Navizan

Package Leaflet: Information for the User

NAVIZAN 2 mg and 4 mg Tablets

(tizanidine)
Generic Medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NAVIZAN is and what it is used for

The active substance tizanidine belongs to a group of medicines called centrally-acting muscle relaxants, which work by relaxing muscles.
NAVIZAN is used to treat involuntary muscle contractions (muscle spasms) causing pain:

• associated with spinal column disorders (arthrosis-related syndromes in the cervical and lumbar regions, torticollis, lumbar pain, etc.);
• following surgical procedures (disc herniation, hip arthrosis, etc.).

NAVIZAN is also used to treat increased resting muscle tone (spasticity) due to neurological conditions such as:

• multiple sclerosis;
• chronic spinal cord disease (chronic myelopathy);
• degenerative spinal cord diseases;
• damage to cerebral blood vessels (cerebrovascular accidents).

2. What you need to know before taking NAVIZAN

Do not take NAVIZAN:

• if you are allergic to tizanidine or to any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems
• if you are taking medicines called fluvoxamine or ciprofloxacin.

Tizanidine is not indicated for children and elderly patients.
Warnings and precautions
Talk to your doctor or pharmacist before taking NAVIZAN:

• if you have kidney disease

Other medicines and NAVIZAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking any of the following:

• oral contraceptives
• antibiotics called norfloxacin, enoxacin or rifampicin
• ticlopidine, used to thin the blood
• cimetidine, used for stomach ulcers
• medicines that may cause drowsiness, for example sedatives (such as diazepam or temazepam)
• medicines for high blood pressure (for example: diuretics, beta-blockers or clonidine)
• medicines for heart rhythm disorders (for example: digoxin, amiodarone, mexiletine or propafenone)
• medicines that may affect the heart's electrical rhythm (QT prolongation, for example: amitriptyline and azithromycin)

Smoking and NAVIZAN
Inform your doctor if you are a smoker, as your tizanidine dose may need to be increased.
NAVIZAN with food, drinks and alcohol
Alcohol may increase the sedative effect of tizanidine or the occurrence of side effects. You should not drink alcohol while taking tizanidine. Consult your doctor before drinking alcohol with tizanidine.
Pregnancy and breastfeeding
Tizanidine is not indicated during 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 taking this medicine.
Driving and using machines
Tizanidine may in some people cause blurred vision, drowsiness or dizziness. If you experience these symptoms, you must not drive or operate machinery.
NAVIZAN contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take NAVIZAN

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Involuntary muscle contractions (muscle spasms) causing pain.
The recommended dose is 2 to 4 mg 2–3 times daily.
In severe cases, your doctor may decide to prescribe you an additional tablet of 2 or 4 mg, preferably before
going to bed.
Increased muscle tone due to neurological disorders
Your doctor will determine the most appropriate dose for you.
The initial dose should not exceed 6 mg per day, divided into 3 doses. Your doctor will then instruct you
to gradually increase the dose by 2–4 mg every 3–6 days.
In most patients, optimal therapeutic response is generally achieved with a dose of 12–24 mg,
divided into 3 or 4 daily doses.
Do not exceed the maximum daily dose of 36 mg.
During treatment, your doctor will evaluate whether it may be possible to reduce the dose.
If you take more NAVIZAN than you should
If you take a higher dose of tizanidine, contact immediately your doctor or go to the Emergency
Department of the nearest hospital. Take the package and this leaflet with you, so that the doctor knows what you are taking.
If you forget to take NAVIZAN
If you forget to take your morning dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten
tablet.
If you stop taking NAVIZAN
The following adverse effects have been observed when patients stop taking tizanidine suddenly after a long period of treatment, particularly in patients who have taken high
doses of tizanidine or who are taking tizanidine together with medicines used to lower blood pressure: high blood pressure, increased heart rate (which may cause headache, blurred vision). Consult your doctor before stopping treatment with tizanidine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately inform your doctor if you experience signs of liver damage, such as dark urine or
yellowing of the skin or eyes, or signs of an allergic reaction such as swelling of the face, lips or
tongue, sudden shortness of breath, itching or hives.
Other side effects include:
Very common side effects (affect more than 1 in 10 patients)

• Drowsiness, fatigue, muscle weakness
• Dry mouth, stomach discomfort
• Dizziness

Common side effects (affect between 1 and 10 in 100 patients)

• Difficulty falling asleep or sleep disturbances
• Low blood pressure
• Feeling unwell
• Abnormal liver function tests (may be detected in a blood test)

Uncommon side effects (affect between 1 and 10 in 1,000 patients)

• Slower heart rate

The following side effects have been reported with the use of tizanidine, but it is not known how often they occur: hallucinations, feeling confused, seizures, vertigo (sensation of spinning or dizziness), loss of consciousness, liver inflammation, feeling weak, blurred vision, stomach ache, vomiting, itching, slurred speech, allergic reactions.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 NAVIZAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." (month/year). The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NAVIZAN contains

• Each tablet contains 2 mg or 4 mg of tizanidine as the active substance.
• The other excipients are: anhydrous lactose, microcrystalline cellulose, anhydrous colloidal silica, and stearic acid.

Description of the appearance of NAVIZAN and contents of the pack
NAVIZAN 2 mg tablets are white to off-white, oval, flat tablets with bevelled edges, marked “R179” on one side and scored with a single notch on the other.
NAVIZAN 4 mg tablets are white to off-white, oval, flat tablets with bevelled edges, marked “R180” on one side and divided into four parts by a cross-shaped notch on the other.
The notch on the tablet is only intended to facilitate breaking for easier swallowing and does not allow division into equal doses.
NAVIZAN 2 mg and 4 mg tablets are available in packs containing 15, 20, 30, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I. B. N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM)
Manufacturer:
Special Product’s Line Spa, Via Fratta Rotonda Vado Largo, 1, Anagni (FR)
Savio Industrial S.r.l., Via Emilia, 21 - Pavia