POSITON 2.5 mg/g + 1 mg/g + 100,000 IU/g OINTMENT

Introduction

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 starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What is Positon ointment and what is it used for
2. What you need to know before starting to use Positon ointment
3. How to use Positon ointment
4. Possible side effects
5. Storage of Positon ointment
6. Package contents and additional information

1. What is Positon ointment and what is it used for

It is a combination of an aminoglycoside antibiotic, an anti-inflammatory (corticosteroid), and an antifungal for skin administration.

Positon ointment belongs to the group of medicines called topical corticosteroids. The word "topical" means that it is applied to the skin.

Positon ointment also contains neomycin, an antibiotic to prevent or treat some bacterial skin infections, and nystatin, an antifungal to treat skin infections caused by fungi.

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

It is essential to 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 down the drain or in the trash.

Positon ointment is used for the treatment of dermatological processes sensitive to corticosteroids where there is or may be a risk of bacterial or fungal infection.

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

2. What you need to know before starting to use 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 dermatitis, acne, or genital or perianal pruritus, inflammatory skin processes due to vaccine administration (cutaneous vaccinal reactions), or atrophic skin diseases.
• If you have skin infections caused by tuberculosis or viral infections, such as herpes simplex or chickenpox.
• It should not be used in dermatosis in children under 1 year of age, as there is a higher risk of increased absorption.

Warnings and precautions

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

• Use this medicine only on your skin.
• Do not let it come into contact with your eyes, mucous membranes, or open wounds, as it may cause irritation.
• Avoid covering the treated area with bandages, diapers, or dressings.
• Do not use Positon ointment on large areas of skin, unless your doctor has indicated it.
• Do not use it on your face or on skin areas subject to friction, such as the groin or other skin areas (such as the flexion areas between arms and legs). Do not use Positon ointment on ulcers, wounds, or stretch marks.
• If severe irritation or dryness occurs, consult your doctor.
• It is not recommended for use in pustular psoriasis 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 will only be done when, in the doctor's opinion, its use is necessary.

Treatment in children must be carefully controlled by the doctor, especially if applied to large areas of skin or if an occlusive dressing or a very tight diaper is used.

Continuous and prolonged topical treatment should always be avoided, especially in children, as it may cause suppression of the hypothalamic-pituitary-adrenal axis with or without the appearance of Cushing's syndrome. If this situation occurs, consult your doctor, as the medicine should be gradually withdrawn and under medical supervision, due to the risk of adrenal insufficiency.

Using Positon ointment with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those purchased without a prescription. Also, consider any medicine used on the skin.

If you are taking oral or injectable antibiotics from the same family as neomycin, toxicity may accumulate.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 using this medicine, consult your doctor immediately.

Breastfeeding

The use of Positon ointment is not recommended during breastfeeding, unless it is strictly necessary.

Driving and using machines

This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use Positon ointment

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

Adults

Apply a thin layer of Positon ointment gently to the affected skin area, two or three times a day. Applying a larger amount will not improve the results. Apply the ointment with your fingers to the affected skin area. Make sure to wash your hands well with water and soap after applying the medicine to avoid introducing it into your eyes or nose accidentally, as it may cause irritation.

To use the ointment, unscrew the cap of the tube and, with the tip included at the outer end, pierce the metal mouth.

Your doctor will determine the duration of treatment. Do not use Positon ointment for a period longer than prescribed.

Use in children and adolescents

The use of this medicine in children and adolescents will only be done when, in the doctor's opinion, its use is necessary, and in this case, a thin layer will be applied once a day, not exceeding 7 days of treatment.

If used in children, the treatment must be carefully controlled by the doctor, which is particularly important if the medicine is applied to more than 5-10% of the body surface or if occlusive dressings or a very tight diaper are used.

If you use more Positon ointment than you should

If you use too much Positon ointment, or if you use it for a long period, part of the medicine may be absorbed by the body and cause unwanted effects.

Inform your doctor if you experience an unwanted effect, such as unusual fatigue, or if you experience any other change.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount used.

If you forget to use Positon ointment

Apply the medicine as soon as possible, then return to the normal dosage regimen.

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

If you interrupt treatment with Positon ointment

If used as normally prescribed, there should be no withdrawal effects when treatment with Positon ointment is interrupted.

If you have been using large amounts of Positon ointment for a long time, your doctor will indicate how to reduce this medicine so that your body can adapt.

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

4. Possible side effects

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

The frequency at which side effects may appear is classified as:

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).

Side effects of unknown frequency (cannot be estimated from available data).

Other side effects include: purpura, acne (especially in prolonged treatments).

Consult 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, inflammation, or suppuration).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can contribute to providing 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 special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration 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 notice any change in the appearance of Positon ointment.

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

6. Package contents and additional information

Composition of Positon ointment

• The active ingredients 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, baquelite, and mineral oil).

Appearance of the product and package contents

Positon ointment is presented 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 last revision of this leaflet:February 2018

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