Sirdalud 4 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sirdalud 4 mg tablets

Tizanidine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Sirdalud is and what it is used for
2. What you need to know 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 Sirdalud is and what it is used for

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

• spinal problems, such as lumbago and torticollis
• surgical interventions, such as for example disc herniation or chronic inflammatory hip disease
• neurological disorders such as for example multiple sclerosis (a disease affecting the covering of central nerves), chronic myelopathy (spinal cord injury), degenerative disorders of the spinal cord, cerebrovascular accidents (strokes or cerebral hemorrhages), or cerebral palsy.

2. WHAT YOU NEED TO KNOW BEFORE STARTING TO 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 containing fluvoxamine (used to treat depression) or ciprofloxacin (an antibiotic used to treat infections)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine, and 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 experience nausea, fatigue, or loss of appetite, you must inform your doctor, as periodic blood tests to monitor liver function may be required
• If you are simultaneously taking medicines for high blood pressure, as Sirdalud may cause low blood pressure, especially when standing up or getting to your feet
• 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 insufficient to maintain normal metabolism)
• If you are simultaneously taking oral contraceptives, 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 planning to become pregnant, as Sirdalud could be harmful to the fetus
• Before starting treatment with Sirdalud, your doctor may request a pregnancy test to ensure you are not pregnant. During treatment with Sirdalud and at least until one day after stopping the medication, reliable contraception methods are recommended. Consult your doctor about the most appropriate methods to use during this period
• Do not stop treatment abruptly; consult your doctor, as this may cause hypertension and tachycardia, especially if you are taking antihypertensive medicines
• May cause hypersensitivity reactions, see section 4
• May cause visual disturbances and sedation, which may interfere with daily activities

Taking Sirdalud with other medicines

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

• Fluvoxamine (used to treat depression) is contraindicated
• Ciprofloxacin (an antibiotic used to treat infections) is contraindicated
• Antiarrhythmics (medicines used to treat irregular heart rhythms)
• Cimetidine (medicines used to treat duodenal or gastric ulcers)
• Cisapride (medicines used to treat heartburn and esophageal reflux)
• Fluoroquinolones, azithromycin, and rifampicin (antibiotics used to treat certain infections)
• Rofecoxib (medicines used to relieve pain or inflammation)
• Oral contraceptives (medicines used to prevent unwanted pregnancy), as the effects of Sirdalud may be intensified
• Amitriptyline (medicines used to treat depression)
• Ticlopidine (a medicine used to reduce the risk of stroke)

Sirdalud may enhance the effects of:

• Antihypertensives (medicines used to treat high blood pressure)
• Diuretics (medicines that increase urine production)
• Sedatives (medicines that reduce nervous excitement)
• Hypnotics (medicines used to induce sleep)
• Antihistamines (medicines used for allergies)
• Strong analgesics (medicines used to treat severe pain)

Taking Sirdalud with food and drinks

Alcohol may increase the sedative effects of Sirdalud; therefore, you are advised not to 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.

Sirdalud must not be taken during pregnancy or breastfeeding. A pregnancy test is recommended before starting treatment.

Use effective contraceptive methods in women of childbearing age during treatment and for at least one day after discontinuation of treatment.

Driving and using machines

Sirdalud may cause drowsiness, dizziness, cold sweats, and visual flashes; therefore, you must not drive or operate dangerous machinery while taking this medicine.

Important information about some of the ingredients of Sirdalud

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. HOW TO TAKE SIRDALUD

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Remember to take your medicine. Your doctor will tell you how long to continue treatment with Sirdalud. Do not stop or extend the treatment earlier than advised.

Swallow the tablets with a glass of water. The tablets may be split along the score line.

Recommended dose:

Adults

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

Patients with kidney disease

A dose reduction may be necessary if you have kidney disease, so you must inform your doctor so that your dose can be appropriately adjusted.

Patients with liver disease

A dose reduction may be necessary if you have liver disease, so you must inform your doctor so that your dose can be appropriately adjusted.

Use in children

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

Elderly

Experience in elderly patients is limited. Treatment should be initiated at the lowest dose, and your doctor will adjust the dose appropriately.

If you take more Sirdalud than you should

Inform your doctor or pharmacist, or go to the nearest hospital. You may require urgent medical attention. Symptoms of overdose include nausea, vomiting, low blood pressure, slowed heart rate, dizziness, drowsiness, pupil constriction, agitation, difficulty breathing, or coma.

In cases of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Sirdalud

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and take the next dose at the scheduled time.

If you stop taking Sirdalud

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Nervous system disorders: somnolence, dizziness

Gastrointestinal disorders: gastrointestinal disturbances, dry mouth

General disorders and administration site conditions: fatigue

Musculoskeletal and connective tissue disorders: muscle weakness

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

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 (affects at least 1 in 1,000 patients but less than 1 in 100 patients):

Cardiac disorders: slowing of the heart rate.

Frequency not known (cannot be estimated from 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), redness of the skin (erythema), itching (pruritus), and itchy rash (skin eruption and urticaria)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 stated on the packaging. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of Sirdalud

• The active substance is tizanidine.

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

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

Appearance of the product and contents of the pack

Sirdalud 4 mg tablets are presented as white, circular tablets, cross-scored on one side and marked with "RL" on the other. Each pack contains 30 tablets.

Marketing Authorization Holder

BEXAL FARMACÉUTICA, S.A.

Parque Norte Business Centre

Roble Building

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 the most recent revision of this leaflet: January 2020