PLACENTEX 0.75 MG/ML Eye drops, solution

Зміст інструкції

1. PLACENTEX 0.08 % cream
   1. What is PLACENTEX and what is it 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
2. PLACENTEX 0.75 mg/3 ml cutaneous solution
   1. What is PLACENTEX and what is it 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
3. PLACENTEX 5,625 mg/3 ml injectable solution, 2,25 mg/3 ml injectable solution
   1. What is PLACENTEX and what is it used for
   2. What you need to know before you use PLACENTEX
   3. How to use PLACENTEX
   4. Possible side effects
   5. How to store PLACENTEX
   6. Contents of the pack and other information
4. PLACENTEX 0.75 mg/ml eye drops, solution
   1. What is PLACENTEX and what is it 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

PLACENTEX 0.08 % cream

Polidesoxyribonucleotide

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 you experience any side effects, including those not listed in this leaflet, tell 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 is PLACENTEX and what is it used for

PLACENTEX is a medicine based on polydeoxyribonucleotide, with a cicatrizing activity (accelerates the
healing process of tissues) and antidystrophic (tissue repair activity in case of damage).
PLACENTEX cream is indicated for the treatment of superficial wounds of small size and mild ulcers.

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.
The product is for external use only.
In case of allergy/hypersensitivity, the doctor will suspend treatment with this medicine and, if necessary,
will initiate a desensitizing medical therapy (treatment to reduce allergy).

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

Pregnancy and breastfeeding
If 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 using this medicine.

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

PLACENTEX0.08 %Cream contains lanolin, cetyl stearyl alcohol, alkyl para-hydroxybenzoates and a
fragrance base
This medicine contains lanolin and cetyl stearyl alcohol. They may cause localized skin reactions
(e.g. contact dermatitis).
This medicine contains alkyl para-hydroxybenzoates. They may cause allergic reactions (even delayed).
This medicine contains a fragrance 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 medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
Apply the product locally 1 or 2 times a day or as prescribed by your doctor.
For cutaneous use.

If you use more PLACENTEX than you should
No cases of overdose have been reported.
In case of accidental ingestion/application of an excessive dose of PLACENTEX, immediately notify your doctor or go to the nearest hospital.

If you forget to use PLACENTEX
Do not use a double dose to make up for a 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 gets them.
Cases of allergy/hypersensitivity have been reported (see section 2 “Warnings and precautions”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
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 PLACENTEX 0.08% cream contains

• The active ingredient is polydeoxyribonucleotide. 100 g of cream contains 80 mg of polydeoxyribonucleotide. The other components are: oleic acid esters of decyl alcohol, cetylstearyl alcohol, anhydrous lanolin, alkyl para-hydroxybenzoates, imidazolidinyl urea, flavoring base (contains citral, eugenol, geraniol, limonene, linalool, citronellol), purified water.

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 0.08% cream - tube of 25 g.

Marketing authorisation holder and manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy

PLACENTEX 0.75 mg/3 ml cutaneous solution

Polidesoxyribonucleotide

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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you use 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 is PLACENTEX and what is it used for

PLACENTEX is a medicine based on polydeoxyribonucleotide, with cicatrizing activity (accelerates the
process of tissue healing) and antidystrophic activity (tissue repair activity of a tissue damage).
PLACENTEX cutaneous solution is indicated for the treatment of wounds and skin ulcers.

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 product is for external use only.
In case of allergy/hypersensitivity, the doctor will suspend treatment with this medicine and, if necessary,
initiate a desensitizing medical therapy (treatment to reduce allergy).

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

Pregnancy and breastfeeding
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
PLACENTEX does not impair the ability to drive vehicles or operate machinery.

3. How to use PLACENTEX

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.
Apply the product locally 1 or 2 times a day, with sterile gauze soaked in the solution or as
prescribed by your doctor.
For cutaneous use.

If you use more PLACENTEX than you should
No cases of overdose have been reported.
In case of ingestion/accidental application of an excessive dose of PLACENTEX, immediately notify
your doctor or go to the nearest hospital.

