Cinnarizin Sopharma - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate (63.12 mg), wheat starch (50.57 mg), microcrystalline cellulose (Type 101) (3.85 mg), povidone K 25 (5.66 mg), silicon dioxide colloid (0.77 mg) , magnesium stearate (1.03 mg).

Description:Round, biconcave tablets, from white to almost white.

Pharmacotherapeutic group:blocker of "slow" calcium channels

ATX: & nbsp

N.07.C.A.02 Cinnarizine

Pharmacodynamics:

Cinnarizine improves cerebral and peripheral circulation, inhibiting the action of a number of endogenous vasoconstrictors and the current of calcium ions into cells through the blockade of "slow" voltage-dependent calcium channels. It has a vasodilating effect especially in relation to cerebral vessels, without having a significant effect on blood pressure (BP). Increases the elasticity of erythrocyte membranes, their ability to deform, reduces the viscosity of blood, increases the resistance of muscles to hypoxia. It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system.

Pharmacokinetics:

It is absorbed relatively slowly in the gastrointestinal tract. The maximum concentration in the blood plasma is reached in 1-3 hours after oral administration. It binds to plasma proteins by 80%, with erythrocytes by 13%. Distribution in tissues more intensively within 4 hours after administration. Completely metabolized in the liver, mainly by N-dealkylation. The half-life is 3-6 hours, it is excreted as metabolites: 1/3 - by the kidneys and 2/3 - with the calves.

Indications:

Adults and children over 12 years of age:

Violation of peripheral circulation (prevention and treatment) - obliterating endarteritis, obliterating thromboangiitis, Raynaud's disease, diabetic angiopathy, thrombophlebitis, trophic disorders (trophic and varicose ulcers), paresthesia, night spasms and cold snaps in limbs;
Prevention of kinetosis ("road disease" - sea and air sickness);
Symptomatic treatment of labyrinthine and vestibular disorders of vascular origin, Meniere's disease.

Contraindications:

Hypersensitivity to the drug components
Pregnancy and breastfeeding.
Children under 12 years.
Lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Celiac disease (gluten enteropathy)

Carefully:Parkinson's disease

Pregnancy and lactation:

Pregnancy

Due to the lack of well-controlled clinical trials regarding safety of use in pregnant women, the use of cinnarizine during pregnancy is not recommended.

Breast-feeding

Due to the lack of data on excretion in breast milk, the use of cinnarizine during breastfeeding is undesirable.In cases of necessity of application of a preparation, feeding by a breast should be stopped.

Dosing and Administration:

Adults and children over 12 years of age

Inside, with a lot of liquid, after eating.

If peripheral circulation is disturbed - 50-75 mg (2-3 tablets) three times a day.

With high sensitivity to the drug, treatment starts with ½ dose, increasing it gradually. To achieve the optimal therapeutic effect, the drug should be taken continuously, continuously - from several weeks to several months.

With vestibular disorders - 25 mg three times a day; with kinetosis ("road disease") - 25 mg for 30 minutes before the forthcoming road (if necessary, repeated intake of 25 mg in 6-8 hours). With labyrinthine disorders, 25 mg three times a day.

The maximum daily dose should not exceed 225 mg.

Side effects:

The most common side effects are drowsiness, gastrointestinal discomfort, which in most cases are transient and go with decreasing dose.

Other less common side effects:

From the side of the cardiovascular system - lowering of blood pressure.

From the nervous system - headache, increased fatigue; in patients receiving cinnarizine in high doses for a long time, possibly the emergence of extrapyramidal symptoms (tremor of limbs and increased muscle tone, hypokinesia, disorientation, imbalance), including Parkinson's syndrome, depression.

From the digestive system - dry mouth, pain in the epigastric region, dyspepsia, extremely rarely - cholestatic jaundice

From the skin: increased sweating, in extremely rare cases - red flat lichen and lupus-like reactions.

Allergic reactions - skin rash.

Other - increase in body weight.

Overdose:

Symptoms: vomiting, drowsiness, lowering blood pressure, tremor, coma.

Treatment: In cases of overdose - gastric lavage, Activated carbon. Symptomatic agents are used. There is no specific antidote.

Interaction:

Strengthens the action of ethanol (alcohol) and sedative drugs. At simultaneous application with nootropic, hypotensive and vasodilating agents strengthens their effect.Reduces the effect of hypertensive medications.

Special instructions:

Cinnarizine can cause "gastric discomfort". Taking tablets after meals reduces irritation of the gastric mucosa.

Patients suffering from Parkinson's disease, cinnarizine should be appointed only if its benefits exceed the possible risk of deterioration.

Patients older than 65 years of age with a family history or clinical symptoms extrapyramidal disorders, should be under constant medical supervision.

In individuals prone to lowering blood pressure (hypotension), it is necessary to monitor the values of blood pressure during treatment.

Cinnarizine can cause a false positive reaction in the conduct of anti-doping tests in athletes.

With prolonged use, it is recommended that a check examination of liver function, kidney function, and peripheral blood picture is recommended.

In view of its antihistamine effects cinnarizine can lead to false negative results in skin tests for increased sensitivity. Treatment with cinnarizine should be canceled 4 days before the study.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets 25 mg.

Packaging:

For 50 tablets in a blister of PVC - film and aluminum foil. 1 blister with instructions for use in a cardboard box.

Storage conditions:

In a dry and dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:П N015329 / 01

Date of registration:29.09.2008

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp09.10.2015

Illustrated instructions

Instructions

Cinnarizin Sopharma (Cinnarizine Sopharma)