Phalanx

Package leaflet: Information for the user

PHALANX 20 mg/ml cutaneous spray, solution

minoxidil
equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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, ask 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 worsening of symptoms 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 PHALANX 20 mg/ml is and what it is used for

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

• increasing the diameter of the hair shaft
• stimulating growth
• prolonging the growth phases

Nevertheless, at least 4 months of treatment are required before any results become visible. If hair follicles are still present, thin and weak hairs may regrow, gradually becoming longer, thicker, and darker over time. The initial rate of hair growth and the amount of hair regrown vary from patient to patient.
Extensive bald areas or hair loss present for more than 10 years are less responsive to PHALANX 20 mg/ml.
The following figures show the stages of female and male pattern hair loss for which the efficacy of minoxidil, the active ingredient in PHALANX 20 mg/ml, has been demonstrated.

Children and adolescents under 18 years of age, patients aged 65 years and over
PHALANX 20 mg/ml must not be used in these patient groups, as efficacy and safety results from controlled studies are not available for 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 to 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 you have any condition affecting your scalp, including psoriasis (an itchy, inflammatory skin condition), sunburn, if your scalp has been shaved, or if the scalp skin is damaged by scars or burns, as hair follicles may be absent.

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

• if you have any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are taking medicines for high blood pressure (antihypertensive agents).

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

• if you have been diagnosed with low blood pressure
• if you experience one or more of the following 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 any other unexpected new symptoms appear (see section “If you use more PHALANX 20 mg/ml than you should”).

Contact of the product with areas other than the scalp may cause unwanted growth of excess hair.
Isolated cases of minor changes in hair color have been reported in patients with very light hair, or when using other hair care products simultaneously, or after swimming in chlorinated water (slight blonde discoloration).
Accidental ingestion may cause serious adverse effects on the cardiovascular system.
Therefore, keep this medicine out of the reach of children.
Avoid inhaling the aerosol 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Currently, there is no available information on interactions between PHALANX 20 mg/ml and other agents.
Although not clinically proven, there is a theoretical possibility that the active substance of PHALANX 20 mg/ml (minoxidil), once absorbed, could worsen orthostatic hypotension (a drop in blood pressure when rising from a lying position) in patients who are simultaneously taking peripheral vasodilators (some medicines for high blood pressure that dilate blood vessels).
PHALANX 20 mg/ml must not be used together with other dermatological products (topical preparations containing active substances such as corticosteroids, retinoids, or dithranol) or with other agents that increase the absorption of the active substance through the skin (cutaneous absorption).

Pregnancy and breastfeeding
Experience with the use of PHALANX 20 mg/ml during pregnancy is limited. Absorbed minoxidil may pass into breast milk. Therefore, PHALANX 20 mg/ml must not be used by pregnant women or breastfeeding mothers.

Driving and use of machines
This medicine may cause dizziness or hypotension (see section 4). If these effects occur, patients must not drive or operate machinery.

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 may cause burning and irritation to the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), rinse these areas thoroughly with plenty of water.
Repeated application of PHALANX 20 mg/ml to the hair rather than the scalp may 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 exactly as stated 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 dry scalp only. Use PHALANX 20 mg/ml only on healthy, undamaged scalp and always follow exactly the instructions for use provided below. Do not apply PHALANX 20 mg/ml to any body areas other than the scalp.

Recommended dose:
Unless otherwise prescribed by your doctor, PHALANX 20 mg/ml should be used as follows:
Apply 1 ml of PHALANX 20 mg/ml twice daily (morning and evening) to the affected area of the scalp.
The daily amount applied, i.e. 2 x 1 ml of solution, must not be exceeded, regardless of the size of the affected scalp area.

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

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

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

Both applicators can be interchanged by detaching one and replacing it with the other.
For a dose of 1 ml, 6 spray actuations 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, spread the liquid over the affected area with the fingertips. At the same time, avoid inhaling the sprayed mist.

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

Duration of use
The onset and extent of hair growth vary from patient to patient.
Generally, treatment twice daily for 2–4 months is required before an effect can be seen. To maintain the effect, continued application twice daily without interruption is recommended.
You will not achieve better results by applying PHALANX 20 mg/ml in larger amounts or more frequently. With regard to possible therapeutic effect, adequate clinical experience exists for a treatment period of up to 48 weeks.
If a desired therapeutic response has not been achieved within 8 months, treatment should be discontinued.

Information regarding increased hair loss
During treatment of hair follicles with the active substance 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 hairs, which dislodge the old, inactive hairs from the scalp. This may initially give the impression of increased hair loss. In some patients, this reaction occurs between 2 and 6 weeks after starting treatment with minoxidil. However, there is no cause for concern, as this reaction is accompanied by increased growth of new hairs. This effect subsides within a few weeks and may be regarded as an initial sign of minoxidil’s effect.

Contact your doctor or pharmacist if you feel that the effect of PHALANX 20 mg/ml is too strong or too weak.

If you use more PHALANX 20 mg/ml than you should
Applying PHALANX 20 mg/ml at higher doses than recommended, or over relatively large body surfaces or areas other than the scalp, may lead to increased systemic absorption of minoxidil. To date, there have been no known cases in which topical use of minoxidil solution has caused symptoms of poisoning.

However, following accidental ingestion, the concentration of the active substance minoxidil in PHALANX 20 mg/ml may cause effects on internal organs similar to those observed when the active substance is ingested orally, e.g. via tablets. This may result in the following adverse effects: rapid heartbeat, low blood pressure, fluid retention and consequent sudden weight gain, dizziness.
In case of accidental ingestion or if signs of overdose occur, seek immediate medical advice so that appropriate measures can be taken. Keep the packaging available so that the doctor can be informed about the active substance used.

If you forget to use PHALANX 20 mg/ml
Do not apply a double dose to make up for the missed dose; continue treatment at the recommended dose. Attempting to make up for a missed dose may not provide benefit and could cause adverse effects.

If you stop using PHALANX 20 mg/ml
Treatment must be continued to improve and maintain hair growth. Otherwise, hair loss will recur.
If treatment is stopped, within 3–4 months the condition will return to what it was before treatment with PHALANX 20 mg/ml.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 which may make swallowing or breathing difficult. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated based on available data)
• Generalised redness of the skin (frequency not known, cannot be estimated based on available data)
• Generalised itching (frequency not known, cannot be estimated based on available data)
• Tightness in 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)
• Skin inflammatory reaction (including acneiform rash, skin rash)
• Shortness of breath, breathing difficulties
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning sensation, burning, dryness, itching, flaking 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 allergy)
• Depressed mood
• Eye irritation
• Fast heartbeat, palpitations, low blood pressure
• Vomiting
• Symptoms at the application site which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin and inflammatory rash up to possible skin peeling, skin inflammation (dermatitis), blistering, bleeding and skin ulceration
• Temporary hair loss, changes in hair colour, altered hair structure
• Chest pain

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 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 stated on the carton and on the bottle after EXP.
The expiry date refers to the last day of the month.
Do not refrigerate.
Contains ethanol, which is flammable. Store away from radiators or open flames.
Note on the shelf-life after opening
After opening the bottle, use the solution within 6 weeks.
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 PHALANX 20 mg/ml contains
The active substance is minoxidil.
1 ml of solution contains 20 mg of minoxidil.
The other ingredients are: 96% ethanol (v/v), propylene glycol (E1520), purified water.

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

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

Manufacturer
mibe GmbH Arzneimittel
Muenchener Strasse 15
Brehna, 06796
Germany

This medicinal product is authorized in the European Economic Area countries under 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

Package leaflet: information for the user

PHALANX 50 mg/ml cutaneous spray, solution

minoxidil
equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.
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 would like more information, 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 worsening of symptoms 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 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

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

PHALANX 50 mg/ml prevents hereditary hair loss in men aged 18 to 65 years and stimulates hair growth. It also promotes regrowth of new hair in already weakened or bald areas and thickens existing hair.
After application, PHALANX 50 mg/ml penetrates the scalp and reaches the hair roots.
The exact mechanism by which hair growth is stimulated has not yet been fully clarified. However, the active substance in PHALANX 50 mg/ml may interrupt hereditary hair loss by:

• increasing the diameter of the hair shaft
• stimulating hair growth
• prolonging the growth phases

Nevertheless, at least 4 months of treatment are required before any results become visible. If hair follicles are still present, thin and weak hair may regrow, gradually becoming longer, thicker, and darker over time. The initial rate of hair growth and the amount of hair regrown may vary from patient to patient.
Extensive 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 efficacy of minoxidil, the active ingredient in PHALANX 50 mg/ml, has been demonstrated.

Children and adolescents under 18 years of age, patients aged 65 years and over
PHALANX 50 mg/ml must not be used in these patient groups, as there are no efficacy and safety data available from controlled studies in these age groups.
Women
For women, PHALANX 20 mg/ml is available (see also “What you need to know before using PHALANX 50 mg/ml”).

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

Do not use PHALANX 50 mg/ml

• if you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6)
• if you are a woman, as facial hair growth may occur, which is cosmetically distressing but reversible during treatment
• if you are using any other medication on the scalp
• if you have any type of dressing or bandage on the scalp
• if you are experiencing sudden or patchy hair loss
• if you have any condition affecting your scalp, including psoriasis (an itchy, inflammatory skin condition), sunburn, if your scalp has been shaved, or if the scalp skin is damaged by scars or burns, since hair follicles may be absent.

Warnings and precautions
Talk to your doctor or pharmacist before using PHALANX 50 mg/ml.
Hormonal causes, underlying diseases, or malnutrition must be ruled out. In such cases, you require specific treatment.
Apply PHALANX 50 mg/ml only to healthy, intact scalp skin. Do not use PHALANX 50 mg/ml if the cause of hair loss is unknown or if the scalp is red, inflamed, or painful.
There is currently no clinical experience regarding the effectiveness of this medicine for hair loss in the temporal region (receding hairline).
If systemic effects (affecting internal organs) 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 to other parts of the body.
Do not use PHALANX 50 mg/ml

• if you have any signs of cardiovascular disease or heart rhythm problems
• if you suffer from high blood pressure
• if you are taking medications for high blood pressure (antihypertensive agents).

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

• if you have been diagnosed with low blood pressure
• if you experience one or more of the following 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 any other new and unexpected symptoms appear (see section “If you use more PHALANX 50 mg/ml than you should”).

Contact of the product with areas other than the scalp may cause unwanted growth of excess hair.
Isolated cases of minor changes in hair color have been reported in patients with very light hair, or when hair care products are used simultaneously, or after swimming in chlorinated water.
Accidental ingestion may cause serious adverse effects on the cardiovascular system.
Therefore, keep this medicine out of the reach of children.
Avoid inhaling the aerosol 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 using, have recently used, or might use any other medicines.
Currently, there is no available information on interactions 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), when absorbed, may worsen orthostatic hypotension (a drop in blood pressure upon standing) in patients who are simultaneously taking peripheral vasodilators (some medications for high blood pressure that dilate blood vessels).
PHALANX 50 mg/ml must not be used together with other dermatological products (topical preparations 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
PHALANX 50 mg/ml is intended for use only in male patients. Experience with the use of PHALANX 50 mg/ml during pregnancy is limited. Absorbed minoxidil may pass into breast milk. Therefore, PHALANX 50 mg/ml must not be used by pregnant women or nursing mothers.

Driving and using machines
This medicine may cause dizziness or hypotension (see section 4). If these effects occur, patients must not drive or operate machinery.

PHALANX 50 mg/ml contains propylene glycol (E 1520) and 96% ethanol (alcohol)
This medicine contains 509 mg of propylene glycol (E 1520) in each ml of solution.
This medicine contains 248 mg of alcohol (ethanol) in each ml of solution.
It may cause a burning sensation on damaged skin.
Ethanol may cause burning and irritation to the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), rinse these areas thoroughly with plenty of water.
Repeated application of PHALANX 50 mg/ml to the hair rather than to the scalp may lead to 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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
PHALANX 50 mg/ml is for external use on dry scalp only. Use PHALANX 50 mg/ml only on healthy, undamaged scalp and always follow exactly the instructions for use provided below. Do not apply PHALANX 50 mg/ml to any other areas of the body apart from the scalp.

