Pelpharma Alopexy 50 mg/ml

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

Contraindications

Alopexy 50 mg/ml must not be used

• 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.
• when the scalp is damaged.

interactions

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

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

Pregnancy, breast-feeding and fertility
The use of this medicine is not recommended for women.
Avoid using this medicine while pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking/using any medicine.

application

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.
The recommended dose is 1 ml applied twice a day to the scalp area to be treated.
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 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 treatment result 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. A twice daily treatment for 2 months may be required before any 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, once treatment is stopped, it is likely to return to baseline after 3 or 4 months.

Method of application
For use on the skin. For external use.
Wash hands thoroughly before and after applying the solution.
Apply to completely dry hair and scalp.
Using your fingertips, spread the medicine over the entire scalp area to be treated, starting in the center of the area to be treated.
Do not use the medicine on other parts of the body.

Instructions for use
Open the bottle: The bottle comes with a child-resistant cap. To open it, press down on the plastic tab while turning the tab counter-clockwise (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 precisely measured and applied to the entire
area to be treated, starting in the center of the area to be treated.

Pump spray applicator
This application system is suitable for use on small areas of the scalp or under the hair
.

1. Place the applicator on the pump: hold the pump firmly at the bottom and at the same time press on the top of the applicator.
2. Insert the spray device with attached applicator into the bottle and screw tight.
3. Before using the pump for the first time, operate the pump several times until liquid emerges. The application system is now ready for use.
4. Use: Point the applicator tip at the center of the area to be treated or under the hair, press the pump once and distribute the solution with your fingertips. To apply a dose of 1 ml, 6 pumps are required.

Rinse applicator with warm water after each use.

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following symptoms, talk to a doctor straight away because you may need urgent medical treatment:

Swelling of the face, lips or throat causing difficulty in swallowing or breathing. These may be signs of a severe allergic reaction (frequency not known cannot be estimated from the available data).

Very common: may affect more than 1 in 10 people:
Abnormal hair growth (hypertrichosis) beyond the application site, especially when the medicine is used by women. Headache.

Common: may affect up to 1 in 10 people:
Local skin reactions at the application site, e.g. irritation with flaking of dead skin cells, itching, skin redness, skin inflammation, skin dryness, allergic skin reaction, inflammatory skin diseases, acne-like pustules, musculoskeletal pain, accumulation of fluid in the tissue (peripheral oedema), breathing difficulties and depression.

Not known: frequency cannot be estimated from the available data
Ear infections, inflammation of the outer ear, inflammation of the nasal mucosa, hypersensitivity, nerve inflammation, tingling sensation, disturbed taste sensation, burning sensation on the skin, visual disturbances, eye irritation, dizziness, drop in blood pressure, increased pulse rate, pain in the chest, weakness, facial swelling (facial oedema), skin redness (erythema), rash, hair loss, irregular hair growth, hair color change, hair texture change, liver inflammation (hepatitis) and kidney stones.

In all cases mentioned, the treatment should be discontinued and your doctor informed immediately.

composition

The active ingredient is minoxidil. 1 ml solution contains 50 mg minoxidil.

The other ingredients are: propylene glycol (see section 2 “Contains Alopexy 50 mg/ml”), ethanol (96%), purified water.