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 using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine 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, 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 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:

Treatment of painful muscle spasms
- Associated with spinal disorders, e.g. lower back pain, neck spasm
- Resulting from surgery, e.g. herniated disc or hip joint inflammation
Treatment of increased muscle tone in neurological disorders, e.g. multiple sclerosis, chronic spinal cord diseases, degenerative spinal cord disorders, 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 impairment,
in case of liver function impairment. 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), including loss of consciousness and vascular collapse, occur. 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 use.
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 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 pregnancy is suspected, or if planning a 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.
Sexually active women of childbearing potential should have a pregnancy test before starting treatment with Sirdalud and use effective contraception during treatment and for at least one day after stopping Sirdalud.
Discuss with your doctor the choice of a suitable contraceptive method for the patient during this time.
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 dosage recommendations for Sirdalud. This medicine should always be used
according to the instructions given by your doctor. If you have any doubts, consult your doctor or pharmacist. Do
not change the prescribed dose or stop taking the medicine without consulting your doctor.
Sirdalud tablets may be taken independently 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, taken 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, the daily dose should not exceed 6 mg, divided into three separate doses. The daily dose may be gradually increased by 2 mg to 4 mg at intervals of half-weekly or weekly.
The 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 you feel that the medicine's effect is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Sirdalud
If an overdose of Sirdalud is taken by accident, 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 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, which reduces 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When lower doses are used, such as those recommended to relieve painful muscle spasms, adverse effects 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 effects observed with lower doses occurred more frequently and were more pronounced. However, they rarely became 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 symptoms or any other adverse effects occur, inform your doctor.
Some adverse effects 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 effects worsen, inform your doctor.

Other possible adverse effects
Other adverse effects include those listed below. If any of the following adverse effects worsen, inform your doctor, pharmacist, or nurse.
Adverse effects 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 (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 - so-called tachycardia), abdominal pain, vomiting, itching, speech disorders, allergic reactions, loss of energy.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects 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 pack and other information

What Sirdalud contains

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

What Sirdalud looks like and contents of the pack
1 tablet (with a cross-shaped score line) contains 4 mg of tizanidine (as tizanidine hydrochloride 4.576 mg).
The pack contains 1, 3 or 5 PVC/PE/PVDC/Al blisters of 10 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Bexal Farmacéutica, S.A., Centro Empresarial Parque Norte, Edificio Roble, C/ Serrano Galvache,
56, 28033 Madrid, Spain
Manufacturer:
Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana 1526, Slovenia
Novartis Farmacéutica, S. A., Gran Vía de les Corts Catalanes, 764, 08013 Barcelona, Spain
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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Spain, the country of export: 989145.9
Parallel import authorisation number: 38/26