PHALANX 20 mg /Ml Spray Do Skóry, Roztwór

Treść ulotki

1. PHALANX 20 mg/ml cutaneous spray, solution
   1. What is PHALANX 20 mg/ml and what is it used for
   2. What you need to know before using PHALANX 20 mg/ml
   3. How to use PHALANX 20 mg/ml
   4. Possible side effects
   5. How to store PHALANX 20 mg/ml
   6. Contents of the pack and other information
2. PHALANX 50 mg/ml cutaneous spray, solution
   1. What is PHALANX 50 mg/ml and what is it used for
   2. What you need to know before using PHALANX 50 mg/ml
   3. How to use PHALANX 50 mg/ml
   4. Possible side effects
   5. How to store PHALANX 50 mg/ml
   6. Contents of the pack and other information

PHALANX 20 mg/ml cutaneous spray, solution

minoxidil
equivalent medicine

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, ask your pharmacist.
• If any side effects occur, including effects 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 after 4 months.

Contents of this leaflet

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

1. What is PHALANX 20 mg/ml and what is it used for

PHALANX 20 mg/ml prevents hereditary hair loss in women and men and stimulates hair growth.
It also promotes the regrowth of new hair on already weakened or bald areas and thickens existing hair.
After application, PHALANX 20 mg/ml penetrates the scalp and reaches the hair roots.
The mechanism through which hair growth is stimulated has not yet been clarified. In any case, the active ingredient of PHALANX 20 mg/ml may interrupt hereditary hair loss, through:

• an increase in the diameter of the hair shaft
• stimulation of growth
• prolongation of the growth phases

However, at least 4 months are required before any results can be seen. If the hair roots are still present, thin and weak hair can regrow, becoming longer, stronger and darker
over time. The initial rate of hair growth or the amount of hair that regrows varies from
patient to patient.
Large bald areas or hair loss present for more than 10 years are less sensitive to PHALANX
20 mg/ml.
The following figures show the stages of hair loss in women and men for which the efficacy of minoxidil, the active ingredient of PHALANX 20 mg/ml, has been demonstrated.

Children and adolescents under 18 years, patients 65 years and over
PHALANX 20 mg/ml should not be used in these patient groups, as there are no results of efficacy and safety derived from controlled studies in these age groups.

2. What you need to know before using PHALANX 20 mg/ml

Do not use PHALANX 20 mg/ml

• if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6)
• if you are using any other medicine on the scalp
• if you have any type of dressing or bandage on the scalp
• if you are experiencing sudden or irregular hair loss
• if you are pregnant or breastfeeding
• if any condition affects your scalp, including psoriasis (a pruritic inflammatory skin condition), sunburn, if your scalp is shaved or if the skin of your scalp is damaged by scars or burns, as there are no hair roots present.

Warnings and precautions
Consult your doctor or pharmacist before using PHALANX 20 mg/ml.
Hormonal causes, underlying diseases or malnutrition must be excluded. In these cases you need specific
treatment.
Apply PHALANX 20 mg/ml only to a normal and healthy scalp. Do not use PHALANX
20 mg/ml if the cause of hair loss is unknown or if hair loss is due to childbirth or if the
scalp is red, inflamed or painful.
If effects on internal organs (systemic effects) or severe skin reactions occur, treatment should be discontinued.
PHALANX 20 mg/ml is for external use on the scalp only. Do not apply PHALANX 20 mg/ml to
other parts of the body.
Do not use PHALANX 20 mg/ml

• if you experience any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are using medicines to treat high blood pressure (antihypertensive agents).

You must stop treatment with PHALANX 20 mg/ml and contact a doctor:

• if you have been found to have low blood pressure
• if you experience one or more of these symptoms: chest pain, rapid heartbeat, weakness or dizziness, sudden and unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp or if other new unexpected symptoms appear (see section “if you use more PHALANX 20 mg/ml than you should”).

Contact of the product on areas other than the scalp can cause unwanted hair growth.
Isolated cases of minor changes in hair color have been reported in patients with very
light hair or in case of simultaneous use of other hair care products, or after swimming in
water with a high chlorine content (slight blonde discoloration).
Accidental ingestion can cause serious adverse effects on the cardiovascular system.
Therefore, you must keep this medicine out of the reach of children.
Avoid inhaling the nebulized spray.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as safety and efficacy
in this patient group have not been established.

Other medicines and PHALANX 20 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Currently, no information is available on interactions between PHALANX 20 mg/ml and other agents.
Although not clinically proven, there is a theoretical possibility that the active ingredient of PHALANX
20 mg/ml (minoxidil) absorbed may worsen orthostatic hypotension (a drop in
blood pressure when getting up from a lying position) in patients who are taking peripheral vasodilators (some medicines for high blood pressure that dilate blood vessels) at the same time.
PHALANX 20 mg/ml should not be used together with other dermatological products (preparations for external use containing active ingredients such as corticosteroids, retinoids or ditranol) or with other agents that
increase the absorption of the active ingredient through the skin (cutaneous absorption).

Pregnancy and breastfeeding
Experience relating to the application of PHALANX 20 mg/ml during pregnancy is limited. The
minoxidil absorbed into the body can pass into breast milk. Therefore, PHALANX 20 mg/ml should not
be used by pregnant women or breastfeeding mothers.

Driving and using machines
This medicine can cause dizziness or hypotension (see section 4). If you experience these effects, you should not drive vehicles or use machines.

Phalanx 20 mg/ml contains propylene glycol (E 1520) and 96% ethanol (alcohol)
This medicine contains 199 mg of propylene glycol (E 1520) in each ml of solution.
This medicine contains 494 mg of alcohol (ethanol) in each ml of solution.
It may cause a burning sensation on damaged skin.
Ethanol can cause burning and irritation to the eyes. In case of accidental contact with sensitive areas
(eyes, skin abrasions, mucous membranes), rinse these areas with plenty of water.
If you repeatedly apply PHALANX 20 mg/ml to the hair instead of the scalp,
this can lead to increased dryness and/or stiffness of the hair due to the ethanol and
propylene glycol contained in PHALANX 20 mg/ml.

3. How to use PHALANX 20 mg/ml

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.
PHALANX 20 mg/ml is for external use on a dry scalp. Use PHALANX 20 mg/ml only on a healthy and undamaged scalp and follow exactly all instructions for use as described below. Do not apply PHALANX 20 mg/ml to areas of the body other than the scalp.
The recommended dose is:
Unless otherwise prescribed by your doctor, PHALANX 20 mg/ml should be used as described below:
Apply 1 ml of PHALANX 20 mg/ml twice a day (morning and evening) to the affected area of the scalp.
The amount applied daily, i.e. 2 x 1 ml of solution, must not be exceeded, regardless of the extent of the affected area of the scalp.

Use in children and adolescents
PHALANX 20 mg/ml should not be used in children and adolescents under 18 years of age, as efficacy and safety data from controlled studies in this patient group are not available.

Method of administration
Cutaneous use (on the scalp).
Each bottle of PHALANX 20 mg/ml contains 2 different pump spray applicators:

• one pre-assembled applicator for application to a large area
• a separate applicator with an extended tip for smaller areas

Both applicators can be exchanged by detaching one applicator and replacing it with the other.
For a dose of 1 ml, 6 sprays are required.
Instructions for use/application:
The solution is sprayed directly onto the scalp in the area of hair loss. To do this, press the pump 6 times. After each application, distribute the liquid on the affected area with your fingertips. At the same time, avoid inhaling the nebulized spray.

What you should keep in mind during use?
Hands must be washed thoroughly after applying PHALANX 20 mg/ml, to avoid accidental contact with mucous membranes and eyes.
After applying PHALANX 20 mg/ml, you can style your hair as usual. However, you should avoid wetting your scalp for at least 4 hours. This will prevent PHALANX 20 mg/ml from being washed away.

Duration of use
The onset and extent of hair growth varies from patient to patient.
In general, treatment twice a day for 2-4 months is required before an effect can be seen. To maintain the effect, it is recommended to continue application twice a day, without interruption. Applying PHALANX 20 mg/ml in larger quantities or more frequently will not achieve a better result. Regarding the possible therapeutic effect, there is adequate clinical experience for a treatment period of up to 48 weeks.
If no desired therapeutic response is obtained within 8 months, treatment should be discontinued.
Information regarding increased hair loss
During treatment of hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair, which pushes out the “old”, inactive hair from the scalp. This leads to an initial impression of increased hair loss. In some patients, this reaction is observed between 2 and 6 weeks after starting treatment with the active ingredient minoxidil. However, you should not be alarmed, as this reaction is accompanied by increased growth of new hair. This effect subsides within a few weeks and can be interpreted as an early sign of the effect of minoxidil.

If you feel that the effect of PHALANX 20 mg/ml is too strong or too weak, talk to your doctor or pharmacist.

If you use more PHALANX 20 mg/ml than you should
Applying PHALANX 20 mg/ml at doses higher than those recommended and to relatively large areas of the body or to areas other than the scalp, may likely lead to increased absorption of minoxidil into the body. So far, no cases have been reported in which external use of minoxidil solution has caused symptoms of poisoning.
Following accidental ingestion, the concentration of the active ingredient minoxidil in PHALANX 20 mg/ml may determine effects on internal organs corresponding to the effects that occur when the active ingredient is swallowed, e.g. through tablets. This may determine the following adverse effects: accelerated heartbeat, lowering of blood pressure, fluid retention and consequent sudden weight gain, dizziness.
If accidental ingestion occurs or if signs of overdose occur, consult your doctor immediately, so that he/she can decide what to do. Keep the packaging at hand, so that the doctor can be informed of the active ingredient you have used.

If you forget to use PHALANX 20 mg/ml
Do not apply a double dose to compensate for the missed dose; continue treatment at the recommended dose. Catching up on the missed dose may not be beneficial and could cause adverse effects.

If you stop using PHALANX 20 mg/ml
It is necessary to continue treatment to improve and maintain hair growth. Otherwise, hair loss will reappear.
If treatment is discontinued, within 3-4 months you will reach a condition equal to that obtained in the absence of treatment with PHALANX 20 mg/ml.
If you have any doubts about using this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Contact your doctor immediately if you experience any of the following side effects – you may
need urgent medical treatment.

• Swelling of the face, lips or throat that may make it difficult to swallow or breathe. This may be a sign of a severe allergic reaction (frequency not known, cannot be estimated based on available data)
• Widespread redness of the skin (frequency not known, cannot be estimated based on available data)
• Generalized itching (frequency not known, cannot be estimated based on available data)
• Constriction of the throat (frequency not known, cannot be estimated based on available data)

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

• Headache

Common(may affect up to 1 in 10 people)

• Itching
• Increased hair growth beyond the scalp (including facial hair growth in women)
• Inflammatory skin reaction (including acneiform eruption, skin rash)
• Shortness of breath, breathing difficulties
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning sensation, burning, dryness, itching, scaling and folliculitis Uncommon(may affect up to 1 in 100 people)
• Dizziness, nausea

Not known(frequency cannot be estimated based on available data)

• Contact dermatitis (skin inflammation due to an allergy)
• Depressed mood
• Eye irritation
• Fast heartbeat, palpitations, low blood pressure
• Vomiting
• Symptoms at the application site that can also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin and inflammatory rash up to possible skin scaling, skin inflammation (dermatitis), blister formation, skin bleeding and ulceration
• Temporary hair loss, altered hair color, altered hair structure
• Chest pain.

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 at https://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 PHALANX 20 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle after SCAD.
The expiry date refers to the last day of the month.
Do not refrigerate.
Contains ethanol which is flammable. Store away from heaters or open flames.

Note on the period of validity after opening
After opening the bottle, use the solution within 6 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PHALANX 20 mg/ml contains
The active ingredient is minoxidil.
1 ml of solution contains 20 mg of minoxidil.
The other ingredients are: 96% (v/v) ethanol, propylene glycol (E1520), purified water.

Description of the appearance of PHALANX 20 mg/ml and contents of the pack
PHALANX 20 mg/ml is a clear, colourless to pale yellow solution and is available in packs
containing 60 ml or 3 x 60 ml of cutaneous solution contained in white HDPE bottles.
Each bottle contains 2 different applicators, a pre-assembled pump spray applicator and an
applicator with an extended tip.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
Via Leonardo da Vinci, 20/B
Bolzano

Manufacturer
mibe GmbH Arzneimittel
Muenchener Strasse 15
Brehna, 06796
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
names
Austria: Minoxidil Dermapharm 20 mg/ml Spray zur Anwendung auf der Haut, Lösung
United Kingdom: Minoxidil Dermapharm 20 mg/ml cutaneous spray, solution
Italy: PHALANX 20 mg/ml spray cutaneo, soluzione

PHALANX 50 mg/ml cutaneous spray, solution

minoxidil
equivalent medicine

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 to do.

• Keep this leaflet. You may need to read it again.
• If you want more information, 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 after 4 months.

Contents of this leaflet

• 1. What PHALANX 50 mg/ml is and what it is used for
• 2. What you need to know before you use PHALANX 50 mg/ml
• 3. How to use PHALANX 50 mg/ml
• 4. Possible side effects
• 5. How to store PHALANX 50 mg/ml
• 6. Contents of the pack and other information

1. What is PHALANX 50 mg/ml and what is it used for

PHALANX 50 mg/ml prevents hereditary hair loss in men aged 18 to 65 and stimulates hair
growth. It also promotes the regrowth of new hair on already weakened or bald areas and thickens
existing hair.
After application, PHALANX 50 mg/ml penetrates the scalp and reaches the hair roots.
The mechanism through which hair growth is stimulated has not yet been clarified. In any case, the active ingredient of PHALANX 50 mg/ml can interrupt hereditary hair loss through:

• an increase in the diameter of the hair shaft
• stimulation of growth
• prolongation of the growth phases

However, at least 4 months are required before any results can be seen. If the hair roots are
still present, thin and weak hair can regrow, which becomes longer, stronger and darker
over time. The initial rate of hair growth or the amount of hair that regrows varies from
patient to patient.
Large bald areas or hair loss present for more than 10 years are less responsive to PHALANX
50 mg/ml.
The following figures show the stages of male pattern hair loss for which the efficacy of minoxidil, the active ingredient of PHALANX 50 mg/ml, has been demonstrated.

Children and adolescents under 18 years, patients over 65 years
PHALANX 50 mg/ml should not be used in these patient groups, as there are no results of efficacy and safety derived from controlled studies in these age groups.

Women
PHALANX 20 mg/ml is available for women (see also “What you need to know before using
PHALANX 50 mg/ml”).

2. What you need to know before using PHALANX 50 mg/ml

Do not use PHALANX 50 mg/ml

• if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6)
• if you are a woman, as the appearance of hair growth on the face, aesthetically traumatic and reversible, may occur during treatment
• if you are using any other medicine on the scalp
• if you have any type of dressing or bandage on the scalp
• if you suffer from sudden or irregular hair loss
• if any condition affects your scalp, including psoriasis (itchy, inflammatory skin condition), sunburn, if your scalp is shaved or if the skin of your scalp is damaged by scars or burns, as hair roots are not present.

Warnings and precautions
Consult your doctor or pharmacist before using PHALANX 50 mg/ml.
Hormonal causes, underlying diseases or malnutrition must be ruled out. In these cases, specific
treatment is needed.
Apply PHALANX 50 mg/ml only to a healthy and normal scalp. Do not use PHALANX
50 mg/ml if the cause of hair loss is unknown or if the scalp is red, inflamed or
painful.
So far, there is no clinical experience regarding the effectiveness of the medicine on hair loss in the
temporal region (receding hairline).
If effects on internal organs (systemic effects) or severe skin reactions occur, treatment must be discontinued.
PHALANX 50 mg/ml is for external use on the scalp only. Do not apply PHALANX 50 mg/ml on
other parts of the body.
Do not use PHALANX 50 mg/ml

• if you experience any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are using medicines to treat high blood pressure (antihypertensive agents).

You must stop treatment with PHALANX 50 mg/ml and contact a doctor:

• if you have been found to have low blood pressure
• if you experience one or more of these symptoms: chest pain, rapid heartbeat, weakness or dizziness, sudden and unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp or if other new unexpected symptoms occur (see section “if you use more PHALANX 50 mg/ml than you should”).

Contact of the product on areas other than the scalp may cause unwanted hair growth.
Isolated cases of minor changes in hair color have been reported in patients with very
light hair or in case of simultaneous use of hair care products, or after swimming in water
with a high chlorine content.
Accidental ingestion may cause serious adverse effects on the cardiovascular system.
Therefore, you must keep this medicine out of reach of children.
Avoid inhaling the nebulized spray.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as safety and efficacy
in this patient group have not been established.

Other medicines and PHALANX 50 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Currently, no information is available on the interaction between PHALANX 50 mg/ml and other agents.
Although not clinically proven, there is a theoretical possibility that the active ingredient of PHALANX
50 mg/ml (minoxidil) absorbed may worsen orthostatic hypotension (a drop in
blood pressure when getting up from a lying position) in patients who are simultaneously taking
peripheral vasodilators (some medicines for high blood pressure that dilate blood vessels).
PHALANX 50 mg/ml must not be used together with other dermatological products (preparations for external use containing active ingredients such as corticosteroids, retinoids or dithranol) or with other agents that
increase the absorption of the active ingredient through the skin (cutaneous absorption).

Pregnancy and breastfeeding
The use of PHALANX 50 mg/ml is indicated only for male patients. Experience regarding the application
of PHALANX 50 mg/ml during pregnancy is limited. Minoxidil absorbed into the body may
pass into breast milk. Therefore, PHALANX 50 mg/ml must not be used by pregnant women or
breastfeeding mothers.

Driving and using machines
This medicine can cause dizziness or hypotension (see section 4). If they experience these effects, patients should not drive vehicles or use machines.

PHALANX 50 mg/ml contains propylene glycol (E 1520) and 96% ethanol (alcohol)
This medicine contains 509 mg of propylene glycol (E 1520) per ml of solution.
This medicine contains 248 mg of alcohol (ethanol) per ml of solution.
It may cause a burning sensation on damaged skin.
Ethanol can cause burning and irritation to the eyes. In case of accidental contact with sensitive areas
(eyes, skin abrasions, mucous membranes), rinse these areas with plenty of water.
If you repeatedly apply PHALANX 50 mg/ml to the hair instead of the scalp, you
may experience increased dryness and stiffness of the hair due to the ethanol and propylene glycol contained in PHALANX 50 mg/ml.

3. How to use PHALANX 50 mg/ml

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.
PHALANX 50 mg/ml is for external use on a dry scalp. Use PHALANX 50 mg/ml only on a healthy and undamaged scalp and follow exactly all the instructions for use given below. Do not apply PHALANX 50 mg/ml to areas of the body other than the scalp.
The recommended dose is:
Apply 1 ml of PHALANX 50 mg/ml twice a day (morning and evening) to the affected areas of the bald scalp.
The amount applied daily, i.e. 2 x 1 ml of solution, must not be exceeded, regardless of the extent of the affected area of the scalp.

Use in children and adolescents
PHALANX 50 mg/ml should not be used in children and adolescents under 18 years of age, as efficacy and safety data from controlled studies in this patient group are not available.

Method of administration
Cutaneous use (on the scalp).
Each bottle of PHALANX 50 mg/ml contains 2 different pump spray applicators:

• one pre-assembled applicator for application to a large area
• a separate applicator with an elongated end for smaller areas

Both applicators can be exchanged by detaching one applicator and replacing it with the other.
For a dose of 1 ml, 6 sprays are required.
Instructions for use/application:
The solution is sprayed directly onto the scalp in the hair loss area. To do this, press the pump 6 times. After each application, distribute the liquid over the affected area with your fingertips. At the same time, avoid inhaling the nebulized spray.

What you should keep in mind during use?
Hands must be washed thoroughly after applying PHALANX 50 mg/ml, to avoid accidental contact with mucous membranes and eyes.
After applying PHALANX 50 mg/ml, you can style your hair as usual. However, you should avoid wetting your scalp for at least 4 hours. This will prevent PHALANX 50 mg/ml from being washed away.

Duration of use
The onset and extent of hair growth vary from patient to patient.
In general, treatment twice a day for 2-4 months is required before an effect can be seen.
To maintain the effect, it is recommended to continue application twice a day, without interruption.
You will not achieve a better result by applying PHALANX 50 mg/ml in larger quantities or more frequently. Regarding the possible therapeutic effect, there is adequate clinical experience for a treatment period of up to 1 year.
If no effect is visible after 4 months, treatment should be discontinued.
Information regarding increased hair loss
During the treatment of hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair, which pushes out the “old”, inactive hair from the scalp. This leads to an initial impression of increased hair loss. In some patients, this reaction is observed between 2 and 6 weeks after starting treatment with the active ingredient minoxidil.
However, you should not be alarmed, as this reaction is accompanied by increased growth of new hair. This effect subsides within a few weeks and can be interpreted as an early sign of the effect of minoxidil.
If you feel that the effect of PHALANX 50 mg/ml is too strong or too weak, talk to your doctor or pharmacist.

