Sirdalud

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Sirdalud

4 mg, tablets

Tizanidine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Sirdalud and what is it used for
• 2. Important information before taking Sirdalud
• 3. How to take Sirdalud
• 4. Possible side effects
• 5. How to store Sirdalud
• 6. Contents of the pack and other information

1. What is Sirdalud and what is it used for

What is Sirdalud

The active substance of Sirdalud is tizanidine hydrochloride, which reduces increased muscle tone.

What is Sirdalud used for

Sirdalud is a centrally acting muscle relaxant. It acts mainly on the spinal cord and reduces excessive muscle tone. Sirdalud is used for:

• treatment of painful muscle spasms
• associated with spinal disorders, such as lower back pain, neck stiffness
• resulting from surgery, such as herniated disc or hip joint inflammation
• treatment of increased muscle tone in neurological diseases, such as multiple sclerosis, chronic spinal cord diseases, degenerative spinal cord diseases, after a stroke, and cerebral palsy in adults who were previously diagnosed with cerebral palsy as children.

2. Important information before taking Sirdalud

Follow the doctor's instructions carefully.

When not to take Sirdalud:

• if you are allergic (hypersensitive) to Sirdalud (tizanidine) or any of the other ingredients of the medicine (listed in section 6),
• if you have significant liver function disorders, persistent triple increase in transaminase activity above the upper limit of normal,
• if you are taking fluvoxamine (a medicine used to treat depression),
• if you are taking ciprofloxacin (an antibiotic used to treat infections).

If any of these points apply to you, do not take Sirdalud and tell your doctor.

Warnings and precautions

Before starting treatment with Sirdalud, discuss it with your doctor or pharmacist, especially:

• in case of kidney function disorders,
• in case of liver function disorders. Tell your doctor if you experience symptoms of liver function disorders, 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 stop treatment. If you are taking doses of the medicine of 12 mg per day or more, your doctor should monitor liver function,
• in case of elderly patients,
• in case of symptoms of hypotension (low blood pressure), including loss of consciousness and vascular collapse. These symptoms may occur as a result of treatment with Sirdalud,
• do not stop taking Sirdalud without consulting your doctor (see also section 3 How to take Sirdalud).

If any of these points apply to you, tell your doctor.

Children and adolescents

Sirdalud is not recommended for children.

Sirdalud and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take. It is especially important to inform your doctor about taking any of the following medicines:

• medicines that lower blood pressure and diuretics,
• medicines used to treat depression (fluvoxamine),
• medicines that facilitate sleep or have a strong analgesic effect,
• 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 to treat stomach and duodenal ulcers),
• 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 you smoke more than 10 cigarettes a day.

Sirdalud and alcohol

Alcohol may enhance the sedative effect of the medicine, so you should avoid drinking it during treatment with Sirdalud.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before taking Sirdalud. Sirdalud may harm the unborn child. Sirdalud should not be used during pregnancy. Sirdalud should 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 stopping Sirdalud. You should discuss with your doctor the choice of a suitable contraceptive method at this time.

Driving and using machines

If you experience drowsiness, dizziness, or other symptoms of hypotension (such as cold sweats, "feeling empty in the head") while taking Sirdalud, do not drive or operate machinery.

Sirdalud contains lactose

If you have been diagnosed with intolerance to some sugars (e.g. lactose), you should consult your doctor before taking Sirdalud.

3. How to take Sirdalud

The standard dosing regimen for Sirdalud is described below. This medicine should always be taken according to the doctor's instructions. 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 can be taken with or without food.

What dose of Sirdalud to take

Relief of painful muscle spasms

Sirdalud is recommended 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 can be taken before bedtime to minimize the sedative effect.

Increased muscle tone in neurological diseases

The doctor will adjust the dose individually for you. Initially, no more than 6 mg per day should be given, the daily dose should be divided into three doses. The daily dose may be gradually increased by 2 mg to 4 mg at intervals of half a week or a week. The optimal response is usually achieved with a daily dose of 12 mg to 24 mg, given in 3 or 4 equal doses. The daily dose should not exceed 36 mg. If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Sirdalud than recommended

If you accidentally take a higher dose of Sirdalud than recommended, contact your doctor or the nearest poison control center or go to the nearest hospital emergency department immediately.

Missing a dose of Sirdalud

If you miss a dose of Sirdalud, take it as soon as possible. However, if it is less than 2 hours before the next dose is due, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Sirdalud

Do not stop taking Sirdalud without consulting your doctor first. Your doctor may recommend gradually reducing the dose before deciding to stop the medicine completely, which will reduce the risk of withdrawal symptoms. Withdrawal symptoms include high blood pressure, headache, dizziness. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sirdalud can cause side effects, although not everybody gets them. When smaller doses are used, as recommended for the relief of painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dry mouth, low blood pressure, nausea, gastrointestinal disorders, increased transaminase activity are usually mild and transient. When higher doses are used, as recommended for the treatment of increased muscle tone, side effects that occurred with smaller doses were more frequent and more pronounced. However, they rarely had a severe course that required discontinuation of the medicine. Additionally, the following side effects may occur: QT interval prolongation and torsades de pointes, hypotension, bradycardia, muscle weakness, insomnia, sleep disorders, hallucinations, and acute hepatitis. If you experience any of the above symptoms or any other side effects, tell your doctor.

Some side effects can be serious:

• hepatitis, liver failure, hallucinations, confusion, severe allergic reactions, including difficulty breathing, dizziness (anaphylaxis) and swelling, mainly of the face and throat (angioedema).

If any of the above serious side effects worsen, tell your doctor.

Other possible side effects

Other side effects include those listed below. If any of the following side effects worsen, tell your doctor, pharmacist, or nurse.

Side effects that occur: very common (may affect more than 1 in 10 people):

• drowsiness, fatigue, dizziness, gastrointestinal disorders, dry mouth, muscle weakness

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

• insomnia, sleep disorders, decreased blood pressure (including significant), nausea, increased transaminase activity

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

• bradycardia (decreased heart rate)

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

• fainting, blurred vision, rash, flushing, skin inflammation, weakness, withdrawal symptoms (such as high blood pressure and increased heart rate - so-called tachycardia), abdominal pain, vomiting, itching, speech disorders, allergic reactions, loss of energy

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sirdalud

Do not store above 25°C. Keep Sirdalud out of the reach and sight of children. Do not use Sirdalud after the expiry date stated on the packaging. Medicines should 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 notch) contains 4 mg of tizanidine (in the form of tizanidine hydrochloride). The pack contains 1 or 3 blisters of PVC/PE/PVDC/Al foil, each with 10 tablets, in a cardboard box. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization 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:

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 1526 Ljubljana Slovenia

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Marketing authorization number in Spain, the country of export: 989145.9 Parallel import authorization number: 73/25

Date of approval of the leaflet: 21.02.2025

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