DEXFENIA*20FC TAB 25MG

Dexfenia 25 mg film-coated tablets
Dexketoprofen
Generic medicine

What it is and what it is used for
Dexfenia is a painkiller belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the treatment of mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), toothache, in adults.

What you need to know before taking the medicine
Do not take Dexfenia:
- if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- if you have asthma or have suffered from asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (nodules inside the nose caused by an allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- if you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or blistering of the skin exposed to sunlight during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (medicines used to reduce blood fat levels);
- if you suffer from a peptic ulcer/bleeding of the stomach or intestine or if you have previously suffered from bleeding of the stomach or intestine, ulceration or perforation;
- if you suffer from chronic digestive problems (e.g., indigestion, heartburn);
- if you have previously suffered from bleeding or perforation of the stomach or intestine due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
- if you suffer from chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
- if you suffer from severe heart failure, or have moderate to severe kidney problems or severe liver problems;
- if you have bleeding problems or blood clotting disorders;
- if you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea or insufficient fluid intake;
- if you are in the third trimester of pregnancy or are breastfeeding.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema) and chest pain, have been reported with dexketoprofen. Stop Dexfenia immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dexfenia:
- if you suffer from allergies, or if you have had allergy problems in the past;
- if you have kidney problems, liver or heart problems (hypertension and/or heart failure) in addition to fluid retention, or if you have previously suffered from any of these conditions;
- if you are taking diuretics or if you have very poor hydration problems or a reduction in blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhoea, vomiting);
- if you suffer from heart conditions, if you have had a stroke or if you think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or if you are a smoker), you should discuss therapy with your doctor or pharmacist; medicines like Dexfenia may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
- if you are elderly: there is a greater chance of being subject to side effects (see section 4). If these occur, consult your doctor immediately;
- if you are a woman with fertility problems (Dexfenia may impair your fertility, so you should not take the medicine if you are planning a pregnancy or if you are undergoing fertility investigations);
- if you suffer from a disorder of blood and blood cell formation;
- if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
- if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- if you have or have previously suffered from other stomach or intestinal disorders;
- if you have an infection, see the section Infections below;
- if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, some antidepressants (SSRI type, i.e., Selective Serotonin Reuptake Inhibitors), agents that prevent blood clots from forming, such as aspirin or anticoagulants such as warfarin. In these cases, consult your doctor before taking Dexfenia: they may prescribe an additional medicine to protect your stomach (for example misoprostol or other medicines that block the production of gastric acid);
- if you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, as you have a greater risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the rest of the population. The administration of this medicine can cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexfenia can mask signs of infection such as fever and pain. It is therefore possible that Dexfenia may delay appropriate treatment of the infection, which can lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections caused by chickenpox. If you take this medicine while you have an infection and your infection symptoms persist or worsen, consult a doctor immediately.

Children and adolescents
Dexfenia has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the medicine should not be used in children and adolescents.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, ordered by the probability with which they may occur.

Common side effects: may affect up to 1 in 10 people:
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people:
Dizziness (vertigo), light-headedness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flashes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general malaise.

Rare side effects: may affect up to 1 in 1,000 people:
Peptic ulcer, bleeding or perforated peptic ulcer (which may manifest as traces of blood in vomit or black faeces), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensitivity (itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects: may affect up to 1 in 10,000 people:
Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulceration of the skin, mouth, eyes and genital area (Stevens-Johnson and Lyell syndromes), facial or lip and throat swelling (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), skin sensitivity, photosensitivity, itching, kidney disorders. Decreased white blood cell count (neutropenia), decreased blood platelets (thrombocytopenia).

Not known: frequency cannot be estimated from the available data
Chest pain, which can be a sign of an allergic reaction called Kounis syndrome which can potentially be life-threatening.

Fixed drug eruption.
A skin reaction of allergic origin, known as fixed drug eruption, which can manifest as round or oval patches with redness and swelling of the skin, blistering rash and itching. Hyperpigmentation of the skin in the affected areas may also occur and may persist after healing. Fixed drug eruption usually recurs in the same location (or locations) upon re-exposure to the medicine.

Inform your doctor immediately if you notice any stomach or intestinal side effects at the beginning of treatment (e.g., stomach pains, acidity or bleeding), if you have previously suffered from any of these side effects due to prolonged use of anti-inflammatory drugs, and especially if you are elderly.

Stop using Dexfenia as soon as you notice the appearance of a skin rash, or any lesions on the inner surface of the mouth or genitals, or any signs of allergy.

Fluid retention and swelling (particularly of the ankles and legs), increased blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs.

Medicines like Dexfenia may be associated with a modest increased risk of heart attack (myocardial infarction) or cerebrovascular accidents (stroke). In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most frequently observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially for the elderly. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the gastric wall (gastritis) has been observed.

As with other NSAIDs, haematological reactions may occur (purpura, aplastic and haemolytic anaemia and rarely agranulocytosis and bone marrow hypoplasia).

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.