Package leaflet: Information for the patient

FELDENE 20 mg hard capsules, 20 mg soluble tablets

Piroxicam
Please read this leaflet carefully before taking this medicine because 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Feldene and what is it used for?

Feldene contains the active substance piroxicam, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Feldene is an anti-inflammatory and analgesic medicine, used in adults to
relieve symptoms such as swelling, stiffness, and joint pain caused by:

osteoarthritis (a degenerative joint disease)
rheumatoid arthritis (a chronic inflammatory joint disease)
ankylosing spondylitis (inflammatory rheumatism of the spine)

Feldene does not cure the underlying cause of these diseases and will relieve your symptoms only as long as you continue taking it. Your doctor will prescribe Feldene only when other non-steroidal anti-inflammatory drugs (NSAIDs) are no longer effective in relieving your symptoms. Your doctor may need to review your condition periodically and will advise you how often monitoring is required during treatment with Feldene.

2. What you should know before taking Feldene

Do not take Feldene

if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6);
if you have or have previously had a stomach or intestinal ulcer, bleeding, or perforation;
if you have had stomach and/or intestinal disorders that make you prone to bleeding, such as:
ulcerative colitis and Crohn's disease (chronic inflammatory bowel diseases)
stomach and/or intestinal tumour
diverticulitis (inflammation/infection of pouches in the wall of the colon, a part of the intestine);
if you suffer from inflammation of the stomach or intestine or have digestive problems;
if you have severe liver problems;
if you have severe kidney problems;
if you have moderate or severe heart problems;
if you suffer from very high blood pressure;
if you have severe blood disorders;
if you are prone to frequent bleeding;
if you are taking the following medicines (see section "Other medicines and Feldene"):
other non-steroidal anti-inflammatory drugs (NSAIDs) at doses used to relieve pain, including acetylsalicylic acid and "selective cyclooxygenase-2 (COX-2) inhibitors" (a class of NSAIDs)
anticoagulants (medicines used to thin the blood);
if you have previously experienced a severe allergic reaction of any kind to medicines, including severe skin reactions such as:
erythema multiforme (a skin disease characterised by bright red lesions on the skin)
Stevens-Johnson syndrome (characterised by red, blistered, damaged, bloody, or crusted skin) and toxic epidermal necrolysis (characterised by blisters and peeling of the skin's superficial layer);
if you are or think you may be pregnant;
if you are breastfeeding;
if you are under 18 years of age;
if you have experienced symptoms such as asthma, runny nose (rhinitis), nasal polyps, swelling, redness and itching of the face, tongue and throat (angioedema), or urticaria during treatment with acetylsalicylic acid or other NSAIDs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Feldene.
Contact your doctor if you think any of the following conditions apply to you:

you suffer or have suffered from high blood pressure or heart problems, or have a history of heart attack or stroke, or think you may be at risk for these conditions (for example, if you have diabetes, high cholesterol, or are a smoker);
you are being treated with medicines that inhibit platelet aggregation (such as acetylsalicylic acid), because Feldene may enhance the effect of these medicines. Your doctor may perform blood tests;
you are being treated with medicines that may increase the risk of bleeding (such as corticosteroids or medicines called "selective serotonin reuptake inhibitors" or acetylsalicylic acid) (see "Other medicines and Feldene"). In this case, your doctor may prescribe a medicine alongside Feldene to protect your stomach and intestines;
you have reduced kidney or liver function or are being treated with diuretics (medicines that increase urine production);
you suffer from reduced blood flow to the kidneys ( renal hypoperfusion );
you have or have previously had blood clotting disorders ;
you are asthmatic, because this medicine may cause breathing difficulties, shock, and allergic reactions;
you are diabetic. In this case, frequent blood sugar monitoring is recommended;
you have or suspect you have a congenital reduced ability to metabolise certain medicines. Your doctor may decide to prescribe a lower dose of this medicine.

During treatment with Feldene, you may experience one of the following conditions (see also
section 4 "Possible side effects"):

serious stomach and intestinal problems such as bleeding, ulceration, and perforation. Stop taking Feldene immediately and contact your doctor if you have stomach pain or notice any signs of stomach or intestinal bleeding, such as passing black or blood-stained stools, or if you vomit blood;
heart attack and stroke. These events are serious and may sometimes lead to death;
eye problems. For prolonged treatments, periodic eye examinations are recommended to assess eye function;
yellow or yellowish skin and whites of the eyes ( jaundice ) and inflammatory liver lesions, which may be fatal. If you experience symptoms of liver problems, stop taking Feldene immediately and consult your doctor;
potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis). If you experience these symptoms, stop taking Feldene immediately and never take this medicine again (see section "Do not take Feldene").

