Sirdalud

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Sirdalud
4 mg, tablets
Tizanidinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Sirdalud is and what it is 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 Sirdalud is and what it is used for

What Sirdalud is
The active substance in Sirdalud is tizanidine in the form of hydrochloride, which reduces increased muscle tone.
What Sirdalud is used for
Sirdalud is a centrally-acting skeletal muscle relaxant. It acts primarily on the spinal cord and reduces excessive muscle tension.
Sirdalud is used in:

• the treatment of painful muscle spasms
  • associated with spinal disorders, e.g. lower back pain, neck spasms
  • following surgery, e.g. herniated disc or hip joint inflammation
• the treatment of increased muscle tone in neurological diseases, e.g. multiple sclerosis, chronic spinal cord disorders, degenerative spinal cord diseases, after stroke, and in cerebral palsy in adults who were previously diagnosed with cerebral palsy in childhood.

2. Important information before using Sirdalud

Strictly follow your doctor's instructions.
When not to use Sirdalud:

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

If any of these points apply to the patient, Sirdalud must not be taken and
the patient should inform their doctor.
Warnings and precautions
Before starting treatment with Sirdalud, discuss this with your doctor or pharmacist,
especially:

• in case of kidney function disorders,
• in case of liver function disorders. Inform your doctor if symptoms of liver dysfunction occur, such as unexplained nausea, loss of appetite (anorexia), fatigue. The doctor may recommend liver function tests to decide whether treatment should continue or be discontinued. If the patient is taking doses of Sirdalud of 12 mg per day or higher, the doctor should monitor liver function,
• in elderly patients,
• if symptoms of hypotension (low blood pressure) occur, including loss of consciousness and circulatory collapse. These symptoms may occur as a result of treatment with Sirdalud,
• do not stop taking the medicine without consulting your doctor (see also section 3 How to take Sirdalud).

If any of these points apply to the patient, inform your doctor.
Children and adolescents
Sirdalud is not recommended for use in children.
Sirdalud with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform your doctor if the patient is taking any of the following
medicines:

• medicines that lower blood pressure and diuretics,
• medicines used to treat depression (fluvoxamine),
• medicines that cause drowsiness or strong pain relief,
• 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 prolongation",
• cimetidine (a medicine used for peptic ulcer disease of the stomach and/or duodenum),
• 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 cigarettes (more than 10 cigarettes per day).

Sirdalud and alcohol
Alcohol may enhance the sedative effect of the medicine; therefore, alcohol consumption should be avoided during treatment with Sirdalud.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, if there is suspicion that a woman is pregnant or if she is planning pregnancy, consult a doctor before using Sirdalud. Sirdalud may have harmful effects on the unborn child.
Sirdalud must not be used during pregnancy.
Sirdalud must not be used during breastfeeding.
In women of childbearing potential and sexually active, a pregnancy test is recommended before starting treatment with Sirdalud, and effective contraception should be used during treatment and for at least one day after stopping Sirdalud.
Discuss with your doctor the choice of a suitable contraceptive method for the patient during this period.
Driving and operating machinery
If drowsiness, dizziness or other symptoms of hypotension (e.g. cold sweats, "feeling of emptiness in the head") occur during treatment with Sirdalud, the patient should not drive or operate machinery.
Sirdalud contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), the patient should contact their doctor before taking the medicine.

3. How to use Sirdalud

The following provides the standard dosage regimen for Sirdalud. This medicine should always be used
according to the doctor's instructions. If in doubt, consult a doctor or pharmacist. Do not change the
recommended dose or discontinue the medicine without consulting your doctor. Sirdalud tablets may be
taken regardless of meals.
What dose of Sirdalud should be used
Relief of painful muscle spasms
Sirdalud tablets are recommended at a dose of 2 mg to 4 mg, three times daily. In severe cases, an
additional dose of 2 mg or 4 mg may be taken before bedtime to minimize sedative effects.
Increased muscle tension in neurological diseases
The doctor will adjust the dose individually for each patient.
Initially, no more than 6 mg/day should be administered, divided into three doses. The daily dose may
be gradually increased by 2 mg to 4 mg at intervals of half-weekly or weekly periods.
The optimal patient response is usually achieved with a daily dose of 12 mg to 24 mg, administered in
3 or 4 equal doses. A daily dose exceeding 36 mg should not be used.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Sirdalud than recommended
If you accidentally take more Sirdalud than recommended, contact your doctor or the nearest
poison control center immediately, or go to the nearest hospital emergency department.
Missing a dose of Sirdalud
If you miss a dose of Sirdalud, take it as soon as possible. However, if less than 2 hours remain until
the next scheduled dose, do not take the missed dose; instead, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Sirdalud treatment
Do not stop using Sirdalud without first consulting your doctor. Your doctor may recommend
gradually reducing the dose before deciding to discontinue the medicine completely, thus reducing the
risk of withdrawal symptoms. Withdrawal symptoms may include arterial hypertension (increased
blood pressure, headache, dizziness) or tachycardia (increased heart rate).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
When lower doses, recommended among others for relieving painful muscle spasms, were used, adverse reactions such as drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased arterial blood pressure, nausea, gastrointestinal disturbances, and increased aminotransferase activity were usually mild and transient.
When higher doses, recommended for treating increased muscle tension, were administered, adverse reactions observed after lower doses occurred more frequently and were more intense. However, they rarely became so severe that discontinuation of the medicine was necessary. Additionally, the following adverse reactions may occur: QT interval prolongation and torsade de pointes, hypotension, bradycardia, muscle weakness, insomnia, sleep disturbances, hallucinations, and acute hepatitis.

If any of the above symptoms or any other adverse reactions occur, inform your doctor.

Some adverse reactions may be serious:

• hepatitis, liver failure, hallucinations, confusion, severe allergic reactions including breathing difficulties, dizziness (anaphylaxis), and swelling, mainly of the face and throat (angioedema). If any of the above serious adverse reactions worsen, inform your doctor immediately.

Other possible adverse reactions
Other adverse reactions include those listed below. If any of the following adverse reactions worsen, inform your doctor, pharmacist, or nurse.

Adverse reactions occurring:
Very commonly (may affect more than 1 in 10 people):

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

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

• insomnia, sleep disturbances, decreased arterial blood pressure (including significant), nausea, increased aminotransferase activity

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

• bradycardia (reduced heart rate)

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sirdalud

Keep this medicine 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 indicated.
Translation of abbreviations on the immediate packaging of the medicine:
Verwendbar bis – expiry date
Ch.-B. – batch number
siehe Prägung – see imprint
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: anhydrous colloidal silica, stearic acid, microcrystalline cellulose, lactose.

What Sirdalud looks like and contents of the pack
1 tablet (with a cross-shaped groove) contains 4 mg of tizanidine (in the form of 4.576 mg
of tizanidine hydrochloride).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany
Manufacturer:
Novartis Pharma GmbH
Roonstraße 25
90429 Nuremberg
Germany
Novartis Farmaceutica SA
Gran Via de les Corts Catalanes 764
08013 Barcelona
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Germany, the country of export: 4844.01.00
Parallel import licence number: 331/19