Structure and form of release

Active ingredient: Ketotifenum.

• 1 tablet contains

  Ketotifenum (in the form of hydrofumarat Ketotifenum) — 1 mg (0.001 g);

• additional substances: lactoses monohydrate, cellulose microcrystalline, magnesium stearate, silicon dioxide colloidal waterless, talc.

release Form

Tablet.

Indications

Preventive treatment of bronchial asthma, especially atopic.

Symptomatic treatment of allergic states, including allergic rhinitis and conjunctivitis.

Contraindication

Hypersensitivity to Ketotifenum or to other components of medicine.

to Avoid simultaneous use of Ketotifenum and oral antidiabetic means (risk of developing reverse thrombocytopenia) until this phenomenon is not rather studied.

Route of administration

to take the Pill inside at meal time, washing down with water.

Dosage.

Adult: on 1 tablet (1 mg) 2 times a day, in the morning and in the evening at meal time. Patients at whom the considerable sedation coming in the first days of use of medicine is observed should accept Ketotifenum on 1 tablet a day only in the evening.

In case of need can increase a daily dose to 4 mg, that is on 2 tablets 2 times a day. At application of higher dose it is possible to expect the fastest approach of therapeutic effect.

Children since 3 years: on 1 tablet (1 mg) 2 times a day, in the morning and in the evening, at meal time.

Patients of advanced age: there are no special recommendations for patients of advanced age.

treatment Duration.

Treatment is long-term, at the same time the therapeutic effect is reached after several weeks of therapy. Treatment has to continue not less than 2-3 months, especially at patients at whom improvement of health in the first weeks was not observed.

Accompanying bronkhodilatatorny therapy: use of Ketotifenum along with bronchodilators can reduce the frequency of use of bronchodilators.

therapy Termination.

should Stop treatment by Ketotifenum gradually, within 2–4 weeks to avoid risk of a recurrence of asthmatic symptoms.

Children. To apply to children from 3 years. To children up to 3 years to appoint medicine in other dosage form.

Drug is inefficient

Feature of application

function Normalization the hypophysis - an adrenal system can proceed till 1 year. Therefore in the first weeks of use of Ketotifenum the previous treatment is recommended to continue and cancel it gradually and a long time.

at the beginning of long-term treatment by Ketotifenum cannot stop suddenly treatment by other antiasthmatic medicines, especially corticosteroids. At patients with steroid dependence the development of adrenocortical insufficiency can be observed.

in case of an intercurrent infection specific anti-infectious therapy.

At medicament treatment needs to be under observation of the doctor, considering possibility of spasms.

carefully to patients with epilepsy in the anamnesis because of a possibility of decrease in a convulsive threshold at medicament treatment.

during treatment by Ketotifenum should not take alcohol as it enhances depressive effect of Ketotifenum on the central nervous system.

Should stop administration of medicament in 10–14 days prior to carrying out skin tests for definition of an allergy.

If needs to stop treatment by Ketotifenum, the dose is gradually reduced within 2–4 weeks to prevent repeated emergence of symptoms of asthma.

Should be careful at use of Ketotifenum to patients with an abnormal liver function.

that simultaneous application with oral hypoglycemic medicines can cause thrombocytopenia, it is necessary to avoid such combination of medicines or to carefully control the level of platelets if such treatment is recommended.

Drug contains lactose therefore it patients should not appoint with rare hereditary forms of intolerance of a galactose, deficiency lactases or a syndrome of glyukozo-galaktozny malabsorption.

As controlled clinical trials at pregnant women were not conducted by

, use of medicine Ketotifenum perhaps only when the expected advantage for mother exceeds potential risk for a fruit.

Ketotifenum gets into breast milk therefore women in case of need use of medicine should stop feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

In an initiation of treatment medicine Ketotifenum can slow down the speed of reactions that demands from the patient of the increased care at control of vehicles and work with the automated mechanisms.

Overdose

Symptoms: considerable violations of psychomotor reaction, drowsiness to the expressed sedation, a headache, a disorientation, tachycardia, a lowering of arterial pressure, a coma (especially at children), symptoms of excitement of nervous system, including a spasm are possible. Also bradycardia, arrhythmia, oppression of function of the center of breath, a nystagmus are observed. In case of the above-stated symptoms of the patient it is necessary to survey carefully.

Treatment: general measures on elimination of nerezorbirovanny amount of medicine in a digestive tract: to cause vomiting, to wash out a stomach. Use of activated carbon can have favorable influence. Performing symptomatic treatment and monitoring of cardiovascular and respiratory systems is in case of need recommended. At conditions of excitement it is possible to apply barbiturates of short action or benzodiazepines.

Side reactions

• Infection and invasion: cystitis.
• from the immune system: skin rashes, heavy skin reactions, multiformny erythema, Stephens-Johnson's syndrome.
• Metabolic violations: increase in body weight because of increase in appetite.
• Mental violations: psychomotor excitement, irritability, insomnia, concern, nervousness, disorientation, drowsiness.
• from nervous system: dizziness, sedation, spasms.
• from a digestive tract: dryness in a mouth, a stomach ache, a lock, nausea, vomiting, dispeptic frustration.
• from a gepatobiliarny system: increase in level of liver enzymes, hepatitis.
• from an urinary system: dysuria.
• In an initiation of treatment can appear dryness in a mouth and dizziness, but they usually pass spontaneously in the treatment course. Symptoms of stimulation of central nervous system, such as excitement, irritability, insomnia and concern, especially at children are seldom observed.

to Store

out of children's reach in original packing at a temperature not above 25 °C. An expiration date - 5 years.