Placentex

Patient Information Leaflet: Information for the User

PLACENTEX 0.08% cream

Polydeoxyribonucleotide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PLACENTEX is and what it is used for

PLACENTEX is a medicinal product based on polydeoxyribonucleotide, with healing properties (accelerates the tissue repair process) and anti-dystrophic activity (tissue damage reparative action).
PLACENTEX cream is indicated for the treatment of small superficial wounds and mild ulcerations.

2. What you need to know before using PLACENTEX

Do not use PLACENTEX

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

Warnings and precautions
Consult your doctor or pharmacist before using PLACENTEX. The solution is for external use only.
This product is for external use only.
In case of allergy/hypersensitivity, the doctor will discontinue treatment with this medicine and, if necessary,
initiate a medical desensitization therapy (treatment to reduce the allergic reaction).

Other medicines and PLACENTEX
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
No interactions with other medicines used concomitantly with PLACENTEX have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
PLACENTEX does not affect the ability to drive vehicles or operate machinery.

PLACENTEX 0.08% Cream contains lanolin, cetyl stearyl alcohol, alkyl parahydroxybenzoates and an aromatic base
This medicine contains lanolin and cetyl stearyl alcohol. These may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains alkyl parahydroxybenzoates. These may cause allergic reactions (including delayed reactions).
This medicine contains an aromatic base, which in turn contains citral, eugenol, geraniol, limonene, linalool, citronellol. Citral, eugenol, geraniol, limonene, linalool, citronellol may cause allergic reactions.

3. How to use PLACENTEX

Use this medicinal product exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply the product locally once or twice daily, or as prescribed by your physician.
For topical use only.
If you use more PLACENTEX than you should
Cases of overdose have not been reported.
In case of accidental ingestion or excessive application, immediately inform your doctor or go to the nearest hospital.
If you forget to use PLACENTEX
Do not apply a double dose to make up for a missed dose.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of allergy/hypersensitivity have been reported (see section 2, "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 PLACENTEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
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 pack and other information

What PLACENTEX 0.08% cream contains

• The active substance is polideoxyribonucleotide. 100 g of cream contain 80 mg of polideoxyribonucleotide.
  The other components are: oleic acid esters of decyl alcohol, cetostearyl alcohol, anhydrous lanolin, alkyl para-hydroxybenzoates, imidazolidinyl urea, aromatic base (containing citral, eugenol, geraniol, limonene, linalool, citronellol), purified water.

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 0.08% cream – 25 g tube.
Marketing Authorization Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy

Patient Information Leaflet: Information for the User

PLACENTEX 0.75 mg/3 ml cutaneous solution

Polydeoxyribonucleotide
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PLACENTEX is and what it is used for
2. What you need to know before using PLACENTEX
3. How to use PLACENTEX
4. Possible side effects
5. How to store PLACENTEX
6. Package contents and other information

1. What PLACENTEX is and what it is used for

PLACENTEX is a medicinal product containing polideoxyribonucleotide, with healing activity (accelerates the tissue repair process) and anti-dystrophic properties (repairs tissue damage).
PLACENTEX cutaneous solution is indicated for the treatment of skin wounds and ulcers.

2. What you need to know before using PLACENTEX

Do not use PLACENTEX

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

Warnings and precautions
Talk to your doctor or pharmacist before using PLACENTEX.
This product is for external use only.
In case of allergy/hypersensitivity, the doctor will discontinue treatment with this medicine and, if necessary,
initiate a medical desensitization therapy (treatment to reduce the allergy).
Other medicines and PLACENTEX
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
No interactions with other medicines used concomitantly with PLACENTEX have been reported.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding with breast milk,
consult your doctor or pharmacist before using this medicine.
Driving and using machines
PLACENTEX does not impair the ability to drive vehicles or operate machinery.

3. How to use PLACENTEX

Use this medicinal product exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply the product locally 1 or 2 times a day, using sterile gauze moistened with the solution, or as otherwise prescribed by your doctor.
For topical use.
If you use more PLACENTEX than you should
Cases of overdose have not been reported.
In case of accidental ingestion or excessive application of PLACENTEX, immediately inform your doctor or go to the nearest hospital.
If you forget to use PLACENTEX
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Cases of allergy/hypersensitivity have been reported (see section 2, "Warnings and precautions").
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store PLACENTEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
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 PLACENTEX 0.75 mg/3 ml cutaneous solution contains

• The active substance is polideoxyribonucleotide. Each 3 ml vial contains 0.75 mg of polideoxyribonucleotide.
• The other components are: sodium chloride, water for injections.

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 0.75 mg/3 ml cutaneous solution - 10 vials of 3 ml.

Marketing Authorization Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia No. 32
18038 Sanremo (IM)
Italy

Package leaflet: Information for the user

PLACENTEX 5.625 mg/3 ml solution for injection, 2.25 mg/3 ml solution for injection

Polydeoxyribonucleotide
Please read this leaflet carefully before using this medicine because 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 give it 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PLACENTEX is and what it is used for
2. What you need to know before using PLACENTEX
3. How to use PLACENTEX
4. Possible side effects
5. How to store PLACENTEX
6. Package contents and other information

1. What PLACENTEX is and what it is used for

PLACENTEX is a medicinal product based on polideoxyribonucleotide, with healing activity (accelerates the tissue repair process) and anti-dystrophic activity (tissue damage reparative action).

2. What you should know before using PLACENTEX

Do not use PLACENTEX

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

Warnings and precautions
Talk to your doctor or pharmacist before using PLACENTEX.
In case of allergy/hypersensitivity, your doctor will discontinue treatment with this medicine and, if necessary, start a medical desensitization therapy (treatment aimed at reducing the allergic reaction).
Other medicines and PLACENTEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines used concomitantly with PLACENTEX have been reported.
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 medicine.
Driving and using machines
PLACENTEX does not affect the ability to drive or operate machinery.
PLACENTEX 5.625 mg/3 ml injectable solution and PLACENTEX 2.25 mg/3 ml injectable
solution contain sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to use PLACENTEX

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
One ampoule daily by intramuscular or subcutaneous route, for cycles of 15–20 days, repeatable or as
otherwise prescribed by a physician.
If you use more PLACENTEX than you should
Cases of overdose have not been reported.
In case of accidental ingestion/over-administration of an excessive dose of PLACENTEX, contact your
doctor immediately or go to the nearest hospital.
If you forget to use PLACENTEX
Do not use a double dose to make up for the missed dose.
If you stop treatment with PLACENTEX
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 will experience them.
Cases of allergy/hypersensitivity have been reported (see section 2, "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store PLACENTEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
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 PLACENTEX contains
PLACENTEX 5.625 mg/3 ml solution for injection

• The active substance is polydeoxyribonucleotide. Each 3 ml vial contains 5.625 mg of polydeoxyribonucleotide.
• The other components are: sodium chloride, water for injections.

PLACENTEX 2.25 mg/3 ml solution for injection

• The active substance is polydeoxyribonucleotide. Each 3 ml vial contains 2.25 mg of polydeoxyribonucleotide.
• The other components are: sodium chloride, water for injections.

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 5.625 mg/3 ml solution for injection – 5 vials of 3 ml
PLACENTEX 2.25 mg/3 ml solution for injection – 5 vials of 3 ml

Marketing Authorization Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia No. 32
18038 Sanremo (IM)
Italy

Package leaflet: Information for the user

PLACENTEX 0.75 mg/ml eye drops, solution

Polydeoxyribonucleotide
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PLACENTEX is and what it is used for

PLACENTEX is a medicinal product based on polydeoxyribonucleotide, with healing properties (accelerates the tissue repair process) and anti-dystrophic activity (reparative action on tissue damage).
PLACENTEX eye drops are indicated for the treatment of eye diseases such as corneal and conjunctival injuries (minor wounds, microtraumas, injuries caused by contact lenses).

2. What you need to know before using PLACENTEX

Do not use PLACENTEX

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

Warnings and precautions
Talk to your doctor or pharmacist before using PLACENTEX.
In case of allergy/hypersensitivity, the doctor will discontinue treatment with this medicine and, if necessary,
initiate a medical desensitization therapy (treatment to reduce the allergy).

Other medicines and PLACENTEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interactions have been reported with other medicines used concomitantly with PLACENTEX.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

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

PLACENTEX 0.75 mg/ml eye drops, solution contains methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216)
This medicine contains methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216). These may cause allergic reactions (including delayed reactions).

3. How to use PLACENTEX

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Gently press on the body of the cap and let 2 or 3 drops of eye drops fall into the space between the eye and
the eyelid (conjunctival fornix) 2-4 times daily, or as prescribed by your doctor.
If you use more PLACENTEX than you should
Cases of overdose have not been reported.
In case of accidental ingestion/over-application of an excessive dose of PLACENTEX, inform your
doctor immediately or go to the nearest hospital.
If you forget to use PLACENTEX
Do not use a double dose to make up for the missed dose.
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 will get them.
Cases of allergy/hypersensitivity have been reported (see section 2, "Warnings and precautions").
Reporting of side effects
If you experience any side effects, 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 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 PLACENTEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
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 PLACENTEX contains

• PLACENTEX 0.75 mg/ml eye drops, solution
• The active substance is polideoxyribonucleotide. The 10 ml bottle contains 7.5 mg of polideoxyribonucleotide.
• The other components are: polyvinylpyrrolidone, monobasic sodium phosphate, dibasic sodium phosphate, sodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injections

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 0.75 mg/ml eye drops, solution, 10 ml dropper bottle
Marketing Authorization Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy