Package Leaflet: Information for the User

Syracerin0.5 mg/g + 20 mg/g topical solution

betametasona/ácido salicílico

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

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

1. What isSyracerin0.5 mg/g + 20 mg/g topical solution and what it is used for

2. What you need to know before usingSyracerin0.5 mg/g + 20 mg/g topical solution

3. How to useSyracerin0.5 mg/g + 20 mg/g topical solution

4. Possible side effects

5. Storage ofSyracerin0.5 mg/g + 20 mg/g topical solution

6. Contents of the pack and additional information

Syracerin0.5 mg/g + 20 mg/g topical solution is a combined product for topical use. It contains betamethasone dipropionate (a corticosteroid) and salicylic acid (a keratolytic agent). Betamethasone dipropionate reduces skin inflammation and allergic reactions, as well as reactions associated with excessive cell division in the skin, and salicylic acid reduces the outer cornified layer of the skin and facilitates the penetration of the corticosteroid.

Syracerin0.5 mg/g + 20 mg/g topical solutionis used to treat psoriasis (psoriasis vulgaris).

No useSyracerin0,5 mg/g + 20 mg/g topical solution

? if you are allergic to betamethasone dipropionate, salicylic acid, or any of the other components of this medication (listed in section 6).

? if you have certain viral diseases (such as chickenpox, herpes)

? if you have bacterial diseases (such as skin tuberculosis, erysipelas, or cutaneous manifestations of syphilis)

? if you have skin infections or fungal infections (unless being treated for them)

? in areas of the skin that show a reaction to a vaccine

? in areas of the skin affected by acne, rosacea (inflammation of the skin that is red/pink), perioral dermatitis (inflammation of the skin around the upper lip and chin)

? in the eye, on mucous membranes, in the genital area, or in deep open wounds.

? in case of repeated use: if you have gastric or intestinal ulcers or certain forms of blood clotting disorders (hypocoagulability)

Syracerin0,5 mg/g + 20 mg/g topical solutionshould not be used in babies or infants.

This medicationshould not be used in occlusive conditions (bandages, patches, etc.).

Warnings and precautions

Consult your doctor or pharmacist before starting to usethis medication

Treatment should be discontinued if skin irritation or sensitization occurs during use ofSyracerin0,5 mg/g + 20 mg/g topical solution.

Corticosteroids, such as the active ingredient betamethasone dipropionate inthis medication,have strong effects on the body. It is not recommended to usethis medicationon large areas of the body or for prolonged periods of time, as this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

? use as little as possible, especially in children;

? use only for the time absolutely necessary to relieve skin condition; the duration of treatment should not exceed 3 weeks in adults; children should not be treated withthis medicationfor more than 1 week;

? Syracerin0,5 mg/g + 20 mg/g topical solutionshould not come into contact with the eyes or mouth, open wounds, or mucous membranes (such as the anal and genital areas);

? do not usethis medicationon large body surfaces; in children, the maximum treated surface area should be less than 10% of the body surface;

? do not usethis medicationunder impermeable materials such as bandages, breathable dressings, clothing, or diapers;

If this medicationis used for conditions other than those prescribed, symptoms may be masked and diagnosis and treatment may be delayed.

This medicationshould only be used on the face with caution and should never be used on the eyes.

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

To avoid symptoms of overdose, do not exceed the maximum daily dose of 2 g of salicylic acid for adults.

Children

Generally, caution should be exercised when treating children withthis medication,as there may be increased absorption of the corticosteroid and salicylic acid through the child's skin.

When using Syracerin0,5 mg/g + 20 mg/g topical solutionin children, do not exceed the daily dose of 0.2 g of salicylic acid. In children, the maximum treated surface area should be less than 10% of the body surface.

Other medications andSyracerin0,5 mg/g + 20 mg/g topical solution

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

During use of this medication, do not use medicated shampoos for hair, as there is currently no practical experience to rule out interactions.

At present, there are no known influences on laboratory tests.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

To avoid any risk to your baby, do not use Syracerin0,5 mg/g + 20 mg/g topical solutionif you are pregnant, unless your doctor has indicated otherwise. If your doctor prescribes this medication, use it as little as possible and only for the time absolutely necessary.

Lactation:

If your doctor recommends using this medication during breastfeeding, do not apply the medication to the breast. Do not put your baby in contact with treated areas. Consult your doctor or pharmacist before taking or using any medication.

Driving and operating machinery

No special precautions are required.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Always follow the usage instructions, as if you do not follow them, this medication may not work correctly.

Recommended dose:

ApplySyracerin0.5 mg/g + 20 mg/g topical solutionone or two times a day on the affected skin areas.

For some medical conditions, a daily application may be sufficient. The application frequency may be reduced as the medical condition improves.

The affected skin areas must be covered with a thin layer of the solution.

Treatment duration:

The treatment duration should not exceed 3 weeks.

Children should not be treated with this medication for more than 1 week.

This medication, Syracerin 0.5 mg/g + 20 mg/g topical solution, should not be used in babies or infants.

If you think the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

If you use moreSyracerin0.5 mg/g + 20 mg/g topical solution than you should

No adverse effects are expected from a single overdose (too large a quantity, too large an area of skin, or used too frequently).

Repeated overdoses or misuse may cause adverse effects.

Excessive use of topical corticosteroids (repeated overdose or misuse) may lead to a condition called hypercorticism with severe symptoms, which will be treated appropriately 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 salicylate poisoning symptoms (buzzing in the ears 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useSyracerin0.5 mg/g + 20 mg/g topical solution

Do not use a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

The evaluation of adverse effects is based on the following frequencies:

Unknown frequency (The frequency cannot be estimated from the available data):

skin irritation, skin thinning (atrophy), stretch marks, blisters, steroid acne, formation of light patches on the skin (hypopigmentation), vascular spiders, skin burns, itching, skin dryness, inflammation of hair follicles (folliculitis), and alteration of hair growth, sensitization, perioral dermatitis (inflammation of the skin around the upper lip and chin), skin allergy reaction (contact dermatitis), skin maceration, delayed wound healing, peeling, secondary infections (additional infections caused by pathogens), blurred vision.

The following secondary effects may occur more frequently when applied under occlusive dressings (diapers, bandages): skin maceration, secondary infections caused by pathogens (additional infections), skin thinning, stretch marks, and blisters.

Secondary effects may occur not only at the treatment site but also in completely different areas of the body (i.e., systemic secondary effects). This happens if the active ingredient (corticosteroid) is absorbed by the body through the skin. This can lead, for example, to the so-called Cushing 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after "EXP". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Information on shelf life after opening

After the bottle is opened for the first time, this medication has a shelf life of 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

The active principles are :

betametasona dipropionato and salicylic acid

1 g of Syracerin 0.5 mg/g + 20 mg/g topical solution contains 0.64 mg of betametasona dipropionato (corresponding to 0.5 mg of betamethasone) and 20 mg of salicylic acid.

The other components are :

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

Appearance of the product and contents of the packaging

Syracerin 0.5 mg/g + 20 mg/g topical solution is a colorless, 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 sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mibe Pharma España S.L.U.

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

28045, Madrid

Spain

Responsible for manufacturing

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 - Brehna

Germany

This medicine is authorized in the member states of the European Economic Area with 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 last review of this leaflet: August 2020

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).