Regain, foam 5% 60 ml

Alopecia (baldness)Treatment of androgenic alopecia in men and women.

Active ingredient

Minoxidil

Composition

1 g of the drug contains:

active ingredient:

Minoxidil – 47.50 mg*,

excipients:

anhydrous ethanol – 536.30 mg,

purified water – 314.10 mg,

butylhydroxytoluene – 0,90 mg**,

lactic acid – 10,00 mg,

anhydrous citric acid – 1,00 mg,

How to take, the dosage

Externally.

Before applying the drug Regain® hair and scalp must be thoroughly dried.

For the effectiveness of the drug and its reaching the hair follicles it is important to apply the drug to the scalp, not on the hair.

Dose for men: 1 g (half-cup) of foam applied 2 times a day (morning and evening) to the affected areas of the scalp. Do not use Regain® more than once every 12 hours. The total daily dose should not exceed 2 g of the drug (100 mg of minoxidil).

Dose for women: 1 g (half cap) of foam should be applied once a day to the affected areas of the scalp. Do not use Regain® more than once a day. The daily dose should not exceed 1 g of the drug (50 mg minoxidil). Do not apply Regain® on other parts of the body.

Recommendations for use of the can:

• Turn the cap so that the arrows on the sprayer and the cap were against each other, tilt the cap backwards and remove it.
• Before squeezing the foam, it is advisable to first rinse your fingers with cold water and dry them thoroughly, as the foam may dissolve if it comes into contact with warm skin.
• Turn the bottle upside down, squeeze the atomiser and squeeze the desired amount of foam onto your fingers.
• Distribute the foam with your fingertips over areas of hair loss and gently rub into the scalp. Check that the arrows on the sprayer and the cap are not aligned, in order to protect the packaging from accidental opening by children.

Interaction

There is a theoretical possibility of increased orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, has not been clinically confirmed.

It cannot be ruled out a very slight increase in minoxidil content in the blood of patients with arterial hypertension and taking minoxidil orally in case of concomitant use of RegainH®, although appropriate clinical studies have not been conducted.

It has been found that minoxidil for external use may interact with some other drugs for external use.

Minoxidil for external use should not be used simultaneously with any other drugs (glucocorticosteroids, tretinoin, anthralin) applied to the scalp.

Simultaneous use of minoxidil foam for external use and cream containing betamethasone (0.05%) leads to decreased systemic absorption of minoxidil.

Simultaneous use of cream containing tretinoin (0.05%) leads to increased absorption of minoxidil.

Simultaneous application of minoxidil and topical products, such as tretinoin and Ditranol, which EXPECT changes in skin protective functions, can lead to increased absorption of minoxidil.

Special Instructions

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

– The drug will not be effective if used:

– Hair dryer after applying lather to the scalp;
– Hair care products that can cause scarring and deep scalp burns;
– Hair care methods that require strong pulling of hair away from the scalp (such as braiding or ponytail hairstyles).

– It is not necessary to wash the head to apply the drug. If you wash your head before applying the medication, you must dry your hair and scalp.

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

– It is allowed to wash the head not less than 4 hours after the application of the drug.

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

– Before coloring and/or perming it is necessary to make sure that the drug has been washed from the hair and scalp to avoid possible scalp irritation.

– For the best results the drug should not be applied on the same day as the chemical hair treatment.

After using any chemicals, do not apply the medication for 24 hours to make sure the scalp is not irritated after perming and/or coloring.

Before beginning treatment with Regain®, patients should undergo a general examination that includes gathering and reviewing a medical history. The physician must ensure that the scalp is healthy. Regain® should only be applied to healthy scalp skin. It should not be used in case of inflammation, infection, irritation, skin soreness, or simultaneously with other medicines applied to the scalp.

Do not use the drug Regain® in cases of sudden hair loss, focal alopecia, when alopecia develops after childbirth, in cases of hair loss caused by taking medicines, improper nutrition (iron and vitamin A deficiency), due to hair styling in “tight” hairstyles and in cases when the cause of hair loss is unknown.

