Active Ingredients

Minoxidil 5%

Indications

Therapeutic group:

Vasodilator, upon topical administration, to treat hair loss.

The preparation contains the active ingredient minoxidil , which facilitates blood flow to the hair follicles of the scalp.

Hairgain Foam is intended to promote growth of scalp hair among healthy men, ages 18-49, in cases of balding of hereditary origin only.

Instructions

Do not swallow! The preparation is intended for external use on the scalp area only.

Topical application of Hairgain Foam to the skin of the scalp stops balding and leads to hair growth in cases of balding in some users of the preparation. This preparation is for long-term use. The hair growth process, just like balding and the hair loss process, is prolonged, therefore, use the preparation for at least two months in order to assess hair growth renewal. If you do not see an improvement after a few months, refer to the attending doctor.

Interruption of treatment may lead to renewed hair loss within 3-4 months.

Hairgain Foam is primarily effective in men whose hair loss or hair thinning is at the front region of the scalp. Users who are young and/or whose balding process began a short time ago and/or whose balding area is not extensive may see better results. If the balding process began many years ago and/or the balding area is extensive, the prospects of treatment are low.

Do not use on areas of the body other than the scalp.

Wash your hands thoroughly before and after using the foam and thoroughly wash other areas that came into contact with the foam.

Be sure that the hair and scalp are completely dry before using the foam.

Take the cap off the canister, turn the canister upside down and press the nozzle to release foam onto your fingers. The required amount should not exceed 1 gram (half a capful).

The foam may melt upon contact with warm skin. If your fingers are hot, wash them thoroughly with cold water and be sure to dry them before use.

Spread the foam on the scalp with your fingers and rub it in by gently massaging the balding areas. Afterwards, wash your hands thoroughly.

The usual dosage is generally:

1 gram (half a capful) on a completely dry scalp, in the balding area, twice a day. Wait at least 12 hours between uses. Do not exceed 2 grams per day. Do not use more than twice a day.

Frequent use and/or use of a larger quantity will not increase hair growth, but may cause more side effects.

Do not exceed the recommended dose.

After using the preparation , avoid washing your head for about two hours , do not use a hair dryer to hasten hair drying , avoid exposure of the hair to the sun.

Do not place your head on a pillow for at least one hour after application on the scalp.

The hair growth process is slow and prolonged. You may need to use the preparation twice a day for at least 8 weeks, before seeing hair regrowth. The initial hair growth will be soft and downy, but with continued treatment, will look like normal hair. After the hair begins to grow, continue treatment twice a day, so that the hair growth with continue.

If there is no improvement after 16 weeks, stop the treatment. The effectiveness of the preparation in clinical trials was not tested beyond 16 weeks.

Adhere to the treatment according to the instructions. Interruption of treatment will most likely lead to loss of the hair that has grown and to renewal of hair loss within 3-4 months.

Warnings

Do not use the preparation if you are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in the preparation.

Do not use Hairgain Foam in women.

Do not use the preparation ifyou are below the age of 18 or older than 49.

Do not use the preparation ifthe hair loss is not of hereditary origin, e.g., hair loss resulting from medicinal treatment, certain severe dietary deficiencies (e.g., iron deficiency or excessive vitamin A) or hypothyroidism.

Do not use this medicine if you are completely bald or have lost all of your body hair.

Do not use the preparation if the reason for balding is unknown or it is sudden and unexpected.

Do not use the preparation if you suffer from hypertension, even if you are not being treated.

Do not use Hairgain Foam if you suffer from any condition that affects your scalp, including sunburns and psoriasis.

Do not use this medicine if your scalp is shaved.

Do not use this medicine if you use creams, ointments or lotions to treat scalp problems, such as:

dithranol – to treat psoriasis, tretinoin – to treat acne or other skin problems, corticosteroids, such as hydrocortisone or betamethasone dipropionate as an anti-inflammatory treatment.

Do not use the preparation if you have a dressing on the scalp.

Use the preparation only if you know that your scalp is in a normal and healthy condition.

If the active ingredient minoxidil reaches the blood circulation, it can cause side effects related to hypotension, such as: chest pain, accelerated heartbeat, fainting, dizziness, swollen hands and legs and prolonged redness. If you experience any of the mentioned side effects, stop using the preparation and inform the doctor. It is very likely that these effects will not occur upon proper

use of the preparation, however, there is a chance that upon excessive use or scalp problems, such as psoriasis, the preparation may enter the blood circulation. Therefore, it is very important to use the preparation exactly as instructed.

The preparation in the canister is highly flammable; therefore, avoid exposing the canister or its contents to an open flame. Protect the canister from the sun and do not expose it to a temperature exceeding 50°C. Do not puncture or burn the canister even after use. Do not spray into an open flame. Keep away from sources of fire. Do not smoke near the canister.

Do not place the canister or use it in polished or painted areas.

Avoid contact of the preparation with the eyes, mouth, cracked skin and sensitive areas in the body. If the foam is accidentally sprayed on a part of the body other than the scalp, wash thoroughly with a lot of water.

Do not use the preparation on any part of the body other than the scalp.

Excessive use of the preparation will not lead to faster hair growth and may cause side effects.

Some of the components of the preparation may cause problems:

Ethanol (alcohol) - may cause stinging and irritation upon contact with the eyes. In the event of contact with the eyes, mouth, cut or injured skin, wash the area with a lot of cold tap water.

Cetyl alcohol and stearyl alcohol – may cause local skin reactions, such as contact dermatitis.

Butylated hydroxytoluene – may cause local skin reactions, such as contact dermatitis or irritation of the eyes and mucosal tissues.

Consult a doctor or pharmacist before using the preparation in the following cases:

• If you are not sure if your scalp is healthy and in normal condition.
• If you are suffering, or have suffered in the past, from a heart disease, including irregular heart rhythm, angina pectoris or chest pains and/or blood circulation problems.
• If you are suffering, or have suffered in the past, from impaired function of the kidney or blood system (e.g., coagulation, etc.).

During the treatment period with this preparation, perform blood and urine tests and kidney, heart and respiratory system function tests. Be alert for changes in your general feeling and health. Weigh yourself twice a week; in the event of sudden weight gain, refer to a doctor immediately.

Patients with heart diseases and/or hypertension, under treatment with this medicine, must be under medical supervision during the entire course of treatment.

Do not use on an inflamed, irritated and/or red scalp or during treatment with another preparation.

If you are taking, or have recently taken, other medicines,including nonprescription medicines and nutritional supplements, tell the doctor or pharmacist in order to prevent hazards or lack of efficacy arising from drug interactions. It is especially important to inform the doctor or pharmacist if you are taking medicines from the following groups:

Medicines for blood pressure from the vasodilator group, such as hydralazine. There is a chance that minoxidil will increase their effect.

Preparations for topical treatment on the scalp.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.

Read the patient package insert carefully before starting to take any medication.