FELDENE 20 mg Tabletka Sublingwalna

Treść ulotki

1. FELDENE FAST 20 mg sublingual tablets
   1. What Feldene Fast is and what it is used for
   2. What you need to know before taking Feldene Fast
   3. How to take Feldene Fast
   4. Possible side effects
   5. How to store Feldene Fast
   6. Contents of the pack and other information

FELDENE FAST 20 mg sublingual tablets

Piroxicam

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Feldene Fast is and what it is used for
• 2. What you need to know before you take Feldene Fast
• 3. How to take Feldene Fast
• 4. Possible side effects
• 5. How to store Feldene Fast
• 6. Contents of the pack and other information

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

Feldene Fast contains the active ingredient piroxicam which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Feldene Fast is an anti-inflammatory and pain-relieving medicine, which is used in adultsfor

relieving symptomssuch as swelling, stiffness and pain in the joints caused by:

• osteoarthritis(a degenerative joint disease)
• rheumatoid arthritis(a chronic inflammatory joint disease)
• ankylosing spondylitis(spinal rheumatism) Feldene Fast does not cure the cause of these diseases and will only give you relief from symptoms as long as you continue to take it. The doctor will prescribe Feldene Fast only when other non-steroidal anti-inflammatory drugs (NSAIDs) are no longer useful in relieving your symptoms.

2. What you need to know before taking Feldene Fast

Do not take Feldene Fast

• if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had in the past an ulcer, bleeding or perforation of the stomach or intestine;
• if you have had 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 problems with digestion;
• if you have severe liver problems;
• if you have severe kidney problems;
• if you have severe or moderate heart problems;
• if you suffer from very high blood pressure;
• if you have severe blood disorders;
• if you are prone to bleeding frequently;
• if you are taking the following medicines (see section “Other medicines and Feldene Fast”):
• other non-steroidal anti-inflammatory drugs (NSAIDs) at doses used to relieve pain, including acetylsalicylic acid and “COX-2 selective inhibitors” (a class of NSAIDs)
• anticoagulants (medicines used to thin the blood)
• if you have had a severe allergic reaction of any kind in the past caused by medicines, including severe skin reactions such as:
• erythema multiforme (skin disease characterized by bright red lesions on the skin)
• Stevens-Johnson syndrome (characterized by skin with red blisters, injured, bleeding or covered with a crust) and toxic epidermal necrolysis (characterized by blisters and shedding of the superficial layer of the skin);
• if you are or think you might be pregnant;
• if you are breastfeeding;
• if you are under 18 years of age;
• if you have had symptoms such as asthma, runny nose, polyps in the nose, swelling, redness and itching of the face, tongue and throat (angioedema) or hives during treatment with acetylsalicylic acid or other NSAIDs;
• if you have phenylketonuria, an inherited metabolic disease.

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Feldene Fast if you think that any of the
following conditions apply to you:

• suffer from or have suffered from high blood pressureor heart problemsor have a history of heart attackor strokeor think you may be at risk for these conditions (for example if you suffer from diabetes, high cholesterol or if you are a smoker);
• are being treated with medicinesthat interfere with platelet aggregation(e.g. low-dose acetylsalicylic acid) because Feldene Fast may increase the effect of these medicines. Your doctor may subject you to blood tests;
• if you are being treated with drugs 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 Fast”). Your doctor may prescribe you a medicine to protect your stomach and intestines together with Feldene Fast in this case;
• have reduced kidneyand liverfunction or are being treated with diuretics(medicines that increase urine production);
• suffer from reduced blood flow to the kidneys (renal hypoperfusion);
• have or have had in the past problemswith blood coagulation;
• are asthmatic, because this medicine can cause difficulty breathing, shock and allergic reactions;
• are diabetic. In this case, it is advisable to have frequent tests to check your blood sugar levels;
• have or suspect you have a reduced congenital ability to metabolize certain medicines. Your doctor may decide to prescribe you a reduced dose of this medicine.

Duringtreatment with Feldene Fast you may experience one of the following conditions
(see also section 4 “Possible side effects”):

• severe problems with the stomachand intestinessuch as bleeding, ulcer and perforation. Stoptaking Feldene Fast immediately and contactyour doctor if you have stomach pain or if you experience any signs of bleeding in the stomach or intestines, such as
  passing black or tarry stools or vomiting blood;
• heart attackand stroke. These events are seriousand can sometimes be fatal;
• eye problems. Periodic checks are recommended to assess eye function in case of prolonged treatments;
• yellowing/yellowish discoloration of the skin and the white of the eyes (jaundice) and inflammatoryliver lesions, even fatal. If you experience symptoms of liver problems, stoptaking Feldene Fast immediately and see your doctor;
• potentially fatal skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis). If you experience these symptoms, stoptaking Feldene Fast immediately and never take this medicine again (see section “Do not take Feldene Fast”).

If you develop a skin rash or skin symptoms, you should stop taking Feldene Fast immediately, see a doctor immediately and tell them that you are taking this medicine.

If you are elderly (over 70 years old)
If you are over 70 years of age, your doctor may prescribe you a medicine to protect your stomach and intestines together with Feldene Fast, as you are at higher risk of experiencing unwanted effects on the stomach and/or intestines.
You should not take this medicine if you are over 80 years old.

Other medicines and Feldene Fast
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Do not takeFeldene Fast together with the following medicines due to the increased risk of
stomach and intestinal bleeding (see section “Do not take Feldene Fast”):

• non-steroidal anti-inflammatory drugs(NSAIDs), including acetylsalicylic acid and “COX-2 selective inhibitors” (a class of NSAIDs), 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 can affect the effectiveness and toxicity of Feldene Fast or Feldene Fast
can 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 for depression;
• antiplatelet agents(e.g. low-dose acetylsalicylic acid) used to prevent blood clot formation;
• diuretics, ACE inhibitors, angiotensin II antagonistsand beta-blockers, medicines used for high blood pressure and heart disease;
• methotrexate, a medicine used against tumors;
• quinolones, used to treat bacterial infections.

Feldene Fast 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
unwanted pregnancies.

Feldene Fast with alcohol
Avoiddrinking alcohol during treatment with Feldene Fast, 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 or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Feldene Fast if you are or think you might be pregnant or if you are breastfeeding (see
section “Do not take Feldene Fast”).
NSAIDs can cause problems with the kidneys and heart of the fetus. NSAIDs may affect
the mother's and baby's tendency to bleed and delay or prolong labor. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus,
thus reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Feldene Fast may cause reversible infertility. Your doctor may advise you to stop
treatment with this medicine if you have difficulty conceiving or if you are undergoing
tests to assess your fertility.

Driving and using machines
Feldene Fast may alter your state of alertness. If you experience dizziness or unusual fatigue, be
especially careful when driving or using machines.

Feldene Fast contains aspartame
This medicine contains 0.25 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful if you have
phenylketonuria (PKU), a rare genetic disease that causes phenylalanine to build up because the body
cannot dispose of it properly

3. How to take Feldene Fast

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dissolve the tablets under the tongue. Do not swallow the tablets whole.
The maximum recommended dose is 20 mg per day (corresponding to 1 tablet).
If you are elderly, your doctor may prescribe a lower dose and reduce the duration of treatment.
Do not exceed or change the doses indicated by your doctor.
The doctor may prescribe Feldene Fast together with another medicine to protect the stomach and
intestine from possible side effects.

If you take more Feldene Fast than you should
If you have accidentally taken an excessive dose of Feldene Fast, 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 Fast
Take the medicine as soon as you remember. If it is almost time to take the next dose, do not take the
dose you forgot, but take the next dose at the right time. Do not take a double dose to
compensate for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

STOPtreatment with Feldene Fast immediately and contact your doctor if you experience:

• stomach painor signs of perforationand bleeding in the stomachor intestinesuch as passing black or tarry stools or vomiting blood;
• yellowing of the skin and the white of the eyes (jaundice);
• liver inflammation;
• severe reduction in kidney function(renal failure);
• any sign of an allergic reactionsuch as skin rash or swelling of the face, lips and throat which can cause difficulty breathing and swallowing;
• skin reactionscharacterized by blisters, redness or peeling of the skin, ulcers in any part of the body (for example skin, mouth, nose, throat, genitals), even severe (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects that you might experience are listed below:

Very common effects:

• stomach ulcers
• nausea, vomiting, diarrhoea, flatulence, constipation, digestive problems, abdominal pain, inflammation and ulcers in the mouth, worsening of inflammatory bowel diseases (colitis and Crohn’s disease)
• swelling of ankles, legs and feet caused by fluid retention
• increased blood pressure
• heart problems that can also cause shortness of breath and fatigue

Common effects:

• heart attack (myocardial infarction)
• stroke
• loss or reduction of appetite
• tiredness
• anaemia, even severe
• increased normal liver function values
• pancreatitis
• blood in the urine, difficulty urinating
• increased levels of nitrogen in the blood
• nosebleeds
• headache
• drowsiness
• hearing loss or ringing in the ears
• dizziness
• vision disturbances
• feeling unwell
• changes in blood tests (e.g. decrease in haemoglobin and haematocrit)
• reduction in the number of red blood cells, white blood cells and platelets in the blood, increase in the number of eosinophils (a type of white blood cells) in the blood
• inflammation of the stomach

Rare effects:

• bruising
• increase or decrease in blood sugar levels (hypoglycaemia and hyperglycaemia)
• sweating
• change in body weight
• insomnia
• depression
• swelling, blisters or peeling of the skin
• increased sensitivity of the skin to light
• appearance of small red spots that usually appear on the legs and buttocks but can also appear in other areas of the body (Schönlein-Henoch purpura)
• dry mouth
• hyper-excitation
• changes in bladder function
• shock
• hair loss
• changes in nail growth

Effects with unknown frequency(frequency cannot be estimated from available data):

• reduced female fertility
• disorders and inflammation of various parts of the kidney (renal tubules and glomeruli) with consequent presence of proteins in the urine, increased levels of cholesterol in the blood and fluid retention
• fixed drug eruption (may appear 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 Feldene Fast

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Expiry”. The expiry date refers to the last day of that month.
Store in a cool and dry place.
Do not dispose of any medicine in wastewater 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 Feldene Fast contains
The active ingredient is piroxicam.
Each sublingual tablet contains 20 mg of piroxicam.
The other ingredients are: aspartame(E951)(see section 2 “Feldene Fast contains aspartame”),
anhydrous citric acid, gelatin and mannitol.

Description of the appearance of Feldene Fastand contents of the pack
Feldene Fast is available in PVC/PVDC/aluminium blisters in packs of 5 and 20 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47,600 - Borgo San Michele
04100 Latina