Package leaflet: Information for the user

MINOVITAL 20 mg/ml topical solution

Minoxidil
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

What MINOVITAL is and what it is used for
What you need to know before using MINOVITAL
How to use MINOVITAL
Possible side effects
How to store MINOVITAL
Contents of the pack and other information

1. What MINOVITAL is and what it is used for

MINOVITAL contains the active substance minoxidil, which belongs to the group of dermatological medicines and
acts by stimulating hair growth in individuals affected by androgenetic alopecia.
MINOVITAL is therefore indicated for the treatment of symptoms of a type of baldness called androgenetic
alopecia.

2. What you need to know before using MINOVITAL

Do not use MINOVITAL

If you are allergic to minoxidil, propylene glycol, ethanol, or any of the other ingredients of this medicine (listed in section 6);
If you suffer from coronary heart disease (diseases of the coronary arteries), arrhythmias (abnormal heart rhythm), congestive heart failure (inability of the heart to supply sufficient oxygen to meet the body's needs), or valvular heart disease (diseases affecting the heart valves). If you have other circulatory or heart conditions, your doctor will decide whether MINOVITAL is suitable for you.

The use of this medicine is not recommended in children and adolescents under 18 years of age and in adults over 55 years of age (see section 2).
Warnings and precautions
Talk to your doctor or pharmacist before using MINOVITAL.
Exercise particular caution with MINOVITAL and consult your doctor:

If you have hypertension (high blood pressure). In this case, your doctor will monitor you closely.
If you have other circulatory or heart conditions (see section "Do not use MINOVITAL").
If you have concomitant skin diseases (dermatological conditions), or are being treated with corticosteroid medicines (anti-inflammatory agents applied to the skin) or other dermatological preparations.

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), MINOVITAL may cause burning sensations and irritation. Therefore, the affected area should be thoroughly washed with fresh water.
Cases of excessive body hair growth in infants have been reported following accidental contact with application sites of minoxidil in patients (caregivers) using topical minoxidil. Excessive hair growth returns to normal within a few months once infants are no longer exposed to minoxidil. Care must be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.
Consult a doctor if you notice excessive body hair growth in a child during the period when topical minoxidil products are being used.

In case of accidental ingestion, MINOVITAL solution may cause serious adverse effects due to its vasodilatory action (see section "If you use more MINOVITAL than you should").
It is not yet fully clear whether occlusive dressings, i.e., the use of bandages on the treated area that do not allow air passage, may increase the absorption of the medicine.
Stop treatment with this medicine and consult your doctor if you notice:
- Skin reactions.
- Other adverse effects, especially increased heart rate (tachycardia), chest pain (angina), swelling due to fluid accumulation (edema), or increased orthostatic hypotension when taking guanethidine (a sudden drop in blood pressure upon changing from lying down to standing up) if you are concurrently taking guanethidine (see section "Other medicines and MINOVITAL" and "Possible side effects").

The efficacy of MINOVITAL has not been established in the following conditions: localized or generalized congenital alopecia (congenital absence of hair and body hair, either localized or affecting the entire body); cicatricial alopecia (scarring alopecia due to disease or other healed causes) of various origins (post-traumatic, psychogenic, or infectious); diffuse acute alopecia caused by toxic substances or drugs, where hair regrowth depends on removal of the specific cause (discontinuation of the drug); occipital hair loss (hair loss at the back of the head, which may spread to the entire scalp).

Special populations
Do not take this medicine if you are over 55 years of age, as safety and efficacy have not been established.
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as safety and efficacy have not been established.
Other medicines and MINOVITAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions associated with the use of MINOVITAL are currently known.
If you are simultaneously undergoing treatment with guanethidine, a peripheral vasodilator that works by dilating arteries, there is a possibility of increased orthostatic hypotension, characterized by a sudden drop in blood pressure upon rapidly changing from a sitting or lying position to standing. In this case, discontinue treatment with MINOVITAL.
Consult your doctor if you are using topical corticosteroids or other dermatological preparations (see "Exercise particular caution with MINOVITAL and consult your doctor").
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
MINOVITAL must not be used in pregnant or breastfeeding women, as the effects of MINOVITAL when used during pregnancy and breastfeeding are unknown.
Minoxidil administered systemically is excreted in breast milk.
Driving and using machines
This medicine appears to have no influence on the ability to drive vehicles or operate machinery.
MINOVITAL contains propylene glycol.
It may cause skin irritation.

3. How to use MINOVITAL

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For external use only.
The recommended dose is 1 ml (20 drops), twice daily, preferably in the morning and evening.
Apply to the scalp, starting from the center of the area affected by baldness, and spread the solution over the entire affected area.
The dose is independent of the size of the area to be treated. The total daily dose must not exceed 2 ml.
After applying MINOVITAL, wash your hands thoroughly.
Apply MINOVITAL to completely dry hair and scalp.
Do not apply MINOVITAL to other areas of the body.
During treatment with MINOVITAL, there is no need to change your usual hygiene practices regarding the scalp. However, a mild shampoo is recommended.
If washing your hair, this should be done exclusively before applying MINOVITAL. Before applying MINOVITAL, ensure that the scalp is completely dry.
Do not use hair dryers to speed up the drying of MINOVITAL, as this method may reduce the effectiveness of the medicine.
Applications twice daily for 3–4 months are required before any visible signs of hair growth appear. The onset and intensity of these signs vary from patient to patient. In all cases, your doctor should evaluate whether treatment should be discontinued if no therapeutic effect is observed within this period. After stopping treatment, reversal to the pre-treatment condition occurs within 3–4 months.
Instructions for use
Instructions for opening the bottle after attaching the dropper:
Press down on the dropper cap and simultaneously unscrew it.
After use, screw the dropper cap back on: the bottle is properly closed when you hear clicking sounds while unscrewing without pressing.
If you use more MINOVITAL than you should
If you use more MINOVITAL than recommended, or in case of accidental ingestion, you may experience undesirable effects on circulation and the heart (cardiovascular effects) associated with fluid retention, low blood pressure, and tachycardia.
In case of accidental ingestion, contact your doctor immediately or go to the nearest hospital.
If you forget to use MINOVITAL
If you forget to use MINOVITAL, do not use a double dose to make up for the missed dose.
If you stop using MINOVITAL
When MINOVITAL use is discontinued, new hair growth stops and symptoms return to the pre-treatment state within 3–4 months.
If application of MINOVITAL is inadvertently interrupted for 1–2 days, resume treatment following the dosing schedule indicated in this leaflet (1 ml of MINOVITAL twice daily).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you notice any of the following symptoms, contact your doctor immediately, as urgent medical treatment may be necessary:

swelling of the face, lips or throat which may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated based on available data).
tachycardia (increased heart rate)
angina (chest pain)
oedema (swelling due to fluid accumulation)
worsening of orthostatic hypotension (low blood pressure when standing up).

The most common side effects associated with the use of MINOVITAL are minor dermatological reactions.
The most frequently reported side effect has been local irritation, including:

desquamation
erythema (redness of the skin)
dermatitis (inflammation of the skin)
dry skin
hypertrichosis (increased hair growth) in areas not treated with MINOVITAL
burning sensation
rash (skin eruption).

Other side effects that have occurred less frequently include:

allergic reactions (sensitization, urticaria, generalized erythema and facial oedema)
dizziness
paraesthesia (tingling)
headache
weakness
neuritis (nerve inflammation)
oedema
eye irritation
taste disturbances
ear infections (particularly otitis externa)
visual disturbances.

Side effects that have occurred rarely include:

hair abnormalities
chest pain
changes in blood pressure
changes in heart rate
hepatitis
kidney stones

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MINOVITAL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MINOVITAL contains

The active substance is minoxidil. 1 ml of solution contains 20 mg of minoxidil.
The other components are: alcohol, propylene glycol, water.

Description of the appearance of MINOVITAL and contents of the pack
60 ml bottle with dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATORIO TERAPEUTICO M.R. S.r.l.
Via D. Veneziano 13
50143 Florence (FI)
Italy
Manufacturer
Lisapharma S.p.a
Via Licinio, 11
22036 Erba (Co)
Italy