Universal reference book for medicines
Product name: GENEROLON ® (GENEROLON)

Active substance: minoxidil

Type: The drug for the treatment of alopecia in men and women

Manufacturer: BELUPO, Pharmaceuticals & Cosmetics (Croatia) manufactured by INDUSTRIAL FARMACEUTICA CANTABRIA (Spain) packed with BELUPO, Pharmaceuticals & Cosmetics (Croatia)
Composition, form of production and packaging
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Spray for external use in the form of a colorless or slightly colored with a yellowish hue, a clear aqueous alcohol solution with the smell of alcohol.
1 ml

minoxidil 20 mg

Excipients: ethanol 96% - 571 mg, propylene glycol - 104 mg, water - up to 1 ml.

60 ml - plastic bottles (1) complete with plastic measuring pump and nozzle for spraying in a protective bag - packs cardboard.

?
Spray for external use in the form of a colorless or slightly colored with a yellowish hue, a clear aqueous alcohol solution with the smell of alcohol.
1 ml

minoxidil 50 mg

Excipients: ethanol 96% - 243 mg, propylene glycol - 520 mg, water - up to 1 ml.

60 ml - plastic bottles (1) complete with plastic measuring pump and nozzle for spraying in a protective bag - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

With topical application of minoxidil stimulates hair growth in people with androgenic alopecia (hair thinning, baldness).
It improves microcirculation, stimulates the transition of hair cells to the active growing phase, changes the effect of androgens on hair follicles. Reduces the formation of 5-alpha-dehydrosterone (possibly, indirectly), which plays an important role in the formation of alopecia. The best effect is for a small prescription of the disease (no more than 10 years), young patients, the bald spot in the top of the head is no more than 10 cm, and there are more than 100 gun and terminal hair in the center of the bald head. The appearance of signs of hair growth is noted after 4 or more months of application of the drug. The onset and severity of the effect may vary in different patients. A 5% solution of the drug stimulates hair growth more than 2% solution, which was noted for increasing hair growth hair: After stopping the use of the drug Generolon, the growth of new hair is suspended, and within 3-4 months it is possible to restore the original appearance. The exact mechanism of action of the drug Generolon in the treatment of androgenetic alopecia is unknown. Minoxidil is ineffective in case of baldness caused by taking a drug, improper nutrition (iron deficiency (Fe), vitamin A), as a result of hair styling in "tight" hairstyles.
PHARMACOKINETICS

With external use, minoxidil is poorly absorbed through normal intact skin: an average of 1.5% (0.3-4.5%) of the total applied dose enters the systemic circulation.

The effect of concomitant skin diseases on the absorption of minoxidil is unknown.

After discontinuation of the drug, approximately 95% of minoxidil, which enters the systemic circulation, is excreted within 4 days.
The profile of metabolic biotransformation of minoxidil after external application of the drug Generolon has not been fully studied to the present.
Minoxidil does not bind to plasma proteins and is excreted by the kidneys through glomerular filtration.
Minoxidil does not penetrate the blood-brain barrier.
Excreted mainly with urine.
Minoxidil and its metabolites are excreted by hemodialysis.
INDICATIONS

Treatment of androgenic alopecia (hair restoration) and stabilization of the process of hair loss in men and women.

DOSING MODE

Outwardly.

Regardless of the size of the treated area, it is necessary to apply 1 ml of solution with a metering device (7 strokes) 2 times / day to the affected areas of the scalp, starting from the center of the problem area.
After application, wash hands. The total daily dose should not exceed 2 mg (the dose does not depend on the size of the affected area). Patients who do not have satisfactory hair growth when using a 2% solution, and patients who want faster hair growth, can use a 5% solution.
For men, the drug Generolon is most effective at hair loss on the crown, for women - with hair loss in the middle part.

The drug Generrolon is applied only to the dry skin of the scalp.
The solution does not require flushing.
The appearance of the first signs of stimulation of hair growth is possible after applying the drug 2 times / day for 4 months or more.
The onset and severity of hair growth, as well as the quality of the hair, can fluctuate in different patients.
According to individual reports, recovery of the initial appearance can be expected within 3-4 months after discontinuation of treatment.

The duration of treatment on average is about 1 year.

Preparation for use: Remove the screw cap and fix the measuring pump.
On the tube on top of the pump, strengthen the elongated nozzle for spraying. Press the spray nozzle 3-4 times to allow the pump to fill with the solution, after which the preparation can be used.
SIDE EFFECT

Local side effects:

The most common side effect is dermatitis of the scalp.
Less pronounced cases of dermatitis, manifested in the form of redness, flaking and inflammation. In rare cases, itching of the head, allergic contact dermatitis, folliculitis, hypertrichosis (unwanted hair growth on the body, including facial hair growth in women), seborrhea.
The use of minoxidil can cause an increase in hair loss during the transition from the resting phase to the phase of hair growth, while old hair falls out and new ones grow on their place.
This temporary phenomenon is usually observed after 2-6 weeks after the initiation of treatment and gradually, within the next 2 weeks, ceases (the appearance of the first signs
action of minoxidil).

Systemic side effects (with accidental ingestion):

Dermatological diseases: nonspecific allergic reactions (skin rash, urticaria), edema of the face.

Respiratory system: shortness of breath, allergic rhinitis.

Nervous system: headache dizziness, vertigo, neuritis.

Cardiovascular system: pain in the chest, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart, swelling.

CONTRAINDICATIONS

- hypersensitivity to minoxidil or other components of the drug;

- the age is under 18 years;

- violation of the integrity of the skin, dermatosis of the scalp.

With caution: the elderly are older than 65 years.

PREGNANCY AND LACTATION

Do not use the drug during pregnancy and lactation.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution: the elderly are older than 65 years.

SPECIAL INSTRUCTIONS

Do not apply the drug to other parts of the body.

The drug Generolon is applied only to the dry skin of the scalp after bathing or you should wait about 4 hours after applying the drug before bathing.
Do not let your head get wet before 4 hours after application.
Wash your hair with the drug Generrolon recommended in the usual way.

During the application of the drug Generolon, you can use hair spray and other hair care products.
Before applying hair care products, first apply the drug Generolon and wait until the treated area of ​​the skin is completely dry. There is no evidence that dyeing hair, perming or using hair softeners can reduce the effectiveness of the drug. However, to prevent possible irritation of the scalp, you need to make sure that the product has been completely washed off the hair and scalp before using these chemicals.
Before starting treatment with the drug Generolon, patients should undergo a general examination, including the collection and study of medical history.
The physician should make sure that the scalp skin is healthy.
When there are systemic side effects.
effects or severe skin reactions, patients should cancel the drug and consult a doctor.
The composition of the drug Generolon includes ethyl alcohol, which can cause inflammation and eye irritation.
In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the area with plenty of cold water.
Avoid inhalation during spraying.

After applying the drug, you should wash your hands thoroughly.

OVERDOSE

Accidental ingestion of the drug Generolon can cause systemic side effects due to the vasodilating properties of minoxidil (5 ml of a 2% solution contains 100 mg of minoxidil, the maximum recommended dose for adults when ingested for the treatment of arterial hypertension, 5 ml of a 5% solution contains 250 mg minoxidil, that is, a dose 2.5 times the maximum recommended daily intake for adults for oral administration in the treatment of hypertension).

Signs of an overdose: fluid retention, lowering blood pressure, tachycardia.

Treatment: diuretics may be prescribed to eliminate fluid retention if necessary;
for the treatment of tachycardia - beta-blockers. To treat hypotension, a 0.9% solution of sodium chloride should be administered. Do not prescribe sympathomimetic drugs, for example, norepinephrine and epinephrine, which have excessive cardiostimulating activity.
DRUG INTERACTION

There is a theoretical possibility (clinical confirmation is not available) of strengthening orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators.
We can not exclude a very small increase in minoxidil in the blood of patients suffering from: arterial hypertension and taking minoxidil inwards in the case of simultaneous use of the drug Generolon, although relevant clinical studies have not been conducted.
It has been established that minoxidil for external use can interact with certain drugs for external use.
The simultaneous use of a solution of minoxidil for external use and cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil. Simultaneous use of cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. The simultaneous application of minoxidil to the skin and preparations for external use such as tretinoin and dithranol, which cause a change in the protective functions of the skin, may lead to an increase in the absorption of minoxidil.
TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Keep the drug out of reach of children at a temperature of no higher than 25 ° C.

Shelf life - 3 years.
Do not use after the expiration date.
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