Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Syracerin 0.5 mg/g + 20 mg/g Cutaneous Solution

betamethasone/salicylic acid

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Syracerin 0.5 mg/g + 20 mg/g cutaneous solution is and what it is used for
2. What you need to know before using Syracerin 0.5 mg/g + 20 mg/g cutaneous solution
3. How to use Syracerin 0.5 mg/g + 20 mg/g cutaneous solution
4. Possible adverse effects
5. How to store Syracerin 0.5 mg/g + 20 mg/g cutaneous solution
6. Contents of the pack and other information

1. What Syracerin 0.5 mg/g + 20 mg/g cutaneous solution is and what it is used for

Syracerin 0.5 mg/g + 20 mg/g cutaneous solution is a combination product for topical use. It contains betamethasone dipropionate (a corticosteroid) and salicylic acid (a keratolytic agent). Betamethasone dipropionate reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive cell division in the skin, and salicylic acid reduces the outer horny layer of the skin and facilitates the penetration of the corticosteroid.

Syracerin 0.5 mg/g + 20 mg/g cutaneous solution is used to treat psoriasis (psoriasis vulgaris).

2. What you need to know before using Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

Do not use Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

• if you are allergic to betamethasone dipropionate, salicylic acid, or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from certain viral diseases (e.g., chickenpox, herpes).
• if you suffer from bacterial diseases (such as cutaneous tuberculosis, erysipelas, or syphilitic skin manifestations).
• if you have bacterial or fungal skin infections (unless specifically treated as such).
• in areas of skin showing a reaction to a vaccine.
• in areas of skin affected by acne, rosacea (skin inflammation that is red/pink), or perioral dermatitis (inflammation of the skin around the upper lip and chin).
• in the eye, on mucous membranes, in the genital area, or on deep open wounds.
• in case of repeated use: if you have gastric or intestinal ulcers or certain forms of blood coagulation disorders (hypocoagulability).

Syracerin 0.5 mg/g + 20 mg/g cutaneous solution must not be used in babies or infants.

This medicine must not be used under occlusive conditions (plasters, patches, etc.).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Treatment must be discontinued if skin irritation or sensitization occurs during use of Syracerin 0.5 mg/g + 20 mg/g cutaneous solution.

Anti-inflammatory medicines (corticosteroids) such as the active substance betamethasone dipropionate in this medicine have strong effects on the body. This medicine should not be used over large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

• use the smallest amount possible, especially in children;
• use only for as long as absolutely necessary to relieve the skin condition; treatment duration should not exceed 3 weeks in adults; children should not be treated with this medicine for longer than 1 week;
• Syracerin 0.5 mg/g + 20 mg/g cutaneous solution must not come into contact with the eyes, mouth, open wounds, or mucous surfaces (e.g., in the anal and genital areas);
• do not use this medicine on large body surfaces; in children, the maximum treated area should be less than 10% of body surface area;
• do not use this medicine under air- and water-impermeable materials such as bandages, non-breathable dressings, clothing, or diapers.

If this medicine is used for conditions other than those prescribed, symptoms may be masked, making correct diagnosis and therapy more difficult.

This medicine should only be used on the face with caution and never in the eye area.

Consult your doctor if you experience blurred vision or other visual disturbances.

To avoid symptoms of intoxication, the maximum daily dose of 2 g of salicylic acid must not be exceeded in adults.

Children

Greater caution should generally be exercised when treating children with this medicine, as there may be increased absorption of the corticosteroid and salicylic acid through a child's skin.

When using Syracerin 0.5 mg/g + 20 mg/g cutaneous solution in children, the daily dose of salicylic acid must not exceed 0.2 g. In children, the maximum treated area should be less than 10% of body surface area.

Other medicines and Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines.

During use of this medicine, medicated shampoos for the hair should not be used, as there is currently no practical experience to rule out interactions.

There are currently no known effects on laboratory tests.

Pregnancy and breastfeeding

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

Pregnancy:

To avoid any risk to your baby, do not use Syracerin 0.5 mg/g + 20 mg/g cutaneous solution during pregnancy unless specifically instructed by your doctor. If your doctor prescribes this medicine, use it as little as possible and only for the time absolutely necessary.

