ENANTYUM 25 MG FILM-COATED TABLETS 10 TABLETS IN ACLAR/AL BLISTER

Name
Enantyum 25 mg film-coated tablets
Dexketoprofen


What is it and what is it for?
Enantyum is a painkiller that belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful periods (dysmenorrhea), and toothache.
Talk to your doctor if you do not feel better or if you feel worse after 3 - 4 days.


What you need to know before taking the medicine
Do not take Enantyum:
• 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 nonsteroidal anti-inflammatory drugs;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to 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 nonsteroidal anti-inflammatory drugs;
• If you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or blistering of the skin following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce fat levels in the blood);
• If you have a peptic ulcer/bleeding in the stomach or intestines or if you have had stomach or intestinal bleeding, ulceration or perforation in the past;
• If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
• If you have suffered in the past from bleeding or perforation in the stomach or intestine due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you suffer from intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If you suffer from severe heart failure, or have moderate to severe kidney problems or serious liver problems;
• If you have bleeding problems or 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 your third trimester of pregnancy or are breastfeeding.


Warnings and precautions
Talk to your doctor or pharmacist before using Enantyum:
• If you suffer from allergies, or have had problems due to allergies in the past;
• If you have kidney problems, liver or heart problems (hypertension and/or heart failure) or fluid retention, or have previously suffered from one of these problems;
• If you are taking diuretics or have problems with very poor hydration or have a reduced blood volume due to excessive fluid loss (for example due to excessive urination, diarrhoea, vomiting);
• If you have heart problems, have had a stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol, or if you smoke), you should discuss your treatment with your doctor or pharmacist. Medicines like Enantyum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. These risks are more likely with high doses of the medicine and with prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• If you are elderly: you are more likely to experience side effects (see section 4);
If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicine may reduce your fertility, so you should not take the medicine if you are planning to become pregnant or if you are undergoing fertility tests);
• 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 suffered in the past from a chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have suffered in the past from other stomach or intestinal problems;
• If you have an infection – see section “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral steroids, certain antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), medicines that prevent blood clots such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking this medicine: he or she may prescribe an additional medicine to protect your stomach (for example, misoprostol or other medicines that block the production of stomach acid);
• If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as you are at greater risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexketoprofen may mask the symptoms of infection, such as fever and pain. Therefore, this medicine may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.
The use of this medicine is not recommended during chickenpox virus infection.

Children and adolescents
This medicine has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product 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.
Possible side effects are listed below, ranked according to how likely they are to occur.

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

Uncommon side effects: may affect up to 1 in 100 patients
Dizziness, lightheadedness, drowsiness, trouble sleeping, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, tiredness, pain, feeling feverish and chills, feeling generally unwell.

Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may manifest as traces of blood in vomit or stool), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), oedema of the larynx, loss of appetite (anorexia), changes in sensation (paraesthesia), itchy rash, acne, increased sweating, low 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 patients
Anaphylactic reaction (hypersensitivity reaction that can lead to collapse), ulceration of the skin, mouth, eyes, and genital area (Stevens-Johnson and Lyell syndromes), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, hypersensitivity to light, itching, kidney problems. Decreased white blood cells (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you notice any side effects affecting your stomach or intestines at the start of treatment (such as stomach pain, heartburn, or bleeding), if you have previously suffered from some of these side effects due to long-term use of anti-inflammatory drugs, and especially if you are elderly.

Stop using this medicine as soon as you notice the appearance of a skin rash, or any lesions on the inside of the mouth or genitals, or any signs of allergy.

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

Medicines like this may be associated with a small increased risk of heart attack ('myocardial infarction') or cerebrovascular accident (stroke).

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, hematemesis, ulcerative stomatitis, and 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 (purpura, aplastic and haemolytic anaemia and rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects
If you experience 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.