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

Introduction

Package Leaflet: Information for the User

Positon 2.5 mg/g + 1 mg/g + 100,000 IU/g Cream

Neomycin / Triamcinolone / Nystatin

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 Package Leaflet

1. What is Positon cream and what is it used for
2. What you need to know before you start using Positon cream
3. How to use Positon cream
4. Possible side effects
5. Storage of Positon cream
6. Contents of the pack and further information

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

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

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

Positon cream 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 that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

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

Positon cream is used for the treatment of dermatological conditions sensitive to corticosteroids where there is or may be 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 you start using Positon cream

Do not use Positon cream

• If you are allergic to Neomycin, Triamcinolone, or Nystatin or 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 conditions due to vaccination (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 cream.

• 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 cream 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 parts of the skin (such as flexural areas between arms and legs). Do not use Positon cream 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 cream in children have not been established.

The use of this medicine in children and adolescents will only be done when, in the doctor's judgment, its use is demonstrated to be necessary.

Treatment in children should be carefully controlled by the doctor, especially if applied to large areas of skin or if an occlusive dressing or a 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 under medical supervision due to the risk of adrenal insufficiency.

Using Positon cream with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. Also, consider any medicines 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The use of Positon cream should be avoided during pregnancy. If you become pregnant while using this medicine, consult your doctor immediately.

Breastfeeding

The use of Positon cream is not recommended during breastfeeding unless strictly necessary.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Important information about some of the ingredients of Positon cream

Positon cream may cause local skin reactions (such as contact dermatitis) or skin irritation because it contains cetyl stearyl alcohol, propylene glycol, and sorbic acid (E 200).

It may also cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

3. How to use Positon cream

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

Adults

Apply a thin layer of Positon cream gently to the affected skin area, two or three times a day. Applying a larger amount will not improve the results. Apply the cream 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 accidental introduction into your eyes or nose, which may cause irritation.

To use the cream, 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 cream 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 judgment, its use is demonstrated to be 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 tight diaper are used.

If you use more Positon cream than you should

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

Tell your doctor if you experience an unwanted effect such as unusual tiredness or if you notice 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 cream

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 stop using Positon cream

If used as normally prescribed, there should be no withdrawal effects when stopping treatment with Positon cream.

If you have been using large amounts of Positon cream 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 everybody gets them.

The frequency at which side effects may occur 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 the available data).

Other side effects include: purpura, acne (especially with 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Positon cream

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 expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use Positon cream if you notice any visible signs of deterioration. Inform your doctor or pharmacist if you notice any change in the appearance of Positon cream.

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

6. Contents of the pack and further information

Composition of Positon cream

• The active ingredients are: neomycin sulfate, triamcinolone acetonide, and nystatin. Each gram of cream contains 2.5 mg of neomycin sulfate, 1 mg of triamcinolone acetonide, and 100,000 IU of nystatin.
• The other ingredients are: polyoxyethylene stearyl ether 40, glyceryl monostearate, white petrolatum, cetyl stearyl alcohol, aluminum hydroxide, titanium dioxide (E 171), sorbitol solution, propylene glycol, ethylenediamine dichloride, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sorbic acid (E 200), dimethicone, sodium hydroxide, and water.

Appearance of the product and pack contents

Positon cream is presented in aluminum tubes containing 30 g or 60 g of cream.

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.gob.es./