PIROXICAM 20 mg Hard Capsules

Зміст інструкції

1. PIROXICAM DOC Generici 20 mg hard capsules
   1. What is PIROXICAM DOC Generici and what is it for
   2. What you need to know before using PIROXICAM DOC Generici
   3. How to use PIROXICAM DOC Generici
   4. Possible side effects
   5. How to store PIROXICAM DOC Generici
   6. Contents of the pack and other information

PIROXICAM DOC Generici 20 mg hard capsules

Equivalent medicine
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous. If any undesirable effect occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph 4.

Contents of this leaflet:

• 1. What PIROXICAM DOC Generici is and what it is used for
• 2. Before you use PIROXICAM DOC Generici
• 3. How to use PIROXICAM DOC Generici
• 4. Possible side effects
• 5. How to store PIROXICAM DOC Generici
• 6. Contents of the pack and other information

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

Before prescribing PIROXICAM DOC Generici, your doctor will assess the benefits of this
medicine compared to the risk of side effects. The doctor may need to review you
periodically and will tell you how often a check-up will be necessary during treatment with
PIROXICAM DOC Generici.
PIROXICAM DOC Generici is an anti-inflammatory and analgesic medicine, which is used
to relieve some symptoms caused by osteoarthritis (osteoarthritis: degenerative joint disease),
rheumatoid arthritis and ankylosing spondylitis (spinal rheumatism), such as swelling,
joint stiffness and pain. PIROXICAM DOC Generici does not cure arthritis and will only give you relief
as long as you continue to take it.
The doctor will prescribe PIROXICAM DOC Generici only when other non-steroidal
anti-inflammatory drugs (NSAIDs) will no longer be useful 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 any of the other ingredients of this medicine (listed in section 6)
• if you have previously had an ulcer or bleeding or perforation of the stomach or intestine
• if you have an ulcer or bleeding or perforation of the stomach or intestine
• if you have or have had previous gastrointestinal disorders (inflammation of the stomach or intestine) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancer, diverticulitis (inflamed or infected pouches/cavities in the colon)
• if you are taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid (present in many medicines used to relieve pain and reduce fever). Remember that many NSAIDs are also available over the counter
• if you are taking anticoagulants, such as warfarin, to prevent blood clots
• if you have previously had a severe allergic reaction to piroxicam, other NSAIDs and other medicines, in particular severe skin reactions (regardless of their intensity), such as erythema multiforme, exfoliative dermatitis (intense redness of the skin, with

scaling or layering), vesiculobullous reactions: Stevens-Johnson syndrome,
characterized by skin with red blisters, corroded, bloody or covered with a crust, and
necrotic epidermalolysis, characterized by blisters and peeling of the superficial layer of the
skin

• if you have had symptoms of asthma, rhinitis, nasal polyps, angioedema or urticaria during treatment with acetylsalicylic acid or other NSAIDs
• if you are pregnant or suspect you may 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 severe blood disorders
• if you have a bleeding diathesis (a predisposition to bleed frequently). If any of these conditions are present, PIROXICAM DOC Generici should not be prescribed to you. Tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before using PIROXICAM DOC Generici.

Pay particular attention with PIROXICAM DOC Generici
Be careful with PIROXICAM DOC Generici and always tell your doctor before
using PIROXICAM DOC Generici; like all non-steroidal anti-inflammatory drugs,
PIROXICAM DOC Generici can cause serious reactions to the stomach and intestines such as pain,
bleeding and ulcers.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have
been reported with the use of piroxicam, these initially appear as round red spots or
circular patches that are often accompanied by blisters on the central part of the trunk.
If you develop a rash or skin symptoms, you should immediately stop taking
PIROXICAM DOC Generici, see a doctor immediately and tell them that you are taking
this medicine.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red
and swollen eyes).
These potentially life-threatening rashes are often accompanied by flu-like symptoms. The rash may progress with the development of widespread blisters or exfoliation of the skin.
The highest risk of developing severe skin reactions occurs within the first few weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of
piroxicam, piroxicam should no longer be reused.
If a skin rash or these skin symptoms develop, stop taking piroxicam,
seek urgent medical attention and tell them you are taking this medicine.
You should immediately stop taking PIROXICAM DOC Generici and contact your
doctor if you have stomach pain or if you experience any signs of bleeding in the stomach or
intestine, such as passing black or tarry stools or if you vomit blood.
You should immediately stop using PIROXICAM DOC Generici and contact your doctor in
case of an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty in
breathing.
If you are over 70 years of age, your doctor may want to minimize the duration of treatment and
visit you more often when you are being treated with PIROXICAM DOC Generici.
If you are over 70 years of age or are taking other medicines such as corticosteroids or some medicines for
treating depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clots, your doctor may prescribe you
a medicine to protect your stomach and intestines together with PIROXICAM DOC Generici.
You should not take this medicine if you are over 80 years of age.
If you have or have had any medical condition or any form of allergy or if you are not sure if
you can take PIROXICAM DOC Generici, tell your doctor before taking this
medicine.
Tell 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. Any risk is more likely with high doses and
prolonged treatments. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, or a history of stroke or think you may be at risk for these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your
therapy with your doctor or pharmacist.
PIROXICAM DOC Generici, like other non-steroidal anti-inflammatory drugs, decreases
platelet aggregation and prolongs coagulation time; this possibility should be kept in mind when performing
hematological tests and requires vigilance when undergoing concomitant treatment with drugs
that inhibit platelet aggregation.
Caution is advised if you have a history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with
NSAID therapy.
Particular caution is required if you have heart failure, arterial hypertension,
reduced liver or kidney function, renal hypoperfusion, ongoing or previous blood disorders, and if you are
undergoing diuretic therapy.
If you are asthmatic, due to the interaction of the drug with arachidonic acid metabolism, bronchospasm and possibly shock and other allergic phenomena may occur.
As ocular alterations have been observed during therapy with NSAIDs, periodic ophthalmological checks are recommended in case of prolonged treatments.
As with other substances with similar action, increases in azotaemia (levels of nitrogen in the
blood) have been observed which do not progress, with prolonged administration, beyond a certain level. They return to
normal values once therapy is discontinued.
If you are diabetic, it is advisable to have frequent blood tests.
Serious allergic reactions (in particular severe skin reactions) have been reported very rarely in
association with the use of NSAIDs (see “Undesirable effects”).
If you are planning a pregnancy, if you have fertility problems or if you are undergoing fertility investigations,you should discuss your therapy with your doctor.

