ALDODERMA 1 mg/g + 3.5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Aldoderma 1mg/g + 3.5mg/g Ointment

triamcinolone acetonide / framycetin sulfate

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. See section 4.

Contents of the pack

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

1. What is Aldoderma and what is it used for

You should consult a doctor if it worsens or does not improve after 7 days.

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

This medicine is used for the relief of 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 related to patient factors (atopic dermatitis and neurodermatitis), seborrheic (eruption with inflammation and scaling), allergic reaction to substances of habitual use such as soap (contact)} and as part of the treatment of psoriasis (scaly red rash with silver scales sometimes).

2. What you need to know before you use Aldoderma

Do not use Aldoderma

• If you are allergic to triamcinolone, framycetin, or any of the other components of this medicine (listed in section 6).
• If you have any type of fungal, tuberculosis, or viral skin infection, such as herpes simplex (including herpes in the eye) or chickenpox.
• In an area where you have been vaccinated and had a reaction.
• In children under 2 years of age.

Warnings and precautions

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

• You should avoid contact with the eyes or surrounding areas.
• You should avoid using it on open wounds and mucous membranes (e.g., genital area).
• In case of skin irritation, you should discontinue treatment with Aldoderma and consult your doctor.
• If you are allergic to aminoglycoside antibiotics, caution is required.
• Corticosteroid drugs, such as triamcinolone acetonide, have significant effects on the body due to some absorption into the body. The use of Aldoderma is not recommended on extensive skin areas or for prolonged periods, as this significantly increases the risk of side effects, especially in children.
• It should not be used under airtight and waterproof materials, including bandages (unless your doctor indicates otherwise), dressings, clothing, or diapers that are not very breathable.
• If you are being treated with other topical aminoglycoside antibiotics, caution is required, as significant systemic absorption may occur after topical administration. You may need to have your blood levels checked.
• You should avoid prolonged use of the medicine due to the antibiotic, as non-sensitive germs such as fungi may occasionally proliferate. In this case, treatment should be discontinued and the appropriate one started.

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

Children

This medicine is contraindicated in children under 2 years of age and is not recommended in children under 12 years of age.

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 skin corticosteroids, alterations in glands located near the kidneys have been reported, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure.

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

Elderly patients

Caution is required in this population group, as it is considered particularly sensitive to suffering from side effects due to absorption.

Other medicines and Aldoderma

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

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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

In general, during the first trimester of pregnancy, the use of topical preparations containing corticosteroids should be avoided. In particular, during pregnancy, women planning a pregnancy, and breastfeeding, treatment of extensive areas, prolonged use, or occlusive dressings should be avoided.

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

Driving and using machines

The influence of this medicine on the ability to drive and use machines is nil or insignificant.

Aldoderma contains cetyl alcohol, stearic alcohol, and methylparaben (E-218)

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearic alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218).

3. How to use Aldoderma

Follow your doctor's instructions for using this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

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

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

For cutaneous use (on the skin).

The recommended dose is:

Adults and adolescents over 12 years

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

Do not use this medicine on the face.

The ointment should be applied with a gentle massage to the affected area in a thin layer until completely absorbed.

Use in children

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

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

If you use more Aldoderma than you should

Due to its topical use, intoxication is unlikely. However, prolonged use or application to large skin areas increases the manifestation of side effects.

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 medicine and the amount ingested.

If you forget to use Aldoderma

Do not use a double dose to make up for forgotten doses.

If you stop using Aldoderma

If you stop treatment prematurely, your skin problems may reactivate. Contact your doctor before stopping treatment with Aldoderma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported, with frequencies defined as: rare (may affect up to 1 in 1000 people), very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

Rare:

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

Very rare:

• Cushing's syndrome (disease caused by increased cortisol, which manifests, among other forms, with obesity, moon face, etc.).
• Increased blood glucose (sugar) in diabetics, hypokalemia (decreased potassium in the blood).
• Tachyphylaxis (loss of the medicine's effect).
• Rebound effect (reappearance of symptoms in long treatments).

Frequency not known:

• Blurred vision, cataracts, increased eye pressure (glaucoma).
• Itching, swelling, dryness, burning, acne-like eruptions, hirsutism (increased hair), perioral dermatitis (specific inflammation of the skin around the mouth), changes in skin color, fissures, skin infection.
• Some hearing loss
• Paresthesia (tingling in the skin).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Aldoderma

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

Do not store above 30°C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Aldoderma ointment composition

• The active ingredients 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 ingredients are: liquid paraffin, white soft paraffin, cetyl alcohol, stearic alcohol, glycerin, cetomacrogol 1000, sodium citrate (E-331), anhydrous citric acid, methylparaben (E-218), and purified water.

Appearance of the product and pack contents

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

Each tube contains 30 g of ointment.

Marketing authorization holder and manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Date of last revision of this leaflet:February 2022.

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