Tradename

Silarud, Силаруд

International generic title

Tizanidine, Тизанидин

Compound

Each tablet contains:

Active ingredient: Tizanidine ( as Tizanidine Hydrochloride) USP 4 mg excipients : Q. S

Dosage form

Tablets.

Pharmacological properties

Mechanism of action

Tizanidine reduces spasticity by causing presynaptic inhibition of motor neurons through agonist action at alpha-2 adrenergic receptor sites. This drug has a central action and leads to decrease release of excitatory amino acids such as glutamate and aspartate, which excitation of neurons, which leads to muscle spasm.

Indications for use

Tizanidine is indicated in adults for the treatment of spasticity associated with disseminated sclerosis or injury or disease of the spinal brain.

Contraindications

Hypersensitivity to tizanidine or any other component of the drug (see. chapter 6.1. List excipients). Use of tizanidine in patients with significant impairment of function the liver is contraindicated, since tizanidine is actively metabolized in the liver (see section "Pharmacodynamic properties"). Simultaneous application tizanidine with strong inhibitors of CYP 1 A 2 (such as fluvoxamine or ciprofloxacin) is contraindicated (see section 4.5 "Interaction with other medicinal products and other forms of interaction” and section 4.4 "Special warnings and special measures precautions for use”).

Special instructions and precautions

Special instructions:

Simultaneous application tizanidine with CYP 1 A 2 inhibitors is not recommended (see section 4.3 "Contraindications" and section 4.5

"Interaction with other drugs means and other types of interactions”). Hypotension may occur during treatment with tizanidine (see section 4.8 "Side effects"), a also in result drug interactions with CYP 1 A 2 inhibitors and / or antihypertensive drugs (see section 4.5 Interaction with other medicinal products and other forms of interaction). There were also severe manifestations hypotension, such as loss of consciousness and vascular collapse.

Precautionary measures:

Tizanidine should be used with caution in the treatment of CYP 450 inhibitors 1 A 2. Simultaneous application tizanidine with fluvoxamine, a potent inhibitor of CYP 450 1 A 2 in humans, resulted in a 33-fold increase in tizanidine AUC under action of fluvoxamine.   (Cm.   chapter   4.5

"Interaction with other drugs means and other forms interactions"). Tizanidine tablets contain lactose. it medicine not recommended patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Tizanidine should be kept out of the reach of children place.

Side effect

Confessional state, arterial hypotension, bradycardia, muscular weakness, insomnia, sleep disturbance, hallucinations, hepatitis.

Hallucinations go away on their own signs of psychosis, and invariably occurred in patients simultaneously hosting potentially hallucinogenic drugs, eg. antidepressants.

Influence on the ability to drive vehicles and mechanisms

Patients with blurred vision, drowsiness, dizziness , or any signs or symptoms of hypotension should be advised to refrain from activities requiring a high degree of alertness, e.g. drive a vehicle or operate machinery.

Interaction with other drugs

Observed interactions leading to contraindications

Concomitant use of tizanidine with fluvoxamine or ciprofloxacin is contraindicated. which are CYP 450 inhibitors 1 A 2 at person. The simultaneous use of tizanidine with fluvoxamine or ciprofloxacin led to an increase AUC of tizanidine 33 and 10 times, respectively. Clinically significant and prolonged hypotension may be accompanied by drowsiness, dizziness and decreased psychomotor activity (cm. chapter 4.3 "Contraindications" and section 4.4 "Special warnings and precautions").

Dosage and administration

When administered orally, the effect of tizanidine on spasticity is maximal within 2-3 hours after ingestion and is relatively short duration of action.

Overdose

Clinical experience is limited. in one adult case, accepted 400 mg tizanidine, recovery was uneventful. This patient received mannitol and furosemide. Symptoms: Nausea, vomiting, hypotension, prolongation of the QT interval ( c ), dizziness, pupillary constriction, respiratory distress, coma, restlessness, drowsiness. Treatment: common supporting measures, and should try to remove not swallowed drug from the gastrointestinal tract using gastric lavage or activated coal. Forced diuresis is expected to accelerate the elimination of tizanidine. Further treatment should be symptomatic. The patient must be well hydrated.

Storage conditions

Store below 30°C, protect from light and moisture.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

1 Alu - Alu Strip 10 tablets in a carton with insert. those. 1 x 10 tablets.