Sirdalud Mr

Package Leaflet: Information for the Patient

Sirdalud MR, 6 mg, Prolonged-Release Hard Capsules

Tizanidine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Sirdalud MR and what is it used for
• 2. Important information before taking Sirdalud MR
• 3. How to take Sirdalud MR
• 4. Possible side effects
• 5. How to store Sirdalud MR
• 6. Contents of the pack and other information

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

What is Sirdalud MR

The active substance of Sirdalud MR is tizanidine hydrochloride, which reduces increased muscle tone.

What is Sirdalud MR 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 (cervical and lumbar syndromes), e.g. lower back pain, neck stiffness
• resulting from surgery, e.g. herniated disc or hip joint inflammation
• treatment of increased muscle tone in neurological diseases
• e.g. in 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 MR

Follow the doctor's instructions carefully.

When not to take Sirdalud MR:

If any of these points apply to you, do not take Sirdalud MR and tell your doctor.

Warnings and precautions

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

• do not stop taking the medicine without consulting your doctor (see also section 3 How to take Sirdalud MR).

If any of these points apply to you, tell your doctor.

Children and adolescents

Sirdalud MR is not recommended for use in children.

Sirdalud MR and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about 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 (medicines used to treat irregular heartbeat, including amiodarone, mexiletine, propafenone) or other medicines that have an adverse effect on heart function, called "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),

Sirdalud MR and alcohol

Alcohol may enhance the sedative effect of the medicine, so you should avoid drinking alcohol during treatment with Sirdalud MR.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Sirdalud MR may harm your unborn baby.
Do not take Sirdalud MR during pregnancy.
Do not take Sirdalud MR during breastfeeding.
In sexually active women of childbearing potential, a pregnancy test should be performed before starting treatment with Sirdalud MR, and effective contraception should be used during treatment and for 2 days after stopping Sirdalud MR.
Talk to your doctor about the choice of contraceptive method suitable for you at this time.

Driving and using machines

If you experience drowsiness, dizziness, or other symptoms of hypotension (e.g. cold sweats, "empty head") while taking Sirdalud MR, do not drive or operate machinery.

Sirdalud MR contains sucrose

If you have been diagnosed with intolerance to some sugars (e.g. sucrose), you should consult your doctor before taking the medicine.

3. How to take Sirdalud MR

The standard dosing regimen for Sirdalud MR 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 MR can be taken with or without food.

What dose of Sirdalud MR to take

Your doctor will adjust the dose individually for you.
The recommended initial dose is one 6 mg capsule taken once a day. Your doctor may increase this dose if necessary, by one 6 mg capsule at weekly or bi-weekly intervals, up to a maximum dose of 24 mg per day.
The optimal response is usually achieved with a dose of 12 mg taken once a day (two 6 mg capsules).
The slow release of the active substance from the prolonged-release capsules allows for once-daily dosing.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Sirdalud MR than recommended

If you accidentally take a higher dose of Sirdalud MR than recommended, contact your doctor or the nearest poison control center or go to the nearest hospital emergency department immediately.

Missing a dose of Sirdalud MR

If you miss a dose of Sirdalud MR, take it as soon as possible. However, if it is less than 2 hours until the next dose, do not take the missed dose, just 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 MR

Do not stop taking Sirdalud MR without consulting your doctor first.
Your 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 high blood pressure, headache, dizziness.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sirdalud MR can cause side effects, although not everybody gets them.
When smaller doses are used, as recommended for the relief of painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dry mouth, low blood pressure, nausea, gastrointestinal disorders, and increased transaminase activity are usually mild and transient.
When higher doses are used, as recommended for the treatment of increased muscle tone, side effects that occurred with smaller doses are more frequent and more pronounced. However, they rarely require discontinuation of the medicine. Additionally, the following side effects may occur: QT interval prolongation and torsade de pointes, hypotension, bradycardia, muscle weakness, insomnia, sleep disorders, hallucinations, and acute hepatitis.
If you experience any of the above symptoms or any other side effects, tell 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 these serious side effects worsen, tell your doctor.

Other possible side effects

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

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

• drowsiness, fatigue, dizziness, gastrointestinal disorders, dry mouth, muscle weakness

common (may affect up to 1 in 10 people):

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

uncommon (may affect up to 1 in 100 people):

• bradycardia (decreased heart rate)

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

• fainting, blurred vision, rash, skin redness (flush), skin inflammation, weakness, withdrawal symptoms (such as high blood pressure 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 those not listed in this leaflet, tell your doctor or pharmacist. 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
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sirdalud MR

Keep the medicine out of the sight and reach of children.
Do not use Sirdalud MR after the expiry date stated on the carton and blister.
Do not store above 25°C, protect from moisture.
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 MR contains

• The active substance is tizanidine hydrochloride. One prolonged-release hard capsule contains 6 mg of tizanidine (as tizanidine hydrochloride 6.864 mg).
• The other ingredients are: ethylcellulose, shellac, talc, corn starch, sucrose, titanium dioxide, gelatin, iron oxide black, ammonium hydroxide.

What Sirdalud MR looks like and contents of the pack

White, opaque hard gelatin capsules, size 2, with gray printing "Sirdalud" on the cap and "6 mg" on the body, containing white to light beige round pellets.
The capsules are packaged in blisters in a cardboard box.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Importer

Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana
Slovenia
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany
Novartis Farmacéutica S.A.
Gran Vía de les Corts Catalanes 764
08013 Barcelona
Spain
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:07/2024