Piroxicam Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

PIROXICAM DOC Generici 20 mg hard capsules

Generic medicine
Please read this leaflet carefully before using 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 others, 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PIROXICAM DOC Generici is and what it is used for
Before you take PIROXICAM DOC Generici
How to take PIROXICAM DOC Generici
Possible side effects
How to store PIROXICAM DOC Generici
Contents of the pack and other information

1. What PIROXICAM DOC Generici is and what it is used for

Before prescribing PIROXICAM DOC Generici, your doctor will evaluate the benefits of this
medication against the risk of adverse effects. Your doctor may need to review your condition
periodically and will inform you how often monitoring is required during treatment with
PIROXICAM DOC Generici.
PIROXICAM DOC Generici is an anti-inflammatory and analgesic medicine used
to relieve certain symptoms caused by osteoarthritis (osteoarthritis: degenerative joint disease),
rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine), such as joint
swelling, stiffness, and pain. PIROXICAM DOC Generici does not cure arthritis and will provide
relief only as long as you continue taking it.
Your doctor will prescribe PIROXICAM DOC Generici only when other non-steroidal
anti-inflammatory drugs (NSAIDs) are no longer effective in relieving your symptoms.

2. What you need to know before using PIROXICAM DOC Generici

Do not take PIROXICAM DOC Generici

if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6)
if you have previously had a stomach or intestinal ulcer, bleeding, or perforation
if you currently have a stomach or intestinal ulcer, bleeding, or perforation
if you have or have previously had gastrointestinal disorders (inflammation of the stomach or intestine) that predispose to hemorrhagic conditions, such as ulcerative colitis, Crohn's disease, gastrointestinal cancer, diverticulitis (inflamed or infected pouches/sacs in the colon)
if you are taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid (found in many medicines used to relieve pain and reduce fever). Remember that many NSAIDs are available without a prescription
if you are taking anticoagulants such as warfarin to prevent blood clot formation
if you have previously experienced a severe allergic reaction to piroxicam, other NSAIDs, or other medicines, particularly severe skin reactions (regardless of severity), such as erythema multiforme, exfoliative dermatitis (intense skin redness with flaking or peeling), or blistering skin reactions: Stevens-Johnson syndrome,
characterized by red, blistered, eroded, bloody, or crusted skin, and
toxic epidermal necrolysis, characterized by blisters and peeling of the outer layer of skin
if you have experienced symptoms of asthma, rhinitis, nasal polyps, angioedema, or urticaria during treatment with acetylsalicylic acid or other NSAIDs
if you are pregnant or suspect you might be pregnant
if you are breastfeeding
if you are under 18 years of age
if you suffer from severe liver disease
if you suffer from severe kidney disease
if you have moderate or severe heart failure
if you have severe hypertension
if you have serious blood disorders
if you have a hemorrhagic diathesis (a tendency to frequent bleeding). If any of these conditions apply, PIROXICAM DOC Generici must not be prescribed to you. Inform your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before using PIROXICAM DOC Generici.
Exercise particular caution with PIROXICAM DOC Generici
Be cautious when using PIROXICAM DOC Generici and always inform your doctor before taking it. Like all non-steroidal anti-inflammatory drugs (NSAIDs), PIROXICAM DOC Generici may cause serious stomach and intestinal reactions such as pain, bleeding, and ulcers.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with piroxicam use. These initially appear as round red spots or circular patches, often accompanied by blisters on the central trunk.
If you develop a skin rash or skin-related symptoms, you must stop taking PIROXICAM DOC Generici immediately, seek medical attention promptly, and inform the doctor that you are taking this medicine.
Additional signs to watch for include mouth, throat, nose, or genital ulcers, and conjunctivitis (red, swollen eyes).
These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
The highest risk of developing severe skin reactions occurs during the first weeks of treatment.
If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using piroxicam, piroxicam must not be used again.
If you develop a skin rash or these skin symptoms, stop taking piroxicam immediately, consult a doctor urgently, and inform them that you are taking this medicine.
You must stop taking PIROXICAM DOC Generici immediately and contact your doctor if you experience stomach pain or any signs of gastrointestinal bleeding, such as passing black or blood-stained stools, or if you vomit blood.
You must stop using PIROXICAM DOC Generici immediately and contact your doctor if you experience an allergic reaction such as a skin rash, facial swelling, wheezing, or difficulty breathing.
If you are over 70 years old, your doctor may want to minimize the duration of treatment and monitor you more frequently while you are taking PIROXICAM DOC Generici.
If you are over 70 years old or are taking other medicines such as corticosteroids or certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clots, your doctor may prescribe a stomach-protective medicine alongside PIROXICAM DOC Generici.
You must not take this medicine if you are over 80 years old.
If you have or have previously had any medical condition or any type of allergy, or if you are unsure whether you can take PIROXICAM DOC Generici, inform your doctor before taking this medicine.
Inform your doctor if you are taking any other medicines, including those available without a prescription.
Medicines such as PIROXICAM DOC Generici may be associated with an increased risk of heart attack ("myocardial infarction") or stroke. This risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking), discuss your treatment with your doctor or pharmacist.
PIROXICAM DOC Generici, like other non-steroidal anti-inflammatory drugs, reduces platelet aggregation and prolongs clotting time; this should be considered when performing hematological tests and requires vigilance when used concomitantly with drugs that inhibit platelet aggregation.
Caution is required if you have a history of hypertension and/or heart failure, as fluid retention and edema have been reported during NSAID therapy.
Particular caution is required if you have cardiac insufficiency, arterial hypertension, impaired liver or kidney function, renal hypoperfusion, existing or previous blood disorders, or are undergoing diuretic therapy.
If you are asthmatic, bronchospasm attacks, and possibly shock or other allergic phenomena, may occur due to the drug's interaction with arachidonic acid metabolism.
Since ocular changes have been observed during NSAID therapy, periodic ophthalmological examinations are recommended during prolonged treatment.
As with other substances with similar action, increases in blood urea nitrogen (azotemia) have been observed, which do not progress beyond a certain level even with prolonged administration and return to normal after discontinuation of treatment.
If you are diabetic, frequent blood tests are advisable.
Severe allergic reactions (particularly severe skin reactions) have been reported very rarely in association with NSAID use (see "Undesirable effects").
If you are planning a pregnancy, if you have fertility problems or are undergoing fertility investigations, discuss your treatment with your doctor.

Other medicines and PIROXICAM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription. Medicines can sometimes interact with each other. Your doctor may limit the use of PIROXICAM DOC Generici or other medicines, or you may need to take a different medicine. It is particularly important to report the following:

if you are taking aspirin or other non-steroidal anti-inflammatory medicines for pain relief
if you are taking corticosteroids, medicines used to treat various conditions such as allergies and hormonal imbalances
if you are taking anticoagulants such as warfarin to prevent blood clot formation
if you are taking certain antidepressants called selective serotonin reuptake inhibitors (SSRIs)
if you are taking any medicine, such as aspirin, to prevent blood clot formation
if you are taking diuretics, ACE inhibitors, or angiotensin II antagonists—used for high blood pressure and heart conditions
if you are taking lithium—used to treat depression
if you are taking quinolone antibiotics, used to treat bacterial infections
if you use intrauterine devices.

If any of these conditions apply, inform your doctor immediately.
PIROXICAM DOC Generici with food and drink
It is advisable not to drink alcohol during treatment with PIROXICAM DOC Generici.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking this medicine.

If you have fertility problems or are undergoing fertility investigations, inform your doctor, as PIROXICAM DOC Generici may not be suitable for you.
Do not take PIROXICAM DOC Generici if you are pregnant, as it may harm the fetus or cause problems during childbirth. NSAIDs can cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and baby and may delay or prolong labor beyond the expected time. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If you are breastfeeding, you must not take PIROXICAM DOC Generici. Ask your doctor: it may be better to stop breastfeeding.

Driving and using machines
If you experience dizziness or unusual tiredness, exercise particular caution when driving or operating machinery.
PIROXICAM DOC Generici contains lactose
PIROXICAM DOC Generici contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use PIROXICAM DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose of PIROXICAM DOC Generici. Your doctor will adjust the treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change the dose without first informing your doctor.

Adults and elderly:
The maximum daily dose of PIROXICAM DOC Generici is 20 milligrams, taken as a single daily dose.
If you are over 70 years old, your doctor may prescribe a lower daily dose and reduce the duration of treatment.
Your doctor may prescribe PIROXICAM DOC Generici together with another medicine to protect your stomach and intestines from possible side effects.

Do not increase the dose:
If you feel the medicine is not working well enough, always discuss this with your doctor.

If you take more PIROXICAM DOC Generici than you should:
Symptoms: the most common signs of overdose are headache, vomiting, drowsiness, dizziness, and fainting.
In case of accidental ingestion of an excessive dose of PIROXICAM DOC Generici 20 mg hard capsules, contact your doctor immediately or go to the nearest hospital.

If you forget to take PIROXICAM DOC Generici:
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose
to make up for the missed dose.

If you stop treatment with PIROXICAM DOC Generici:
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop treatment with PIROXICAM DOC Generici immediately and contact your doctor:

if you develop blisters, redness or peeling of the skin (skin rash), ulceration in any part of the body (e.g. skin, mouth, eyes, lips or tongue), or any other sign of allergic reaction such as skin rash, swelling of the face, lips or tongue, which may cause difficulty in breathing or wheezing
if your skin or the whites of your eyes turn yellow (jaundice)
if you show signs of stomach or intestinal bleeding, such as passing black stools or stools with blood spots, or if you vomit blood.

Listed below are all the side effects associated with PIROXICAM DOC Generici 20 mg hard capsules.

Most common side effects

Gastrointestinal ulcers and gastrointestinal bleeding
nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, ulcerative stomatitis, inflammatory bowel diseases (colitis, Crohn's disease)
Swelling of ankles, legs and feet (fluid retention)
Increase in blood pressure
Heart failure (breathlessness and fatigue)

Less common side effects

Heart attack (myocardial infarction)
Stroke
Anorexia
Tiredness
Anaemia
Blisters, redness or peeling of the skin (skin rash) or ulceration in any part of the body (e.g. skin, mouth, eyes, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips, tongue, wheezing
Yellowing of the skin and eyes (jaundice)
Increase in normal liver function values
Pancreatitis
Acute kidney failure, blood in urine, difficulty urinating
Increase in non-protein nitrogen in the blood (elevated blood urea)
Swelling of ankles, legs and feet (fluid retention)
Increase in blood pressure (hypertension)
Nosebleeds
Headache
Drowsiness
Deafness or ringing in the ears
Dizziness
Visual disturbances
Malaise
Blood and lymphatic system disorders
Gastritis

Rare side effects

Appearance of bruises
Changes in blood sugar levels (hypo- and hyperglycaemia)
Sweating
Changes in body weight
Insomnia
Depression
Swelling, blisters or peeling of the skin
Skin photosensitivity
Dry mouth
Irritability
Bladder dysfunction
Shock
Alopecia
Nail growth abnormalities
Fatal hepatitis

Very rare side effects

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

Side effects with unknown frequency

Fixed drug eruption (may appear as round or oval patches of redness and swelling of the skin), hives (urticaria), itching

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to 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 PIROXICAM DOC Generici

Keep PIROXICAM DOC Generici out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and on the inner label.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PIROXICAM DOC Generici contains
The active substance is piroxicam. Each capsule contains 20 mg of piroxicam.
The other components are:

Capsule contents: monohydrate lactose, microcrystalline cellulose (PH 102), maize starch, stearic acid, talc.
Capsule shell components: gelatin, titanium dioxide, brilliant blue FCF (E133), iron oxide red (E172), and allura red AC (E129).

Description of the appearance of PIROXICAM DOC Generici and package contents
Opaque bordeaux-red hard capsules containing white powder.
The pack contains 30 hard capsules. The hard capsules are packaged in PVC/aluminum blisters.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer
La.Fa.Re S.r.l. - Via Sacerdote Benedetto Cozzolino 77 - 80056 Ercolano (Naples) – Italy.