Tizanor

Package leaflet: Information for the patient

Tizanor, 2 mg, tablets
Tizanor, 4 mg, tablets
Tizanidinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tizanor is and what it is 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 Tizanor is and what it is used for

What Tizanor is
The active substance in Tizanor, tizanidine, reduces increased muscle tone.
What Tizanor is used for
Tizanor is a centrally-acting skeletal muscle relaxant. Tizanor acts primarily on the spinal cord and reduces excessive muscle tension.
Tizanor is used for:

• Treatment of painful muscle spasms associated with:
  o Spinal disorders, e.g. lower back pain, neck spasm
  o Surgical procedures, e.g. removal of a herniated nucleus pulposus or hip joint inflammation.
• Treatment of increased muscle tone in neurological disorders such as multiple sclerosis, chronic spinal cord diseases, degenerative spinal cord disorders, stroke, and cerebral palsy*
  * In adults previously diagnosed with childhood cerebral palsy.

2. Important information before using Tizanor

When not to use Tizanor:

• if the patient is allergic to tizanidine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver dysfunction causing persistent, threefold increase in aminotransferase activity above the upper limit of normal,
• if the patient is taking a medicine called fluvoxamine (a medicine used to treat depression),
• if the patient is taking a medicine called ciprofloxacin (an antibiotic used to treat infection).

If any of these apply to the patient, Tizanor must not be taken. Before starting treatment with Tizanor, discuss this with the doctor or pharmacist.

Warnings and precautions

Before starting treatment with Tizanor, discuss this with the doctor or pharmacist, especially:

• if the patient has kidney problems;
• if the patient has liver problems. Inform the doctor about symptoms of liver dysfunction such as unexplained nausea, loss of appetite (anorexia), fatigue. The doctor may recommend liver function tests to decide whether treatment should continue or be stopped. If the patient is taking doses of Tizanor of 12 mg per day or higher, the doctor should monitor liver function;
• if the patient is elderly;
• if the patient has low blood pressure (hypotension), including episodes of fainting and vasodilatory collapse. These symptoms may occur as a result of treatment with Tizanor;
• do not stop taking the medicine unless instructed by the doctor (see also section 3. "How to use Tizanor").

Children and adolescents

This medicine is not recommended for use in children and adolescents.

Tizanor with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is especially important if the patient is 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 cause drowsiness or strong pain relief,
• medicines used to treat irregular heartbeat (e.g. amiodarone, mexiletine or propafenone) or other medicines that have an adverse effect on a heart function known as "QT interval prolongation" (e.g. cisapride, amitriptyline, azithromycin),
• cimetidine, a medicine used for peptic ulcer disease of the stomach and/or duodenum,
• 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 the patient smokes cigarettes (more than 10 cigarettes per day), they should inform the doctor, as a higher dose of Tizanor may be required to achieve the desired effect.

Tizanor and alcohol

Alcohol may enhance the sedative effect of Tizanor. Therefore, alcohol consumption should be avoided during treatment with Tizanor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult the doctor or pharmacist before using this medicine. Tizanor may have harmful effects on the unborn child.

Tizanor must not be used during pregnancy or breastfeeding.

In sexually active women capable of becoming pregnant, a pregnancy test should be performed before starting treatment with Tizanor. Effective contraception should be used during treatment and for at least one day after stopping Tizanor. Discuss with the doctor the most appropriate method of contraception for the patient during this time.

Driving and operating machinery

If drowsiness, dizziness, or symptoms of hypotension (e.g. cold sweats, "empty-headed" feeling) occur during treatment with Tizanor, the patient should 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 the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Tizanor

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. Do not change the recommended dose or stop taking
the medicine unless instructed by a doctor. Tizanor tablets may be taken
independently of meals.
What dose of Tizanor should be used
Relief of painful muscle spasms
Tizanor tablets are 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 may be taken before bedtime, in order to
minimize sedative effects.
Increased muscle tension in neurological diseases
The doctor will adjust the dose individually for each patient.
The initial dose should not exceed 6 mg per day, and the daily dose should be taken
in three divided doses. The daily dose may be gradually increased by 2 mg to 4 mg
at intervals of one to two weeks. The optimal patient response is usually achieved with a
daily dose of 12 mg to 24 mg, administered in 3 or 4 equal doses.
The maximum daily dose is 36 mg.
In patients with kidney disease, the dose may need to be increased more slowly, and blood tests may be necessary
to monitor kidney function.
If the effect of the medicine seems too strong or too weak, consult a doctor or
pharmacist.
Taking more Tizanor than recommended
If an overdose of tizanidine is taken, contact a doctor or go to the emergency department of the nearest hospital immediately.
Bring the medicine package and this leaflet so the doctor knows which medicine has been taken.
Missed dose of Tizanor
If a dose is missed, take it as soon as possible. Do not take a double
dose to make up for a missed dose.
Stopping Tizanor
Do not stop taking Tizanor unless instructed by a doctor. The doctor may recommend gradually
reducing the dose before completely discontinuing the medicine, which reduces
the risk of withdrawal symptoms. Withdrawal symptoms may include hypertension
(increased blood pressure, headache, and dizziness) or tachycardia
(increased heart rate).
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
After administration of lower doses recommended to relieve painful muscle spasms, the following adverse effects have been reported: drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased arterial blood pressure, nausea, gastrointestinal disturbances, and increased aminotransferase activity. These were usually mild and transient.

When higher doses are administered, recommended for the treatment of increased muscle tension, the adverse effects observed after lower doses occurred more frequently and were more pronounced. However, they rarely were severe enough to require discontinuation of the medicine. Additionally, the following adverse effects may occur: QT interval prolongation and torsade de pointes, hypotension, bradycardia, muscle weakness, insomnia, sleep disturbances, hallucinations, and acute hepatitis.

If any of the above-mentioned symptoms or any other adverse effects occur, inform your doctor immediately.
Some adverse effects may be serious:

• Hepatitis, liver failure (symptoms of liver damage, such as 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), urticaria. If any of these adverse effects occur, contact your doctor immediately.

Other adverse effects include:
Other adverse effects are listed below. If any of these adverse effects worsen, inform your doctor.
Very common (may affect more than 1 in 10 patients):

• Drowsiness, fatigue, dizziness, gastrointestinal disturbances, dryness of the oral mucosa, muscle weakness.

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

• Difficulty falling asleep, sleep disturbances, low blood pressure, nausea, increased aminotransferase activity.

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

• Slowing of heart rate.

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

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Marketing Authorisation Holder or to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Tizanor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the pack and other information

What Tizanor contains

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

What Tizanor looks like and contents of the pack
Tizanor 2 mg tablets are oval-shaped, flat with bevelled edges, white to almost white in colour,
with the symbol “R179” embossed on one side and a score line on the other side.
Tizanor 4 mg tablets are oval-shaped, flat with bevelled edges, white to almost white in colour,
with the symbol “R180” embossed on one side and a quadriscore line on the other side.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not ensure equal dose division.
Tizanor 2 mg and Tizanor 4 mg are packed in cardboard boxes.
Pack sizes: 30, 100 tablets.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]