Sirdalud

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language

Sirdalud

4 mg, tablets

Tizanidine

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 packaging and other information

1. What is Sirdalud and what is it used for

What is Sirdalud

The active substance of Sirdalud is tizanidine in the form of tizanidine hydrochloride, which causes a decrease in increased muscle tone.

What is Sirdalud used for

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

• 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 in cerebral palsy*. *in adults who were previously diagnosed with cerebral palsy.

2. Important information before taking Sirdalud

The doctor's instructions should be followed carefully.

When not to take Sirdalud:

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

If any of these points apply to the patient, they should not take Sirdalud and should inform their doctor.

Warnings and precautions

Before starting treatment with Sirdalud, the patient should discuss it with their doctor or pharmacist, especially:

• in case of kidney function disorders,
• in case of liver function disorders. The patient should inform their doctor about the occurrence of liver function disorder symptoms, such as unexplained nausea, loss of appetite (anorexia), fatigue. The doctor may recommend liver function tests, on the basis of which they will decide on the continuation or discontinuation of treatment. If the patient is taking doses of the medicine exceeding 12 mg per day, the doctor should monitor liver function,
• in the 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,
• the patient should not stop taking the medicine without consulting their 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 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the 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 (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 the patient smokes more than 10 cigarettes per day.

Sirdalud and alcohol

Alcohol may enhance the sedative effect of the medicine, so it should be avoided during treatment with Sirdalud.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, the patient should consult their doctor before taking Sirdalud. Sirdalud may have a harmful effect on the unborn child. Sirdalud should not be used during pregnancy. Sirdalud should not be used during breastfeeding. In sexually active women who are able to become pregnant, 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. The patient should discuss with their doctor the choice of a suitable contraceptive method at this time.

Driving and operating machinery

In case of drowsiness, dizziness, or other symptoms of hypotension (e.g., cold sweats, "empty head" feeling) during treatment with Sirdalud, the patient should not drive vehicles or operate machinery.

Sirdalud contains lactose

If the patient has previously been diagnosed with intolerance to some sugars (e.g., lactose), they should contact their doctor before taking the medicine.

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. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not change the prescribed dose or stop taking the medicine without consulting their doctor. Sirdalud tablets can be taken independently of meals.

What dose of Sirdalud to take

Relief of painful muscle spasms

Sirdalud in the form of tablets is recommended to be taken 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 the patient. Initially, no more than 6 mg/day should be administered, and the daily dose should be divided into three doses. The daily dose may be gradually increased by 2 mg to 4 mg at weekly or bi-weekly intervals. The optimal response is usually achieved with a daily dose of 12 mg to 24 mg, divided into 3 or 4 equal doses. The daily dose should not exceed 36 mg. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Sirdalud than recommended

In case of accidental taking of a higher dose of Sirdalud than recommended, the patient should immediately contact their doctor or the nearest toxicology information center or go to the nearest hospital emergency department.

Missing a dose of Sirdalud

In case of missing a dose of Sirdalud, the patient should take it as soon as possible. However, if there is less than 2 hours left before the next dose, the patient should not take the missed dose, but only take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Sirdalud

The patient should not stop taking Sirdalud without consulting their doctor first. The doctor may recommend gradual reduction of the dose before deciding to completely stop the medicine, which will reduce the risk of withdrawal symptoms. Withdrawal symptoms include hypertension (increased blood pressure), headache, dizziness, or tachycardia (increased heart rate). If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sirdalud can cause side effects, although not everybody gets them. When taking lower doses, recommended for the relief of painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dry mouth, decreased blood pressure, nausea, gastrointestinal disorders, and increased transaminase activity were usually mild and transient. When taking higher doses, recommended for the treatment of increased muscle tone, side effects that occurred with lower doses were more frequent and more severe. However, they rarely 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 the patient experiences any of the above symptoms or any other side effects, they should inform their 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, the patient should inform their doctor.

Other possible side effects

Other side effects include those listed below. If any of the below side effects worsen, the patient should inform their doctor, pharmacist, or nurse.

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

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

common (may occur less frequently than in 1 in 10 people):

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

uncommon (may occur less frequently than in 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 hypertension and tachycardia), abdominal pain, vomiting, itching, speech disorders, allergic reactions, loss of energy.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sirdalud

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use Sirdalud after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sirdalud contains

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

What Sirdalud looks like and what the packaging contains

1 tablet (round, flat, white or almost white tablet with beveled edges and a cross dividing it on one side and the code RL on the other) contains 4 mg of tizanidine (in the form of tizanidine hydrochloride 4.576 mg). For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Novartis s.r.o., Na Pankráci 1724/129, 140 00 Prague 4, Czech Republic

Manufacturer:

Novartis s.r.o., Na Pankráci 1724/129, 140 00 Prague 4, Czech Republic, Novartis Pharma GmbH, Roonstrasse 25, and Obere Turnstrasse 8-10, 90429 Nuremberg, Germany, Novartis Farmaceutica S.A., Gran Vía de les Corts Catalanes 764, 08013 Barcelona, Spain

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Authorization number in the Czech Republic, the country of export: 63/209/88-B/C

Parallel import authorization number: 116/21

Date of leaflet approval: 22.11.2023

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