AGROCIA

Package leaflet: Information for the user

Agrocia, 50 mg/mL, solution for topical use
Minoxidilum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 30 days of treatment, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What Agrocia is and what it is 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 pack and other information

1. What Agrocia is and what it is used for

The active substance in Agrocia is minoxidil. Agrocia is used in the treatment of male-pattern
hair loss (androgenetic alopecia).
Male-pattern hair loss is characterised by hair loss at the top of the head (in the crown area).
Agrocia 50 mg/mL must not be used in women.

2. Important information before using Agrocia

When not to use Agrocia:

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

Warnings and precautions
Before starting to use Agrocia, discuss this with your doctor or pharmacist.

• Do not use Agrocia if hair loss is not hereditary, if hair loss is sudden and (or) patchy, or if the cause of hair loss is unknown.
• Do not use Agrocia if hair loss is associated with certain medical treatments (such as chemotherapy, anticancer therapy) or diseases such as iron deficiency in the blood, thyroid disorders, lupus (an autoimmune disease), syphilis (a sexually transmitted infection), severe malnutrition, or certain hair care practices such as tight braids or ponytails.
• Do not use Agrocia if you are using occlusive dressings (sealed coverings) or other topical medicines applied to the scalp.
• Do not use Agrocia if there is inflammation, irritation, infection, or a skin condition called psoriasis on the scalp, in case of severe sunburn or severe abrasion (irritation) of the scalp, or if the scalp is shaved.
• Do not use Agrocia if there are any diseases or wounds on the scalp, as the medicine may be absorbed to a greater extent. This should be checked before using the medicine.
• If the patient has a history of any blood vessel (circulatory system) or heart disease, the doctor will need to monitor blood pressure and pulse.
• If any other general or skin-related symptoms occur, stop treatment and contact your doctor or pharmacist.
• Wash hands thoroughly after applying the medicine to the scalp, as contact with areas other than the scalp may result in unwanted hair growth in those areas.
• If the medicine comes into contact with the eyes or mucous membranes, flush the area thoroughly with water. If necessary, consult an ophthalmologist.
• Accidental ingestion of the medicine may cause serious adverse effects on the cardiovascular system. Therefore, the medicine must be stored out of sight and reach of children.
• Agrocia may change the colour and (or) texture of hair.
• This medicine may cause a sudden drop in blood pressure in patients taking peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines used to treat high blood pressure.
• Do not expose the treated area of skin to sunlight (even on cloudy days) or lamps emitting ultraviolet radiation (UVA). It is important to provide adequate protection for the treated skin area.
• At the beginning of treatment with this medicine, increased hair loss may occur due to hair renewal. If increased hair loss persists for more than 2 weeks, discontinue use of Agrocia and consult your doctor.
• Due to the presence of ethanol (alcohol) and propylene glycol, the medicine may cause skin irritation and dryness.

Do not inhale the aerosol.
Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil was applied by caregivers using topical minoxidil. Hair growth returned to normal within several months after the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with areas of the body where minoxidil has been applied topically.
If excessive hair growth is observed in a child during the use of topical products containing minoxidil, consult your doctor.
Discontinue use of Agrocia and consult your doctor if hypotension or chest pain, rapid heartbeat, fainting or dizziness, sudden unexplained weight gain, swelling of hands or feet, or persistent redness or irritation of the scalp occur.

Agrocia with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Using Agrocia together with medicines that dilate peripheral blood vessels (medicines used to treat cerebrovascular disorders) and medicines used to treat high blood pressure (such as guanethidine and its derivatives) may cause a sudden drop in blood pressure.
Do not apply this medicine simultaneously with other topical medicines or hair products such as corticosteroids, retinoids (e.g. tretinoin creams), or occlusive-action ointments, as they may increase absorption of the medicine.
Betamethasone dipropionate (a medicine used to treat skin diseases) may reduce the systemic absorption of Agrocia.
When used concomitantly with systemic cyclosporine (a medicine used to prevent organ transplant rejection), excessive hair growth may occur.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use of Agrocia is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
Although there is currently no data indicating that Agrocia affects the ability to drive or operate machinery, patients should avoid these activities until they know how they tolerate the medicine.

Agrocia contains ethanol and propylene glycol.
Agrocia contains 243 mg of alcohol (96% ethanol) in each mL of topical solution. The medicine may cause stinging on damaged skin. Due to the ethanol content, the medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
Agrocia contains 520 mg of propylene glycol in each mL of topical solution.

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 in doubt, consult your doctor, pharmacist, or nurse.

The recommended daily dose is 1 mL of solution (10 sprays of aerosol using the metering pump) twice daily.