Breastfeeding:

If your doctor recommends using this medicine during breastfeeding, do not apply the medicine to the breast. Avoid contact between your baby and treated areas. Consult your doctor or pharmacist before taking or using any medicine.

Driving and using machines

No special precautions are required.

3. How to use Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Always follow the instructions for use, as the medicine may not work properly if they are not observed.

Recommended dose:

Apply Syracerin 0.5 mg/g + 20 mg/g cutaneous solution once or twice daily to the affected areas of the skin.

For certain medical conditions, once-daily application may be sufficient. The frequency of application may be reduced as the medical condition improves.

The affected areas of skin should be covered with a thin film of the solution.

Duration of treatment:

The duration of treatment should not exceed 3 weeks.

Children should not be treated with this medicine for longer than 1 week.

Syracerin 0.5 mg/g + 20 mg/g cutaneous solution must not be used in babies or infants.

If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you use more Syracerin 0.5 mg/g + 20 mg/g cutaneous solution than you should

No risk is expected from a single overdose (excessive amount, too large an area of skin treated, or too frequent use).

Repeated overdoses or misuse may cause adverse effects.

Excessive use of topical corticosteroids (repeated overdose or misuse) may lead to so-called hypercorticism with serious symptoms, which will be appropriately treated by your doctor. Acute symptoms of hypercorticism (e.g., "moon face") are largely reversible. Electrolyte imbalances should be treated as needed.

Excessive use of topical preparations containing salicylic acid may cause symptoms of salicylate poisoning (tinnitus with hearing loss, nasal bleeding, nausea, vomiting, irritability, and dryness of mucous membranes). Your doctor may initiate appropriate treatment for these symptoms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

Do not use a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you are affected by any of the following side effects, stop using this medicine and consult your doctor as soon as possible.

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

Frequency not known (frequency cannot be estimated from available data):

skin irritation, thinning of the skin (atrophy), stretch marks, blistering, steroid acne, development of pale spots on the skin (hypopigmentation), spider veins, skin burning, itching, dry skin, inflammation of hair follicles (folliculitis), abnormal hair growth, sensitization, perioral dermatitis (inflammation of the skin around the upper lip and chin), allergic skin reaction (contact dermatitis), skin maceration, delayed wound healing, peeling, secondary infections (additional infections caused by pathogens), blurred vision.

The following side effects may occur more frequently when occlusive dressings (diapers, plasters) are used: skin maceration, secondary infections (additional infections caused by pathogens), thinning of the skin, stretch marks and blistering.

Side effects may occur not only at the site of treatment but also in completely different areas of the body (i.e. systemic side effects). This may happen if the active substance (corticosteroid) is absorbed into the body through the skin. This may lead, for example, to Cushing's syndrome; in children, growth retardation, reduced weight gain, and increased intracranial pressure have been observed. This is especially important in children, as they are more susceptible.

Reporting of side effects

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Syracerin 0.5 mg/g + 20 mg/g cutaneous solution

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

Do not use this medicine after the expiry date stated on the bottle and the carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Information on shelf life after first opening

After first opening the bottle, this medicine is stable for 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substances are:

betamethasone dipropionate and salicylic acid

1 g of Syracerin 0.5 mg/g + 20 mg/g cutaneous solution contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) and 20 mg of salicylic acid.

The other components are:

disodium edetate, hypromellose, isopropyl alcohol, sodium hydroxide and hydrochloric acid (for pH adjustment), purified water

Appearance of the product and contents of the pack

Syracerin 0.5 mg/g + 20 mg/g cutaneous solution is a colourless, slightly viscous solution and is available in polyethylene bottles with polyethylene dropper and polyethylene screw cap containing 15 ml (14.1 g), 20 ml (18.8 g), 30 ml (28.2 g), 50 ml (47.0 g), 60 ml (56.4 g) or 100 ml (94.0 g).

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 - Brehna

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria Betamethason/Salicylsäure Dermapharm 0.5 mg/g + 20 mg/g Lösung zur Anwendung auf der Haut

Italy Soderm plus 0.5 mg/g + 20 mg/g soluzione cutanea

Spain Syracerin 0.5 mg/g + 20 mg/g solución cutánea

Date of the most recent revision of this leaflet: August 2020

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