SIRDALUD 4 mg Tablets

Зміст інструкції

1. Sirdalud 2 mg tablets, 4 mg tablets, 6 mg tablets
   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

Sirdalud 2 mg tablets, 4 mg tablets, 6 mg tablets

tizanidine

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

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sirdalud is and what it is used for
• 2. What you need to know before you take 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 contains the active ingredient tizanidine, a substance that belongs to the class of central muscle relaxants and
that works by relaxing the muscles.
Sirdalud is used to treat involuntary muscle contractions (muscle spasms) that cause pain:

• associated with problems of the spine (arthrotic syndromes in the cervical and lumbar area, torticollis, lower back pain, etc.);
• resulting from surgical interventions (herniated disc, hip arthrosis, etc.).

Sirdalud is also used to treat increased muscle tone at rest (spasticity) due to problems of a
neurological type such as:

• multiple sclerosis;
• chronic spinal cord disease (chronic myelopathy);
• degenerative diseases of the spinal cord;
• damage to the vessels of the brain (cerebrovascular accidents).

2. What you need to know before taking Sirdalud

Do not take Sirdalud

• if you are allergic to tizanidine or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver problems
• if you are taking medicines that contain the active ingredient fluvoxamine (used to treat depression) or ciprofloxacin (antibiotic used to treat infections). See also section Other medicines and Sirdalud.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sirdalud.
Tell your doctor:

• if you experience symptoms of liver dysfunction such as unexplained nausea, decreased or loss of appetite and loss of strength (asthenia) because your doctor will have you undergo tests to assess liver function every month for the first 4 months of treatment with Sirdalud and will evaluate whether to continue treatment
• if you have kidney problems because the doctor may decide to prescribe you a low daily dose of Sirdalud
• if you have heart or blood circulation problems (cardiovascular and coronary insufficiency), in these cases the doctor will have you undergo regular electrocardiograms and other diagnostic tests.

Pay particular attention:

• because you may experience episodes of low blood pressure during treatment with Sirdalud which may also be severe (loss of consciousness and circulatory system collapse)
• if you are taking a daily dose of Sirdalud of 12 mg or more because you may have liver problems. The doctor will have you undergo tests to assess liver function every month for the first 4 months of treatment with Sirdalud and will evaluate whether to continue treatment
• if you experience a severe allergic reaction in the first few days after starting treatment with Sirdalud. If you experience symptoms such as swelling of the lips, eyelids, face, throat or mouth (angioedema), sudden breathing problems, skin rash or blisters on the skin, dryness and redness of the skin, itching, contact your doctor immediately.

Children and adolescents
Administration to children and adolescents under 18 years of age is not recommended.

Other medicines and Sirdalud
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Sirdalud with:

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

Tell your doctor and be particularly careful if you take:

• antiarrhythmic medicines (used to treat irregular heartbeat) such as amiodarone, mexiletine and propafenone
• cimetidine (used to treat ulcers)
• fluoroquinolones (antibiotics used to treat infections) such as enoxacin, pefloxacin and norfloxacin
• rofecoxib (used to reduce pain and inflammation)
• oral contraceptives
• ticlopidine (used to reduce the risk of stroke)
• clonidine or other alpha2-adrenergic medicines (used to lower blood pressure)
• medicines that can cause an alteration of the heart rhythm called “prolongation of the QT interval”, for example cisapride, amitriptyline, azithromycin: concomitant use with tizanidine at high doses is not recommended.
• medicines to reduce blood pressure, including diuretics
• rifampicin (antibiotic used to treat infections)
• sedative and hypnotic medicines (used to reduce anxiety and induce sleep) such as benzodiazepines or baclofen
• antihistamines (used to reduce allergy symptoms)

Tell your doctor if you smoke heavily (more than 10 cigarettes a day) and are male because it may be
necessary to increase the dose of Sirdalud.

Sirdalud with alcohol
During treatment with Sirdalud you should reduce or avoid alcohol consumption because it may increase the risk
of experiencing unwanted effects such as sedation and hypotension.
Sirdalud can increase the depressive effect of alcohol on the central nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, the doctor will assess whether the benefits for you clearly outweigh the risks to the fetus before
prescribing Sirdalud.
Before starting treatment with Sirdalud, the doctor may ask you to undergo a pregnancy test to
ensure that you are not pregnant. It is recommended to use a reliable method of contraception
during the intake of Sirdalud and the day after discontinuation of treatment.
Breastfeeding
Do not take Sirdalud if you are breastfeeding.

Driving and using machines
You must not drive vehicles or use machines if you experience any symptoms related to low
blood pressure, drowsiness or dizziness. If you take Sirdalud together with alcohol, these effects may be increased.

Sirdalud contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Sirdalud

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Involuntary muscle contractions (muscle spasms) that cause pain.
The recommended dose is 2 to 4 mg 2-3 times a day.
In severe cases, the doctor will assess whether to have you take also 1 tablet of 2 or 4 mg, preferably before going to
bed.
Increased muscle tone following neurological disorders
The doctor will assess the most suitable dose for you.
The initial dose should not exceed 6 mg per day divided into 3 administrations. The doctor will then tell you to
gradually increase the dose by 2-4 mg every 3-6 days.
In most patients, the optimal therapeutic response is generally achieved with a dose of
12-24 mg divided into 3 or 4 daily administrations
Do not exceed the maximum daily dose of 36 mg.
During the course of treatment, the doctor will assess whether it is possible to reduce the dose.

Use in elderly patients
Experience with the use of Sirdalud in the elderly is limited. Therefore, the doctor will prescribe you the lowest dose of
Sirdalud and tell you to increase the dose gradually.

Use in patients with severe kidney problems
The recommended dose at the beginning of treatment is 2 mg once a day. The doctor will then increase the dose
gradually.

Use in patients with liver problems
In patients with severe liver problems, the use of Sirdalud is contraindicated (see “Do not use Sirdalud”).
If you have moderate liver problems, the doctor will keep you under strict control and prescribe you the lowest dose of
Sirdalud. The doctor will carefully assess how to increase the dose of Sirdalud.

If you take more Sirdalud than you should
In case of accidental ingestion of an excessive dose of Sirdalud, immediately inform your doctor or go to
the nearest hospital.
The doctor will treat the accidental ingestion of an excessive dose of Sirdalud based on your condition.
The symptoms that occur if you take more Sirdalud than you should are:

• nausea
• vomiting
• lowering of blood pressure
• alterations in heart rate (prolongation of the QT interval)
• dizziness
• decrease in pupil diameter (miosis)
• respiratory disorders
• coma
• agitation
• drowsiness

If you forget to take Sirdalud
Do not take a double dose to make up for a missed dose.

If you stop taking Sirdalud
Do not suddenly stop treatment with Sirdalud, especially if you have been taking Sirdalud for a long time, at
high doses or if you are also taking other medicines used to lower blood pressure. This is because
you may experience a sudden increase in blood pressure and increased heart rate
(tachycardia). In extreme cases, hypertension could cause a stroke. See paragraph 4.
If you need to stop treatment with Sirdalud, consult your doctor who will gradually reduce the dose. The
dosage must be decreased slowly to avoid or decrease the risk of increased blood pressure
(hypertension) and tachycardia.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people)

• stomach or intestinal disorders
• dry mouth
• muscle weakness
• fatigue
• drowsiness
• dizziness

Common side effects (may affect up to 1 in 10 people)

• nausea
• insomnia
• sleep disorders
• low blood pressure
• increase in certain liver enzymes indicating liver problems (transaminases)

Uncommon side effects (may affect up to 1 in 100 people)

• slowed heartbeat (bradycardia)

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• hallucinations
• confused state
• confused speech
• vertigo
• syncope
• blurred vision
• stomach pain
• vomiting
• liver inflammation (hepatitis)
• liver failure
• loss of strength (asthenia)
• itching
• allergic reactions with swelling of the lips, eyelids, face, throat or mouth accompanied by difficulty breathing (signs of anaphylactic reactions and angioedema), rash, blisters on the skin, dry and reddened skin, itching (signs of dermatitis, urticaria and erythema).

Withdrawal syndrome
After sudden discontinuation of Sirdalud, a sudden increase in blood pressure and an increase in
heart rate (tachycardia) have been observed. In extreme cases, hypertension could cause stroke.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Sirdalud

Sirdalud 2 mg tablets and Sirdalud 4 mg tablets

• This medicine does not require any particular storage conditions.

Sirdalud 6 mg tablets

• Do not store at a temperature above 25°C.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Expires.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sirdalud contains
Sirdalud 2 mg tablets

• The active ingredient is tizanidine hydrochloride. Each tablet contains 2.29 mg of tizanidine hydrochloride (corresponding to 2 mg of tizanidine base).
• The other ingredients are: anhydrous colloidal silica, stearic acid, microcrystalline cellulose, anhydrous lactose.

Sirdalud 4 mg tablets

• The active ingredient is tizanidine hydrochloride. Each tablet contains 4.58 mg of tizanidine hydrochloride (corresponding to 4 mg of tizanidine base).
• The other ingredients are: anhydrous colloidal silica, stearic acid, microcrystalline cellulose, anhydrous lactose.

Sirdalud 6 mg tablets

• The active ingredient is tizanidine hydrochloride. Each tablet contains 6.86 mg of tizanidine hydrochloride (corresponding to 6 mg of tizanidine base).
• The other ingredients are: anhydrous colloidal silica, stearic acid, microcrystalline cellulose, anhydrous lactose.

Description of the appearance of Sirdalud and contents of the pack
Each pack of Sirdalud 2 mg tablets contains 20 tablets of 2 mg.
Each pack of Sirdalud 4 mg tablets contains 30 tablets of 4 mg.
Each pack of Sirdalud 6 mg tablets contains 30 tablets of 6 mg.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata - NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcellona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany