Tizanidine 2mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tizanidine 2mg and 4mg Tablets (tizanidine)
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 or pharmacist.
- 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 or pharmacist. 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
.What Tizanidine Tablets are and what they are used foi
The active ingredient Tizanidine belongs to a group of medicines called muscle relaxants. Tizanidine is used to relax muscles which have become stiff due to multiple sclerosis, or other diseases affecting 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 liver problems.
• If you are taking a medicine called fluvoxamine or ciprofloxacin.
Tizanidine is not suitable for children or elderly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tizanidine Tablets:
• If you have kidney problems
Other medicines and Tizanidine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking any of the following:
- The oral contraceptive pill.
- Antibiotics called norfloxacin, enoxacin or rifampicin.
- Ticlopidine to thin the blood.
- Cimetidine for stomach ulcers.
- Medicines which may make you drowsy e.g. sedatives (such as diazepam or temazepam).
- Medicines for high blood pressure (e.g. water tablets, beta-blockers or clonidine).
- Medicines for abnormal heart rhythm (e.g. digoxin, amiodarone, mexiletine or propafenone).
- Medicines that could affect the electrical rhythm of your heart (QT prolongation, for example amitriptyline and azithromycin).
Smoking and Tizanidine Tablets
You should also tell your doctor if you are a smoker as this may mean you are require a higher dose of Tizanidine for it to work properly.
Tizanidine Tablets with food, drink and alcohol
Alcohol may increase the chance of you feeling drowsy or experiencing side effects while taking Tizanidine. You should not drink alcohol with Tizanidine, consult your doctor before taking alcohol with Tizanidine.
Pregnancy and breast-feeding
Tizanidine is 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 can sometimes cause blurred vision, drowsiness or dizziness in some people. If you are affected you should not drive or operate machinery.
Tizanidine 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will usually start treatment with one 2 mg tablet once a day but may instruct you to gradually increase the number of tablets you take and spread them out over the day. The exact dose will depend on your response to the tablets.
The total dose should not exceed 36 mg.
ln patients with kidney disease the dose may be increased more slowly and you may need blood tests to check on your kidneys.
If you take more Tizanidine Tablets than you should
If you take too much Tizanidine you should contact your doctor or go to the nearest hospital emergency department immediately. Take the packet and this leaflet with you so that the doctor will know what you have taken.
If you forget to take Tizanidine Tablets
If you forget to take your dose in the morning you should take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Tizanidine Tablets
The following side effects have been observed when patients stop taking Tizanidine suddenly after a long period of time, especially in patients on a high dose of Tizanidine or patients who take Tizanidine with drugs used to lower blood pressure: high blood pressure, increased heart rate (which may result in headache, blurred vision). Talk to your doctor before stopping treatment with Tizanidine.
If you have any further questions on the ise 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.
You should tell your doctor immediately if you experience signs of liver damage such as dark urine or yellowing of the eyes or skin or signs of an allergic reaction such as swelling of the face, lips or tongue, sudden wheezing, itching or nettle rash.
Other side effects include:
Very common side effects (affecting more than 1 in 10 patients)
- Drowsiness, feeling tired, weak muscles
- Dry mouth, stomac problems
- Dizziness
Common side effects (affecting 1 to 10 patients in 100)
- Difficulty in sleeping or problems whilst sleeping
- Low blood pressure
- Feeling sick
- Abnormal liver tests (this may be found on a blood test)
Uncommon side effects (affecting 1 to 10 patients in 1000)
- Slower heart rate
The following side effects have also been reported with the use of Tizanidine but it is not known how often they occur: Hallucinations, feeling confused, vertigo (a feeling of dizziness or spinning) loss of consciousness, inflammation of the liver, a feeling of weakness, blurred vision, stomach pain, vomiting, itching, blurred speech and allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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
Do not use this medicine 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.
Do not store above 30°C.
Do not throw a way any m edicines via w astewater o r hous ehold w aste. A sk y our 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
Each tablet contains either 2 mg or 4 mg 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:
D r 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 PL:Tizanor
IT: NAVIZAN 2 mg & 4 mg compresse FI:Tizanidin Orion
This leaflet was last updated in November 2015. (PL 08553/0342 & 0343)