TRAVOGEN 1% Vaginal cream

Зміст інструкції

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

Travogen 1% cream

isoconazole 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 you feel worse.

Contents of this leaflet:

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

1. What is Travogen and what is it used for

Travogen is a topical antifungal, i.e. a medicine that acts locally against fungi that
cause skin infections (mycoses).
Travogen is used to treat superficial mycoses (dermatophytoses, ringworm, candidiasis, pityriasis versicolor) and
erythrasma (which manifests with brownish patches on the skin).
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using Travogen

Do not use Travogen

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

Warnings and precautions
Consult your doctor or pharmacist before using Travogen.
Avoid contact with eyes.
Wash your hands thoroughly after using the medicine.
In case of lesions between the fingers, insert a gauze pad soaked in Travogen cream.
To ensure the success of the treatment, strictly observe some hygiene rules:

• dry the spaces between the fingers carefully, in case of mycosis localized to the feet
• keep towels and underwear separate for personal use in order to avoid infecting other people;
• change clothes that come into contact with the infected area regularly to avoid re-infection. If Travogen is applied to the genital area, some of its components may damage latex products such as condoms or diaphragms, so they may no longer be effective. The use, especially if prolonged, of topical products can give rise to sensitization phenomena (allergy). In such a case, discontinue treatment and consult your doctor to establish appropriate therapy.

Paediatric population
The use of the medicine in infants (0-2 years) is not recommended unless in cases of actual need and under
strict medical control, as data in subjects of this age are very limited.
The effect of isoconazole if ingested, for example following suction of the treated part,
is not known.

Other medicines and Travogen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are breastfeeding and use Travogen as prescribed by your doctor, do not apply
Travogen to the nipples to avoid the infant ingesting it.

Driving and using machines
Travogen does not impair the ability to drive and operate machinery.

Travogen contains cetostearyl alcohol
This medicine contains cetostearyl alcohol which may cause local skin reactions (e.g.
contact dermatitis).

3. How to use Travogen

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.
Unless otherwise prescribed by your doctor, the recommended dose is 1 application per day to the affected areas of the skin.
Local treatment of fungal infections should generally last 2-3 weeks, and sometimes even 4 weeks in difficult cases, especially in the interdigital spaces. According to a specific medical prescription, treatments of even longer duration are possible.
To avoid relapses, it is advisable to continue treatment for at least 2 weeks after clinical healing.
Regular hygiene is essential for the success of treatment with Travogen (see section “Warnings and precautions”).

Paediatric population
No dosage adjustments are necessary when Travogen is administered to infants, children and adolescents.
Although clinical experience in the paediatric population is much more limited, the medicine can be used in subjects of this age group as directed by the doctor.

If you use more Travogen than you should
No risks of acute intoxication are known following a single cutaneous application of an excessive amount of the medicine (application to a large surface area under conditions that favour absorption).
In case of accidental ingestion of an excessive dose of Travogen, immediately inform your doctor or go to the nearest hospital.

If you forget to use Travogen
Do not use a double dose to make up for a missed dose, but simply apply the next dose, continuing treatment as prescribed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are listed according to their frequency:

Common: may affect 1 in 10 people

• Skin irritation, burning sensation at the application site.

Uncommon: may affect 1 in 100 people

• Itching, dryness at the application site; rash (eczema) with exudation, blisters containing fluid (dyshidrosis), skin inflammation (contact dermatitis).

Rare: may affect 1 in 1,000 people

• Swelling of the application site, skin cracking.

Frequency not known

• Redness (erythema), blisters at the application site, allergic skin reaction.

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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Travogen

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 packaging. The expiry date refers to the last day of that month. The expiry date indicated refers to the product
in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
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 Travogen contains

• The active ingredient is isoconazole nitrate. 1 g of Travogen contains 10 mg (1%) of isoconazole nitrate.
• The other ingredients are: polysorbate 60, sorbitan stearate, cetostearyl alcohol, white petrolatum, liquid paraffin, purified water.

Description of the appearance of Travogen and contents of the pack
Cream, tube containing 20 g.

Marketing Authorisation Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.

Manufacturer
LEO Pharma Manufacturing Italy S.r.l. - Via E. Schering, 21 - 20090 Segrate (MI), Italy.
Distributor in Italy:
LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Roma.

Travogen 1% vaginal cream

isoconazole nitrate

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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist or doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, or pharmacist or nurse. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse.

