What is Brexin Used for, Uses of Brexin Tablets

 

What is Brexin Tablet?

This medicine contains the active substance piroxicam-B-cyclodextrin that belongs to a group of drugs known as NSAIDs (non-steroidal anti-inflammatory drugs) active against pain, fever and inflammations.

What Brexin Used for?

Brexin is used relieve pain, swelling or stiffness in the joints due to rheumatoid arthritis (a disease that affects chiefly hands and wrists), ankylosing spondylitis (rheumatism of the spine) and osteoarthritis (arthrosis: degenerative joints disease).

Your Doctor will prescribe BREXIN to you only when you have had unsatisfactory relief of symptoms with other NSAIDs.

What you need to know before you use BREXIN?

Do not take BREXIN:

• if you are allergic to piroxicam or to any of the excipients of this medicine (listed in section 6);

• if you previously had any allergic reaction and/or skin reactions, regardless of severity. For example, erythema multiforme, Stevens-Johnson syndrome and toxic

epidermal necrolysis, after taking other medicines, including other

NSAIDs, or medicines containing the same active substance;

• if you have had symptoms of angioedema, asthma, rash, nasal polyposis or rhinitis due to the administration of NSAIDs or acetylsalicylic acid otherwise known

as aspirin;

• if you are taking other NSAIDs or acetylsalicylic acid (aspirin) to relieve pain;

• if you have stomach and/or duodenal (peptic) ulcer, or if you have digestion problems (dyspepsia) or stomach inflammation (gastritis);

• if you have suffered from intestinal or stomach ulcer, bleeding or perforation (including blood

in vomit or during defecation or black, tarry faeces);

• if you have inflammation or bleeding of stomach or intestines (gastrointestinal) even if caused by diseases such as gastrointestinal cancer, diverticulitis,

ulcerative colitis, Crohn's disease;

• if you have a severe liver or kidney disease;

• if you have high blood pressure (severe hypertension) or serious heart problems (moderate to severe heart failure;

• if you have a tendency to bleed frequently (haemorrhagic diathesis), or severe coagulation problems or if you are taking drugs that fluidify blood (anticoagulants);

• if you are or think you may be pregnant or if you are breast-feeding (see section Fertility, pregnancy and lactation)

BREXIN is not intended for use in children and adolescents under the age of 18.

Warning and precautions

Inform your doctor before taking BREXIN:

• if you are elderly (especially if you are over 70 years old) because you have a higher chance of suffering from adverse effects from this drug;

• if you are asthmatic or subject to asthma attacks;

• if you have eye problems;

• if you have diabetes;

if you have kidney problems;

• if you have liver problems,

• if you have heart or blood vessels problems like heart attacks, strokes or congestive heart failure or if you think you may be at risk for any of these conditions (if,

for example you have high blood pressure, or if you have diabetes or if you are a smoker), since drugs like BREXIN may slightly increase the risk of heart attack (myocardial infarction or stroke.

IN ALL THE ABOVE DESCRIBED CASES PLEASE INFORM YOUR DOCTOR WHO MAY WANT TO REFER YOU FOR FURTHER TESTS.

The administration to patients older than 80 years is not recommended.

TAKE SPECIAL CARE because, like all NSAIDs, this medicine can:

• cause, severe or even life-threatening bleeding, ulcers and perforation to stomach and intestines (gastrointestinal) at any time, with or without warning symptoms, even in patients with no history of serious condition of this type;

• cause, though rarely reported, severe and in some cases, life-threatening, skin reactions that include reddening, blisters or exfoliation (for example Stevens-Johnson syndrome and toxic epidermal necrolysis). Risk is reported to be higher in the earlier stages of treatment.

The risk of having side effects increases with high doses and prolonged treatments. Always follow your doctor's instructions carefully.

STOP your treatment and inform your Doctor:

• if you experience any symptom in stomach and intestines (gastrointestinal), especially in the case of bleeding:

• if you experience any skin alteration (skin rash), lesions to the mucosae or any other sign of allergic reaction (reddening, itching, swelling of face or throat with breathing difficulties, sudden fall in blood pressure).

BREXIN may interfere with the results of some blood tests, for example clotting time. Always inform your doctor you are taking BREXIN in these cases.

Children and adolescents

Children and adolescents under the age of 18 must not take BREXIN.

Taking BREXIN with other medicines

Tell your doctor or pharmacist about any other drugs you are taking or may take. Some medicines may interact with BREXIN or even increase the risk of, often very serious, side effects

It's especially important to inform your doctor whether you are taking any of the following:

• Drugs containing cortisone (corticosteroids):

• blood thinning drugs (anticoagulant or antiaggregating) such as warfarin or acetylsalicylic acid (aspirin);

• anti-high blood pressure (hypertension) drugs like: diuretics, ACE inhibitors and angiotensin II antagonists;

• medicines containing potassium;

• medicines known as 'selective serotonin reuptake inhibitors' (SSRIs), used as antidepressants;

• other NSAIDs or salicylate or acetylsalicylic acid (aspirin) to relieve pain;

• lithium used as an anti-depressant;

• cimetidine, a medicine used to treat stomach ulcers;

• quinolone antibiotics used to treat bacterial infections;

• if you use any intrauterine devices;

• cyclosporin and tacrolimus, drugs that impair the immune system.

Alcohol intake and BREXIN

It is recommended to avoid consumption of alcohol during treatment with this medicine.

Fertility, pregnancy and breastfeeding

Do not use BŘEXIN if you are or think you may be pregnant as it may damage the foetus' heart, lungs or kidneys or cause complications during delivery.

Do not use BREXIN when breastfeeding.

This medicine may impair fertility. If you have fertility problems and are using BREXIN, stop taking it.

If you are pregnant, suspect or plan to become pregnant, or if you are breastfeeding, this medicine should only be used in cases of real need and under direct

medical supervision. Ask your doctor for advice before taking this medicine.

Driving and using machines

This medicine may cause dizziness or unusual tiredness, pay particular attention when driving or operating machinery.

BREXIN tablets contains:

• lactose. If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine;

• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially “sodium-free".

 How to take BREXIN

Always take this medicine exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

The maximum daily dose is 1 tablet. Your doctor may prescribe another drug to protect your stomach (gastroprotectants) or prescribe a lower dose, especially if

you are older than 70.

Method of administration

Take the Brexin tablet with a glass of water. The score on the tablet serves to ease the splitting and swallowing of the tablet and not to divide it into equal parts. To divide

the tablet, put it on a flat surface with the score upwards. Press gently with your thumb to break the tablet into two halves.

Do not exceed the daily dose and take BREXIN only for the time needed. If you do not feel any relief of the symptoms or if you think they are worsening please contact your doctor.

If you take more BREXIN than you should you may suffer from vomiting, drowsiness, fainting, dizziness headache. In case of accidental ingestion of excessive doses of BREXIN inform your doctor immediately or go to the nearest hospital, as it may be necessary to take additional measures.

If you forget to take BREXIN

Do not take a double dose to compensate the dose you missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody has them.

Stop treatment with BREXIN immediately and contact your doctor in the following cases:

• serious stomach pain, bleeding or burning abdominal pain due to stomach or duodenal (peptic) ulcers;

• sudden, intense pain to the stomach pit (perforation of the ulcer);

• vomit with blood (hematemesis) or black faeces (melaena) together with stomach or intestinal (gastrointestinal) bleeding or excessive fatigue with reduced urination (due to undetected bleeding):

• allergic reactions, including severe ones (anaphylaxis), with swelling (angioedema) of the face, lips and throat, that may cause difficulty in breathing or swelling of the hands, including serum disease;

• sudden drop in blood pressure (shock) that may cause confusion, increase of heart rate, paleness, fatigue or feebleness or breathing difficulty (warning symptoms);

• severe skin reactions including skin blisters, reddening or exfoliation (for example Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme).

The following are all the side effects that may appear during treatment with BREXIN, ordered by frequency:

Common (may affect up to 1 in 10 people):

• decrease in red blood cells (anaemia):

• headache (cephalea);

• abdominal pain and distress, constipation (obstipation), diarrhoea, gas (flatulence), stomach (epigastric) pain or distress, nausea, vomiting, poor digestion

• vertigo, tinnitus (noise in the ears);

(dyspepsia);

• skin rashes, itching.

Uncommon (may affect up to 1 in 100 people):

• dizziness:

• drowsiness;

• blurred vision;

• inflammation of mouth with ulcers (ulcerative stomatitis).

Rare (may affect up to 1 in 1000 people):

• decrease in number of haemoglobins in blood due to a fall in the production of red blood cells by the bone marrow (aplastic anaemia):

• decrease in number of haemoglobins in blood due to the formation of anti-bodies that destroy red blood cells (haemolytic anaemia);

• decrease in number of platelets (thrombocytopenia), decrease in number of white blood cells (leukopenia) increase in eosinophil white blood cells (eosinophilia),

reduction red and white blood cells and platelets (pancytopenia):

• swelling (oedema), due to allergic reactions, of face and hands;

• sight impairment;

yellowing of the skin or eyes (jaundice);

• inflammation of the liver with subsequent patient's death (fatal hepatitis);

• skin sensitivity to sunlight (photosensitisation of the skin), urticaria;

• red coloration of the skin due to small blood extravasation (non-thrombocytopenic purpural:

• Henoch-Schonlein purpura (inflammation that affects the blood vessels of the skin, bowel and kidneys);

• inflammation of the kidneys (interstitial nephritis), severe renal impairment (renal papillery necrosis, nephrotic syndrome), alterations in kidney function (kidney failure):

swelling (oedema);

• increase in liver function indexes:

Very rare (may affect up to 1 in 10,000 people):

• bladder disorders (vesicular failure).

Unknown (frequency cannot be estimated from the available data):

• fluid retention;

increase or decrease in blood sugar levels (hyperglycaemia, hypoglycaemia);

• abnormal weight gain;

• depression, abnormal dreams, hallucinations, sleep disorders (insomnia), confusion, mood swings, nervousness, increased excitability (erethism);

• ear impairment;

• inflammation of blood vessels (vasculitis);

• narrowing of bronchi (bronchospasm);

• nose bleeding (epistaxis);

• stomach inflammation (gastritis): pancreas inflammation (pancreatitis);

• mouth dryness;

liver inflammation (hepatitis);

• hair loss (alopecia);

• skin desquamation;

• bruises (ecchymosis)

• sweating;

• changes in nail growth;

• blood in the urine (haematuria), difficulty urinating (dysuria);

• malaise, fatigue (asthenia);

• lack of or reduced appetite (anorexia):

• body weight gain:

• abnormal blood parameters (decrease in haemoglobin or haematocrit, increased transaminase levels, positive antinuclear antibody):

• exacerbation of inflammation of the colon (colitis) and Crohn's disease;

changes in kidney function (acute renal failure), fluid retention,

increase in heart blood pressure (hypertension), impaired cardiac function (cardiovascular Reporting of side effects reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, ask your doctor or pharmacist. You can also report side effects directly via the national reporting. By reporting Side Effects, you can help provide more information on the safety of this medicine. 

How to store BREXIN

Keep this medicine out of the reach and sight of children

Store Below 30°C

Do not use this medicine after the expiry date indicated on the outer packaging after the word Exp. The expiry day shall be intended as the last day of the month.

The expiry date refers to the medicinal product in its unopened and correctly stored package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist about how to dispose of unused medicines. This will help to protect

the environment.

Content of the package and further information

What BREXIN contains

The active ingredient is piroxicam-B-cyclodextrin

BREXIN tablets

Each tablet contains: piroxicam-B-cyclodextrin 191.2 mg, equivalent to piroxicam 20 mg.

Other ingredients are: lactose, crospovidone, sodium carboxymethyl starch, colloidal anhydrous silica, modified starch, magnesium stearate.

What BREXIN looks like and contents of the pack

BREXIN tablets are available in packages of 30 pale yellow scored tablets.

Manufactured by CHIESI FARMACEUTICI.