Patient Information Leaflet

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Sirdalud is and what it is used for
What you need to know 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 hydrochloride, which reduces increased muscle tone.
What Sirdalud is used for
Sirdalud is a centrally-acting skeletal muscle relaxant. It acts primarily on the spinal cord and reduces excessive muscle tone.
Sirdalud is used:

for the treatment of painful muscle spasms
- associated with spinal disorders, e.g. lower back pain, neck spasm
- following surgery, e.g. herniated disc or hip joint inflammation
for the 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 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), 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 discontinue treatment without consulting your doctor (see also section 3 How to take 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 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 cause drowsiness or strong pain-relieving effects,
antiarrhythmic medicines (medicines used to treat irregular heartbeat, including amiodarone, mexiletine, propafenone) or other medicines that have an adverse effect on heart function known as "QT interval prolongation",
cimetidine (a medicine used in 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 and breastfeeding, if there is suspicion that a woman is pregnant or if she plans to become pregnant, consult a 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 time.
Driving and operating machinery
If drowsiness, dizziness, or other symptoms of hypotension (e.g. cold sweats, "empty-headed" feeling) 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 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 prescribed dose or stop taking the medicine without consulting a
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 to be used 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 disorders
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 or 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. 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 a higher than recommended dose of Sirdalud is accidentally taken, contact a doctor or the nearest
toxicology information center 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
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 treatment with Sirdalud
Do not stop using Sirdalud without first consulting your doctor.
The doctor may recommend gradually reducing the dose before deciding to discontinue the medicine completely, thereby reducing the risk of withdrawal symptoms. Withdrawal symptoms may include hypertension (elevated 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
arterial 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
tone, the adverse reactions observed with lower doses occurred more frequently and were more
intense. However, they rarely became severe enough to require discontinuation of the medicine.
Additionally, 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.
Other possible adverse reactions
Other adverse reactions include those listed below. If any of the adverse reactions listed below
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 arterial blood pressure (including marked decrease), nausea, increased aminotransferase activity

Uncommonly (may occur in 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—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, inform your doctor or
pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of
Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Sirdalud

Do not store above 25°C.
Sirdalud should be stored in a place inaccessible and out of sight of children.
Do not use Sirdalud after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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
Each tablet (with a cross-shaped score line) contains 4 mg of tizanidine (as tizanidine hydrochloride).
The pack contains 1 or 3 blisters made of PVC/PE/PVDC/Al foil, each containing 10 tablets, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Bexal Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Novartis Farmacéutica, S. A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
Ljubljana 1526
Slovenia
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Spain, country of export: 989145.9
Parallel Import Licence number: 73/25