Package leaflet: Information for the patient

Topsyn cream

Topsyn topical solution
Topsyn gel
Fluocinonide
Please read this leaflet carefully before 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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Topsyn is and what it is used for

Topsyn is a medicine containing the active substance fluocinonide, a corticosteroid (i.e. a substance with structure and activity similar to those produced by the adrenal glands) for topical use, possessing potent anti-inflammatory action. Topsyn is indicated for all skin diseases responsive to corticosteroid treatment, such as psoriasis, eczematous dermatitis, contact eczema, seborrheic eczema, dyshidrosis, pruritus, neurodermatitis, atopic dermatitis, toxic-allergic dermatitis, stasis dermatitis, lucite, lichenoid dermatitis.

2. What you need to know before using Topsyn

Do not use Topsyn:
If you are allergic to fluocinonide or to any of the other ingredients of this medicine
(listed in section 6).
If you have tuberculous lesions, luetic (syphilitic) infections, fungal or viral infections.

Warnings and precautions
The use, especially if prolonged, of topical (local) products may lead to sensitization phenomena (an immune system reaction similar to allergy) and adverse effects.
If this occurs, discontinue treatment and consult your doctor.
Applying high doses of a corticosteroid medicine such as Topsyn to the skin, especially for prolonged periods and/or under occlusive dressing, may result in significant absorption of the substance, potentially causing systemic effects throughout the body.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
The use of Topsyn in early infancy should only be considered by a doctor and reserved for cases of absolute necessity.

Important information about excipients
Topsyn contains propylene glycol (18.73 g in 30 g of cream; 16.5 g in 30 ml of cutaneous solution; 28.48 g in 30 g of gel). Propylene glycol may cause skin irritation. Do not use on open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
Topsyn cream contains stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).
Topsyn cutaneous solution contains ethanol (300 mg in 1 ml of cutaneous solution), which may cause a burning sensation on damaged skin. In newborns, high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

Topsyn must not be applied to the eyes or on the conjunctiva.

Other medicines and Topsyn
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines. No interactions between Topsyn and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, the use of Topsyn should only be considered by a doctor and reserved for cases of absolute necessity, as the risk of harmful effects on the fetus and/or newborn following administration of fluocinonide cannot be excluded.

Driving and using machines
Topsyn does not affect the ability to drive vehicles or operate machinery.

3. How to use Topsyn

TOPSYN Cream should be applied in small amounts as a thin layer, gently massaged until completely absorbed. Applications should be performed 1 or 2 times daily; only in special cases will it be necessary to increase to 3 daily applications. The cream's formulation allows its use both in dry conditions (such as psoriasis) and in moist forms (such as weeping eczema). Indeed, the special hydro-miscible glycolipidic vehicle, endowed with marked emollient properties (which prevent skin irritation by softening the skin and making it elastic), mixes with exudates (fluids leaking from blood vessels during inflammation), exerting a drying effect upon them. In dry, crusted, lichenified (thickened and dehydrated) forms, occlusive dressing technique—i.e., covering the application area with a bandage—may optionally be preferred.

In exudative forms (with fluid discharge) or when, for particular localizations, a transparent vehicle is preferred, TOPSYN Gel may be more suitable. For scalp seborrhea (excess oil), dandruff, and dermatitis affecting hairy areas or intertriginous areas (red, moist skin in skin folds such as armpits, groin, under the breasts, etc.), application of TOPSYN Cutaneous Solution is indicated 1–2 times daily (exceptionally up to 3 times daily).

If you use more Topsyn than you should:
In case of accidental ingestion/overdose of this medicinal product, consult your physician or go immediately to the nearest hospital.

If you forget to use Topsyn:
Do not apply a double dose to make up for the missed dose.

If you stop using Topsyn:
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.
Following the instructions contained in this leaflet reduces the risk of side effects.
During topical corticosteroid treatment, especially with intensive and prolonged therapy, some of the following side effects may occur: burning sensations, itching, irritation, dry skin, cutaneous atrophy (thinning of the skin), acneiform eruptions (acne-like rash), hypopigmentation (reduced skin pigmentation); atrophy (reduction in volume of body tissues or organs) and striae at the sites treated for a long time with occlusive dressing.
Blurred vision may occur with uncommon frequency (possibly affecting up to 1 in 100 people).

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 the following website:
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 Topsyn

Keep this medicine out of the sight and reach of children.
Topsyn does not require any special storage conditions. 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.
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 Topsyn contains
Cream – 100 g of cream contain:
Active substance: Fluocinonide 0.05 g
Other components: citric acid, stearyl alcohol, polyethylene glycol 6000, 1,2,6-hexanetriol, propylene glycol.
Topical solution – 100 ml of lotion contain:
Active substance: Fluocinonide 0.05 g
Other components: citric acid, isopropyl adipate, alcohol, propylene glycol.
Gel – 100 g of gel contain:
Active substance: Fluocinonide 0.05 g
Other components: propyl gallate, edetate disodium, carboxypolymethylene, purified water, propylene glycol.

Description of the appearance of Topsyn and package contents
TOPSYN Cream: 30 g tube of ointment
TOPSYN Topical Solution: 30 ml bottle of lotion
TOPSYN Gel: 30 g tube of gel

Marketing Authorization Holder and Manufacturer
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
27100 Pavia