Regein aerosol for external use 5% 60ml №3

Indications

- androgenic alopecia in men and women.

Dosage and administration

The drug is intended for external use. Before using the drug Regeyn^® hair and scalp should be thoroughly dried. To improve the effectiveness of the drug, it is necessary to ensure that the drug reaches hair follicles, so it is important to apply an aerosol on the scalp and not on the hair.

For men Apply 1 g (1/2 cap) of the aerosol 2 times / day (morning and evening) to the affected areas of the scalp. Reagain should not be used^® more often than once every 12 hours. The total daily dose should not exceed 2 g of the drug (100 mg of Minoxidil).

For women Apply 1 g (1/2 cap) of the aerosol 1 time / day to the affected areas of the scalp. Reagain should not be used^® more often than 1 time / day. The daily dose should not exceed 1 g of the drug (50 mg of minoxidil).

Do not apply the drug Regeyn^® to other parts of the body.

Recommendations for the use of an aerosol can

1. Turn the cap so that the arrows on the sprayer and cap are aligned.

2. Tilt the cap back to remove it.

3. Before squeezing out the aerosol, it is recommended to first rinse the fingers with cold water and dry thoroughly, ascontact with warm skin may dissolve.

4. Turning the aerosol can upside down, press the sprayer and squeeze the required amount of aerosol onto your fingers.

5. Distribute the aerosol with the tips of your fingers over the areas of baldness and gently rub it into the skin of the scalp.

6. After using the drug Regeyn^® put a cap on the aerosol can. In order to keep the package protected from accidental opening by children, it is necessary to check that the arrows on the sprayer and cap are not aligned.

After applying the drug Regeyn^® wash hands thoroughly.

The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after using the drug Regein ^® 2 times / day in men for 2–4 months and 1 time / day in women for 3–6 months.

To achieve and maintain the achieved effect of hair regrowth, the patient should not interrupt the use of the drug, otherwise the hair loss will resume.

Increasing the dose of the drug or its more frequent use will not lead to an improvement in the results of therapy.

If after using the drug Regeyn^® in men for 16 weeks and in women for 24 weeks hair growth is not observed, then the use of the drug should be stopped.

After starting to use the drug Regein^® increased hair loss may occur. This effect is caused by the influence of minoxidil.It is expressed in stimulating the transition of hair from the resting phase (telogen) to the growth phase (anagen). Thus, there is a loss of old hair, in place of which grow new. Temporary enhancement of hair loss usually lasts for 2–6 weeks from the start of treatment, and then decreases within 2 weeks.

Adverse effects

The frequency of adverse reactions is given in the form of the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000), including individual unspecified frequency messages (frequency cannot be calculated from available data).

Adverse events reported during clinical trials

Nervous system: often - a headache.

Skin and Subcutaneous Tissues: often - pruritus, rash; rarely - dermatitis, manifested in the form of redness, peeling and inflammation.

Post-marketing data

Allergic reactions: very rarely - angioedema (swelling of the lips, swelling of the oral tissues, swelling of the oropharynx, swelling of the throat and swelling of the tongue), hypersensitivity (swelling of the face, generalized erythema, generalized pruritus, feeling of tightness in the throat), allergic contact dermatitis.

From the nervous system: very rarely - dizziness, headache.

On the part of the organ of vision: very rarely - eye irritation.

Cardiovascular: very rarely - tachycardia, palpitations; infrequently - decrease in blood pressure.

Respiratory: very rarely - shortness of breath.

From the digestive system: very rarely - nausea, vomiting.

Skin and Subcutaneous Tissues: very rarely - reactions at the site of application (these reactions can spread to the ears and face, include: pruritus, irritation, pain, rash, swelling, dry skin, erythema; however, in some cases the reactions may be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration), temporary hair loss, changes in hair color, impaired hair texture, hypertrichosis (unwanted hair growth outside of the application site).

Other: very rarely - peripheral edema, pain in the chest.

If any of the side effects indicated in the instructions are aggravated or any other side effects that are not indicated in the instructions are noted, the patient should inform the doctor.

Contraindications

- violation of the integrity of the skin of the head;

- dermatosis of the scalp;

- simultaneous use of other drugs on the scalp;

- pregnancy;

- lactation period (breastfeeding);

- age up to 18 years;

- age over 65 years;

- Hypersensitivity to Minoxidil or other components of the drug.

WITH caution It should be prescribed to patients with cardiovascular diseases, arrhythmias, renal and hepatic insufficiency.

Use during pregnancy and lactation

Drug regeyn^® in the form of an aerosol is contraindicated in women during pregnancy and during breastfeeding.

Application for violations of the liver

WITH caution It should be prescribed to patients with liver failure.

Application for violations of kidney function

WITH caution It should be prescribed to patients with renal insufficiency.

Use in children

The drug is contraindicated for use in patients under the age of 18 years.

Use in elderly patients

The drug is contraindicated for use in patients older than 65 years.

Special notes

Before you begin treatment with Regein^®, it is necessary to conduct a general examination, including the collection and study of medical history. The doctor should make sure that the scalp is healthy.

Apply the drug Regeyn^® should only be on healthy scalp. You can not use the drug for inflammation, infection, irritation, pain of the skin, as well as simultaneously with other drugs applied to the skin of the scalp.

Do not use the drug Regeyn^® in cases of sudden hair loss, focal alopecia, when alopecia develops after childbirth, in case of baldness caused by medication, poor diet (iron deficiency, vitamin A), as a result of hair styling in "tight" hairstyles, and also when the cause of hair loss is unknown.

With a decrease in blood pressure or chest pain, palpitations,weakness or dizziness, sudden unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp, the patient should stop using Regein^® and consult a doctor.

Some components of the drug may cause burning and irritation. In case of contact with the drug on sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the affected area with plenty of cool water. The drug contains butylhydroxytoluene, cetyl and stearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).

Accidental intake of the drug may lead to the development of serious adverse events on the part of the heart. Therefore, this drug should be stored out of the reach of children.

The contents of the aerosol can are under pressure. Do not pierce or burn the aerosol can. The drug is flammable, so do not spray the contents of the aerosol can near an open flame, polished or painted surfaces. Contact of the aerosol can with open flame sources during use, storage and disposal should be avoided. Do not heat the balloon above 50 ° C. When applying the drug should refrain from smoking.

The patient should be informed that if the drug has become unusable or the expiration date has expired, it should not be poured into sewage or thrown into the street. It is necessary to put the drug in the bag and put it in the trash.These measures will help protect the environment.

Recommendations for the use of the drug in conjunction with hair care products

The drug will not be effective when using:

- hair dryer after applying the aerosol on the scalp;

- hair care products that can cause scarring, as well as deep burns of the scalp;

- methods of hair care, requiring a strong pulling of hair from the scalp (for example, weaving "tight" braids (brading) or horsetail).

For the application of the drug is not necessary to wash the head. In the case of shampooing before using the drug, it is necessary to dry the hair and scalp.

When using hair styling products, you must first apply an aerosol and wait until it dries, and then use hair styling products.

Shampooing is allowed no less than 4 hours after applying the drug.

There is no data on the effect of coloring, perm, hair straighteners on the effectiveness of the drug. Since perm and dyeing can irritate the scalp, the following precautions are recommended:

- Before dyeing and / or perming, make sure that the drug has been washed off the hair and scalp to avoid possible irritation of the scalp;

- for best results do not apply the drug in one day with a chemical treatment of the hair;

- after using any chemicals, do not apply the drug for 24 hours to ensure that the scalp is not irritated after perm and / or dyeing.

Influence on ability to drive motor transport and control mechanisms

In connection with the possible development of headache, dizziness, irritation of the eyes, caution should be exercised when driving vehicles and doing certain types of activities that require increased concentration of attention and psychomotor speed. When the described adverse events should refrain from performing these activities.

Overdose

If doses higher than recommended are applied to large areas of the body or other areas of the body, in addition to the scalp, an increase in the systemic absorption of minoxidil is possible, which can lead to the development of undesirable effects.

Symptoms: undesirable cardiovascular effects associated with sodium and water retention, as well as tachycardia, decreased blood pressure and dizziness.

Treatment: conducting symptomatic and supportive therapy. Beta-blockers may be prescribed for the treatment of tachycardia, and diuretics for edema. In case of a decrease in blood pressure, a 0.9% solution of sodium chloride should be introduced into / in. You should not use sympathomimetic agents, such as epinephrine and norepinephrine, which have excessive cardiac stimulating activity.

Drug interaction

There is a theoretical possibility of enhancing orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, has not received clinical confirmation.

We can not exclude a very slight increase in the content of minoxidil in the blood of patients with arterial hypertension, taking minoxidil orally, in case of simultaneous use of the drug Regein^®although no relevant clinical studies have been conducted.

It has been found that minoxidil for topical use may interact with certain other topical drugs.

When applied topically, minoxidil should not be used simultaneously with any other drugs (GCS, tretinoin, anthralin) applied to the skin of the scalp.

The simultaneous use of minoxidil in the form of an aerosol for external use and a cream containing betamethasone (0.05%) leads to a decrease in systemic absorption of minoxidil.

The simultaneous use of tretinoin containing cream (0.05%) leads to an increase in the absorption of Minoxidil.

The simultaneous application to the skin of minoxidil and topical preparations, such as tretinoin and dithranol, which cause changes in the protective functions of the skin, can lead to an increase in the absorption of minoxidil.

Pharmacy sales terms

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

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.