Agrocia helps stabilize male-pattern hair loss (androgenetic alopecia) in the scalp area with a diameter of 3 to 10 cm in men. Therefore, treatment may halt the progression of androgenetic hair loss. The onset and extent of response to treatment vary from patient to patient; however, individual response cannot be predicted due to lack of available data.

Do not discontinue treatment too early, as stopping treatment may result in a return to the initial state of hair loss within 3 to 4 months after discontinuation.

• Wash hands thoroughly after applying the medicine.
• Before application, ensure that hair and the scalp skin are completely dry. Then apply the medicine starting from the center of the affected area. Do not apply the medicine to any other part of the body due to the risk of unwanted hair growth in those areas.
• The medicine is applied using a metering pump equipped with a dosing button and an applicator with an extended tip. Before use, attach the applicator connected to the metering pump to the bottle. Please refer to the instructions below for attaching the applicator and inserting the metering pump into the bottle:
• Attach the applicator to the metering pump: hold the pump firmly and press the upper part of the applicator firmly into place.

• Unscrew and remove the cap from the bottle.

• Insert the metering pump into the bottle and screw it tightly.

• Release the metering pump; the dispenser is now ready for use.

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

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

As with other medicines, individual response to treatment varies; therefore, it may be necessary to use the medicine for up to 4 months before noticeable hair growth is observed. During long-term use, treatment effects remain consistent over time. If no improvement in hair growth is observed after six months, treatment should be discontinued.

Dosage

For topical use only. DO NOT swallow the medicine.

The recommended daily dose is 1 mL of solution (10 sprays of aerosol using the metering pump) twice daily.

The maximum daily dose is 2 mL.

The recommended daily dose should be followed regardless of the size of the bald area on the scalp.

If you feel that the effect of Agrocia is too strong or too weak, consult your doctor or pharmacist.

Use in children and adolescents

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

Use in patients over 65 years of age

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

Use of a higher than recommended dose of Agrocia

If more Agrocia is used than recommended, contact your doctor or pharmacist immediately.

Accidental or intentional overdose of Agrocia may intensify skin-related adverse effects, particularly itching, dryness, skin irritation, and rash (acute or chronic inflammatory skin conditions).

Objective and subjective symptoms following accidental or intentional ingestion of Agrocia may include hypotension (low blood pressure), tachycardia (rapid heartbeat), edema (swelling, excessive fluid retention), and congestive heart failure.

In case of overdose or accidental ingestion, seek immediate medical help and inform the healthcare provider which medicine and in what quantity was taken.

Missed dose of Agrocia

Apply the next dose as scheduled and return to the regular dosing regimen. Do not use a double dose to make up for a missed dose.

Stopping Agrocia treatment

If treatment with Agrocia is stopped, hair loss may recur and return to the pre-treatment state within 3 to 4 months.

If such symptoms occur, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Contact your doctor immediately if any of the following symptoms occur,
as urgent treatment may be necessary.
Swelling of the face, lips or throat, which makes swallowing or breathing difficult. These may be symptoms
of a severe allergic reaction (frequency unknown, cannot be estimated from available data).

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The most commonly occurring adverse effects are: itching, skin inflammation (redness), dryness, skin irritation, rash (inflammatory skin disease), excessive hair growth (excessive growth of hair on the skin). These effects are usually mild to moderate
and reversible upon discontinuation of treatment.

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

• Headache

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

• Local skin irritation (peeling and redness)
• Contact dermatitis
• Dry skin
• Swelling (excessive fluid accumulation)
• Burning and itching of the skin
• Excessive hair growth (excessive growth of hair on the skin)
• Dyspnea (difficulty breathing)
• Musculoskeletal pain
• Depression
• Acneiform rash

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

• Rash (inflammatory skin disease)
• Dizziness, discomfort
• Eye irritation
• Change in hair colour
• Change in hair texture

Very 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

Not known (frequency cannot be estimated from available data):

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Agrocia

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicinal product.
Do not use this medicine after the expiry date stated on the bottle and carton after "EXP"
and "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Period of use after first opening of the bottle: 30 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the packaging and other information

What Agrocia contains
The active substance is minoxidil: each millilitre (mL) of solution contains 50 mg of minoxidil.
One mL of solution corresponds to 10 sprays.
The other ingredients (excipients) are: ethanol 96%, propylene glycol, and purified water.

What Agrocia looks like and contents of the pack
Agrocia is a solution for the skin. The solution is clear, colourless or slightly yellowish, with an alcoholic odour.
The medicine is supplied in an HDPE bottle with a PP cap and a PP metering pump, packed in a cardboard box. The pack contains 60 mL of solution or 120 mL of solution (2 x 60 mL).

Marketing Authorisation 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

Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl