МИКОТЕФ 2% Вагинальный крем

Содержание инструкции

1. MICOTEF 2 % cutaneous cream
   1. What is MICOTEF cutaneous cream and what is it used for:
   2. What you need to know before using MICOTEF cutaneous cream:
   3. How to use MICOTEF cutaneous cream
   4. Possible side effects
   5. How to store MICOTEF cutaneous cream
2. MICOTEF 100 mg vaginal suppositories
   1. What is Micotef vaginal suppositories and what is it used for
   2. What you need to know before using Micotef vaginal suppositories
   3. How to use Micotef vaginal ovules
   4. Possible side effects
   5. How to store Micotef vaginal ovules
   6. Contents of the pack and other information
3. MICOTEF 2% vaginal cream
   1. What is Micotef vaginal cream and what is it used for
   2. What you need to know before using Micotef vaginal cream
   3. How to use Micotef vaginal cream
   4. Possible side effects
   5. How to store Micotef vaginal cream
   6. Contents of the pack and other information
4. MICOTEF 2 % oral gel
   1. What is MICOTEF oral gel and what is it used for:
   2. What you need to know before you take MICOTEF oral gel:
   3. How to take MICOTEF oral gel
   4. Possible side effects
   5. How to store MICOTEF oral gel
5. MICOTEF 0.2% vaginal solution
   1. What is Micotef vaginal solution and what is it used for
   2. What you need to know before using Micotef vaginal solution
   3. How to use Micotef vaginal solution
   4. Possible side effects
   5. How to store Micotef vaginal solution
   6. Contents of the pack and other information

MICOTEF 2 % cutaneous cream

Miconazole

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is MICOTEF cutaneous cream and what is it used for:

MICOTEF cutaneous cream is an antifungal for dermatological use. It is used for the treatment of
skin and
nail infections caused by dermatophytes and Candida. Due to its antibacterial activity against gram-positive bacteria,
MICOTEF cutaneous cream can be used for the treatment of fungal infections with superinfections
caused by these microorganisms.

2. What you need to know before using MICOTEF cutaneous cream:

Do not use MICOTEF cutaneous cream:
If you are allergic to the active ingredient or other similar antifungal medicines or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Topical preparations, especially if used for prolonged treatments, can cause
sensitization phenomena. If this happens, it is necessary to interrupt the treatment and establish
suitable therapy.
Avoid contact with eyes. Wash your hands thoroughly after each application, unless
the treatment involves the hands themselves. It is advisable to apply the following hygienic measures
to avoid sources of infection or
reinfection:

• keep towels and underwear for personal use to avoid infecting other people;
• change clothes that come into contact with the infected area regularly to avoid reinfection;
• disinfect socks and shoes. MICOTEF cutaneous cream does not stain the skin or clothing Other medicines and MICOTEF cutaneous creamInform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In patients treated with oral anticoagulants, such as warfarin, caution is required and monitoring of the anticoagulant action is necessary. The effectiveness and side effects of other drugs (for example oral hypoglycemic agents and phenytoin), if administered simultaneously with miconazole, may be increased and therefore particular caution is required. Pregnancy and breastfeedingIf 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 this medicine. PregnancyIn pregnant women and during breastfeeding, the product should only be used in case of actual need, under the direct control of the doctor. BreastfeedingThere are no data on the excretion of miconazole in breast milk, so great caution should be exercised when using Micotef cutaneous cream during breastfeeding. Effects on ability to drive and operate machineryMicotef cutaneous cream does not impair the ability to drive vehicles or operate machinery.

3. How to use MICOTEF cutaneous cream

Skin infections
Apply 1 cm of cream (or more depending on the extent of the lesion) to the lesion 1-2 times a day, then spread with your fingers.

Nail infections
Cut the infected nails as short as possible. Apply a little cream 1-2 times a day to the infected nail, then spread with your fingers; cover the nail with an occlusive, non-perforated bandage.
Continue treatment uninterruptedly, even after the infected nail falls off (usually after 2-3 weeks), until it has completely regrown and the lesions have definitively healed (usually after 2 months or more).

If you use more MICOTEF cutaneous cream than you should:
In case of ingestion/accidental intake of an excessive dose of Micotef cutaneous cream, immediately inform your doctor or go to the nearest hospital. Excessive use of MICOTEF cutaneous cream may cause skin irritation which generally disappears with discontinuation of therapy. In case of ingestion/accidental intake of large quantities of MICOTEF cutaneous cream, adopt, if necessary, an appropriate method of gastric emptying. There is no specific antidote.

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

If you stop using MICOTEF cutaneous cream
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, MICOTEF cutaneous cream may cause side effects, although not everyone will experience them.
Use, especially if prolonged, of the product may give rise to sensitization phenomena. In such
cases it is necessary to interrupt the treatment and establish suitable therapy. Respect of the
contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate as excipients, therefore it may
cause allergic reactions (even delayed).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact 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.

5. How to store MICOTEF cutaneous cream

Keep this medicine out of the sight and reach of children. MICOTEF cutaneous cream
does not require any particular precautions for storage. Do not use this medicine after
the expiry date stated on the packaging. The expiry date refers to the last day of
that month and to the product in intact packaging,
correctly stored.
Caution: do not use the medicine after the expiry date stated on the packaging. Do not use
this medicine if you notice visible signs of deterioration.
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 MICOTEF cutaneous cream contains:
100 g of cutaneous cream contains:

Active ingredient: miconazole 2 g

Other ingredients:
lecithin, cholesterol, propylene glycol, butylhydroxytoluene, methyl parahydroxybenzoate, propyl p-
hydroxybenzoate, sodium chloride, sodium hydroxide, sodium edetate, citric acid monohydrate,
hypromellose, purified water.

Description of the appearance of MICOTEF and contents of the pack
MICOTEF cream is presented in the form of a cream for topical use, contained in a tube of 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Teofarma S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A - 27100 Pavia

MICOTEF 100 mg vaginal suppositories

miconazole nitrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

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

Contents of this leaflet:

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

1. What is Micotef vaginal suppositories and what is it used for

Micotef vaginal suppositories is a gynecological antiseptic and anti-infective medicine. It is used for
the treatment of mycotic (pure or mixed) and Gram-positive bacterial vulvo-vaginal infections (primary or
secondary).

2. What you need to know before using Micotef vaginal suppositories

Do not use Micotef vaginal suppositories:
If you are allergic to the active ingredient or other similar antifungal medicines or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Topical preparations, especially if used for prolonged treatments, can cause
sensitization phenomena. In these cases, it is necessary to interrupt the treatment and establish
appropriate therapy.
It is advisable to adopt adequate preventive hygiene measures in order to limit the possibility of
infection or reinfection.
Appropriate therapy should also be followed by the partner if they have been infected.
Micotef vaginal suppositories does not stain the skin and clothing
Micotef should not be used simultaneously with latex condoms or diaphragms. Micotef
may damage latex-based products and prevent them from working properly.

Special warnings
Contact with certain latex products, such as diaphragm or condom contraceptives, and Micotef vaginal suppositories should be avoided, as the rubber could be
damaged by the emollient base. In such situations, the use of gynecological cream
may be recommended.

Other medicines and Micotef vaginal suppositories
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Be careful and tell your doctor if you are using:

• medicines that make the blood more fluid (oral anticoagulants) as this association may increase the risk of bleeding. Pregnancy and breastfeedingPregnancyIf you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. In pregnant women and during breastfeeding, the product should be administered only when absolutely necessary, under the direct supervision of a doctor. BreastfeedingNo data are available regarding the excretion of miconazole nitrate in breast milk, so extreme caution should be exercised when administering Micotef during breastfeeding. Driving and using machinesMicotef vaginal suppositories does not impair the ability to drive vehicles or operate machinery.

3. How to use Micotef vaginal ovules

Insert 1 ovule into the vagina in the morning and 1 in the evening before bedtime, or as directed by your doctor. The
treatment should be continued for at least 15 days. Simultaneous
treatment of the partner with an antifungal dermatological cream is recommended.

If you take more Micotef vaginal ovules than you should:
In case of ingestion/accidental intake of an excessive dose of Micotef vaginal ovules
immediately inform your doctor or go to the nearest hospital.
No cases of intoxication or overdose have been reported. In case of accidental ingestion
no particular problems are expected. However, if this occurs in conjunction with
taking other medications, such as medications that thin the blood
(oral anticoagulants), medications to treat epilepsy (phenytoin), and medications to lower
blood glucose levels (oral hypoglycemic agents), consult your doctor.
If accidental ingestion of large amounts of the drug occurs, adopt, if
necessary, an appropriate method of gastric emptying.

If you forget to use Micotef vaginal ovules
Do not take a double dose to make up for the missed dose.

If you stop using Micotef vaginal ovules
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Micotef vaginal ovules may cause side effects, although not everybody gets them.
Some disturbances such as vaginal burning and irritation, redness and itching,
pelvic cramps and, more rarely, headache and skin rashes have been reported. In these cases it is necessary
to stop the treatment and establish appropriate therapy.

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

5. How to store Micotef vaginal ovules

Do not store at a temperature above 25°C. Keep this medicine out of sight and
reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date
refers to the last day of that month and to the product in intact packaging,
correctly stored.
Caution: do not use the medicine after the expiry date stated on the packaging. Do not use
this medicine if you notice visible signs of deterioration.
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 Micotef vaginal ovules contain
One vaginal ovule contains:
Active ingredient: Miconazole nitrate 100 mg
Other ingredients:
Solid semisynthetic glycerides.

Description of the appearance of Micotef vaginal ovules and contents of the pack
Micotef vaginal ovules are presented in a pack containing 15 white vaginal ovules

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l. - Viale Certosa, 8/A - 27100 Pavia

MICOTEF 2% vaginal cream

Miconazole nitrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

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

Contents of this leaflet:

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

1. What is Micotef vaginal cream and what is it used for

Micotef vaginal cream is an antifungal and antiseptic gynecological medicine. It is used for
the treatment of mycotic (pure or mixed) vulvo-vaginal infections and by Gram-positive bacteria (primary or
secondary).

2. What you need to know before using Micotef vaginal cream

Do not use Micotef vaginal cream
If you are allergic to the active ingredient or other similar antifungal medicines or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Topical preparations, especially if used for prolonged treatments, may cause
sensitization phenomena. In these cases it is necessary to interrupt the treatment and establish
appropriate therapy.
It is advisable to adopt adequate hygiene measures to limit the possibility of
infection or reinfection.
Appropriate therapy should also be followed by the partner if they have been infected.
Micotef vaginal cream does not stain the skin or clothing.
Micotef should not be used simultaneously with latex condoms or diaphragms. Micotef
may damage latex-based products and prevent them from working correctly.

Other medicines and Micotef vaginal cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Be careful and tell your doctor if you are using:

• medicines that make the blood more fluid (anticoagulants) as this association may increase the risk of bleeding Pregnancy and breastfeedingIf 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 this medicine. PregnancyIn pregnant women and during breastfeeding, the product should be administered only when absolutely necessary, under the direct supervision of a doctor. BreastfeedingNo data are available regarding the excretion of miconazole nitrate into breast milk, therefore extreme caution should be exercised when administering Micotef during breastfeeding. Driving and using machinesMicotef vaginal cream does not impair the ability to drive vehicles or operate machinery.

3. How to use Micotef vaginal cream

Introduce deeply into the vagina the contents of the applicator (approximately 5 g of cream) once a day, preferably in the evening before going to bed.
The treatment should be continued for at least 10-15 days, even after the disappearance of
itching and leucorrhea (vaginal discharge of whitish loss).
The introduction of the vaginal applicator is painless and easy to perform.

Instructions for use:
After piercing the tube closure with the tip of the cap, screw the applicator onto the tube
and fill it, applying slight pressure to the end of the tube. Unscrew the applicator from the tube
and introduce it deeply into the vagina (it is preferable to assume a lying position, knees spread and raised) and push the plunger to the bottom of the cylinder.
Wash the applicator with warm water and mild soap after each use.
Micotef does not stain the skin or laundry.

If you take more Micotef vaginal cream than you should:
In case of ingestion/accidental intake of an excessive dose of Micotef cream, immediately inform your doctor or go to the nearest hospital.
No cases of intoxication or overdose have been reported.
In case of accidental ingestion, no particular problems are expected. However, if this occurs
concurrently with the intake of other drugs, for example, medicines that make the blood more
fluid (anticoagulants), medicines to treat epilepsy (phenytoin) and medicines to lower
blood glucose levels (oral hypoglycemic agents), consult your doctor.
If accidental ingestion of large quantities of the drug occurs, adopt, if
necessary, an appropriate method of gastric emptying.

If you forget to use Micotef vaginal cream
Do not take a double dose to make up for the missed dose.

If you stop using Micotef vaginal cream
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Micotef cream may cause side effects, although not everyone will experience them.
Some disorders such as burning and vaginal irritation, redness and itching,
pelvic cramps and, more rarely, headache and skin rashes have been reported. In these cases it is necessary
to discontinue treatment and establish appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact 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.

5. How to store Micotef vaginal cream

Do not store at a temperature above 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. The expiry date
refers to the last day of that month and the product in intact packaging,
correctly stored.
Caution: do not use the medicine after the expiry date stated on the packaging. Do not use
this medicine if you notice visible signs of deterioration.
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 Micotef vaginal cream contains
100 g of vaginal cream contains:

Active ingredient
miconazole nitrate 2 g

Other components:
butylhydroxyanisole, benzoic acid, polyoxyethylene oleic glyceride, liquid paraffin,
polyethylene glycol, palmitostearate, purified water.

Description of the appearance of Micotef vaginal cream and contents of the pack
Micotef cutaneous cream is presented in a pack containing 1 tube of 30 g of vaginal cream
+ applicator.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A - 27100 Pavia

MICOTEF 2 % oral gel

Miconazole

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• Always take this medicine exactly as described in this leaflet or as your doctor has told you to.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is MICOTEF oral gel and what is it used for:

Micotef oral gel is an anti-infective medicine and belongs to the category of stomatological drugs.
It is indicated for the treatment of oral candidiasis (Candida infection of the mouth and throat): stomatitis and thrush.

2. What you need to know before you take MICOTEF oral gel:

Do not take MICOTEF oral gel:

• If you are allergic to the active ingredient or other similar antifungal medicines or to any of the other ingredients of this medicine (listed in section 6).
• In infants under 6 months of age or in whom swallowing is not yet sufficiently developed
• In patients with liver disease
• In patients who are receiving other drugs metabolized by the same route concurrently, in particular: o Mizolastine, pimozide, quinidine, sertindole o Ergot alkaloids o HMG-CoA reductase inhibitors such as simvastatin and lovastatin o Triazolam and midazolam. Warnings and precautionsIn case of concomitant use of Micotef oral gel and oral anticoagulants, such as warfarin, the anticoagulant effect should be carefully monitored. Particular attention should be paid when administering Micotef oral gel to infants over 6 months of age and children to prevent the gel from obstructing the throat. For this reason, the gel should not be applied to the throat and it is advisable to divide each dose into smaller portions and monitor the patient to avoid possible choking. Other medicines and MICOTEF oral gelInform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effectiveness and side effects of other medicines, if administered simultaneously with miconazole, may be increased and therefore particular caution is required. If necessary, their dosage should be reduced and, possibly, their plasma levels monitored:
• Oral anticoagulants such as warfarin
• Oral hypoglycemic agents such as sulfonylureas
• Phenytoin
• HIV protease inhibitors such as saquinavir
• Some antineoplastic agents such as vinca alkaloids, busulfan and docetaxel
• Some calcium channel blockers such as dihydropyridines and verapamil
• Some immunosuppressant agents: cyclosporine, tacrolimus, sirolimus (rapamycin)
• Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazol, disopyramide, ebastine, methylprednisolone, midazolam, reboxetine, rifabutin, sildenafil and trimetrexate. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. PregnancyIn pregnant women and during breastfeeding, the product should be administered only when absolutely necessary, under the direct control of the doctor. BreastfeedingThere are no data on the excretion of miconazole in breast milk, so great caution should be exercised when administering Micotef oral gel during breastfeeding.

Effects on ability to drive and operate machinery
Micotef oral gel does not impair the ability to drive vehicles or operate machinery.

3. How to take MICOTEF oral gel

Infants: ¼ of a measuring spoon 4 times a day after meals.

Children and Adults: ½ measuring spoon 3-4 times a day after meals.
Spread the gel on the mucous membrane in such a way as to allow the miconazole to come into contact with the infected areas
of the oral cavity, taking care to keep the gel in the mouth for as long as possible. Continue the
treatment for at least one week after the
symptoms disappear.

If you take more MICOTEF oral gel than you should:
In case of ingestion/accidental intake of an excessive dose of Micotef oral gel, immediately inform your doctor or go to the nearest hospital.
In case of accidental overdose, vomiting and diarrhea may occur. In the event of
accidental ingestion of large amounts of MICOTEF oral gel, adopt, if necessary, an
appropriate method of gastric emptying. There is no specific antidote.

If you forget to take MICOTEF oral gel
Do not take a double dose to make up for the missed dose.

If you stop taking MICOTEF oral gel
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Micotef oral gel can cause side effects, although not everybody gets them.
If ingested, diarrheal episodes may occur during long-term treatment. Rare onset of nausea, headache and skin rashes.
If any of the following side effects occur, do not use Micotef and immediately consult your
doctor:

• swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing (angioedema, anaphylactic reaction). Inform your doctor or pharmacist if you notice any of the following side effects: not known:
• skin rash with blisters filled with pus (acute generalised exanthematous pustulosis).

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.

5. How to store MICOTEF oral gel

Do not store at a temperature above 25°C. Keep this medicine out of sight and
reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date
refers to the last day of that month and the product in intact packaging,
correctly stored.
Caution: do not use the medicine after the expiry date stated on the packaging. Do not use
this medicine if you notice visible signs of deterioration.
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 MICOTEF oral gel contains:
Active ingredient
Miconazole 20 mg

Other ingredients:
Pregelatinized starch, sodium saccharin salt, polysorbate 20, purified water, tetraroma of
orange, cocoa aroma, alcohol, glycerin.

Description of the appearance of MICOTEF and contents of the pack
MICOTEF oral gel is presented as a white-colored gel for oral use, contained in a tube
of 30 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia

MICOTEF 0.2% vaginal solution

Miconazole

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Micotef vaginal solution and what is it used for

Micotef vaginal solution is an antiseptic and antifungal gynecological medicine. It is used
as an adjunct to the therapy of vulvo-vaginal conditions caused by Candida, even if superinfected by
gram-positive germs: it can also be used after other therapy, oral or topical, in order to
reduce the risk of recurrence.

2. What you need to know before using Micotef vaginal solution

Do not use Micotef vaginal solution:
If you are allergic to the active ingredient or other similar antifungal medicines or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Micotef must not be used simultaneously with latex condoms or diaphragms. Micotef
may damage latex-based products and prevent them from working correctly.
This medicine contains propylene glycol which can cause skin irritation.

Other medicines and Micotef vaginal solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
During the first trimester of pregnancy, the product should only be used if absolutely
necessary and under direct medical supervision.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Micotef vaginal solution does not impair the ability to drive vehicles or operate machinery.

3. How to use Micotef vaginal solution

In the morning, apply the solution into the vagina using the entire bottle.
Daily applications can be prolonged at the doctor's discretion, beyond the normal 5-6 days of
therapy.
Use:
Perform the following operations:

• 1) hold the bottle by the knurled ring and rotate the cap until the safety seal is broken and tighten it until it touches the underlying cannula head
• 2) extract the cannula always holding it through the cap, until it stops, continue to pull the head until you feel the click of correct positioning. Note: Only complete sliding of the cannula head allows the correct outflow of the solution.
• 3) gently insert the cannula into the vagina and press the walls of the bottle by applying more or less intense pressure, in order to completely empty it; a special valve prevents the solution from returning into the bottle. Irrigation should preferably be performed in a lying position. Slow irrigation promotes better medicated cleansing. If you use more Micotef vaginal solution than you should:In case of ingestion/accidental intake of an excessive dose of Micotef vaginal solution, immediately inform your doctor or go to the nearest hospital. If you forget to use Micotef vaginal solutionDo not take a double dose to make up for the missed dose. If you stop using Micotef vaginal solutionIf you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Micotef vaginal solution can cause side effects, although not everyone will experience them.
Therapy with miconazole is usually well tolerated. Rarely, miconazole may cause
vaginal burning or irritation, pelvic cramps; even more rarely skin rashes and headaches.
In these cases, it is necessary to discontinue treatment and establish appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact 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.

5. How to store Micotef vaginal solution

Do not store at a temperature above 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. The expiry date
refers to
the last day of that month and to the product in intact packaging, correctly
stored. The period of validity is 2 years.
Caution: do not use the medicine after the expiry date stated on the packaging. Do not use
this medicine if you notice visible signs of deterioration.
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 Micotef vaginal solution contains
1 ml of vaginal solution contains:

Active ingredient:
Miconazole 2 mg

Other components:
Propylene glycol, lactic acid, undecylenoyl phenol, ricinoleic acid, polysorbate 20, fragrance composition,
purified water.

Description of the appearance of Micotef vaginal solution and contents of the pack
Micotef vaginal solution is presented in a pack containing 5 single-dose containers of
150 ml of colorless or slightly straw-colored solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
TEOFARMA S.r.l. -
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A - 27100 Pavia