol or sedatives, as they may enhance the sedative effect of tizanidine.
• are a woman taking oral contraceptives.
Pregnancy and breastfeeding
Do not take Tizanidine Tablets if you are pregnant, become pregnant or planning to become pregnant. Please seek advice from your doctor.
Do not take Tizanidine Tablets if you are breast-feeding. Seek advice from your doctor.
Driving and using machinery
Tizanidine may make you drowsy and affect your alertness. If this happens do not drive or use machines.
Important information about some of the ingredients of Tizanidine Tablets
These tablets 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 Tablets
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 timing and frequency of dosing has been tailored to meet your needs, so take your medication exactly as directed by your doctor.
Adults and the elderly:
Your doctor will usually start your treatment with one 2 mg tablet a day and will ask you to gradually increase the number of tablets you take, until the best relief of your symptoms can be obtained.
You should not increase your dose of Tizanidine Tablets more often than every 3 to 4 days.
The usual daily dose is up to 24 mg (12 of the 2mg or 6 of the 4 mg).
Do not take more than 36mg a day (18 of the 2 mg tablets or 9 of the 4 mg tablets in a 24 hour period).
Always keep to your appointments to see your doctor so that your progress can be checked.
Kidney impairment: Your doctor will start you on one 2 mg tablet and will advise you on how to increase your dose.
Liver impairment: Tizanidine Tablets must not be taken if you have severe liver problems.
Children and adolescents: Tizanidine Tablets are not recommended in patients under 18 years of age.
If you forget to take Tizanidine tablets
If you forget to take a dose, take it as soon as you remember. If it is nearly time for your next dose, just take the next dose. Do not take a double dose to make up for a forgotten dose.
If you take more than you should
Never take more than the prescribed dose. If you suspect that you or someone else has taken an overdose of Tizanidine Tablets, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if empty. The symptoms of an overdose are nausea, vomiting, fall in blood pressure, pupil constriction, dizziness, difficulty in breathing, restlessness, drowsiness or coma.
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.
4. Possible side effects
Tizanidine may cause unwanted effects although not everybody gets them. Speak to your doctor or pharmacist if any of the following side effects continue or become troublesome.
Skin rash or itching suggest an allergic reaction, in which case you should stop taking the tablets immediately and see your doctor or go to a hospital.
Common (affects 1 to 10 users in 100):
• Drowsiness, fatigue, dizziness
• Reduced blood pressure, rebound of a high blood pressure
• Slow pulse rate
• Very rapid heart rate
• Dry mouth, nausea, tummy or bowel upset.
Rare (affects 1 to 10 users in 10,000):
• Difficulty in sleeping, sleeplessness
• Allergic reactions such as rash and itchiness
• Hallucinations
• Muscle weakness,
• Increases in liver enzymes
Very rare (affects less than 1 user in 10,000):
Liver disease, liver failure.
Frequency not known (cannot be estimated from the available data):
• QT-prolongation (a certain interval in the electrocardiogram [ECG])
• Visual disturbance
• Headache
• Movement disorders
• Anxiety
• Absence of appetite
Important: If have a sudden loss of appetite and develop yellowing of the skin or whites of the eyes, pain or swelling in the midriff (between chest and waist) contact your doctor as soon as possible.
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.
5. How to store Tizanidine Tablets
Keep out of sight and reach of children Do not store above 30°C.
Do not use tizanidine tablets after the expiry date which is stated on the carton after 'Exp {MM/YYYY}'.
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 to protect the environment.
6. Further information
What Tizanidine Tablets contain
Each tablet contain either 2mg or 4mg of tizanidine as active substance.
The other ingredients are lactose anhydrous, microcrystalline cellulose, collidal anhydrous silica and stearic acid.
What Tizanidine Tablets look like and contents of the pack
Tizanidine 2mg tablets are white to off-white, oval, flat, bevelled edged tablets embossed with 'R179' on one side and bisecting score on the other side.
Tizanidine 4mg tablets are white to off-white, oval, flat, bevelled edged tablets embossed with 'R180' on one side and quadrisecting score on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Tizanidine 2mg and 4mg tablets are packed in cartons of 15, 20, 30, 100 and 120 tablets. Not all pack sizes will be marketed.
Marketing authorisation holder and manufacturer:
Dr. Reddy's Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK
This medicinal product is also authorised in some Member States of the EEA under the following name:
UK: Tizanidine 2 mg & 4 mg Tablets AT: Tizanidin betapharm 2 mg & 4 mg Tabletten
IT: Tizanidina Dr. Reddy's 2 mg & 4 mg compresse
BG: Sizolan 2 mg, 4 mg Ta6neTKa RO: Tizanidina Dr Reddy's 2 mg, 4 mg comprimate
PL: Tizanor FI + HU: Tizanidin Orion
IE: Tizanidine Dr. Reddy's 2 mg & 4 mg Tablets
This leaflet was last updated in October 2009. (PL 08553/0389 & 0390)
4/4