SIRDALUD 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sirdalud 4 mg Tablets

Tizanidine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack and other information

1. What is Sirdalud and what is it used for
2. What you need to know before you take Sirdalud
3. How to take Sirdalud
4. Possible side effects
5. Storing Sirdalud
6. Contents of the pack and further information

1. What is Sirdalud and what is it used for

Sirdalud belongs to a group of medicines called muscle relaxants (medicines used to relax muscles). It is indicated for the treatment of muscle problems associated with:

• spinal problems, such as lumbago and torticollis
• surgical interventions, such as herniated disc or inflammatory disease of the hip

chronic disease of the hip

• neurological disorders such as multiple sclerosis (a disease that affects the coating of the central nerves), chronic myelopathy (lesion in the spinal cord), degenerative disorders of the spinal cord, cerebrovascular accidents (strokes or cerebral hemorrhages) or cerebral palsy.

2. What you need to know before you take Sirdalud

Do not take Sirdalud

• If you are allergic to the active substance or to any of the other ingredients of this medicine

(listed in section 6)

• If you have severe liver disease
• If you are taking medicines that contain fluvoxamine (used to treat depression) or ciprofloxacin (antibiotic to treat infections)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine, especially:

• If you have any liver or kidney disease, as your doctor may need to adjust your dose of Sirdalud

If you are taking more than 3 tablets (12 mg of tizanidine) per day and feel nausea, fatigue, and have no appetite, you should inform your doctor as you may need to have periodic tests to check your liver function

• If you are taking blood pressure medications at the same time, as Sirdalud may cause low blood pressure, especially when standing up or getting up

Sirdalud may cause serious symptoms due to low blood pressure, such as loss of consciousness and circulatory collapse (the volume of fluid circulating in the body is not sufficient to maintain normal metabolism)

• If you are taking oral contraceptives at the same time, your doctor may need to adjust the dose of Sirdalud

If you are a smoker (more than 10 cigarettes per day)

• If you are pregnant or plan to become pregnant, as Sirdalud may be harmful to the fetus.
• Before starting treatment with Sirdalud, your doctor may ask you to have a pregnancy test to ensure you are not pregnant. During treatment with Sirdalud and at least until one day after stopping it, it is also recommended to use reliable methods to avoid pregnancy. Consult your doctor about the most suitable methods to use during this period.
• Do not stop treatment abruptly, consult your doctor, as it may cause hypertension and tachycardia, especially if you are taking antihypertensives.
• It may cause hypersensitivity reactions, see section 4.
• It may cause visual disturbances and sedation, and may interfere with daily activities.

Taking Sirdalud with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines:

• fluvoxamine (used to treat depression) is contraindicated
• ciprofloxacin (antibiotic to treat infections) is contraindicated

• antiarrhythmics (medicines to treat heart rhythm disorders)
• cimetidine (medicines to treat duodenal or gastric ulcers)
• cisapride (medicines to treat heartburn and esophageal reflux)
• fluoroquinolones, acitromycin, and rifampicin (antibiotics used to treat certain infections)
• rofecoxib (medicines used to relieve pain or inflammation),
• oral contraceptives (medicines used to prevent unwanted pregnancies), as they may increase the effects of Sirdalud

Sirdalud may enhance the effects of:

• antihypertensives (medicines for high blood pressure)
• diuretics (medicines that increase urine production)
• sedatives (medicines that reduce nervous excitement)
• hypnotics (sleeping medicines)
• antihistamines (medicines used for allergies)
• potent analgesics (medicines used to treat intense pain)

Taking Sirdalud with food and drinks

Alcohol may increase the sedative effects of Sirdalud, so it is recommended that you do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take during pregnancy or breastfeeding. A pregnancy test is recommended before starting treatment.

Use contraceptive methods in women of childbearing age during treatment and at least until one day after stopping it.

Driving and using machines

Sirdalud may make you feel drowsy, dizzy, and cause sweating, see flashes, so you should not drive or use hazardous machinery while taking this medicine.

