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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 packaging 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 surgery on the musculoskeletal system (e.g., spine or hip joint).
Tizagelan may also be prescribed to treat muscle spasms that occur 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 the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• in case of severe liver dysfunction.
• when taking certain medicines such as fluvoxamine (used in depression) or ciprofloxacin (an antibiotic) (see also section "Tizagelan and other medicines").

Warnings and precautions

Before starting treatment with Tizagelan, the patient should discuss it with their doctor or pharmacist:

• if the patient has severe kidney disease. The patient may need a lower dose.
• if the patient has heart disease, such as coronary artery disease.
• if the patient has liver disease. The doctor may regularly check liver enzymes, especially after taking high doses. The patient should stop taking Tizagelan if their skin or eyes turn yellow (jaundice) or if they experience unexplained nausea, loss of appetite, or fatigue, and immediately consult their doctor.
• if the patient has kidney disease.

Children and adolescents

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

Tizagelan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tizagelan should not be taken at the same time as fluvoxamine (a medicine used to treat depression) or ciprofloxacin (an antibiotic) (see "When not to take Tizagelan").
The patient should inform their doctor or pharmacist, especially if they 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. The patient may react to a lower dose of tizanidine if they are taking oral contraceptives.
• ticlopidine (a medicine that prevents blood clots from forming).
• any medicines used to treat high blood pressure, including diuretics.
• Beta-adrenergic blockers, including atenolol, propranolol.
• digoxin (a medicine used to treat heart failure and irregular heartbeat).
• any sedatives (sleeping pills or anti-anxiety medicines).
• any other medicines that may affect heart rhythm when taken with tizanidine. The patient should consult their doctor or pharmacist.

Tizagelan with food, drink, and alcohol

Tizagelan can be taken with or without food.
The patient should 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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. The doctor will decide whether to take Tizagelan.

Driving and using machines

Tizagelan may cause drowsiness and dizziness. This may affect the patient's ability to drive or operate machinery. The patient should not drive or operate machinery until they know how this medicine affects them.

Tizagelan contains sucrose and lactose

If the doctor has previously determined that the patient has an intolerance to some sugars, the patient should consult their doctor before taking this medicine.

3. How to take Tizagelan

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their 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 that occur as a result of nervous system disorders

The usual initial dose for adults is 2 mg three times a day.
The dose can then 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)

There is limited evidence of the use of Tizagelan in elderly patients. Additionally, 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.
The tablets should be swallowed with a glass of water.
Tizagelan can be taken with or without food.
If the patient feels that Tizagelan is too strong or too weak, they should consult their doctor or pharmacist.
The tablet can be divided into equal doses.

Taking a higher dose of Tizagelan than recommended

If the patient (or someone else) has taken too many tablets or thinks that a child has swallowed any of the tablets, they should immediately contact the emergency department of the nearest hospital or their doctor.
Overdose may cause nausea, vomiting, low blood pressure, slow or irregular heartbeat, dizziness, blurred vision, difficulty breathing, drowsiness, restlessness, or sleepiness.

Missing a dose of Tizagelan

If the patient forgets to take one or more tablets, they should remember to take only the prescribed number of tablets at the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Tizagelan

The patient should not stop taking Tizagelan unless their doctor advises them to do so. Treatment with Tizagelan should be stopped gradually, especially if the patient has been taking a high dose, unless the doctor advises otherwise. Stopping treatment suddenly may cause effects such as increased heart rate and high blood pressure.
In case of any further doubts related to the use of this medicine, the patient should consult their 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 are 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, drowsiness, 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, 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 side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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 helps to gather more information on the safety of the medicine.

5. How to store Tizagelan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
There are no special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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:

What Tizagelan looks like and contents of the pack

Tizagelan, 2 mg, tablets
The tablets are white to yellowish in color, 8 mm in diameter, round, biconvex, with a dividing line on one side.
Tizagelan, 4 mg, tablets
The tablets are white to yellowish in color, 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: