Patient Information Leaflet

Sirdalud MR, 6 mg, modified-release hard capsules
Tizanidinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can 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. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Sirdalud MR is and what it is used for
Important information before taking Sirdalud MR
How to take Sirdalud MR
Possible side effects
How to store Sirdalud MR
Contents of the pack and other information

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

What Sirdalud MR is
The active substance in Sirdalud MR is tizanidine in the form of hydrochloride, which reduces increased muscle tone.
What Sirdalud MR 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 for:

Treatment of painful muscle spasms
- associated with spinal disorders (cervical and lumbar syndromes), e.g. lower back pain, neck spasm
- resulting from 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 diseases, degenerative spinal cord disorders, following stroke, and in cerebral palsy in adults who were previously diagnosed with cerebral palsy in childhood.

2. Important information before using Sirdalud MR

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

if the patient is allergic (hypersensitive) to Sirdalud MR (tizanidine) or to any of the other ingredients of this medicine (listed in section 6),
if the patient has significant liver function disorders, 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 MR must not be taken and the patient should inform their doctor.
Warnings and precautions
Before starting treatment with Sirdalud MR, discuss this with your doctor or pharmacist, especially:

in case of kidney function disorders. In patients with renal insufficiency (creatinine clearance less than 25 mL/min), treatment with Sirdalud tablets is recommended, starting at a dose of 2 mg per day.
in case of liver function disorders. Inform your doctor if symptoms of liver dysfunction occur, such as unexplained nausea, loss of appetite (anorexia), or fatigue. Your doctor may recommend liver function tests to decide whether treatment should continue or be discontinued. If the patient is taking doses of 12 mg per day or higher, the doctor should monitor liver function.
in elderly patients,
if symptoms of hypotension (low blood pressure), including loss of consciousness and vascular collapse, occur. These symptoms may occur as a result of treatment with Sirdalud MR,
do not stop taking the medicine without consulting your doctor (see also section 3 How to use Sirdalud MR).

If any of these points apply to the patient, inform 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 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, e.g. 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 (more than 10 cigarettes per day).

Sirdalud MR and alcohol
Alcohol may enhance the sedative effect of the medicine. Therefore, alcohol consumption should be avoided during treatment with Sirdalud MR.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. Sirdalud MR may have harmful effects on the unborn child.
Sirdalud MR must not be used during pregnancy.
Sirdalud MR must not be used during breastfeeding.
In sexually active women of childbearing potential, a pregnancy test is recommended before starting treatment with Sirdalud MR, and effective contraception should be used during treatment and for two days after discontinuation of Sirdalud MR.
Discuss with your doctor the choice of an appropriate contraceptive method 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 MR, the patient should not drive or operate machinery.
Sirdalud MR contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. sucrose), the patient should contact their doctor before taking this medicine.

3. How to use Sirdalud MR

The following provides the standard dosing instructions for Sirdalud MR. This medicine should always be used
according to the doctor's recommendations. If in doubt, consult a doctor or pharmacist. Do not
change the recommended dose or stop taking the medicine without consulting your doctor.
Sirdalud MR may be taken independently of meals.
What dose of Sirdalud MR should be used
The doctor will adjust the dose individually for each patient.
The recommended starting dose is one 6 mg capsule once daily. If necessary, the doctor may
gradually increase the dose by one 6 mg capsule every week or every two weeks, up to a maximum
daily dose of 24 mg.
The optimal patient response is usually achieved with a dose of 12 mg once daily (two capsules of 6 mg).
The modified release formulation allows the active substance to be slowly released from the capsules, enabling once-daily dosing.
If the effect of the medicine seems too strong or too weak, consult a doctor or pharmacist.
Taking more Sirdalud MR than recommended
If more Sirdalud MR is taken by accident than recommended, contact a doctor or the nearest toxicology information centre immediately, or go to the nearest hospital emergency department.
Missing a dose of Sirdalud MR
If a dose of Sirdalud MR is missed, take it as soon as possible. However, if less than 2 hours remain before the next scheduled dose, do not take the missed dose and take only the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Sirdalud MR treatment
Do not stop taking Sirdalud MR without first discussing it with your doctor.
The 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After administration of lower doses, recommended, among others, to relieve painful muscle spasms, 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.
After administration of higher doses, recommended for the treatment of increased muscle tension, adverse reactions observed after lower doses occurred more frequently and were more pronounced. However, they rarely became so severe as to necessitate discontinuation of the medicine. In addition, 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.

Other possible adverse reactions
Other possible 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 occur in more than 1 in 10 people):

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

commonly (may occur in less than 1 in 10 people):

insomnia, sleep disturbances, decreased arterial blood pressure (including marked decrease), nausea, increased aminotransferase activity

uncommonly (may occur in less than 1 in 100 people):

bradycardia (reduced heart rate)

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

fainting, blurred vision, rash, skin redness (erythema), 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 pack.
Do not store above 25°C; protect from moisture.
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 pack and other information

What Sirdalud MR contains

The active substance is tizanidine in the form of hydrochloride. One modified-release hard capsule contains 6 mg of tizanidine (as tizanidine hydrochloride 6.864 mg).
Other ingredients are: ethylcellulose, shellac, talc, maize starch, sucrose, titanium dioxide, gelatin, black iron oxide, ammonium hydroxide.

What Sirdalud MR looks like and contents of the pack
White, opaque hard gelatin capsules, size 2, with grey printing "Sirdalud" on the cap and "6 mg" on the body, containing round pellets ranging in colour from white to slightly beige.
The capsules are packed in blisters contained in a cardboard box.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Importers
Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana
Slovenia
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Poland
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Vía de les Corts Catalanes 764
08013 Barcelona
Spain

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00