Alpicort E

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Alpicort E (Alpicort F)

(2 mg + 0.05 mg + 4 mg)/ml, liquid for the skin
Prednisolone + Estradiol benzoate + Salicylic acid
Alpicort E and Alpicort F are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this 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 tell 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. Contents of the packaging 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 the course of 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, on or near the eyes, or on the genitals, 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 inflammatory skin diseases (symptoms of skin irritation around the mouth with redness and bumps) and rosacea (redness of the face with possible inflammatory or purulent pimples),
• in wet or acute scalp diseases.

Warnings and precautions

Before starting to use Alpicort E, you should consult a 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 solution, special precautions should be taken:

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

Protect your eyes and mucous membranes from contact with the medicine.
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 effect of other externally used active substances due to its composition.
You should tell 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. During pregnancy, Alpicort E should not be used due to its salicylic acid content, except when used on small areas (surface area less than 5 cm).
Alpicort E should not be used due to its estrogen content.
If you become pregnant during treatment, you should stop using Alpicort E 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 harm to the unborn child cannot be excluded.
Breastfeeding
Your doctor should consider that prednisolone passes into breast milk.
The doctor will carefully assess whether it is necessary to use Alpicort E during breastfeeding. If long-term treatment is necessary, you should stop breastfeeding.
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, you should not breastfeed, or you should start treatment with Alpicort E only after the end of the breastfeeding period.

Driving and using machines

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

Alpicort E contains propylene glycol

The medicine contains 50 mg of propylene glycol in 1 ml of solution (which approximately corresponds 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 always 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 solution 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 your 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 your 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 solution. Clinical experience includes a treatment period of up to 6 months. No studies have been conducted on the duration of the effect after stopping the medicine.

Using a higher dose of Alpicort E than recommended

In case of using a higher dose of Alpicort E 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 planned dose at the usual time.

Stopping the use of Alpicort E

You should discuss further action with your doctor, as the effectiveness of the treatment is at risk.
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 for and measures to take if they occur: