Sirdalud

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.

2. Important information before taking Sirdalud

Follow the doctor's instructions 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 (a medicine used to treat depression),
• if the patient is taking ciprofloxacin (an antibiotic used to treat infections).

If any of these points apply to the patient, they should not take Sirdalud and 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 symptoms of liver function disorders, such as unexplained nausea, loss of appetite (anorexia), fatigue. The doctor may recommend liver function tests, based on which they will decide on 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 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 (medicines used to treat irregular heartbeat, including amiodarone, mexiletine, propafenone) or other medicines that have a negative effect on heart function, known as "QT interval prolongation",
• cimetidine (a medicine used to treat stomach ulcers and/or 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 the patient should avoid drinking it 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.
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.
The patient should discuss with their doctor the choice of a suitable contraceptive method at this time.

Driving and using machines

If the patient experiences drowsiness, dizziness, or other symptoms of hypotension (e.g., cold sweats, "feeling of emptiness in the head") during treatment with Sirdalud, they should not drive or operate machinery.

Sirdalud contains lactose

If the patient has 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 dosage of Sirdalud is given below. This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they 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 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 the patient.
Initially, no more than 6 mg per day should be given, 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 biweekly intervals.
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 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

If the patient accidentally takes a higher dose of Sirdalud than recommended, they should immediately contact their doctor or the nearest poison control center or go to the nearest hospital emergency department.

Missing a dose of Sirdalud

If the patient misses a dose of Sirdalud, they should take it as soon as possible. However, if there is less than 2 hours before the next dose is due, 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 gradually reducing the dose before deciding to completely stop the medicine, which will reduce the risk of withdrawal symptoms. Withdrawal symptoms include hypertension (high 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.
After taking smaller doses, such as those recommended for relieving 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.
After taking higher doses, such as those recommended for treating increased muscle tone, side effects that occurred with smaller 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 these serious side effects worsen, the patient should tell their doctor.

Other possible side effects

Other side effects include those listed below. If any of these side effects worsen, the patient should tell their 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 hypertension and increased heart rate - so-called 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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 side effects will help gather more information on the safety of the medicine.

5. How to store Sirdalud

The medicine should be stored out of 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 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 pack and other information

What Sirdalud contains

• The active substance is 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).
PVC/PE/PVDC/Al blisters in a cardboard box contain 10 or 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia

Manufacturer:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes 764
08013 Barcelona
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:00-0449

Parallel import authorization number: 271/23

Date of leaflet approval: 24.11.2023

[Information about the registered trademark]