Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Sirdalud is and what it is used for
Important information before taking Sirdalud
How to take Sirdalud
Possible side effects
How to store Sirdalud
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:

treatment of painful muscle spasms
associated with spinal disorders, e.g. lower back pain, neck spasm
following surgery, e.g. herniated intervertebral disc or hip joint inflammation
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 previously diagnosed with cerebral palsy.

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 significant liver function impairment, persistent threefold increase in aminotransferase activity above the upper limit of normal,
if the patient is taking medicines containing fluvoxamine (a medicine used in the treatment of 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. Your doctor may recommend liver function tests, based on which they will decide whether to continue or discontinue treatment. 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 arterial 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 have strong analgesic effects,
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 interval prolongation",
cimetidine (a medicine used in 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 (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 plans 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 sexually active women capable of becoming 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.
Talk to your doctor about choosing a suitable method of contraception for the patient during this time.
Driving and operating machinery
If drowsiness, dizziness, or other symptoms of arterial 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 dosing instructions for Sirdalud. This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not change the prescribed dose or stop taking the medicine without consulting your doctor.
Sirdalud tablets may be taken independently of meals.
What dose of Sirdalud should be used
Relief of painful muscle spasms
Sirdalud tablets are recommended in 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 disorders
The doctor will adjust the dose individually for each patient.
Initially, the daily dose should not exceed 6 mg, divided into three separate doses. The daily dose may be gradually increased by 2 mg to 4 mg at intervals of one to two weeks.
The optimal response is usually achieved with a daily dose of 12 mg to 24 mg, administered in 3 or 4 equal doses. A daily dose higher than 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 toxicology information centre immediately, or go to the nearest hospital emergency department.
If you miss a dose of Sirdalud
If you miss a dose of Sirdalud, take it as soon as possible. However, if less than 2 hours remain before 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 treatment with Sirdalud
Do not stop taking Sirdalud without first consulting your doctor. Your doctor may recommend gradually reducing the dose before completely discontinuing the medicine, which reduces the risk of withdrawal symptoms. Withdrawal symptoms may include 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
When lower doses are used, such as those recommended to relieve painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dryness of the oral mucosa, decreased blood pressure, nausea, gastrointestinal disturbances, and increased aminotransferase activity were usually mild and transient.
When higher doses are administered, as recommended for the treatment of increased muscle tension, the side effects observed after lower doses occurred more frequently and were more pronounced. However, they rarely became severe enough to require discontinuation of the medicine. In addition, the following side effects 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 side effects occur, inform your doctor.
Some side effects 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-mentioned serious side effects worsen, inform your doctor immediately.

Other possible side effects
Other side effects include those listed below. If any of the side effects listed below worsen, inform your doctor, pharmacist, or nurse.
Side effects 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 blood pressure (including marked decrease), nausea, increased aminotransferase activity. uncommonly (may affect less than 1 in 100 people):
bradycardia (reduced heart rate).

frequency not known (cannot be estimated from the available data):

fainting, blurred vision, rash, skin redness (erythema), skin inflammation, malaise, withdrawal symptoms (such as high blood pressure and increased heart rate – so-called tachycardia), abdominal pain, vomiting, itching, speech disturbances, allergic reactions, loss of energy. Reporting of side effects If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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, additional information on the safety of the medicine can be collected.
Side effects may also be reported to the marketing authorization holder or parallel importer.

5. How to store the medicine Sirdalud

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use the medicine Sirdalud after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
Medicines must 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 packaging and other information

What Sirdalud contains

The active substance is tizanidine in the form of tizanidine hydrochloride.
Other ingredients are: anhydrous colloidal silicon dioxide, stearic acid, microcrystalline cellulose, lactose.

What Sirdalud looks like and contents of the packaging
1 tablet (with a cross-shaped groove) contains 4 mg of tizanidine (as tizanidine hydrochloride 4.576 mg).
The packaging contains 10 or 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany
Manufacturer:
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorisation number in Germany, country of export: 4844.01.00
Parallel import authorisation number: 444/24