Tizanidine Doc Generici

Package leaflet: Information for the patient

TIZANIDINA DOC 2 mg tablets, 4 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TIZANIDINA DOC is and what it is used for

TIZANIDINA DOC contains the active substance tizanidine, a compound belonging to the class of
centrally-acting muscle relaxants, which works by relaxing muscles.
TIZANIDINA DOC is used to treat involuntary muscle contractions (muscle spasms) that cause pain:

• associated with spinal disorders (osteoarthritic syndromes of the cervical and lumbar regions, torticollis, lower back pain, etc.);
• following surgical procedures (herniated disc, hip osteoarthritis, etc.).

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

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

2. What you should know before taking TIZANIDINE DOC

Do not take TIZANIDINE DOC

• if you are allergic to tizanidine or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely impaired liver function.
• if you are taking certain medicines containing fluvoxamine (used to treat depression) or ciprofloxacin (an antibiotic) (see also “Other medicines and TIZANIDINE DOC”).

Warnings and precautions
Talk to your doctor before taking TIZANIDINE DOC.
Inform your doctor:

• if you have kidney problems. A lower dose may be required.
• if you have heart problems such as coronary artery disease.
• if you have liver problems. Your doctor may regularly monitor your liver enzymes, especially when taking higher doses. Stop taking TIZANIDINE DOC and contact your doctor immediately if you develop yellowing of the skin or whites of the eyes (“jaundice”), or if you experience unexplained nausea, anorexia, or fatigue.

Take special care:

• because you may experience episodes of low blood pressure during treatment with TIZANIDINE DOC, which may be severe (loss of consciousness and circulatory collapse);
• if you are taking a daily dose of tizanidine equal to or greater than 12 mg, as you may be at risk of liver problems. Your doctor will perform liver function tests monthly during the first 4 months of treatment with TIZANIDINE DOC and will evaluate whether to continue treatment;
• if you develop a severe allergic reaction in the first days after starting treatment with TIZANIDINE DOC. If you experience symptoms such as swelling of the lips, eyelids, face, throat or mouth (angioedema), sudden breathing difficulties, skin rash or blisters, dryness and redness of the skin, or itching, contact your doctor immediately.

Children and adolescents
TIZANIDINE DOC is not recommended for children and adolescents under 18 years of age because experience with tizanidine in this patient group is limited.

Other medicines and TIZANIDINE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIZANIDINE DOC must not be taken together with fluvoxamine (used to treat depression) or ciprofloxacin (an antibiotic) (see “Do not take TIZANIDINE DOC”).
Inform your doctor or pharmacist especially if you are taking:

• any medicine to treat abnormal heart rhythm, such as amiodarone, mexiletine, propafenone or verapamil.
• cimetidine or famotidine (for indigestion and peptic ulcer).
• certain antibiotics, such as rifampicin, or so-called “fluoroquinolones” (such as enoxacin, pefloxacin, norfloxacin).
• rofecoxib, a pain reliever.
• aciclovir, an antiviral drug.
• oral contraceptives. You may be more sensitive to lower doses of TIZANIDINE DOC if you are taking oral contraceptives.
• ticlopidine (to prevent blood clots).
• any medicine used to treat high blood pressure, including diuretics.
• clonidine or other α2-adrenergic medicines (used to lower blood pressure).
• beta-blockers, for example atenolol, propranolol.
• digoxin (used to treat congestive heart failure and heart rhythm problems).
• any sedative (sleeping pills or medicines for anxiety).
• any other medicine that, when taken with tizanidine, could affect heart rhythm. Check with your doctor or pharmacist.
• medicines that may cause a heart rhythm disturbance called “QT interval prolongation”, such as cisapride, amitriptyline, azithromycin: concomitant use with high-dose tizanidine is not recommended.
• antihistamines (used to reduce allergy symptoms).

TIZANIDINE DOC with food, drinks and alcohol
TIZANIDINE DOC can be taken with or without food.
Do not take TIZANIDINE DOC with alcohol, as it may increase the sedative effect of tizanidine.

TIZANIDINE DOC and cigarette smoking
Cigarette smoking may reduce the effect of tizanidine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy
If you are pregnant, your doctor will assess whether the benefits to you outweigh the risks to the fetus before prescribing tizanidine.
Before starting treatment with TIZANIDINE DOC, your doctor may ask you to take a pregnancy test to ensure you are not pregnant. It is recommended to use a reliable method of contraception during treatment with tizanidine and on the day after stopping treatment.

Breastfeeding
Do not take TIZANIDINE DOC if you are breastfeeding.

Driving and using machines
TIZANIDINE DOC may cause drowsiness and dizziness. This may impair your ability to drive or operate tools or machinery. You should not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

TIZANIDINE DOC contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take TIZANIDINA DOC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Involuntary muscle contractions (muscle spasms) causing pain
The recommended dose for adults is 2–4 mg three times daily.
In more severe cases, an additional dose of 2–4 mg may be required. This additional dose should be taken late in the evening.

Increased muscle tone due to neurological disorders
The usual initial dose for adults is 2 mg three times daily.
Subsequently, the dose may be gradually increased up to 12–24 mg daily, divided into 3–4 equal doses.
The maximum daily dose is 36 mg.

Use in children and adolescents up to 18 years of age
TIZANIDINA DOC must not be taken by children, as its use in children has not been sufficiently evaluated.

Use in elderly patients
Experience with the use of tizanidine in the elderly is limited. In addition, renal function may be impaired in elderly patients. Therefore, TIZANIDINA DOC should be used with caution in this patient group.

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

Use in patients with liver problems
Tizanidine is contraindicated in patients with severe liver problems (see “Do not use TIZANIDINA DOC”).
If you have moderate liver problems, your doctor will monitor you closely and prescribe the lowest dose of TIZANIDINA DOC. Your doctor will carefully evaluate how to increase the dose of TIZANIDINA DOC.

How to take TIZANIDINA DOC
TIZANIDINA DOC is for oral use.
The tablets should be swallowed with a glass of water.
You may take TIZANIDINA DOC with or without food.
The tablet may be divided into equal doses.

If you take more TIZANIDINA DOC than you should
If you (or someone else) take too many tablets, or if you think a child has swallowed one of the tablets, contact the nearest emergency department or your doctor immediately.
Overdose may cause nausea, vomiting, low blood pressure, slow or irregular heartbeat, dizziness, small pupils, breathing difficulties, coma, restlessness, or drowsiness.

If you forget to take TIZANIDINA DOC
Do not take a double dose to make up for the missed dose.

If you stop taking TIZANIDINA DOC
Do not stop treatment with TIZANIDINA DOC suddenly, especially if you have been taking TIZANIDINA DOC 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 lead to stroke. See section 4.
If you need to stop treatment with TIZANIDINA DOC, consult your doctor, who will gradually reduce your dose. The dose should be decreased slowly to avoid or reduce the risk of increased blood pressure (hypertension) and tachycardia.

If you have any questions 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 everyone experiences them.
At low doses, such as those recommended for relief of painful muscle spasms, side effects are usually mild and transient.
At higher doses, recommended for the treatment of spasticity, side effects occur more frequently and are more pronounced, but are rarely so severe as to require discontinuation of treatment.

The following side effects have been reported:

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

• Difficulty sleeping or falling asleep
• Dry mouth, gastrointestinal disturbances
• Muscle weakness

Common (may affect up to 1 in 10 people)

• Drowsiness, lethargy, dizziness, fatigue
• Slow or fast heartbeat
• Low or reduced blood pressure
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Increased levels of liver enzymes in the blood

Not known (frequency cannot be estimated from the available data)

• Infections, stuffy or runny nose, throat infections
• Allergic reactions:
  o Hives
  o Severe, life-threatening allergic reaction requiring immediate medical treatment. The reaction may include extremely low blood pressure, swelling of the throat, difficulty breathing, and loss of consciousness.
• Confusion, nervousness, hallucinations (seeing and/or hearing things that are not real)
• Headache
• Difficulty controlling movements, involuntary muscle movements, difficulty speaking
• Fainting
• Sensation of spinning (vertigo)
• Difficulty focusing vision, blurred vision
• Irregular heart rhythms
• Vomiting, abdominal pain, constipation
• Liver infection or liver failure
• Itching, skin rash, skin infection
• Urinary tract infection
• Unusually frequent passage of relatively small amounts of urine
• Loss of appetite
• Feeling weak, flu-like illness

Withdrawal syndrome
After abrupt discontinuation of tizanidine, sudden increase in blood pressure and increased heart rate (tachycardia) have been observed. In extreme cases, hypertension could lead to stroke in the brain.

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 TIZANIDINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 TIZANIDINE DOC contains

• The active substance is tizanidine. Each tablet contains 2 mg of tizanidine (as 2.29 mg tizanidine hydrochloride) or 4 mg of tizanidine (as 4.57 mg tizanidine hydrochloride).
• The other ingredients are monohydrate lactose, pregelatinized starch (maize), macrogol 4000, stearic acid, sucrose, magnesium stearate.

Description of the appearance of TIZANIDINE DOC and package contents
TIZANIDINE DOC 2 mg tablets: round, biconvex tablets, white to yellowish in colour, with a score line on one side and a diameter of approximately 8 mm.
TIZANIDINE DOC 4 mg tablets: round, biconvex tablets, white to yellowish in colour, with a score line on one side and a diameter of approximately 8 mm.
TIZANIDINE DOC 2 mg is available in PVC/PVdC/PVC-aluminium blisters containing 20 tablets.
TIZANIDINE DOC 4 mg is available in PVC/PVdC/PVC-aluminium blisters containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl - Via Turati 40 - 20121 Milan, Italy.

Manufacturer
G.L. Pharma GmbH - Schlossplatz 1, A-8502 Lannach, Austria.