Brexin

Brexin

piroxicam beta-cyclodextrin

Manufacturer:

Chiesi

Distributor:

Germax
Full Prescribing Info
Contents
Piroxicam-beta-cyclodextrin.
Description
Brexin contains the active ingredient piroxicam-beta-cyclodextrin.
Each tablet contains: piroxicam-beta-cyclodextrin 191.2 mg, equal to piroxicam 20 mg.
Excipients/Inactive Ingredients: Lactose, crospovidone, sodium starch glycolate, silica, colloidal hydrated, starch, pregelatinised, magnesium stearate.
Indications/Uses
BREXIN is an anti-inflammatory and anti-pain drug, used to relieve some symptoms caused by osteoarthritis (arthrosis: degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain. BREXIN does not cure arthritis.
Dosage/Direction for Use
Adults and the elderly: The maximum daily dose is 20 miligrams of piroxicam as one single daily dose. Patients who are older than 70 years must be prescribed with a lower daily dose and a reduced duration of treatment.
Instructions for Use: To divide the tablet, it must be placed on a flat surface with the scoring line upwards. The tablet can then be broken into two equal parts by gently pressing it with the thumb.
Overdosage
The most significant overdose symptoms are headache, drowsiness and syncope.
In case of accidental intake of an excessive dose of BREXIN, inform immediately the doctor or go to the nearest hospital.
Contraindications
Do not take Brexin: If the patient is allergic/hypersensitive to piroxicam or to any of the excipients of BREXIN; if the patient previously had a stomach or intestinal ulcer, bleeding or perforation; if the patient currently have stomach or intestinal ulcer, bleeding or perforation; if the patient has or has had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/pockets in the colon); if the patient is taking other NSAIDs, icluding selective inhibitors of COX-2 and acetyl-salicylic acid (a substance present in many medicines used to relieve pain and lower fever). Remember that many NSAIDs can be purchased without medical prescription; if the patient is taking anticoagulants, such as warfarin, to prevent blood clots; if the patient previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reations (regardless of severity) such as multiform erythema, exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions: Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin, and toxic epidermal necrolysis, a disease with blistering and peeling of the top layer of the skin; if the patient had symptoms of asthma, rhinitis, nasal polyposis, angioedema or rash during treatment with acetyl-salicylic acid or other NSAIDs; if the patient is suspected to be pregnant; if the patient is breast-feeding; if the patient is aged less than 18 years; if the patient has a severe hepatic disease; if the patient has moderate or severe heart failure; if the patient has blood alterations; if the patient has hemorrhagic diathesis (predisposition to frequent bleeding).
If any of these applies to the patient, BREXIN should not be given. Tell the doctor immediately.
Special Precautions
Take special care with BREXIN and always tell the doctor before using BREXIN: Like all non-steroidal-anti-inflammatory drugs, BREXIN can cause serious reactions in the stomach and intestines, such as pain, bleeding and ulceration. The patient should immediately stop taking piroxicam and tell the doctor if the patient has stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
The patient should immediately stop taking BREXIN and tell the doctor if the patient has any allergic reaction such as skin rash, swelling of the face, wheezing or difficulty in breathing.
If patient is over 70 years old, the doctor may wish to minimise treatment duration, and to see the patient more often while they are taking BREXIN.
If the patient is over 70 years old, or the patient is taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetyl-salicylic acid to prevent blood clotting, the doctor may like to prescribe medicine for protecting their stomach and intestines.
Patient should not be use this medicine if the patient is older than 80 years.
If the patient has or had any medical problems or any allergies or if the patient is not sure as to whether the patient can use BREXIN, they should tell the doctor before using this medicine.
The patient must make sure that the patient have told the doctor about any other medicines that the patient is taking, including those that the patient has brought without a prescription.
Medicines like BREXIN may be associated to an increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely to occur with high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment. If the patient has heart problems, or had stroke or think to be at risk for these conditions (for example, if the patient has high blood pressure, diabetes or high cholesterol levels or smoke addiction) the patient should discuss the therapy with the doctor or pharmacist. BREXIN, like other non-steroidal anti-inflammatory drugs, decreases platelet aggregation and prolongs coagulation time; this should be taken into account when the patient undergoes blood testing and requires vigilance when the patient is concomitantly taking drugs inhibiting platelet aggregation.
Caution is required if the patient has a history of hypertension and/or heart failure, as water retention and oedema have been reported with NSAIDs therapy. Particular caution is required in patients with cardio-circular failure, hypertension, reduced hepatic or renal function, poor renal perfusion, active or previous blood alterations and if the patient is taking diuretics.
If the patient is asthmatic, due to the drug interaction with arachidonic acid metabolism, broncho-spastic attacks and eventually shocks, and other allergic reactions may occur.
As some ocular changes were observed during therapy with NSAIDs, periodic ophthalmologic checks are advised during prolonged treatment.
As for other drugs with similar action, some patients showed increase of blood urea nitrogen not exceeding certain levels, in case of prolonged treatment; once therapy is discontinued, values return to baseline.
If the patient is diabetic, it is advisable to perform frequent blood testing.
Severe allergic reactions (especially severe skin reactions) were very rarely reported with the use of NSAIDs. (See Adverse Reactions.)
In case the patient is programming a pregnancy, if the patient has fertility problems or in case the patient is undergoing fertility tests, the patient must discuss therapy with the doctor.
Important information on some excipients of BREXIN: The dosage forms tablets contain lactose: if the patient have a diagnosed intolerance to some sugars, the patient must contact the doctor before taking this medicine.
Ability to Drive or Use Machines: In case of dizziness or unusual tiredness, patient must pay particular attention while driving or operating machines.
Use In Pregnancy & Lactation
Always ask the doctor or pharmacist for advise before taking any medicine.
If patient is or suspects to be pregnant, inform the doctor as BREXIN is not indicted to pregnant patients. If the patient is programming a pregnancy or in case the patient is undergoing fertility tests, inform the doctor anyway, as Brexin may not be indicated to the patient.
Do not take Brexin if the patient is breast-feeding. Ask the doctor: It may be advisable to withdraw breast-feeding.
Adverse Reactions
As all medicines, BREXIN may cause undesirable effects, although not all has that. BREXIN is better tolerated than plain piroxicam at gastro-intestinal level; in fact, the reduced permanence of the active ingredient in the gastro-intestinal tract reduces the risk of irritation due to direct contact.
Withdraw immediately treatment with BREXIN and contact the doctor: if there is development of skin blisters, reddening or desquamation (skin rash), ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of allergic reaction, such as skin rash, swelling of the face, lips or tongue, that may cause difficulty in breathing; skin or the white part of the eyes are yellow coloured (jaundice); signs of stomach bleeding, such as passing black or bloodstained bowel movements, or vomiting blood.
Most common effects: Ulcers of the digestive tract and gastrointestinal bleeding; nausea, vomiting, diarrhoea, flatulence, constipation, gastric acidity, abdominal pain, ulcerative stomatitis, bowel inflammatory diseases (colitis and Crohn's disease); swelling of ankles, legs and feet (water retention); increase of blood pressure; heart failure (difficult breathing and tiredness).
Least common effects: Heart attack ("myocardial infarction"); stroke; anorexia; tiredness; anemia; skin blisters, reddening or desquamation (skin rash); ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of allergic reaction, such as skin rash, swelling of the face, lips or tongue, wheezing, yellow coloured skin or eyes (jaundice); increased normal parameters of hepatic function; pancreatitis; acute renal failure, blood in urine, difficult urination; increase of blood non-proteic nitrogen (increase of azotemia); swelling of ankles, legs and feet (water retention); increase of blood pressure (hypertension); nose bleeding; headache; sleepiness; hearing loss or buzzing in the ears; dizziness; sight disturbances; discomfort; blood or lymphatic alterations; gastritis.
Rare effects: Bruises occurrence; alteration of blood glucose parameters (hypo- and hyper-glycemia); sweating; body weight changes; insomnia; depression; swelling, blisters or skin desquamation; skin photosensitivity; dry mouth; erethism; impairment of bladder function; shock; hair loss; impairment of nails growth; fatal hepatitis.
Inform the doctor or pharmacist in case any of the undesirable effects is worsening or if any unwanted effect, if not described previously, occurs.
Drug Interactions
Taking Brexin with Other Medicines: Tell the doctor about any other medicines being taken or took recently (in the last week) - even medicines brought without a prescription. Medicines can sometimes interfere with each other. The doctor may limit the patient's use of piroxicam or other medicines, or the patient may need to take a different medicine. It's especially important to mention: if the patient is taking apirin or other non-steroidal anti-inflammatory drugs for pain relief; if the patient is taking corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalance; if the patient is taking anticoagulants such as warfarin to prevent blood clots; if the patient is taking any drugs, such as acetylsalicylic acid to prevent platelet clumping; if the patient is taking diuretics, ACE inhibitors and angiotensin II antagonists, used in case of blood high pressure or heart diseases; if the patient is taking lithium, used to cure depression; if the patient is taking antibacterial quinolone drugs, used to treat bacterial infections; if the patient uses intra-uterine devices.
If any of these applies to the patient, tell the doctor immediately.
Taking Brexin with Food and Drinks: It is advisable not to drink alcohol during the treatment with BREXIN.
Caution For Usage
Medicines should not be disposed in water or domestic waste. Ask the pharmacist about how to dispose not used medicines. This will help to protect environment.
Patient Counseling Information
Always use piroxicam as the doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change the dose without first speaking to your doctor.
Do not decrease the dose: If you feel that the medicine is not very effective, always talk your doctor.
If you forget to use piroxicam: Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not double the dose.
ATC Classification
M01AC01 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.
Presentation/Packing
Tab 20 mg (pale yellow, hexagonal, scored) x 20's.
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