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

• if you are taking aspirin or other non-steroidal anti-inflammatory drugs to relieve pain
• if you are taking corticosteroids, medicines used to treat a variety of conditions such as allergies and hormonal imbalances
• if you are taking anticoagulants such as warfarin to prevent blood clots
• if you are taking some medicines for depression called selective serotonin reuptake inhibitors (SSRIs)
• if you are taking any medicine, such as aspirin, to prevent blood clots
• if you are taking diuretics, ACE inhibitors and angiotensin II antagonists - used for high blood pressure and heart disease
• if you are taking lithium - used to treat depression
• if you are taking quinolone antibacterial drugs, used to treat bacterial infections
• if you are using intrauterine devices.

If any of these conditions are present, tell 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 if you are undergoing fertility investigations, tell your doctor, asPIROXICAM 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 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, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
• If you are breastfeeding, you should 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 fatigue, be particularly careful when driving or using
machinery.

PIROXICAM DOC Generici contains lactose
PIROXICAM DOC Generici contains a sugar called lactose. If your doctor has
diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to use PIROXICAM DOC Generici

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

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

Do not increase the dose:
if you feel that the medicine is not very effective, always talk to your doctor.

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

If you forget to take PIROXICAM DOC Generici
Take the medicine as soon as you remember. If it is almost time to take the next dose, do not take the
forgotten dose, but take the next dose at the right time. Do not take a double dose
to make up for a forgotten dose.
If you stop taking PIROXICAM DOC Generici
If you have any further doubts about the use of this medicine, ask your doctor.

4. Possible side effects

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

Stop taking PIROXICAM DOC Generici immediately and contact your doctor:

• if you develop blisters, redness or peeling skin (skin rash), an ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of an allergic reaction such as skin rash, swelling of the face, lips or tongue which can cause difficulty in breathing or wheezing
• if the skin or whites of the eyes turn yellow (jaundice)
• if you experience signs of bleeding in the stomach or intestine, such as passing black or tarry stools or vomiting blood.

Below are listed all the side effects related to PIROXICAM DOC Generici 20 mg
hard capsules.

More common side effects

• Ulcers of the digestive tract and gastrointestinal bleeding
• nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, ulcerative stomatitis, inflammatory bowel diseases (colitis and Crohn's disease)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure
• Heart failure (difficulty breathing and fatigue)

Less common side effects

• Heart attack (myocardial infarction)
• Stroke
• Anorexia
• Fatigue
• Anemia
• Blisters, redness or peeling skin (skin rash) or ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of allergic reactions such as rash, swelling of the face, lips, tongue, wheezing
• Yellowing of the skin and eyes (jaundice)
• Increased normal liver function values
• Pancreatitis
• Acute renal failure, blood in the urine, difficulty urinating
• Increased non-protein nitrogen in the blood (increased azotemia)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure (hypertension)
• Nosebleeds
• Headache
• Drowsiness
• Hearing loss or ringing in the ears
• Dizziness
• Vision disturbances
• Feeling unwell
• Alterations of the blood and lymphatic system
• Gastritis

Rare side effects

• Appearance of bruises
• Alteration of blood sugar values (hypo and hyperglycemia)
• Sweating
• Modification of body weight
• Insomnia
• Depression
• Swelling, blisters or peeling of the skin
• Photosensitivity
• Dry mouth
• Irritability
• Alterations of bladder function
• Shock
• Alopecia
• Alterations nail growth
• 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 (can manifest as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the package and on the inner label.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 PIROXICAM DOC Generici contains
The active ingredient is piroxicam. Each capsule contains 20 mg of piroxicam.
The other ingredients are:

• Contents of the hard capsules:lactose monohydrate, microcrystalline cellulose (PH 102), corn 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 contents of the pack
Opaque burgundy-colored hard capsules containing white powder.
The pack contains 30 hard capsules. The hard capsules are packaged in PVC/aluminum blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano - Italy.

Manufacturer
La.Fa.Re S.r.l. - Via Sacerdote Benedetto Cozzolino 77 - 80056 Ercolano (Napoli) – Italy.