Connettivina

Package leaflet: Information for the user

Connettivina 2 mg/g cream

Sodium hyaluronate
Please read all of this leaflet carefully before you start 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.

• 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 any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Connettivina is and what it is used for

Connettivina 2 mg/g cream contains the active substance sodium hyaluronate, a component naturally produced by our body. Local application of hyaluronic acid facilitates the healing process of skin lesions.

Connettivina 2 mg/g cream is a topical medicinal product indicated for the treatment of:

• abrasions, scrapes, superficial wounds, burns, mild burns and small cuts, including those affecting the nipple and the surrounding areola (cracked nipples);
• localized skin irritations caused by sun, cold, wind, diaper rash, and skin irritation and dehydration resulting from radiotherapy (a medical treatment that uses high-energy radiation to destroy cancer cells). Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Connettivina

Do not use Connettivina:
if you are allergic to the active substance 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 Connettivina.
Connettivina is for external use only.
The use of Connettivina, especially if prolonged, may lead to sensitization reactions (allergic reactions). If this occurs, stop treatment and consult your doctor, who will recommend appropriate therapy.

Other medicines and Connettivina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Connettivina simultaneously with disinfectants containing quaternary ammonium salts.

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.
Connettivina may be used during pregnancy and breastfeeding.

Driving and operating machinery
Connettivina does not affect the ability to drive or operate machinery.

Connettivina 2 mg/g cream contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Connettivina 2 mg/g cream contains polyethylene glycol 400 monostearate, which may cause skin irritation.

3. How to use Connettivina

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.
Before applying Connettivina, carefully clean and disinfect the area of skin to be treated.
Apply Connettivina 2 mg/g cream 2 or 3 times a day, using a sufficient amount to cover the affected skin area. Spread a uniform layer of cream. After application, if necessary, cover the area with an appropriate dressing.
Use Connettivina only for short treatment periods. Do not exceed the recommended dose.
Consult your doctor if symptoms persist after a short period of treatment or, at any time, if they worsen.

If you use more Connettivina than you should
If you accidentally use too much Connettivina, contact your doctor immediately or go to the nearest hospital.
Cases of intoxication due to excessive use of Connettivina have never been reported.

If you forget to use Connettivina
If you forget to apply the cream, do so as soon as you remember. Then continue with the treatment according to the usual schedule.

If you stop using Connettivina
If you have any doubts about using 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.
Local reactions, including allergic-type reactions, have been observed.
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 the following address: http://www.agenziafarmaco.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Connettivina

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 "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine kept in its original, unopened packaging and stored correctly.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Connettivina contains
The active substance is sodium hyaluronate.
1 g of Connettivina cream contains 2 mg of sodium hyaluronate.
The other components are: polyethylene glycol 400 monostearate, decyl oleate, emulsifying wax, glycerol, sorbitol 70% solution, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, flavour (Dalin PH), purified water.

Description of the appearance of Connettivina and contents of the pack
Connettivina is a white cream contained in an aluminium tube of 15 g, 30 g or 100 g.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Instructions for the user: package leaflet

Connettivina 2 mg/g gel

Hyaluronic acid sodium salt
Please read this entire 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 instructed.

• 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.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Connettivina is and what it is used for

Connettivina 2 mg/g gel contains the active substance sodium hyaluronate, a substance naturally produced by our body. Local application of hyaluronic acid facilitates the healing process of lesions.

Connettivina 2 mg/g gel is a topical medicinal product indicated for the treatment of:

• abrasions, excoriations, superficial wounds, sunburns, mild burns, and minor cuts, including those affecting the nipple and areola, i.e. the surrounding skin area (cracked nipples);
• localized skin irritations caused by sun, cold, wind, diaper rash, and skin irritation and dehydration resulting from radiotherapy (a medical treatment using high-energy radiation to destroy tumor cells).

Consult a doctor if you do not feel better or feel worse after a few days.

2. What you need to know before using Connettivina

Do not use Connettivina:
if you are allergic to the active substance 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 Connettivina.
Connettivina is for external use only.
The use of Connettivina, especially if prolonged, may lead to sensitization (allergic reactions). If this occurs, discontinue treatment and consult your doctor, who will prescribe appropriate therapy.

Other medicines and Connettivina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Connettivina simultaneously with disinfectants containing quaternary ammonium salts.

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

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

Connettivina 2 mg/g gel contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

4. How to use Connettivina

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.
Before applying Connettivina, carefully clean and disinfect the area of skin to be treated.
Apply Connettivina 2 mg/g gel 2 or 3 times a day, in sufficient quantity to cover the affected area of skin. Spread a uniform layer of gel. After application, cover the area, if necessary, with an appropriate dressing.
Use Connettivina only for short treatment periods. Do not exceed the recommended dose.
Consult your doctor if symptoms persist after a short period of treatment, or if they worsen at any time.

If you use more Connettivina than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
No cases of intoxication due to excessive use of Connettivina have ever been reported.

If you forget to use Connettivina
If you forget to apply the gel, do so as soon as you remember. Then continue treatment according to the usual schedule.

If you stop using Connettivina
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Local reactions, including allergic-type reactions, have been observed.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at: http://www.agenziafarmaco.it/it/responsabili .
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Connettivina

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 "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine kept in its original, unopened packaging and stored correctly.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

7. Contents of the pack and other information

What Connettivina contains
The active substance is sodium hyaluronate.
1 g of gel contains 2 mg of sodium hyaluronate. Each 30 g tube of gel contains 60 mg of
sodium hyaluronate.
The other components are: sorbitol 70% non-crystallising, methyl p-hydroxybenzoate, propyl p-
hydroxybenzoate, carbomer, sodium hydroxide, purified water.

Description of the appearance of Connettivina and contents of the pack
Connettivina is a transparent gel dispensed in a 30 g aluminium tube.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Package leaflet: information for the user

Connettivina 2 mg/ml Cutaneous Spray, solution

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

1. What Connettivina is and what it is used for

Connettivina 2 mg/ml cutaneous spray contains the active substance sodium hyalurononate, a substance naturally produced by our body.
Local administration of hyaluronic acid facilitates the healing process of skin lesions.
Connettivina 2 mg/ml cutaneous spray is a topical medicinal product indicated for the treatment of:

• abrasions, excoriations, superficial wounds, burns, mild burns, and small cuts, more or less deep, including those affecting the nipple and the areola, i.e. the surrounding skin area (cracked nipples);
• localized skin irritations caused by sun, cold, wind, diaper rash, skin irritations and dehydration of the skin following radiotherapy (a medical treatment using high-energy radiation to destroy tumor cells);
• as an adjunctive treatment, for skin lesions (ulcers) due to circulatory disorders and wounds characterized by difficult healing, such as pressure sores.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Connettivina

Do not use Connettivina:
if you are allergic to the active substance 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 Connettivina.
Connettivina is for external use only.
The use of Connettivina, especially if prolonged, may lead to sensitization (allergic reactions). If this occurs, discontinue treatment and consult your doctor, who will prescribe appropriate therapy.
Other medicines and Connettivina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Connettivina simultaneously with disinfectants containing quaternary ammonium salts.
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.
Connettivina can be used during pregnancy and breastfeeding.
Driving and using machines
Connettivina does not affect the ability to drive or operate machinery.
Connettivina 2 mg/ml cutaneous spray contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate,
which may cause allergic reactions (including delayed reactions).

5. How to use Connettivina

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.
Before applying Connettivina, carefully clean and disinfect the area of skin to be treated.
Wounds due to vascular ulcers and pressure sores should preferably be cleaned with physiological saline solution (NaCl 0.9%); if necessary, surgical debridement should be performed. Subsequently, wounds should be disinfected preferably with povidone-iodine or chlorhexidine. Quaternary ammonium solutions must be avoided.
Apply Connettivina 2 mg/ml cutaneous spray 2 or 3 times daily, in sufficient quantity to cover the affected skin area. Spray the Connettivina solution evenly over the lesion. After application, cover the wound, if appropriate, with a suitable dressing.
Use Connettivina only for short treatment periods. Do not exceed the recommended dose.
Consult your doctor if symptoms persist after a short period of treatment or worsen at any time.
If you use more Connettivina than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
No cases of intoxication due to excessive use of Connettivina have ever been reported.
If you forget to use Connettivina
If you forget to apply the cutaneous spray, do so as soon as you remember. Then continue using it according to the usual schedule.
If you stop using Connettivina
If you have any questions 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.
Local reactions, including allergic reactions, have been observed.

Reporting of side effects
If you experience any side effects, 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: http://www.agenziafarmaco.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Connettivina

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 "Exp". The expiry date refers to the last day of that month.
The expiry date indicated applies to the medicine kept in its original, unopened packaging and stored correctly.
Store below 30°C.
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.

