Positon 2.5 mg/g + 1 mg/g + 100000 IU/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Positon 2.5 mg/g + 1 mg/g + 100,000 IU/g ointment
Neomycin / Triamcinolone / Nystatin
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 other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Positon ointment is and what it is used for
- What you need to know before using Positon ointment
- How to use Positon ointment
- Possible adverse effects
- How to store Positon ointment
- Contents of the pack and other information
1. What Positon ointment is and what it is used for
It is a combination of an aminoglycoside antibiotic, an anti-inflammatory (corticosteroid), and an antifungal agent for topical administration.
Positon ointment belongs to the group of medicines known as topical corticosteroids. The word "topical" means that it is applied to the skin.
Positon ointment also contains neomycin, an antibiotic used to prevent or treat certain bacterial skin infections, and nystatin, an antifungal agent used to treat fungal skin infections.
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 keep or reuse this medicine. If, after completing the treatment, you have leftover antibiotic, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Positon ointment is used in the treatment of dermatological conditions responsive to corticosteroids when there is, or there is a risk of, bacterial or fungal infection.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before using Positon ointment
Do not use Positon ointment
- If you are allergic to neomycin, triamcinolone, or nystatin, or to any of the other components of this medicine (listed in section 6).
- If you have rosacea (a skin condition characterized by facial redness), perioral inflammation (perioral dermatitis), acne, genital or perianal pruritus (itching), inflammatory skin reactions following vaccination (cutaneous vaccine reactions), or atrophic skin diseases.
- If you have skin infections caused by tuberculosis or by viruses such as herpes simplex or varicella (chickenpox).
- It should not be used in dermatoses in children under 1 year of age, due to an increased risk of enhanced absorption.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Positon ointment.
- Use this medicine only on your skin.
- Avoid contact with your eyes, mucous membranes, and open wounds, as this may cause irritation.
- Avoid covering the treated area with bandages, diapers, or dressings.
- Do not use Positon ointment over large areas of skin unless specifically instructed by your doctor.
- Do not use on the face, or in skin friction areas such as the groin, or other body areas (such as skin folds in arms and legs). Do not use Positon ointment on ulcers, wounds, or stretch marks.
- If irritation or severe dryness occurs, consult your doctor.
- Its use is not recommended in pustular or guttate psoriasis.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
The safety and efficacy of Positon ointment in children have not been established.
The use of this medicine in children and adolescents should only occur when, in the physician's judgment, its use is clearly necessary.
Treatment in children must be carefully monitored by the physician, especially if applied over large skin areas or if an occlusive dressing or tight diaper is used.
Prolonged and continuous topical treatment should be avoided whenever possible, particularly in children, as it may lead to suppression of the hypothalamic-pituitary-adrenal axis, with or without development of Cushing's syndrome. If this occurs, consult your doctor, as the medicine should be withdrawn gradually and under medical supervision due to the risk of adrenal insufficiency.
Use of Positon ointment with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Also consider any medicines applied to the skin.
If you are taking antibiotics of the same family as neomycin orally or by injection, toxicity may accumulate.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Positon ointment should be avoided during pregnancy.
If you become pregnant while being treated with this medicine, consult your doctor immediately.
Breastfeeding
The use of Positon ointment during breastfeeding is not recommended unless strictly necessary.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
3. How to use Positon ointment
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults
Apply a thin layer of Positon ointment gently to the affected area of skin two or three times daily. Applying a larger amount will not improve results. Apply the ointment with your fingers to the affected skin area. Be sure to wash your hands thoroughly with water and soap after applying the medicine to prevent accidental entry into your eyes or nose, as this may cause irritation.
To use the ointment, unscrew the cap from the tube and, using the tip included on the outer end, pierce the metal seal.
Your doctor will determine the duration of treatment. Do not use Positon ointment for longer than prescribed.
Use in children and adolescents
This medicine should only be used in children and adolescents when, in the doctor's judgment, its use is clearly necessary. In such cases, apply a thin layer once daily, and treatment should not exceed 7 days.
If used in children, treatment must be carefully monitored by the doctor. This is particularly important if the medicine is applied to more than 5 to 10% of the body surface area or if occlusive dressings or a tightly fitted diaper are used.
If you use more Positon ointment than you should
If you apply too much Positon ointment or use it for a prolonged period, part of the medicine may be absorbed into the body and cause unwanted effects.
Inform your doctor if you experience any adverse effect such as unusual tiredness or any other changes.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount used.
If you forget to use Positon ointment
Apply the medicine as soon as possible, then continue with your normal dosing schedule.
Do not use a double dose to make up for a missed dose.
If you stop using Positon ointment
If used as prescribed, withdrawal effects should not occur when stopping treatment with Positon ointment.
If you have been using large amounts of Positon ointment for a prolonged period, your doctor will advise you on how to gradually reduce the dose so that your body can adapt.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The frequency with which adverse effects may occur is classified as follows:
Very common (may affect more than 1 in 10 people).
Common (may affect up to 1 in 10 people).
Uncommon (may affect up to 1 in 100 people).
Rare (may affect up to 1 in 1,000 people).
Adverse effects with unknown frequency (cannot be estimated from the available data).
Very common adverse reactions | Hypersensitivity reactions (especially if used over prolonged periods), including: contact dermatitis, burning, erythema, rash, and urticaria. |
Common adverse reactions | Mild to moderate burning sensation at the application site, pruritus (itching), local cutaneous atrophy, pain, stinging, irritation, inflammation or erythema of the skin at the application site, which usually does not require discontinuation of treatment. |
Uncommon adverse reactions | Striae, secondary infection, papular facial rosacea, ecchymosis (appearance of small hemorrhages in the skin), folliculitis, erythema, pruritus (itching), burning sensation. |
Rare adverse reactions | Hirsutism, sensitization, hyper/hypopigmentation (changes in skin coloration), telangiectasias (dilation of small blood vessels in the skin), hypercorticism, adrenal corticosuppression, anaphylactic reactions, contact dermatitis, perioral dermatitis, systemic activity. On rare occasions, corticosteroid treatment of psoriasis may have led to the development of the pustular form of the disease. |
Adverse reactions with unknown frequency | Blurred vision. |
Other adverse effects include: purpura, acne (especially with prolonged treatment).
Contact your doctor immediately if you experience any of the following symptoms: appearance of a rash or skin eruption, difficulty breathing or swallowing, wheezing, or skin infection (redness, swelling, or pus).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Positon ointment
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
Do not use Positon ointment if you notice any visible signs of deterioration. Inform your doctor or pharmacist if you observe any changes in the appearance of Positon ointment.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Positon ointment
- The active substances are: neomycin sulfate, triamcinolone acetonide and nystatin. Each gram of ointment contains 2.5 mg of neomycin sulfate, 1 mg of triamcinolone acetonide and 100,000 IU of nystatin.
- The other components are: plastibase (polyethylene phenolic resin and mineral oil).
Appearance of the product and contents of the pack
Positon ointment is available in aluminum tubes containing 30 g or 60 g of ointment.
Marketing Authorization Holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer
Faes Farma Portugal, S.A.
Rua Elías García 28
2700-327 Amadora
Portugal
Date of the most recent review of this leaflet: February 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es.