MECLON 100 mg/500 mg Pessary

Treść ulotki

1. MECLON “100 mg + 500 mg ovuli”
   1. What Meclon is and what it is used for
   2. What you need to know before using Meclon
   3. How to use Meclon
   4. Possible side effects
   5. How to store Meclon
   6. Contents of the pack and other information
2. MECLON “20% + 4% vaginal cream”
   1. What Meclon is and what it is used for
   2. What you need to know before using Meclon
   3. How to use Meclon
   4. Possible side effects
   5. How to store Meclon
   6. Contents of the pack and other information
3. MECLON “200 mg/10 ml + 1 g/130 ml vaginal solution”
   1. What Meclon is and what it is used for
   2. What you need to know before using Meclon
   3. How to use Meclon
   4. Possible side effects
   5. How to store Meclon
   6. Contents of the pack and other information

MECLON “100 mg + 500 mg ovuli”

Metronidazole, Clotrimazole
Read this leaflet carefully before you use this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like 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 Meclon is and what it is used for
• 2. What you need to know before you use Meclon
• 3. How to use Meclon
• 4. Possible side effects
• 5. How to store Meclon
• 6. Contents of the pack and other information

1. What Meclon is and what it is used for

Meclon contains metronidazole and clotrimazole, active ingredients that belong to the class of drugs
known as gynecological anti-infectives and antiseptics.
Meclon is used for the treatment of infections of the female genital tract (cervicitis,
cervico-vaginitis, vaginitis and vulvo-vaginitis due to Trichomonas vaginaliseven if associated with Candida

albicansor with a bacterial component). The symptoms that most frequently characterize these infections
are: abundant and/or unusual vaginal discharge, itching, redness, burning when passing
urine, pain during sexual intercourse.

2. What you need to know before using Meclon

DO NOT use Meclon
if you are allergic to metronidazole or clotrimazole or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Avoid contact with the eyes.
Avoid treatment during your menstrual period.
In case of concomitant use of Metronidazole orally, you must consider the
containing metronidazole that you take orally.
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure) have been reported with medicines containing metronidazole,
including cases leading to death, in patients with Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently monitor your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, soft and greyish-green stools or itching.

Children
Meclon suppositories should only be used in early infancy if absolutely necessary and under the direct
supervision of a doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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.
During pregnancy, the product should only be used if absolutely necessary and under the direct
supervision of a doctor.

Driving and operating machinery
Meclon does not impair the ability to drive vehicles or operate machinery.

3. How to use Meclon

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 Meclon vaginal suppository, once a day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Meclon immediately if you experience any side effects.

Very rare side effects(may affect up to 1 in 10,000 people)
Local irritations such as:

• itching
• skin inflammation (allergic contact dermatitis)
• spots and/or swelling on the skin (skin rashes)

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available data)

• allergic reactions (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 www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help to provide more information on the safety of this medicine .

5. How to store Meclon

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.
Do not use this medicine if the packaging is opened or damaged.
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 Meclon contains

• The active ingredients are metronidazole and clotrimazole. One 2.4 g pessary contains 500 mg of metronidazole and 100 mg of clotrimazole.
• The other component is constituted by a hydrophilic mixture of mono-, di-, tri-glycerides of saturated fatty acids.

Description of the appearance of Meclon and contents of the pack
Meclon is presented in the form of pessaries. Each pack contains 10 pessaries.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. – Viale Sarca, n. 223 – 20126 Milano (MI)

Manufacturer:
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe n. 1 – Cortemaggiore (PC).
August 2017

MECLON “20% + 4% vaginal cream”

Metronidazole, Clotrimazole
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 6 days of treatment.

Contents of this leaflet

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

1. What Meclon is and what it is used for

Meclon contains metronidazole and clotrimazole, active ingredients that belong to the class of drugs
called gynaecological anti-infectives and antiseptics.
Meclon is used for the treatment of infections of the female genital tract (cervico-
vaginitis and vulvo-vaginitis) caused by microorganisms ( Trichomonas vaginalisalso associated with Candida

albicans, Gardnerella vaginalisand other sensitive bacterial flora). The symptoms that most frequently
characterize these infections are: abundant and/or unusual vaginal discharge, itching,
redness, burning when urinating, pain during sexual intercourse.
Meclon vaginal cream can also be used in the partner for prophylactic purposes.

2. What you need to know before using Meclon

Do not use Meclon
if you are allergic to metronidazole or clotrimazole or to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Avoid contact with eyes.
Avoid treatment during your menstrual period.
In case of concomitant use of metronidazole orally, you must consider the
containing metronidazole that you take orally.
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure) have been reported with medicines containing metronidazole, including cases leading to death, in patients suffering
from Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently monitor your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greyish-green stools or itching.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine
During pregnancy, the product should only be used if absolutely necessary and under direct
medical supervision.

Driving and operating machinery
Meclon does not impair the ability to drive or operate machinery.

Meclon contains Sodium methyl p-hydroxybenzoate and Sodium propyl p-hydroxybenzoate
The medicine contains Sodium methyl p-hydroxybenzoate and Sodium propyl
p-hydroxybenzoate as preservatives and may therefore cause allergic reactions (including delayed ones).

3. How to use Meclon

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 one applicator once a day for at least six consecutive days.
Administer the contents deeply into the vagina, preferably in the evening before going to bed.
In inflammations caused by the microorganism Trichomonas, the simultaneous use of metronidazole
orally, in both non-pregnant women and the male partner, allows for a
greater certainty of therapeutic outcome.

Method of use

• 1. Pierce the opening of the tube using the appropriate tip in the plastic cap;
• 2. Screw a single-use applicator onto the open tube (fig. 1);
• 3. Press the tube until the applicator is completely filled (fig. 2);
• 4. Unscrew the applicator from the tube and insert it deeply into the vagina (fig. 3);
• 5. Press the plunger and administer the cream into the vagina, until the applicator is completely emptied (fig. 3).

For optimal administration, it is recommended to lie on your back (supine position), with your
legs slightly bent.
It is also recommended to spread some Meclon vaginal cream externally, in the area
surrounding the vagina and anus, to obtain a better antiseptic effect. If the doctor recommends
treatment of the partner for preventive purposes, the cream should be applied to the end of the penis and
on the skin covering it (glans and foreskin) for at least six days.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Meclon immediately if you experience side effects.

Very rare side effects(may affect up to 1 in 10,000 people)
Local irritations such as:

• itching
• Inflammation of the skin (allergic contact dermatitis)
• appearance of spots and/or swelling on the skin (skin rashes)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• allergic reactions (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 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 Meclon

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.
Do not use this medicine if the packaging is opened or damaged.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meclon contains

• The active ingredients are metronidazole and clotrimazole; 100 g of cream contains 20 g of metronidazole and 4 g of clotrimazole.
• The other ingredients are glyceryl stearate and polyethylene glycol, liquid paraffin, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, purified water.

Description of the appearance of Meclon and contents of the pack
Meclon is presented in the form of vaginal cream. Each pack contains a 30 g tube of cream and
6 single-use applicators.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Alfasigma S.p.A. – Viale Sarca, n. 223 – 20126 Milan (MI)

Manufacturer:
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe n. 1 – Cortemaggiore (PC).
August 2017

MECLON “200 mg/10 ml + 1 g/130 ml vaginal solution”

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

1. What Meclon is and what it is used for

Meclon contains clotrimazole and metronidazole, active ingredients that belong to the class of drugs
known as gynecological anti-infectives and antiseptics.
Meclon is used as an adjunct to the treatment of infections of the female genital tract
(cervico-vaginitis and vulvo-vaginitis) caused by microorganisms ( Trichomonas vaginalisalso
associated with Candida albicans, Gardnerella vaginalisand other sensitive bacterial flora). The symptoms that
most frequently characterize these infections are: abundant and/or vaginal discharge different from
usual, itching, redness, burning when passing urine, pain during sexual intercourse.
Meclon vaginal solution can also be used after other local or oral therapy, in order to
reduce the risk of recurrence.

2. What you need to know before using Meclon

Do not use Meclon
if you are allergic to metronidazole or clotrimazole or any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Avoid contact with the eyes.
Avoid treatment during your menstrual period.
In case of concomitant use of Metronidazole orally, you must consider the
containing metronidazole that you take orally.
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure) have been reported with medicines containing metronidazole, including cases leading to death, in patients with
Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently monitor your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greenish-grey stools or itching.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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.
During pregnancy, the product should only be used if absolutely necessary and under direct
medical supervision.

Driving and operating machinery
Meclon does not impair the ability to drive vehicles or operate machinery.

Meclon contains Sodium methyl p-hydroxybenzoate and Sodium propyl p-hydroxybenzoate
The medicine contains Sodium methyl p-hydroxybenzoate and Sodium propyl
p-hydroxybenzoate as preservatives and may therefore cause allergic reactions (including delayed reactions).

3. How to use Meclon

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 one container of ready-to-use vaginal solution once a day.
Administer the contents, preferably in the morning or as directed by your doctor.
In the initial phase of treatment, you should combine the use of the vaginal solution with adequate local and/or oral therapy.

Method of use

• 6. Open the bottle and the vial (fig. 1 and 2);
• 7. Pour the contents of the vial into the bottle (fig. 3);
• 8. Insert the vaginal cannula onto the bottle (fig. 4);
• 9. Gently insert the cannula into the vagina and administer the entire contents of the bottle by pressing on the body of the bottle.

For optimal irrigation, it is recommended to lie on your back (supine position).
It is also recommended to empty the bottle slowly, which will favor a more prolonged stay in the vagina of the active ingredients and therefore a more effective antimicrobial and cleansing action.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Meclon immediately if you experience any side effects.

Very rare side effects(may affect up to 1 in 10,000 people)
Local irritations such as:

• itching
• skin inflammation (allergic contact dermatitis)
• appearance of spots and/or swelling on the skin (skin rashes)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• allergic reactions (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 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 Meclon

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
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 use this medicine if the packaging has been opened or damaged.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meclon contains
10 ml bottle:

• The active ingredient is clotrimazole; 10 ml of solution contains 200 mg of clotrimazole
• The other ingredients are castor oil, ethanol, purified water. 130 ml bottle:
• The active ingredient is metronidazole; 130 ml of solution contains 1 g of metronidazole
• The other ingredients are sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, purified water.

Description of the appearance of Meclon and contents of the pack
Meclon is presented in the form of a vaginal solution. Each pack contains 5 bottles of 10 ml, 5
bottles of 130 ml and 5 applicators.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 – 20126 Milan (MI)

Manufacturer
ALFASIGMA S.p.A. - Via E. Fermi, n.1 - Alanno (PE)
September 2017