Contents of this leaflet:

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

1. What is Travogen and what is it used for

Travogen is an antifungal (antimycotic) medicine.
Travogen is used to treat fungal (mycotic) vulvovaginal infections.
This medicine can also be used in the partner for prophylactic purposes.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using Travogen

Do not use Travogen

• if you are allergic to isoconazole nitrate, to other imidazole antifungal derivatives or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist or nurse before using Travogen. When using Travogen it is
important to know:
Avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.

• If the skin around the vagina needs to be treated or if preventive treatment for your partner is necessary, it is recommended to use Travogen cream.
• During and in the weeks following treatment, avoid vaginal cleansing with water (douches).
• During treatment of vaginal mycoses and in the days immediately following, to avoid reinfection, change towels and underwear (preferably cotton) daily and sterilize them by boiling.
• For the same reason, consult your doctor about the possibility of simultaneous local treatment of the partner.
• The use, especially if prolonged, of topical products can cause sensitization reactions (allergies). In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
• Some of the components of Travogen may damage latex products such as preservatives or diaphragms. Consequently, these may no longer be effective as contraceptives or in preventing sexually transmitted diseases such as HIV infections. Consult your doctor or pharmacist if you need more information.

Other medicines and Travogen
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions between Travogen and other medicines are known to date. However, it is advisable to inform
your doctor if you are taking:

• Medicines to thin the blood (anticoagulants) such as warfarin.

Cross-sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Experience with the use of preparations containing isoconazole during pregnancy does not indicate that there
are risks of birth defects (teratogenic effects) in humans. If you are pregnant, use
the single-use applicator with caution and only as directed by your doctor.

Breastfeeding
It is not known whether the active ingredient of Travogen vaginal cream passes into breast milk. The risk to
the infant cannot be excluded.

Fertility
There is no data to demonstrate that fertility is impaired by the use of Travogen.

Driving and operating machinery
Isoconazole nitrate does not affect the ability to drive and operate machinery.

Travogen contains cetostearyl alcohol
This medicine contains cetostearyl alcohol which can cause local skin reactions (e.g.
contact dermatitis).

3. How to use Travogen

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The single-use applicator is used to insert the cream deeply into the vagina. This is
preferable before bedtime and in a supine position, with legs slightly bent.
Treatment should not be carried out during the menstrual period.
If you are pregnant, use the applicator device with caution and only as directed by your
doctor.
If your doctor prescribes treatment for your partner for prevention purposes, the cream should be applied
to the genital organ, in particular to the glans and prepuce, twice a day for about a week.
For correct application of Travogen, perform the following operations:

• first remove the cap from the tube and screw the applicator onto the open tube;
• push the plunger progressively until it reaches the stop position;
• fill the applicator by applying slight pressure to the tube;
• unscrew the applicator from the tube and close the tube with its cap;
• insert the applicator deeply into the vagina and empty it into the cavity, gently pushing the plunger.

7-day treatment: the cream is applied once a day for 7 consecutive days.
If you think that the effect of Travogen is too strong or too weak, contact your doctor or pharmacist.

Use in children or adolescents
No dose adjustment is necessary when Travogen is used in adolescents (over
15 years of age).

If you use more Travogen than you should
In case of excessive application or accidental ingestion of Travogen, it is unlikely to
be dangerous. Immediately inform your doctor or pharmacist if this worries you.

If you forget to use Travogen:
Do not use a double dose to make up for the missed dose. When you remember, simply
use the next dose and continue treatment as prescribed.
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.
The following side effects are listed according to their frequency:
Common: may affect up to 1 in 10 people

• burning, itching or irritation at the application site

Uncommon: may affect up to 1 in 100 people

• Feeling unwell (nausea), dizziness, headache or vaginal discharge Rare: may affect up to 1 in 1000 people:
• rash at the application site Not known: the frequency cannot be estimated based on the available data
• Blisters, pain, swelling (edema), or redness (erythema) in the vagina and external female genital organs; hypersensitivity (allergy) at the application site.
• pelvic cramps, headache.

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 www.agenziafarmaco.gov.it/it/responsabili . By reporting side
effects you can help provide more information on the safety of this medicine.
Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
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. Contents of the pack and other information

What Travogen contains

• The other ingredients are: polysorbate 60, sorbitan stearate, cetostearyl alcohol, white petrolatum, liquid paraffin, purified water.

Description of the appearance of Travogen and contents of the pack
Vaginal cream, opaque, from white to light straw-yellow in colour, in a 30 g tube + 6 single-use applicators.

Marketing Authorisation Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.

Manufacturer
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering, 21 - 20090 Segrate (MI), Italy.
Marketing Authorisation Holder in Italy:
LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome.