GINETANTUM 500 mg Vaginal Solution

Зміст інструкції

1. GINETANTUM 500 mg granules for cutaneous solution for external genitals
   1. What is Ginetantum and what is it used for
   2. What you need to know before you take Ginetantum
   3. How to take Ginetantum
   4. Possible side effects
   5. How to store Ginetantum
   6. Contents of the pack and other information
2. GINETANTUM 0,1% vaginal solution
   1. What is Ginetantum and what is it used for
   2. What you need to know before taking Ginetantum
   3. How to take Ginetantum
   4. Possible side effects
   5. How to store Ginetantum
   6. Contents of the pack and other information

GINETANTUM 500 mg granules for cutaneous solution for external genitals

Benzydamine hydrochloride

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

• 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 7 days of treatment.

Contents of this leaflet:

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

1. What is Ginetantum and what is it used for

Ginetantum contains the active ingredient benzydamine hydrochloride, a non-steroidal anti-inflammatory drug.
Ginetantum is used for:

• local treatment of the external genitalia in case of inflammation of the vulva and vagina (e.g. vulvovaginitis) of any origin and nature characterized by slight vaginal discharge, itching, irritation, burning and pain,
• intimate hygiene in the postpartum period (puerperium).

If you do not observe appreciable results after 7 days of treatment, consult your doctor.

2. What you need to know before you take Ginetantum

Do not take Ginetantum

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

Warnings and precautions
Consult your doctor or pharmacist before taking Ginetantum.
Do not use Ginetantum in case of vaginal bleeding and/or whitish vaginal discharge (leucorrhea) without first consulting your doctor.
Ginetantum must be used locally for washing the external genitals. DO NOT INGEST (see
section “If you take more Ginetantum than you should”).
The use of Ginetantum, especially if prolonged, may lead to sensitization phenomena (allergic
reactions). In this case, discontinue treatment and consult your doctor to start appropriate therapy (see
section 4 “Possible side effects”).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking any medicine.
Do not use Ginetantum during pregnancy unless clearly necessary and as directed by
your doctor. If treatment is necessary, the lowest dose should be used for the shortest possible time.
Ginetantum can be used during breastfeeding.

Driving and operating machinery
The use of Ginetantum does notalter the ability to drive vehicles or operate machinery.

3. How to take Ginetantum

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 washes of the external genitals per day, for 7 consecutive days.
Do not exceed the indicated doses without the advice of your doctor.
Dissolve the contents of 1-2 sachets in 1 liter of water to be used for washing the external genitals.
Do not use Ginetantum for more than 7 days.
See your doctor if the discomfort persists for more than 7 days, if it occurs repeatedly, or if you notice any recent change in its characteristics.

If you take more Ginetantum than you should
Ginetantum must be used only for washing the external genitals. With the correct use of the medicine, no cases of overdose have been reported.
Ginetantum must not be ingested. If you accidentally ingest the medicine, consult your doctor or pharmacist immediately.

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

If you stop taking Ginetantum
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.
While taking Ginetantum, skin irritation may occasionally be observed, especially with prolonged use.
In this case, consult your doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Ginetantum

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. 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 Ginetantum containsGranules for cutaneous solution for external genitals

• the active ingredient is: benzydamine hydrochloride (each sachet contains 500 mg of benzydamine hydrochloride equivalent to 447.3 mg of benzydamine)
• the other ingredients are: trimethylcetylammonium p-toluenesulfonate, sodium chloride, povidone.

Description of the appearance of GinetantumGranules for cutaneous solution for external genitals

and contents of the pack
It is presented in the form of granules to be dissolved in water for local use on the external genitals.
The granules are contained in sachets. Each pack contains 10 sachets.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
FINE FOODS & PHARMACEUTICALS NTM S.p.A., Via Grignano, 43 – 24041 Brembate (BG)

INDICATIONS
Inflammations affecting the lower parts of the female genital tract are generally
defined by the terms vulvitis (inflammation of the vulva) or vulvovaginitis (inflammation of the vulva and vagina).
Vulvitis can be caused by various conditions: the transmission of sexually transmitted infections or more
frequently poor hygiene. To avoid the onset of vulvitis, therefore, it is good to constantly
maintain adequate hygiene of the external genitals.
Vulvitis, accompanied by abundant whitish and/or malodorous vaginal discharge or the
frequent recurrence of various episodes of vulvitis require medical intervention.

GINETANTUM 0,1% vaginal solution

Benzydamine hydrochloride

Read this leaflet carefully before you start 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.

• Keep this leaflet. You may need to read it again.
• If you want any further 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.
• Talk to your doctor if your symptoms do not improve or get worse after 7 days of treatment.

Contents of this leaflet:

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

1. What is Ginetantum and what is it used for

Ginetantum contains the active ingredient benzydamine hydrochloride, a non-steroidal anti-inflammatory drug.
Ginetantum is used for:

• the local treatment of inflammation of the vulva and vagina (e.g. vulvovaginitis) of any origin and nature, characterized by slight vaginal discharge, itching, irritation, burning and pain,
• intimate hygiene in the period after childbirth (puerperium).

If you do not observe appreciable results after 7 days of treatment, consult your doctor.

2. What you need to know before taking Ginetantum

Do not take Ginetantum

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Ginetantum.
Do not use Ginetantum in case of vaginal bleeding and/or whitish vaginal discharge (leucorrhoea) without first consulting your doctor.
The use of Ginetantum, especially if prolonged, may lead to sensitization phenomena (allergic reactions). In this case, discontinue treatment and consult your doctor to start appropriate therapy (see section 4 “Possible side effects”).
Ginetantum must be used only for vaginal irrigations and must not be ingested (see section “If you take more Ginetantum than you should”).

Other medicines and Ginetantum
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No negative interactions between Ginetantum and other drugs commonly used in relevant therapy have been observed.

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 taking any medicine.
Do not use Ginetantum during pregnancy unless clearly necessary and as directed by your doctor. If treatment is necessary, the lowest dose should be used for the shortest possible time. Ginetantum can be used during breastfeeding.

Driving and operating machinery
The use of Ginetantum does notalter the ability to drive vehicles or operate machinery.

Ginetantum contains benzalkonium
This medicine contains 28 mg of benzalkonium chloride per vial equivalent to 28 mg/140 ml.
Benzalkonium chloride may cause local irritation.
This medicine contains rose base fragrance which in turn contains benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool, D-limonene.
Benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, linalool, D-limonene may cause allergic reactions.
This medicine contains 107.8 mg of alcohol (ethanol) in 140 ml which is equivalent to 1.54 mg/kg.
May cause a burning sensation on damaged skin.

3. How to take Ginetantum

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.
The recommended dose is 1-2 vaginal irrigations per day, for seven consecutive days.
Caution: do not exceed the indicated doses without the advice of your doctor.
The solution can be used at room temperature. If you want to warm the solution, expose the closed
bottle to a stream of warm water for a few minutes.

• 1. To open the bottle, hold the knurled ring firmly and rotate the cap to break the safety seal, as illustrated in the figure below:

• 2. Extract the cannula until you feel a click, as illustrated in the figure below. The cannula remains attached to the bottle and therefore only complete extraction allows the liquid to flow out.
• 3. Gently insert the cannula into the vagina and compress the bottle until it is empty. Emptying can be gradual and adjusted as needed, as a special valve prevents the solution from flowing back into the bottle. Perform the irrigation while lying down if possible. The liquid should be retained in the vagina for a few minutes.

Do not use Ginetantum for more than 7 days.
See your doctor if the disorder persists for more than seven days, if it occurs repeatedly, or if you notice any
recent change in its characteristics.

If you take more Ginetantum than you should
Ginetantum must be used only for vaginal irrigations. With the correct use of the medicine, no cases of overdose have been
reported.
Ginetantum must not be ingested. If you accidentally ingest the medicine, consult your doctor or pharmacist immediately.

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

If you stop taking Ginetantum
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.

During the use of Ginetantum, skin irritation may occasionally be observed, especially with prolonged use.
In this case, consult your doctor immediately.

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 Ginetantum

Keep this medicine out of sight and reach of children.
Keep the bottle in an upright position.
Do not use this medicine after the expiry date which is stated on the packaging. 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 Ginetantum contains

• the active ingredient is: benzydamine hydrochloride (100 ml of solution contains 100 mg of benzydamine hydrochloride equivalent to 89.46 mg of benzydamine)
• the other ingredients are: benzalkonium chloride(see paragraph Ginetantum contains benzalkonium chloride), disodium edetate, rose base fragrance (see paragraph “GINETANTUM 500 mg/10 ml concentrate contains rose base fragrance”) and purified water.

Description of the appearance of Ginetantum and contents of the pack
Ginetantum is presented as a solution for vaginal use, in 140 ml bottles equipped with a cannula.
Each pack contains 1 or 5 bottles of 140 ml.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 Rome

Manufacturer
A.C.R.A.F. S.p.A.,
Via Vecchia del Pinocchio, 22
60131 Ancona

NDES
Inflammations affecting the lower parts of the female genital tract are generally
defined by the terms vulvitis (inflammation of the vulva) or vulvovaginitis (inflammation of the vulva and the
vagina).
Vulvitis can be caused by various conditions: transmission of sexually transmitted infections or more
frequently poor hygiene. To avoid the onset of vulvitis, therefore, it is good to constantly maintain
adequate hygiene of the external genitalia.
Vulvitis, accompanied by abundant whitish and/or malodorous vaginal discharge or the
frequent recurrence of various episodes of vulvitis, requires medical intervention.