FASTUMDOL ANTINF*20 SACHETS ORAL SOLUTION 25MG

Fastumdol Anti-inflammatory 25 mg oral solution in sachet
Dexketoprofen

What it is and what it is used for
This medicine 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 acute pain of mild to moderate intensity, such as acute 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 Fastumdol Anti-inflammatory
• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in paragraph 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 inflammation of the nasal lining), 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 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 the intake of ketoprofen (an NSAID) or fibrates (drugs used to lower blood lipid levels);
• if you suffer from peptic ulcer/bleeding of the stomach or intestine or if you have a history of bleeding, ulceration, or perforation of the stomach or intestine;
• if you have chronic digestive problems (e.g., indigestion, heartburn);
• if you have a history of 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 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 Fastumdol Anti-inflammatory:
• 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., from excessive urination, diarrhea, vomiting);
• if you have heart disease, if you have had a stroke, or if you 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 therapy with your doctor or pharmacist; drugs like Fastumdol Anti-inflammatory 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 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, therefore you should not take the drug 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 a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you suffer or have suffered in the past from other stomach or intestinal disorders;
• if you have an infection - see Infections section below;
• if you are taking other medications that increase the risk of peptic ulcer or bleeding, e.g., oral steroids, certain antidepressants (e.g., SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking this medicine: they may prescribe an additional drug to protect your stomach (e.g., misoprostol or other drugs 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. Administration of this medicine can cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs.

Infections
Dexketoprofen can mask the symptoms of infections such as fever and pain. Therefore, it is possible that this medicine may delay appropriate 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 infection symptoms persist or worsen, consult 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, Fastumdol Anti-inflammatory can cause side effects, although not everybody gets them.
The possible side effects are listed below, ordered by their likelihood of occurrence. Since the list is partly based on the side effects of the tablet formulation of Fastumdol Anti-inflammatory, and Fastumdol Anti-inflammatory oral solution is absorbed more rapidly than tablets, it is possible that the actual frequency of (gastrointestinal) side effects may be higher with Fastumdol Anti-inflammatory oral solution in sachet.

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), lightheadedness, drowsiness, insomnia, nervousness, headache, palpitations, flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, fatigue, pain, feeling feverish and chills, general feeling of ill health (malaise).

Rare side effects (may affect up to 1 in 1,000 patients):
Peptic ulcer, bleeding or perforated peptic ulcer (manifested by 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, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), 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 wounds on the skin, mouth, eyes, and genital area (Stevens-Johnson and Lyell syndromes), facial edema or swelling of the lips and throat (angioneurotic edema), shortness of breath due to contraction of the muscles surrounding the airways (bronchospasm), rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Reduced number of white blood cells (neutropenia), decrease in blood platelets (thrombocytopenia).

Inform your doctor immediately if you notice any side effects in your stomach or intestines at the beginning of treatment (e.g., stomach pains, heartburn, or bleeding), if you have previously suffered from these side effects due to prolonged 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 lesion inside your mouth or genitals, or any sign 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.

Drugs like Fastumdol Anti-inflammatory 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, gastrointestinal perforation or bleeding, sometimes fatal, especially for the elderly, may occur. 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 gastric wall (gastritis) has been observed. As with other NSAIDs, aseptic meningitis may occur, predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and hemolytic anemia, and more 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.