Sirdalud

Package Leaflet: Information for the Patient

Sirdalud, 4 mg, Tablets

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 any not listed in this leaflet, tell your 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

Follow the doctor's instructions carefully.

When not to take Sirdalud:

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

Warnings and precautions

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

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

If any of these points apply to you, tell your 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 now or have taken recently, as well as about medicines you plan to take.
It is especially important to tell 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,
• anti-arrhythmic medicines (medicines used to treat irregular heartbeat, including amiodarone, mexiletine, propafenone) or other medicines that have a negative 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 and alcohol

Alcohol may enhance the sedative effect of the medicine, so you should avoid drinking 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, consult your 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.
For women of childbearing potential, 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.
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, do not drive or operate machinery.

Sirdalud contains lactose

If you have been diagnosed with an intolerance to some sugars (e.g. lactose), consult 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. 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

Relief of painful muscle spasms

Sirdalud in tablet form is recommended at 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

Your doctor will adjust the dose individually for you.
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 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 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 than recommended

In case of accidental overdose of Sirdalud, contact your doctor or the nearest poison information center or go to the nearest hospital emergency department immediately.

Missing a dose of Sirdalud

If you miss a dose of Sirdalud, take it as soon as possible. However, if it is less than 2 hours before 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 the missed dose.

Stopping treatment with Sirdalud

Do not stop taking Sirdalud 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 hypertension (high blood pressure, headache, dizziness) or tachycardia (increased heart rate).
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sirdalud can cause side effects, although not everybody gets them.
After taking lower doses, such as those recommended for the relief of painful muscle spasms, side effects such as drowsiness, fatigue, dizziness, dry mouth, decreased blood pressure, nausea, gastrointestinal disorders, and increased transaminase activity were usually mild and transient.
After taking higher doses, such as those recommended for the treatment of increased muscle tone, side effects that occurred with low doses were more frequent and more severe. However, they rarely required 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 occur more often than 1 in 10 people):

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

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

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

uncommon (may occur less often than 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, skin inflammation, weakness, withdrawal symptoms (such as hypertension and tachycardia), abdominal pain, vomiting, itching, speech disorders, allergic reactions, loss of energy

Reporting side effects

If you experience any side effects, including any 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
Al. Jerozolimskie 181C
02-222 Warsaw
phone: +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

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

6. Contents of the pack and other information

What Sirdalud contains

• The active substance is tizanidine hydrochloride.
• The other ingredients are: colloidal anhydrous silica, stearic acid, microcrystalline cellulose, anhydrous 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 1, 3, or 5 blisters of PVC/PE/PVDC/Al foil with 10 tablets, in a cardboard box or
1 blister of PVC/PE/PVDC/Al foil with 14 tablets in a cardboard box
Not all pack sizes may be marketed.

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 Farmaceutica S.A.
Gran Vía de les Corts Catalanes 764
08013 Barcelona
Spain
Date of last revision of the leaflet:07/2024