Bertelli patch - Package leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: oleoresin capsicum, capsicum-based preparations

192 mg MEDICATED PATCH "1 patch 12.5x16 cm

Why is Patch Bertelli used? What is it for?

Pharmacotherapeutic group: PATCH BERTELLI is a revulsive.

Therapeutic indications: PATCH BERTELLI is used in cases of lumbago, muscle strains, intercostal neuralgia, painful states of a rheumatic nature.

Contraindications When Patch Bertelli should not be used

Do not use PATCH BERTELLI in case of:

  • hypersensitivity to the components or other closely related substances from a chemical point of view.

Precautions for use What you need to know before taking Patch Bertelli

Apply PATCH BERTELLI exclusively on intact skin.

Interactions Which drugs or foods can modify the effect of Patch Bertelli

Ask your doctor or pharmacist for advice if you are using any other medicines, including those without a prescription.

Warnings It is important to know that:

Pregnancy and breastfeeding: PATCH BERTELLI can be used during pregnancy and breastfeeding.

Pediatric use: PATCH BERTELLI is contraindicated in pediatric age.

Effects on ability to drive and use machines: none.

Dose, Method and Time of Administration How to use Bertelli Patch: Posology

How much and how: EXTERNAL USE. Freed from the silicone paper that protects the adhesive layer, PATCH BERTELLI is applied on previously dried skin making it adhere perfectly with a light massage. It is recommended to replace it preferably every 24 hours. The removal of the patch is facilitated by using a cotton swab soaked in warm water or olive oil. Warning: do not exceed the indicated doses without the advice of a doctor.

When and for how long: the action of PATCH BERTELLI generally takes place within 24 hours. However, if the effect has not been achieved within this period of time, PATCH BERTELLI can remain applied longer (in fact it can be applied several times consecutive without drawbacks), or, it can be replaced with another. Warning: use only for short periods of treatment. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics. Contact your doctor or pharmacist if you have any questions about the use of this medicine.

Conduct to follow if you forget to use PATCH BERTELLI: none. Do not take an extra dose than the indicated methods of use.

Overdose What to do if you have taken an overdose of Bertelli Patch

If an excessive dose of PATCH BERTELLI is used: an inadequate use of the preparation can cause local irritation phenomena that require the suspension of the drug and a generic anti-inflammatory treatment. In case of improper use of an excessive dose of PATCH BERTELLI, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Patch Bertelli

Like all medicines, PATCH BERTELLI can cause side effects, compliance with the instructions contained in the package leaflet reduces the risk of side effects. The use, especially if prolonged, can give rise to sensitization phenomena. Communicate to the doctor or pharmacist the appearance of undesirable effects not described in the package leaflet.

Expiry and Retention

Do not use the medicine after the expiry date indicated on the package.

Do not store above 30 ° C.

Deadline "> Other Information

Composition 1 patch of 200 cmq surface of 16 cm x 12.5 cm contains:

  • Active substance: Capsicum oleoresin 192 mg (3.3% in total capsaicinoids expressed as capsaicin)
  • Excipients: Arnica essence, olibanum, natural rubber, iron oxide, hydrogenated and esterified rosin, iris rhizome, methyl p-hydroxybenzoate, 2,2 "methylene-bis- (4 methyl-6 tertbutylphenol).

Dose released per unit of time: not applicable.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Bertelli Patch is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

PATCH BERTELLI

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 g contain:

Active principle:

Capsicum oleoresin 3.00 g (3.3% in total capsaicinoids expressed as capsaicin)

Excipients:

Arnica essence 0.01 g

Olibanum 4.20 g

Natural rubber 30.19 g

Iron oxides 0.80 g

Hydrogenated and esterified rosin 35.70 g

Iris rhizome 24.60 g

Methyl p-hydroxybenzoate 0.25 g

2.2 "Methylene-bis- (4 methyl-6 tertbutylphenol) 1.25 g

03.0 PHARMACEUTICAL FORM -

Medicated plaster, external use.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Lumbago, muscle strains, intercostal neuralgia, painful states of a rheumatic nature.

04.2 Posology and method of administration -

Freed from the silicone paper that protects the adhesive layer. Cerotto Bertelli is applied to previously dried skin making it adhere perfectly with a light massage.

The action of the Bertelli patch is generally carried out within 24 hours.

However, if the effect has not been achieved within this period of time, Bertelli Patch can remain applied for longer (in fact, Bertelli Patch can be applied several consecutive times without problems), or more conveniently, it can be replaced with another.

04.3 Contraindications -

Individual ascertained hypersensitivity to the product.

The product is contraindicated in pediatric age.

04.4 Special warnings and appropriate precautions for use -

It is advisable to remove the Bertelli patch using a cotton swab dipped in warm water or olive oil.

04.5 Interactions with other medicinal products and other forms of interaction -

There are no known interactions of any kind with other medicaments.

04.6 Pregnancy and breastfeeding -

No contraindications to use during pregnancy and lactation are described.

04.7 Effects on ability to drive and use machines -

Nobody.

04.8 Undesirable effects -

The use, especially if prolonged of the product for topical use, can give rise to sensitization phenomena.

04.9 Overdose -

Relative overdose may be due to inadequate use of the preparation so as to determine local irritation phenomena that require drug suspension and generic anti-inflammatory treatment.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

The active ingredients have an effective, but limited revulsive action.

05.2 "Pharmacokinetic properties -

-----

05.3 Preclinical safety data -

-----

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Arnica essence, olibanum, natural rubber, iron oxides, hydrogenated and esterified rosin, iris rhizome, methyl p-hydroxy-benzoate, 2,2 "methylene-bis- (4 methyl-6 tertbutylphenol).

06.2 Incompatibility "-

There is no incompatibility whatsoever from the literature.

06.3 Period of validity "-

5 years.

06.4 Special precautions for storage -

Keep in a cold and dry place.

06.5 Nature of the immediate packaging and contents of the package -

Printed paper envelope containing a plaster, consisting of a primed canvas support on which the adhesive layer is spread, protected by a sheet of silicone paper.

06.6 Instructions for use and handling -

The patch should only be applied to healthy skin.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

KELEMATA S.p.A. Via San Quintino n. 28 Turin.

08.0 MARKETING AUTHORIZATION NUMBER -

AIC N ° 004844027.

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Date of first authorization: 7 June 1984.

Renewal date: June 2000

10.0 DATE OF REVISION OF THE TEXT -

01/11/2002

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

none:  hygiene cooking-food dictionary