Patient Information Leaflet

BART 20 mg coated tablets

tenoxicam
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See Section 4.

Contents of this leaflet:

What BART is and what it is used for
What you need to know before taking BART
How to take BART
Possible side effects
How to store BART
Contents of the pack and other information

1. What BART is and what it is used for

BART contains the active substance tenoxicam.
Tenoxicam belongs to a group of medicines called non-steroidal oxicam-derived anti-inflammatory/anti-rheumatic agents.
This active substance has marked anti-inflammatory, pain-relieving (analgesic), and antipyretic properties.
BART is indicated for the treatment of painful conditions of rheumatic, inflammatory, and degenerative origin.

2. What you should know before taking BART

Do not take BART:

if you are allergic to tenoxicam or to any of the other ingredients of this medicine listed in section 6;
if you are allergic to other medicines chemically similar to BART;
if you suffer from gastrointestinal (gastric or duodenal) ulcers, gastritis, or indigestion;
if you have severe liver or kidney problems;
if you have severe heart dysfunction;
if you have severely elevated blood pressure; severe abnormalities in blood test values;
if you are undergoing intensive treatment with diuretics;
if you are experiencing active bleeding or have a particular predisposition to bleeding (hemorrhagic diathesis), or are taking medications that reduce blood clotting;
if taking other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid causes you allergic reactions (such as asthma, rhinitis, or urticaria);
if you are scheduled for surgery or anesthesia;
if you are pregnant, think you may be pregnant, or are breastfeeding.

Do not give BART to children and adolescents under 15 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking BART:

if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see “Other medicines and BART”). Do not take BART and inform your doctor;
if you are elderly, or have previously experienced gastrointestinal ulcers, especially if complicated by bleeding or perforation (see “Do not take BART”). In such cases, the risk of gastrointestinal bleeding, ulceration, or perforation is higher, particularly when taking higher NSAID doses. Therefore, your doctor may recommend starting treatment with the lowest available dose and may prescribe concomitant medications to protect the stomach lining (misoprostol or proton pump inhibitors) (see below and “Other medicines and BART”);
if you are taking other concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, drugs that reduce blood clotting (anticoagulants like warfarin), antidepressants (selective serotonin reuptake inhibitors), or agents that inhibit platelet aggregation (antiplatelet agents) such as aspirin (see “Other medicines and BART”);
if you suffer from gastrointestinal diseases (ulcerative colitis, Crohn’s disease). These conditions may worsen with BART use (see section 4);
if you have high blood pressure and/or heart problems. Treatment with NSAIDs may cause fluid retention and swelling (edema). The use of NSAIDs (such as tenoxicam) may lead to a modest increase in the risk of heart attack or stroke;
if you have heart or blood vessel problems (cardiovascular system), high blood pressure (arterial hypertension), liver or kidney problems, abnormalities in blood cell counts, either currently or in the past, respiratory problems (bronchial asthma), or if you are elderly. In all these cases, the use of BART is not recommended, and only your doctor can determine whether your condition requires BART;
if you are near term in pregnancy. Do not take BART as it may delay labor and cause respiratory problems in the newborn;
if you suffer from asthma or respiratory problems. Allergic reactions and/or respiratory crises may occur;
if you have gastrointestinal tract infections. Always consult your doctor, who will determine the most appropriate therapy for you;
if you are undergoing blood tests or suffer from coagulation disorders, or are taking medications that inhibit platelet aggregation. Be aware that tenoxicam, like other non-steroidal anti-inflammatory drugs, reduces platelet aggregation and interferes with hemostasis (the process of stopping bleeding);
if you have lactose intolerance or other sugar intolerances, or suffer from glucose/galactose malabsorption syndrome. Do not take this medicine as it contains lactose.

During treatment with BART, keep in mind that:

