Tizagelan

Leaflet included in the packaging: patient information

Tizagelan, 2 mg, tablets

Tizagelan, 4 mg, tablets

Tizanidine
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tizagelan and what is it used for
• 2. Important information before taking Tizagelan
• 3. How to take Tizagelan
• 4. Possible side effects
• 5. How to store Tizagelan
• 6. Contents of the pack and other information

1. What is Tizagelan and what is it used for

Tizagelan belongs to a group of muscle relaxants.
Tizagelan may be prescribed by a doctor to treat muscle spasms caused by certain spinal cord disorders or as a result of musculoskeletal system surgery (e.g., spine or hip joint).
Tizagelan may also be prescribed to treat muscle spasms occurring as a result of nervous system disorders, such as multiple sclerosis and after a stroke.

2. Important information before taking Tizagelan

When not to take Tizagelan:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• in case of severe liver dysfunction.
• in case of concomitant use of such medicines as fluvoxamine (used in depression) or ciprofloxacin (antibiotic) (see also section "Tizagelan and other medicines").

Warnings and precautions

Before starting treatment with Tizagelan, you should discuss it with your doctor or pharmacist:

• if you have severe kidney disease. You may need a lower dose.
• if you have heart diseases, such as coronary artery disease.
• if you have liver diseases. Your doctor may regularly check your liver enzymes, especially after taking high doses. You should stop taking Tizagelan if your skin or eye whites turn yellow ("jaundice") or if you experience unexplained nausea, loss of appetite, or fatigue, and immediately consult your doctor.
• if you have kidney diseases.

Children and adolescents

Tizagelan is not recommended for use in children and adolescents under 18 years of age, as the evidence for tizanidine in this patient group is limited.

Tizagelan and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Do not take Tizagelan with fluvoxamine (a medicine used to treat depression) or ciprofloxacin (an antibiotic) (see "When not to take Tizagelan").
Tell your doctor or pharmacist, especially if you are taking:

• any medicine used to treat irregular heartbeat, such as amiodarone, mexiletine, propafenone, or verapamil.
• cimetidine or famotidine (for indigestion and stomach ulcers).
• certain antibiotics, such as rifampicin or so-called "fluoroquinolones" (such as enoxacin, pefloxacin, norfloxacin).
• rofecoxib, a pain reliever.
• acyclovir, an antiviral medicine.
• oral contraceptives. You may react to a lower dose of tizanidine if you are taking oral contraceptives.
• ticlopidine (a medicine that prevents blood clots).
• any medicines used to treat high blood pressure, including diuretics.
• Beta-adrenergic blockers, including atenolol, propranolol.
• digoxin (a medicine used to treat congestive heart failure and heart rhythm disorders).
• any sedatives (sleeping pills or antihistamines).
• any other medicines that may affect heart rhythm when taken with tizanidine. Consult your doctor or pharmacist.

Tizagelan with food, drink, and alcohol

Tizagelan can be taken with or without food.
Do not take Tizagelan with alcohol, as it may increase the sedative effect of tizanidine.

Tizagelan and smoking

Smoking may reduce the effect of tizanidine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Tizagelan is not recommended during pregnancy or breastfeeding, as its effect on pregnancy, the unborn child, or the infant is not known. Your doctor will decide whether you should take Tizagelan.

Driving and using machines

Tizagelan may cause drowsiness and dizziness. This may affect your ability to drive or operate machinery. Do not drive or operate machinery until you know how this medicine affects you.

Tizagelan contains sucrose and lactose

If your doctor has previously determined that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Tizagelan

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.

Muscle spasms caused by certain spinal cord disorders or as a result of musculoskeletal system surgery

The recommended dose for adults is 2-4 mg three times a day.
In severe cases, an additional dose of 2-4 mg may be required. The last dose should be taken late at night.

Muscle spasms occurring as a result of nervous system disorders

The usual initial dose for adults is 2 mg three times a day.
Then the dose can be gradually increased to 12-24 mg, divided into 3-4 equal doses per day.
The maximum daily dose is 36 mg.

