Agrocia

Leaflet attached to the packaging: information for the user

Agrocia, 20 mg/mL, solution for the skin

Minoxidil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 30 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Agrocia and what is it used for
• 2. Important information before using Agrocia
• 3. How to use Agrocia
• 4. Possible side effects
• 5. How to store Agrocia
• 6. Contents of the packaging and other information

1. What is Agrocia and what is it used for

The active substance of Agrocia is minoxidil. Agrocia is used to treat male and female pattern hair loss (androgenetic alopecia). Male pattern hair loss can be recognized by a balding spot on the top of the head (in the tonsure area). Female pattern hair loss can be recognized by thinning or falling hair in the middle part of the top of the head (in the partition area). Thinning of the hair is evenly distributed over the entire scalp.

2. Important information before using Agrocia

When not to use Agrocia:

• if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You should discuss the use of Agrocia with your doctor or pharmacist before starting treatment.

• If your relatives do not have hair loss, hair loss is sudden and/or partial, hair loss occurred due to pregnancy or childbirth (in women) or if the cause of hair loss is unknown, you should not use Agrocia.
• If hair loss is associated with certain treatments (such as chemotherapy, anticancer treatment) or diseases, such as iron deficiency in the blood, thyroid dysfunction, lupus (an autoimmune disease) or syphilis (a sexually transmitted infection), or severe eating disorders or certain grooming habits, such as tight braiding or ponytails.

If you are using occlusive dressings or other topical medicines on the scalp. If there is inflammation, irritation, or infection on the scalp or a skin disease called psoriasis, in case of severe sunburn or skin irritation on the scalp, or if you have a shaved scalp, you should not use Agrocia. You should not use Agrocia if there are any diseases or wounds on the scalp, as the medicine may be absorbed to a greater extent. You should check this before using the medicine. If you have a history of any vascular or heart disease, your doctor will need to monitor your blood pressure and pulse.

Do not inhale the aerosol. There have been cases of excessive hair growth on the body of infants following contact with the skin of areas where minoxidil was applied topically to patients (caregivers). Hair growth returned to normal within a few months when the infant was no longer exposed to minoxidil. You should be careful not to let children come into contact with areas of the body where minoxidil has been applied topically. If excessive hair growth on the body of a child is observed during the use of minoxidil-containing products, you should consult a doctor. You should stop using Agrocia and contact your doctor if you experience low blood pressure or chest pain, rapid heartbeat, fainting, or dizziness, sudden, unexplained weight gain, swelling of the hands or feet, or persistent redness or irritation of the scalp.

Agrocia and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Using Agrocia with vasodilators (medicines used to treat cerebrovascular disorders) and medicines used to treat high blood pressure (such as guanethidine and its derivatives) may cause a sudden decrease in blood pressure. You should not apply this medicine at the same time as other topical medicines and hair products, such as corticosteroids, retinoids, such as tretinoin creams or ointments with occlusive effects, as they may increase the absorption of the medicine. Betamethasone dipropionate (a medicine used to treat skin diseases) may decrease the systemic absorption of Agrocia. When used concomitantly with cyclosporine administered systemically (a medicine that prevents organ transplant rejection), excessive hair growth may occur.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before using this medicine. The use of Agrocia is not recommended during pregnancy and breastfeeding.

Driving and using machines

Although there is no data to suggest that Agrocia affects the ability to drive and use machines, you should avoid performing these activities until you have established how you tolerate the medicine.

Agrocia contains ethanol and propylene glycol.

Agrocia contains 571 mg of alcohol (96% ethanol) in each mL of the solution for the skin. The medicine may cause burning of damaged skin. Due to the content of ethanol, the medicine is flammable. You should not use the medicine near an open flame, a lit cigarette, or certain devices (such as hair dryers). Agrocia contains 104 mg of propylene glycol in each mL of the solution for the skin.

3. How to use Agrocia

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, you should ask your doctor, pharmacist, or nurse. The recommended daily dose is 1 mL of the solution (10 sprays of the aerosol using the dosing pump) twice a day. Agrocia stabilizes the process of male or female pattern hair loss (androgenetic alopecia) in an area of 3 to 10 cm in diameter on the scalp in men and in the vertex area in women. Treatment may stop the progression of androgenetic alopecia. The onset and degree of response to treatment vary from person to person, but individual reactions cannot be predicted due to the lack of available data. You should not stop using the medicine too early, as stopping treatment may cause a return to the initial state of hair loss before starting treatment within 3 to 4 months.

• You should wash your hands thoroughly after using the medicine.
• Before using the medicine, you should thoroughly dry your hair and the hairy scalp, then apply the medicine, starting from the center of the treated area. You should not use the medicine on any other part of the body, due to the risk of hair growth in those areas.
• The medicine is applied using a dosing pump equipped with a dose button and an applicator with an extended tip. Before using the medicine, you should place the applicator, connected to the dosing pump, in the bottle. You should read the following instructions for attaching the applicator and placing the dosing pump in the bottle:
• Attach the applicator to the dosing pump: you should hold the pump firmly and press the top part of the applicator.

• Remove the cap from the bottle.

• Place the dosing pump in the bottle and screw it tightly.

• Release the dosing pump; the dispenser is ready for use.

• Direct the applicator towards the center of the bald area, press the pump once, and spread the solution over the entire area with your fingertips (with or without massaging).

• A dose of 1 mL of minoxidil is obtained after 10 presses of the pump button.

As with other medicines, the degree of response to treatment varies from person to person, so it may be necessary to use the medicine for a period of 4 months to achieve noticeable hair growth. During long-term use, the effects of treatment remain unchanged over time. If there is no improvement in hair growth after 6 months, treatment should be stopped. DosingThe medicine should be applied only to the skin. DO NOT swallow the medicine. The recommended daily dose is 1 mL of the solution (10 sprays of the aerosol using the dosing pump) twice a day. The maximum daily dose is 2 mL. You should follow the recommended daily dose, regardless of the size of the hairy scalp area affected by hair loss. If you feel that the effect of Agrocia is too strong or too weak, you should contact your doctor or pharmacist.

Use in women

Women should wash their hands thoroughly after applying the medicine to the scalp, as there is a risk of hair growth in other areas if the medicine comes into contact with them.

Use in children and adolescents

Agrocia should not be used in patients under 18 years of age, as the efficacy and safety of use in this age group have not been established.

Use in patients over 65 years of age

Agrocia should not be used in patients over 65 years of age, as the efficacy and safety of use in this age group have not been established.

Use of a higher dose of Agrocia than recommended

If you use a higher dose of Agrocia than recommended, you should contact your doctor or pharmacist immediately. Accidental or intentional overdose of Agrocia may cause an increase in skin-related side effects, such as itching (pruritus), dryness, irritation, and rash (acute or chronic inflammatory skin diseases). Objective and subjective symptoms after accidental or intentional ingestion of Agrocia may include low blood pressure (decreased blood pressure), rapid heartbeat (tachycardia), swelling (edema), and congestive heart failure (heart failure). In case of overdose or accidental ingestion, you should seek medical attention immediately and indicate which medicine and what amount was taken.

Missing a dose of Agrocia

You should take the next dose and then return to your normal treatment schedule. You should not take a double dose to make up for a missed dose.

Stopping treatment with Agrocia

If treatment with Agrocia is stopped, hair loss may recur and return to the state before treatment within 3 to 4 months. If you experience such symptoms, you should talk to your doctor. If you have any further doubts about using this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

You should contact your doctor immediately if you experience any of the following symptoms, as you may need urgent medical attention. Swelling of the face, lips, or throat, which makes swallowing or breathing difficult. These may be symptoms of a severe allergic reaction (frequency not known, cannot be estimated from the available data). Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects are: itching (pruritus), skin inflammation (redness), dryness, skin irritation, rash (inflammatory skin disease), and excessive hair growth (excessive hair growth on the skin). These effects are usually mild to moderate and reversible after stopping treatment.

Very common(may affect more than 1 in 10 people):

• Headache

Common(may affect up to 1 in 10 people):

• Local skin irritation (flaking and redness)
• Contact dermatitis
• Dry skin
• Swelling (edema)
• Burning and itching of the skin
• Excessive hair growth (excessive hair growth on the skin)
• Dyspnea (breathing difficulties)
• Musculoskeletal pain
• Depression
• Acne-like rash

Uncommon(may affect up to 1 in 100 people):

• Rash (inflammatory skin disease)
• Dizziness, discomfort
• Eye irritation
• Change in hair color
• Change in hair structure

Rare(may affect up to 1 in 10,000 people):

• Changes in blood pressure and heart rate
• Transient hair loss, uneven hair growth
• Chest pain

Unknown(frequency cannot be estimated from the available data)

• Allergic reactions, including angioedema (difficulty swallowing or breathing)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agrocia

The medicine should be stored out of sight and reach of children. There are no special precautions for storage of the medicinal product. You should not use this medicine after the expiry date stated on the bottle and carton after “EXP” and “Expiry date (EXP)”. The expiry date stated on the carton is the last day of the stated month. Shelf life after first opening of the bottle: 30 days. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Agrocia contains

The active substance of Agrocia is minoxidil: each mL of the solution contains 20 mg of minoxidil. One mL of the solution corresponds to 10 sprays. The other ingredients (excipients) are: 96% ethanol, propylene glycol, and purified water.

What Agrocia looks like and contents of the packaging

Agrocia is a solution for the skin. The solution is clear, colorless, or slightly yellowish, with an alcoholic odor. The medicine is available in an HDPE bottle with a PP cap and a PP dosing pump, in a cardboard box. The packaging contains 60 mL of the solution or 120 mL of the solution (2 x 60 mL).

Marketing authorization holder

Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden

Manufacturer

Industrial Farmacéutica Cantabria S.A., Barrio Solía, nº 30, La Concha, Villaescusa, 39690 Santander, Cantabria, Spain. Date of last revision of the leaflet:08/2024

Other sources of information

Detailed information about this medicine can be found on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych http://urpl.gov.pl.