TIZANOR 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tizanor, 2 mg, tablets
3. Tizanor, 4 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Tizanor and what is it used for
   1. What is Tizanor
   2. What is Tizanor used for
   3. Tizanor is used for:
5. Important information before taking Tizanor
   1. When not to take Tizanor:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tizanor and other medicines
   5. Smoking and Tizanor
   6. Tizanor and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Tizanor contains lactose
6. How to take Tizanor
   1. What dose of Tizanor to take
   2. Relieving painful muscle spasms
   3. Increased muscle tone in neurological diseases
   4. Taking a higher dose of Tizanor than recommended
   5. Missing a dose of Tizanor
   6. Stopping treatment with Tizanor
7. Possible side effects
   1. Some side effects can be serious:
   2. Other side effects include:
   3. Reporting side effects
8. How to store Tizanor
9. Contents of the pack and other information
   1. What Tizanor contains
   2. What Tizanor looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Tizanor, 2 mg, tablets

Tizanor, 4 mg, tablets

Tizanidine

Read the package 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 or pharmacist.
• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Tizanor and what is it used for

What is Tizanor

The active substance of the medicine, tizanidine, causes a decrease in increased muscle tone.

What is Tizanor used for

Tizanor is a centrally acting muscle relaxant. Tizanor mainly acts on the spinal cord and reduces excessive muscle tone.

Tizanor is used for:

• Treating painful muscle spasms associated with: spinal diseases, e.g. lower back pain, cervical spine pain, surgical procedures, e.g. removal of a herniated disc or hip joint inflammation.
• Treating increased muscle tone in neurological diseases, such as multiple sclerosis, chronic spinal cord diseases, degenerative spinal cord diseases, stroke, and cerebral palsy * * In adults who have previously been diagnosed with cerebral palsy.

2. Important information before taking Tizanor

When not to take Tizanor:

• if you are allergic to tizanidine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver function disorders, resulting in persistent, three-fold increased liver enzyme activity above the upper limit of normal,
• if you are taking a medicine called fluvoxamine (a medicine used to treat depression),
• if you are taking a medicine called ciprofloxacin (an antibiotic used to treat infections).

If any of these points apply to you, do not take Tizanor. Before starting to take Tizanor, discuss this with your doctor or pharmacist.

Warnings and precautions

Before starting to take Tizanor, discuss this with your doctor or pharmacist, especially:

• if you have kidney function disorders;
• if you have liver function disorders. You should inform your doctor about the occurrence of liver function disorder symptoms, such as unexplained nausea, loss of appetite (anorexia), fatigue. Your doctor may recommend performing tests to check liver function, on the basis of which they will decide on the continuation or discontinuation of treatment. If you are taking doses of the medicine of 12 mg per day or more, your doctor should monitor liver function;
• if you are elderly;
• if you have low blood pressure (hypotension), including cases of loss of consciousness and vascular collapse. These symptoms may occur as a result of treatment with Tizanor;
• do not stop taking the medicine unless your doctor advises you to do so (see also section 3. "How to take Tizanor").

Children and adolescents

This medicine is not recommended for children and adolescents.

Tizanor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take. This is especially important if you are taking any of the following medicines:

• medicines used to treat high blood pressure (e.g. diuretics, clonidine)
• medicines used to treat depression (such as fluvoxamine)
• medicines that facilitate sleep or have a strong analgesic effect
• medicines used to treat irregular heartbeat (e.g. amiodarone, mexiletine or propafenone) or other medicines that have an adverse effect on heart function, called "QT interval prolongation" (e.g. cisapride, amitriptyline, azithromycin)
• cimetidine, a medicine used to treat stomach and (or) duodenal ulcers
• fluoroquinolones (e.g. ciprofloxacin, enoxacin, pefloxacin, norfloxacin) and rifampicin (antibiotics used to treat infections)
• rofecoxib (a medicine used to reduce pain and inflammation)
• oral contraceptives
• ticlopidine (a medicine used to reduce the risk of stroke)
• antihistamines (used to treat allergies).

Smoking and Tizanor

If you smoke more than 10 cigarettes a day, you should inform your doctor, as it may be necessary to use a higher dose of Tizanor to achieve the desired effect.

Tizanor and alcohol

Alcohol may enhance the sedative effect of Tizanor. Therefore, you should avoid consuming alcohol while taking Tizanor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Tizanor may harm your unborn baby.
Do not take Tizanor during pregnancy and breastfeeding.
In sexually active women of childbearing potential, a pregnancy test should be performed before starting treatment with Tizanor. You should use effective contraception during treatment and for at least one day after stopping Tizanor. You should discuss with your doctor the choice of a contraceptive method suitable for you at this time.

Driving and using machines

If you experience drowsiness, dizziness or symptoms of hypotension (e.g. cold sweats, "feeling of emptiness in the head") while taking Tizanor, do not drive or operate machinery.

Tizanor contains lactose

This medicine contains 47.2 mg of lactose in one tablet (2 mg tablets) and 94.4 mg of lactose in one tablet (4 mg tablets). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Tizanor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not change the prescribed dose or stop taking the medicine unless your doctor advises you to do so.

What dose of Tizanor to take

Relieving painful muscle spasms

Tizanor in tablet form is usually taken in a dose of 2 mg to 4 mg, three times a day. In severe cases, an additional dose of 2 mg or 4 mg can be taken before bedtime to minimize the sedative effect.

Increased muscle tone in neurological diseases

Your doctor will adjust the dose individually for you.
The initial dose should not be more than 6 mg/day, and the daily dose should be taken in three divided doses. The daily dose can be gradually increased by 2 mg to 4 mg at weekly or bi-weekly intervals.
The optimal response is usually achieved with a daily dose of 12 mg to 24 mg, given in 3 or 4 equal doses. The maximum daily dose is 36 mg.
In patients with kidney disease, the dose may be increased more slowly, and blood tests may be necessary to monitor kidney function.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Tizanor than recommended

If you have taken more than the recommended dose of tizanidine, you should contact your doctor or go to the emergency department of the nearest hospital. You should take the package and this leaflet with you, so that the doctor knows what medicine you have taken.

Missing a dose of Tizanor

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping treatment with Tizanor

Do not stop taking Tizanor unless your doctor advises you to do so. Your doctor may recommend gradually reducing the dose before deciding to completely stop the medicine, which will reduce the risk of withdrawal symptoms. Withdrawal symptoms include high blood pressure (increased blood pressure, headache, and dizziness) or tachycardia (rapid heart rate).
If you have any further questions about 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 everybody gets them.
After taking lower doses, recommended for relieving painful muscle spasms, the following side effects have been reported: drowsiness, fatigue, dizziness, dry mouth, decreased blood pressure, nausea, gastrointestinal disorders, increased liver enzyme activity. They were usually mild and transient.
After taking higher doses, recommended for treating increased muscle tone, the side effects that occurred with low doses were more frequent and more severe. However, they rarely had a severe course, requiring discontinuation of the medicine. Additionally, the following side effects may occur: QT interval prolongation and torsade de pointes, hypotension, bradycardia, muscle weakness, insomnia, sleep disorders, hallucinations, and acute hepatitis.
If you experience any of the above symptoms or any other side effects, you should inform your doctor.

Some side effects can be serious:

• Hepatitis, liver failure (symptoms of liver damage, e.g. dark urine or yellowing of the eyes or skin)
• Hallucinations, confusion
• Severe allergic reactions, including difficulty breathing, dizziness (anaphylaxis) and swelling, mainly of the face and throat (angioedema), hives. If you experience any of these side effects, you should contact your doctor immediately.

Other side effects include:

Other side effects are listed below. If any of the side effects get worse, you should tell your doctor.
Very common ( may affect more than 1 in 10 people):

• Drowsiness, fatigue, dizziness, gastrointestinal disorders, dry mouth, muscle weakness.

Common ( may affect up to 1 in 10 people):

• Difficulty sleeping, sleep disorders, low blood pressure, nausea
• Increased liver enzyme activity.

Uncommon ( may affect up to 1 in 100 people):

• Slow heart rate.

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

• Fainting, blurred vision, rash, skin redness (erythema), skin inflammation, weakness, withdrawal symptoms after sudden discontinuation of treatment (such as high blood pressure and rapid heart rate - so-called tachycardia), abdominal pain, vomiting, itching, speech disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the competent authority or to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tizanor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Do not store above 30°C.
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 Tizanor contains

• The active substance of the medicine is tizanidine. Each tablet contains 2 mg or 4 mg of tizanidine (in the form of tizanidine hydrochloride).
• The other ingredients of the medicine are: lactose, microcrystalline cellulose, anhydrous colloidal silica, and stearic acid.

What Tizanor looks like and contents of the pack

Tizanor 2 mg tablets are oval, flat with beveled edges, white to almost white, with the symbol "R179" embossed on one side and a score line on the other side.
Tizanor 4 mg tablets are oval, flat with beveled edges, white to almost white, with the symbol "R180" embossed on one side and a score line on the other side.
The score line on the tablet is only to facilitate breaking the tablet, and not to divide it into equal doses. Tizanor 2 mg and Tizanor 4 mg are packaged in cartons.
Package sizes: 30, 100 tablets.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1,
FI-02200 Espoo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:13.03.2023