Package Insert: Information for the User

Aldoderma 1mg/g + 3.5mg/g Ointment

Triamcinolone Acetonide/Framycetin Sulfate

Read this package insert carefully before starting to use the medication, as it contains important information for you.

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

Consult a doctor if symptoms worsen or do not improve after 7 days.

Aldoderma is a topical skin medication containing triamcinolone acetonide, a medium-potency topical corticosteroid that relieves skin inflammation and/or itching, and framycetin sulfate, an aminoglycoside antibiotic that acts on certain types of bacteria.

This medication is used to relieve skin symptoms such as inflammation and/or itching due to skin disorders that respond to corticosteroids, secondarily infected by bacteria sensitive to framycetin, such as eczema and dermatitis, {(endogenous or patient-related factors (atopic dermatitis and neurodermatitis), seborrheic (inflammatory eruption with scaling), contact dermatitis due to common substances like soap (contact dermatitis), and as part of the treatment for psoriasis (scaly, red skin condition with silvery scales).}

No use Aldoderma

• If you are allergic to triamcinolona, framycetin, or any of the other components of this medication (listed in section 6).
• If you have any type of skin infection caused by fungi, tuberculosis, or viruses, such as herpes simplex (including herpes in the eye) or varicella.
• In an area where you have been vaccinated and had a reaction.
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aldoderma ointment.

• You should avoid contact with the eyes or nearby areas.
• You should avoid using it on open wounds and on mucous membranes (for example, the genital area).
• In case of skin irritation, you should suspend treatment with Aldoderma and consult your doctor.
• If you have an allergy to aminoglycoside antibiotics, caution is required.
• Corticosteroid medications, such as triamcinolona acetónido, have significant effects on the body due to some absorption into the body. It is not recommended to use Aldoderma on extensive areas of the skin or for prolonged periods, as this significantly increases the risk of adverse effects, especially in children.
• Do not use under impermeable materials to air and water, including bandages (unless your doctor tells you otherwise), dressings, clothing, or diapers, which are poorly breathable.
• If you are being treated with other topical aminoglycoside antibiotics, caution is required, as significant systemic absorption may occur after topical administration. Your doctor may need to monitor your blood levels.
• You should avoid prolonged use of the medication due to the antibiotic, as occasional bacteria may become resistant, such as fungi. In this case, treatment should be suspended and the appropriate one should be initiated.

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

Children

This medication is contraindicated in children under 2 years old and is not recommended for children under 12 years old.

The administration of Aldoderma should be limited to short periods of time and the minimum effective amount should be administered, always under medical supervision.

In children treated with corticosteroids on the skin, there have been reports of alteration of some glands located near the kidneys that cause symptoms such as obesity, growth delay, etc. (Cushing's syndrome) or an increase in intracranial pressure.

No specific information is available on the use of the antibiotic framycetin in children.

Older adults

Caution is required in this population, as it is considered particularly sensitive to adverse effects due to absorption.

Other medications and Aldoderma

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

During treatment, it is advisable to avoid simultaneous use in the same area of other antibiotics or antimicrobials.

Pregnancy, breastfeeding, and fertility

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

Do not use Aldoderma if you are pregnant or breastfeeding, unless your doctor considers that the potential benefit justifies the possible risks.

Generally, during the first trimester of pregnancy, the use of topical preparations containing corticosteroids should be avoided. Specifically, during pregnancy, women planning to become pregnant and breastfeeding should avoid treating extensive areas, prolonged use, or occlusive dressings.

If your doctor decides to use it, do not apply ointment to the breasts.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Aldodermacontains cetomacrogol, stearyl alcoholand methyl parahydroxybenzoate (E-218)

This medication may cause local skin reactions (such as contact dermatitis) due to cetomacrogol and stearyl alcohol.

It may cause allergic reactions (possibly delayed), due to methyl parahydroxybenzoate (E-218).

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tube contains a seal that is opened by following the instructions:

• Remove the cap.
• Invert it and align it with the thread by pressing gently until the seal is pierced. Be careful not to squeeze the tube while pressing to avoid losing the ointment.

Topical use (on the skin).

The recommended dose is:

Adults and adolescents over 12 years old

Apply a small amount of Aldoderma 2 to 3 times a day on the affected area.

Do not use this medication on the face.

The ointment should be applied with a gentle massage on the affected area in a thin layer until complete absorption.

Use in children

In children over 2 years and up to 12 years, treatment should be limited to short periods of time and the minimum effective amount of the product should be administered, always under medical supervision.

Wash your hands thoroughly after use, unless your hands are the area being treated.

If you use more Aldoderma than you should

Due to its topical use, poisoning is unlikely. However, prolonged use or applied to large skin areas increases the manifestation of adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Aldoderma

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

If you interrupt the treatment with Aldoderma

If you interrupt the treatment prematurely, your skin problems may reactivate. Contact your doctor before interrupting the treatment with Aldoderma.

If you have any other questions 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.

The following adverse effects have been reported, with frequencies defined as: rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people); unknown frequency (cannot be estimated from available data).

Rare:

• Allergic reactions (hypersensitivity) in the form of itching and irritation after administration.
• Skin atrophy, decrease in skin thickness (more common when the medication is administered under occlusive applications).
• Telangiectasia (dilation of small blood vessels in the skin, appearing as bright red spots that disappear with pressure).
• Striae.
• Folliculitis (inflammation of hair follicles).
• Erythema (redness of the skin).

Very rare:

• Cushing's syndrome (disease caused by increased cortisol levels, manifesting in various ways, including obesity, moon face, etc.).
• Increased blood glucose (hyperglycemia) in diabetics, hypokalemia (decreased potassium levels in the blood).
• Tachyphylaxis (loss of medication effect).
• Rebound effect (reappearance of symptoms in long-term treatments).

Unknown frequency:

• Blurred vision, cataracts, increased eye pressure (glaucoma).
• Itching, swelling, dryness, burning, acneiform eruptions, hirsutism (excessive hair growth), perioral dermatitis (inflammation of the skin around the mouth), changes in skin color, fissures, skin infections.
• Some hearing loss.
• Paresthesia (tingling sensation in the skin).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to the Spanish 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 store at a temperature above30°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubtask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aldoderma ointment

• The active principles are triamcinolone acetonide and framycetin sulfate.

Each gram contains 1 mg of triamcinolone acetonide (0.1%) and 3.5 mg of framycetin sulfate (0.35%).

• The other components are: liquid petrolatum, petrolatum, cetyl alcohol, stearic alcohol, glycerin, cetomacrogol 1000, sodium citrate (E-331), anhydrous citric acid, methyl parahydroxybenzoate (E-218) and purified water.

Appearance of the product and contents of the packaging

Aldoderma is a white ointment that is presented in tubes fitted with a screw cap that requires an initial break of the safety seal.

Each tube contains 30 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet:February2022.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/