Cerotto Bertelli

Package leaflet/labeling: information for the user

Cerotto Bertelli 96.5 mg medicated patch

Capsicum oleoresin
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 to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, 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 Cerotto Bertelli is and what it is used for
2. What you need to know before using Cerotto Bertelli
3. How to use Cerotto Bertelli
4. Possible side effects
5. How to store Cerotto Bertelli
6. Contents of the pack and other information

1. What Cerotto Bertelli is and what it is used for

Cerotto Bertelli contains the active substance capsaicin oleoresin, which belongs to the class of
topical medications for joint and muscle pain.
Cerotto Bertelli is indicated for the relief of muscle pain such as lumbago (backache).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before using Cerotto Bertelli

Do not use Cerotto Bertelli

• if you are allergic to capsicum oleoresin or to any of the other ingredients of this medicine (listed in section 6).
• if you have damaged skin, wounds, or eczema (a skin inflammation).

Warnings and precautions
Talk to your doctor or pharmacist before using Cerotto Bertelli.
Remove the Cerotto Bertelli using a cotton pad soaked in warm water or olive oil.
Do not apply the patch near the eyes or on mucous membranes.
Apply the patch only on intact, healthy skin.
During treatment, avoid applying additional sources of heat (e.g. sunlight or infrared radiation, heating pads, or hot water). The warming effect may also be intensified by physical activity (sweating).
Discontinue treatment if the warming sensation becomes excessive. In this case, remove the patch.
If symptoms worsen during use of the medicine, consult your doctor or pharmacist.

Children and adolescents
Use in children and adolescents is not recommended.

Other medicines and Cerotto Bertelli
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not apply the patch simultaneously with other topical products, such as other rubefacients (medicines that increase blood flow and cause skin reddening), or analgesic gels, at the same application site.
Interactions with other medicines applied at the same site may occur even up to 12 hours after patch removal.

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.
Capsicum oleoresin, the active substance of this medicine, crosses the placenta and may pass into breast milk; therefore, the use of this medicine during pregnancy and breastfeeding should only occur after careful medical assessment of the risk/benefit ratio.

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

Cerotto Bertelli contains Methyl p-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Cerotto Bertelli

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.
Adults
The recommended dose is 1 medicated patch per day, applied to the affected area and left in place for at least 4–12 hours. A minimum interval of 12 hours must elapse before applying a new patch to the same application site.
Do not exceed the maximum recommended daily dose.
Children and adolescents
Use in children and adolescents is not recommended.
The safety and efficacy of Cerotto Bertelli in children and adolescents has not been established. No data are available.
Method of administration
Cutaneous use.
Apply to dry skin and press gently with a light massage to ensure adhesion.
Duration of treatment
Use only for a short period.
Prolonged use should be established by the doctor after appropriate clinical evaluation.
If you use more Cerotto Bertelli than you should
If the patch is used improperly, local irritative reactions may occur, requiring discontinuation of the medicine and administration of general anti-inflammatory treatment.
If you use more Cerotto Bertelli than you should, inform your doctor or go to the nearest hospital immediately.
If you forget to use Cerotto Bertelli
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them, such as:

• Sensitization phenomena, especially during prolonged use;
• Increased blood circulation with marked skin reddening and a sensation of warmth. This reaction is part of the medicine's normal pharmacological action and usually diminishes shortly after removal of the patch;
• Skin hypersensitivity and allergic reactions, such as hives, blisters and blistering at the application site. In such cases, you must immediately stop treatment;
• Sensation of irritation or itching during the first days of treatment.

If, in individual cases, the side effects experienced are excessive, discontinue treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via
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 Bertelli Patch

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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.
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 Cerotto Bertelli contains

• The active substance is refined and titrated capsicum oleoresin, from dried ripe fruits of Capsicum annuum L. var. minimum Miller (Heiser) or Capsicum frutescens L., small-fruit varieties, corresponding to 12.2 mg of capsaicinoids expressed as capsaicin. Extraction solvent: ethanol minimum 90% V/V. One patch contains 96.5 mg of refined and titrated capsicum oleoresin, corresponding to 12.2 mg of capsaicinoids expressed as capsaicin.
• The other components are: arnica essence, olibanum, natural rubber, iron oxide, staybelite resin, staybelite ester 3, Hercolin, iris rhizome, methyl p-hydroxybenzoate, 2,2' methylene-bis- (4 methyl-6 tert-butylphenol), castor oil (excipient of the herbal preparation).

Description of the appearance of Cerotto Bertelli and pack contents
Medicated patch measuring 24 x 16 cm, brown in colour, on a non-woven fabric support, with an adhesive layer protected by a polyethylene-coated paper sheet.
Pack containing 1 patch.
Marketing Authorization Holder
Kelémata S.r.l. Corso Re Umberto, 20 - 10128 Torino
Manufacturer
Kelémata S.r.l.
Via Castellana, 120
30030 Martellago (Ve)
Over-the-counter medicinal product

Batch No.
Expiry date
AIC No. 004844027 - “96.5 mg medicated patch” – 1 patch
Optical Seal
Braille: Cerotto Bertelli 96.5 mg

Patient Information Leaflet / Labelling: Information for the User

Bertelli Patch 50.3 mg medicated patch

Capsicum oleoresin
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 you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Cerotto Bertelli is and what it is used for

Cerotto Bertelli contains the active substance capsicum oleoresin, which belongs to the group
of topical medicines for joint and muscular pain.
Cerotto Bertelli is indicated for the relief of muscle pain such as lumbago (back pain).
Consult your doctor if you do not feel better or if you feel worse after a short period of
treatment.

