Package leaflet: Information for the user

ALOXIDIL 20 mg/ml topical solution

minoxidil
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 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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms. Contents of this leaflet:

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

1. What ALOXIDIL is and what it is used for

ALOXIDIL contains the active substance minoxidil, which belongs to the group of dermatological medicines.
ALOXIDIL is indicated for the symptomatic treatment of androgenetic alopecia (excessive hair loss in men).

2. What you need to know before using ALOXIDIL

Do not take ALOXIDIL

If you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6);
If you have coronary heart disease (problems with the coronary arteries), arrhythmias (abnormal heart rhythm), congestive heart failure (a condition in which the heart is unable to supply adequate blood flow to the body), or valvular heart disease (diseases affecting the heart valves). In the case of other cardiovascular disorders, the use of ALOXIDIL should be decided according to the physician's judgment. If you suffer from hypertension (high blood pressure), your doctor will assess whether treatment with this medicine is suitable for you and will monitor you closely.

Warnings and precautions
Talk to your doctor or pharmacist before using ALOXIDIL.
Exercise particular caution when using ALOXIDIL:

In case of accidental contact with sensitive surfaces (eyes, abraded skin, mucous membranes), ALOXIDIL may cause burning sensations and irritation. Therefore, the affected area should be thoroughly rinsed with plenty of fresh water.
In case of accidental ingestion of the solution: accidental ingestion may cause serious adverse effects.
If you experience systemic effects, as minoxidil may be absorbed through the scalp and cause effects on organs throughout the body, such as tachycardia (increased heart rate), angina (chest pain due to blocked heart arteries), edema (swelling due to fluid accumulation), pericarditis (inflammation of the membrane surrounding the heart), pericardial effusion, cardiac tamponade (compression of the heart by accumulated fluid), or worsening of orthostatic hypotension (drop in blood pressure upon standing) caused by antihypertensive medications such as guanethidine and its derivatives. You should be periodically monitored to detect any signs of systemic effects caused by minoxidil.
If you have latent heart disorders, ALOXIDIL may worsen these conditions.
If you have concomitant skin diseases, or if you are undergoing treatment with topical corticosteroids (local cortisone, cortisone creams) or other dermatological preparations. If you experience systemic adverse effects (generalized effects) or dermatological reactions, discontinue use of the medicine and consult your doctor.
If you have localized congenital alopecia (congenital absence of hair in specific areas) or generalized congenital alopecia (absence of hair over the entire body); cicatricial alopecia (scarring hair loss due to disease or other healed causes), of various origins (post-traumatic, psychogenic, or infectious); diffuse acute alopecia caused by toxic substances or medications, in which hair regrowth depends on removal of the causative factor (discontinuation of the drug); or celsi area (hair loss on the nape of the neck, which may spread to the entire scalp), since the efficacy of ALOXIDIL has not been established for these types of alopecia.

Children and adolescents
The safety and efficacy of ALOXIDIL in children and adolescents under 18 years of age have not been studied.

Other medicines and ALOXIDIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
No interactions associated with the use of ALOXIDIL are currently known.
Nevertheless, exercise caution and inform your doctor if you are taking the following medicines:

guanethidine, a medicine used for high blood pressure;
peripheral vasodilators, which dilate the arteries.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ALOXIDIL if you are pregnant or breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

ALOXIDIL contains 207 mg of propylene glycol per ml.
This medicine contains 514 mg of alcohol per ml.
It may cause a burning sensation on damaged skin.

3. How to use ALOXIDIL

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For topical use only.
Use this medicine only on the scalp and nowhere else on the body.
The recommended dose is 1 ml, applied twice daily, directly to the areas affected by hair loss, starting from the centre. The dose is independent of the surface area to be treated. The daily dosage must not exceed 2 ml.
Method of use:
Use of the dropper: Fill the dropper up to the 1 ml mark. Then apply several drops of ALOXIDIL onto the scalp, spreading the solution by gently massaging with the fingertips over the entire area affected by hair loss. Repeat until the full dose contained in the dropper has been applied. Close the bottle tightly after use.
After applying ALOXIDIL, wash your hands thoroughly with plenty of water.
Apply ALOXIDIL only to completely dry hair and scalp.
Do not apply ALOXIDIL to other areas of the body. Do not use hair dryers to speed up drying of ALOXIDIL, as this may reduce the effectiveness of the product.
Treatment lasting 3–4 months with two daily applications may be necessary before any noticeable signs of hair regrowth appear.
The onset and intensity of these signs may vary from patient to patient.
In any case, your doctor should evaluate whether treatment should be discontinued if no therapeutic effect is observed within this time period.
If you use more ALOXIDIL than you should
If you or another person accidentally ingest this medicine, symptoms such as fluid retention, low blood pressure, and rapid heartbeat (tachycardia) may occur.
If this happens, contact your doctor immediately.
If you stop using ALOXIDIL
If treatment is stopped, it is likely that hair loss will resume and return to the initial state within 3–4 months.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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).

The most common side effects are minor dermatological reactions affecting the skin.
The most frequently occurring side effect is local irritation, such as desquamation, erythema (redness of the skin), dermatitis (inflammation of the skin), dry skin, hypertrichosis (excessive growth of hair and hairiness) (in areas different from those treated with ALOXIDIL), burning sensation and skin rash.
Other side effects that have occurred less frequently include: allergic reactions (sensitization, urticaria, generalized erythema and facial swelling), dizziness, tingling, headache, weakness, neuritis (nerve inflammation), edema (swelling due to fluid retention), eye irritation, taste disturbances, ear infections (particularly external otitis, inflammation of the outer ear) and visual disturbances.
Side effects that have occurred rarely include hair abnormalities, chest pain, changes in blood pressure, changes in heart rate, hepatitis (liver inflammation) and 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 http://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 ALOXIDIL

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 ALOXIDIL contains

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

Description of the appearance of ALOXIDIL and contents of the pack
60 ml glass bottle with a screw cap made of plastic material and a dropper.
3 x 60 ml glass bottles with screw caps made of plastic material and droppers.

Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI srl
Via dei Castelli Romani 83/85
POMEZIA (Roma)

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