BREXIN 20 mg Tablet

Зміст інструкції

1. BREXIN 20 mg tablets, 20 mg effervescent tablets
   1. What is BREXIN and what is it used for
   2. What you need to know before taking BREXIN
   3. How to take BREXIN
   4. Possible side effects
   5. How to store BREXIN
   6. Contents of the pack and other information

BREXIN 20 mg tablets, 20 mg effervescent tablets

Piroxicam-β-cyclodextrin

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BREXIN is and what it is used for
• 2. What you need to know before you take BREXIN
• 3. How to take BREXIN
• 4. Possible side effects
• 5. How to store BREXIN
• 6. Contents of the pack and other information

1. What is BREXIN and what is it used for

This medicine contains the active ingredient piroxicam-β-cyclodextrin and belongs to a class of drugs
called NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain, fever and
inflammation.
BREXIN is used to reduce pain, swelling or stiffness of the joints due to rheumatoid arthritis
(a disease that most often affects the hands and wrists) or ankylosing spondylitis (a disease
that affects the back) or osteoarthritis (a degenerative joint disease).
The doctor will prescribe BREXIN only when other NSAIDs are no longer useful in giving you relief for your
symptoms.

2. What you need to know before taking BREXIN

Do not take BREXIN if:

• you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6);
• you have had allergy 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 containing the same active ingredient;
• you have had symptoms of angioedema, asthma, urticaria, nasal polyps or rhinitis caused by the use of NSAIDs or acetylsalicylic acid, also known as aspirin;
• to relieve pain, you are taking other NSAIDs or acetylsalicylic acid (aspirin);
• you have a stomach and/or duodenal ulcer (peptic), have problems with indigestion (dyspepsia) or inflammation of the stomach (gastritis);
• you have had episodes of ulcer, perforation or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);

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• you have inflammation or bleeding in the stomach or intestine (gastrointestinal), even caused by diseases such as stomach or intestinal tumors, diverticulitis, ulcerative colitis, Crohn's disease;
• you have serious problems with the liver or kidneys;
• you suffer from high blood pressure (severe hypertension) or have serious heart problems (moderate or severe heart failure);
• you are prone to bleeding (bleeding diathesis), for example, you have serious coagulation problems or are using medicines that thin the blood (anticoagulants);
• you are pregnant or think you may be, or are breastfeeding (see Pregnancy, breastfeeding and fertility).

BREXIN should not be used in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor before taking BREXIN if:

• you are elderly (especially if you are over 70 years old) as you are more likely to develop adverse events with this medicine;
• you have asthma or are prone to asthma attacks;
• you have eye problems;
• you have diabetes;
• you have kidney problems;
• you have liver problems;
• you have problems eliminating Brexin, i.e. your body has few enzymes that break down the medicine;
• you have heart or blood vessel problems, such as stroke, heart attack or congestive heart failure, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or smoke), as medicines like BREXIN may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE THE NEED TO PERFORM CHECK-UP EXAMS.
Administration to patients over 80 years of age is not recommended.

BE CAREFUL, as during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal;
• although very rarely, serious skin reactions, some of which have been fatal, have been reported, which manifest with redness, blistering and exfoliation (Stevens-Johnson syndrome and toxic epidermal necrolysis), may sometimes present with fever and enlarged lymph nodes (DRESS syndrome). In the early stages of therapy, patients appear to be at higher risk;
• if you develop a rash or skin symptoms, you should immediately stop taking piroxicam, see a doctor immediately and tell them that you are taking this medicine.

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

STOPtreatment and contact your doctor if:

• you notice any symptoms affecting the stomach, liver and intestine (gastrointestinal), especially if it is bleeding;
• skin changes appear (a rash appears), mucosal lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat with difficulty breathing, a sudden drop in blood pressure);
• blood tests that evaluate the liver are altered.

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BREXIN can alter some blood tests, for example, coagulation time and eosinophil count. See your doctor, but do not forget to tell them that you are using BREXIN.

Children and adolescents
BREXIN should not be used in children and adolescents under 18 years of age.

Other medicines and BREXIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Some medicines can interact with BREXIN or increase the risk of adverse events,
even serious.
In particular, contact your doctor if you are using:

• medicines that contain cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), for example warfarin or acetylsalicylic acid (aspirin);
• medicines for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, angiotensin II antagonists, beta-blockers;
• medicines that contain potassium;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other NSAIDs and salicylates or acetylsalicylic acid (aspirin) to relieve pain;
• lithium, used in depression;
• cimetidine, a medicine used to treat stomach ulcers;
• quinolone antibiotics, used against bacterial infections;
• devices inside the uterus (intrauterine);
• cyclosporine and tacrolimus, drugs that reduce the immune defenses;
• methotrexate, a medicine used in rheumatoid arthritis, psoriasis, Crohn's disease and some cancers;
• beta-blockers medicines used as drugs for high blood pressure (hypertension), in heart failure, post-infarction, angina pectoris, prophylaxis of migraine.

BREXIN with alcohol
The use of alcohol is not recommended during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, this medicine should only be used in cases of actual need and under direct
medical supervision. Ask your doctor for advice before taking this medicine.
Do not take BREXIN if you are pregnant as it may harm the fetus or cause problems during childbirth.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the mother's and
baby's tendency to bleed and delay or prolong labor more than expected. From the 20th week of
pregnancy, NSAIDs can cause kidney problems in the fetus by reducing the levels of amniotic fluid
surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus) in
the baby's heart.
Do not use BREXIN if you are breastfeeding with breast milk.
This medicine may impair fertility. If you have trouble conceiving and are using BREXIN,
stop treatment.

Driving and using machines
This medicine may cause dizziness or unusual fatigue. Be careful before driving vehicles or using machinery.
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BREXIN tabletscontains:

• lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine;
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

BREXIN effervescent tabletscontains:

• lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine;
• aspartame. This medicine contains 15 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it properly;
• sodium. This medicine contains 50 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.5% of the recommended maximum daily intake with the diet of an adult.

3. How to take BREXIN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Tablets/effervescent tablets
The maximum dose is 1 tabletor 1 effervescent tablet per day. Your doctor may advise you to
use medicines that protect the stomach (gastroprotectors) or establish a lower dose, especially if
you are elderly (over 70 years of age).

Method of administration
Take the tabletwith a glass of water. The score line on the tablet is to facilitate
breaking it to make it easier to swallow and not to divide it into equal parts. To divide the
tablet, place it on a flat surface with the median score line facing upwards and break it with a
light pressure of the thumb.
Take the effervescent tabletby dissolving it completely in a glass of water.
Do not exceed the daily dose of BREXIN and take it for the shortest possible time. Consult your doctor
if you do not notice any improvement or if you notice a worsening of symptoms.

If you take more BREXIN than you shouldyou may experience vomiting, dizziness, fainting, drowsiness, headache.
In case of taking doses higher than those prescribed of BREXIN, immediately inform your
doctor or go to the nearest hospital, as appropriate measures may be necessary.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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Stop taking BREXIN immediatelyand contact your doctor if any of the following
conditions occur:

• severe stomach problems, bleeding, burning or abdominal pain due to stomach or duodenal ulcer (peptic);
• sudden and severe pain in the epigastric region (perforation of the ulcer);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• allergic reactions, including severe ones (anaphylaxis) manifested by swelling (angioedema) of the face, tongue and throat with difficulty breathing, of the hands, including serum sickness;
• sudden drop in blood pressure (shock) which can cause mental confusion, increased heart rate, paleness, weakness, low blood pressure, difficulty breathing (premonitory symptoms);
• severe skin rashes with redness, blistering and exfoliation (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme) (see section “Warnings and precautions”).
• The following are listed other possible side effects of BREXIN, in order of frequency:

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

• decrease in the number of red blood cells (anemia);
• headache;
• dizziness, tinnitus (ringing in the ears);
• discomfort and pain in the abdomen, constipation, diarrhea, intestinal gas (flatulence), discomfort or pain in the stomach (epigastric) nausea, vomiting, difficulty digesting food (dyspepsia);
• skin rashes, itching.

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

• dizziness;
• drowsiness;
• blurred vision;
• inflammation of the mouth with ulcers (ulcerous stomatitis).

Rare(may affect up to 1 in 1,000 people):

• reduction in the amount of hemoglobin in the blood caused by insufficient production of red blood cells in the bone marrow (aplastic anemia);
• reduction in the amount of hemoglobin in the blood caused by the formation of antibodies that destroy red blood cells (hemolytic anemia);
• decrease in the number of platelets (thrombocytopenia), decrease in the number of white blood cells (leukopenia) increase in the number of a type of white blood cells called eosinophils (eosinophilia), decrease of red blood cells, white blood cells and platelets (pancytopenia);
• swelling (edema) due to allergic reaction, of the face and hands;
• impaired vision;
• yellowing of the skin and eyes (jaundice);
• inflammation of the liver that has caused patient death (fatal hepatitis);
• skin sensitivity to light (cutaneous photosensitivity), urticaria;
• reddish discoloration of the skin due to small blood leakage (non-thrombocytopenic purpura);
• Schoenlein-Henoch purpura (inflammation affecting the blood vessels of the skin, intestines and kidneys);
• inflammation of the kidney (interstitial nephritis), severe kidney damage (renal papillary necrosis, nephrotic syndrome), alterations in kidney function (renal insufficiency);
• swelling (edema);
• increased levels indicating liver function;

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

• bladder disorders (vesical dysfunction).

Not known(frequency cannot be estimated based on available data):

• fluid retention;
• increase or decrease in blood sugar (hyperglycemia, hypoglycemia);
• abnormal weight gain;
• depression, abnormal dreams, hallucinations, sleep disorders (insomnia), confused state, altered mood, nervousness, increased excitability (irritability);
• inflammation of the membranes surrounding the brain and spinal cord not infectious (aseptic meningitis);
• impaired hearing;
• inflammation of blood vessels (vasculitis);
• narrowing of the diameter of the bronchi (bronchospasm);
• nosebleeds (epistaxis);
• inflammation of the stomach (gastritis);
• inflammation of the pancreas (pancreatitis);
• dry mouth;
• inflammation of the liver (hepatitis);
• hair loss (alopecia);
• skin scaling;
• bruising (ecchymosis);
• fixed drug eruption (may manifest as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching;
• sweating;
• alterations in nail growth;
• presence of blood in the urine (hematuria), difficulty urinating (dysuria);
• malaise, weakness (asthenia);
• lack or reduction of appetite (anorexia);
• weight gain;
• altered blood tests (decrease in hemoglobin or hematocrit, increase in transaminases, positive antinuclear antibody;
• worsening of inflammation in the colon (colitis) and Crohn's disease;
• altered kidney function (acute renal failure); fluid retention (water retention);
• increased blood pressure (hypertension), impaired heart function (heart failure, circulatory decompensation), heart attack (myocardial infarction);
• stroke;
• female infertility.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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. . Reporting side
effects can help provide more information on the safety of this medicine.

5. How to store BREXIN

Keep this medicine out of the sight and reach of children.
Effervescent tablets: do not store at a temperature above 25°C.
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Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
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 BREXIN contains
The active ingredient is piroxicam-β-cyclodextrin.

BREXIN tablets
One tablet contains: 191.2 mg of piroxicam-β-cyclodextrin equivalent to 20 mg of piroxicam.
The other ingredients are: lactose, crospovidone, sodium carboxymethylamide, hydrated colloidal silica, modified
starch, magnesium stearate.

BREXIN effervescent tablets
One effervescent tablet contains: 191.2 mg of piroxicam-β-cyclodextrin equivalent to 20 mg of piroxicam.
The other ingredients are: lactose monohydrate, glycine sodium carbonate, fumaric acid, aspartame, macrogol
6000, lemon flavour.

Description of the appearance of BREXIN and contents of the pack
BREXIN tabletsare available in packs of 6, 10 and 30 divisible tablets of pale yellow colour.

BREXIN effervescent tabletsare available in packs of 6, 10, 20 and 30 effervescent tablets of
pale yellow colour.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PROMEDICA S.r.l., Via Palermo, 26/A – 43122 Parma
Manufacturers

BREXIN effervescent tablets,
CHIESI FARMACEUTICI S.p.A., Parma Manufacturing Plant, Via San Leonardo 96

BREXIN tablets,
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG) Italy
CHIESI FARMACEUTICI S.p.A., Parma Manufacturing Plant, Via San Leonardo 96
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