ENANTYUM 25 MG ORAL SOLUTION IN SACHET 10 SINGLE-DOSE SACHETS IN PES/AL/LDPE OF 10 ML

Name
Enantyum 25 mg oral solution in sachet
Dexketoprofen


What is it and what is it for?
This medicine is a painkiller that belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of acute pain of mild to moderate intensity, such as sharp muscle pain, joint pain, painful menstruation (dysmenorrhea), and toothache. This medicine is indicated for adults.


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 suffer from asthma or have suffered from asthma attacks, acute allergic rhinitis (short periods of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergies), 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 irritation of the skin exposed to sunlight) in conjunction with taking ketoprofen (an NSAID) or fibrates (drugs used to lower the level of lipids in the blood);
• if you suffer from peptic ulcer/bleeding of the stomach or intestine or if you have suffered from bleeding, ulceration or perforation of the stomach or intestine in the past;
• if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have suffered in the past from bleeding or perforation of the stomach or intestine due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;
• if you suffer from chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• if you suffer from severe heart failure, moderate or severe kidney failure, severe liver failure;
• if you have bleeding problems or clotting disorders;
• if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• if you are in the third trimester of pregnancy or if you are breastfeeding.


Warnings and precautions
Talk to your doctor or pharmacist before taking Enantyum:
• if you suffer from allergies, or have had allergy problems in the past;
• if you have kidney, liver or heart problems (hypertension and/or heart failure) and fluid retention, or if you have suffered from one of these conditions in the past;
• if you are taking diuretics or if you are poorly hydrated and if you have a reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
• if you have heart disease, 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), 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 drug and with prolonged therapy. Do not exceed the recommended dose or duration of treatment;
• if you are elderly, the risk of side effects is higher (see point 4); if they occur, consult your doctor immediately;
• if you are a woman with fertility problems (this medicine may reduce female fertility, you should therefore not take the medicine if you are planning a pregnancy or if you are undergoing fertility tests);
• if you suffer from a disorder of blood formation and blood cells;
• 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 suffer or have suffered in the past from other stomach or intestinal problems;
• if you have an infection – see “Infections” section below;
• if you are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral steroids, certain antidepressants (e.g., SSRIs, selective serotonin reuptake inhibitors), antiplatelet drugs 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 (e.g., misoprostol or other drugs that reduce stomach acid production);
• 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, especially in subjects allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexketoprofen may mask the symptoms of infections, 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.

Children and adolescents
The use of dexketoprofen 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, Enantyum can cause side effects, although not everybody gets them.
Possible side effects are listed below, ranked by likelihood of occurrence. Since the list is based in part on side effects from the Enantyum tablet formulation, and Enantyum oral solution is absorbed more rapidly than tablets, it is possible that the actual frequency of (gastrointestinal) side effects may be higher with Enantyum oral solution sachet.

Common side effects (may affect up to 1 in 10 people):
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 people):
Feeling dizzy (vertigo), dizziness, drowsiness, insomnia, nervousness, headache, palpitations, flushing, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, rash, tiredness, pain, feeling feverish and chills, feeling generally unwell (malaise).

Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, haemorrhagic or perforated peptic ulcer (manifested by haematemesis (vomiting blood) or black stools), fainting, high blood pressure, slowed breathing, fluid retention and peripheral edema (e.g. swollen ankles), laryngeal edema, loss of appetite (anorexia), altered sensation, 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 reactions (hypersensitivity reactions that can lead to collapse), open sores on the skin, mouth, eyes, and genital area (Stevens-Johnson and Lyell syndromes), facial swelling or swelling of the lips and throat (angioneurotic edema), shortness of breath 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), sensitive skin, sensitivity to light, itching, kidney problems. Reduced white blood cell count (neutropenia), decreased blood 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 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 a skin rash or any sores inside the mouth or on the 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 nonsteroidal anti-inflammatory drugs.

Medicines such as Enantyum 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, in rare cases, 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, aseptic meningitis may occur, which can occur predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease and haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

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.