Meclon

PACKAGE LEAFLET

Package leaflet: information for the patient

MECLON “100 mg + 500 mg ovuli”

Metronidazole, Clotrimazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms 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 using Meclon
3. How to use Meclon
4. Possible side effects
5. How to store Meclon
6. Package contents and other information

1. What Meclon is and what it is used for

Meclon contains metronidazole and clotrimazole, active substances belonging to the class of medicinal products known as gynaecological anti-infectives and antiseptics.
Meclon is used to treat infections of the female genital tract (cervicitis, cervicovaginitis, vaginitis and vulvovaginitis caused by Trichomonas vaginalis, even when associated with Candida albicans or with a bacterial component). The symptoms most frequently associated with these infections are: abundant and/or unusual vaginal discharge, itching, redness, burning during urination, and 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
medicinal product (listed in section 6).
Warnings and precautions
Avoid contact with the eyes.
Avoid treatment during menstruation.
If you are simultaneously using oral metronidazole, consider the contraindications, adverse reactions, and warnings described in the package leaflet of the oral metronidazole-containing medicine you are taking.
Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including fatal outcomes, have been reported in patients with Cockayne syndrome treated with metronidazole-containing medicines.
If you have Cockayne syndrome, your doctor will 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 or grey-green stools, or itching.

Children
Meclon vaginal suppositories should be used in early infancy only when strictly necessary and under direct medical supervision.
Other medicines and Meclon
Inform your doctor or pharmacist if you are currently 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
During pregnancy, this product should be used only if clearly necessary and under direct medical supervision.
Driving and using machines
Meclon does not impair the ability to drive vehicles or operate machinery.

3. How to use Meclon

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 Meclon vaginal ovule inserted once daily.

4. Possible side effects

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

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

• itching
• skin inflammation (allergic contact dermatitis)
• skin rashes and/or swellings (skin eruptions)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 stated on the packaging.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of any medicine via wastewater 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 Meclon contains

• The active substances are metronidazole and clotrimazole. One 2.4 g ovule contains 500 mg of metronidazole and 100 mg of clotrimazole.
• The other component consists of a hydrophilic mixture of mono-, di-, and triglycerides of saturated fatty acids.

Description of the appearance of Meclon and package contents
Meclon is available in the form of ovules. Each package contains 10 ovules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Patient information leaflet

MECLON “20% + 4% vaginal cream”

Metronidazole, Clotrimazole
Please read this leaflet carefully before using 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms 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 substances belonging to the class of medicines known as gynaecological anti-infectives and antiseptics.
Meclon is used to treat infections of the female genital tract (cervicovaginitis and vulvovaginitis) caused by microorganisms (such as Trichomonas vaginalis, possibly associated with Candida albicans, Gardnerella vaginalis, and other sensitive bacterial flora). The most common symptoms of these infections include: abundant and/or unusual vaginal discharge, itching, redness, burning during urination, and pain during sexual intercourse.
Meclon vaginal cream may also be used in the partner for preventive 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 the eyes.
Avoid treatment during menstruation.
If metronidazole is used concomitantly by oral route, consider the contraindications, adverse effects, and warnings stated in the package leaflet of the oral metronidazole-containing medicinal product.
Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including fatal cases, have been reported in patients affected by Cockayne syndrome treated with metronidazole-containing medicinal products.
If you suffer from Cockayne syndrome, your doctor will 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 greasy stools, or itching.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
During pregnancy, this product should be used only if clearly needed and under direct medical supervision.

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

Meclon contains Sodium methyl p-hydroxybenzoate and Sodium propyl p-hydroxybenzoate
The medicinal product 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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one applicator once daily for at least six consecutive days.
Administer the contents deep into the vagina, preferably in the evening before going to bed.
In inflammations caused by the microorganism Trichomonas, the concomitant use of oral metronidazole, both in non-pregnant women and in the male partner, helps achieve greater therapeutic efficacy.

Instructions for use

1. Pierce the tube opening using the special tip on the plastic cap;
2. Screw a single-use applicator onto the opened tube (Fig. 1);
3. Squeeze 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. Push the plunger to 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 knees slightly bent and apart.
It is also advisable to apply a small amount of Meclon vaginal cream externally on the area surrounding the vagina and anus to achieve a better antiseptic effect. If your doctor recommends treating the partner for preventive purposes, apply the cream to the tip of the penis and 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 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 swellings on the skin (skin rashes)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of any medicine via 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 package and other information

What Meclon contains

• The active substances are metronidazole and clotrimazole; 100 g of cream contain 20 g of metronidazole and 4 g of clotrimazole.
• The other components are glycol stearate and polyethylene glycol, liquid paraffin, methylparaben sodium, propylparaben sodium, purified water.

Description of the appearance of Meclon and contents of the pack
Meclon is a vaginal cream. Each pack contains one 30 g tube of cream and
6 single-use applicators.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Patient Information Leaflet

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

Clotrimazole, Metronidazole
Please read this leaflet carefully before using 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement 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 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 clotrimazole and metronidazole, active substances belonging to the class of medicinal products known as gynaecological antiseptics and anti-infectives.
Meclon is used as an adjunctive treatment for infections of the female genital tract (cervicovaginitis and vulvovaginitis) caused by microorganisms (Trichomonas vaginalis, either alone or associated with Candida albicans, Gardnerella vaginalis, and other sensitive bacterial flora). The most common symptoms of these infections include: abundant and/or unusual vaginal discharge, itching, redness, burning during urination, and pain during sexual intercourse.
Meclon vaginal solution may also be used following other local or oral therapies with the aim of reducing 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 to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Avoid contact with the eyes.
Avoid treatment during the menstrual period.
If you are simultaneously taking oral metronidazole, consider the contraindications, adverse effects, and warnings stated in the package leaflet of the oral metronidazole-containing medicine you are taking.
Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including cases resulting in death, have been reported in patients with Cockayne syndrome treated with medicinal products containing metronidazole.
If you suffer from Cockayne syndrome, your doctor will 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 grey-green stools, or pruritus.

Other medicines and Meclon
Inform 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
During pregnancy, this product should be used only if clearly needed and under direct medical supervision.

Driving and using machines
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 reactions).

3. How to use Meclon

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one ready-to-use vaginal solution container once daily.
Administer the contents preferably in the morning, or as otherwise directed by your doctor.
During the initial phase of treatment, you must associate the use of the vaginal solution with appropriate local and/or oral therapy.

Instructions for 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. Attach the vaginal cannula to 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).
Furthermore, it is advised to empty the bottle slowly, which will promote longer retention of the active ingredients in the vagina, thus enhancing antimicrobial and cleansing efficacy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 swellings on the skin (skin rashes)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via 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 above 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of medicines via wastewater 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 Meclon contains
10 ml vial:

• The active substance is clotrimazole; 10 ml of solution contain 200 mg of clotrimazole.
• The other components are ricinoleyl alcohol, ethanol, purified water.

130 ml vial:

• The active substance is metronidazole; 130 ml of solution contain 1 g of metronidazole.
• The other components are methyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium, purified water.

Description of the appearance of Meclon and contents of the pack
Meclon is a vaginal solution. Each package contains 5 vials of 10 ml, 5 vials of 130 ml, and 5 cannulas.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. – Viale Sarca, No. 223 – 20126 Milan (MI)

Manufacturer
ALFASIGMA S.p.A. - Via E. Fermi, No.1 - Alanno (PE)
September 2017