Lorenil: detailed information

Patient Information Leaflet

LORENIL 2% cream

fenticloazole nitrate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What LORENIL is and what it is used for
What you need to know before using LORENIL
How to use LORENIL
Possible side effects
How to store LORENIL
Package contents 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) to treat the following conditions:

fungal skin infections caused by fungi known as dermatophytes (dermatomycoses due to Trichophyton, Microsporum, Epidermophyton) affecting various parts of the body: scalp ringworm (tinea capitis), body ringworm (tinea corporis), groin ringworm (tinea cruris), athlete’s foot (tinea pedis), hand ringworm (tinea manuum), facial ringworm (tinea faciei), beard ringworm affecting hair follicles (tinea barbae), nail ringworm (tinea unguium)
skin infections caused by fungi of the genus Candida (candidiasis such as intertrigo, angular cheilitis, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis)
localized infections of certain parts of the male genitals (balanitis, balanoposthitis)
localized nail infections (onychia and paronychia)
a fungal infection known as "pityriasis versicolor" (due to Pityrosporum orbiculare and P. ovale)
ear infections caused by fungi (otomycosis due to Candida or molds), only if there are no lesions affecting a part of the ear called the tympanic membrane
a skin infection called "erythrasma"
fungal infections (mycoses) associated with bacterial superinfections (by Gram-positive bacteria).

Consult your doctor if you do not feel better or 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 substance or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before using LORENIL.
The use, especially if prolonged, of topical medicines (topical use) may cause allergic reactions (sensitization phenomena).
If this occurs, discontinue treatment and consult your doctor, who will advise appropriate therapy.
Consult your doctor if you do not observe noticeable improvement after a short period of treatment.
After applying LORENIL to the lesion, you may experience a mild burning sensation which disappears quickly.

Other medicines and LORENIL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
No interactions with other medicines are known for LORENIL.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use of LORENIL during pregnancy and breastfeeding is not recommended, although skin absorption of fenticonazole is rather low.

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

Lorenil 2% cream contains cetyl alcohol and hydrogenated lanolin, which may cause local skin reactions (e.g. contact dermatitis).
Lorenil 2% cream contains 750 mg of propylene glycol per 15 g tube of LORENIL cream, equivalent to 50 mg/g of LORENIL cream. Propylene glycol 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 talking to your doctor or pharmacist.

3. How to use LORENIL

Use this medicine exactly as stated in this leaflet or according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
Apply LORENIL 1-2 times daily, as directed by your physician, after washing and drying the affected area, using the formulation appropriate for the location of the lesion.
LORENIL is non-greasy, does not stain, and can be easily removed with water.

LORENIL cream: indicated for the treatment of hairless skin areas (glabrous skin), skin folds, and mucous membranes. Gently massage in.

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

infection known as “pityriasis versicolor”
skin infection called “erythrasma”
nail infections (onychomycosis). In these infections, apply the cream under occlusive dressing
localized infections of the male genitals.

If you use more LORENIL than you should
In case of accidental ingestion/overdose of LORENIL, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you forget to use LORENIL
Do not use a double dose to make up for the missed dose.
If you stop using LORENIL
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 everyone experiences them.
When used as recommended, LORENIL is poorly absorbed and side effects affecting the whole body (systemic effects) are not expected. Prolonged use of topical medicines (local use) may lead to sensitization phenomena (see section "Warnings and precautions").
The following side effects have been observed with LORENIL:
Very rare (may affect up to 1 in 10,000 people)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through 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 LORENIL

This medicine does not require any special storage conditions.
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 "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. Contents of the pack and other information

What LORENIL contains
LORENIL 2% cream

The active substance is fenticonazole nitrate. 100 g of cream contain 2 g of fenticonazole nitrate.
The other ingredients are propylene glycol, hydrogenated lanolin, refined almond oil, polyglycolized fatty acid esters, cetyl alcohol, glycerol monostearate, edetate sodium, purified water.

Description of the appearance of LORENIL and contents of the pack
LORENIL is available as:

2% cream. The pack contains one 15 g tube.

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.