Recommended dose:
Apply 1 ml of PHALANX 50 mg/ml twice daily (morning and evening) to the affected bald areas of the scalp.
The daily amount applied, i.e. 2 x 1 ml of solution, must not be exceeded, regardless of the size of the affected scalp area.

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

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

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

Both applicators can be interchanged by detaching one and replacing it with the other.
For a dose of 1 ml, 6 spray actuations 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, spread the liquid over the affected area with the fingertips. At the same time, avoid inhaling the sprayed mist.

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

Duration of use
The onset and extent of hair growth vary from patient to patient.
Generally, treatment twice daily for 2–4 months is required before any effect becomes visible.
To maintain the effect, it is recommended to continue applying the product twice daily without interruption.
You will not achieve better results by applying PHALANX 50 mg/ml in larger amounts or more frequently. With regard to possible therapeutic effects, adequate clinical experience exists 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 treatment of hair follicles with the active substance 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 hairs, which dislodge the old, inactive hairs from the scalp. This may initially give the impression of increased hair loss. In some patients, this reaction occurs between 2 and 6 weeks after starting treatment with the active substance minoxidil.
However, there is no cause for concern, as this reaction is accompanied by increased growth of new hairs. This effect disappears within a few weeks and can be regarded as an early sign of minoxidil’s action.

Contact your doctor or pharmacist if you feel that the effect of PHALANX 50 mg/ml is too strong or too weak.

If you use more PHALANX 50 mg/ml than you should
Applying PHALANX 50 mg/ml at doses higher than recommended, over relatively large body surfaces or on areas other than the scalp, may lead to increased absorption of minoxidil into the body. To date, there have been no reported cases in which topical use of minoxidil solution caused symptoms of poisoning.
In case of accidental ingestion, the concentration of the active substance minoxidil in PHALANX 50 mg/ml may cause effects on internal organs similar to those occurring when the active substance is ingested orally, e.g. via tablets. This may result in the following adverse effects: rapid heartbeat, low blood pressure, fluid retention and consequent sudden weight gain, dizziness.
In case of accidental ingestion or signs of overdose, seek immediate medical advice so that appropriate measures can be taken. Keep the packaging available so that the doctor can be informed about the active substance used.

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

If you stop using PHALANX 50 mg/ml
Treatment must be continued to improve and maintain hair growth. Otherwise, hair loss will reappear.
If treatment is stopped, within 3–4 months the condition will return to what it was before treatment with PHALANX 50 mg/ml.

If you have any doubts 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 everyone gets them.
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 which may make swallowing or breathing difficult. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated based on available data)
• Generalized 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)
• Tightness in 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)
• Skin inflammatory reaction (including acneiform rash, skin rash)
• Shortness of breath, difficulty breathing
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation with burning sensation, burning, dryness, itching, flaking, 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 allergy)
• Depressed mood
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Vomiting
• Reactions at the application site which may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, skin dryness, inflammatory rash up to possible skin peeling, skin inflammation (dermatitis), blistering, bleeding, and skin ulceration
• Temporary hair loss, changes in hair colour, altered hair structure
• Chest pain

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 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 stated on the vial and carton after EXP. The expiry date refers to the last day of the month.
Do not refrigerate.
Contains ethanol which is flammable. Store away from radiators or open flames.
Note on shelf life after opening
After opening the vial, use the solution within 6 weeks.
Do not dispose of any medicine 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 PHALANX 50 mg/ml contains
The active substance is minoxidil.
1 ml of solution contains 50 mg of minoxidil.
The other ingredients are: ethanol 96% (v/v), propylene glycol (E 1520), purified water.

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

Marketing Authorization Holder
mibe pharma Italia S.r.l.
Via Leonardo da Vinci, 20/B
39100 - Bolzano
Italy

Manufacturer
mibe GmbH Arzneimittel
Muenchener Strasse 15
Brehna, 06796
Germany

This medicinal product is authorized in the European Economic Area Member States under 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