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 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 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, cervical spine syndrome
• 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 should inform their doctor.

Warnings and precautions

Before starting treatment with Sirdalud, discuss it with your doctor or pharmacist, especially:

• in case of kidney function disorders,
• in case of liver function disorders. Inform your 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 whether to continue or stop treatment. If the patient is taking doses of the medicine of 12 mg per day or more, the doctor should monitor liver function,
• in the 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,
• 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, they should inform their doctor.

Children and adolescents

Sirdalud is not recommended for use in children.

Sirdalud and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 (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 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.
In sexually active women of childbearing age, 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.
The patient should discuss the choice of a suitable contraceptive method with her doctor at this time.

Driving and using machines

If the patient experiences drowsiness, dizziness, or other symptoms of hypotension (e.g., cold sweats, "feeling empty-headed") 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 consult their 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. 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 can be taken with or without food.

What dose of Sirdalud to take

Relieving 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/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 weekly or bi-weekly intervals.
The optimal response is usually achieved with 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 overdose, 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

If a dose of Sirdalud is missed, it should be taken as soon as possible. However, if there are less than 2 hours left before the next dose, the missed dose should not be taken, and the next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Sirdalud

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

4. Possible side effects

Like all medicines, Sirdalud can cause side effects, although not everybody gets them.
When smaller doses are taken, as 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 are usually mild and transient.
When higher doses are taken, as recommended for treating increased muscle tone, side effects that occurred with smaller doses are more frequent and more severe. However, they rarely require stopping 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 inform their doctor.

Other possible side effects

Other side effects include those listed below. If any of the following side effects worsen, the patient should inform their doctor, pharmacist, or nurse.

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

• drowsiness, fatigue, dizziness, gastrointestinal disorders, dry mouth, muscle weakness. common (may occur in less than 1 in 10 people):
• insomnia, sleep disorders, decreased blood pressure (including significant), nausea, increased transaminase activity. uncommon (may occur in less than 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 the patient experiences any side effects, including any side effects not listed in this 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.
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder or parallel importer.

5. How to store Sirdalud

Keep the 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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: see embossing – batch number/expiry date: see embossing.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer used. 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, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the 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 by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export: 4844.01.00

Parallel import authorization number: 444/24

Date of leaflet approval: 18.12.2024

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