Structure and form of release

Active ingredient: hifenadin.

Structure

• 1 tablet supports a hifenadin of a hydrochloride of 10 mg;
• additional substances: sucrose, potato starch, calcium stearate.

release Form

Tablet.

Pharmacological properties

Pharmacodynamics. Active agent of medicine Phencarolum is derivative a hinuklidilkarbinol who reduces influence of a histamine on bodies and systems. Hifenadin is a competitive blocker of n1-receptors. Besides, it activates enzyme diaminoxidase which splits about 30% of an endogenous histamine. The efficiency of a hifenadin at the patients insensitive to other antihistamines is explained by it. Hifenadin badly gets through geb and influences processes of deamination of serotonin in a head brain a little, poorly affects Mao's activity. Antihistaminic properties of a hifenadin are connected with existence of a cyclic kernel of a hinuklidin in structure and distance between group of diphenylcarbinol and a nitrogen atom. On antihistaminic activity and duration of action hifenadin exceeds Dimedrol. Reduces toxic action of a histamine, in particular eliminates or weakens its bronkhokonstriktorny effect and spasmodic influence on unstriated muscles of intestines, has moderate protivoserotoninovy and weak cholinolytic effect, obviously expressed the antipruritic and desensibilizing properties. Hifenadin reduces expressiveness of hypotensive action of a histamine and its influence on permeability of capillaries, does not influence directly warm activity and hell, has no protective action in aconitic arrhythmias.

Hifenadin has no oppressing effect on central nervous system, but at individual hypersensitivity the weak sedation is possible. Drug has low lipophilicity therefore its content in brain tissues low (0.05%), than speaks lack of the oppressing influence on central nervous system.

Pharmacokinetics. Hifenadin is quickly soaked up in a digestive tract and in 30 min. medicament is defined in body tissues. The C _max in blood plasma is reached for 1 h. Metabolites and not changed part of a hifenadin generally are removed with urine, bile and allocated with lungs during 48 h. Phencarolum is metabolized in a liver.

Indication

Pollinoses, food and medicinal allergy, other allergic diseases, acute and chronic urticaria, (angioneurotic) Quincke, hay fever, an allergic rhinopathy, a dermatosis (eczema, psoriasis, neurodermatitis, a skin itching) and also infectious and allergic reactions with a bronkhospastichesky component swelled.

Use

Phencarolum is accepted inside right after food.

Tablet of 10 mg. To children at the age of 3–7 years — on 10 mg 2 times a day (the daily dose should not exceed 20 mg); to children at the age of 7–12 years — on 10 mg 2–3 times a day (the daily dose should not exceed 50 mg), to children are more senior than 12 years — 25 mg 2–3 times a day (the daily dose should not exceed 100 mg).

to use medicament in other dosage form (Phencarolum, tablets on 25 mg)

Duration of a course of treatment — 10–15 days. If necessary the course of treatment is repeated.

If did not accept the next dose in time, it is necessary to continue a course of treatment, applying earlier appointed doses. In case of need it is necessary to consult with the doctor.

Contraindication

Hypersensitivity to a hifenadin or excipients of drug.

Side effects

from nervous system: dizziness, headache.

.

from a GIT: dryness of mucous membranes of an oral cavity, the dispeptic phenomena (nausea, vomiting, bitterness in a mouth) which usually pass at a dose decline or medicament withdrawal.

from the respiratory system, bodies of a thorax and mediastinum: sneezing, the complicated breath.

from mentality: concern.

from kidneys and urinary tract: proteinuria, interstitial nephrite.

from musculoskeletal and connective tissue: joint pain.

from an organ of sight: dacryagogue.

At persons with gastrointestinal diseases the possibility of side effects increases.

At manifestation of any side effects, it is necessary to stop use of medicament and to consult with the doctor.

Special instructions

Should be careful in a serious illness of a cardiovascular system, a GIT or liver. medicament contains sucrose that should be considered sick diabetes. to patients with rare hereditary diseases, such as intolerance of fructose or insufficiency of invertase-isomaltase, it is not necessary to take the drug. by

Pregnancy and feeding by a breast

it is contraindicated to p to appoint medicament in the I trimester of pregnancy. Its use in II and III trimester of pregnancy is not recommended. There are no data on penetration of medicament into breast milk therefore use of the medicament Phencarolum during feeding by a breast contraindicated.

Children

Tablet of 10 mg at children from 3-year age.

Drivers

to Persons whose work demands fast physical or mental reaction (drivers of vehicles, etc.), should be established previously individual sensitivity (by short appointment) regarding sedative action. These persons need to observe extra care.

Interaction

Phencarolum does not strengthen the oppressing effect of alcohol and sleeping medicines on central nervous system. Phencarolum possesses weak m-holinoblokiruyushchimi properties therefore due to decrease in motility of a GIT it is capable to strengthen absorption of slowly absorbed medicines (for example anticoagulants of indirect action of a coumarinic row).

Overdose

Daily dose up to 300 mg/days does not cause heavy side effects. in a high dose can cause dryness of a mucous membrane, a headache, pain in epigastric area, vomiting and other dispeptic phenomena. there is no specific antidote. if necessary carry out symptomatic treatment.

Storage conditions

B the dry, protected from light place at a temperature not above 25 °C.