If you develop a skin rash or skin symptoms, you must stop taking Feldene immediately, contact a doctor immediately, and inform them that you are taking this medicine.
If you are elderly (over 70 years)
If you are over 70 years of age, your doctor may prescribe a medicine alongside Feldene to protect your stomach and intestines, as you are at higher risk of experiencing unwanted effects in the stomach and/or intestines.
You must not take this medicine if you are over 80 years of age.
Other medicines and Feldene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Feldene together with the following medicines due to increased risk of stomach and intestinal bleeding (see section "Do not take Feldene"):

non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and "selective cyclooxygenase-2 (COX-2) inhibitors" (a class of NSAIDs), used to relieve pain and/or reduce fever;
anticoagulants (e.g., warfarin, coumarin derivatives, apixaban, dabigatran, and rivaroxaban), medicines used to thin the blood.

The following medicines may affect the efficacy and toxicity of Feldene, or Feldene may affect the efficacy and toxicity of the following medicines:

corticosteroids, medicines used to treat allergies and severe inflammation;
selective serotonin reuptake inhibitors (SSRIs) and lithium, medicines used to treat depression;
antiplatelet agents (such as acetylsalicylic acid), used to prevent blood clots;
diuretics, ACE inhibitors, angiotensin II antagonists, and beta-blockers, medicines used for high blood pressure and heart conditions;
methotrexate, a medicine used to treat cancer;
quinolones, used to treat bacterial infections.

Feldene may reduce the effectiveness of intrauterine devices. It is advisable to use alternative contraceptive methods (e.g., condoms) during treatment with this medicine to avoid unintended pregnancies.
Feldene and alcohol
Do not consume alcohol during treatment with Feldene, as it may increase the risk of serious stomach or intestinal problems (see section "Warnings and precautions").
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Feldene if you are or think you may be pregnant or if you are breastfeeding (see section "Do not take Feldene").
NSAIDs may cause kidney and heart problems in the unborn child. NSAIDs may affect the tendency to bleeding in both mother and child and may delay or prolong labour beyond the expected time. From week 20 of pregnancy, NSAIDs may cause kidney problems in the unborn child, 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.
Feldene may cause reversible infertility. Your doctor may advise you to discontinue treatment with this medicine if you have difficulty conceiving or are undergoing fertility investigations.
Driving and using machines
Feldene may affect your level of alertness. If you experience dizziness or unusual tiredness, take special care when driving or operating machinery.
Feldene contains lactose and sodium
Feldene contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule/soluble tablet, i.e. essentially “sodium-free”.

3. How to take Feldene

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the hard capsules with a glass of water.
Dissolve the soluble tablets in a small amount of water.
The recommended maximum dose is 20 mg per day (equivalent to 1 capsule or 1 soluble tablet).
If you are elderly, your doctor may prescribe a lower dose and reduce the duration of treatment.
Do not exceed or alter the doses prescribed by your doctor.
Your doctor may prescribe Feldene together with another medicine to protect your stomach and
intestine from possible undesirable effects.
If you take more Feldene than you should
If you have accidentally taken an excessive dose of Feldene, inform your doctor immediately or go
to the nearest hospital.
You may experience headache, vomiting, drowsiness, dizziness, and fainting.
If you forget to take Feldene
Take the medicine as soon as you remember. If it is almost time for your next dose, do not take the
missed dose, but take the next dose at the scheduled time. Do not take a double dose to make up
for a forgotten dose.
If you have any doubts about how to use 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.
STOP treatment with Feldene immediately and contact your doctor if you experience:

stomach pain or show signs of perforation and bleeding in the stomach or intestine, such as passing black stools or stools stained with blood, or if you vomit blood;
yellow/yellowish discoloration of the skin and whites of the eyes ( jaundice );
liver inflammation ;
severe reduction in kidney function (renal failure);
any signs of allergic reaction such as skin rash or swelling of the face, lips, and throat which may cause difficulty breathing and swallowing; skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g., skin, mouth, nose, throat, genitals), even severe ones (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects you may experience are listed below:
Common side effects:

increased blood sugar levels (hyperglycaemia)
loss or reduced appetite
drowsiness
dizziness
headache
ringing in the ears
excessive sweating
decreased haemoglobin
decreased haematocrit
abnormal body weight
skin rash
increased blood count of eosinophils (a type of white blood cells)
reduced platelet count
oedema
stomach ulcers
diarrhoea
constipation
vomiting
digestive problems
abdominal pain
flatulence
nausea