PACKAGE LEAFLET

LORENIL 2% gel
LORENIL 2% lotion
LORENIL 1% and 2% cutaneous powder
LORENIL 2% cutaneous spray, solution
Fenticlozole nitrate
Pharmacotherapeutic category
Topical antifungal agent
Therapeutic indications

Dermatomycoses caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) at various sites: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
Cutaneous candidiasis (intertrigo, angular cheilitis, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis); balanitis, balanoposthitis, onychia and paronychia.
Pityriasis versicolor (due to Pityrosporum orbiculare and P. ovale).
Otomycosis (caused by Candida or molds); only if there are no tympanic membrane lesions.
Erythrasma.
Fungal infections with bacterial superinfections (by 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 low, it is recommended not to use
the product during pregnancy and lactation.
Interactions
Not known.
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
without a prescription.
Special warnings
Although absorption of the medicine is low, the use of Lorenil during pregnancy and
lactation is not recommended except in particular cases and after careful assessment of the
benefit/risk ratio by the physician.
Prolonged use, especially, of topical products may lead to sensitization phenomena.
At the time of application to the affected area, a mild burning sensation may occur, which rapidly
disappears.
Dosage, method and duration of administration
Lorenil should be applied once or twice daily, as directed by the physician, after washing and
drying the affected area, using the formulation appropriate for the site of the lesion.
Gel – has a drying effect 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 scalp and hairy skin areas. The cutaneous
spray is also convenient and easy to use for extensive fungal infections and hard-to-reach areas.
Cutaneous powder 1% and 2% – is used for athlete's foot and generally for intertriginous areas
and moist lesions, either as monotherapy or as a complement to the cream. In foot infections, it is
advised to sprinkle Lorenil cutaneous powder inside socks and shoes as well.
In athlete's foot and onychomycoses, to prevent reinfection, it is advisable to continue the
above treatment for an additional one or two weeks after the symptoms have disappeared.
Lorenil treatments should be performed regularly until complete resolution of the lesions.
Lorenil is non-greasy, does not stain, and is easily removed with water.
Undesired effects
Mild and transient erythematous reactions have been reported.
At the time of application to the lesion, a mild burning sensation may occur, which normally
disappears quickly.
If persistent irritative phenomena or development of resistant microorganisms occur, treatment
should be discontinued and medical advice sought.
Lorenil is poorly absorbed, thus systemic effects can be excluded under the recommended
conditions of use.
Following the instructions in this leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist about any adverse effect, even if not described
in this leaflet.
Expiry date and storage
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in unopened packaging, correctly stored.
Caution: do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer used. 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 2 g - Excipients: carbomer; purified water; propylene
glycol.
Lorenil 2% lotion
100 g of lotion contains: fenticonazole nitrate 2 g - Excipients: ethyl alcohol; hydroxypropyl
cellulose; purified water; propylene glycol.
Lorenil 1% cutaneous powder
100 g of powder contains: fenticonazole nitrate 1 g - Excipients: precipitated silica; zinc oxide;
talc.
Lorenil 2% cutaneous powder
100 g of powder contains: fenticonazole nitrate 2 g - Excipients: precipitated silica; zinc
oxide; talc.
Lorenil 2% cutaneous spray, solution
100 g of solution contains: fenticonazole nitrate 2 g - Excipients: ethyl alcohol; propylene glycol;
purified water.
Pharmaceutical forms and contents
Gel – 30 g tube.
Cutaneous spray, solution – 30 ml bottle.
Lotion – 30 ml bottle.
Cutaneous powder 1% and 2% – 50 g jar.
MARKETING AUTHORIZATION HOLDER
Effik Italia S.p.A. - Via Lincoln 7/A – 20092 Cinisello Balsamo (MI). Manufacturer
2% Gel Recordati Spa _Milan.
2% Cutaneous spray Recordati Spa _Milan.
2% Lotion Recordati Spa _Milan.
1% Cutaneous powder Recordati Spa _Milan.
2% Cutaneous powder Recordati Spa _Milan and Zeta Farmaceutici SpA Sandrigo (VI).

PACKAGE LEAFLET

LORENIL 2% Shampoo

fenticonazole nitrate
Pharmacotherapeutic category
Antifungal agent for topical use.
Therapeutic indications
Treatment of scalp infections involving the yeast Pityrosporum, such as seborrheic dermatitis and Pityriasis capitis.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use
After prolonged topical treatment with corticosteroids, it is advisable to wait approximately fifteen days before applying Lorenil Shampoo.
Special warnings
Although absorption of the medicinal product is minimal, the use of Lorenil during pregnancy and lactation is not recommended except in special cases and only after careful assessment of the benefit-risk ratio by the physician.
The use, especially if prolonged, of topical products may lead to sensitization phenomena.
Avoid contact with the eyes.
If the product comes into contact with the eyes, rinse thoroughly with water.
Method, route and frequency of administration
Wash the infected areas with Lorenil Shampoo; leave on for approximately 3–4 minutes, then rinse thoroughly.
Treatment should be carried out twice a week for 2–4 weeks.
Undesired effects
Lorenil is generally well tolerated both on the skin and mucous membranes; only rarely have mild and transient erythematous reactions or burning sensations been reported, which normally disappear quickly.
If more persistent irritative phenomena or hypersensitivity reactions occur, treatment must be discontinued.
Under the recommended conditions of use, Lorenil Shampoo is only poorly absorbed, thus excluding systemic adverse reactions; however, its use is generally contraindicated during pregnancy and breastfeeding.
INFORM YOUR DOCTOR OR PHARMACIST IF ANY UNEXPECTED ADVERSE EFFECTS OCCUR THAT ARE NOT LISTED IN THIS LEAFLET.
Expiry date and storage
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under appropriate storage conditions.
Do not use the medicinal product after the expiry date stated on the packaging.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Composition
100 g of solution contain: fenticonazole nitrate 2 g.
Excipients: propylene glycol, sodium laureth sulfate solution, alkylamidobetaine solution, purified water.
Pharmaceutical form and contents
Shampoo.
100 g bottle.
Marketing Authorization Holder
Effik Italia S.p.A. - Via Lincoln 7/A – 20092 Cinisello Balsamo (MI)
Manufacturer
Recordati S.p.A., Pomezia plant (RO)
May 2011

INSTRUCTIONS FOR USE

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

fenticonazole nitrate
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Antimycotic (antifungal).
THERAPEUTIC INDICATIONS
Candidiasis (fungal infection caused by species of the genus Candida) of genital mucosa (vulvovaginitis, vaginitis, infectious discharge).
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 medicinal products, including those without a prescription.
SPECIAL WARNINGS
Although absorption of the drug is minimal, the use of Lorenil during pregnancy and breastfeeding is not recommended except in special cases and only after careful assessment of the benefit-risk ratio by the physician.
The use, especially if prolonged, of topical products may lead to sensitization phenomena.
A mild burning sensation may occur at the time of intravaginal insertion, which rapidly disappears.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Soft vaginal capsules
One 200 mg soft capsule to be administered in the evening before bedtime for 3 consecutive days, or as otherwise directed by the physician.
One 600 mg soft capsule administered once in the evening. If symptoms persist, a second dose may be administered after 3 days.
The soft capsules should be inserted deeply into the vagina.
UNDESIRABLE EFFECTS
Lorenil is generally well tolerated on both skin and mucous membranes; mild and transient skin erythema has been reported only rarely.
A mild burning sensation may occur upon vaginal insertion, which normally disappears quickly.
If persistent irritative phenomena or development of resistant microorganisms occur, treatment should be discontinued and a physician consulted.
Lorenil is only poorly absorbed; therefore, under the recommended conditions of use, systemic effects on the entire organism can be excluded.
Following the instructions provided in the package leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist of any adverse effect, even if not described in this leaflet.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product kept in its original, unopened packaging and stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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
LORENIL 200 mg soft vaginal capsules
One vaginal soft capsule contains: active substance: fenticonazole nitrate 200 mg.
Excipients: saturated fatty acid triglycerides, anhydrous colloidal silica.
Capsule shell constituents: gelatin, glycerol, titanium dioxide, sodium ethylhydroxybenzoate, sodium propylhydroxybenzoate.
LORENIL 600 mg soft vaginal capsules
One vaginal soft capsule contains: active substance: fenticonazole nitrate 600 mg.
Excipients: liquid paraffin, white soft paraffin, soybean lecithin.
Capsule shell constituents: gelatin, glycerol, titanium dioxide, sodium ethylhydroxybenzoate, sodium propylhydroxybenzoate.
PHARMACEUTICAL FORM AND CONTENT
LORENIL 200 mg soft vaginal capsules: box containing 3 soft capsules.
LORENIL 600 mg soft vaginal capsules: box containing 1 soft capsule.
MARKETING AUTHORISATION HOLDER
EFFIK ITALIA SpA, Via Lincoln 7/A, 20092 Cinisello Balsamo (MI), Italy.
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.
Mixed vaginal infections caused by Trichomonas vaginalis and Candida albicans.
Genital mucosal candidiasis (vulvovaginitis, vaginitis, infectious discharge).
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Precautions for Use
None.
Interactions
Not known.
Special Warnings
Although absorption of the medicinal product is minimal, the use of Lorenil during pregnancy and lactation is not recommended except in special cases and only after careful assessment of the benefit-risk ratio by the physician.
The use, especially if prolonged, of topical products may lead to sensitization reactions.
Dosage, Method and Duration of Administration
For vaginal infections caused by Trichomonas and mixed infections (Trichomonas + Candida), it is recommended to administer one 1 g soft capsule, followed if necessary by a second application after 24 hours. For Candida infections: one 1 g soft capsule at bedtime as a single dose. If symptoms persist, a second dose may be administered after 3 days.
The soft capsules must be inserted deeply into the vagina.
To prevent reinfection, simultaneous local treatment (glans and foreskin) of the sexual partner with Lorenil cream is recommended.
Undesirable Effects
Lorenil is generally well tolerated on mucous membranes; mild and transient skin redness has been reported only exceptionally.
A mild burning sensation may occur upon insertion into the vagina, which normally disappears quickly.
If persistent irritation or development of resistant microorganisms occurs, treatment should be discontinued and the physician consulted.
Lorenil is poorly absorbed, thus systemic effects on the organism can be excluded under the recommended conditions of use.
If any undesirable effects not described in this leaflet occur, consult your doctor.
Expiry and Storage
Expiry date: See the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging.
Warning: Do not use the medicinal product after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Do not store above 30°C. Keep the medicinal product out of the reach and sight of children.
Composition
Each soft capsule contains: fenticonazole nitrate 1 g.
Excipients: liquid paraffin; white vaseline; soy lecithin; gelatin; glycerin; titanium dioxide; sodium ethylhydroxybenzoate; sodium propylhydroxybenzoate.
Pharmaceutical Form and Packaging
1 g soft capsule.
Pack containing 1 capsule.
Marketing Authorization Holder
EFFIK ITALIA SpA
Via Lincoln 7/A
20092 Cinisello Balsamo (MI), Italy.
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
LORENIL 0.2% Vaginal Solution