Adverse effects due to BART can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 3).
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 3).
During treatment with all NSAIDs, gastrointestinal bleeding, ulceration, and perforation have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events, and may be fatal.
If you have previously experienced gastrointestinal toxicity, especially if you are elderly, inform your doctor immediately if you notice any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
If gastrointestinal bleeding or ulceration occurs after taking BART, treatment must be discontinued.
Very rare but serious skin reactions, some of which have been fatal, have been reported in association with NSAID use, including widespread skin irritation and peeling (exfoliative dermatitis), severe skin reactions with peeling and swelling, blisters on the skin, mouth, eyes, or genitals (Stevens-Johnson syndrome), and extensive skin rash with fever (toxic epidermal necrolysis) (see section 4). Patients appear to be at higher risk during the early stages of therapy (first few weeks). At the first sign of symptoms such as skin irritation, lesions, or any other sign of allergic reaction (hypersensitivity), discontinue BART immediately. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis after taking BART, do not use BART again.
If you are at risk of developing kidney disease (e.g., elderly patients, those with pre-existing kidney problems, diabetes, liver or heart problems, reduced blood volume, or those taking diuretics or drugs known to be nephrotoxic), your doctor will closely monitor your cardiac and renal function.
Like other non-steroidal anti-inflammatory drugs, tenoxicam may mask the usual signs of infection.

Children and adolescents
BART is contraindicated in children and adolescents under 15 years of age (see “Do not take BART”).
Other medicines and BART
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tenoxicam may affect the action of other medicines, and these may in turn affect the action of tenoxicam. Therefore, it is important to inform your doctor if you are taking:

corticosteroids (steroid-type medicines): concomitant use may increase gastric side effects (see “Warnings and precautions”);
anticoagulants (drugs that inhibit blood clotting): NSAIDs may enhance the effects of anticoagulants such as warfarin (see “Warnings and precautions”);
antiplatelet agents (which inhibit platelet aggregation) and selective serotonin reuptake inhibitors (antidepressants): concomitant use increases the risk of bleeding (see “Warnings and precautions”);
diuretics, ACE inhibitors, angiotensin II antagonists, and α-adrenergic blockers (antihypertensives): NSAIDs may reduce the blood pressure-lowering effect of diuretics and other antihypertensive drugs. In patients with impaired renal function (e.g., dehydrated patients or elderly patients with compromised kidney function), co-administration of an ACE inhibitor or angiotensin II antagonist with NSAIDs may worsen renal function. Therefore, your doctor will monitor your kidney function during concomitant therapy, especially if you are elderly;
potassium-containing medications or potassium-sparing diuretics. When used with NSAIDs, there is a risk of increased potassium levels in the blood (hyperkalemia);
the clinical efficacy of oral antidiabetic agents (glibornuride, glibenclamide, tolbutamide) is not altered by concomitant use of tenoxicam. However, inform your doctor, who will ensure close monitoring of your clinical condition.

No interactions or interactions without clinical relevance have been reported with the concomitant use of non-steroidal anti-inflammatory drugs and:

antihypertensives such as: central α-adrenergic agents or calcium channel blockers, atenolol, and digitalis drugs such as digoxin;
antacids (used for heartburn or reflux diseases), cimetidine (antihistamine), warfarin (anticoagulant) at recommended doses;
low molecular weight heparin;
gold salts and penicillamine (used in the treatment of arthritis) or probenecid (used in the treatment of gout).

Do not take BART with:

oral anticoagulants or heparin. Concomitant use increases the risk of bleeding episodes;
lithium (used for mood disorders): simultaneous intake may increase lithium levels in the blood (lithemia);
methotrexate (used in the treatment of cancers and autoimmune diseases). Concomitant therapy may enhance the blood-related toxic effects of methotrexate;
triamterene (a diuretic). Co-administration with BART may impair kidney function;
ticlopidine (antiplatelet agent). Used in combination with BART, it may enhance the antiplatelet effect;
salicylic acid derivatives (salicylates) and other anti-inflammatory drugs. Concomitant use with BART increases the risk of adverse effects. Concurrent administration of glucocorticoids may increase the risk of gastrointestinal bleeding. Avoid such combinations unless your doctor considers them strictly necessary. In such cases, your doctor will prescribe appropriate doses to minimize adverse effects and will closely monitor your clinical condition.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take BART if you are pregnant, think you may be pregnant, or are breastfeeding, as BART may interfere with pregnancy and/or embryonic/fetal development.
During the third trimester of pregnancy, all medicines with the same mechanism of action as BART (prostaglandin synthesis inhibitors) may expose:
the fetus to:

increased risk of heart and lung malformations (premature closure of the ductus arteriosus and pulmonary hypertension);
kidney dysfunction that may progress to renal failure with reduced amniotic fluid (oligo-hydramnios);

the mother and newborn, at the end of pregnancy, to:

possible prolongation of bleeding time and antiplatelet effects, which may occur even with very low doses;
inhibition of uterine contractions, leading to delayed or prolonged labor.

Do not take tenoxicam during pregnancy, as it may harm the fetus or cause complications during delivery. NSAIDs can cause kidney and heart problems in the fetus. They may affect the tendency to bleeding in both mother and child and may delay or prolong labor beyond expected duration. From the 20th week of pregnancy, NSAIDs may cause kidney problems in the fetus, reducing amniotic fluid levels (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart.
Driving and using machines
Do not drive or operate machinery if you experience adverse effects such as dizziness, vertigo, or visual disturbances that may impair your ability to drive or use machines.
BART contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take BART

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of BART is 20 mg once daily.
For long-term treatment, the maintenance daily dose may be reduced to 10 mg.
In acute rheumatic conditions, the recommended dosage is 40 mg daily for the first two days, followed by 20 mg once daily for 7–14 days.

Elderly patients
Your doctor will determine the appropriate dose, which is usually lower than that prescribed for other adults. While undergoing treatment with BART, your doctor will want to see you regularly to assess the suitability of the dose and monitor for any adverse effects. This is particularly important if you are an elderly patient. The risk of adverse events is more likely with higher doses and prolonged use. Therefore, it is important not to exceed the recommended dose or extend the duration of treatment.

If you take more BART than you should
If you accidentally or intentionally take an excessive dose of BART, inform your doctor immediately or go to the nearest hospital.
Your doctor will initiate treatments to reduce drug absorption and increase the rate of elimination. You will receive appropriate pharmacological therapy (antacids and drugs known as H2 blockers) to reduce the gastrointestinal effects of excessive BART intake.

If you forget to take BART
Do not take a double dose to make up for the missed dose. Simply take the next dose as scheduled.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BART can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking BART and contact your doctor immediately:

severe skin reaction with peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals (Stevens-Johnson syndrome) (see "Warnings and precautions");
severe widespread skin rash with fever (toxic epidermal necrolysis);
severe decrease in the number of white blood cells in the blood;
reduced blood flow to various parts of the body and consequent oxygen deficiency in tissues (shock and its pre-stage);
serious heart problems;
severe impairment of kidney function;
gastrointestinal ulcer, perforation or bleeding, sometimes fatal, particularly in the elderly (see "Warnings and precautions").

Other side effects that may occur with the use of BART:
Side effects not known (frequency cannot be established from available data):

gastric burning and pain, nausea, feeling of fullness, constipation, diarrhea, flatulence, indigestion, abdominal pain, blood in stool, vomiting blood;
inflammation of the mouth, worsening of colitis and Crohn's disease (see "Warnings and precautions");
allergic reactions (hypersensitivity) such as skin rashes;
dry throat;
headache;
dizziness;
fatigue;
sleep disorders;
changes in blood test values;
increased levels of nitrogen and creatinine in the blood;
inflammation of the inner lining of the stomach (gastritis);
vomiting;
gastric ulcers with or without bleeding;
swelling due to allergy affecting the face and hands or generalized swelling;
increased skin sensitivity to sunlight (itching, redness, macular and vesicular eruptions);
yellowing of the skin and whites of the eyes (jaundice);
fluid retention which may manifest as swelling (edema), especially in the lower limbs, or circulatory and heart problems (palpitations, hypertension, heart failure);
side effects that may be detected by blood tests:
reduction in haemoglobin levels in the blood (anaemia), reduction in the number of all blood cells due to bone marrow dysfunction, reduction in the number of platelets;
increased liver function tests (transaminases and alkaline phosphatase);
bladder disorders;
hair loss;
nail changes;
vision disturbances;
confusion, hallucinations (seeing or hearing non-existent things);
paraesthesia (abnormal sensations such as tingling and prickling, numbness, especially in hands and feet), drowsiness.

Very rare side effects (may affect up to 1 in 10,000 patients):

Pancreatitis (inflammation of the pancreas).

Other reported side effects include:

increased blood pressure, impaired function, formation of blood clots in arteries leading to possible heart attack or stroke) (see "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BART

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister
after 'Exp'.
The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BART contains
The active substance is tenoxicam.
One coated tablet of BART contains 20 mg of tenoxicam.
The other components are: lactose, maize starch, pregelatinized starch, talc, colloidal silicon dioxide,
magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, iron oxide (yellow) (E172).
Description of the appearance of BART and package contents
BART is available as coated tablets.
Each carton contains 30 20 mg tablets in blisters.
Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia
Italy
MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo n.1
03012 Anagni (FR) - Italy