LORENIL 2% Gel

Зміст інструкції

1. LORENIL 2% cream
   1. What LORENIL is and what it is used for
   2. What you need to know before using LORENIL
   3. How to use LORENIL
   4. Possible side effects
   5. How to store LORENIL
   6. Package contents and other information
2. LORENIL 2% gel, 2% lozione
3. LORENIL 2% Shampoo
4. LORENIL 200 mg soft vaginal capsules, 600 mg soft vaginal capsules
5. LORENIL 1 g soft vaginal capsules
6. LORENIL 2% Vaginal cream, 0.2% Vaginal solution

LORENIL 2% cream

fenticonazole nitrate

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What LORENIL is and what it is used for

LORENIL contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called “antifungals” for dermatological use and acts
against infections caused by fungi.
LORENIL is used locally (topical use) for the treatment of the following conditions:

• skin infections caused by fungi called dermatophytes (dermatophytoses from Trichophyton,Microsporum, Epidermophyton) located in different parts of the body: tinea capitis (scalp ringworm), tinea corporis (body ringworm), tinea cruris (groin ringworm), tinea pedis (foot ringworm, also known as athlete's foot), tinea manuum (hand ringworm), tinea faciei (facial ringworm), tinea barbae (beard ringworm affecting hair follicles), tinea unguium (nail ringworm)
• skin infections caused by fungi of the genus Candida (candidiasis such as intertrigo, angular cheilitis, facial candidiasis, diaper rash, perineal and scrotal candidiasis)
• infections located in some parts of the male genitals (balanitis, balanoposthitis)
• infections located in the nails (onychomycosis and paronychia)
• infection caused by fungi called “pityriasis versicolor” (from Pityrosporum orbiculareand P. ovale)
• ear infections caused by fungi (otomycosis from Candida or molds), only if there are no lesions of a part of the ear called the eardrum
• skin infection called “erythrasma”
• infections caused by fungi (mycoses) that also present with bacterial superinfections (from Gram-positive bacteria).

See your doctor if you do not feel better or if you feel worse after a short period of time.

2. What you need to know before using LORENIL

Do not use LORENIL

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Consult your doctor or pharmacist before using LORENIL.
The use, especially if prolonged, of medicines for local use (topical use) can cause allergic
reactions (sensitization phenomena).
In this case, discontinue treatment and consult your doctor who will advise you on appropriate
therapy.
Consult your doctor if you do not observe appreciable results after a short period of treatment.
After applying LORENIL to the lesion, you may experience a mild burning sensation that
disappears quickly.

Other medicines and LORENIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines are known for LORENIL.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
It is advisable not to use LORENIL during pregnancy and breastfeeding, even though the
absorption of fenticonazole through the skin is rather poor.

Driving and operating machinery
LORENIL does not impair the ability to drive vehicles or operate machinery.
Lorenil 2% cream contains cetyl alcohol and hydrogenated lanolin which can cause local
skin reactions (e.g. contact dermatitis).
Lorenil 2% cream contains 750 mg of propylene glycol per 15g tube of LORENIL cream
equivalent to 50 mg/g of LORENIL cream. Propylene glycol can cause skin irritation.
Do not use this medicine in children under 4 weeks of age with open wounds or large
areas of damaged skin (such as burns) without talking to your doctor or pharmacist.

3. How to use LORENIL

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply LORENIL 1-2 times a day, as directed by your doctor, after washing and drying the affected area, using the formulation suitable for the location of the lesion.
LORENIL does not grease, does not stain and is easily removed with water.

• LORENIL cream:is indicated for the treatment of hairless skin areas (glabrous skin), skin folds and mucous membranes. Apply by rubbing gently.

LORENIL cream is preferably used for infections caused by dry fungi:

• infection called “pityriasis versicolor”
• skin infection called “erythrasma”
• nail infection (onychomycosis). In these infections, apply the cream with an occlusive bandage
• infections located in the male genitals.

If you use more LORENIL than you should
In case of ingestion/accidental intake of an excessive dose of LORENIL, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to use LORENIL
Do not use a double dose to make up for a missed dose.

If you stop using LORENIL
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.
When used as recommended, LORENIL is only poorly absorbed and no systemic effects are expected
(effects that can affect the whole body). Prolonged use of medicines for local use (topical use) may
cause sensitization phenomena (see paragraph “Warnings and precautions”).
The following side effects have been observed with LORENIL:

Very rare (may affect up to 1 in 10,000 people)

• redness of the skin (erythema)
• itching
• skin rash
• rash and redness of the skin (erythematous rash)
• skin irritation
• burning sensation of the skin.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 LORENIL

This medicine does not require any particular storage conditions.
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 pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 LORENIL contains
LORENIL 2% cream

• The active ingredient is fenticonazole nitrate. 100 g of cream contains 2 g of fenticonazole nitrate.
• The other ingredients are propylene glycol, hydrogenated lanolin, refined almond oil, polyglycol esters of fatty acids, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.

Description of the appearance of LORENIL and package contents
LORENIL is available in the following form:

• 2% cream. The package contains a tube of 15 g.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
EFFIK Italia SpA – Via dei Lavoratori, 54 – 20092 Cinisello Balsamo (MI).

Manufacturer
Laboratoires Effik - Parc Tertiaire de Meudon, Immeuble Le Newton, 9/11 rue Jeanne Braconnier,
F-92 366 MEUDON LA FORET CEDEX, France.

LORENIL 2% gel, 2% lozione

LORENIL 1% e 2% cutaneous powder
LORENIL 2% cutaneous spray, solution
Fenticonazole nitrate

Pharmacotherapeutic category
Topical antifungal

Therapeutic indications

• Dermatophytoses (Trichophyton, Microsporum, Epidermophyton) with different locations: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
• Skin candidiasis (intertrigo, angular cheilitis, facial candidiasis, candidiasis "of the diaper area", perineal and scrotal); balanitis, balanoposthitis, onychia and paronychia.
• Pityriasis versicolor (due to Pityrosporum orbiculare and P. ovale).
• Otomycosis (due to Candida or molds); only if there are no lesions of the tympanic membrane.
• Erythrasma.
• Fungal infections with bacterial superinfections (due to Gram-positive bacteria).

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Precautions for use
Although percutaneous absorption of fenticonazole is rather poor, it is advisable not to use
the preparation during pregnancy and breastfeeding.

Interactions
Not known.
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.

Special warnings
Although the absorption of the medicine is poor, the use of Lorenil during pregnancy and
breastfeeding is not recommended except in special cases and after careful evaluation of
the benefit/risk ratio by the doctor.
The use, especially if prolonged, of topical products can lead to sensitization phenomena.
A mild burning sensation may be experienced upon application to the lesion
which disappears quickly.

Dosage, method and duration of administration
Lorenil should be applied 1-2 times a day, as directed by your doctor, after washing and
drying the affected area, using the formulation suitable for the location of the lesion.

Gel- has a drying action and is more suitable for intertrigo, athlete's foot, inguinal epidermophytosis
and in general for moist lesions.

Lotion and Cutaneous spray, solution- are indicated for locations on the scalp and for
skin areas covered with hair. The cutaneous spray is also easy and convenient to use for
extensive fungal infections and for hard-to-reach areas.

Cutaneous powder 1% and 2%- is used for athlete's foot and in general for intertriginous areas and
for moist lesions, both as a single treatment and as a complement to the cream. In foot infections
it is advisable to sprinkle Lorenil powder also inside socks and shoes.
In athlete's foot and onychomycosis, in order to avoid reinfections, it is advisable to continue
the above treatment for another one or two weeks after the disappearance of
the manifestations.
Treatments with Lorenil should be carried out regularly until the complete disappearance of the lesions.
Lorenil does not grease, does not stain and is easily removable with water.

Undesirable effects
Mild and transient erythematous reactions have been reported.
A mild burning sensation may be experienced upon application to the lesion
which normally disappears quickly.
In the event of persistent irritations or development of resistant microorganisms, discontinue treatment and consult your doctor.
Lorenil is only poorly absorbed, so systemic effects can be ruled out under the recommended conditions of use.
It is important to inform your doctor or pharmacist of the occurrence of any adverse effect.

Shelf life and storage
Shelf life: see the expiry date reported on the packaging.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Caution: do not use the medicine after the expiry date indicated on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Keep the medicine out of the reach and sight of children.

Composition
Lorenil 2% gel
100 g of gel contains: fenticonazole nitrate 2g - Excipients: carbomer; purified water; propylene
glycol.

Lorenil 2% lozione
100 g of lotion contains: fenticonazole nitrate 2g - Excipients: ethyl alcohol; hydroxypropylcellulose; purified water; propylene glycol.

Lorenil 1% cutaneous powder
100 g of powder contains: fenticonazole nitrate 1g - Excipients: precipitated silica; zinc oxide
talc.

Lorenil 2% cutaneous powder
100 g of powder contains: fenticonazole nitrate 2g - Excipients: precipitated silica; zinc
oxide; talc.

Lorenil 2% cutaneous spray, solution
100 g of solution contains: fenticonazole nitrate 2g - Excipients: ethyl alcohol; propylene glycol;
purified water.

Pharmaceutical form and content
Gel - tube containing 30 g.
Cutaneous spray, solution - bottle containing 30 ml.
Lotion – bottle containing 30 ml.
Cutaneous powder 1% and 2% - jar containing 50 g.

Holder of the marketing authorisation
Effik Italia S.p.A. - Via Lincoln 7/A – 20092 Cinisello Balsamo (MI). Manufacturer
2% GelRecordati Spa _Milan.

2% Cutaneous SprayRecordati Spa _Milan.

2% LotionRecordati Spa _Milan.

1% Cutaneous PowderRecordati Spa _Milan.

2% Cutaneous PowderRecordati Spa _Milan and Zeta Farmaceutici SpA Sandrigo (VI).

PACKAGE LEAFLET

LORENIL 2% Shampoo

fenticonazolo nitrato

Pharmacotherapeutic category
Topical antifungal.

Therapeutic indications
Treatment of scalp infections involving the yeast Pityrosporum such as seborrheic dermatitis and Pityriasis capitis.

Contraindications
Hypersensitivity to the active ingredient or to any of the excipients.

Precautions for use
After prolonged topical treatment with corticosteroids, it is advisable to wait about fifteen days before applying Lorenil Shampoo.

Special warnings
Although the absorption of the medicine is poor, the use of Lorenil during pregnancy and breastfeeding is not recommended except in particular cases and after careful evaluation of the benefit/risk ratio by the doctor.
The use, especially if prolonged, of topical products can cause sensitization phenomena.
Avoid contact with eyes.
If the product comes into contact with the eyes, rinse thoroughly with water.

Method of administration, route and frequency of administration
Wash the affected areas with Lorenil Shampoo; leave on for about 3-4 minutes, then rinse thoroughly.
Treatment should be carried out 2 times a week for 2-4 weeks.

Undesirable effects
Lorenil is generally well tolerated, both on the skin and mucous membranes; only exceptionally have mild and transient erythematous reactions or a burning sensation been reported, which normally disappear quickly.
In case of persistent irritative phenomena or hypersensitivity reactions, discontinue treatment.
Lorenil Shampoo, in the recommended conditions of use, is only poorly absorbed, so systemic adverse reactions can be ruled out; however, its use is generally contraindicated in pregnancy and during breastfeeding.
REPORT ANY ADVERSE EFFECTS TO YOUR DOCTOR OR PHARMACIST

Shelf life and storage
Expiry date: see the expiry date printed on the packaging.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Caution: do not use the medicine after the expiry date printed on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Composition
100 g of solution contains: fenticonazolo nitrato 2g.
Excipients: propylene glycol, sodium lauryl ether sulfate solution, cocamidopropyl betaine solution, purified water.

Pharmaceutical form and content
Shampoo.
Bottle of 100 g.

Marketing Authorisation Holder
Effik Italia S.p.A. - Via Lincoln 7/A – 20092 Cinisello Balsamo (MI)

Manufacturer
Recordati S.p.A., Officina di Pomezia (RO
May 2011

LORENIL 200 mg soft vaginal capsules, 600 mg soft vaginal capsules

fenticonazole nitrate

PHARMACOTHERAPEUTIC CATEGORY
Antimycotic (antifungal).

THERAPEUTIC INDICATIONS
Candidiasis (fungal infection caused by Candida species) of the genital mucous membranes (vulvovaginitis, colpitis,
infectious fluor).

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
None.

INTERACTIONS
Not known.
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available over the counter.

SPECIAL WARNINGS
Although the absorption of the medicine is poor, the use of Lorenil during pregnancy and
breastfeeding is not recommended except in special cases and after careful evaluation of the
benefit/risk ratio by the doctor.
The use, especially if prolonged, of topical products can cause sensitization reactions.
A mild burning sensation may be experienced upon vaginal insertion, which disappears quickly.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Soft vaginal capsules
1 soft capsule of 200 mg in the evening before bedtime for 3 days, or as directed by the
doctor.
1 soft capsule of 600 mg in the evening in a single administration. If symptoms persist, a second administration may be repeated after 3 days.
The soft capsules should be inserted deeply into the vagina.

UNDESIRABLE EFFECTS
Lorenil is generally well tolerated, both on the skin and mucous membranes; only rarely have
mild and temporary redness of the skin been reported.
A mild burning sensation may be experienced upon vaginal insertion, which usually disappears quickly.
If persistent irritant phenomena occur or if resistant microorganisms develop, stop treatment and consult your doctor.
Lorenil is only poorly absorbed, so effects on the whole organism can be ruled out under the recommended conditions of use.
Following the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of the occurrence of any adverse effect
even if it is not described in the package leaflet.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date reported on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: do not use the medicine after the expiry date reported on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment. Do not store at a temperature above 30°C.
Keep the medicine out of the reach and sight of children.

COMPOSITION
LORENIL200 mg soft vaginal capsules
One soft vaginal capsule contains: active ingredient: fenticonazole nitrate 200 mg.
Excipients: triglycerides of saturated fatty acids, anhydrous colloidal silica.
Constituents of the capsule shell: gelatin, glycerol, titanium dioxide, sodium ethylhydroxybenzoate, sodium
propylhydroxybenzoate.

LORENIL600 mg soft vaginal capsules
One soft vaginal capsule contains: active ingredient: fenticonazole nitrate 600 mg.
Excipients: liquid paraffin, white petrolatum, soybean lecithin.
Constituents of the capsule shell: gelatin, glycerol, titanium dioxide, sodium ethylhydroxybenzoate, sodium
propylhydroxybenzoate.

PHARMACEUTICAL FORM AND CONTENT
LORENIL 200 mg soft vaginal capsules: pack of 3 soft capsules.
LORENIL 600 mg soft vaginal capsules: pack of 1 soft capsule.

MARKETING AUTHORISATION HOLDER

EFFIK ITALIA SpAVia Lincoln 7/A 20092 Cinisello Balsamo (MI).

MANUFACTURER
Laboratoires EFFIK – Parc Tertiaire de Meudon, Immeuble Le Newton, 9/11 rue Jeanne Braconnier,
F-92 366 MEUDON LA FORET CEDEX, France.
PACKAGE LEAFLET

LORENIL 1 g soft vaginal capsules

Pharmacotherapeutic category
Antimycotic (antifungal).

Therapeutic indications
Vaginal trichomoniasis.
Vaginal infections caused in mixed form by Trichomonas vaginalis and Candida albicans.
Candida infections of the genital mucous membranes (vulvovaginitis, colpitis, infectious fluor).

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Precautions for use
None.

Interactions
Not known.

Special warnings
Although the absorption of the medicine is poor, the use of Lorenil during pregnancy and
breastfeeding is not recommended except in particular cases and after careful evaluation of the
benefit/risk ratio by the doctor.
The use, especially if prolonged, of products for local use can give rise to sensitization phenomena.

Dosage, method and duration of administration
In vaginal infections caused by Trichomonas and in those mixed (Trichomonas+Candida) it is advisable to
apply one 1 g soft capsule followed, if necessary, by a second application after 24
hours. In Candida infections: 1 soft capsule of 1 g in the evening in a single administration. In
case of persistence of symptoms, a second administration may be repeated after 3 days.
The soft capsules should be inserted deeply into the vagina.
In order to avoid re-infection, simultaneous local treatment (glans and
prepuce) of the partner with Lorenil cream is recommended.

Undesirable effects
Lorenil is generally well tolerated on the mucous membranes; only exceptionally have mild
and temporary redness of the skin been reported.
At the time of introduction into the vagina, a modest burning sensation may be experienced which
usually disappears quickly.
In the event of the appearance of more persistent irritative phenomena or the development of resistant microorganisms,
treatment should be discontinued and the treating physician consulted.
Lorenil is only poorly absorbed, so repercussions on the entire organism can be ruled out, in the recommended conditions of use.

Shelf life and storage
Expiry date: See the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: Do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Do not store at temperatures above 30°C. Keep the medicine out of the reach and
sight of children.

Composition
Each soft capsule contains: fenticonazole nitrate 1 g.
Excipients: liquid paraffin; white petrolatum; soybean lecithin; gelatin; glycerol; titanium dioxide;
sodium ethyl hydroxybenzoate; sodium propyl hydroxybenzoate.

Pharmaceutical form and packaging
1 g soft capsule.
Pack of 1 capsule.

Marketing authorisation holder
EFFIK ITALIA SpA
Via Lincoln 7/A
20092 Cinisello Balsamo (MI).

Manufacturer
Laboratoires EFFIK – Parc Tertiaire de Meudon, Immeuble Le Newton, 9/11 rue Jeanne Braconnier,
F-92 366 MEUDON LA FORET CEDEX, France.

LORENIL 2% Vaginal cream, 0.2% Vaginal solution

PHARMACOTHERAPEUTIC CATEGORY
Antifungal (antimycotic).

THERAPEUTIC INDICATIONS
Candidiasis (fungal infection caused by Candida species) of the genital mucosa (vulvovaginitis, colpitis,
infectious fluor).

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients. Generally contraindicated
during pregnancy and breastfeeding.

PRECAUTIONS FOR USE
None.

INTERACTIONS
Not known.
Inform your doctor or pharmacist if you have recently taken any other
medicines, including those available without a prescription.

SPECIAL WARNINGS
Although the absorption of the medicine is poor, the use of Lorenil during pregnancy and
breastfeeding is not recommended except in special cases and after careful evaluation of the
benefit/risk ratio by the doctor.

Vaginal cream 2%:contains hydrogenated lanolin and cetyl alcohol which may
cause local skin reactions (e.g. contact dermatitis).

Vaginal solution 0.2%:contains benzalkonium chloride which is irritating and may cause local skin
reactions.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Vaginal cream
Introduce the contents of the applicator (approximately 5 g) deep into the vagina. Apply using
single-dose applicators in the evening before bedtime, if necessary also in the morning.
To avoid reinfection, simultaneous local treatment (glans and
prepuce) of the partner with Lorenil cream is recommended.

Vaginal wash
1-2 times a day for 7 days as adjuvant therapy to other forms of Lorenil, to prevent
recurrence.

Fig. 1 Fig.2 Fig. 3

Fig. 1Hold the bottle by the knurled ring and fold the cap until the
safety seal breaks.

Fig. 2Extract the cannula always holding it through the cap, until the
locking click.

Fig. 3The cannula is adjustable according to needs. Gently insert the cannula
into the vagina and press the walls of the bottle with more or less intensity, in order to completely empty it; a
special valve prevents the wash from returning into the bottle.
Irrigation should preferably be performed in a lying position.
Slow irrigation promotes a better action of the drug.

UNDESIRABLE EFFECTS
Lorenil is generally well tolerated, both on the skin and mucous membranes; only rarely have
mild and temporary skin rednesses been reported.
At the time of introduction into the vagina, a modest burning sensation may be felt which
usually disappears quickly.
In the event of persistent irritative phenomena or the development of resistant microorganisms, stop the treatment and consult your doctor.
Lorenil is only poorly absorbed, so effects on the whole organism can be ruled out, in the recommended conditions of use.
Following the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of the occurrence of any undesirable effect
even if not described in the package leaflet.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date
indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: do not use the medicine after the expiry date indicated on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Keep the medicine out of the reach and sight of children.
COMPOSITION
LORENIL 2% Vaginal cream
100 g of cream contains: active ingredient: fenticonazole nitrate 2 g.
Excipients: propylene glycol, hydrogenated lanolin, sweet almond oil, polyglycol esters of fatty
acids, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.

LORENIL 0.2% Vaginal solution
100 ml of solution contains: active ingredient: fenticonazole nitrate 0.2 g.
Excipients: propylene glycol, benzalkonium chloride, alkylamidobetaine solution, purified water.

PHARMACEUTICAL FORM AND CONTENT
Vaginal cream 2%tube containing 78 g of vaginal cream + 16 applicators.

Vaginal solution 0.2%5 bottles of 150 ml vaginal solution.

MARKETING AUTHORISATION HOLDER
EFFIK ITALIA S.p.A.
Cinisello Balsamo (MI).

MANUFACTURER
Vaginal cream 2%Farmila Farmaceutici Milano S.r.l., Settimo
Milanese (MI)
Officina Farmaceutica Recordati Industria Chimica e
Farmaceutica S.p.A. Milano

Sol. vaginal 0.2%
Officina Farmaceutica Agipharma S.r.l. , Pomezia (RM).
.
Applicator CE
The medical device complies with Directive 93/42/EEC