ADVENTAN 1 mg/ml CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adventan 1mg/ml cutaneous solution

Methylprednisolone aceponate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Adventan solution is and what it is used for
2. What you need to know before you use Adventan solution
3. How to use Adventan solution
4. Possible side effects
5. Storage of Adventan solution
6. Contents of the pack and other information

1. What Adventan 1 mg/ml solution is and what it is used for

Adventan solution is an anti-inflammatory medicine (a corticosteroid) for exclusive cutaneous use on the scalp.

Adventan solution inhibits inflammatory and allergic skin reactions, as well as those associated with an increase in the number of cells (hyperproliferation), leading to a reduction in redness and fluid accumulation (edema), and relieving itching, burning, or pain.

Adventan solution is indicated for the treatment of inflammatory scalp conditions, such as:

• Acute eczema related to an external cause, such as:

- Allergy to a substance that has come into contact with the scalp (allergic contact dermatitis), or

- Irritation due to substances of habitual use (irritant contact dermatitis)

• Unspecified eczema (vulgar eczema)
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Seborrheic eczema with inflammation and scaling.

2. What you need to know before you start using Adventan 1 mg/ml solution

Do not use Adventan 1 mg/ml solution

• If you are allergic (hypersensitive) to the active substance or any of the other components of this medicine included in section 6.
• If you have tuberculosis or syphilitic processes or viral infections (e.g., chickenpox or herpes).
• In ulcers or open wounds or acne.
• In scalp infections caused by bacteria or fungi (unless treated with a specific treatment).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Adventan 1 mg/ml solution.

• Corticosteroids should be used with caution, in the lowest possible dose, and only for the time strictly necessary to relieve the skin condition.
• If your doctor diagnoses a bacterial or fungal infection, additional specific treatment is required, as the infection may worsen if not treated.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Adventan solution is flammable, so it should not be applied near an open flame.
• When applying Adventan solution, avoid contact with the eyes, open wounds, and mucous membranes.
• Applying corticosteroids to large areas of the body or for prolonged periods increases the risk of local or systemic side effects (in areas of the body other than the application site).
• Adventan solution should not be used under airtight and waterproof materials, such as bandages or non-breathable clothing.
• If you use Adventan solution for conditions other than those for which it has been prescribed, you may mask symptoms and make diagnosis and correct treatment more difficult.

Use in children and adolescents

Adventan solution should not be used in children under 18 years of age, as there is no clinical experience available in this age group.

Use of Adventan with other medicines

Tell your doctor, pharmacist, or nurse that you are using, have recently used, or might use any other medicines.

No interactions with other medicines are known for Adventan solution.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

To avoid any risk to the child, do not use Adventan solution if you are pregnant or breastfeeding, unless your doctor advises you to do so.

During breastfeeding, do not let the child come into contact with areas treated with Adventan solution.

Driving and using machines

Adventan solution does not affect the ability to drive or use machines.

3. How to use Adventan 1 mg/ml solution

Follow exactly the application instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

CUTANEOUS USE ONLY ON THE SCALP.

The recommended dose is:

Adults and adolescents over 18 years:

Adventan solution is applied once a day to the affected areas of the scalp.

The solution should be applied in the form of drops with a gentle massage.

Your doctor will indicate the duration of treatment with Adventan solution, but it should not exceed 4 weeks.

Use in children

Children under 18 years of age should not use Adventan solution, as its safety has not been established in this age group.

If you use more Adventan 1 mg/ml solution than you should

Studies have shown that there is no expected risk after the application of a single overdose. Repeated overdoses may produce side effects (see section 4).

After accidental oral ingestion of the solution, effects due to the excipient isopropyl alcohol may be expected. These effects may manifest as symptoms of central nervous system depression after ingestion of only a few milliliters or gastrointestinal disturbances.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Adventan 1 mg/ml solution

Do not apply a double dose to make up for forgotten doses. If you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in the leaflet.

If you stop using Adventan 1 mg/ml solution

If you stop using Adventan solution prematurely, the original symptoms of your skin problem may reappear. Please contact your doctor before stopping treatment with Adventan solution.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adventan solution can cause side effects, although not everybody gets them.

The assessment of side effects is based on the following frequencies:

Very common: affects more than 1 in 10 patients

Common: affects 1 to 10 in 100 patients

Uncommon: affects 1 to 10 in 1,000 patients

Rare: affects 1 to 10 in 10,000 patients

Very rare: affects less than 1 in 10,000 patients.

Frequency not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Uncommon: seborrheic dermatitis of the scalp and hair loss

Frequency not known: skin atrophy, acne, telangiectasias, skin striae, perioral dermatitis, skin discoloration, and allergic skin reactions

General disorders and administration site conditions

Common: burning sensation at the application site

Uncommon: pruritus, pain, dryness, folliculitis, irritation, and eczema at the application site, and localized sensation of heat.

Frequency not known: vesicles and erythema at the application site, hirsutism

Eyes disorders:

Frequency not known: Blurred vision.

Side effects may occur not only in the treated area but also in completely different areas of the body. This occurs if the active substance (a corticosteroid) passes into the body through the skin. This, for example, can increase the pressure in the eye (glaucoma).

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adventan 1 mg/ml solution

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Adventan solution after the expiry date stated on the pack after CAD. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

• The active substance is Methylprednisolone aceponate. Each ml of solution contains 1 mg of methylprednisolone aceponate.
• The other components (excipients) are: isopropyl myristate and isopropyl alcohol.

Appearance of the product and pack contents

Adventan 1 mg/ml cutaneous solution is a clear, transparent liquid, presented in a multidose container with a dropper cap, with 50 ml and 20 ml.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer:

Berlimed, S.A.

Polígono Industrial Santa Rosa

C/ Francisco Alonso, 7

28806 Alcalá de Henares (Madrid) - Spain

Date of last revision of this leaflet: October 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/