Sirdalud

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Sirdalud, 4 mg, tablets

Tizanidine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

2. Important information before taking Sirdalud

You should strictly follow the doctor's instructions.

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, you should discuss it with your doctor or pharmacist, especially:

• in case of kidney function disorders,
• in case of liver function disorders. You should inform your doctor about the occurrence of liver function disorder symptoms, such as unexplained nausea, loss of appetite (anorexia), fatigue. The doctor may recommend performing 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,
• you should not stop taking Sirdalud without consulting your 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any 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 (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 you should avoid consuming 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, 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 use effective contraception during treatment and for at least one day after stopping Sirdalud.
You should discuss with your doctor the choice of a suitable contraceptive method for you at this time.

Driving and using machines

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

Sirdalud contains lactose

If you have been diagnosed with intolerance to some sugars (e.g., lactose), you should contact your 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, you should consult a doctor or pharmacist.
You should not change the prescribed dose or stop taking the medicine without consulting your doctor.
Sirdalud tablets can be taken regardless of meals.

What dose of Sirdalud to take

Relieving 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, 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 you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Sirdalud than recommended

In case of accidental administration of a higher dose of Sirdalud than recommended, you should immediately contact your 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, you should take it as soon as possible. However, if there is less than 2 hours left before the next dose, you should not take the missed dose, but only take the next dose at the usual time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Sirdalud

You should not stop taking Sirdalud without consulting your doctor first. The doctor may recommend gradually reducing the dose before deciding to completely discontinue the medicine, which will reduce the risk of withdrawal symptoms. Withdrawal symptoms include hypertension (increased blood pressure), headache, dizziness, or tachycardia (increased heart rate).
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sirdalud can cause side effects, although not everybody gets them.
After administration of smaller doses, recommended for relieving painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased blood pressure, nausea, gastrointestinal disorders, and increased transaminase activity were usually mild and transient.
After administration of higher doses, recommended for treating increased muscle tone, side effects that occurred after administration of 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, you should inform 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, you should tell your doctor.

Other possible side effects

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

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

• drowsiness, fatigue, dizziness, gastrointestinal disorders, dryness of the oral mucosa, muscle weakness.

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

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

not very often (may occur less frequently than in 1 in 100 people):

• bradycardia (decreased heart rate).

with unknown frequency (frequency cannot be estimated from the available data):

• fainting, blurred vision, rash, skin redness (erythema), 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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, you can 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.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 what the pack contains

1 tablet (with a score line in the shape of a cross) contains 4 mg of tizanidine (in the form of 4.576 mg of tizanidine hydrochloride).
To obtain more detailed information, you 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:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 63/209/88-B/C

Parallel import authorization number: 468/21

Date of leaflet approval: 22.02.2024

[Information about the trademark]