Alpicort E

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Alpicort E

(2 mg + 0.05 mg + 4 mg)/ml, liquid for the skin
Prednisolone + Estradiol benzoate + Salicylic acid

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Alpicort E and what is it used for
• 2. Important information before using Alpicort E
• 3. How to use Alpicort E
• 4. Possible side effects
• 5. How to store Alpicort E
• 6. Package contents and other information

1. What is Alpicort E and what is it used for

Alpicort E is a liquid for the skin, containing prednisolone, female sex hormones, and salicylic acid for use on the scalp.
Indications: in various forms of alopecia, especially androgen-dependent alopecia.

2. Important information before using Alpicort E

When not to use Alpicort E:

• if the patient is allergic to prednisolone, salicylic acid, estradiol benzoate, or any of the other ingredients of this medicine (listed in section 6),
• in infants, children, and adolescents under 18 years of age,
• in cases of estrogen-dependent tumors or suspected estrogen-dependent tumors,
• in cases of unexplained bleeding from the reproductive organs,
• on mucous membranes, in the mouth, or in the eyes, or on the genital area or internally,
• in cases of chickenpox, certain skin diseases (tuberculosis, syphilis), and inflammatory reactions to vaccinations,
• in cases of fungal or bacterial skin infections,
• in cases of perioral dermatitis (skin irritation around the mouth with redness and bumps) and rosacea (redness of the face with possible inflammatory or purulent pimples),
• in cases of wet or acute scalp diseases.

Warnings and precautions

Before starting treatment with Alpicort E, you should discuss it with your doctor or pharmacist.
Alpicort E may be used only externally on the scalp due to its isopropyl alcohol content.
When treating for more than 2-3 weeks, due to the estrogen content in the liquid, special precautions should be taken:

• in cases of endometriosis (endometrial tissue outside the uterus) or mastopathy (breast tissue changes),
• in women who are already taking estrogen-containing preparations, treatment should be carried out only under close medical supervision.

Protect your eyes and mucous membranes from contact with the preparation.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Alpicort E and other medicines

Alpicort E may enhance the effects of other topically applied active substances due to its composition.
You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Alpicort E should not be used during pregnancy due to its salicylic acid content, except when used on small areas (less than 5 cm²).
Alpicort E should not be used due to its estrogen content.
If the patient becomes pregnant during treatment, Alpicort E treatment should be stopped immediately. However, previous studies have not shown any effect on subsequent fertility due to exposure to estrogen. During long-term treatment with glucocorticoids, a component of Alpicort E, during pregnancy, growth disturbances and damage to the unborn child cannot be excluded.
Breastfeeding
The doctor should consider that prednisolone passes into breast milk during breastfeeding.
The doctor will carefully assess whether it is necessary to use Alpicort E during breastfeeding. If long-term treatment is necessary, breastfeeding should be stopped.
During breastfeeding, estrogens may change the amount and composition of human milk. Small amounts of estrogens or their metabolites may pass into the milk of breastfeeding women and affect the child. Glucocorticoids also pass into human milk. Therefore, during treatment with Alpicort E, breastfeeding should not be done, or treatment with Alpicort E should only be started after the end of the breastfeeding period.

Driving and using machines

Alpicort E does not affect the ability to drive vehicles or operate machinery.

Alpicort E contains propylene glycol

The medicine contains 50 mg of propylene glycol in 1 ml of liquid (approximately equivalent to 180 mg of propylene glycol in a single application). Propylene glycol may cause skin irritation.

3. How to use Alpicort E

This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Alpicort E should be used according to the doctor's recommendations and the instructions in this leaflet. In case of doubts, you should contact your doctor again.
Alpicort E is a liquid for use on the skin.
If the doctor does not recommend otherwise, Alpicort E should be used once a day, preferably in the evening.
Once the inflammatory symptoms have subsided, it is sufficient to use 2 to 3 times a week.
During each use, proceed as follows:

• Remove the cap from the applicator.
• Turn the bottle with the applicator over the head so that the opening at the top is facing down.
• Apply the medicine by drawing the applicator with the opening facing down over the treated areas.
• After using Alpicort E, put the cap back on the applicator.
• Then massage the scalp with your fingers for 2-3 minutes.

Treatment duration

The treatment duration for small areas should not be longer than 2-3 weeks due to the presence of prednisolone in the liquid. Clinical experience includes a treatment period of up to 6 months.
No studies have been conducted on the duration of action after discontinuation of the medicine.

Using more than the recommended dose of Alpicort E

In case of using a higher dose than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Alpicort E

You should not take a double dose to make up for a missed dose.
You should continue treatment by taking the next scheduled dose at the usual time.

Stopping treatment with Alpicort E

You should discuss further action with your doctor, as the effectiveness of the treatment may be compromised.
In case of any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Alpicort E can cause side effects, although not everybody gets them.

Important side effects or symptoms to watch out for and measures to be taken if they occur: