Aldoderm 1 mg/g + 3.5 mg/g ointment
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aldoderma 1mg/g + 3.5mg/g ointment
triamcinolone acetonide/framicetin sulfate
Read the entire 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, 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Aldoderma is and what it is used for
- What you need to know before using Aldoderma
- How to use Aldoderma
- Possible adverse effects
- How to store Aldoderma
- Contents of the pack and other information
1. What Aldoderma is and what it is used for
You should consult a doctor if your condition worsens or does not improve after 7 days.
Aldoderma is a topical skin medication containing triamcinolone acetonide, a medium-potency topical corticosteroid that relieves inflammation and/or itching of the skin, and framycetin sulfate, an aminoglycoside antibiotic that acts against certain types of bacteria.
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medication. If any antibiotic remains after treatment is completed, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
This medicine is used to relieve skin symptoms such as inflammation and/or itching due to skin disorders that respond to corticosteroids, when secondarily infected by bacteria sensitive to framycetin, such as eczemas and dermatitis {(endogenous or related to patient factors (atopic dermatitis and neurodermatitis), seborrheic (rash with inflammation and scaling), allergic reaction to substances commonly used, such as soap (contact dermatitis)} and as part of the treatment of psoriasis (a scaly red condition with silvery scales sometimes present).
2. What you need to know before using Aldoderma
Do not use Aldoderma
- If you are allergic to triamcinolone, framycetin, or any of the other ingredients of this medicine (listed in section 6).
- If you have any fungal, tuberculosis, or viral skin infection, such as herpes simplex (including herpes of the eye) or chickenpox.
- In areas where you have received a vaccine that caused 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 nearby areas.
- Avoid use on open wounds and on mucous membranes (e.g., genital area).
- If skin irritation occurs, discontinue treatment with Aldoderma and consult your doctor.
- Use caution if you are allergic to aminoglycoside antibiotics.
- Corticosteroid medicines, such as triamcinolone acetonide, can have significant effects on the body due to some absorption into the system. Use of Aldoderma over large skin areas or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects, especially in children.
- Do not use under air- and water-impermeable materials, including dressings (unless directed by your doctor), occlusive dressings, non-breathable clothing, or diapers.
- Use caution if you are being treated with other topical aminoglycoside antibiotics, as significant systemic absorption may occur following topical application. Blood levels may need to be monitored.
- Avoid prolonged use of the medicine due to the antibiotic component, as this may occasionally lead to overgrowth of non-sensitive organisms such as fungi. In such cases, discontinue treatment and initiate appropriate therapy.
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 for children under 12 years.
Administration of Aldoderma should be limited to short periods, and the smallest effective amount should be used, always under medical supervision.
In children treated with topical corticosteroids, disturbances of glands located near the kidneys have been reported, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), or increased intracranial pressure.
Specific information on the use of the antibiotic framycetin in children is not available.
Elderly patients
Caution is required in this population group, as they are considered particularly sensitive to adverse effects due to potential systemic absorption.
Other medicines and Aldoderma
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
During treatment, it is advisable to avoid simultaneous use of other antibiotics or antimicrobials on the same area.
Pregnancy, breastfeeding and fertility
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.
Do not use Aldoderma during pregnancy or breastfeeding unless your doctor considers that the potential benefit justifies the possible risks.
In general, topical corticosteroid preparations should be avoided during the first trimester of pregnancy. Specifically, during pregnancy, in women planning pregnancy, and during breastfeeding, treatment of large skin 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 negligible or none.
Aldoderma contains cetyl alcohol, stearyl alcohol, and methyl parahydroxybenzoate (E-218)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).
3. How to use Aldoderma
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The tube contains a seal which is opened by following these instructions:
- Unscrew the cap.
- Turn it upside down and align it with the thread, then press gently until the seal is pierced. Take care not to squeeze the tube while pressing to avoid loss of ointment.
For cutaneous use (on the skin).
The recommended dose is:
Adults and adolescents over 12 years of age
Apply a small amount of Aldoderma 2 to 3 times daily to the affected area.
Do not use this medicine on the face.
The ointment should be applied with a gentle massage in a thin layer over the affected area until completely absorbed.
Use in children
In children over 2 years of age and up to 12 years of age, treatment should be limited to short periods and the minimum effective amount of the product should be used, 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 application over large areas of skin may increase the occurrence of adverse effects.
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, 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 recur. Contact your doctor before stopping treatment with Aldoderma.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will 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); frequency not known (cannot be estimated from available data).
Rare:
- Allergic reactions (hypersensitivity) such as itching and irritation following administration.
- Skin atrophy, decreased skin thickness (more common when the medicine is administered under occlusive dressings).
- Telangiectasia (dilation of small blood vessels appearing as bright red lines on the skin, which disappear with pressure).
- Striae.
- Folliculitis (inflammation of hair follicles).
- Erythema (redness of the skin).
Very rare:
- Cushing's syndrome (a disease caused by increased cortisol levels, manifested among other signs by obesity, moon-shaped face, etc.).
- Increased blood glucose (sugar) levels (hyperglycaemia) in diabetics, hypokalaemia (decreased potassium levels in blood).
- Tachyphylaxis (loss of response to the medicine).
- Rebound effect (return of symptoms after long-term treatment).
Frequency not known:
- Blurred vision, cataracts, increased eye pressure (glaucoma).
- Itching, swelling, dryness, burning, acneiform rashes, hypertrichosis (excessive hair growth), perioral dermatitis (specific inflammation of the skin around the mouth), changes in skin pigmentation, skin fissures, skin infection.
- Some loss of hearing.
- Paresthesia (tingling sensations in the skin).
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aldoderma
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are in any doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Aldoderma ointment
- The active substances 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 paraffin, soft white paraffin, cetyl alcohol, stearyl alcohol, glycerin, cetomacrogol 1000, sodium citrate (E-331), anhydrous citric acid, methyl parahydroxybenzoate (E-218), and purified water.
Appearance of the medicine and contents of the pack
Aldoderma is a white ointment supplied in tubes fitted with a screw cap requiring initial breaking of the safety 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 the most recent revision of this leaflet: February 2022.
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/