Leaflet: information for the user

Sirdalud 4 mg tablets

Tizanidina

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

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

1. What Sirdalud is and for what it is used

2. What you need to know before starting to take Sirdalud

3. How to take Sirdalud

4. Possible side effects

5. Storage of Sirdalud

6. Contents of the pack and additional information

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

• back problems, such as lumbago and torticollis
• surgical interventions, such as for example herniated disc or inflammatory disease

chronic hip disease

• neurological disorders such as for example multiple sclerosis (a disease that affects the central nervous system's covering), chronic myelopathy (spinal cord injury), degenerative spinal cord disorders, cerebrovascular accidents (strokes or brain hemorrhages) or cerebral palsy.

Do not take Sirdalud

• If you are allergic to the active ingredient or any of the other components of this medication

(listed in section 6)

• If you have severe liver disease
• If you are taking medications 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 medication and especially:

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

• If you are taking more than 3 tablets (12 mg of tizanidine) per day and feel nausea, fatigue, and lack of appetite, you should inform your doctor as it may be necessary to perform periodic tests to monitor your liver function

• If you are taking medications for high blood pressure, as Sirdalud may cause blood pressure drops, especially when standing up or getting up

• Sirdalud may cause severe manifestations due to blood pressure drops, 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, your doctor may need to adjust your Sirdalud dose

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

- If you are pregnant or intend to become pregnant, as Sirdalud may be harmful to the fetus.

- Before starting treatment with Sirdalud, your doctor may ask you to perform a pregnancy test to ensure you are not pregnant. During treatment with Sirdalud and at least until a day after stopping, it is recommended to use reliable methods to avoid pregnancy. Consult your doctor about the most suitable methods to use during this time.

- Do not stop treatment abruptly, consult your doctor, as it may cause hypertension and tachycardia, especially if you are taking antihypertensive medications.

- It may cause hypersensitivity reactions, see point 4.

- It may cause visual disturbances and sedation, which may interfere with daily activities.

Taking Sirdalud with other medications

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

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

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

it may intensify the effects of Sirdalud

-amitriptiline (medications used to treat depression)

• ticlopidine (medication used to reduce the risk of suffering a cerebrovascular accident)

Sirdalud may intensify the effects of:

• antihypertensive medications (medications to treat high blood pressure)
• diuretics (medications that increase urine production)
• sedatives (medications that decrease nervous excitement)
• hypnotics (medications to sleep)
• antihistamines (medications used to treat allergies)
• potent analgesics (medications 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 medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take during pregnancy or breastfeeding. It is recommended to perform a pregnancy test before starting treatment with Sirdalud. During treatment with Sirdalud and at least until a day after stopping, it is recommended to use reliable methods to avoid pregnancy. Consult your doctor about the most suitable methods to use during this time.

Driving and operating machinery

Sirdalud may make you feel drowsy, cause dizziness and cold sweats, and see flashes, so you should not drive or operate hazardous machinery while taking this medication.

Important information about some of the components of Sirdalud

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

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

Swallow the tablets with a glass of water. The tablets can be split along the notch.

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 to a maximum daily dose of four tablets (16 mg of tizanidine). Patients with neurological disorders should not take more than nine tablets a day (36 mg of tizanidine).

Patients with any kidney disease

A dose reduction may be necessary if you have any kidney disease, so inform your doctor so that they can adjust the dose accordingly.

Patients with any liver disease

A dose reduction may be necessary if you have any liver disease, so inform your doctor so that they can adjust the dose accordingly.

Use in children

Experience in children is limited, therefore it is not recommended for use in children under 18 years.

Seniors

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

If you take more Sirdalud than you should

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

In cases of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you forgot to take Sirdalud

Do not take a double dose to compensate for the missed doses. Take the missed 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 interrupt treatment with Sirdalud

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Mental and behavioural 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.

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

Cardiac disorders: bradycardia.

Unknown frequency(cannot be estimated from available data):

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

Mental and behavioural disorders:hallucinations, confusion.Consult your doctor immediately

Nervous system disorders: vertigo, speech confusion

Vascular disorders: fainting

Eye disorders:blurred vision

Gastrointestinal disorders:abdominal pain, vomiting

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

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sirdalud

• The active ingredient is tizanidine.

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

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

colloidal anhydrous silica.

Appearance of the product and content of the container

Sirdalud 4 mg tablets are presented in the form of a white, circular, scored tablet on one face and with the mark RL on the other. Each container contains 30 tablets.

Holder of the marketing authorization

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:January 2020