Important information about some of the ingredients of Sirdalud

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Sirdalud

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Remember to take your medicine. Your doctor will indicate the duration of your treatment with Sirdalud. Do not stop it before or prolong it.

Swallow the tablets with a glass of water. The tablets can be broken in half.

The recommended dose is:

Adults

Half or one tablet (2 mg to 4 mg of tizanidine) three times a day. In severe cases, it may be increased up to a maximum daily dose of four tablets (16 mg of tizanidine). Patients with neurological disorders should not take more than nine tablets per day (36 mg of tizanidine).

Patient with kidney disease

A dose reduction may be necessary if you have kidney disease, so you should inform your doctor to adjust the dose accordingly.

Patient with liver disease

A dose reduction may be necessary if you have liver disease, so you should inform your doctor to adjust the dose accordingly.

Use in children

Experience in children is limited, therefore its use is not recommended in children under 18 years of age.

Elderly

Experience in the elderly is limited. Treatment should be started with the lowest dose and your doctor will adjust the dose accordingly.

If you take more Sirdalud than you should

Tell your doctor or pharmacist or go to the nearest hospital. You may need urgent medical attention. The symptoms of overdose are nausea, vomiting, low blood pressure, slow heart rate, dizziness, drowsiness, contraction of the pupils, agitation, difficulty breathing, or coma.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Sirdalud

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible, unless it is almost time for the next dose, in which case skip the missed dose and take the next dose when it is due.

If you stop taking Sirdalud

Do not change or stop taking Sirdalud without first consulting your doctor. Your doctor will gradually reduce the dose before stopping treatment completely. This will prevent worsening and reduce the risk of hypertension (high blood pressure, headache, dizziness) or tachycardia (rapid heart rate).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(at least 1 in 10 patients) are:

Nervous system disorders: drowsiness, dizziness

Gastrointestinal disorders: gastrointestinal disturbances, dry mouth

General disorders and administration site conditions: fatigue

Musculoskeletal and connective tissue disorders: muscle weakness

Common(at least 1 in 100 patients but less than 1 in 10 patients) are:

Psychiatric disorders: insomnia, sleep disorders

Vascular disorders: decreased blood pressure. Consult your doctor immediately.

Gastrointestinal disorders: nausea

Investigations: a transient increase in liver enzymes (transaminases) may occur.

Uncommon(at least 1 in 1000 patients but less than 1 in 100 patients) are:

Cardiac disorders: slow heart rate.

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

Immune system disorders: allergic reactions, severe allergic reactions including difficulty breathing, dizziness (anaphylaxis) and swelling mainly of the face and throat (angioedema). Consult your doctor immediately.

Psychiatric disorders: hallucinations, confusion. Consult your doctor immediately.

Nervous system disorders: vertigo, speech confusion

Vascular disorders: fainting

Eye disorders: blurred vision

Gastrointestinal disorders: stomach pain, vomiting

Hepatobiliary disorders: acute hepatitis, liver failure. Consult your doctor immediately.

Skin and subcutaneous tissue disorders: skin inflammation with rash (dermatitis), skin redness (erythema), itching (pruritus), and itchy rash (urticaria and rash)

General disorders: loss of vitality and withdrawal symptoms (rebound hypertension and tachycardia).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sirdalud

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sirdalud

• The active substance is tizanidine.

Each tablet contains 4 mg of tizanidine (as hydrochloride).

• The other ingredients are lactose, microcrystalline cellulose, stearic acid, and anhydrous colloidal silica.

Appearance of the product and pack contents

Sirdalud 4 mg tablets are presented as a circular tablet, white in color, scored on one face and marked with RL on the other. Each pack contains 30 tablets.

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Novartis Farmacéutica, S. A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

or

Lek Pharmaceuticals d.d.

Verovskova Ulica 57,

Ljubljana 1526,

Slovenia

Date of last revision of this leaflet:January 2020