2. What you need to know before using Cerotto Bertelli

Do not use Cerotto Bertelli

• if you are allergic to capsicum oleoresin or to any of the other ingredients of this medicine (listed in section 6).
• if you have damaged skin, wounds, or eczema (a skin inflammation).

Warnings and precautions
Talk to your doctor or pharmacist before using Cerotto Bertelli.
Remove the Cerotto Bertelli using a cotton pad soaked in lukewarm water or olive oil.
Do not apply the patch near the eyes or on mucous membranes.
Apply the patch only on intact, healthy skin.
During treatment, avoid applying additional heat sources (e.g. sunlight or infrared radiation, heating pads, or hot water). The warming effect may be intensified even by physical activity (sweating).
Discontinue treatment if the warming sensation becomes excessive. In this case, remove the patch.
If symptoms worsen during use of the medicine, consult your doctor or pharmacist.

Children and adolescents
Use in children and adolescents is not recommended.

Other medicines and Cerotto Bertelli
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not apply the patch simultaneously with other topical products, such as other rubefacients (medicines that increase blood flow and cause reddening of the skin), or analgesic gels, at the same application site.
Interactions with other medicines applied at the same site may occur even up to 12 hours after patch removal.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Capsicum oleoresin, the active substance of this medicine, crosses the placenta and may pass into breast milk. Therefore, the use of this medicine during pregnancy and breastfeeding should only occur after careful medical assessment of the risk/benefit ratio.

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

Cerotto Bertelli contains Methyl p-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Cerotto Bertelli

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 1 medicated patch per day applied to the affected area and left in place for at least 4–12 hours. A minimum interval of at least 12 hours must elapse before applying a new patch to the same application site.
Do not exceed the recommended maximum daily dose.

Children and adolescents
Use in children and adolescents is not recommended.
The safety and efficacy of Cerotto Bertelli in children and adolescents have not been established. No data are available.

Method of administration
For cutaneous use.
Apply to dry skin and press down gently with light massage to ensure adhesion.

Duration of treatment
Use only for a short period.
Prolonged use should be established by the physician only after adequate clinical evaluation.

If you use more Cerotto Bertelli than you should
If you use the patch incorrectly, local irritative reactions may occur, requiring discontinuation of the medicine and administration of general anti-inflammatory treatment.
If you use more Cerotto Bertelli than you should, inform your doctor immediately or go to the nearest hospital.

If you forget to use Cerotto Bertelli
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use 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, such as:

• Sensitization phenomena, especially during prolonged use;
• Increased blood circulation with marked skin redness and a sensation of warmth. This reaction is part of the medicine's normal pharmacological action and usually diminishes shortly after removal of the patch;
• Skin hypersensitivity and allergic reactions, such as hives, blisters and blistering at the application site. In such cases, you must immediately stop treatment;
• Sensation of irritation or itching during the first few days of treatment.

If, in individual cases, the side effects experienced are excessive, discontinue treatment.
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 the website 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 Bertelli Patch

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cerotto Bertelli contains

• The active substance is refined and standardized capsicum oleoresin, derived from dried ripe fruits of Capsicum annuum L. var. minimum Miller (Heiser) or Capsicum frutescens L., small-fruited varieties, equivalent to 6.3 mg of capsaicinoids expressed as capsaicin. Extraction solvent: ethanol minimum 90% V/V. One patch contains 50.3 mg of refined and standardized capsicum oleoresin, equivalent to 6.3 mg of capsaicinoids expressed as capsaicin.

The other components are: arnica essence, olibanum, natural rubber, iron oxide, staybelite resin, staybelite ester 3, Hercolin, iris rhizome, methyl p-hydroxybenzoate, 2,2'-methylene-bis-(4-methyl-6-tert-butylphenol), castor oil (excipient of the herbal preparation).

Description of the appearance of Cerotto Bertelli and pack contents

Medicated patch measuring 16 x 12.5 cm, brown in colour, on a non-woven fabric support with an adhesive layer protected by a polyethylene-coated paper liner.

Packs containing 1 or 3 patches are available.

Marketing Authorization Holder

Kelémata S.r.l.
Corso Re Umberto, 20 - 10128 Torino

Manufacturer

Kelémata S.r.l.
Via Castellana, 120
30030 Martellago (VE)

Over-the-counter medicinal product

Batch No.
Expiry date
AIC No. 004844015 - “50.3 mg medicated patch”, 1 patch
AIC No. 004844041 - “50.3 mg medicated patch”, 3 patches
Optical seal
Braille: Cerotto Bertelli 50.3 mg