MINOVITAL 2% Topical solution

Зміст інструкції

1. MINOVITAL 20 mg/ml cutaneous solution
   1. What is MINOVITAL and what is it used for
   2. What you need to know before using MINOVITAL
   3. How to use MINOVITAL
   4. Possible side effects
   5. How to store MINOVITAL
   6. Contents of the pack and other information

MINOVITAL 20 mg/ml cutaneous solution

Minoxidil

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What MINOVITAL is and what it is used for
• 2. What you need to know before using MINOVITAL
• 3. How to use MINOVITAL
• 4. Possible side effects
• 5. How to store MINOVITAL
• 6. Contents of the pack and other information

1. What is MINOVITAL and what is it used for

MINOVITAL contains the active ingredient minoxidil, belonging to the group of dermatological medicines that
works by stimulating hair growth in individuals affected by androgenetic alopecia.
MINOVITAL is therefore indicated in 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 artery disease (heart artery diseases), arrhythmias (irregular heartbeat), congestive heart failure (inability of the heart to provide oxygen in sufficient quantity to the needs of the entire organism) or valvular heart disease (diseases affecting the heart valves). If you suffer from other circulatory or heart disorders, your doctor will decide whether MINOVITAL is suitable for you.

The use of the medicine is not recommended in children and adolescents under the age of 18 and in adults of
age over 55 (see section 2).

Warnings and precautions
Consult your doctor or pharmacist before using MINOVITAL.
Pay particular attention with MINOVITAL and consult your doctor:

• If you suffer from hypertension (high blood pressure). In this case your doctor will keep you under strict control.
• If you suffer from other circulatory or heart disorders (see “Do not use Minovital”).
• If you have concomitant skin diseases (dermatological) or are being treated with medicines based on corticosteroids (anti-inflammatory drugs to be applied to the skin) or other dermatological preparations.

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) MINOVITAL can
cause burning and irritation. Therefore, the affected area must be washed thoroughly with cool water.
Cases of excessive hair growth on the body of children in early childhood have been reported following
contact with the sites of application of minoxidil by patients (assistants) using topical minoxidil. Hair
growth returns to normal within a few months when children in early childhood 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 hair growth on the child's body during the period in which
topical minoxidil-based products are being used.
In case of accidental ingestion of the MINOVITAL solution, it can cause serious side effects due to
its vasodilating action (see section “If you use more MINOVITAL than you should”).
It is not yet fully clear whether an occlusive bandage, i.e. the use of gauze on the treated area that does not
allow air to pass through, may increase the absorption of the medicine.

Stop treatment with this medicine and consult your doctor if you notice:
- skin reactions.
- other side effects, in particular accelerated heartbeat (tachycardia), chest pain
(angina), swelling caused by fluid retention (edema), or increased orthostatic pressure
guanethidine (sudden drop in pressure when moving from a lying to an upright position) if you are
taking guanethidine at the same time (see section “Other medicines and MINOVITAL” and
Possible side effects”).
The effectiveness of MINOVITAL has not been established in the following forms: localized congenital alopecia
(local congenital absence of hair and hair) or generalized (absence of hair and hair throughout the body);
cicatricial alopecia (from illness or from another cause healed with scarring) of various nature (post-traumatic, of
psychic or infectious origin); acute diffuse alopecia from toxic substances, from drugs in which hair regrowth
is conditional on suppressing the specific cause (stopping the drug); area celsi (hair loss
on the nape of the neck, which can spread to the entire scalp).

Special populations
Do not take this medicine if you are over 55 years old because safety and efficacy have not been established.

Children and adolescents
Do not give this medicine to children and adolescents under the age of 18 because safety and
efficacy have not been established.

