Pelpharma

Alopexy 50 mg/ml solution for application on the skin

This medicine is recommended for certain moderate cases of so-called androgenetic alopecia (excessive hair loss) in men.

Application

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

This medicine is recommended for certain moderate cases of androgenetic alopecia (excessive hair loss) in men.

This medicine is not recommended for use in women due to the frequent occurrence of abnormal hair growth (hypertrichosis)

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How is it applied?

What is Alopexy 50 mg/ml and what is it used for?

This medicine is recommended for certain moderate cases of so-called androgenetic alopecia (excessive hair loss) in men.

This medicine is not recommended for use in women due to the frequent occurrence of abnormal hair growth (hypertrichosis).

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What should you pay attention to before taking it?

What should you be aware of before using Alopexy 50 mg/ml?

Alopexy 50 mg/ml must not be used

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• If you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6.
• If you have had an intolerance reaction to the 2% minoxidil solution.
• if the scalp is damaged.

Children and elderly patients.
The efficacy and safety have not been studied in patients younger than 18 years or older than 65 years.
Warnings and precautions.
Please talk to your doctor or pharmacist before using Alopexy 50 mg/ml.
Special caution is required when using Alopexy 50 mg/ml,

• If you have or have had a heart condition, you should consult a doctor before using Alopexy 50 mg/ml.
• The recommendation that this medicine should not be used by women is due to the risk of abnormal hair growth (hypertrichosis)
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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 ask a doctor for advice before using ALOPEXY 50 mg/ml, as the treatment may not be effective for these types of hair loss.
• If your scalp is red, inflamed, infected, irritated or painful. This medicine should only be used on a healthy scalp (see "How to use Alopexy 50 mg/ml"). If the scalp is damaged, the active ingredient (minoxidil) may be transferred into the blood to a greater extent (see "Alopexy 50 mg/ml must not be used").
• Do not apply this medicinal product to the scalp at the same time as other skin preparations.

During application

• Due to the alcohol content, the solution may cause a burning sensation or irritation in case of accidental contact with the eyes, a wound, irritated skin or mucous membranes. The affected area should be rinsed with plenty of cold tap water. Consult a doctor if the symptoms persist.
• Do not expose the treated scalp to sunlight, wear head protection (hat)
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• Do not swallow. Accidental ingestion may lead to adverse effects due to the effects of minoxidil on the cardiovascular system. Therefore, keep this medicine out of the reach of children. SEEK A DOCTOR IMMEDIATELY!
• Do not inhale.
• A change in hair colour and/or hair texture has been observed in some patients.

You should stop using it immediately and consult a doctor:.

• If you have low blood pressure, chest pain, increased pulse rate,
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• for attacks of weakness or dizziness,
• in case of sudden unexplained weight gain, swollen hands or feet (oedema),
• for persistent redness or irritation of the scalp.

Use of Alopexy 50 mg/ml with other medicines.
Do not use this medicine at the same time as other skin preparations such as tretinoin, anthralin or betamethasone dipropionate, as these products may change the amount of minoxidil in the blood.

Please tell your doctor or pharmacist if you are taking / using or have recently taken any other medicines, including medicines obtained without a prescription.
Use Alopexy 50 mg/ml with food and drink.
Not applicable.
Pregnancy, lactation and reproductive capacity.
The use of this medicinal product is not recommended for women.
Avoid the use of this medicinal product during pregnancy or breast-feeding.
Be sure to ask your doctor or pharmacist for advice before taking / using any medicines. Driving ability and ability to operate machinery.
It is unlikely to have an adverse effect.
Alopexy 50 mg/ml contains propylene glycol and ethanol.
This medicinal product contains 240 mg propylene glycol per dosage unit, corresponding to 240 mg/ml.
This medicinal product contains ethanol (alcohol) and is therefore flammable.

How should the medicine be taken?

How to use Alopexy 50 mg/ml?

Dosage
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

As a recommended dose, apply 1 ml to the scalp area to be treated 2 times daily.
The daily dose should not exceed 2 ml, regardless of the size of the area to be treated.Frequency of use
Apply 1 ml in the morning and 1 ml in the evening.
Do not increase the dose and frequency of applications.
In any case, stick to the dose prescribed by your doctor.
Duration of use
A result of treatment is not immediately visible: a stop to hair loss and/or new hair growth can only be expected some time after the start of treatment. Treatment twice daily for 2 months may be required before a stimulation of hair growth is visible. The time of onset and the extent of response to treatment vary from patient to patient.

According to some reports, it is likely that after discontinuation of the treatment, the initial state is regained after 3 or 4 months.
Type of application
For application on the skin. For external use.
Wash hands thoroughly before and after applying the solution.
Apply to completely dry hair and scalp.
Distribute the medicine with the fingertips over the entire scalp area to be treated,
starting in the centre of the area to be treated.
Do not apply the medicine to other parts of the body.

Instructions for use
Open the bottle: The bottle comes with a childproof cap. It is opened as follows: Push down the plastic cap while turning the cap counterclockwise (to the left).
Only the safety ring should remain on the bottle.

According to the applicator system used:
1 ml dosing dropper
With the dosing dropper, 1 ml of solution can be accurately measured and applied to the entire area to be treated, starting in the centre of the area to be treated.

Pump spray 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 top of the applicator at the same time.


2. Insert the spray device with the applicator in place into the bottle and screw tight.

3. Before the first application, operate the pump several times until liquid comes out. The application system is now ready for use.

4. Application: Point applicator tip at the centre of the area to be treated or under the hair, pump once and distribute solution with fingertips.
To apply a dose of 1 ml, 6 pump strokes are required.

Rinse the applicator with warm water after each application.
If you have used a larger amount of Alopexy 50 mg/ml than you should
If used as directed, an overdose is unlikely. When applied to a damaged scalp, absorption of the active substance may be increased and side effects may occur (see section 2 "What should you be aware of before using Alopexy 50 mg/ml?")

If you forget to use Alopexy 50 mg/ml
Do not use a double dose if you have forgotten to use it before.
Continue normal use: 1 use in the morning, 1 use in the evening.
If you stop using Alopexy 50 mg/ml
Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Alopexy 50 mg/ml?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the bottle after "EXP". The expiry date refers to the last day of the month indicated.

Flammable product.

Use within one month after first opening.

Do not dispose of medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store Alopexy 50 mg/ml?

Keep this medicine out of the reach of children.

Flammable product.

Do not use Alopexy 50 mg/ml after the expiry date which is stated on the bottle after ,,Use by". The expiry date refers to the last day of the month indicated.

Use within one month after first opening.

Do not dispose of the medicinal product in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

Special notes on the content

Contents of the pack and other information
What Alopexy 50 mg/ml contains

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• The active ingredient is: minoxidil.
  1 ml solution contains 50 mg minoxidil.
• The other ingredients are: Propylene glycol (see section 2 "Alopexy 50 mg/ml contains"), ethanol (96 %), purified water.

What Alopexy 50 mg/ml looks like and contents of the pack.
This medicinal product is a clear, slightly yellow solution for application to the skin.

60 ml bottle with child-proof screw cap and 1 ml dosing dropper and pump spray applicator. Carton with 1 or 3 bottles.

Not all pack sizes may be marketed.