Alopexy solution 5% 3 sprays of 60 ml

The effectiveness and safety of Alopexy 5% (Switzerland) was only briefly tested by Swissmedic. The approval of Alopexy 5% (Switzerland) is based on Alopexy 50 mg/ml (France) as of November 2021, which contains the same active ingredient and is approved in France.

What is Alopexy 5% and when is it used?

Alopexy 5% is a solution for use on the skin that contains minoxidil, an active ingredient that stimulates hair growth.  This medicine is used to treat certain moderate cases of a condition called androgenetic alopecia (excessive hair loss) in men.  This medicine is not recommended for use  in women  because abnormal hair growth (hypertrichosis) is often expected.

When should Alopexy 5% not be used?

Alopexy 5% must not be used:

• if you are allergic to minoxidil or any of the other ingredientsif you have already had an intolerance reaction to the 2% minoxidil solution.If you have a scalp illness or injury.

Children and young people

The safety and effectiveness of Alopexy 5% in children under 18 years of age have not been established.  No data is available.  Therefore, Alopexy 5% is not recommended in children under 18 years of age.

Elderly patients

This medicine should not be used by people over 65 years of age because its effectiveness and safety have not been established in these patient groups.

When should you be careful when using Alopexy 5%?

Please talk to your doctor, pharmacist or druggist before using Alopexy 5%.

• Particular caution is required if you have cardiovascular disease or heart rhythm disorders, such as low blood pressure (hypotension), tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of water retention (swelling of the hands or feet ).  Under these circumstances you should consult a doctor before using this medicine.  Monitoring should occur at the start of treatment and regularly thereafter.The recommendation that this medicine should not be used by women is due to the risk of abnormal hair growth (hypertrichosis).

You should not use this medicine in the following cases:

• If there is no family history of hair loss, sudden and/or uneven hair loss, pregnancy-related hair loss or hair loss of unknown cause.  In these cases, you should consult a doctor before using Alopexy 5%, as the treatment may be ineffective for these types of hair loss.If your scalp is red, inflamed, infected, irritated or painful.  This medicine should only be used on healthy scalp (see «How do you use Alopexy 5%?»).  If the scalp is damaged, the active ingredient (minoxidil) can pass more into the blood (see ?When should Alopexy 5% not be used??).Do not use this medicine on the scalp at the same time as other skin preparations.Do not use this medicine on other parts of the body.

During application

• This medicine, which contains ethanol (alcohol), may cause burning or irritation if accidental contact with eyes, wounds, irritated skin or mucous membranes occurs.  Rinse the affected area with plenty of cold tap water.  If symptoms persist, see a doctor.A temporary increase in hair loss may occur during the first 2 to 6 weeks of treatment.  If hair loss persists or worsens after 6 weeks, you should stop using Alopexy 5% and consult your doctor.The treated scalp should not be exposed to sunlight: wear head protection (hat).Don't swallow  .  Accidental ingestion may result in adverse effects due to minoxidil's effects on the cardiovascular system.  Therefore, keep this medicine out of the reach and reach of children.  SEE A DOCTOR IMMEDIATELY!Do not inhale spray mist  .Some patients have experienced changes in hair color and/or texture.

If you experience the following symptoms, stop using it immediately and consult a doctor:

• low blood pressure, chest pain, increased pulse rate,attacks of weakness or dizziness,sudden unexplained weight gain, swollen hands or feet (edema),persistent redness or irritation of the scalp

Using Alopexy 5% together with other medicines

Do not use this medicine at the same time as other skin preparations such as tretinoin, anthralin, betamethasone dipropionate, as these medicines may change the amount of minoxidil that enters the blood.Tell your doctor, pharmacist or druggist if you

• suffer from other illnesses,Have allergies ortake other medicines (including those you have bought yourself!) or apply externally

Effects on the ability to drive and operate machines

Alopexy 5% has no or negligible influence on the ability to drive and use machines.1 ml Alopexy 5% solution for use on the skin contains 240 mg propylene glycol and 520 mg ethanol 96% (v/v).  Ethanol can cause a burning sensation on damaged skin.This medicine contains ethanol and is therefore flammable.

Can Alopexy 5% be used during pregnancy or while breastfeeding?

This medicine is not recommended for women.Avoid using Alopexy 5% during pregnancy or breastfeeding.  If you are pregnant or breast-feeding, may be pregnant or are planning to become pregnant, ask your doctor, pharmacist or druggist for advice before using this medicine.

How do you use Alopexy 5%?

Always use this medicine exactly as described in this leaflet or exactly as discussed with your doctor, pharmacist or druggist.  If you are not sure, ask your doctor, pharmacist or druggist.  The recommended dose is to apply 1 ml twice daily to the scalp area to be treated.  The amount used daily should not exceed 2 ml, regardless of the size of the area to be treated.

Frequency of application

Use 1 ml of Alopexy 5% in the morning and evening.  The amount of application and the frequency of applications must not be increased.  Under no circumstances should you change the recommended dose on your own.

Duration of application

A treatment result is not immediately visible.  A stop to hair loss and/or new hair growth can only be expected a certain time after the start of treatment.  Consistent treatment is required to increase and maintain hair regrowth.  First results can be expected after 2 to 4 months of twice daily use.  The response to treatment and the degree of response varies from person to person.  If treatment is stopped, a return to baseline is likely within 3 to 4 months.

type of application

For application on the skin.  For external use.Wash your hands thoroughly before and after applying the solution.Before application, hair and scalp must be completely dry.Using your fingertips, spread the medicine over the entire scalp area to be treated.  Start in the middle of the area to be treated.  You must not use the medicine on other parts of the body.

Application procedure

Opening the bottle: The bottle has a child-resistant cap.  Opening Instructions: Press down on the plastic latch while turning the latch counterclockwise (to the left).  Only the safety ring should remain on the bottle.The application depends on the respective application system, dosing pipette or dosing pump with applicator:

Dosing pipette

The dosing pipette can be used to accurately measure 1 ml of solution and apply it to the entire area to be treated, starting from the center of the area to be treated.

Dosing pump with applicator

This application system is suitable for use on small scalp areas or under the hair.1. Place the applicator on the pump.  To do this, hold the pump firmly at the bottom and press the applicator at the top at the same time.2. Insert the spray device with the applicator attached into the bottle and screw it tight.3. Before the first use, activate the pump several times until liquid comes out.  The application system is now ready for use.4. Application: Point the applicator tip towards the center of the area to be treated or under the hair, press the pump once and distribute the solution with your fingertips.  6 pumps are necessary to apply 1 ml.Rinse applicator with warm water after each use.

If you have used more Alopexy 5% than you should.

When used as directed, an overdose is unlikely.  When used on damaged scalp, absorption of the active ingredient may be increased and side effects may occur (see ?When should Alopexy not be used??).

If you forget to use Alopexy 5%

Do not use a double dose if you forget the previous dose.  Continue normal use: 1 application in the morning, 1 application in the evening.  Do not change the prescribed dosage on your own.If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Alopexy 5% have?

Like all medicines, this medicine can cause side effects, although not everyone gets 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 it difficult to swallow or breathe.  This could be a sign of a serious allergic reaction (frequency not known and cannot be estimated from the available data).The most commonly observed reactions were minor skin reactions.Frequent use on the skin can cause irritation and dry skin due to the alcohol it contains.The following reported side effects have been classified by frequency:

Very common (affects more than 1 in 10 users)

Abnormal hair growth (hypertrichosis) beyond the application site, especially when the medicine is used by women.Headache.

Common (affects 1 to 10 users in 100)

Local skin reactions at the application site, eg irritation with shedding of dead skin cells (desquamation), itching, reddening of the skin, inflammation of the skin, dry skin, allergic skin reaction, inflammatory skin diseases, acne-like pustules, pain in the musculoskeletal system, fluid accumulation in the tissue (peripheral edema), difficulty breathing and depression.

Frequency not known (cannot be estimated from available data)

Ear infections, inflammation of the outer ear, inflammation of the nasal mucosa, hypersensitivity, inflammation of the nerves, tingling sensation, impaired taste sensation, burning sensation on the skin, visual disturbances, eye irritation, dizziness, drop in blood pressure, increased pulse rate, palpitations, chest pain, weakness, swelling in the facial area (facial edema), redness of the skin (erythema), rash, hair loss, irregular hair growth, change in hair color, change in hair texture, inflammation of the liver (hepatitis) and kidney stones.In all cases mentioned, the treatment should be stopped and your doctor should be informed immediately.If you notice any side effects, contact your doctor, pharmacist or druggist.  This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

The medicine may only be used until the date marked ?EXP? on the container.  The expiry date refers to the last day of this month.

Use by period after opening

1 month.

Storage instructions

Store at 15-30°C.Keep containers tightly closed.Keep out of reach of CHILDREN.

More information

The medicine is flammable.  Do not use near a flame or glowing object.  Do not dispose of medications through the sewer or with household waste.  To protect the environment, ask your pharmacist or druggist to dispose of all medications that you no longer use.Your doctor, pharmacist or druggist can provide you with further information.  These people have the detailed information for specialists.

What is contained in Alopexy 5%?Active ingredient:

Minoxidil

Excipients:

Ethanol 96% (v/v), propylene glycol, purified water.

Approval number

67747 (Swissmedic)

Where can you get Alopexy 5%? Which packs are available?

In pharmacies and drugstores, without medical prescription.

• 60 ml with graduated dosing pipette of 1 ml and dosing pump with applicator.3 x 60 ml with graduated dosing pipette of 1 ml each and dosing pump with applicator.

Authorization holder

Pierre Fabre Pharma AG, Allschwil.