FASTUMDOL ANTINF * 20CPR 25MG

What it is and what it is used for
Fastumdol Anti-inflammatory is a painkiller belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat pain of mild to moderate intensity, such as muscle pain, painful menstruation (dysmenorrhea), 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 Fastumdol Anti-inflammatory:
• 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 (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 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 following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates ( drugs used to reduce blood fat levels);
• If you suffer from a peptic ulcer/stomach or intestinal bleeding or if you have previously suffered from stomach or intestinal bleeding, ulceration or perforation;
• If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
• If you have ever had bleeding or perforation in your stomach or intestines 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 disease 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, diarrhea or insufficient fluid intake;
• If you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Fastumdol Anti-inflammatory:
• 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 water retention, or have previously suffered from one of these disorders;
• If you are being treated with diuretics or have very poor hydration problems or have a reduced blood volume due to excessive fluid loss (for example due to excessive urination, diarrhoea, vomiting);
• If you have heart disease, have had a stroke or 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 treatment with the doctor or pharmacist; Medicines such as Fastumdol Anti-Inflammatory 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: you are more likely to experience side effects (see section 4).
In the event that these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Fastumdol Anti-inflammatory can reduce your fertility, therefore you should not take the medicine if you are planning a pregnancy or if you are undergoing fertility investigations);
• If you suffer from a blood and blood cell formation disorder;
• 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 disorders;
• If you have an infection - see 'Infections' section below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, for example oral steroids, some antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), medicines that prevent the formation of blood clots such as aspirin or anticoagulants such as warfarin. In these cases, consult your doctor before taking Fastumdol Anti-inflammatory: he may prescribe an additional medicine to protect your stomach (for example misoprostol or other medicines that block the production of gastric acids);
• If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis given that you have a greater risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs.

Infections
Fastumdol Anti-inflammatory can hide symptoms of infection such as fever and pain. It is therefore possible that Fastumdol Anti-Inflammatory could 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 get worse, contact your doctor immediately.
We do not recommend using this medicine during chickenpox virus infection.

Children and adolescents
Fastumdol Anti-inflammatory 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, diarrhoea, digestive problems (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 patients
Vertigo, dizziness, drowsiness, sleep disturbance, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, rash, tiredness, pain, feeling feverish and chills , feeling of general malaise.

Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, haemorrhagic or perforated peptic ulcer (which may appear as blood in vomit or stool), fainting, high blood pressure, slow breathing, fluid retention and peripheral edema (e.g. swollen ankles), laryngeal edema , loss of appetite (anorexia), changes in sensitivity (paraesthesia), itchy rash, acne, increased sweating, low back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), hepatocellular damage (hepatitis ), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 patients
Anaphylactic reaction (hypersensitivity reaction which can also lead to collapse), ulceration of the skin, mouth, eyes and genital area (Stevens Johnson and Lyell syndromes), facial edema or swelling of the lips and throat (angioedema), difficulty breathing due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, hypersensitivity to light, itching, problems kidneys. Decrease in white blood cells (neutropenia), decrease in blood platelets (thrombocytopenia).

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

Stop using Fastumdol Anti-Inflammatory as soon as you notice the appearance of a skin rash, or any lesion on the inside surface of the mouth or genitals, or any sign of allergy.

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

Medicines such as Fastumdol Anti-Inflammatory may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke).

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

The most 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 anemia and rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any not listed in this leaflet. 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.