Alocutan 50 mg/ml solution for cutaneous spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alocutan 50 mg/ml cutaneous spray solution

Minoxidil

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not see improvement after 4 months.

Leaflet Contents

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

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

3. How to use Alocutan 50 mg/ml

4. Possible side effects

   1. Storage of Alocutan 50 mg/ml

5. Package contents and additional information

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

Alocutan 50 mg/ml prevents hereditary hair loss in men aged between 18 and 65 years and stimulates hair growth. It also promotes regeneration of new hair in areas already weakened or bald and thickens existing hair.

After application, Alocutan 50 mg/ml penetrates the scalp and reaches the hair roots. The mechanism by which hair growth is stimulated has not yet been fully clarified. However, the active ingredient in Alocutan 50 mg/ml may stop hereditary hair loss by:

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

Nevertheless, at least four months of treatment are required before any results become visible. If hair follicles are still present, thin and weak hair may regrow, becoming longer, denser, and darker over time. The speed at which hair growth begins and the number of hairs that regrow depend on the individual patient. Extensive bald areas or hair loss present for more than 10 years are less responsive to Alocutan 50 mg/ml.

The following images show the stages of male pattern hair loss for which efficacy of minoxidil, the active substance in Alocutan 50 mg/ml, has been demonstrated.

Children and adolescents under 18 years of age, patients aged 65 years and older

Alocutan 50 mg/ml should not be used in these patient groups, as there are no available efficacy and safety study results in these age groups.

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

Do not use Alocutan 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 there have been occasional reports of cosmetically bothersome and reversible facial hair growth during treatment
• if you are using other medicines on the scalp
• if you have any type of dressing or occlusive bandage on the scalp
• if you are experiencing sudden or patchy hair loss
• if you have any condition affecting your scalp, including psoriasis (an inflammatory skin condition with itching), sunburn, recent scalp shaving, or if the scalp skin is damaged by scars or burns, as there are no hair follicles present.

Warnings and precautions

Talk to your doctor or pharmacist before using Alocutan 50 mg/ml.

Hormonal causes, underlying diseases, or malnutrition should be ruled out. In such cases, specific treatment is required.

Apply Alocutan 50 mg/ml only to healthy, normal scalp. Do not use Alocutan 50 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.

There is no clinical experience to date regarding its effectiveness for hair loss in the temporal region (receding hairline).

If systemic effects (affecting internal organs) or severe skin reactions occur, treatment must be discontinued.

Alocutan 50 mg/ml is intended for external use on the scalp only. Do not apply Alocutan 50 mg/ml to other parts of the body.

You must not use Alocutan 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 medicines for high blood pressure (antihypertensive agents).

You should stop using Alocutan 50 mg/ml and consult a doctor

• if you have low blood pressure, or
• if you experience one or more of the following symptoms: chest pain, faster heartbeat, weakness or dizziness, sudden 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 Alocutan 50 mg/ml than you should").

Unwanted hair growth may occur due to transfer of the product to areas other than the scalp.

Isolated cases of mild changes in hair color have been reported in patients with very light blonde hair when using other hair care products simultaneously or after swimming in heavily chlorinated water.

Accidental ingestion may cause serious cardiovascular side effects. Therefore, this medicine must be kept out of the reach of children.

Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil was applied on patients (caregivers) using topical minoxidil. Excessive hair growth resolved within months once infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.

Consult your doctor if you notice excessive body hair growth in your child during your use of topical minoxidil products.

Avoid inhaling the spray mist.

Children and adolescents

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

Other medicines and Alocutan 50 mg/ml

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

To date, there is no available information on interactions between Alocutan 50 mg/ml and other active substances. Although not clinically proven, there is a theoretical possibility that absorption of the active substance in Alocutan 50 mg/ml (minoxidil) into the body could worsen orthostatic hypotension (a drop in blood pressure upon standing from a lying position) in patients who are also taking peripheral vasodilators (certain medicines for high blood pressure that widen blood vessels).

Alocutan 50 mg/ml should not be used together with other dermatological products (topical preparations containing active substances such as corticosteroids, retinoids, or dithranol) or with active substances that increase the absorption of the active ingredient through the skin (cutaneous absorption).

Pregnancy and breastfeeding

Alocutan 50 mg/ml is indicated for male patients only.

Experience with the use of Alocutan 50 mg/ml during pregnancy is limited. Minoxidil absorbed into the body may pass into breast milk. Therefore, Alocutan 50 mg/ml must not be used by pregnant women or women who are breastfeeding.

Driving and using machines

This product may cause dizziness or hypotension (see section 4). If affected, you should not drive or operate machinery.

Alocutan 50 mg/ml contains propylene glycol (E 1520) and ethanol 96% (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 itching and irritation in the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), rinse thoroughly with plenty of water.

Repeated application of Alocutan 50 mg/ml to the hair rather than the scalp may increase dryness and/or stiffness of the hair due to the ethanol and propylene glycol content in Alocutan 50 mg/ml.

3. How to use Alocutan 50 mg/ml

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. Consult your doctor or pharmacist if you are unsure.

Alocutan 50 mg/ml is for external use on dry scalp only. Use Alocutan 50 mg/ml only on healthy, undamaged scalp and follow the instructions for use below precisely at all times. Do not apply Alocutan 50 mg/ml to areas of the body other than the scalp.

The recommended dose is:

Apply 1 ml of Alocutan 50 mg/ml twice daily (morning and evening) to the affected areas of the scalp.

The daily amount applied must not be exceeded, i.e., 2 x 1 ml solution, regardless of the size of the affected skin area.

Use in children and adolescents

Alocutan 50 mg/ml must not be used in children and adolescents under 18 years of age, as there are no available safety and efficacy results from controlled studies in these age groups.

Method of administration

Cutaneous use (scalp).

Each Alocutan 50 mg/ml container contains two different spray applicators:

• pre-assembled applicator for large surface applications
• separate applicator with extended tip for smaller areas

Both applicators can be interchanged by detaching the applicator and replacing it with the other.

For a dose of 1 ml, six sprays are required.

Instructions for use/application:

The solution is sprayed directly onto the scalp within the area of hair loss. To deliver 1 ml, press down the pump six times. After each spray, spread the liquid over the affected area with the fingertips. At the same time, avoid inhaling the spray mist.

What else you should keep in mind during use

Hands must be washed thoroughly after applying Alocutan 50 mg/ml to avoid accidental contact with mucous membranes and eyes.

After applying Alocutan 50 mg/ml, you may style your hair normally. However, you should not wet the scalp for approximately 4 hours. This will prevent Alocutan 50 mg/ml from being washed off.

Duration of treatment

The onset and extent of hair growth vary among individual patients.

Generally, treatment twice daily for 2 to 4 months is required before an effect is observed. To maintain the effect, continued application twice daily without interruption is recommended.

You will not achieve better results by applying Alocutan 50 mg/ml in larger amounts or more frequently. With regard to a possible therapeutic effect, sufficient clinical experience is available for a treatment period of up to one year.

If the desired therapeutic response has not been achieved within 4 months, treatment should be discontinued.

Information on increased hair loss

When treating hair follicles with the active ingredient minoxidil, the resting phase of the hair cycle (telogen phase) is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair, which pushes out the "old," no longer active hairs from the scalp. This may initially give the impression of increased hair loss. In some patients, this reaction has been observed between two and six weeks after starting treatment with minoxidil. However, there is no cause for concern, as this reaction is accompanied by increased hair growth. The effect disappears within a few weeks and may be interpreted as the first sign of minoxidil's action.

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

If you use more Alocutan 50 mg/ml than you should

Applying Alocutan 50 mg/ml at a higher dose than recommended, or on relatively large body surfaces or areas other than the scalp, may possibly lead to increased absorption of minoxidil into the body. To date, there have been no reported cases in which topical use of minoxidil solution has caused symptoms of poisoning.

After accidental ingestion, the concentration of the active ingredient minoxidil in Alocutan 50 mg/ml may produce effects on internal organs corresponding to those caused when the active substance is ingested orally, for example in tablet form. This may cause the following side effects: faster heartbeat, decreased blood pressure, fluid accumulation, and subsequent sudden weight gain, dizziness.

In case of accidental ingestion or if signs of overdose occur, inform your doctor immediately so that he or she can decide on the next steps. Please have the medicine's package leaflet available so that the doctor can be informed about which active substance has been ingested.

If you forget to use Alocutan 50 mg/ml

Do not apply a double dose to make up for a missed dose; continue your treatment at the recommended dose. Making up for the missed dose will not provide any benefit and could cause unwanted effects.

If you stop treatment with Alocutan 50 mg/ml

Continued treatment is necessary to improve and maintain hair growth. Otherwise, hair loss will recur.

If treatment is stopped within 3 to 4 months, the effects will revert to those that would have been present without treatment with Alocutan 50 mg/ml.

If you have further 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 everyone experiences them.

Contact a doctor immediately if you notice any of the following symptoms: you may need urgent medical treatment.

• Swelling of the face, lips, or throat that makes swallowing or breathing difficult. This could be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data)
• Widespread redness of the skin (frequency unknown, cannot be estimated from available data)
• Generalized itching (frequency unknown, cannot be estimated from available data)
• Throat tightness (frequency unknown, cannot be estimated from 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)
• Difficulty breathing, shortness of breath
• Swollen arms and legs
• Weight gain
• High blood pressure
• Scalp irritation such as stinging, burning, dryness, itching, flaking, folliculitis

Uncommon (may affect up to 1 in 100 people):

• Dizziness, nausea

Unknown (frequency cannot be estimated from available data):

• Contact dermatitis (skin inflammation related to allergy)
• Depressed mood
• Eye irritation
• Faster heartbeat, palpitations, low blood pressure
• Vomiting
• Administration site symptoms, 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 ulceration
• Temporary hair loss, changes in hair color, altered hair structure
• Chest pain

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alocutan 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 pack and bottle after "EXP". The expiry date refers to the last day of that month.

Do not freeze.

Contains ethanol, which is flammable. Store away from heat sources or flames.

Note on shelf-life after opening

After opening the bottle, use the solution within 6 weeks.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alocutan 50 mg/ml

The active substance is minoxidil.

1 ml of solution contains 50 mg of minoxidil.

The other components are: 96% ethanol (v/v), propylene glycol (E1520), purified water.

Appearance of Alocutan 50 mg/ml and contents of the pack

Alocutan 50 mg/ml is a clear, colourless to pale yellow solution and is available in 60 ml and 3 x 60 ml packs of cutaneous solution in white HDPE bottles.

Each pack contains 2 different applicators: a pre-assembled pump spray applicator and an applicator with extended tip.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Strasse, 15

06796 Brehna

Germany

This medicinal product is authorised in EEA Member States under the following names:

Austria: Minoxidil Dermapharm 50 mg/ml Spray zur Anwendung auf der Haut, Lösung

Italy: Phalanx 50 mg/ml spray cutaneo, soluzione

Spain: Alocutan 50 mg/ml solución para pulverización cutánea

Date of the most recent review of this leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).