Patient information leaflet

Localyn 0.25 mg/g + 3250 IU/g cream

fluocinolone acetonide + neomycin sulfate
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 others, even if their symptoms are the same as yours, as it could 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 Localyn is and what it is used for
What you need to know before using Localyn
How to use Localyn
Possible side effects
How to store Localyn
Contents of the pack and other information

1. What Localyn is and what it is used for

Localyn contains two active substances: fluocinolone acetonide and neomycin sulfate.
Fluocinolone acetonide belongs to a group of medicines called "corticosteroids" and acts against inflammation (anti-inflammatory), allergies (antiallergic), and itching (antipruritic); it is intended specifically for local use.
Neomycin sulfate belongs to a group of medicines called "antibiotics" and fights infections caused by various microorganisms known as bacteria (broad-spectrum antibacterial).

Localyn is used for local treatment of the following conditions when there is a risk of, or an existing, local infectious complication:

inflammatory or allergic skin diseases, such as dermatitis:
- atopic (characterized by itching, redness, scaling, and skin elevations)
- eczematous (characterized by vesicles, blisters, crusts, and itching)
- seborrheic (characterized by yellowish, greasy scales, redness, small crusts, and sometimes itching)
- exfoliative (characterized by itching, red skin with erythema and scaling)
- contact (characterized by redness, scaling, small vesicles, blisters, small superficial wounds, and crusts that appear upon contact with certain substances)
- drug-induced (characterized by skin eruptions appearing after taking medications)
- stasis-related (characterized by darker areas, red spots, thin skin, sometimes thickened, with presence of itching and pain)
- actinic origin (affecting skin areas exposed to UV radiation from sunlight or artificial lamps)
skin conditions characterized by itching or scaling (neurodermatitis and lichen simplex)
anal pruritus and consequences of surgical interventions near the anus (perianal surgery)
a skin condition caused by constant friction between two adjacent body surfaces (intertrigo)
a condition characterized by the appearance on the skin of wheals, raised areas of varying size, red or pale, usually very itchy (urticaria)
burns
insect bites
small blisters on hands and feet (dyshidrosis)
cutaneous lesions sometimes accompanied by blisters (polymorphic erythema)
an inflammatory disease affecting the lips (cheilitis)
a condition characterized by skin patches (pityriasis rosea)
a skin disease characterized by plaques, thickening, silvery-white scaling, and sometimes itching (chronic stabilized psoriasis, etc.)
a disease characterized by skin lesions and inflammation (lupus erythematosus).

2. What you need to know before using Localyn

Do not use Localyn

if you are allergic to fluocinolone acetonide, neomycin sulfate, or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to medicines of the same class as fluocinolone acetonide and neomycin sulfate
if you have a skin disease characterized by red-brown lesions and plaques (cutaneous tuberculosis), infections caused by the Herpes simplex virus, or other viral diseases affecting the skin (such as smallpox, chickenpox, etc.).

Warnings and precautions
Talk to your doctor or pharmacist before using Localyn.
Prolonged use of Localyn may cause allergic reactions and irritation. In such cases, contact your doctor, who will stop treatment and prescribe appropriate therapy.
Use of Localyn may lead to systemic absorption (throughout the body), which increases with longer treatment duration, larger skin surface areas treated, and use of occlusive dressings (plastic bandages applied to keep the medicine on the lesion).
This medicine must not be applied under an occlusive dressing. In infants, diapers may act as an occlusive dressing.
Even with topical corticosteroids such as Localyn, especially in children and adolescents, adverse effects described for systemic corticosteroids may occur, including reduced and/or insufficient adrenal function (adrenal insufficiency).
Contact your doctor if:

you develop excessive dryness or increased irritation of the skin. In this case, your doctor may advise you to stop using Localyn
you have an infection caused by microorganisms or fungi (fungal infection). In this case, your doctor may add specific treatment alongside Localyn. If you do not achieve rapid improvement, your doctor may advise you to stop using Localyn until the infection resolves
you develop a systemic infection or an infection caused by microorganisms not sensitive to the treatment. In this case, your doctor will recommend appropriate therapy
you experience blurred vision or other visual disturbances.

Localyn must not be used in the eyes (ophthalmic use).
Avoid contact with the eyes and internal body surfaces (mucous membranes).
Children and adolescents
In very early infancy, Localyn should be used only when strictly necessary and under direct medical supervision.
Children and adolescents may be more sensitive than adults to the effects of corticosteroids.
Topical corticosteroids may reduce the activity of certain glands in the body (hypothalamus, pituitary, adrenal glands), interfere with growth and development, increase intracranial pressure (intracranial hypertension), or cause a condition characterized by excessive production of a hormone called cortisol (Cushing's syndrome). Therefore, your doctor will carefully monitor for any potential effects of the medicine.
Other medicines and Localyn
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known for Localyn.
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.
Pregnancy
During pregnancy, your doctor will prescribe Localyn only when strictly necessary and under direct medical supervision.
Breastfeeding
If you are breastfeeding, your doctor will assess whether to discontinue breastfeeding or treatment with Localyn.
During breastfeeding, your doctor will prescribe Localyn only when strictly necessary and under direct medical supervision.
Driving and using machines
Localyn does not affect the ability to drive or operate machinery.
Localyn contains

methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions)
propylene glycol, in an amount of 150 mg per gram of cream. It may cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without first consulting your doctor or pharmacist
stearyl alcohol and cetyl alcohol, which may cause localized skin reactions (e.g., contact dermatitis).

3. How to use Localyn

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is an amount of cream sufficient to cover the affected area, applied
2 or 3 times daily, with gentle massage.
If you use more Localyn than you should
Excessive or prolonged use of corticosteroids for topical use, medicines belonging to the same
family as Localyn, may cause reduced activity of certain glands in the body (pituitary and
adrenal glands, causing secondary adrenal insufficiency) and manifestations of hypercorticism (increased production of corticoadrenal hormones), including:

a disease characterized by excessive production of a hormone called cortisol (Cushing's syndrome)
reduced muscle strength (asthenia)
weakness (adynamia)
high blood pressure (arterial hypertension)
disturbances in heart rhythm (cardiac rhythm disorders)
reduced potassium levels in the blood (hypokalaemia)
increased acid levels in the blood (metabolic acidosis).

If Localyn is accidentally ingested in excessive amounts, inform your doctor immediately or
go to the nearest hospital.
If you forget to use Localyn
Do not use a double dose to make up for the missed dose.
If you stop treatment with Localyn
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The following may occur, especially with intensive and prolonged use:

burning sensation
itching
skin irritation and dryness
reduction in skin thickness (cutaneous atrophy)
acne
decreased skin pigmentation (hypopigmentation)
thinning (atrophy) and appearance of striae at sites treated for a prolonged period of time.

Blurred vision may occur, frequency unknown.
Systemic side effects (affecting the whole body) are very rare, as the active substances are present in very low doses in the medicine.
However, for neomycin—one of the two active substances in Localyn—there is a potential risk of ear and kidney toxicity (oto- and nephrotoxicity).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Localyn

Do not store above 25°C.
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 "Expiry".
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. Pack contents and other information

What Localyn contains

The active substances are fluocinolone acetonide and neomycin sulfate. 1 g of cream contains 0.25 mg of fluocinolone acetonide and 3250 I.U. of neomycin sulfate.
The other components are citric acid, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, propylene glycol, stearyl alcohol, cetyl alcohol, vaseline oil, sorbitan monostearate, polysorbate 60, purified water.

Description of the appearance of Localyn and pack contents
Localyn is presented as a cream.
The pack contains one 30 g tube.
Marketing Authorization Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan, Italy.