Use in children and adolescents under 18 years of age

Tizagelan should not be given to children, as its use in children is not well studied.

Elderly patients (65 years and older)

Experience with Tizagelan in elderly patients is limited. Moreover, in elderly patients, kidney function may be impaired. Therefore, in this patient group, Tizagelan should be used with special caution.

How to take Tizagelan

Tizagelan is intended for oral use.
Swallow the tablets with a glass of water.
Tizagelan can be taken with or without food.
If you feel that Tizagelan is too strong or too weak, consult your doctor or pharmacist.
The tablet can be divided into equal doses.

Taking a higher dose of Tizagelan than recommended

If you (or someone else) have taken too many tablets or think that a child has swallowed any of the tablets, contact the emergency department of the nearest hospital or your doctor immediately.
Overdose may cause nausea, vomiting, low blood pressure, slow or irregular heartbeat, dizziness, narrowed pupils, difficulty breathing, sleepiness, restlessness, or drowsiness.

Missing a dose of Tizagelan

If you miss a dose, remember to take only the prescribed number of tablets at the next dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Tizagelan

Do not stop taking Tizagelan unless your doctor tells you to. Treatment with Tizagelan should be stopped gradually, especially if you have been taking a high dose, unless your doctor tells you otherwise. Stopping treatment abruptly may cause effects such as increased heart rate and high blood pressure.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tizagelan can cause side effects, although not everybody gets them.
At low doses, such as those recommended for the relief of painful muscle spasms, side effects are usually mild and temporary.
At high doses recommended for the treatment of spasticity, side effects occur more frequently and are more pronounced, but rarely so severe that treatment needs to be stopped.
The following side effects have been reported:

Very common(may affect more than 1 in 10 people)

• Difficulty sleeping or falling asleep
• Dry mouth, gastrointestinal disturbances
• Muscle weakness

Common(may affect up to 1 in 10 people)

• Drowsiness, lethargy, dizziness, fatigue
• Slow or fast heartbeat
• Low or decreased blood pressure
• Nausea

Uncommon(may affect up to 1 in 100 people)

• Increased activity of liver enzymes in the blood

Frequency not known(cannot be estimated from the available data)

• Infections, stuffy nose or cold, throat infection
• Allergic reactions:
• Hives
• Severe, life-threatening allergic reaction requiring immediate treatment. The reaction may include very low blood pressure, swelling of the throat, difficulty breathing, and loss of consciousness.
• Confusion, nervousness, hallucinations (seeing and/or hearing things that are not real)
• Headache
• Difficulty controlling movements, involuntary muscle movements, difficulty speaking
• Fainting
• Feeling of "spinning" (dizziness)
• Difficulty with vision clarity, blurred vision
• Abnormal heart rhythm
• Vomiting, abdominal pain, constipation
• Liver infection or failure
• Itching, rash, skin infection
• Urinary tract infection
• Unusually frequent urination of relatively small amounts of urine
• Loss of appetite
• Feeling of weakness, withdrawal syndrome, flu-like illness.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tizagelan

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 and blister after EXP.
The expiry date refers to the last day of that month.
There are no special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tizagelan contains

• The active substance is tizanidine. Each tablet contains 2 mg of tizanidine (in the form of 2.29 mg of tizanidine hydrochloride) or 4 mg of tizanidine (in the form of 4.57 mg of tizanidine hydrochloride).
• The other ingredients are:
• Lactose monohydrate, maize starch, macrogol 4000, stearic acid, sucrose, magnesium stearate.

What Tizagelan looks like and contents of the pack

Tizagelan, 2 mg, tablets
The tablets are white to yellowish, 8 mm in diameter, round, biconvex, with a dividing line on one side.
Tizagelan, 4 mg, tablets
The tablets are white to yellowish, 8 mm in diameter, round, biconvex, with a cross-shaped dividing line on one side.
Opaque PVC/PVDC/PVC/Aluminum blisters containing 10, 30, 60, 90, 100, or 120 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more information and information on the names of the medicinal product in other EEA countries, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: