ENANTYUM*10SACH ORAL GRANULES 25MG

Enantyum 25 mg granules for oral solution
Dexketoprofen

What it is and what it's for
Enantyum is a painkiller belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate pain, such as acute muscle pain, joint pain, painful menstruation (dysmenorrhea), and toothache.

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 non-steroidal anti-inflammatory drugs;
• if you suffer from asthma or have suffered from asthma attacks, acute allergic rhinitis (short periods of nasal mucous membrane inflammation), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties) 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 (medicines used to lower blood lipid levels);
• if you suffer from peptic ulcer/stomach or intestinal bleeding or if you have a history of stomach or intestinal bleeding, ulceration or perforation;
• if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have a history of stomach or intestinal bleeding or perforation 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 coagulation disorders;
• if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhea 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 conditions (hypertension and/or heart failure) and fluid retention, or if you have a history of any of these disorders;
• if you are on diuretics or if you are poorly hydrated and have reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhea, vomiting);
• if you have heart disease, have had a stroke or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or if you are a smoker), discuss treatment with your doctor or pharmacist; medicines like Enantyum may be associated with a slight increased risk of heart attack (myocardial infarction) or cerebrovascular accident (stroke).
These risks are more likely with high doses of the medicine 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 (Enantyum may reduce female fertility, therefore you should not take the medicine if you are planning a pregnancy or 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 a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you have a history of other stomach or intestinal disorders;
• if you have an infection – see section "Infections" below;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral steroids, some antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents like aspirin or anticoagulants like warfarin. In these cases, consult your doctor before taking Enantyum: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines that reduce gastric acid production);
• if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs.

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

Children and adolescents
The use of Enantyum 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 according to their probability of occurrence. Since the list is partly based on the side effects of the tablet formulation of Enantyum, and Enantyum in granules is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with Enantyum in granules.

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 (vertigo), dizziness, drowsiness, insomnia, nervousness, headache, palpitations, hot flashes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, fever and chills, general feeling of unwellness (malaise).

Rare side effects (may affect up to 1 in 1,000 patients)
Peptic ulcer, bleeding or perforated peptic ulcer (manifesting as hematemesis, i.e. vomiting blood, or black stools), fainting, hypertension, slowed breathing, fluid retention and peripheral edema (e.g. swollen ankles), laryngeal edema, loss of appetite (anorexia), altered sensation (particularly touch), itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function test (blood analysis), hepatocellular damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 patients)
Anaphylactic reactions (hypersensitivity reactions that can also lead to collapse), open sores on the skin, mouth, eyes and genital area (Stevens-Johnson and Lyell syndromes), facial edema or swelling of the lips and throat (angioedema), shortness of breath due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased blood platelets (thrombocytopenia).

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

Stop using Enantyum as soon as you notice a skin rash or any lesion inside the mouth or genitals, or any sign of allergy.

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

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

In patients suffering from immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs can, 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 for the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, hematological reactions may occur (purpura, aplastic and hemolytic anemia and rarely agranulocytosis and bone marrow hypoplasia).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.