Uncommon side effects:

decreased blood sugar levels (hypoglycaemia)
vision disorders
inflammation and ulcers in the mouth

Side effects with unknown frequency (frequency cannot be estimated from the available data):

female infertility
disorders and inflammation of various parts of the kidney (renal tubules and glomeruli), resulting in protein in the urine, increased blood cholesterol levels, and fluid retention
swelling of ankles, legs, and feet due to fluid retention
severe reduction in kidney function (renal failure)
increased levels of nitrogen in the blood
blood in the urine, difficulty urinating
changes in bladder function
abnormal blood tests
liver inflammation
increased liver function test values
yellow/yellowish discoloration of the skin and whites of the eyes (jaundice)
heart problems which may also cause difficulty breathing and fatigue
stroke
shock
increased blood pressure
heart attack (myocardial infarction)
skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g., skin, mouth, nose, throat, genitals), even severe ones (Stevens-Johnson syndrome, toxic epidermal necrolysis)
any signs of allergic reaction such as skin rash or swelling of the face, lips, and throat which may cause difficulty breathing and swallowing
swelling, blisters, or peeling of the skin
appearance of small red spots usually located on the legs and buttocks but which may also appear in other areas of the body (Henoch-Schönlein purpura)
appearance of bruises
skin sensitivity to light
abnormal nail growth
hair loss
fixed drug eruption (may present as round or oval patches of redness and swelling of the skin), hives (urticaria), itching
stomach pain or signs of perforation and bleeding in the stomach or intestine such as passing black stools or stools stained with blood, or if you vomit blood;
reduced count of red blood cells, white blood cells, and platelets
anaemia
anaemia, which may be severe (aplastic anaemia, haemolytic anaemia)
depression
irritability
insomnia
deafness
nosebleeds
inflammation of the pancreas
inflammation of the stomach
dry mouth
worsening of inflammatory bowel diseases (colitis and Crohn's disease)
malaise
fatigue

† All NSAIDs may be associated with an increased risk of cardiovascular adverse effects:
heart problems which may cause difficulty breathing and fatigue (heart failure),
heart attack (myocardial infarction), and stroke.
Reporting of side effects
If you experience any side effect, 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: 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 Feldene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
"Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Feldene contains
The active substance is piroxicam.
Feldene hard capsules
Each hard capsule contains 20 mg of piroxicam.
The other ingredients are: maize starch, lactose (see section 2 "Feldene contains lactose"),
magnesium stearate, sodium lauryl sulfate. The capsule shell ingredients are: gelatin, titanium dioxide (E171).
Feldene soluble tablets
Each soluble tablet contains 20 mg of piroxicam.
The other ingredients are: lactose (see section 2 "Feldene contains lactose"), microcrystalline cellulose, hydroxypropylcellulose, sodium stearyl fumarate.

Description of the appearance of Feldene and contents of the pack
Feldene 20 mg hard capsules are available in PVC/aluminum blisters, pack sizes of 30 capsules.
Feldene 20 mg soluble tablets are available in PVC/aluminum blisters, pack sizes of 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Feldene 20 mg hard capsules:
Fareva Amboise
Zone Industrielle – 29 route des Industries
37530 Pocé-sur-Cisse, France
Feldene 20 mg soluble tablets:
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47.600 - Borgo San Michele
04100 Latina

Patient information leaflet: information for the patient

FELDENE 20 mg suppositories

Piroxicam
Please read this leaflet carefully before using this medicine because 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Feldene is and what it is used for
What you need to know before taking Feldene
How to use Feldene
Possible side effects
How to store Feldene
Package contents and other information

1. What Feldene is and what it is used for

osteoarthritis (a degenerative joint disease)
rheumatoid arthritis (a chronic inflammatory joint disease)
ankylosing spondylitis (spinal rheumatism)

Feldene does not cure the underlying cause of these diseases and will relieve your symptoms only for as long as you continue taking it. Your doctor will prescribe Feldene only when other non-steroidal anti-inflammatory drugs (NSAIDs) are no longer effective in relieving your symptoms. Your doctor may need to review your condition periodically and will advise you how often monitoring is required during treatment with Feldene.

2. What you need to know before using Feldene

Do not use Feldene

if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6);
if you have or have previously had a stomach or intestinal ulcer, bleeding, or perforation;
if you have had stomach and/or intestinal disorders that make you prone to bleeding, such as:
ulcerative colitis and Crohn’s disease (chronic inflammatory bowel diseases)
stomach and/or intestinal tumour
diverticulitis (inflammation/infection of pouches in the wall of the colon, a part of the intestine);
if you suffer from inflammation of the stomach or intestine or have digestive problems;
if you have severe liver problems;
if you have severe kidney problems;
if you have moderate or severe heart problems;
if you suffer from very high blood pressure;
if you have serious blood disorders;
if you are prone to frequent bleeding;
if you are taking the following medicines (see section “Other medicines and Feldene”):
other non-steroidal anti-inflammatory drugs (NSAIDs) at doses used to relieve pain, including acetylsalicylic acid and “selective cyclooxygenase-2 (COX-2) inhibitors” (a class of NSAIDs)
anticoagulants (medicines used to thin the blood)
if you have previously experienced a severe allergic reaction of any kind to medicines, including severe skin reactions such as:
erythema multiforme (a skin disease characterized by bright red lesions on the skin)
Stevens-Johnson syndrome (characterized by red, blistered, damaged, bleeding or crusted skin) and toxic epidermal necrolysis (characterized by blisters and peeling of the superficial layer of the skin);
if you are or think you may be pregnant;
if you are breastfeeding;
if you are under 18 years of age;
if you have experienced symptoms such as asthma, runny nose (rhinitis), nasal polyps, swelling, redness and itching of the face, tongue and throat (angioedema), or urticaria during treatment with acetylsalicylic acid or other NSAIDs.

Warnings and precautions
Talk to your doctor or pharmacist before using Feldene.
Contact your doctor if you think any of the following conditions apply to you:

you suffer or have suffered from high blood pressure or heart problems, or have a history of heart attack or stroke, or think you may be at risk for these conditions (for example, if you have diabetes, high cholesterol, or are a smoker);
you are being treated with medicines that inhibit platelet aggregation (such as acetylsalicylic acid), because Feldene may enhance the effect of these medicines. Your doctor may perform blood tests;
you are being treated with medicines that may increase the risk of bleeding (such as corticosteroids or medicines called “selective serotonin reuptake inhibitors” or acetylsalicylic acid) (see “Other medicines and Feldene”). In this case, your doctor may prescribe a medicine to protect your stomach and intestines alongside Feldene;
you have reduced kidney or liver function or are being treated with diuretics (medicines that increase urine production);
you suffer from reduced blood flow to the kidneys ( renal hypoperfusion );
you have or have previously had blood clotting disorders ;
you are asthmatic, because this medicine may cause breathing difficulties, shock, and allergic reactions;
you are diabetic. In this case, frequent blood sugar monitoring is recommended;
you have or suspect you have a congenital reduced ability to metabolize certain medicines. Your doctor may decide to prescribe a lower dose of this medicine.

During treatment with Feldene, you may develop one of the following conditions (see also section 4 “Possible side effects”):

serious stomach and intestinal problems such as bleeding, ulceration, and perforation. Stop taking Feldene immediately and contact your doctor if you have stomach pain or any signs of stomach or intestinal bleeding, such as passing black or bloody stools, or if you vomit blood;
heart attack and stroke. These events are serious and may sometimes be fatal;
eye problems. For prolonged treatments, periodic eye examinations to assess eye function are recommended;
yellow or yellowish discoloration of the skin and whites of the eyes ( jaundice ) and inflammatory liver lesions, even fatal ones. If you experience symptoms of liver problems, stop taking Feldene immediately and consult your doctor;
potentially fatal skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis). If you experience these symptoms, stop taking Feldene immediately and never take this medicine again (see section “Do not use Feldene”).

If you develop a skin rash or skin symptoms, you must stop taking Feldene immediately, contact a doctor immediately, and inform them that you are taking this medicine.
If you are elderly (over 70 years)
If you are over 70 years of age, your doctor may prescribe a medicine to protect your stomach and intestines alongside Feldene, as you are at higher risk of experiencing unwanted effects in the stomach and/or intestines.
You must not take this medicine if you are over 80 years of age.
Other medicines and Feldene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not use Feldene together with the following medicines due to increased risk of stomach and intestinal bleeding (see section “Do not use Feldene”):

non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and “selective cyclooxygenase-2 (COX-2) inhibitors” (a class of NSAIDs), used to relieve pain and/or reduce fever;
anticoagulants (e.g. warfarin, coumarin derivatives, apixaban, dabigatran, and rivaroxaban), medicines used to thin the blood.

The following medicines may affect the efficacy and toxicity of Feldene, or Feldene may affect the efficacy and toxicity of the following medicines:

corticosteroids, medicines used to treat allergies and severe inflammation;
selective serotonin reuptake inhibitors (SSRIs) and lithium, medicines used for depression;
antiplatelet agents (such as acetylsalicylic acid) used to prevent blood clots;
diuretics, ACE inhibitors, angiotensin II antagonists, and beta-blockers, medicines used for high blood pressure and heart conditions;
methotrexate, a medicine used to treat cancer;
quinolones, used to treat bacterial infections.

Feldene may reduce the effectiveness of intrauterine devices. It is recommended to use alternative contraceptive methods (e.g. condoms) during treatment with this medicine to avoid unintended pregnancies.
Feldene and alcohol
Do not consume alcohol during treatment with Feldene, as it may increase the risk of developing serious stomach or intestinal problems (see section “Warnings and precautions”).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Feldene if you are or think you may be pregnant or if you are breastfeeding (see section “Do not use Feldene”).
NSAIDs may cause kidney and heart problems in the fetus. NSAIDs may affect the tendency of the mother and baby to bleed and may delay or prolong labour beyond the expected time. From week 20 of pregnancy, NSAIDs may 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.
Feldene may cause reversible infertility. Your doctor may advise you to stop treatment with this medicine if you have difficulty conceiving or are undergoing fertility assessments.
Driving and using machines
Feldene may affect alertness. If you experience dizziness or unusual tiredness, take particular care when driving or using machines.

3. How to use Feldene

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended maximum dose is 20 mg per day (equivalent to 1 suppository).
If you are elderly, your doctor may prescribe a lower dose and reduce the duration of treatment.
Do not exceed or alter the doses prescribed by your doctor.
Your doctor may prescribe Feldene together with another medicine to protect your stomach and
intestine from possible undesirable effects.
If you use more Feldene than you should
If you have accidentally used an excessive dose of Feldene, inform your doctor immediately or go
to the nearest hospital.
You may experience headache, vomiting, drowsiness, dizziness, and fainting.
If you forget to use Feldene
Use the medicine as soon as you remember. If it is almost time for the next dose, do not take the
missed dose, but take the next dose at the correct time. Do not take a double dose to make up for
the 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 everyone will experience them.
STOP treatment with Feldene immediately and contact your doctor if you experience:

stomach pain or show signs of perforation and bleeding in the stomach or intestine, such as passing black stools or stools stained with blood, or if you vomit blood;
yellow/yellowish discoloration of the skin and the white part of the eye ( jaundice );
inflammation of the liver ;
severe reduction in kidney function (renal failure);
any signs of allergic reaction such as skin rash or swelling of the face, lips, and throat which may cause difficulty breathing and swallowing; skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g. skin, mouth, nose, throat, genitals), even severe ones (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects you may experience are listed below:
Common side effects:

increased blood sugar levels (hyperglycaemia)
loss or reduction of appetite
drowsiness
dizziness
headache
ringing in the ears
excessive sweating
decrease in haemoglobin
decrease in haematocrit
abnormal body weight
skin rash
increase in blood eosinophil count (a type of white blood cells)
decrease in platelet count
oedema
stomach ulcers
diarrhoea
constipation
vomiting
digestive problems
abdominal pain
flatulence
nausea

Uncommon side effects:

decrease in blood sugar levels (hypoglycaemia)
visual disturbances
inflammation and ulcers in the mouth

Side effects with unknown frequency (frequency cannot be estimated from the available data):

female infertility
disorders and inflammation of various parts of the kidney (renal tubules and glomeruli), leading to presence of protein in urine, increased blood cholesterol levels, and fluid retention
swelling of ankles, legs, and feet due to fluid retention
severe reduction in kidney function (renal failure)
increased levels of nitrogen in the blood
blood in urine, difficulty urinating
changes in bladder function
abnormal blood tests
inflammation of the liver
increased liver function test values
yellow/yellowish discoloration of the skin and the white part of the eye (jaundice)
heart problems which may also cause difficulty breathing and fatigue
stroke
shock
increased blood pressure
heart attack (myocardial infarction)
skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g. skin, mouth, nose, throat, genitals), even severe ones (Stevens-Johnson syndrome, toxic epidermal necrolysis)
any signs of allergic reaction such as skin rash or swelling of the face, lips, and throat which may cause difficulty breathing and swallowing
swelling, blisters, or skin peeling
appearance of small red spots usually located on the legs and buttocks but which may also appear in other areas of the body (Henoch-Schönlein purpura)
appearance of bruises
skin sensitivity to light
abnormal nail growth
hair loss
fixed drug eruption (may present as round or oval red and swollen patches on the skin), hives (urticaria), itching
stomach pain or signs of perforation and bleeding in the stomach or intestine such as passing black stools or stools stained with blood, or vomiting blood
reduction in red blood cells, white blood cells, and platelets
anaemia
anaemia, which may be severe (aplastic anaemia, haemolytic anaemia)
depression
irritability
insomnia
deafness
nosebleeds
inflammation of the pancreas
inflammation of the stomach
dry mouth
worsening of inflammatory bowel diseases (colitis and Crohn's disease)
malaise
fatigue

† All NSAIDs may be associated with an increased risk of cardiovascular adverse effects:
heart problems which may cause difficulty breathing and fatigue (heart failure),
heart attack (myocardial infarction), and stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: 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 Feldene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines 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 Feldene contains
The active substance is piroxicam.
Each suppository contains 20 mg of piroxicam.
The other components are: semisynthetic glycerides, microcrystalline wax and propyl gallate.
Description of the appearance of Feldene and package contents
Feldene 20 mg suppositories are available in PVC/PE blisters, packs of 10 suppositories.
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Farmea
10, rue Bouché Thomas - ZAC Sud d’Orgemont
49007 Angers Cedex
France

Package leaflet: information for the patient

FELDENE 20 mg/1 ml injectable solution for intramuscular use

Piroxicam
Please read this leaflet carefully before using this medicine because 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 could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Feldene is and what it is used for
What you need to know before using Feldene
How to use Feldene
Possible side effects
How to store Feldene
Package contents and other information

1. What Feldene is and what it is used for

osteoarthritis (a degenerative joint disease)
rheumatoid arthritis (a chronic inflammatory joint disease)
ankylosing spondylitis (a rheumatic condition affecting the spine)

Feldene does not cure the underlying cause of these diseases and will relieve your symptoms only as long as you continue taking it. Your doctor may need to review your condition periodically and will advise you how often monitoring is required during treatment with Feldene.

Your doctor will prescribe Feldene to you only when other non-steroidal anti-inflammatory drugs (NSAIDs)
are no longer effective in relieving your symptoms.

2. What you should know before using Feldene

Do not use Feldene

if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6);
if you have or have previously had a stomach or intestinal ulcer, bleeding, or perforation;
if you have previously experienced stomach and/or intestinal disorders that predispose you to bleeding, such as:
ulcerative colitis and Crohn’s disease (chronic inflammatory bowel diseases)
stomach and/or intestinal cancer
diverticulitis (inflammation/infection of pouches in the wall of the colon, a part of the intestine);
if you suffer from inflammation of the stomach or intestine or have digestive problems;
if you have severe liver problems;
if you have severe kidney problems;
if you have moderate or severe heart problems;
if you suffer from very high blood pressure;
if you have severe blood disorders;
if you are prone to frequent bleeding;
if you are taking the following medicines (see section “Other medicines and Feldene”):
other non-steroidal anti-inflammatory drugs (NSAIDs) at doses used to relieve pain, including acetylsalicylic acid and "selective cyclooxygenase-2 (COX-2) inhibitors" (a class of NSAIDs)
anticoagulants (medicines used to thin the blood)
if you have previously experienced a severe allergic reaction of any type to medicines, including serious skin reactions such as:
erythema multiforme (a skin disease characterized by bright red lesions on the skin)
Stevens-Johnson syndrome (characterized by red, blistered, damaged, bleeding, or crusted skin) and toxic epidermal necrolysis (characterized by blisters and peeling of the skin's superficial layer);
if you are or think you may be pregnant;
if you are breastfeeding;
if you are under 18 years of age. In particular, Feldene must not be administered to children under 3 years of age;
if you have experienced symptoms such as asthma, runny nose (rhinitis), nasal polyps, swelling, redness, and itching of the face, tongue, or throat (angioedema), or hives during treatment with acetylsalicylic acid or other NSAIDs.

Warnings and precautions
Talk to your doctor or pharmacist before using Feldene.
Talk to your doctor if you think any of the following conditions apply to you:

you suffer or have suffered from high blood pressure or heart problems, or have a history of heart attack or stroke, or think you may be at risk for these conditions (for example, if you have diabetes, high cholesterol, or are a smoker);
you are being treated with medicines that inhibit platelet aggregation (such as acetylsalicylic acid), because Feldene may increase the effect of these medicines. Your doctor may perform blood tests;
you are being treated with medicines that may increase the risk of bleeding (such as corticosteroids or medicines called "selective serotonin reuptake inhibitors" or acetylsalicylic acid) (see “Other medicines and Feldene”). In this case, your doctor may prescribe a medicine alongside Feldene to protect your stomach and intestines;
you have reduced kidney or liver function or are being treated with diuretics (medicines that increase urine production);
you suffer from reduced blood flow to the kidneys ( renal hypoperfusion );
you have or have previously had blood clotting disorders ;
you are asthmatic , because this medicine may cause breathing difficulties, shock, and allergic reactions;
you are diabetic . In this case, frequent blood sugar level checks are recommended;
you have or suspect you have a congenital reduced ability to metabolize certain medicines. Your doctor may decide to prescribe a lower dose of this medicine. During treatment with Feldene, you may experience one of the following conditions (see also section 4 “Possible side effects”):
serious stomach and intestinal problems such as bleeding, ulcers, and perforation. Stop taking Feldene immediately and contact your doctor if you have stomach pain or notice any signs of stomach or intestinal bleeding, such as passing black or bloody stools or vomiting blood;
heart attack and stroke . These events are serious and may occasionally result in death;
eye problems . For prolonged treatment, periodic eye examinations are recommended to assess eye function;
yellow or yellowish skin and whites of the eyes ( jaundice ) and inflammatory liver lesions , which may be fatal. If you experience symptoms of liver problems, stop taking Feldene immediately and consult your doctor;
potentially fatal skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis). If you experience these symptoms, stop taking Feldene immediately and never take this medicine again (see section “Do not use Feldene”). If you develop a skin rash or skin symptoms, you must stop taking Feldene immediately, seek immediate medical attention, and inform the doctor that you are taking this medicine.

If you are elderly (over 70 years)
If you are over 70 years of age, your doctor may prescribe a medicine alongside Feldene to protect your stomach and intestines, as you are at higher risk of experiencing unwanted effects in the stomach and/or intestines.
You must not take this medicine if you are over 80 years of age.
Children
Feldene must not be administered to children.
Other medicines and Feldene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not use Feldene together with the following medicines due to the increased risk of stomach and intestinal bleeding (see section “Do not use Feldene”):

non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and "selective cyclooxygenase-2 (COX-2) inhibitors" (a class of NSAIDs), used to relieve pain and/or reduce fever;
anticoagulants (e.g., warfarin, coumarin derivatives, apixaban, dabigatran, and rivaroxaban), medicines used to thin the blood. The following medicines may affect the effectiveness and toxicity of Feldene, or Feldene may affect the effectiveness and toxicity of the following medicines:
corticosteroids , medicines used to treat allergies and severe inflammation;
selective serotonin reuptake inhibitors (SSRIs) and lithium , medicines used to treat depression;
antiplatelet agents (such as acetylsalicylic acid) used to prevent blood clots;
diuretics , ACE inhibitors , angiotensin II antagonists , and beta-blockers , medicines used for high blood pressure and heart conditions;
methotrexate , a medicine used to treat cancer;
quinolones , used to treat bacterial infections.

Feldene may reduce the effectiveness of intrauterine devices . It is recommended to use alternative contraceptive methods (e.g., condoms) during treatment with this medicine to avoid unintended pregnancies.
Feldene and alcohol
Do not take alcohol during treatment with Feldene, as it may increase the risk of serious stomach or intestinal problems (see section “Warnings and precautions”).
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
You must not use Feldene if you are or think you may be pregnant or if you are breastfeeding (see section “Do not use Feldene”).
NSAIDs may cause kidney and heart problems in the fetus. NSAIDs may affect the bleeding tendency in both mother and baby and may delay or prolong labor beyond the expected time. From week 20 of pregnancy, NSAIDs may 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.
Feldene may cause reversible infertility . Your doctor may advise stopping treatment with this medicine if you have difficulty conceiving or are undergoing fertility tests.
Driving and using machines
Feldene may affect alertness. If you experience dizziness or unusual tiredness, take special care when driving or operating machinery.
Feldene contains benzyl alcohol, propylene glycol, alcohol (ethanol), and sodium:

This medicine contains 20 mg of benzyl alcohol in each 1 ml vial. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems (gasping syndrome), in young children. Medicines containing benzyl alcohol must not be administered to newborns (up to 4 weeks of age) and must not be used for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor. Taking large amounts of Feldene may cause accumulation of benzyl alcohol in the body, leading to increased acid levels in the blood (called “metabolic acidosis”). Patients with liver or kidney disease and pregnant or breastfeeding women should take special precautions and consult their doctor.
This medicine contains 400 mg of propylene glycol in each 1 ml vial. If the child is under 4 weeks of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
This medicine contains 100 ml of alcohol (ethanol) in each 1 ml vial. The amount of alcohol in each 1 ml vial is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is essentially “sodium-free”.

For those engaged in sports
The use of medicines containing ethyl alcohol may result in positive doping tests according to the blood alcohol concentration limits set by certain sports federations.

3. How to use Feldene

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The maximum recommended dose is 20 mg per day.
If you are elderly, your doctor may prescribe a lower dose and reduce the duration of treatment.
Do not exceed or change the dose prescribed by your doctor.
Your doctor may prescribe Feldene together with another medicine to protect your stomach and
intestine from possible undesirable effects.
If you use more Feldene than you should
If you have accidentally taken an excessive dose of Feldene, inform your doctor immediately or go
to the nearest hospital.
You may experience headache, vomiting, drowsiness, dizziness, and fainting.
If you forget to use Feldene
Take the medicine as soon as you remember. If it is almost time for your next dose, do not take the
missed dose, but take the next dose at the scheduled time. Do not take a double dose to make up for
the forgotten 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 everyone experiences them.
STOP treatment with Feldene immediately and contact your doctor if you experience:

stomach pain or signs of perforation and bleeding in the stomach or intestine, such as passing black stools or stools stained with blood, or if you vomit blood;
yellow/yellowish discoloration of the skin and the white part of the eye ( jaundice );
liver inflammation ;
severe reduction in kidney function (renal failure);
any signs of allergic reaction, such as skin rash or swelling of the face, lips, and throat, which may cause difficulty breathing and swallowing; skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g., skin, mouth, nose, throat, genitals), even severe ones (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects you may experience are listed below:
Common side effects:

increased blood sugar levels (hyperglycaemia)
loss of appetite or reduced appetite
drowsiness
dizziness
headache
ringing in the ears
excessive sweating
decreased haemoglobin
decreased haematocrit
abnormal body weight
skin rash
increased blood count of eosinophils (a type of white blood cells)
reduced platelet count
oedema
stomach ulcers
diarrhoea
constipation
vomiting
digestive problems
abdominal pain
flatulence
nausea

Uncommon side effects:

decreased blood sugar levels (hypoglycaemia)
visual disturbances
inflammation and ulcers in the mouth

Side effects with unknown frequency (frequency cannot be determined from the available data):

female infertility
disorders and inflammation of various parts of the kidney (renal tubules and glomeruli), leading to protein in the urine, increased blood cholesterol levels, and fluid retention
swelling of ankles, legs, and feet due to fluid retention
severe reduction in kidney function (renal failure)
increased blood nitrogen levels
blood in the urine, difficulty urinating
disturbances in bladder function
abnormal blood test results
liver inflammation
increased liver function test values
yellow/yellowish discoloration of the skin and the white part of the eye (jaundice)
heart problems that may also cause difficulty breathing and fatigue
stroke
shock
increased blood pressure
heart attack (myocardial infarction)
skin reactions characterized by blisters, redness, or peeling of the skin, ulcers anywhere on the body (e.g., skin, mouth, nose, throat, genitals), even severe ones (Stevens-Johnson syndrome, toxic epidermal necrolysis)
any signs of allergic reaction such as skin rash or swelling of the face, lips, and throat, which may cause difficulty breathing and swallowing
swelling, blisters, or peeling of the skin
appearance of small red spots usually located on the legs and buttocks but which may also appear in other areas of the body (Henoch-Schönlein purpura)
appearance of bruises
skin photosensitivity reaction
abnormal nail growth
hair loss
fixed drug eruption (may appear as round or oval red patches with swelling of the skin), hives (urticaria), itching
stomach pain or signs of perforation and bleeding in the stomach or intestine, such as passing black stools or stools stained with blood, or vomiting blood
reduced count of red blood cells, white blood cells, and platelets
anaemia
anaemia, which may be severe (aplastic anaemia, haemolytic anaemia)
depression
irritability
insomnia
deafness
nosebleeds
pancreatitis
stomach inflammation
dry mouth
worsening of inflammatory bowel diseases (colitis and Crohn's disease)
malaise
injection site reactions such as pain, skin rash, abscess formation, and cell death
fatigue

All NSAIDs may be associated with an increased risk of cardiovascular adverse effects: heart problems that may cause difficulty breathing and fatigue (heart failure), heart attack (myocardial infarction), and stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Feldene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after "Expiry". The expiry date refers to the last day of that month.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Feldene contains
The active substance is piroxicam.
Each ampoule contains 20 mg of piroxicam.
The other ingredients are: monosodium phosphate, nicotinamide, propylene glycol (E1520), ethanol, benzyl alcohol (E1519), sodium hydroxide (see section 2 “Feldene contains benzyl alcohol, propylene glycol, alcohol (ethanol) and sodium”), concentrated hydrochloric acid and water for injectable preparations.
Description of the appearance of Feldene and contents of the pack
Feldene is available in packs containing 6 glass ampoules of 1 ml each.
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Fareva Amboise
Zone Industrielle – 29 route des Industries
37530 Pocé-sur-Cisse
France