8. Contents of the pack and other information

What Connettivina contains
The active substance is sodium hyaluronate.
1 ml of solution contains 2 mg of sodium hyaluronate. Each 20 ml bottle of Connettivina cutaneous spray contains 40 mg of sodium hyaluronate.
The other components are: sodium chloride, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.
Description of the appearance of Connettivina and contents of the pack
Connettivina cutaneous spray is supplied as a solution in a 20 ml amber glass bottle, type I, equipped with a plastic spray pump and closed with a polyethylene cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Package leaflet: Information for the user

Connettivina 2 mg impregnated gauzes, 4 mg impregnated gauzes, 12 mg impregnated gauzes

Sodium hyaluronate
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 any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Connettivina is and what it is used for

Connettivina gauze contains the active substance sodium hyaluronate, a substance naturally produced by our body. Local application of hyaluronic acid facilitates the healing process of wounds.
Connettivina gauze is a topical medicinal product indicated for the treatment of:

• healing of abrasions, excoriations, superficial wounds, burns, mild burns and small cuts, more or less deep, including those affecting either the nipple or the areola, i.e. the surrounding skin area (cracked nipples);
• localized skin irritations caused by sun, cold, wind, diaper rash, and skin irritation and dehydration resulting from radiotherapy (a medical treatment using high-energy radiation to destroy cancer cells);
• as an adjunctive treatment, for skin lesions (ulcers) due to circulatory disorders and wounds characterized by difficult healing, such as pressure ulcers.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Connettivina

Do not use Connettivina:
If you are allergic to the active substance 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 Connettivina.
Connettivina is for external use only.
The use of Connettivina, especially if prolonged, may lead to sensitization phenomena (allergic reactions). If this occurs, stop treatment and consult your doctor, who will prescribe appropriate therapy.

Other medicines and Connettivina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Connettivina simultaneously with disinfectants containing quaternary ammonium salts.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Connettivina may be used during pregnancy and breastfeeding.

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

Connettivina 2 mg medicated gauzes, Connettivina 4 mg medicated gauzes, and Connettivina 12 mg medicated gauzes contain polyethylene glycol 4000. It may cause skin irritation.

6. How to use Connettivina

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.
Before applying Connettivina, carefully clean and disinfect the area of skin to be treated.
Wounds due to vascular ulcers and pressure sores should preferably be cleaned with physiological solution (NaCl 0.9%); if necessary, surgical debridement should be performed. Subsequently, wounds should preferably be disinfected with povidone-iodine or chlorhexidine. Quaternary ammonium solutions should be avoided.
Take the gauze from the sealed pouch, being careful to touch only one end. Apply one or more medicated gauzes, depending on the size of the area to be treated. If necessary, cover the gauze with an appropriate dressing. Replace the gauzes two or three times a day.
Use Connettivina only for short-term treatment. Do not exceed the recommended dose.
Consult your doctor if symptoms persist after a short period of treatment or, at any time, if they worsen.

If you use more Connettivina than you should
In case of accidental overdose, inform your doctor immediately or go to the nearest hospital.
No cases of intoxication due to excessive use of Connettivina have ever been reported.

If you forget to use Connettivina
If you have forgotten to apply the gauze, do so as soon as you remember. Then continue using it according to the usual schedule.

If you stop using Connettivina
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.
Local reactions, including allergic reactions, have been observed.

Reporting of side effects
If you experience any side effects, 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: http://www.agenziafarmaco.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Connettivina

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine kept in its original intact packaging and stored correctly.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

9. Package contents and other information

What Connettivina contains
Connettivina 2 mg Impregnated Dressings

• The active substance is sodium hyaluronate. Each dressing is impregnated with 4 g of cream containing 2 mg of sodium hyaluronate.
• The other components are: glycerol, polyethylene glycol 4000, purified water.

Connettivina 4 mg Impregnated Dressings
The active substance is sodium hyaluronate.
Each dressing is impregnated with 8 g of cream containing 4 mg of sodium hyaluronate.
The other components are: glycerol, polyethylene glycol 4000, purified water.
Connettivina 12 mg Impregnated Dressings
The active substance is sodium hyaluronate 12.
Each dressing is impregnated with 24 g of cream containing 12 mg of sodium hyaluronate.
The other components are: glycerol, polyethylene glycol 4000, purified water.

Description of the appearance of Connettivina and package contents
Connettivina 2 mg Impregnated Dressings
One package contains 10 sterile impregnated dressings of size 10x10 cm, each enclosed in a sealed individual pouch made of paper-aluminium-polyethylene.

Connettivina 4 mg Impregnated Dressings
One package contains 10 sterile impregnated dressings of size 10x20 cm, each enclosed in a sealed individual pouch made of paper-aluminium-polyethylene.

Connettivina 12 mg Impregnated Dressings
One package contains 5 sterile impregnated dressings of size 20x30 cm, each enclosed in a sealed individual pouch made of paper-aluminium-polyethylene.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)