Sirdalud

Package Leaflet: Information for the Patient

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

Sirdalud

4 mg, tablets
Tizanidine

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 pack 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 hydrochloride, which causes a decrease in 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

It is necessary to strictly follow the doctor's recommendations.

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 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, based on 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 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 Sirdalud 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 about 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 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, she should consult her 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 should 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, "empty head" feeling) during treatment with Sirdalud, they should not drive or operate machines.

Sirdalud contains lactose

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

3. How to take Sirdalud

Below is the standard dosing regimen for Sirdalud. This medicine should always be taken according to the doctor's recommendations. 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 regardless 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 intervals of half a week or a week.
The optimal response is usually achieved after administration of 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 ingestion of a higher dose of Sirdalud than recommended, the patient should immediately contact their doctor or the nearest poison control 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. 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 (high blood pressure) and tachycardia (increased heart rate).
In case of any further doubts about the use of this medicine, the patient 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, 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.
After taking higher doses, recommended for the treatment of increased muscle tone, side effects that occurred after taking small doses were more frequent and more severe. However, they rarely had a severe course, requiring 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.
In case of occurrence of any of the above symptoms or any other side effects, the patient 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 the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
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 of Sirdalud 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 4.576 mg). The pack contains 10 or 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

Manufacturer:

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

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
German authorization number: 4844.01.00

Parallel import authorization number: 333/13 Date of approval of the leaflet: 26.04.2023

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