If you use more PHALANX 50 mg/ml than you should
Applying PHALANX 50 mg/ml at doses higher than those recommended and to relatively large areas of the body or to areas other than the scalp, may likely lead to increased absorption of minoxidil into the body. So far, no cases have been reported in which external use of minoxidil solution has resulted in symptoms of poisoning.
In case of accidental ingestion, the concentration of the active ingredient minoxidil in PHALANX 50 mg/ml may determine effects on internal organs corresponding to the effects that occur when the active ingredient is swallowed, e.g. through tablets. This can determine the following adverse effects: accelerated heartbeat, lowering of blood pressure, accumulation of fluids and consequent sudden weight gain, dizziness.
If accidental ingestion occurs or signs of overdose appear, consult a doctor immediately, so that they can decide what to do. Keep the packaging at hand, so that the doctor can be informed of the active ingredient you have used.

If you forget to use PHALANX 50 mg/ml
Do not apply a double dose to make up for the missed dose; continue treatment at the recommended dose. Catching up on the missed dose may not be beneficial and could cause adverse effects.

If you stop using PHALANX 50 mg/ml
It is necessary to continue treatment to improve and maintain hair growth. Otherwise, hair loss will reappear.
If treatment is discontinued, a condition equal to that obtained in the absence of treatment with PHALANX 50 mg/ml will be reached within 3-4 months.
If you have any doubts about using this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
manifest.

Contact your doctor as soon as possible if you experience any of the following side effects – you may
need urgent medical treatment.

• Swelling of the face, lips or throat that may make swallowing or breathing difficult. This may be a sign of a serious allergic reaction (frequency not known, cannot be defined based on available data)
• Widespread redness of the skin (frequency not known, cannot be defined based on available data)
• Generalized itching (frequency not known, cannot be defined based on available data)
• Constriction of the throat (frequency not known, cannot be defined based on available data)

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

• Headache

Common(may affect up to 1 in 10 people)

• Itching
• Increased hair growth beyond the scalp (including facial hair growth in women)
• Inflammatory skin reaction (including acneiform eruption, rash)
• Shortness of breath, difficulty breathing
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning sensation, burning, dryness, itching, scaling and folliculitis Uncommon(may affect up to 1 in 100 people)
• Dizziness, nausea

Not known(frequency cannot be estimated from available data)

• Contact dermatitis (skin inflammation due to an allergy)
• Depressed mood
• Eye irritation
• Fast heartbeat, palpitations, low blood pressure
• Vomiting
• Symptoms at the site of administration that can also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin and inflammatory rash up to possible skin scaling, skin inflammation (dermatitis), blistering, bleeding and skin ulceration
• Temporary hair loss, altered hair color, altered hair structure
• Chest pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 PHALANX 50 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package leaflet after SCAD. The
expiry date refers to the last day of the month.
Do not refrigerate.
Contains ethanol which is flammable. Store away from heaters or open flames.

Note on the period of validity after opening
After opening the vial, use the solution within 6 weeks.
Do not dispose of any medicine in wastewater 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 PHALANX 50 mg/ml contains
The active ingredient is minoxidil.
1 ml of solution contains 50 mg of minoxidil.
The other ingredients are: 96% (v/v) ethanol, propylene glycol (E 1520), purified water.

Description of the appearance of PHALANX 50 mg/ml and contents of the pack
PHALANX 50 mg/ml is a clear solution from colorless to pale yellow and is available in packs
containing 60 ml or 3 x 60 ml of cutaneous solution contained in white HDPE bottles.
Each bottle contains 2 different applicators, a pre-assembled pump spray applicator and an
applicator with an elongated end.

Marketing authorisation holder
mibe pharma Italia S.r.l.
Via Leonardo da Vinci, 20/B

• 39100 - Bolzano

Manufacturer
mibe GmbH Arzneimittel
Muenchener Strasse 15
Brehna, 06796
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
names
Austria: Minoxidil Dermapharm 50 mg/ml Spray zur Anwendung auf der Haut, Lösung
United Kingdom: Minoxidil 50 mg/ml cutaneous spray, solution
Italy: PHALANX 50 mg/ml spray cutaneo, soluzione
Spain: Alocutan 50 mg/ml solución para pulverización cutánea