CEROTTO 50,3 MG Медицинский пластырь

Содержание инструкции

1. Cerotto Bertelli 96.5 mg medicated patch
   1. What is Cerotto Bertelli and what is it 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
2. Cerotto Bertelli 50.3 mg medicated patch
   1. What is Cerotto Bertelli and what is it 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

Cerotto Bertelli 96.5 mg medicated patch

Capsicum oleoresin

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See your doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

Cerotto Bertelli contains the active ingredient capsicum oleoresin which belongs to the category of
medicinal products for topical use for joint and muscle 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 any of the other ingredients of this medicine (listed in section 6).
• In case of damaged skin, wounds and eczema (skin inflammation).

Warnings and precautions
Consult your doctor or pharmacist before using Cerotto Bertelli.
Remove Cerotto Bertelli using a cotton ball soaked in warm water or olive oil.
Do not apply the patch near the eyes or on mucous membranes.
Apply the patch exclusively to healthy skin.
During treatment, avoid applying additional heat sources (e.g. solar or
infrared radiation, heating pad or hot water). The effect of heat can also be intensified by
physical activity (sweating).
Stop treatment if the heat effect 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not apply the patch at the same time as other products for local use, such as other
rubefacients (medicines that increase perfusion and cause redness of the skin), or gels
pain relievers in the same application site.
Interactions with other medicines applied to the same application site may occur even up to
12 hours after removing the patch.

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.
Capsicum oleoresin, the active ingredient of this medicine, crosses the placenta and can pass into
breast milk, therefore, the use of this medicine during pregnancy and breastfeeding can be
carried out only after careful medical evaluation of the risk/benefit ratio.

Driving and using machines
It does not impair the ability to drive vehicles and use machinery.

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

3. How to use Cerotto Bertelli

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults
The recommended dose is 1 medicated patch per day to be applied to the affected area and maintained for at least 4-12 hours. An interval of at least 12 hours must elapse before applying a new patch to the same application area.
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 have not been established. No data are available.
Route of administration
Cutaneous use.
Apply to dry skin and adhere with a light massage.
Duration of treatment
Use for a short period.
Prolonged use should be established by the doctor after adequate clinical evaluation.

If you use more Cerotto Bertelli than you should
If the patch is used inappropriately, local irritations may occur, requiring discontinuation of the medicine and generic anti-inflammatory treatment.
If you use more Cerotto Bertelli than you should, notify your doctor or go to the nearest hospital.

If you forget to use Cerotto Bertelli
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Sensitization phenomena, especially during prolonged use;
• Increased blood circulation with marked redness of the skin and a sensation of heat. This reaction is part of the normal pharmacological action of the medicine and generally subsides shortly after removal of the patch;
• Skin hypersensitivity and allergic reactions, such as urticaria, blisters and blistering at the application site. In these 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, please inform your doctor or pharmacist. You can also report side effects directly through
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Cerotto Bertelli

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging after Scad. 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 Cerotto Bertelli contains

• The active ingredient is refined and titrated Capsicum oleoresin, from dried mature fruits of Capsicum annuumL. var. minimum Miller (Heiser) or Capsicum frutescensL. small-fruited varieties, corresponding to 12.2 mg of capsaicinoids expressed as capsaicin. Extraction solvent: ethanol minimum 90% V/V. One plaster 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, frankincense, natural rubber, iron oxide, staybelite resin, staybelite ester 3, Hercolin, iris rhizome, methyl parahydroxybenzoate, 2,2'-methylene-bis-(4 methyl-6 tert-butylphenol), castor oil (excipient of the plant preparation).

Description of the appearance of Cerotto Bertelli and contents of the pack
Medicinal plaster with dimensions of 24 x 16 cm, brown in colour, on a non-woven fabric support and adhesive layer protected by a polyethylene paper sheet.
Pack of 1 plaster.

Marketing Authorisation Holder
Kelémata S.r.l. Corso Re Umberto, 20 - 10128. Turin

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

Over-the-counter medicine

Lot no.
exp.
AIC no. 004844027 - “96.5 mg medicated plaster” – 1 plaster
Optical Seal
Braille: Cerotto Bertelli 96.5 mg

Cerotto Bertelli 50.3 mg medicated patch

Capsicum oleoresin

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 is Cerotto Bertelli and what is it used for?

Cerotto Bertelli contains the active ingredient capsicum oleoresin which belongs to the category
of topical medicines for joint and muscle 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).
• In case of broken skin, wounds and eczema (an inflammation of the skin).

Warnings and precautions
Consult your doctor or pharmacist before using Cerotto Bertelli.
Remove Cerotto Bertelli using a cotton ball soaked in warm water or
olive oil.
Do not apply the patch near the eyes or on mucous membranes.
Apply the patch exclusively to healthy skin.
During treatment, avoid the application of additional heat sources (e.g. solar or infrared radiation, heating pad or hot water). The effect of heat can also be
intensified by physical activity (sweating).
Stop treatment if the heat effect 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not apply the patch at the same time as other topical products, such as other rubefacients (medicines that increase perfusion and cause redness
of the skin), or pain-relieving gels in the same application site.
Interactions with other medicines applied to the same application site may occur
even up to 12 hours after the patch is removed.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
Capsicum oleoresin, the active ingredient of this medicine, crosses the placenta and may
pass into breast milk, therefore, the use of this medicine during pregnancy and
breastfeeding can only be carried out after careful medical evaluation of the risk/benefit ratio.

Driving and using machines
It does not impair the ability to drive vehicles and use machinery.

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

3. How to use Cerotto Bertelli

Use this medicine following exactly the instructions in this leaflet or as indicated 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 to be applied to the affected area and maintained for at least 4-12 hours. An interval of at least 12 hours must elapse before applying a new patch to the same application area.
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.
Route of administration
Cutaneous use.
Apply to dry skin and adhere with a light massage.
Duration of treatment
Use for a short period.
Prolonged use should be established by the doctor after adequate clinical evaluation.

If you use more Cerotto Bertelli than you should
If the patch is used inappropriately, local irritations may occur, requiring suspension of the medicine and generic anti-inflammatory treatment.
If you use more Cerotto Bertelli than you should, immediately inform your doctor or go to the nearest hospital.

If you forget to use Cerotto Bertelli
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 redness of the skin and a sensation of heat. This reaction is part of the normal pharmacological action of the medicine and generally subsides shortly after removing the patch;
• Skin hypersensitivity and allergic reactions, such as urticaria, blisters and blistering at the application site. In these cases, you should immediately stop treatment.
• A sensation of irritation or itching during the first few days of treatment.

If, in individual cases, the side effects experienced are excessive, stop the
treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform 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 Cerotto Bertelli

Keep this medicine out of the sight and reach of children.
Do not store at a temperature 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 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 Cerotto Bertelli contains

• The active ingredient is Capsicum oleoresin refined and titrated, from dried mature fruits of Capsicum annuumL. var. minimum Miller (Heiser) or Capsicum frutescensL. small-fruited varieties, corresponding to 6.3 mg of capsaicinoids expressed as capsaicin. Extraction solvent: ethanol minimum 90% V/V. One plaster contains 50.3 mg of Capsicum oleoresin refined and titrated corresponding to 6.3 mg of capsaicinoids expressed as capsaicin.

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

Description of the appearance of Cerotto Bertelli and contents of the pack
Medicinal plaster with dimensions of 16 x 12.5 cm, brown in color, on a non-woven fabric support and adhesive layer protected by a polyethylene paper sheet.
Packs of 1 and 3 plasters are available.

Marketing Authorisation Holder
Kelémata S.r.l. Corso Re Umberto, 20 - 10128. Turin

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

Self-medication medicine

Lot No.
exp.
AIC No. 004844015 - “50.3 mg medicated plaster”, 1 plaster
AIC No. 004844041 - “50.3 mg medicated plaster”, 3 plasters
Optical Seal
Braille: Cerotto Bertelli 50.3 mg