ALOXIDIL 2% Topical solution

Зміст інструкції

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

ALOXIDIL 20 mg/ml cutaneous solution

minoxidil

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take 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 ALOXIDIL is and what it is used for
• 2. What you need to know before you take ALOXIDIL
• 3. How to take ALOXIDIL
• 4. Possible side effects
• 5. How to store ALOXIDIL
• 6. Contents of the pack and other information

1. What is ALOXIDIL and what is it used for

ALOXIDIL contains the active ingredient minoxidil, belonging to the group of dermatological drugs.
ALOXIDIL is indicated in the symptomatic treatment of androgenetic alopecia (excessive hair loss
in men).

2. What you need to know before you take ALOXIDIL

Do not take ALOXIDIL

• If you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• If you suffer from coronary heart disease (problems with the coronary arteries), arrhythmias (irregular heartbeat), congestive heart failure (a condition in which the heart fails to provide blood in an adequate quantity to the body) or valvular heart disease (diseases affecting the heart valves). If you have other cardiovascular disorders, the use of ALOXIDIL is subject to the doctor's judgment. If you suffer from hypertension (high blood pressure), the 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 taking ALOXIDIL.
Pay particular attention with ALOXIDIL:

• In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), ALOXIDIL may cause burning and irritation. Therefore, the affected area must be washed with plenty of fresh water.
• In case of accidental ingestion of the solution: accidental ingestion can cause serious side effects.
• If you experience systemic effects as minoxidil may be absorbed through the scalp and cause effects on all organs such as tachycardia (increased heart rate), angina (chest pain due to closure of the heart arteries), edema (swelling due to fluid accumulation), pericarditis (inflammation of the membrane lining the heart externally), pericardial effusion, cardiac tamponade (compression of the heart by this fluid) or increased orthostatic hypotension (lowering of blood pressure when standing up) from antihypertensive drugs such as guanethidine and derivatives. You should be monitored periodically to
  identify any suspected systemic effects caused by minoxidil.

If you suffer from latent heart disorders ALOXIDIL may worsen these disorders.

• If you are affected by concomitant skin diseases, or if you are undergoing topical corticosteroid therapy (local cortisone, cortisone ointments) or other dermatological preparations. If you experience systemic side effects (at a general level) or dermatological reactions, stop taking the medicine and consult your doctor.
• If you suffer from localized congenital alopecia (congenital local absence of hair and scalp) or generalized (absence of hair and scalp throughout the body); cicatricial alopecia (from disease or from other 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 conditioned by the suppression of the specific cause (suspension of the drug); area celsi (hair loss on the nape of the neck, which can spread to the entire scalp), as the efficacy of ALOXIDIL has not been established for these forms of alopecia. Children and adolescentsThe safety and efficacy of ALOXIDIL in children and adolescents under the age of 18 have not been studied.

Other medicines and ALOXIDIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions are currently known with the use of ALOXIDIL.
However, be careful and tell your doctor if you are taking the following medicines:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use ALOXIDIL if you are pregnant or breastfeeding with breast milk.

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

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

3. How to take ALOXIDIL

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Cutaneous use.
Use this medicine only on the scalp and not on any other part of the body.
The recommended dose is 1 ml, twice a day, applied to the areas affected by baldness, starting from the centre. The dose is independent of the surface area to be treated. The daily dosage should not exceed 2 ml.
Method of use:
Using the dropper: Fill the dropper up to the 1 ml mark. Then apply a few drops of ALOXIDIL to the scalp, distributing the liquid by rubbing it with your fingertips over the entire affected area of baldness. Repeat until all the dose contained in the dropper has been applied. Close the bottle carefully.
After applying ALOXIDIL, wash your hands thoroughly with 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 the drying of ALOXIDIL, as this system may decrease the effect of the product.
Treatment for 3-4 months with two applications a day may be necessary before there are evident signs of hair growth.
The onset of these signs and their intensity vary from patient to patient.
In all cases, the doctor will have to assess the opportunity to discontinue treatment if no therapeutic result is observed within this period.

If you take more ALOXIDIL than you should
If you or another person accidentally ingest this medicine, fluid retention, lowering of blood pressure and rapid heartbeat (tachycardia) may occur.
If this happens, contact your doctor immediately.

If you stop taking ALOXIDIL
If treatment is stopped, a return to the initial state is likely to occur within 3-4 months.
If you have any further questions on 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 that can cause difficulty 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 skin reactions.
The most frequent side effect is local irritation, consisting of scaling, erythema (redness of the skin),
dermatitis (skin inflammation), dry skin, hypertrichosis (exaggerated increase in hair and hair) (in areas
other than those treated with ALOXIDIL), burning sensation and rash.
Other side effects that have occurred infrequently 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, altered taste, 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 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 ALOXIDIL contains

• The active ingredient is minoxidil. 1 ml of solution contains 20 mg of minoxidil
• The other ingredients are: ethyl alcohol, propylene glycol, purified water. Description of the appearance of ALOXIDIL and contents of the pack60 ml glass bottle equipped with a plastic screw cap with a dropper. 3 glass bottles of 60 ml equipped with a plastic screw cap with a dropper.

Marketing authorisation holder and manufacturer
IDI FARMACEUTICI srl
Via dei Castelli Romani 83/85
POMEZIA (Roma)