Active ingredients: Piroxicam
BREXIDOL 14 mg medicated plaster
Why is Brexidol used? What is it for?
WHAT IS IT
BREXIDOL is a medicated plaster based on piroxicam, a non-steroidal anti-inflammatory drug with a strong anti-inflammatory and analgesic action.
The activity of the active principle administered topically in the various models of acute and chronic inflammation occurs even in the presence of reduced plasma levels.
WHY IT IS USED
BREXIDOL is used for the local treatment of pain and inflammation of a rheumatic and traumatic nature of the joints, muscles, tendons and ligaments.
Contraindications When Brexidol should not be used
Hypersensitivity to the active substance or to any of the excipients.
BREXIDOL patch should not be used on open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.
Do not use BREXIDOL:
- In case of a history of hypersensitivity reaction (asthma, allergic rhinitis, rash and anaphylactic reactions) or gastrointestinal bleeding from anti-inflammatory drugs.
- In the presence of active peptic ulcer, in patients with bronchial asthma or on anticoagulant therapy.
- Pregnancy and breastfeeding.
- Children under the age of 12.
Precautions for use What you need to know before taking Brexidol
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug.
Brexidol should be used with great caution and on doctor's prescription in the elderly, in subjects with chronic bronchitis, allergic rhinitis or inflammation of the nasal mucosa (in which asthmatic attacks or severe inflammatory reactions of the skin and mucosa are more frequent), in patients with a history of gastrointestinal diseases (such as gastrointestinal ulcer, ulcerative colitis or Crohn's disease), in patients with a history of gastrointestinal bleeding not secondary to NSAID administration or with other bleeding disorders, with liver or kidney dysfunction or heart failure.
To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight.
Interactions Which drugs or foods can modify the effect of Brexidol
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The use of piroxicam-based patches is unlikely to have interactions with other medicinal products, foods or drinks. The concomitant topical or systemic use of other drugs containing piroxicam or other NSAIDs is however not recommended.
Warnings It is important to know that:
When it can be used only after consulting your doctor
- in case of a history of hypersensitivity reaction (asthma, allergic rhinitis, rash and anaphylactic reactions) or gastrointestinal bleeding from anti-inflammatory drugs;
- in the presence of active peptic ulcer, in patients with bronchial asthma or on anticoagulant therapy.
It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. BREXIDOL is contraindicated during pregnancy and breastfeeding and is not recommended in women intending to become pregnant. Administration should be suspended in women with fertility problems or who are undergoing fertility investigations.
Effects on ability to drive and use machines
BREXIDOL does not affect the ability to drive or use machines.
Dosage and method of use How to use Brexidol: Dosage
How many
One patch once a day.
Warning: do not exceed the indicated doses.
When and for how long
The patch can be applied at any time of the day.
Use only one medicated plaster at a time and replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches in the same day.
If after a short period of treatment no appreciable benefits are observed, consult your doctor.
Like
BREXIDOL is to be used exclusively on intact skin. After having carefully washed and dried the painful area, rub one of the corners of BREXIDOL between your fingers to remove the protective film and apply the adhesive part directly on the skin.
In the event that BREXIDOL must be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint, in order to keep the patch in place.
WHAT TO DO IF YOU HAVE FORGOTTEN TO TAKE ONE OR MORE DOSES
Apply the forgotten patch as soon as you remember.
However, if it is almost time to apply the next patch, apply only the next regularly scheduled one.
Do not apply two patches in the same day.
IF YOU ARE IN ANY DOUBT ABOUT THE USE OF BREXIDOL, CONTACT YOUR DOCTOR OR PHARMACIST.
Overdose What to do if you have taken too much Brexidol
In case of accidental intake of an excessive dose of BREXIDOL, notify your doctor immediately or contact the nearest hospital.
Side Effects What are the side effects of Brexidol
Like all medicines, BREXIDOL medicated plaster can cause side effects, although not everybody gets them.
The use of Brexidol may lead to allergic skin reactions, erythema, itching, irritation, burning, contact dermatitis, numbness and tingling at the application site; cases of extensive and severe dermatological lesions such as urticaria, Quincke's edema, erythema multiforme.
Photosensitivity reactions and more extensive and more severe reactions are possible, including asthma attacks.
Systemic undesirable reactions following the topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but highly variable from individual to individual, it is not possible to exclude, especially in the case of prolonged therapies beyond the recommended term and non-compliance with contraindications and warnings, the appearance of systemic side effects, especially at the gastrointestinal level.
In case of local or general side effects it is necessary to stop the treatment and consult the doctor to establish a suitable therapy.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
The side effects described are generally transient. However, when they arise, it is advisable to consult your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Other information
COMPOSITION
What BREXIDOL contains:
One patch measuring 100 x 70 mm (70 cm2) contains 14 mg of piroxicam.
The other ingredients are: Acrylic copolymer, Eudragit E 100, non-woven fabric, silicone-coated polyester.
HOW IT LOOKS
Carton containing 8 laminated pouches: each pouch contains 1 medicated plaster of 14 mg.
Carton containing 4 laminated pouches: each pouch contains 1 medicated plaster of 14 mg.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
BREXIDOL 14 MG MEDICATED PATCH
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One patch measuring 100 x 70 mm (70 cm2) contains 14 mg of piroxicam.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Medicated plaster.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
BREXIDOL is indicated for the treatment of painful and inflammatory conditions of a rheumatic and traumatic nature of the joints, muscles, tendons and ligaments.
04.2 Posology and method of administration
It is recommended to use only one medicated plaster at a time and to replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches in the same day.
BREXIDOL is to be used exclusively on intact skin. After having carefully washed and dried the painful area, rub one of the corners of BREXIDOL between your fingers to remove the protective film and apply the adhesive part directly on the skin.
In the event that BREXIDOL must be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint, in order to keep the patch in place.
Do not exceed the recommended doses.
04.3 Contraindications
Hypersensitivity to the active substance (piroxicam) or to any of the excipients.
Patients in whom substances with a similar mechanism of action (NSAIDs) have caused hypersensitivity reactions (see section 4.4).
BREXIDOL is contraindicated in patients with active peptic ulcer, patients with bronchial asthma, a history of gastrointestinal haemorrhage from NSAIDs.
Patients on anticoagulant therapy.
Pregnancy and lactation (see section 4.6).
Children under the age of 12.
BREXIDOL patch should not be used on open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.
04.4 Special warnings and appropriate precautions for use
The serum levels achieved with BREXIDOL were significantly lower than those obtained by oral administration but with a strong individual variability for which the onset of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded.
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions.
BREXIDOL should be used with caution in subjects with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyps) in which asthma attacks or localized inflammatory reactions of the skin and mucosa (Quincke's edema) are more frequent.
Use caution in patients with a history of peptic ulcer, in patients with a history of gastrointestinal bleeding not secondary to NSAID administration or with other bleeding disorders, in patients with Crohn's disease or ulcerative colitis, with severe liver or kidney dysfunction or heart failure.
Prolonged or repeated use of products for cutaneous use can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, it is necessary to interrupt the therapy.
Caution should be exercised when treating elderly patients who are generally more predisposed to adverse events.
After a short therapy without results, consult your doctor.
To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
The use of piroxicam-based patches is unlikely to have interactions with other medicinal products. However, the possibility of competition between absorbed piroxicam and other drugs with high plasma protein binding cannot be excluded.
Do not use the product together with other drugs for oral or local use, containing piroxicam or other NSAIDs.
04.6 Pregnancy and breastfeeding
Brexidol is contraindicated during pregnancy and breastfeeding and is not recommended in women intending to become pregnant. Administration should be discontinued in women with fertility problems or undergoing fertility investigations.
04.7 Effects on ability to drive and use machines
BREXIDOL does not affect the ability to drive and use machines.
04.8 Undesirable effects
The use of the product may cause local irritative or allergic skin reactions such as erythema, itching, burning, contact dermatitis, numbness and tingling at the application site; cases of extensive and severe dermatological lesions such as urticaria, Quincke's edema, erythema multiforme More extensive and more severe photosensitivity reactions and skin and mucosal reactions are possible, including asthma attacks.
Undesirable systemic reactions following the topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but very variable from individual to individual, it is not possible to exclude, especially in the case of prolonged therapies beyond the recommended term and non-compliance with contraindications and warnings, the appearance of systemic undesirable effects, especially at the gastrointestinal level (see sections 4.4 and 5.2).
Any occurrence of general or application site side effects requires discontinuation of therapy.
04.9 Overdose
There are no known cases of overdose.
In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the necessary common emergency measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Topical drugs for joint and muscle pain.
ATC code: M02AA07
BREXIDOL is a medicated plaster based on piroxicam, a non-steroidal anti-inflammatory drug with a strong anti-inflammatory and analgesic action. The pharmacological effects are mainly due to the inhibition of prostaglandinsynthetase.
The activity of the active principle administered topically in the various models of acute and chronic inflammation occurs even in the presence of reduced plasma levels.
05.2 Pharmacokinetic properties
The application of BREXIDOL to healthy volunteers for 8 consecutive days confirmed that the systemic absorption is, on average, significantly lower than the oral administration but with a strong individual variability; the levels of piroxicam in plasma can only be determined after the second-third application and reach a plateau value around the sixth day. As with other forms of topical piroxicam, the mean systemic bioavailability of piroxicam was no more than 1/10 of that of oral piroxicam with the use of BREXIDOL.
05.3 Preclinical safety data
p> Toxicological tests carried out on various animal species have shown that topical piroxicam is well tolerated and lacks teratogenic and mutagenic activity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Acrylic copolymer, Eudragit E 100; non-woven fabric, silicone-coated polyester.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Carton containing 8 laminated pouches, each pouch contains 1 medicated plaster of 14 mg.
Carton containing 4 laminated pouches, each pouch contains 1 medicated plaster of 14 mg.
06.6 Instructions for use and handling
Any unused product or waste material must be disposed of in accordance with local regulations in force.
07.0 MARKETING AUTHORIZATION HOLDER
Promedica S.r.l. - Via Palermo 26 / A - 43122 Parma
08.0 MARKETING AUTHORIZATION NUMBER
AIC 038370021 - Box containing 8 plasters
AIC 038370019 - Box containing 4 plasters
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 20, 2009
10.0 DATE OF REVISION OF THE TEXT
December 2012
