FLUOVITEF 0.25 MG/G Krem

Treść ulotki

1. FLUOVITEF 0,25 mg/g Cream
   1. What FLUOVITEF is and what it is used for
   2. What you need to know before using FLUOVITEF
   3. How to use FLUOVITEF
   4. Possible side effects
   5. How to store FLUOVITEF
   6. Contents of the pack and other information

FLUOVITEF 0,25 mg/g Cream

Fluocinolone acetonide

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLUOVITEF is and what it is used for
• 2. What you need to know before you use FLUOVITEF
• 3. How to use FLUOVITEF
• 4. Possible side effects
• 5. How to store FLUOVITEF
• 6. Contents of the pack and other information

1. What FLUOVITEF is and what it is used for

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

• of skin allergies (acute, subacute and chronic dermatoses, of allergic and inflammatory nature, atopic dermatitis, eczematous, contact dermatitis);
• of skin inflammation and irritation (seborrheic dermatitis, itching, urticaria, simple lichen and neurodermatitis, burns, erythema, psoriasis);
• of pain and irritation from 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 skin infections or diseases caused by viruses (e.g. Herpes simplex).

Warnings and precautions
Talk to your doctor or pharmacist before using FLUOVITEF.
The use of FLUOVITEF in case of extensive skin infections and for prolonged periods, may determine
the absorption of the medicine into the entire organism. These effects are more likely to occur
in case of non-breathable dressings (occlusive bandage), in newborns the diaper can
act as an occlusive bandage.
The use of FLUOVITEF for prolonged periods of time may cause allergic skin reactions (sensitization phenomena); in this case, discontinue treatment with this medicine and consult your doctor who will
prescribe a suitable therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and FLUOVITEF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions of FLUOVITEF with other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Use this medicine if you are pregnant only in cases of actual necessity and under the direct control of
your doctor.

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

FLUOVITEF contains para-hydroxybenzoates, propylene glycol, butylated hydroxyanisole,
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 butylated hydroxyanisole 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 (tingling 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 following exactly the instructions of 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) massaging gently. Repeat
the application 2-3 times a day or as directed by your doctor.
In case of very resistant infections you can perform a non-breathable dressing (occlusive bandage)
to better absorb the medicine. Apply a thin layer of cream, massaging and leaving some on
the surface and cover with a waterproof sheet, fixing it with adhesive tape to healthy skin. If the lesion produces
fluid (exudate) perform the dressing in a less rigid manner and use absorbent material sheets.
Change the dressing every 12-24 hours washing and disinfecting the skin or if it is not possible perform
the bandage only at night. When you notice improvements continue the treatment applying the cream without
covering with the dressing.

If you use more FLUOVITEF than you should
In case of ingestion/taking an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.
The use of this medicine for prolonged periods of time, on extensive and/or damaged surfaces and in case of
non-breathable dressing (occlusive bandage), can cause a reduced activity of some glands
of the body (inhibition of the pituitary-adrenal axis) and manifestations of hypercorticism (increased
production of cortico-adrenal hormones) or in the most severe cases can cause symptoms of absorption of
the medicine into the blood (see the paragraph “Possible undesirable effects”). In such cases, discontinue treatment
and consult your doctor.

If you forget to use FLUOVITEF
Do not use a double dose of this medicine to compensate for forgetting the dose.
If you have any doubts about the use of 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 available data)

• burning sensation of the skin;
• itching and irritation;
• dryness of the skin;
• skin changes (skin atrophy);
• appearance of pimples and irritation (acneiform eruptions);
• decrease in skin color (poor pigmentation);
• skin disorders such as maceration, streaks due to sweat retention (under occlusive dressings).
• blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FLUOVITEF contains

• The active ingredient is fluocinolone acetonide. Each tube contains 7.5 mg of fluocinolone acetonide.
• The other ingredients are polyunsaturated fatty acids, liquid paraffin, acetylated lanolin, lanolin alcohols, stearic acid, glyceryl monostearate, butylated hydroxyanisole, butylated hydroxytoluene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium lauryl sulfate, Manila fragrance, purified water.

Description of the appearance of FLUOVITEF and contents of the pack
Pack containing one tube of 30 g.

Marketing Authorisation Holder
TEOFARMA S.r.l. via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l. Viale Certosa, 8/A - Pavia