Alpicort

PATIENT INFORMATION LEAFLET

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

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Leaflet attached to the packaging: information for the patient

Alpicort, (2 mg + 4 mg)/ml, skin solution

Prednisolone + 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 and what is it used for
• 2. Important information before using Alpicort
• 3. How to use Alpicort
• 4. Possible side effects
• 5. How to store Alpicort
• 6. Contents of the pack and other information

1. What is Alpicort and what is it used for

Alpicort is a skin solution containing prednisolone, for use on the skin.
Indications: hair loss in diseases such as: psoriasis of the hairy scalp, seborrheic dermatitis, seborrhea, alopecia areata, diffuse hair loss, as well as after systemic infections.

2. Important information before using Alpicort

When not to use Alpicort:

• if you are allergic to prednisolone, salicylic acid or any of the other ingredients of this medicine (listed in section 6.),
• in infants and children under 12 years of age,
• on mucous membranes, in the mouth, on or near the eyes, and on or near the genitals or internally,

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• in case of chickenpox, certain skin diseases (tuberculosis, syphilis) and inflammatory reactions to vaccinations,
• in case of fungal and bacterial skin infections,
• in case of peri-oral inflammatory skin diseases (symptoms of skin irritation around the mouth with redness and nodules) and rosacea (redness of the face with possible inflammatory or purulent pimples).

Warnings and precautions

Before starting to use Alpicort, discuss it with your doctor or pharmacist.
Alpicort, due to its isopropyl alcohol content, should only be used externally.
If you experience blurred vision or other vision disturbances, contact your doctor.

Children and adolescents

In children, do not exceed the daily dose of 0.2 g of salicylic acid (= 50 ml of Alpicort).
Protect the eyes and mucous membranes from contact with Alpicort.

Alpicort and other medicines

Alpicort, due to its composition, may enhance the effect of other externally used active substances.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In pregnancy, Alpicort should not be used due to its salicylic acid content.
If your doctor decides to use Alpicort during pregnancy, it should only be used on small areas of skin (less than 5 cm²) and for a short time.
During breastfeeding, your doctor should consider that prednisolone passes into breast milk.
Your doctor will decide whether it is necessary to use Alpicort during breastfeeding. If long-term treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

Alpicort has no influence on the ability to drive and use machines.

Alpicort contains propylene glycol

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

3. How to use Alpicort

This medicine should always be used exactly as your doctor has instructed. If you are not sure, ask your doctor or pharmacist.
Alpicort is a solution for use on the skin.
Unless your doctor has told you otherwise, use Alpicort once a day, preferably in the evening.
As soon as the inflammatory symptoms have subsided, it is sufficient to use it 2 to 3 times a week.
Each time you use it, proceed as follows:

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

Duration of use

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

Use in children and adolescents

Alpicort is contraindicated in children under 12 years of age.
In children over 12 years of age, the medicine should only be used for a short time and on small areas of skin.

Using more than the recommended dose of Alpicort

Alpicort is generally well tolerated even in large doses when used for a short time. No special precautions are required.
If you have used more than the recommended dose of Alpicort, contact your doctor or pharmacist immediately.

Missing a dose of Alpicort

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

Stopping use of Alpicort

If you have any further questions about using this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, Alpicort 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:

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

Other side effects:

Very rarely(may affect up to 1 in 10,000 people): skin changes (skin thinning, widening of small blood vessels, formation of striae, steroid acne, peri-oral inflammatory skin disease, excessive body hair)
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 (more than 2-3 weeks) or on large areas (e.g. the entire scalp) and in case of use not in accordance with the intended use, systemic effects of corticosteroids are possible.

Reporting side effects

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 for the 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

Keep this medicine out of the sight and reach of children.

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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 carton and bottle.
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 contains

• The active substances are prednisolone and salicylic acid.
• 1 ml of skin solution contains 2 mg of prednisolone and 4 mg of salicylic acid.
• The other ingredients are: isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort looks like and contents of the pack

Alpicort is a skin solution.

Packaging

The packaging of the medicine is an orange bottle with an applicator and a plastic closure containing 100 ml of the medicine, placed in a cardboard box.

Marketing authorization holder and manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld, GERMANY
Phone: +49 521 8808-05
Fax: +49 521 8808-334
Email: [email protected]
To obtain more detailed information, contact the local representative of the marketing authorization holder:
SOLPHARM Sp. z o.o.
Zakątek 1 Street
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