Other medicines and MINOVITAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions are currently known associated with the use of MINOVITAL.
If you are simultaneously undergoing therapy with guanethidine, a peripheral vasodilator that acts
by dilating the arteries, there is a possibility of an increase in orthostatic hypotension, which consists of a sudden
drop in blood pressure following the sudden transition from a seated or lying position to an upright position.
In this case, stop treatment with MINOVITAL.
Consult your doctor if you are being treated with topical corticosteroids or other dermatological preparations (see
“Pay particular attention with MINOVITAL and consult your doctor”)

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
MINOVITAL should not be used in pregnant or breastfeeding women as the effects of
MINOVITAL used during pregnancy and breastfeeding are unknown.
Minoxidil administered systemically is excreted in breast milk.

Driving and operating machinery
This medicine does not appear to interfere with 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 following exactly as described in this leaflet or as instructed 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 a day, preferably in the morning and evening.
Apply to the scalp starting from the center of the affected bald area and distribute the solution over
the entire affected area.
The dose is independent of the size of the area to be treated. The total daily dose should not exceed
2 ml.
After applying MINOVITAL, wash your hands carefully.
Apply MINOVITAL to completely dry hair and scalp.
Do not apply MINOVITAL to other areas of the body.
During treatment with MINOVITAL, it is not necessary to change your hygienic habits
regarding the scalp. However, a mild shampoo is recommended.
If washing your hair, it must be done exclusively before applying
MINOVITAL. Before applying MINOVITAL, make sure the scalp is perfectly dry.
Do not use hair dryers to speed up the drying of MINOVITAL, as this system
may decrease the effect of the medicine.
Before there are evident signs of hair growth, applications twice a day are necessary for
3-4 months. The onset and intensity of these signs vary from patient to patient: in all cases, your doctor
must assess the opportunity to discontinue treatment if no therapeutic result is observed within that period.
Following discontinuation of therapy, a return to the state prior to the start of treatment
occurs within 3-4 months.

Method of use
Instructions for opening the bottle after applying the dropper:
Press and unscrew the cap-dropper simultaneously.
After use, screw the cap-dropper on: the bottle is well closed when you hear clicks while unscrewing without
pressing.

If you use more MINOVITAL than you should
If you use more MINOVITAL than you should, or in case of accidental ingestion, you may experience undesirable effects on
circulation and the heart (cardiovascular) associated with fluid retention, low blood pressure
and tachycardia.
In case of accidental ingestion, immediately notify your doctor 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 compensate for the missed dose.

If you stop using MINOVITAL
With the suspension of MINOVITAL use, the growth of new hair ceases and the reappearance of pre-treatment symptoms
occurs within 3-4 months.
If the application of MINOVITAL is inadvertently interrupted for 1-2 days, resume treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• swelling of the face, lips or throat which can cause difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be defined based on the available data).
• tachycardia (increased heart rate)
• angina (chest pain)
• edema (swelling caused by fluid retention)
• increased orthostatic hypotension (lowering of blood pressure when standing up).

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

• scaling
• erythema (redness of the skin)
• dermatitis (skin inflammation)
• dry skin
• hypertrichosis (increased hair and hair growth) in areas other than those treated with MINOVITAL
• burning sensation
• rash (skin rash).

Other side effects that have occurred infrequently include:

• allergic reactions (sensitization, urticaria, generalized erythema and facial edema)
• dizziness
• tingling
• headache
• weakness
• neuritis (inflammation of the nerves)
• edema
• eye irritation
• altered taste
• ear infections (particularly otitis externa)
• visual disturbances.

Side effects that have occurred rarely include:

• hair abnormalities
• chest pain
• blood pressure variations
• heart rate variations
• hepatitis
• kidney stones

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system www.aifa.gov.it/content/segnalazioni-reazioni- a vverse .
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 which is stated on the pack.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MINOVITAL contains

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

Description of the appearance of MINOVITAL and contents of the pack
60 ml bottle with dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATORIO TERAPEUTICO M.R. S.r.l.
Via D. Veneziano 13
50143 Firenze (FI)
Italy

Manufacturer
Lisapharma S.p.a
Via Licinio, 11
22036 Erba (Co)
Italy