FALVIN 20 mg /G Cream

Зміст інструкції

1. Falvin 20 mg/g cream, 20 mg/ml cutaneous spray, solution
   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
2. Falvin 2% vaginal cream, 200 mg soft vaginal capsules, 600 mg soft vaginal capsules, 0.2% vaginal solution
   1. What is Falvin and what is it 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
3. Falvin 1000 mg soft vaginal capsules
   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

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

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 Falvin is and what it is used for
• 2. What you need to know before you use 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 “antifungals” for cutaneous use and acts against infections
caused by fungi.
Falvin is used locally (topical use) for the treatment of the following conditions:

• skin infections caused by fungi called dermatophytes (dermatomycoses caused by Trichophyton, Microsporum, Epidermophyton) located in different parts of the body: scalp ringworm (tinea capitis), body ringworm (tinea corporis), groin ringworm (tinea cruris), foot ringworm (tinea pedisalso known as athlete's foot ), hand ringworm ( tinea manuum), facial ringworm (tinea faciei), 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, candidiasis “of the diaper area”, perineal and scrotal)
• 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 tympanic membrane
• skin infection called “erythrasma”
• infections caused by fungi (mycoses) that also present with bacterial superinfections (from Gram-positive bacteria).

Talk to 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 nitrate or 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 the supervision of a doctor (see section “Pregnancy, breastfeeding and fertility”);
• you experience any irritation or sensitivity to the product, as treatment should be discontinued and your doctor should be consulted to advise on appropriate therapy.
• Prolonged use, for example 3-4 weeks, of topical medicines (topical use) can cause allergic reactions (sensitization phenomena).

Falvin is only for cutaneous use, for external use, do not apply to mucous membranes or broken/damaged skin. Avoid contact with the eyes, if this should happen, rinse thoroughly with water. Falvin contains excipients that have known effects and require particular warnings and precautions (see section “Important information about some excipients”).

Other medicines and Falvin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
No studies have been conducted on the interaction of other medicines with Falvin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this medicine.
Falvin should be used during pregnancy and breastfeeding under the supervision of a doctor.

Driving and operating machinery
Falvin does not or negligibly alters the ability to drive vehicles or operate machinery.

Important information about some excipients
Falvincream 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 talking to your doctor or pharmacist.
• cetyl alcoholand hydrogenated lanolin.May cause local skin (cutaneous) reactions, such as 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 talking to your doctor or pharmacist;
• ethanol:337 in 1 ml of solution. May cause a burning sensation on damaged skin. In newborns (premature and full-term), high concentrations of ethanol can cause serious local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

3. How to use Falvin

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 Falvin 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.

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

Falvin cream is preferably used for dry fungal infections:

• 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.
• Falvin cutaneous spray, solution:is indicated for infections located on the scalp and in skin areas covered with hair, for widespread infections, for areas that are difficult to reach.

Falvin does not grease, does not stain and is removed with water.

Use in children and adolescents
Falvin contains excipients that have known effects and require special warnings and
precautions (see section “Important information on certain excipients”).

If you use more Falvin than you should
In case of ingestion/accidental intake of an excessive dose of Falvin, 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 Falvin
Do not use a double dose to make up for a 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 everybody gets them.
When used as recommended, Falvin is only poorly absorbed and no side effects are expected that can affect the entire body (systemic effects). Prolonged use of medicines for local use (topical use) may cause 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
• rash and redness of the skin (erythematous rash)
• skin irritation
• burning sensation of the skin.

Not known (frequency cannot be estimated based on available data)

• hypersensitivity

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 Falvin

Store at a temperature 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 pack after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 Falvin contains
Falvin 20 mg/g cream

• The active ingredient is fenticonazole nitrate. 1 g of cream contains 20 mg 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.

Falvin 20 mg/ml cutaneous spray, solution

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

Description of the appearance of Falvin and contents of the pack
Falvin is presented in the form of:

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milano.

Manufacturer
Falvin cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milano.
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 Milano.

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

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 to do.

• 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 get worse 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 you use 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 is Falvin and what is it used for

Falvin contains the active ingredient fenticonazole nitrate.
It belongs to a group of medicines called “antimicrobial and gynecological antiseptics”.
Falvin is used for the treatment of infections of the mucous membranes of the genital organs caused by a fungus
called Candidasuch as:

• inflammations of the vulva and vagina (vulvovaginitis)
• inflammations of the cervix of the uterus (cervicitis)
• increased vaginal discharge due to the presence of infections (infectious fluor).

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 any of the other ingredients of this medicine (listed in section 6).
• Falvin 600 mg soft vaginal capsules contains 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”). As a result, 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 a week or in case of 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 of age.
• You have any of the following symptoms:
• Abnormal or irregular vaginal bleeding.
• Trace of blood in vaginal discharge.
• Sores, ulcers or blisters of 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 eyes.

Children and adolescents
Falvin is not recommended in children under the age of 16 years.

Other medicines and Falvin
The fatty excipients and oils contained in the vaginal cream and soft vaginal capsules can
damage latex contraceptives, such as condoms and diaphragms (see section “Warnings and
precautions”).
The use of spermicides (substances inserted vaginally, which destroy sperm and are
used as contraceptives on their own or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment can inactivate a local contraceptive spermicide.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are breastfeeding, ask
your doctor for advice before using this medicine. Falvin should be used during pregnancy and
breastfeeding under the supervision of a doctor.
Falvin vaginal cream: the applicator should not be used during pregnancy.

Driving and using machines
Falvin does not impair the ability to drive and use machines.

Falvin vaginal cream contains:

• cetyl alcohol and hydrogenated lanolin which can cause localized skin reactions (e.g. contact dermatitis)
• 50 mg of propylene glycol per 1 g of cream.

Falvinvaginal solution contains:

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

Falvinsoft vaginal capsules contains:

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

3. How to use Falvin

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.

• Falvin vaginal creamThe recommended dose is the contents of the applicator (approximately 5 g). Introduce the contents of the applicator deeply into the vagina (see instructions for use). Apply Falvin cream using the applicator (washable and reusable) before bedtime, and if necessary also in the morning. To avoid reinfection, simultaneous local treatment (glans and foreskin) of the partner with Falvin cream is recommended.

Instructions for use:

• 1.Screw the applicator onto the tube in place of the cap.
• 2.Gently press the tube at its lower end to fill the applicator. If the piston offers some resistance, pull it gently. Unless otherwise prescribed by the doctor, fill the applicator completely.
• 3.Remove the applicator from the tube, which should be immediately closed with the cap.
• 4.In a lying position, with your knees bent and spread, gently insert the applicator into the vagina as deeply as possible. Push the piston in completely. Then withdraw the applicator without touching the piston.

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

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

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

• Falvin vaginal solutionThe recommended dose is 1-2 vaginal irrigations per day, for 7 days, as adjuvant therapy to other formulations for the prevention of recurrences.

Instructions for use:

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

Fig. 2Extract the cannula by holding it through the cap until it clicks into place.

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 to completely empty it; a special valve prevents the solution from returning into the bottle. Perform the irrigation preferably in a lying position. Slow irrigation promotes better medicated cleansing.

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

If you use more Falvin than you should
In the event that the vaginal capsules or vaginal cream or vaginal solution 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 make up for a 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 disappear quickly. When used as recommended, Falvin is absorbed only slightly and no
systemic side effects (effects involving the whole body) have been reported.
The use of topical medicines, especially if prolonged, can cause sensitisation (see the
“Warnings and precautions” section).
The following side effects have been reported with Falvin:

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

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

Frequency not known:

• hypersensitivity at the application site.

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 Falvin

Store at a temperature below 25°C.
Keep this medicine out of 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 Falvin contains
Falvin 2% vaginal 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.

Falvin 200 mg soft vaginal capsules

• The active ingredient is fenticonazole nitrate. 1 capsule contains 200 mg of fenticonazole nitrate.
• The other ingredients are triglycerides of saturated fatty acids, anhydrous colloidal silica. Constituentsof the capsule shell:gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Falvin 600 mg soft vaginal capsules

• The active ingredient is fenticonazole nitrate. 1 capsule contains 600 mg of fenticonazole nitrate.
• The other ingredients are liquid paraffin, white petrolatum, soybean lecithin. Constituentsof the capsule shell:gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Falvin 0.2% vaginal solution

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

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

• 2% vaginal cream. The package contains a 78 g tube with 1 applicator.
• 200 mg soft vaginal capsules. The package contains 6 capsules.
• 600 mg soft vaginal capsules. The package contains 2 capsules.
• 0.2% vaginal solution. The package contains 5 bottles of 150 ml equipped with a single-use applicator.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milano.

Manufacturer
Falvin vaginal cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milano.
Vamfarma S.r.l. - via Kennedy, 5 - 26833 Comazzo (LO).

Falvin vaginal solution
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR).

Falvin soft vaginal capsules
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT).

Falvin 1000 mg soft vaginal capsules

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 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 “antimicrobial and gynecological antiseptics”.
Falvin is used for the treatment of the following conditions:

• infections of the vagina caused by a microorganism called Trichomonas vaginalis(vaginal trichomoniasis
• infections of the vagina caused in a mixed form by two microorganisms called Trichomonas vaginalisand Candida albicans
• infections of the mucous membranes of the genital organs caused by a fungus called Candidasuch as:
• inflammations of the vulva and vagina (vulvovaginitis)
• inflammations of the cervix of the uterus (cervicitis)
• increased vaginal discharge due to the presence of infections (infectious fluor).

Contact 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 any of the other ingredients of this medicine (listed in section 6).
• Falvin 1000 mg soft gelatin vaginal capsules contains 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 “Pregnancy, breastfeeding and fertility” section).
• You are using a “barrier” latex contraceptive method (see “Other medicines and Falvin” section). Consequently, you should use alternative precautions while using this product.
• You are using spermicides, vaginal douches or other vaginal products (see “Other medicines and Falvin” section).
• You experience any irritation or sensitivity to the medicine.
• Your symptoms do not improve within a week or in case of 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.
• Trace of blood in vaginal discharge.
• Sores, ulcers or blisters of 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 in children under the age of 16.

Other medicines and Falvin
The fatty excipients and oils contained in the soft gelatin vaginal capsules can damage latex contraceptives, such as condoms and diaphragms (see “Warnings and precautions” section).
The use of spermicides (substances inserted vaginally, which destroy sperm and are
used as contraceptives on their own or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment can inactivate a local contraceptive spermicide.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are breastfeeding, ask
your doctor for advice before using this medicine. Falvin should be used during pregnancy and
breastfeeding under the supervision of a doctor.

Driving and using machines
Falvin does not impair the ability to drive and use machines.

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 following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In vaginal infections caused by Trichomonasand in those mixed (Trichomonasand Candida)the recommended dose is:

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

In infections caused by Candidathe recommended dose is:

• 1 soft vaginal capsule of 1000 mg in the evening in a single administration. In case of persistence of symptoms, a second administration may be repeated after 3 days.

Instructions for use:
The 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 in children aged 16 years and over is the same as for adults.

If you use more Falvin than you should
In the event that the vaginal capsules are taken by mouth 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 a 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 everybody gets them.
When the medicine is inserted into the vagina, a slight burning sensation may occur, which
will disappear quickly. When used as recommended, Falvin is absorbed only slightly and no
systemic side effects (effects involving the whole body) are reported.
The use of topical medicines, especially if prolonged, can cause sensitization (see the
“Warnings and precautions” section).
The following side effects have been reported with Falvin:

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

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

Frequency not known:

• hypersensitivity at the application site

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

Store at a temperature 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 pack after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 Falvin contains

• The active ingredient is fenticonazole nitrate. 1 capsule contains 1000 mg of fenticonazole nitrate.
• The other ingredients are liquid paraffin, white petrolatum, soybean lecithin. Constituentsof the capsule shell:gelatin, glycerin, titanium dioxide, sodium ethylparaben, sodium propylparaben.

Description of the appearance of Falvin and contents of the pack
Falvin is presented in the form of 1000 mg soft vaginal capsules. The pack contains 2 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milano.

Manufacturer
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT).