Sirdalud 2 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sirdalud 2 mg tablets
Tizanidine
Read the entire leaflet carefully before you start taking this medicine, because 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, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Sirdalud is and what it is used for
- What you need to know before taking Sirdalud
- How to take Sirdalud
- Possible adverse effects
- How to store Sirdalud
- 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 problems associated with:
- spinal disorders, 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 the 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 taking Sirdalud
Do not take Sirdalud
- If you are allergic to the active substance or to any of the other components 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 6 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 up from a lying position
- 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 confirm you are not pregnant. During treatment with Sirdalud and for at least one day after stopping it, reliable contraception methods are recommended. Please 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.
- Hypersensitivity reactions may occur; see section 4.
- May cause visual disturbances and sedation, which could 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 heart rhythm disorders)
- 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 enhanced
- 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 excitation)
- hypnotics (medicines used to help sleep)
- antihistamines (medicines used for allergies)
- strong analgesics (medicines used to treat severe pain)
Taking Sirdalud with food and drink
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 are planning 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.
Women of childbearing age should use effective contraception during treatment and for at least one day after stopping the medicine.
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 components of Sirdalud
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Sirdalud
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor. If in doubt, ask your doctor or pharmacist.
Remember to take your medicine. Your doctor will tell you how long to take Sirdalud. Do not stop treatment earlier or extend it beyond the prescribed duration.
Swallow the tablets with a glass of water. The tablets may be divided along the score line.
Recommended dose:
Adults
One or two tablets (2 mg to 4 mg of tizanidine) three times daily. In severe cases, the dose may be increased up to a maximum of eight tablets daily (16 mg of tizanidine). Patients with neurological disorders should not take more than eighteen tablets per day (36 mg of tizanidine).
Patients with kidney disease
A dose reduction may be necessary if you have kidney disease; therefore, inform your doctor so that your dose can be adjusted appropriately.
Patients with liver disease
A dose reduction may be necessary or the medicine may be contraindicated if you have liver disease; therefore, inform your doctor so that your dose can be adjusted appropriately.
Use in children
Experience in children is limited; therefore, use is not recommended in individuals under 18 years of age.
Elderly
Experience in the elderly is limited. Treatment should be initiated with the lowest dose, and your doctor will adjust the dose appropriately.
If you take more Sirdalud than you should
Inform your doctor or pharmacist immediately 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, breathing difficulties, 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 can avoid worsening symptoms and reduce the risk of hypertension (high blood pressure, headache, dizziness) or tachycardia (increased heart rate).
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 experiences 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 primarily of the face and throat (angioedema). Consult your doctor immediately.
Psychiatric disorders: hallucinations, confusion. Consult your doctor immediately.
Nervous system disorders: dizziness, 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 Medicinal Products: 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 sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to 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. Unused medicines and containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sirdalud
- The active substance is tizanidine.
Each tablet contains 2 mg of tizanidine (as hydrochloride).
- The other components are lactose, microcrystalline cellulose, stearic acid and anhydrous colloidal silicon dioxide.
Appearance of the product and contents of the pack
Sirdalud 2 mg tablets are presented as white, round, scored tablets marked with "OZ". Each pack contains 30 tablets.
Marketing Authorization Holder
BEXAL FARMACÉUTICA, S.A.
Parque Norte Business Center
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
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es