Label: information for the user

Position 2.5 mg/g + 1 mg/g + 100,000 IU/g cream

Neomycin / Triamcinolone / Nystatin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What it isPosition creamand its use

2. What you need to know before starting to usePosition cream

3. How to usePosition cream

4. Possible adverse effects

5. Storage ofPosition cream

6. Contents of the package and additional information

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

Positon cream belongs to the group of medications called topical corticosteroids. The word “topical” means it is applied on 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.

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

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

No use Position cream

• If you are allergic to Neomycin, Triamcinolone, Nystatin, or any of the other components of this medication (listed in section 6).
• If you have rosacea (a skin condition characterized by facial redness), inflammation around the mouth (perioral dermatitis), acne, genital or perianal pruritus, skin inflammatory processes due to vaccine administration (cutaneous vaccine reactions), or skin atrophic diseases.
• If you have skin infections caused by tuberculosis or produced by viruses, such as herpes simplex or varicella.
• Do not use in dermatoses in children under 1 year, as there is a higher risk of increased absorption.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Position cream.

• Use this medication only on your skin.
• Do not let it come into contact with your eyes, mucous membranes, and open wounds, as it may cause irritation.
• Avoid covering the treated area with bandages, diapers, or dressings.
• Do not use Position cream on extensive areas of skin, unless your doctor has instructed you to do so.
• Do not use it on your face, or in areas of skin friction such as the groin, or other skin areas (such as the areas of flexion between arms and legs). Do not use Position cream on ulcers, wounds, or striae.
• If irritation or severe dryness occurs, consult your doctor.
• Its use is not recommended in pustular psoriasis or gout (guttata).
• Consult your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

The safety and efficacy of Position cream in children have not been established.

The use of this medication in children and adolescents will only be made when, in the doctor's opinion, it is necessary to use it.

Treatment in children should be carefully controlled by the doctor, especially if it is applied to extensive areas of skin or if a occlusive dressing or a tight diaper is used.

It should be avoided as much as possible the administration of a prolonged and prolonged topical treatment, especially in children, as it may cause suppression of the hypothalamic-pituitary-adrenal axis with the appearance or not of a Cushing's syndrome. If this situation occurs, consult your doctor as the medication should be withdrawn gradually and under medical supervision, due to the risk of adrenal insufficiency.

Use of Position cream with other medications

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Use of Position cream should be avoided during pregnancy. If you become pregnant while taking this medication, consult your doctor immediately.

Breastfeeding

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

Driving and operating machinery

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

Important information about some of the components of Position cream

Position cream may cause local skin reactions (such as contact dermatitis) or skin irritation because it contains cetearyl 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).

Follow exactly the administration instructions of this medication 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 over the affected skin area. Make sure to wash your hands thoroughly with water and soap after applying the medication to avoid accidentally introducing it into your eyes or nose, which may cause irritation.

To use the cream, twist off the cap from the tube and, with the point included at the external end, pierce the metal mouth.

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

Use in children and adolescents

The use of this medication in children and adolescents will only be made when, in the doctor's opinion, it is demonstrated to be necessary, and in this case, a thin layer will be applied once a day, not exceeding a treatment period of 7 days.

If used in children, the treatment must be carefully controlled by the doctor, which is particularly important if the medication is applied to more than 5 to 10% of the body surface or if occlusive dressings or a very 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 of time, part of the medication may be absorbed by the body and cause unwanted effects.

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

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

If you forgot to use Positon cream

Apply the medication as soon as possible, then return to the normal dosing regimen.

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Positon cream

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

If you have been using large amounts of Positon cream for a long period of time, your doctor will instruct you on how to taper off this medication so that your body can adapt.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 available data).

Other side effects include: purpura, acne (especially with prolonged treatment).

Seek medical attention immediately if you experience any of the following symptoms: appearance of a rash or eruption on the skin, difficulty breathing or swallowing, wheezing, or skin infection (redness, inflammation, or pus).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Positon cream

• The active principles 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 components are: polyoxyl 40 stearate, glyceryl monostearate, white petrolatum, cetearyl alcohol, aluminum hydroxide, titanium dioxide (E 171), sorbitol solution, propylene glycol, ethylenediamine dihydrochloride, methylparaben (E 218), propylparaben (E 216), sorbic acid (E 200), dimethicone, sodium hydroxide, and water.

Appearance of the product and content of the packaging

Positon cream is presented in aluminum tubes containing30 gor60 gof cream.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.

Rua Elías García 28

2700-327 Amadora

Portugal

Last review date of this leaflet:February 2018

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es./