In case of decreased blood pressure or chest pain, palpitations, weakness or dizziness, sudden unexplained increase in body weight, swelling of hands or feet, persistent redness or irritation of the scalp, stop using Regain® and consult a physician.

In case of contact of the drug with sensitive surfaces (eyes, irritated skin, mucous membranes) you should rinse the affected area with plenty of cool water.

The drug contains butylhydroxytoluene, cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Accidental ingestion of the drug may lead to serious adverse effects in the heart. Therefore, this drug should be kept out of the reach of children.

The contents of the cylinder is under pressure.

The drug is easily flammable, therefore the contents of the can should not be sprayed near an open fire, polished or painted surfaces.

Avoid contact of the can with sources of open flame during use, storage and disposal. Do not heat the can above 50 °C. When applying the drug you should refrain from smoking.

If the drug is obsolete or expired – do not pour it into the sewage and do not throw it on the street! Place the medication in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

The foam is white to yellowish-white in color and retains its structure during the observation period of one minute.

Contraindications

• High sensitivity to Minoxidil or other drug components;
• damage of the integrity of the skin;
• dermatoses of the scalp;
• concurrent use of other medications on the scalp;
• pregnancy;
• breastfeeding period;
• Age:
• under 18 years of age and over 65 years of age.

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Side effects

The frequency of adverse reactions is given as the following gradation: very common (>1/10); common (21/100, <1/10); infrequent (>1/1000, <1/100); rare (21/10000, <1/1000); very rare (<1/10000), including individual reports of unspecified frequency (frequency cannot be counted from available data).

Adverse events that have been reported in patients in clinical trials:

Nervous system disorders.

Often: Headache. Disorders of the skin and subcutaneous tissues. Often: skin itching, rash. Rarely: dermatitis, manifested as redness, peeling and inflammation.

Postmarketing data:

Immune system disorders. Very rare: angioedema (manifestations of angioedema may be: swelling of the lips, swelling of the tissues of the oral cavity, swelling of the oropharynx, oedema of the tract and tongue swelling), Hypersensitivity (manifestations of Hypersensitivity may be: facial edema, generalized erythema, generalized skin itching, facial swelling and feeling of tightness in the throat), allergic contact dermatitis.

Nervous system disorders. Very rarely: Dizziness, Headache. Visual organ disorders. Very rarely: eye irritation.

Cardiac disorders. Very rarely: tachycardia, palpitations.

Respiratory system disorders, thoracic and mediastinal organs. Very rarely: shortness of breath.

Gastrointestinal tract disorders. Very rarely: nausea, vomiting. General disorders and disorders at the site of administration. Very rarely: peripheral edema, pain in the chest.

Skin and subcutaneous tissue disorders. Very rare: reactions together with application (these reactions may extend to the ears and face, include: skin itching, irritation, pain, rash, swelling, dry skin, erythema. However, in some cases, reactions may be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration), temporary hair loss, hair color changes, hair texture disorders, hypertrichosis (unwanted hair growth outside the application site).

Vascular disorders. Infrequent: decreased arterial blood pressure. If any of the side effects specified in the Instructions is aggravated or if you notice any other side effects not specified in the Instructions, inform your doctor.

Overdose

If doses in excess of the recommended doses are applied to larger areas of the body or to areas of the body other than the scalp, increased systemic absorption of minoxidil may occur, which may lead to the development of adverse events.

Signs and symptoms of overdose may include unwanted cardiovascular effects associated with sodium and water retention, as well as tachycardia, decreased blood pressure, and dizziness.

Treatment is symptomatic and supportive. Beta-adrenoblockers may be prescribed for tachycardia, diuretics for edema elimination.

In case of arterial pressure decrease 0.9% sodium chloride solution should be administered intravenously. Sympathomimetic agents such as epinephrine and norepinephrine with excessive cardiac stimulatory activity should not be used.

Pregnancy use

Regain® in foam form is contraindicated for women during pregnancy and while breastfeeding.

Similarities

Alerana, Alerana spray, Generolon, Alerana spray