Alpicort E

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! 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 + Salicylic Acid

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 you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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. 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 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, and 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 to use Alpicort E, you should discuss it with your doctor or pharmacist.
Alpicort E may only be used 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 (endometrial tissue outside the uterus) or mastopathy (breast tissue changes),
• in women who are already taking estrogen-containing preparations, treatment should only be carried out 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 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 baby, 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 (less than 5 cm²).
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.
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 breast milk. Small amounts of estrogens or their metabolites may pass into breast milk and affect the child. Glucocorticoids also pass into breast milk. Therefore, you should not breastfeed during treatment with Alpicort E, or you should only start treatment after the breastfeeding period has ended.

Driving and using machines

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

Alpicort E contains propylene glycol

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

3. How to use Alpicort E

This medicine should always be used exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Alpicort E should always be used in accordance with the doctor's recommendations and the instructions in this leaflet. If you have any doubts, you should consult your doctor again.
Alpicort E is a solution for use on the skin.
If your doctor does not recommend otherwise, you should use Alpicort E once a day, preferably in the evening.
Once the inflammatory symptoms have improved, you can reduce the application to 2-3 times a week.
Each time you use the medicine, follow these steps:

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

Duration of use

The duration of treatment for small areas should not exceed 2-3 weeks due to the presence of prednisolone in the solution. Clinical experience includes treatment periods 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

If you use more than the recommended dose, you should contact your doctor or pharmacist immediately.

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 use of Alpicort E

You should discuss further action with your doctor, as the effectiveness of the treatment may be compromised.
If you have any further doubts about using this medicine, you should consult your 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 look out for and measures to be taken if they occur: