20 mg piroxicam tablets 

1. What Brexidol is and what it is used for

Brexidol has an anti-inflammatory , analgesic and antipyretic effect. The anti-inflammatory effect is probably due to the fact that Brexidol reduces the formation of harmful substances ( prostaglandins ), which are formed during inflammation . The analgesic effect is believed to be due to a similar mechanism.

Brexidol is used to relieve some of the symptoms caused by osteoarthritis ( osteoarthritis , a degenerative joint disease), rheumatoid arthritis ( rheumatoid arthritis ) and Bechterew’s disease (rheumatism of the spine), e.g. swelling, stiffness and joint pain. The drug does not cure arthritis and only helps as long as you take it.

Before your doctor prescribes Brexidol, he or she will assess the benefit you can get from the medicine in relation to the risk of side effects . Your doctor may need to examine you and will tell you how often you need to be followed up because you are taking Brexidol.

Your doctor will only prescribe Brexidol if you have not had sufficient relief from the symptoms of other non-steroidal anti-inflammatory drugs ( NSAIDs ).

2. What you need to know before using Brexidol

Do not use Brexidol

  • if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6).
  • if you have previously had ulcers, bleeding or perforation in the stomach or intestines
  • if you currently have ulcers, bleeding or perforation in the stomach or intestines.
  • if you, or anyone in your family, have or have had gastrointestinal diseases ( inflammation of the stomach or intestines) that increase the susceptibility to bleeding disorders such as ulcerative colitis , Crohn’s disease , gastrointestinalcancer or diverticulitis (inflamed or infected pockets in the colon).
  • if you are taking other NSAIDs , including COX-2 -selective NSAIDs and acetylsalicylic acid (a substance found in many painkillers and antipyretics).
  • if you are taking blood thinners, e.g. warfarin , to prevent blood clots.
  • if you have previously had a severe allergic drug reaction to Brexidol, other NSAIDs or other drugs, especially severe skin reactions (regardless of severity), e.g. exfoliative dermatitis , (intense skin redness with flaking of the skin in the scales or layers), vesiculobulous reactions ( Stevens-Johnson syndrome , a condition with red and blistered, eroded, bloody or scaly skin) and toxic epidermal necrolysis (a disease with blistering and flaking in the upper part skin layer)
  • if you have previously had asthma , difficulty breathing, hay fever or hives with Brexidol, acetylsalicylic acid or other medicines belonging to the group of NSAIDs(used for pain, inflammation and fever).
  • during the last three to three months of pregnancy.
  • if you have severe heart failure or severe liver or kidney disease.
  • if you suffer from an increased risk of bleeding.

Warnings and cautions

Talk to your doctor or pharmacist before using Brexidol:

  • If you are taking other painkillers. For painkillers, it generally applies that higher doses than those recommended can lead to serious risks. Therefore, do not use different painkillers at the same time without consulting a doctor.
  • If you are over 70 years old. The risk of serious side effects in the stomach and intestines increases with age. Your doctor may therefore prescribe Brexidol together with a medicine that protects the stomach and intestines. If you are over 80 years old, your doctor should avoid prescribing this medicine to you.
  • If you are taking other medicines such as corticosteroids , certain antidepressants, so-called selective serotonin reuptake inhibitors ( SSRIs ) or acetylsalicylic acid to prevent blood clots; as the risk of serious side effects in the stomach and intestines increases. Your doctor may therefore prescribe Brexidol together with a medicine that protects the stomach and intestines.
  • If you have any of the following diseases: SLE (connective tissue disease), diseases with increased bleeding tendency, impaired heart function, cardiovascular disease including high blood pressure and heart failure , liver or kidney disease, diabetes too high cholesterol or blood fat value.
  • If you have chickenpox. This medicine should not be used.
  • If you have previously had edema (accumulation of fluid in the body) during treatment with this medicine or any other medicine that belongs to the group of NSAIDs (used for pain, inflammation and fever).
  • If you are planning a pregnancy or if you have problems getting pregnant. This medicine may make it harder for you to get pregnant. See section “Pregnancy, breast-feeding and fertility” for more information.
  • If you have asthma.
  • If you smoke.

Pay attention to:

  • Like all NSAIDs , Brexidol can cause severe reactions in the stomach and intestines, e.g. pain, bleeding, sores and perforation .

Stop taking Brexidol and contact a doctor immediately if you experience any of the following symptoms:

  • At the first sign of abdominal pain or signs of bleeding in the stomach or intestines, e.g. black or blood-stained stools or bloody vomit; or other new or unusual stomach symptoms.
  • If you get an allergic reaction , e.g. skin rash, swelling of the face, wheezing or difficulty breathing.
  • Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with the use of Brexidol. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso. Additional signs to be aware of are sores in the mouth, throat, nose, genitals or eye inflammation (red and swollen eyes). The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas or skin detachment. The risk of serious skin reactions is greatest during the first weeks of treatment. If you suffer from Stevens-Johnson syndrome or toxic epidermal necrolysisOnce you have used piroxicam contained in Brexidol, you should never use piroxicam-containing medicines again. At the first symptoms or signs of these skin reactions or rashes, stop taking Brexidol immediately, and contact your doctor immediately and tell them that you are taking this medicine.

Children and young people

Safety and efficacy in children have not yet been established. No data are available. Treatment of children is therefore not recommended.

Other medicines and Brexidol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Different drugs can sometimes affect each other. Your doctor may want to limit your use of Brexidol or other medicines, or you may need to take another medicine.

It is especially important to mention:

  • if you are taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
  • if you are taking corticosteroids, medicines used for a variety of conditions, e.g. allergies and hormonal disorders
  • if you are taking blood thinners such as warfarin or heparin to prevent blood clots
  • if you are taking methotrexate which is used to treat rheumatic diseases, severe psoriasis, and certain tumor diseases
  • if you are taking certain antidepressants, so-called selective serotonin reuptake inhibitors ( SSRIs )
  • if you take lithium used in e.g. bipolar disease
  • if you are taking cimetidine used for heartburn and stomach ulcers
  • if you are taking cholestyramine which can be used to treat certain types of diarrhea or to lower elevated blood fats
  • if you are taking diuretics (eg furosemide , bumetanide or medicines belonging to the group thiazides ) used in e.g. edema (accumulation of fluid in the body) and against high blood pressure .
  • if you are taking medicines used for e.g. high blood pressure, heart failure, angina ( ACE inhibitor, angiotensin II antagonist s or beta-receptor blocking drugs)
  • if you are taking medicines that suppress the immune system e.g. ciclosporin or tacrolimus

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Pregnant women should not use Brexidol during the last three months of pregnancy. Taking Brexidol should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Breast-feeding

Brexidol passes into breast milk. As the safety of newborns has not been studied, it is not recommended that breastfeeding mothers use Brexidol.

Fertility

Brexidol can affect the chances of getting pregnant and is not recommended in women trying to conceive. Talk to your doctor before using this medicine if you are trying to conceive or undergo a fertility test.

Driving and using machines

Brexidol has no or negligible effect on the ability to drive and use machines. However, this medicine may cause side effects such as dizziness, tiredness and blurred vision, see section 4 “Possible side effects” for further information.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Brexidol contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How to use Brexidol

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will examine you regularly to make sure you are taking the correct dose of Brexidol. Your doctor will adjust your dosage so that you get the lowest dose that provides the best relief from your symptoms. Never change your dose without first consulting your doctor.

Adults and the elderly:

The maximum dose is 20 mg Brexidol once a day.

If you are older, your doctor may prescribe a lower dose. If you are over 80 years old, your doctor should avoid prescribing this medicine to you.

The tablets should be swallowed with water.

The tablet can be divided into two equal doses.

Divide the tablet by placing it on a flat surface with the notch facing up. Gently press with your thumb to divide the tablet into two equal parts.

Your doctor may prescribe Brexidol together with any other medicine that may protect your stomach and intestines from any side effects.

Do not increase the dose one

If you have the impression that the medicine does not have the desired effect, contact your doctor.

Symptoms of overdose may include nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, drowsiness, unconsciousness, seizures and impaired respiratory function ( respiratory depression ).

If you forget to take Brexidol

Take the medicine as soon as you remember. If it is soon time to take the next tablet, do not take the dose you forgot, just take the next tablet at the right time. Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

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

The most frequently reported adverse event increases have been side-effects is from the gastrointestinal tract.

Stop taking Brexidol and contact a doctor immediately or see your nearest emergency department if you experience any of the following symptoms:

  • An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals. The very rare side effect may affect up to 1 in 10,000 people. See section 2 “Warnings and Cautions” for more information. 
  • Toxic epidermal necrolysis: Severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes). Very rare side effect , may affect up to 1 in 10,000 people. See section 2 “Warnings and Precautions” for more information.
  • Severe allergic reaction ( anaphylaxis ) with symptoms such as skin rash, difficulty swallowing, wheezing or difficulty breathing, fainting and drop in blood pressure. The rare side effect may affect up to 1 in 1,000 people.
  • Stomach pain or signs of bleeding in the stomach and intestines, e.g. black or blood-stained stools or bloody vomit; or other new or unusual stomach symptoms. An uncommon side effect may affect up to 1 in 100 people. See section 2 “Warnings and Cautions” for more information.

Other side effects that may occur:

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

  • anemia
  • headache
  • feeling dizzy or moving ( vertigo ), tinnitus (ringing in the ears or ringing in the ears)
  • diarrhea, acid regurgitation 
  • rash, itching
  • altered blood levels (increase in urea in the blood)

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

  • dizziness, fatigue
  • dimsyn
  • gastric ulcer 
  • fluid retention ( edema ), elevated liver values

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

  • change in the number of blood cells ( aplastic anemia, hemolytic anemia, thrombocytopenia, leukopenia, eosinophilia )
  • hearing loss
  • asthma, respiratory cramps/difficulty breathing with symptoms such as wheezing and wheezing, runny nose ( rhinitis )
  • jaundice, hepatitis
  • photosensitivity; hives; a disease with symptoms such as purple rashes that look like bruises, inflammation of the joints, abdominal pain, and bleeding from the intestine (Henoch-Schönlein purpura); a skin and mucous membrane disease with rash and/or blisters (erythema multiforme)
  • perforation (holes) in the stomach or intestines
  • kidney effects, kidney failure
  • increased tendency to bleed

In rare cases, severe skin infections are associated with chickenpox.

Has been reported ( occurs in an unknown number of users )

  • depression, abnormal dreams, hallucinations, difficulty sleeping, states of confusion, mood swings, nervousness
  • vascular inflammation
  • stomach upset, constipation, discomfort or pain in the upper abdomen, bloating, nausea, vomiting, inflammation in/near the mouth, gastritis, black and foul-smelling stools, vomiting with blood in, inflammation of the pancreas

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Brexidol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is 191.2 mg piroxicam-ß-cyclodextrin equivalent to piroxicam 20 mg.
  • The other ingredients are lactose monohydrate (102.8 mg), magnesium stearate, colloidal silica, sodium starch glycolate, corn starch pregelatinized, crospovidone. See “Brexidol contains lactose and sodium” in section 2 of this leaflet for further information.

What the medicine looks like and the contents of the pack

Brexidol is a pale yellow hexagonal tablet with a score line on one side. The tablet can be divided into two equal doses.

Brexidol is available in pack sizes of 7 and 20 tablets in thermoformed PVC / PVdC blisters with Al / PVdC closure.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Chiesi Farmaceutici SpA

via Palermo 26 / A

43122 Parma

Italy

Manufacturer

Chiesi Farmaceutici SpA

via San Leonardo 96

43122 Parma

Italy

Chiesi SAS

2 rue des Doctors Alberto and Paolo Chiesi

41260 La Chaussée Saint Victor

France

Muhammad Nadeem

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