Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Sirdalud, 4 mg, tablets
Tizanidinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents:

What Sirdalud is and what it is used for
Important information before taking Sirdalud
How to take Sirdalud
Possible side effects
How to store Sirdalud
Contents of the pack and other information

1. What Sirdalud is and what it is used for

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

treatment of painful muscle spasms
- associated with spinal disorders, e.g. lower back pain, neck spasm
- following surgery, e.g. herniated intervertebral disc or hip joint inflammation
treatment of increased muscle tone in neurological diseases, e.g. multiple sclerosis, chronic spinal cord disorders, degenerative spinal cord diseases, after stroke, and in cerebral palsy*.
* in adults previously diagnosed with cerebral palsy in childhood.

2. Important information before using Sirdalud

Strictly follow your doctor's instructions.
When not to use Sirdalud:

if the patient is allergic (hypersensitive) to Sirdalud (tizanidine) or to any of the other ingredients of the medicine (listed in section 6),
if the patient has significant liver function disorders or persistent threefold increase in aminotransferase activity above the upper limit of normal,
if the patient is taking medicines containing fluvoxamine (a medicine used to treat depression),
if the patient is taking medicines containing ciprofloxacin (an antibiotic used to treat infections).

If any of these points apply to the patient, Sirdalud must not be taken, and
the patient should inform their doctor.
Warnings and precautions
Before starting treatment with Sirdalud, discuss this with your doctor or pharmacist,
especially:

in case of kidney function disorders,
in case of liver function disorders. Inform your doctor if symptoms of liver dysfunction occur, such as unexplained nausea, loss of appetite (anorexia), or fatigue. Your doctor may recommend liver function tests to decide whether treatment should continue or be discontinued. If the patient is taking doses of Sirdalud of 12 mg per day or higher, the doctor should monitor liver function,
in elderly patients,
if symptoms of hypotension (low blood pressure) occur, including loss of consciousness and vascular collapse. These symptoms may occur as a result of treatment with Sirdalud,
do not stop taking the medicine without consulting your doctor (see also section 3. How to use Sirdalud).

If any of these points apply to the patient, inform your doctor.
Children and adolescents
Sirdalud is not recommended for use in children.
Sirdalud and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform your doctor if the patient is taking any of the following
medicines:

medicines that lower blood pressure and diuretics,
medicines used to treat depression (fluvoxamine),
medicines that cause drowsiness or have strong analgesic effects,
antiarrhythmics (medicines used to treat irregular heartbeat, including amiodarone, mexiletine, propafenone) or other medicines that adversely affect a heart function known as "QT interval prolongation",
cimetidine (a medicine used for peptic ulcer disease of the stomach and/or duodenum),
fluoroquinolones (e.g. ciprofloxacin) 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),
if the patient smokes cigarettes (more than 10 cigarettes per day).

Sirdalud and alcohol
Alcohol may enhance the sedative effect of the medicine; therefore, alcohol consumption should be avoided
during treatment with Sirdalud.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if there is suspicion that a woman is pregnant, or when
planning pregnancy, consult your doctor before using Sirdalud. Sirdalud may
have harmful effects on the unborn child.
Sirdalud must not be used during pregnancy.
Sirdalud must not be used during breastfeeding.
In sexually active women capable of becoming pregnant, a pregnancy test is recommended
before starting treatment with Sirdalud, and effective contraception should be used during
treatment and for at least one day after stopping Sirdalud.
Discuss with your doctor the choice of an appropriate contraceptive method for the patient during
this period.
Driving and operating machinery
If drowsiness, dizziness, or other symptoms of hypotension (e.g. cold sweats, "feeling of emptiness in the head") occur during treatment with Sirdalud, the patient should not
drive or operate machinery.
Sirdalud contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), the patient
should contact their doctor before taking this medicine.

3. How to use Sirdalud

The following is the standard dosage regimen for Sirdalud. This medicine should always be used
according to the doctor's instructions. If in doubt, consult a doctor or pharmacist. Do not
change the prescribed dose or stop taking the medicine without consulting your doctor.
Sirdalud tablets can be taken independently of meals.
What dose of Sirdalud should be used
Relief of painful muscle spasms
Sirdalud tablets are recommended in a dose of 2 mg to 4 mg, three times daily. In severe cases, an additional dose of 2 mg or 4 mg may be taken before bedtime to minimize sedative effects.
Increased muscle tension in neurological diseases
The doctor will adjust the dose individually for each patient.
Initially, no more than 6 mg/day should be administered, with the daily dose divided into three separate 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, given in 3 or 4 equal doses. A daily dose exceeding 36 mg should not be used.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Sirdalud than recommended
If you take more Sirdalud than recommended, contact your doctor or the nearest toxicology information centre immediately, or go to the nearest hospital emergency department.
Missed dose of Sirdalud
If you miss a dose of Sirdalud, take it as soon as possible. However, if less than 2 hours remain before the next scheduled dose, do not take the missed dose; instead, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Sirdalud
Do not stop using Sirdalud without first consulting your doctor. Your doctor may recommend gradually reducing the dose before completely discontinuing the medicine, thereby reducing the risk of withdrawal symptoms. Withdrawal symptoms may include arterial hypertension (increased blood pressure, headache, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After administration of lower doses, recommended, among others, to relieve painful muscle spasms, adverse reactions such as drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased arterial blood pressure, nausea, gastrointestinal disturbances, and increased aminotransferase activity were usually mild and transient.
After administration of higher doses, recommended for the treatment of increased muscle tension, the adverse reactions observed following lower doses occurred more frequently and were more pronounced. However, they rarely became so severe as to necessitate discontinuation of the medicine. In addition, the following adverse reactions 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 symptoms or any other adverse reactions occur, inform your doctor.
Some adverse reactions may be serious:

hepatitis, liver failure, hallucinations, confusion, severe allergic reactions including breathing difficulties, dizziness (anaphylaxis), and swelling, mainly of the face and throat (angioedema). If any of the above serious adverse reactions worsen, inform your doctor immediately.

Other possible adverse reactions
Other adverse reactions include those listed below. If any of the following adverse reactions worsen, inform your doctor, pharmacist, or nurse.
Adverse reactions occurring:
very commonly (may affect more than 1 in 10 people):

drowsiness, fatigue, dizziness, gastrointestinal disturbances, dryness of the oral mucosa, muscle weakness

commonly (may affect less than 1 in 10 people):

insomnia, sleep disturbances, decreased arterial blood pressure (including marked decrease), nausea, increased aminotransferase activity

uncommonly (may affect less than 1 in 100 people):

bradycardia (reduced heart rate)

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

fainting, blurred vision, rash, skin redness (flushing), skin inflammation, asthenia, withdrawal symptoms (such as hypertension and increased heart rate - so-called tachycardia), abdominal pain, vomiting, itching, speech disorders, allergic reactions, loss of energy.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sirdalud

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use Sirdalud after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Sirdalud contains

The active substance is tizanidine (in the form of tizanidine hydrochloride).
The other ingredients are: anhydrous colloidal silicon dioxide, stearic acid, microcrystalline cellulose, lactose.

What Sirdalud looks like and contents of the pack
1 tablet (with a cross-shaped groove) contains 4 mg of tizanidine (as tizanidine hydrochloride 4.576 mg).
PVC/PE/PVDC//Al blisters in cardboard packaging contain 10 or 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, country of export:
Sandoz Hungária Kft.
Bartók Béla út 43-47., 1114 Budapest
Hungary
Manufacturer:
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmaceutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Hungary, country of export: OGYI-T-5903/04
Parallel import authorisation number: 9/26
[Trademark notice]