Package leaflet: Information for the user

FLUOVITEF 0.25 mg/g Cream

Fluocinolone acetonide
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FLUOVITEF is and what it is used for
What you need to know before you use FLUOVITEF
How to use FLUOVITEF
Possible side effects
How to store FLUOVITEF
Contents of the pack and other information

1. What FLUOVITEF is and what it is used for

FLUOVITEF contains the active substance fluocinolone acetonide, which belongs to a group of medicines called corticosteroid derivatives that work by reducing inflammation and allergic reactions.
FLUOVITEF is indicated for local treatment (topical therapy):

of skin allergies (acute, subacute and chronic dermatoses of allergic and inflammatory nature, atopic, eczematous and contact dermatitis);
of skin inflammations and irritations (seborrheic dermatitis, pruritus, urticaria, lichen simplex and neurodermatitis, burns, erythemas, psoriasis);
of pain and irritation caused by insect bites;
of skin problems due to systemic lupus erythematosus.

2. What you need to know before using FLUOVITEF

Do not use FLUOVITEF

if you are allergic to fluocinolone or to any of the other ingredients of this medicine (listed in section 6);
if you have a skin infection (cutaneous tuberculosis);
if you have viral skin infections or skin diseases (e.g. Herpes simplex).

Warnings and precautions
Talk to your doctor or pharmacist before using FLUOVITEF.
The use of FLUOVITEF on extensive skin areas or for prolonged periods may result in absorption of the medicine into the entire body. These effects are more likely to occur when using non-breathable dressings (occlusive dressings); in newborns, diapers may act as occlusive dressings.
Prolonged use of FLUOVITEF may cause allergic skin reactions (sensitization phenomena); if this occurs, discontinue treatment with this medicine and consult your doctor, who will prescribe an appropriate therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and FLUOVITEF
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between FLUOVITEF and other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine during pregnancy only if strictly necessary and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

FLUOVITEF contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, butylhydroxyanisole, butylhydroxytoluene, lanolin, and sodium lauryl sulfate

This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains 75 mg of propylene glycol per maximum daily dose, equivalent to 0.05 mg/mg, which may cause skin irritation.
This medicine contains butylhydroxyanisole and butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
This medicine contains lanolin, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 7.5 mg of sodium lauryl sulfate per maximum daily dose, equivalent to 0.005 mg/mg.
Sodium lauryl sulfate may cause skin irritation (prickling or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

3. How to use FLUOVITEF

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before applying this medicine, it may be necessary to clean and disinfect the area to be treated.
Apply a thin layer of FLUOVITEF (or as needed), gently massaging it in. Repeat the application 2–3 times a day, or as directed by your doctor.
In cases of particularly resistant infections, you may apply an occlusive dressing (non-breathable dressing) to enhance absorption of the medicine. Apply a layer of cream, gently massaging it, leaving some on the surface, and cover with a waterproof sheet, securing it with adhesive tape to healthy skin. If the lesion is producing fluid (exudate), apply the dressing less tightly and use absorbent material sheets.
Change the dressing every 12–24 hours, washing and disinfecting the skin; if this is not possible, apply the dressing only at night. Once improvement is observed, continue treatment by applying the cream without covering it with a dressing.

If you use more FLUOVITEF than you should
If you accidentally ingest or otherwise take too much of this medicine, inform your doctor immediately or go to the nearest hospital.
Prolonged use of this medicine, application over large and/or damaged skin areas, and use under occlusive dressings (non-breathable dressings) may lead to reduced activity of certain glands in the body (inhibition of the hypothalamic-pituitary-adrenal axis) and signs of hypercorticism (increased production of corticoadrenal hormones), or in more severe cases, symptoms due to systemic absorption of the medicine into the bloodstream (see section “Possible side effects”). In such cases, stop treatment and consult your doctor.

If you forget to use FLUOVITEF
Do not use a double dose of this medicine to make up for a missed dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

sensation of skin burning;
itching and irritation;
dryness of the skin;
skin changes (cutaneous atrophy);
appearance of pimples and irritation (acneiform eruptions);
loss of skin colour (hypopigmentation);
skin disorders such as maceration, streaks due to sweat retention (in occlusive bandaging);
blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLUOVITEF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLUOVITEF contains

The active substance is fluocinolone acetonide. Each tube contains 7.5 mg of fluocinolone acetonide.
The other components are polyunsaturated fatty acids, liquid paraffin, acetylated lanolin, lanolin alcohols, stearic acid, glyceryl monostearate, butylhydroxyanisole, butylhydroxytoluene, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, propylene glycol, sodium lauryl sulfate, Manila fragrance, purified water.

Description of the appearance of FLUOVITEF and package contents
Packaging containing one 30 g tube.
Marketing Authorization Holder
TEOFARMA S.r.l., via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l., Viale Certosa, 8/A - Pavia