Zanaflex 4 Mg Tablets
>v
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANAFLEX 2mg tablets ZANAFLEX 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 of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What ZANAFLEX is and what it is used for.
2. What you need to know before you take ZANAFLEX.
3. How to take ZANAFLEX.
4. Possible side effects.
Illlllllllllll
20213
5. How to store ZANAFLEX.
6. Contents of the pack and other information.
1. What ZANAFLEX is and what it is used for
The name of this medicine is ZANAFLEX. The active ingredient is tizanidine hydrochloride which belongs to a group of medicines called muscle relaxants.
ZANAFLEX 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 use ZANAFLEX
Do not take ZANAFLEX:
• if you are allergic to tizanidine hydrochloride or any of the other ingredients in ZANAFLEX.
• if you have liver problems.
• if you are taking a medicine called fluvoxamine or ciprofloxacin.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZANAFLEX:
• if you have kidney problems
Children and the Elderly
ZANAFLEX is not suitable for children or the elderly.
Other medicines and ZANAFLEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
This is especially important if you are taking any of the following:
• The oral contraceptive pill
• Antibiotics called norfloxacin, enoxacin or rifampicin.
• Ticlopine to thin the blood.
• Cimetidine for stomach ulcers.
• Medicines which may make you drowsy e.g. sedatives (such as diazepam or temazepam), baclofen or antihistamines.
• Medicines for high blood pressure (e.g. water tablets, beta-blockers or clonidine).
• Medicines for abnormal heart rhythms e.g. digoxin, amiodarone, mexiletine or propafenone.
• Medicines that could affect the electrical rhythm of your heart (QT prolongation, for example amitriptyline and azithromycin).
Taking ZANAFLEX if you are a smoker
You should also tell your doctor if you are a smoker as this may mean you require a higher dose of ZANAFLEX for it to work properly.
ZANAFLEX with drink
Alcohol may increase the chance of you feeling drowsy or experiencing side effects while taking ZANAFLEX. You should not drink alcohol with ZANAFLEX, consult your doctor before taking alcohol with ZANAFLEX.
Pregnancy and breast-feeding
ZANAFLEX 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 before taking this medicine.
Driving and using machines
ZANAFLEX can sometimes cause blurred vision, drowsiness or dizziness in some people. If you are affected you should not drive or operate machinery.
ZANAFLEX contains Lactose
ZANAFLEX contains Lactose which is a type of sugar. If you have been told you have an intolerance to some sugars contact your doctor before taking this medicine.
3. How to use ZANAFLEX
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 does will depend on your response to the tablets. The total dose should not exceed 36 mg.
In 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 ZANAFLEX than you should
If you take too much ZANAFLEX 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 ZANAFLEX
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 one.
If you stop taking ZANAFLEX:
The following side effects have been observed when patients stop taking ZANAFLEX suddenly after a long period of time, especially in patients on a high dose of ZANAFLEX or patients who take ZANAFLEX 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 ZANAFLEX.
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 everyone gets them.
Serious side effects
Stop taking Zanaflex and tell your doctor immediately if you experience:
• any signs of liver damage, such as dark urine or yellowing of the eyes or skin
• signs of an allergic reaction, such as swelling of the face, lips or tongue, sudden wheezing (which can cause great difficulty in breathing); itching or nettle rash.
Other side effects
Very common: may affect more than 1 in 10 people
• Drowsiness, feeling tired, weak muscles
• Dry mouth, stomach problems
• Dizziness
Common: may affect up to 1 in 10 people
• Difficulty in sleeping or problems whilst sleeping
• Low blood pressure
• Feeling sick
• Abnormal liver tests (this may be found on a blood test)
Uncommon: may affect up to 1 in 100 people
• Slower heart rate
• Stomach pain
• Vomiting
• Itching
• Blurred speech
Not known: frequency cannot be estimated from the available data
• Hallucinations
• Feeling confused
• Vertigo (a feeling of dizziness or spinning)
• Loss of consciousness
• Inflammation of the liver
• a feeling of weakness
• Blurred vision.
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 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 ZANAFLEX
Keep out of the sight and reach of children.
Keep the tablets in the pack.
Do not use this medicine after the expiry date which is stated on the pack.
There are no special precautions for storage
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 to protect the environment.
6. Contents of the pack and other information
What ZANAFLEX contains
Each ZANAFLEX 2 mg tablet contains 2 mg of tizanidine (as hydrochloride) as the active ingredient.
Each ZANAFLEX 4 mg tablet contains 4 mg of tizanidine (as hydrochloride) as the active ingredient.
It also contains colloidal anhydrous silica, stearic acid, microcrystalline cellulose and lactose anhydrous as the inactive ingredients.
What ZANAFLEX looks like and contents of the pack
ZANALFEX is supplied as white, round tablets marked with “A”and “592” (for the 2 mg tablets) or “A” and “594”
(for the 4 mg tablets).
The tablets come in blister strips of 20 tablets and each packet contains 6 blister strips to give a packet size of 120 tablets.
Marketing Authorisation Holder
Cephalon UK Limited,
Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX, UK
Manufacturer
Almac Pharma Services Seagoe Industrial Estate, Craigavon,
M Cephalon
County Armagh, BT63 5UA, UK This leaflet was last revised in 05/2016
ZANAFLEX is a registered trademark of Cephalon, Inc., or its affiliates.
H44518
75019-C
REG0076071 Version 1.10 Approved Page 2 of 2