Package leaflet: Information for the user

LAUROMICINA

16.67 mg/g + 0.25 mg/g Ointment
Fluocinolone acetonide - Erythromycin stearate
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What LAUROMICINA is and what it is used for

LAUROMICINA contains the active substances erythromycin and fluocinolone.
Erythromycin is an antibiotic belonging to the macrolide class.
Fluocinolone is a corticosteroid, used particularly in dermatology to reduce an inflammatory process.
LAUROMICINA is used for:
acute, subacute and chronic dermatitis of inflammatory nature, when there is an existing local infection or a tendency for one to develop.

2. What you should know before taking LAUROMICINA

Do not take LAUROMICINA

if you are allergic to erythromycin or fluocinolone, or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from local viral or tubercular diseases.

Warnings and precautions
Talk to your doctor or pharmacist before taking LAUROMICINA.
The use, especially if prolonged, of topical products may lead to sensitization phenomena; such use, particularly at high doses, should be avoided in infectious processes due to extensive burns, atrophic ulcers, and in other conditions that may favor the absorption of the corticosteroid and antibiotic.
Contact your doctor if you experience blurred vision or other visual disturbances.
This product is not for ophthalmic use.
Avoid contact with eyes and mucous membranes.

Other medicines and LAUROMICINA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
No cases of interactions between LAUROMICINA and other drugs are known.

Pregnancy, breast-feeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is not known whether LAUROMICINA has a significant effect on your ability to drive or operate machinery.

LAUROMICINA contains methyl hydroxybenzoate and propyl hydroxybenzoate
This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate. It may cause allergic reactions (including delayed reactions).

3. How to take LAUROMICINA

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage and administration schedule
Apply locally to the affected area with gentle massage; repeat the treatment 2–3 times
daily, as directed by the physician.
If using the occlusive bandage technique, since this may enhance absorption of the
components with possible onset of systemic effects, it is advisable, in cases of
extensive lesions, to treat one area at a time.
Keep in mind that plastic films are flammable and may cause individual
sensitization reactions, requiring replacement of the material used.
If you use more LAUROMICINA than you should
If you accidentally use too much ointment, contact your doctor or the nearest Emergency
Department immediately.
If you forget to use LAUROMICINA
Do not take a double dose to make up for the missed dose. Inform your doctor, who
will advise you on how to continue the treatment.
If you stop treatment with LAUROMICINA
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Do not stop or modify your treatment without consulting your doctor, even if
symptoms improve.

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.
Consult your doctor if you experience any side effects, even if they are not listed in this leaflet.

Systemic side effects are extremely unlikely due to the low dosages used; however, their occurrence may be favored by occlusive therapy or when large skin areas are treated with high doses or for prolonged periods.

Based on the available data, it is not possible to determine the frequency of the following adverse reactions:

burning sensation, irritation;
dry skin;
nausea;
skin disorders and rashes;
hypertrichosis;
hypopigmentation;
folliculitis;
blurred vision.

Contact your doctor immediately if you experience a severe skin reaction: red, scaly rash with formation of pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated from the available data).

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 LAUROMICINA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 LAUROMICINA contains
100 g of ointment contain:

Active substances: erythromycin stearate 1.667 g, equivalent to erythromycin 1 g; fluocinolone acetonide 0.025 g;
Other components: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, Deymuls, Eumulgin, Cetiol V.

Description of the appearance of LAUROMICINA and pack contents
Carton box containing a 30 g ointment tube.
Marketing Authorization Holder and Manufacturer
Morgan srl
Via Canestrello n° 2/B
36050 Monteviale (VI)
Manufacturer
LACHIFARMA S.r.l. Laboratorio Chimico Farmaceutico Salentino
S.S. 16 - Zona Industriale 73010 Zollino (Lecce)