Alpicort E

PATIENT INFORMATION LEAFLET

Alpicort F - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

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Leaflet enclosed with the packaging: information for the patient

Alpicort E (2 mg + 0.05 mg + 4 mg)/ml solution for the skin

Prednisolone + Estradiol + Salicylic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack and other information

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

Alpicort E is a solution 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 you are 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 vaginal bleeding,

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• on mucous membranes, in the mouth, on or near 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 wet or acute scalp conditions.

Warnings and precautions

Before starting treatment with Alpicort E, 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 solution, take special precautions:

• in cases of endometriosis (endometrial tissue outside the uterus) or mastopathy (breast tissue changes),
• in women who are already taking estrogen-containing products, treatment should be carried out only under close medical supervision. Protect your eyes and mucous membranes from contact with the product. If you experience blurred vision or other vision disturbances, contact your doctor.

Alpicort E and other medicines

Due to its composition, Alpicort E may enhance the effects of other topically applied active substances.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. In 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, stop using Alpicort E immediately. Regarding fetal exposure to estrogen, previous studies have not shown any effect on subsequent fertility.

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During prolonged 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, breastfeeding should be discontinued.
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, do not breastfeed, or 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 or use machines.

Alpicort E contains propylene glycol

The medicine contains 50 mg of propylene glycol in 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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Use Alpicort E exactly as your doctor has told you and follow the instructions in this leaflet. If you are not sure, talk to your doctor again.
Alpicort E is a solution for use on the skin.
Unless your doctor has told you otherwise, use Alpicort E once a day, preferably in the evening.
Once the inflammatory symptoms have subsided, it is sufficient to use 2 to 3 times a week.
Each time you use it, follow these steps:

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

Duration of use

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The duration of treatment 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 action after discontinuation of the medicine.

Using more than the recommended dose of Alpicort E

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

Missing a dose of Alpicort E

Do not take a double dose to make up for a forgotten dose.
Continue treatment with the next planned dose at the usual time.

Stopping use of Alpicort E

Discuss further action with your doctor, as the effectiveness of the treatment may be compromised.
If you have any further questions about using this medicine, ask 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 actions to take if they occur:

Rare(may affect up to 1 in 1,000 people): skin hypersensitivity (allergic contact dermatitis)

Other side effects:

Very rare(may affect up to 1 in 10,000 people): as with the use of any corticosteroid products, long-term use may lead to skin changes (thinning of the skin, widening of small blood vessels, formation of striae, steroid acne, perioral dermatitis, excessive hair growth).
Unknown(frequency cannot be estimated from the available data): blurred vision
Additionally, short-term skin irritation (e.g., burning, redness) is possible.
During long-term use in high doses or on large areas, as well as in cases of misuse, systemic corticosteroid effects are possible.

Reporting side effects

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If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the
Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alpicort E

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alpicort E contains

• The active substances are prednisolone, estradiol benzoate, and salicylic acid.
• The other ingredients are isopropyl alcohol, propylene glycol, arginine, and purified water.

What Alpicort E looks like and contents of the pack

Alpicort E is a clear, colorless solution. The pack contains a brown glass bottle with an applicator and a plastic cap containing 100 ml of the medicine and a leaflet.

Marketing authorization holder and manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56, 33611 Bielefeld, GERMANY
Phone: +49 521 8808-05

Alpicort F - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

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Fax: +49 521 8808-334
Email: [email protected]
For more detailed information, please contact the representative of the marketing authorization holder:
SOLPHARM Sp. z o.o.
Zakątek 1
05-270 Marki
Poland
Phone: +48 /22/ 616 28 08
Email: [email protected]
www.solpharm.pl
Date of last revision of the leaflet:08/2022