PHARMACOTHERAPEUTIC CATEGORY
Antimycotic (antifungal).
THERAPEUTIC INDICATIONS
Candidiasis (fungal infection caused by Candida species) of genital mucosa (vulvovaginitis, vaginitis, infectious discharge).
CONTRAINDICATIONS
Hypersensitivity to the active substance 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 without a prescription.
SPECIAL WARNINGS
Although absorption of the medicinal product is minimal, the use of Lorenil during pregnancy and breastfeeding is not recommended except in special cases and only after careful assessment of the benefit-risk ratio by the physician.
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, METHOD AND DURATION OF ADMINISTRATION
Vaginal Cream
Insert the contents of the applicator (approximately 5 g) deeply into the vagina. Apply using single-use applicators at bedtime, and if necessary also in the morning.
To prevent reinfection, simultaneous local treatment (glans and foreskin) of the partner with Lorenil cream is recommended.
Vaginal Lavage
Once or twice daily for 7 days as an adjunctive therapy to other forms of Lorenil, to prevent relapse.
Fig. 1 Fig. 2 Fig. 3
Fig. 1 Hold the bottle by the knurled ring and twist the cap until the safety seal breaks.
Fig. 2 Remove the cannula by pulling it through the cap until it clicks into position.
Fig. 3 The cannula is adjustable according to need. Gently insert the cannula into the vagina and press the bottle walls with more or less pressure to ensure complete emptying; a special valve prevents backflow of the solution into the bottle.
Irrigation should preferably be performed in a lying position.
Slow irrigation promotes better drug action.
UNDESIRABLE EFFECTS
Lorenil is generally well tolerated both on skin and mucous membranes; mild and transient skin redness has been reported only exceptionally.
A mild burning sensation may occur upon vaginal insertion, which normally disappears quickly.
If persistent irritative phenomena or development of resistant microorganisms occur, treatment should be discontinued and the physician consulted.
Lorenil is poorly absorbed; therefore, under the recommended conditions of use, systemic effects on the entire organism can be excluded.
Following the instructions in this leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of any undesirable effects, even if not described in this leaflet.
EXPIRY AND STORAGE
Expiry date: See the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging.
Warning: Do not use the medicinal product after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
COMPOSITION
LORENIL 2% Vaginal Cream
100 g of cream contain: active substance: fenticonazole nitrate 2 g.
Excipients: propylene glycol, hydrogenated lanolin, sweet almond oil, polyglycolyzed fatty acid esters, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.
LORENIL 0.2% Vaginal Solution
100 ml of solution contain: active substance: 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 vaginal cream + 16 applicators.
Vaginal solution 0.2%: 5 bottles of 150 ml vaginal solution each.
MARKETING AUTHORIZATION HOLDER
EFFIK ITALIA S.p.A.
Cinisello Balsamo (MI), Italy.
MANUFACTURER
Vaginal cream 2%: Farmila Farmaceutici Milano S.r.l., Settimo Milanese (MI) facility
Officina Farmaceutica Recordati Industria Chimica e
Vaginal solution 0.2%
Farmaceutica S.p.A., Milan
Officina Farmaceutica Agipharma S.r.l., Pomezia (RM).
.
Applicator CE
The medical device complies with Directive 93/42/EEC.