Falvin

Patient Information Leaflet

Falvin 20 mg/g cream, 20 mg/ml cutaneous spray, solution

fenticloconazole nitrate
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more 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.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What Falvin is and what it is used for
2. What you need to know before using Falvin
3. How to use Falvin
4. Possible side effects
5. How to store Falvin
6. Package contents and other information

1. What Falvin is and what it is used for

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

• fungal skin infections caused by fungi known as dermatophytes (dermatophytosis due to Trichophyton, Microsporum, Epidermophyton) affecting various body areas: scalp ringworm (tinea capitis), body ringworm (tinea corporis), groin ringworm (tinea cruris), foot ringworm (tinea pedis, also known as athlete's foot), 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 in certain areas 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 of a part of the ear called the eardrum
• 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 treatment.

2. What you need to know before using Falvin

Do not use Falvin

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

Warnings and precautions
Talk to your doctor or pharmacist if:

• you are pregnant or breastfeeding; in both cases, Falvin should be used under medical supervision (see section “Pregnancy, breastfeeding and fertility”);
• you experience any irritation or sensitivity to the product, as treatment should be discontinued and you should consult your doctor, who will recommend appropriate therapy.
• prolonged use, for example 3-4 weeks, of topical medicines (topical use) may cause allergic reactions (sensitization phenomena).

Falvin is for external cutaneous use only. Do not apply on mucous membranes or on damaged/irritated skin. Avoid contact with the eyes; if contact occurs, rinse thoroughly with water. Falvin contains excipients with known effects that require specific warnings and precautions (see section “Important information on some excipients”).
Other medicines and Falvin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No studies have been conducted on interactions between other medicines and Falvin.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Falvin should be used during pregnancy and breastfeeding under medical supervision.
Driving and using machines
Falvin does not affect or affects negligibly the ability to drive vehicles or operate machinery.
Important information on some excipients
Falvin cream contains: propylene glycol, cetyl alcohol, hydrogenated lanolin.

• propylene glycol: 50 mg in 1 g of cream. 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 consulting your doctor or pharmacist.
• cetyl alcohol and hydrogenated lanolin: may cause local skin reactions (e.g. contact dermatitis).

Falvin 20 mg/ml cutaneous spray, solution contains: propylene glycol and ethanol

• propylene glycol: 350 mg in 1 ml of solution. 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 consulting your doctor or pharmacist;
• ethanol: 337 mg in 1 ml of solution. May cause a burning sensation on damaged skin. In neonates (premature and full-term), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

3. How to use Falvin

Use this medicine 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 Falvin 1–2 times daily, as directed by your doctor, after washing and drying the affected area, using the formulation appropriate for the location of the lesion.

• Falvin cream: indicated for the treatment of hairless skin areas (glabrous skin), skin folds, and mucous membranes. Apply Falvin cream with gentle rubbing.

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

• infection known as “pityriasis versicolor”

• skin infection called “erythrasma”

• nail infections (onychomycosis). For these infections, apply the cream under occlusive dressing

• localized infections in the male genital area.

• Falvin cutaneous spray, solution: indicated for infections localized on the scalp and hairy skin areas, for extensive infections, and for hard-to-reach areas.

Falvin is non-greasy, does not stain, and can be removed with water.
Use in children and adolescents
Falvin contains excipients with known effects that require specific warnings and precautions (see section “Important information about some excipients”).
If you use more Falvin than you should
In case of accidental ingestion/overdose of Falvin, 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 Falvin
Do not use a double dose to make up for the missed dose.
If you stop using Falvin
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, Falvin is only minimally absorbed and unwanted 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 Falvin:
Very rare (may affect up to 1 in 10,000 people)

• Redness of the skin (erythema)
• Itching
• Skin rash
• Skin rash and redness (erythematous exanthema)
• Skin irritation
• Burning sensation of the skin

Not known (frequency cannot be estimated from available data)

• Hypersensitivity

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Falvin

Store below 25°C.
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 carton 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 Falvin contains
Falvin 20 mg/g cream

• The active substance is fenticonazole nitrate. 1 g of cream contains 20 mg of fenticonazole nitrate.
• The other components are propylene glycol, hydrogenated lanolin, refined almond oil, polyglycolyzed fatty acid esters, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.

Falvin 20 mg/ml cutaneous spray, solution

• The active substance is fenticonazole nitrate. 1 ml of solution contains 20 mg of fenticonazole nitrate.
• The other components are ethanol, propylene glycol, purified water.

Description of the appearance of Falvin and contents of the pack
Falvin is available in the following forms:

• 20 mg/g cream. The package contains a 30 g tube.
• 20 mg/ml cutaneous spray, solution. The package contains a 30 ml bottle with spray pump.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan.
Manufacturer
Falvin cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan.
Vamfarma S.r.l. - via Kennedy, 5 - 26833 Comazzo (LO).
Falvin cutaneous spray, solution
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan.

Patient Information Leaflet

Falvin 2% vaginal cream, 200 mg soft vaginal capsules, 600 mg soft vaginal capsules, 0.2% vaginal solution

Fenticonazole nitrate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always 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 would like more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Falvin is and what it is used for

Falvin contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called "gynaecological antimicrobials and antiseptics".
Falvin is used to treat infections of the genital mucous membranes caused by a fungus called Candida, such as:

• inflammation of the vulva and vagina (vulvovaginitis)
• inflammation of the cervix (cervicitis)
• increased vaginal discharge due to infection (infectious leucorrhoea).

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

2. What you need to know before using Falvin

Do not use Falvin

• if you are allergic to fenticonazole or to any of the other ingredients of this medicine (listed in section 6).
• Falvin 600 mg soft vaginal capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist if:

• You are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You are using a latex barrier contraceptive method (see section “Other medicines and Falvin”). Therefore, you should use alternative precautions during the use of this product.
• You are using spermicides, vaginal douches, or other vaginal products (see section “Other medicines and Falvin”).
• You experience any irritation or sensitivity to the medicine.
• Your symptoms do not improve within one week, or if you have severe or recurrent symptoms.
• Your partner is also infected.
• You have had more than two previous infections in the last 6 months.
• You or your partner have ever had a sexually transmitted infection.
• You have ever had hypersensitivity to imidazoles or other vaginal antifungal products.
• You are over 60 years old.
• You have any of the following symptoms:
  • Abnormal or irregular vaginal bleeding.
  • Blood traces in vaginal discharge.
  • Sores, ulcers, or blisters on the vulva or vagina.
  • Lower abdominal pain or difficulty urinating (dysuria).
  • Adverse effects such as redness, itching, or rash associated with treatment.

Falvin vaginal cream: avoid contact with the eyes.
Children and adolescents
Falvin is not recommended for children under 16 years of age.
Other medicines and Falvin
The fatty excipients and oils contained in the vaginal cream and soft vaginal capsules may damage latex contraceptives such as condoms and diaphragms (see section “Warnings and precautions”).
The use of spermicides (substances inserted vaginally that destroy sperm and are used as contraceptives alone or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment may inactivate a locally acting spermicidal contraceptive.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are breastfeeding, consult your doctor before using this medicine. Falvin should be used during pregnancy and breastfeeding only under medical supervision.
Falvin vaginal cream: during pregnancy, the applicator must not be used.
Driving and operating machinery
Falvin does not affect the ability to drive or operate machinery.
Falvin vaginal cream contains:

• cetyl alcohol and hydrogenated lanolin, which may cause local skin reactions (e.g. contact dermatitis)
• 50 mg of propylene glycol in 1 g of cream.

Falvin vaginal solution contains:

• 15 g of propylene glycol in 150 ml of solution
• 15 mg of benzalkonium chloride in 150 ml of solution, which may cause local irritation.

Falvin soft vaginal capsules contain:

• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

3. How to use Falvin

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Falvin vaginal cream
  The recommended dose is the contents of the applicator (approximately 5 g). Insert the contents of the applicator deeply into the vagina (see instructions for use). Apply Falvin cream using the applicator (which is washable and reusable) before going to bed, and if necessary also in the morning. To avoid reinfection, it is advisable to simultaneously treat the partner locally (glans and foreskin) with Falvin cream.

Instructions for use:

1. Screw the applicator onto the tube in place of the cap.
2. Gently squeeze the tube at its lower end to fill the applicator. If the plunger offers resistance, pull it out gently. Unless otherwise prescribed by the doctor, fill the applicator completely.
3. Remove the applicator from the tube and immediately close the tube with the cap.
4. Lie down with knees raised and apart, gently insert the applicator as deeply as possible into the vagina. Push the plunger fully. Then remove the applicator without touching the plunger.

Ensure the applicator is always perfectly clean. After each use, wash it thoroughly with warm water and soap. If your doctor has advised you to sterilize the applicator for specific reasons, follow their instructions.
However, do not use water hotter than 50°C or organic solvents.
Dry the applicator thoroughly and store it in its container.

• Falvin soft vaginal capsules
  The recommended dose is:
  • 1 soft vaginal capsule of 200 mg in the evening before bedtime, for three days, depending on the doctor's judgment; or
  • 1 soft vaginal capsule of 600 mg as a single dose in the evening. If symptoms persist, a second dose may be administered after 3 days.

Instructions for use:
The soft vaginal capsules must be inserted deeply into the vagina (up to the level of the fornices).

• Falvin vaginal solution
  The recommended dose is 1–2 vaginal irrigations per day for 7 days, as an adjunctive therapy to other formulations for the prevention of recurrences.

Instructions for use:

Fig. 1 Hold the bottle by the ridged ring and bend the cap until the safety seal breaks.
Fig. 2 Remove the cannula by holding it through the cap until it clicks into position.
Fig. 3 The cannula can be oriented according to need. Gently insert the cannula into the vagina and press the sides of the bottle with more or less force to ensure complete emptying; a special valve prevents the solution from flowing back into the bottle. Perform the irrigation preferably while lying down.
A slow irrigation promotes better medicated cleansing.

Use in children and adolescents
The recommended dose in children aged 16 years and older is the same as in adults.

If you use more Falvin than you should
If the vaginal capsules, vaginal cream, or vaginal solution are accidentally swallowed or ingested orally, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Falvin
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 gets them.
When the medicine is inserted into the vagina, a slight burning sensation may occur, which will quickly disappear. When used as recommended, Falvin is only minimally absorbed and adverse effects involving the whole body (systemic effects) have not been reported.
The use of topical medicines, especially if prolonged, may lead to sensitization (see section “Warnings and precautions”).
The following adverse reactions have been reported with Falvin:
Very rare (may affect up to 1 in 10,000 people):

• vulvovaginal burning sensation
• skin redness (erythema), itching, and skin rash.

Frequency not known:

• hypersensitivity at the site of application.

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 Falvin

Store below 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 “Exp”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Falvin contains
Falvin 2% vaginal cream

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

Falvin 200 mg vaginal soft capsules

• The active substance is fenticonazole nitrate. Each capsule contains 200 mg of fenticonazole nitrate.
• The other components are saturated fatty acid triglycerides, anhydrous colloidal silicon dioxide. Shell constituents: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Falvin 600 mg vaginal soft capsules

• The active substance is fenticonazole nitrate. Each capsule contains 600 mg of fenticonazole nitrate.
• The other components are liquid paraffin, white vaseline, soybean lecithin. Shell constituents: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Falvin 0.2% vaginal solution

• The active substance is fenticonazole nitrate. 100 ml of solution contains 0.2 g of fenticonazole nitrate.
• The other components are propylene glycol, benzalkonium chloride, alkylamidobetaine solution, purified water.

Description of the appearance of Falvin and pack contents
Falvin is available in the following forms:

• 2% vaginal cream. Pack contents: one 78 g tube with 1 applicator.
• 200 mg vaginal soft capsules. Pack contents: 6 capsules.
• 600 mg vaginal soft capsules. Pack contents: 2 capsules.
• 0.2% vaginal solution. Pack contents: 5 bottles of 150 ml each, supplied with single-use applicators.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Manufacturers
Falvin vaginal cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Vamfarma S.r.l. - via Kennedy, 5 - 26833 Comazzo (LO), Italy.
Falvin vaginal solution
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR), Italy.
Falvin vaginal soft capsules
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT), Italy.

Patient information leaflet

Falvin 1000 mg soft vaginal capsules

fenticonazole nitrate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always 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 more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Falvin is and what it is used for

Falvin contains the active substance fenticloramidazole nitrate.
It belongs to a group of medicines called "gynaecological antimicrobials and antiseptics".
Falvin is used to treat the following conditions:

• vaginal infections caused by a microorganism called Trichomonas vaginalis (vaginal trichomoniasis)
• mixed vaginal infections caused by two microorganisms called Trichomonas vaginalis and Candida albicans
• genital mucosal infections caused by a fungus called Candida, such as:
  • inflammation of the vulva and vagina (vulvovaginitis)
  • inflammation of the cervix (cervicitis)
  • increased vaginal discharge due to infection (infectious leucorrhoea).

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

2. What you need to know before using Falvin

Do not use Falvin

• if you are allergic to fenticonazole or to any of the other ingredients of this medicine (listed in section 6).
• Falvin 1000 mg soft capsules for vaginal use contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist if:

• You are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You are using latex barrier contraceptives (see section “Other medicines and Falvin”). Therefore, you must use alternative precautions during the use of this product.
• You are using spermicides, vaginal douches, or other vaginal products (see section “Other medicines and Falvin”).
• You experience any irritation or sensitivity to the medicine.
• Your symptoms do not improve within one week, or if you have severe or recurrent symptoms.
• Your partner is also infected.
• You have had more than two previous infections in the last 6 months.
• You or your partner have ever had a sexually transmitted disease.
• You have ever had hypersensitivity to imidazoles or other vaginal antifungal products.
• You are over 60 years old.
• You have any of the following symptoms:
  • Abnormal or irregular vaginal bleeding.
  • Blood traces in vaginal discharge.
  • Sores, ulcers, or blisters on the vulva or vagina.
  • Lower abdominal pain or difficulty urinating (dysuria).
  • Adverse effects such as redness, itching, or rash associated with treatment.

Children and adolescents
Falvin is not recommended for children under 16 years of age.
Other medicines and Falvin
The fatty excipients and oils contained in the vaginal soft capsules may damage latex-based barrier contraceptives, such as condoms and diaphragms (see section “Warnings and precautions”).
The use of spermicides (substances inserted vaginally that destroy sperm and are used as contraceptives alone or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment may inactivate locally acting spermicidal contraceptives.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are breastfeeding, please consult your doctor before using this medicine. Falvin should be used during pregnancy and breastfeeding only under medical supervision.
Driving and using machines
Falvin does not affect the ability to drive or operate machinery.
Falvin contains:

• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Falvin

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.

For vaginal infections caused by Trichomonas and mixed infections (Trichomonas and Candida), the recommended dose is:

• 1 vaginal soft capsule of 1000 mg, followed by a second application after 24 hours, if necessary.

For infections caused by Candida, the recommended dose is:

• 1 vaginal soft capsule of 1000 mg at bedtime as a single dose. If symptoms persist, a second dose may be repeated after 3 days.

Instructions for use:

Soft vaginal capsules should be inserted deeply into the vagina (up to the level of the fornices).
Use in children and adolescents
The recommended dose for children aged 16 years and older is the same as for adults.
If you use more Falvin than you should
If the vaginal capsules are taken orally or ingested, contact your doctor immediately or go to the nearest hospital.
If you forget to use Falvin
Do not use a double dose to compensate for the missed dose.
If you stop using Falvin
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 everyone experiences them.
When the medicine is inserted into the vagina, a mild burning sensation may occur, which will disappear quickly. When used as recommended, Falvin is only minimally absorbed and no side effects affecting the whole body (systemic effects) have been reported.
The use of topical medicines, especially if prolonged, may lead to sensitization (see section “Warnings and precautions”).
The following side effects have been reported with Falvin:
Very rare (may affect up to 1 in 10,000 people):

• vulvovaginal burning sensation
• skin redness (erythema), itching, and skin rash.

Frequency not known:

• hypersensitivity at the site of application

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Falvin

Store below 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 “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 no longer in use. This will help protect the environment.

6. Pack contents and other information

What Falvin contains

• The active substance is fenticonazole nitrate. Each capsule contains 1000 mg of fenticonazole nitrate.
• The other components are liquid paraffin, white vaseline, soybean lecithin. Components of the shell: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Description of the appearance of Falvin and pack contents
Falvin is presented as soft vaginal capsules of 1000 mg. The pack contains 2 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Manufacturer
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT), Italy.