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 the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those 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 in the form of tizanidine hydrochloride, which reduces increased muscle tone.
Why Sirdalud is used
Sirdalud is a centrally-acting skeletal muscle relaxant. It acts primarily on the spinal cord and reduces excessive muscle tone.
Sirdalud is used for:

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 severe liver function impairment 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), fatigue. Your doctor may recommend liver function tests, based on which they will decide whether to continue or discontinue treatment. 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), including loss of consciousness and vascular collapse, occur. These symptoms may occur as a result of treatment with Sirdalud,
do not discontinue treatment without consulting your doctor (see also section 3 How to take Sirdalud).

If any of these points apply to the patient, they should inform their doctor.
Children and adolescents
Sirdalud is not recommended for use in children.
Sirdalud with 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 help sleep or have strong analgesic effects,
antiarrhythmics (medicines used to treat irregular heartbeat, e.g. amiodarone, mexiletine, propafenone) or other medicines that have an adverse effect on 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 (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 if pregnancy is planned, 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 of childbearing potential, a pregnancy test should be performed before starting treatment with Sirdalud, and effective contraception should be used during treatment and for at least one day after discontinuation of Sirdalud.
Discuss with your doctor the choice of a suitable 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 consult their doctor before taking this medicine.

3. How to use Sirdalud

The following provides the standard dosing 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
recommended dose or stop taking the medicine without consulting your doctor.
Sirdalud tablets may be taken regardless of meals.
What dose of Sirdalud should be used
Relief of painful muscle spasms
Sirdalud tablets are recommended at 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, divided into three doses. The daily dose may
be gradually increased by 2 mg to 4 mg at intervals of one to two weeks.
Optimal response is usually achieved with a daily dose of 12 mg to 24 mg, administered in 3 or 4 equal
doses. A daily dose exceeding 36 mg should not be used.
If the effect of the medicine seems too strong or too weak, consult a doctor or pharmacist.
Use of a higher than recommended dose of Sirdalud
If an overdose of Sirdalud is taken by accident, contact a doctor or the nearest toxicology information
centre immediately, or go to the nearest hospital emergency department.
Missed dose of Sirdalud
If a dose of Sirdalud is missed, take it as soon as possible. However, if less than 2 hours remain until
the next scheduled dose, the missed dose should not be taken; only take the next dose at the usual
time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with 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 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.
When lower doses are used, such as those recommended to relieve painful muscle spasms, adverse reactions such as drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased blood pressure, nausea, gastrointestinal disturbances, and increased aminotransferase activity were usually mild and transient.
When higher doses are administered, as recommended for the treatment of increased muscle tension, the adverse reactions observed with lower doses occurred more frequently and were more pronounced. However, they rarely became severe enough to require 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, they should be reported to a 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 occur in more than 1 in 10 people):

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

Commonly (may occur in less than 1 in 10 people):

insomnia, sleep disturbances, decreased blood pressure (including marked hypotension), nausea, increased aminotransferase activity.

Uncommonly (may occur in less than 1 in 100 people):

bradycardia (reduced heart rate).

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, they should be reported to a doctor, pharmacist, or nurse. Adverse reactions can also 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
Tel.: +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 the medicine Sirdalud contains

The active substance is tizanidine in the form of tizanidine hydrochloride. One tablet contains 4 mg of tizanidine.
Other ingredients: colloidal anhydrous silica, stearic acid, microcrystalline cellulose, lactose.

What Sirdalud looks like and contents of the pack
One tablet (a round, flat, white or almost white tablet with bevelled edges, marked with a cross on one side and the code RL on the other) contains 4 mg of tizanidine (as tizanidine hydrochloride 4.576 mg).
The pack contains 10 or 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, country of export:
Sandoz d.d.
Verovškova 57, SI-1000 Ljubljana, Slovenia
Manufacturer:
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing authorisation number in Latvia, country of export: 00-0449
Parallel import authorisation number: 362/24