If you forget to use PLACENTEX
Do not use a double dose to make up for a 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 gets them.
Cases of allergy/hypersensitivity have been reported (see section 2 “Warnings and precautions”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
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 PLACENTEX 0.75 mg/3 ml cutaneous solution contains

• The active ingredient is polydeoxyribonucleotide. Each 3 ml vial contains 0.75 mg of polydeoxyribonucleotide.
• The other ingredients 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 authorisation holder and manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy

PLACENTEX 5,625 mg/3 ml injectable solution, 2,25 mg/3 ml injectable solution

Polidesossiribonucleotide

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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 is PLACENTEX and what is it used for

PLACENTEX is a medicine based on polydeoxyribonucleotide, with cicatrizing activity (accelerates the
process of tissue healing) and antidystrophic activity (tissue repair activity of a tissue damage).

2. What you need to know before you use 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.
In case of allergy/hypersensitivity, the doctor will suspend treatment with this medicine and, if necessary,
initiate a desensitizing medical therapy (treatment to reduce allergy).

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

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

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

PLACENTEX 5.625 mg/3 ml injectable solution and PLACENTEX 2.25 mg/3 ml solution
injectable 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 following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
One vial per day by intramuscular or subcutaneous route, for cycles of 15-20 days, repeatable or as
prescribed by your doctor.

If you use more PLACENTEX than you should
No cases of overdose have been reported.
In case of accidental ingestion/administration of an excessive dose of PLACENTEX, immediately notify your
doctor or go to the nearest hospital.

If you forget to use PLACENTEX
Do not use a double dose to make up for a 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 gets them.
Cases of allergy/hypersensitivity have been reported (see section 2 “Warnings and precautions”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment .

6. Contents of the pack and other information

What PLACENTEX contains
PLACENTEX 5.625 mg/3 ml injectable solution

• The active ingredient is polydeoxyribonucleotide. Each 3 ml vial contains 5.625 mg of polydeoxyribonucleotide.
• The other ingredients are: sodium chloride, water for injections
• PLACENTEX 2.25 mg/3 ml injectable solution
• The active ingredient is polydeoxyribonucleotide. Each 3 ml vial contains 2.25 mg of polydeoxyribonucleotide.
• The other ingredients are: sodium chloride, water for injections

Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX 5.625 mg/3 ml injectable solution - 5 vials of 3 ml
PLACENTEX 2.25 mg/ 3ml injectable solution - 5 vials of 3 ml

Marketing authorisation holder and manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy

PLACENTEX 0.75 mg/ml eye drops, solution

Polidesossiribonucleotide

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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 is PLACENTEX and what is it used for

PLACENTEX is a medicine based on polydeoxyribonucleotide, with cicatrizing activity (accelerates the
tissue healing process) and antidystrophic activity (tissue repair activity for tissue damage).
PLACENTEX eye drops are indicated for the treatment of eye diseases such as lesions of the cornea and
conjunctiva (small wounds, microtraumas, contact lens injuries).

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.
In case of allergy/hypersensitivity, the doctor will suspend treatment with this medicine and, if necessary,
initiate a desensitizing medical therapy (treatment to reduce allergy).

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

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

Driving and operating machinery
PLACENTEX does not alter the ability to drive vehicles or operate machinery.

PLACENTEX 0.75 mg/ml eye drops, solutioncontains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216)
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216). They may cause allergic reactions (including delayed reactions).

3. How to use PLACENTEX

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Gently press on the cap body and let 2 or 3 drops of eye drops fall into the space between the eye and
the eyelid (conjunctival fornix) 2-4 times a day 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/application of an excessive dose of PLACENTEX, immediately notify 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 medicine, 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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
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 PLACENTEX contains

• PLACENTEX 0.75 mg/ml eye drops, solution
• The active ingredient is polydeoxyribonucleotide. The 10 ml bottle contains 7.5 mg of polydeoxyribonucleotide.
• The other ingredients are: polyvinylpyrrolidone, sodium phosphate monobasic, sodium phosphate dibasic, 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 Authorisation Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy