KETODOTASK 40 MG GRANULES 24 PAPER/AL/PE SACHETS

Name
KETODOTASK 40 mg granules
Ketoprofen Lysine Salt


What is it and what is it for?
KETODOTASK contains the active substance ketoprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (“NSAIDs”), used to treat pain and inflammation.

KETODOTASK is indicated in adults and adolescents over 15 years of age for the treatment of acute pain of mild to moderate severity.


What you need to know before taking the medicine
Do not take KETODOTASK
- if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
- if taking medicines such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) has caused you in the past to have problems such as asthma (asthma attacks), difficulty breathing due to temporary narrowing of the bronchi (bronchospasm) or lumps in the nose (nasal polyps), colds (acute rhinitis), allergic skin reactions such as hives, or swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing and breathing (angioedema). This may cause a sudden, life-threatening allergic reaction.
- if you suffer or have suffered from a stomach or intestinal problem (active or recurrent peptic ulcer), or digestive disorders;
- if you suffer or have suffered from bleeding or perforation of the stomach and intestine, even following the taking of non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have severe heart problems (heart failure);
- if you have severe liver or kidney problems (hepatic or renal failure);
- if you have a predisposition to blood loss (haemorrhagic diathesis) or a problem due to a defect in blood clotting or are taking medicines to improve blood thinning (anticoagulants);
- if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
- if the person who is to take the medicine is a child or adolescent under 15 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking KETODOTASK.

Take special care with KETODOTASK if:
- are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and KETODOTASK”);
- is elderly, as this increases the risk of injury or bleeding in the stomach or intestines, which can be life-threatening;
- you suffer or have suffered in the past from stomach and/or intestinal problems (e.g., peptic ulcers, perforation, or bleeding from the stomach and intestines). In this case, your doctor may decide to monitor you closely and treat you with an additional medicine to protect your stomach (e.g., misoprostol or medicines that block stomach acid production);
- have a disease called systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
- suffer from allergies or have had allergy problems in the past;
- have kidney, liver, or heart problems and fluid retention, or have had any of these conditions in the past. In these cases, your doctor will need to monitor you closely;
- have hepatic porphyria (a rare blood disease characterized by the alteration of the activity of one of the liver enzymes), as the medicine could trigger an attack;
- have suffered in the past from a chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- are taking medicines that may increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, certain antidepressants (selective serotonin reuptake inhibitors), or agents that prevent blood clots such as aspirin or anticoagulants such as warfarin (see section “Other medicines and KETODOTASK”). In these cases, talk to your doctor before taking KETODOTASK because you may need to take an additional medicine to protect your stomach (for example, misoprostol or medicines that block the production of stomach acid);
- you are a woman with fertility problems and are planning to become pregnant, as this medicine may interfere with your fertility;
- have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, or a previous stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high blood cholesterol, or are a smoker). KETODOTASK may be associated with a slightly increased risk of heart attack and stroke. This risk is more likely at high doses and over prolonged periods. You should not exceed the recommended dose and duration of treatment;
- suffers from asthma associated with chronic allergic cold and/or nasal polyps;
- have an infection – see “infections” section below.

Infections
KETODOTASK may hide the symptoms of infections, such as fever and pain. Therefore, KETODOTASK may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria 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.

As with other anti-inflammatories, ketoprofen may hide the symptoms or signs of an infection (such as fever) and may cause small, transient increases in some liver tests and also increases in transaminases. In case of significant increases, stop treatment and consult your doctor.

Avoid sun exposure while taking this medicine because your skin may become more sensitive.

Take this medicine at the lowest doses and for short periods of time to reduce the occurrence of side effects.

Stop taking this medicine and contact your doctor immediately if

- develops skin rashes, mucosal lesions, or any other signs of hypersensitivity;
- experience a serious, life-threatening skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
- experience eye problems (such as blurred vision);
- has burning, bleeding, or pain in your stomach.

Children and adolescents
KETODOTASK should not be administered to children and adolescents under 15 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly observed side effects are gastrointestinal in nature. Stomach or intestinal disorders (peptic ulcers, perforation, or bleeding from the stomach or intestines, which can be life-threatening, especially in elderly patients) may occur.

Tell your doctor immediately if you notice any side effects affecting your stomach and/or intestine (stomach pain, heartburn, bleeding), especially if you are an elderly patient.

Stop taking KETODOTASK immediately and contact your doctor if you notice any skin rash, any sores inside your mouth or on your genitals, or any signs of an allergic reaction.

Side effects that may occur with KETODOTASK are:

Common (may affect up to 1 in 10 people)
Nausea, vomiting, digestive difficulties (dyspepsia), abdominal pain/discomfort.

Uncommon (may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, diarrhea, excessive gas production in the gastrointestinal tract (flatulence), constipation (constipation), inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to fluid accumulation (edema), fatigue.

Rare (may affect up to 1 in 1,000 people)
Reduction in the number of red blood cells due to bleeding (haemorrhagic anaemia), tingling and numbness in the hands and feet (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), stomach or intestinal problems (peptic ulcer), liver problems (hepatitis, increased levels of transaminases and bilirubin in the blood), yellowing of the skin and whites of the eyes (jaundice), increased body weight.

Frequency not known (frequency cannot be estimated from the available data)
Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis), inflammation of the lymph vessels (lymphangitis), reduction in the number of platelets (thrombocytopenia), reduction in the number of white blood cells (agranulocytosis), increase in the number of white blood cells (leukocytosis), reduction in the number of white blood cells (leukopenia), reduction in the number of neutrophils, a type of white blood cell (neutropenia), formation of numerous haemorrhagic spots on the skin due to a reduction in the number of platelets (thrombocytopenic purpura), reduction in the activity of the bone marrow (aplastic anemia), destruction of red blood cells (haemolytic anemia), reduced production of red blood cells (aplastic anemia), sudden life-threatening allergic reaction (including anaphylactic shock), depression, seeing and hearing things that are not there (hallucinations), mood changes, overexcitability, insomnia, temporary loss of consciousness (syncope), convulsions, taste disturbance (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), dizziness, swelling of the eyes due to fluid accumulation (periorbital oedema), heart problems (cardiac failure), awareness of your heartbeat (palpitations), rapid heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of the blood vessels (vasculitis), swelling of the larynx, difficulty breathing (bronchospasm), cold (rhinitis), shortness of breath (dyspnoea), difficulty breathing due to contraction of the larynx (laryngospasm), acute respiratory failure, skin rash (exanthema, maculopapular exanthema), inflammation of the skin (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue or throat which may cause difficulty breathing and swallowing (angioedema), rare condition skin with blisters and bleeding from the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), serious skin disease (Lyell's syndrome, toxic epidermal necrolysis), worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), bleeding and perforation of the stomach and intestines, stomach or duodenal ulcer, heartburn, stomach pain, damage to the stomach lining without perforation leading to bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, passing blood in the stools (melena), loss of blood when vomiting (haematemesis), kidney problems such as blood in the urine (haematuria), acute renal failure, tubulointerstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormal kidney function tests, fluid retention, decreased urine output (oliguria), difficulty urinating (dysuria), chills, tiredness (asthenia), swelling of the extremities (peripheral edema), swelling of the face (facial edema).

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.