ILMOTASK*OS FREE 10BUST 40MG

What it is and what it is used for
ILMOTASK contains the active ingredient ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.

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

What you need to know before taking the medicine
Do not take ILMOTASK
- if you are allergic to ketoprofen, other non-steroidal anti-inflammatory medicines (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
- if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory medicines (NSAIDs) has caused you problems in the past such as asthma (asthma attacks), difficulty breathing due to temporary narrowing of the bronchi (bronchospasm) or the presence of lumps inside the nose (nasal polyps), cold (acute rhinitis), allergic skin reactions such as hives or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and in breathing (angioedema). In this case, a sudden allergic reaction may occur, which can be life-threatening;
- 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 intestines also following the intake of non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have severe heart problems (heart failure);
- if you have severe liver or kidney problems (liver or kidney failure);
- if you have a predisposition to blood loss (haemorrhagic diathesis) or a problem due to a blood clotting defect or are taking medicines to improve blood fluidity (anticoagulants);
- if you are in the last three months of pregnancy or are breastfeeding (see paragraph “Pregnancy, breastfeeding and fertility”);
- if the person who needs 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 ILMOTASK .

Take special care with ILMOTASK if:
- you are taking other non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin, even at low doses (see paragraph “Other medicines and ILMOTASK”);
- you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestines, which can be life-threatening;
- suffer or have suffered in the past from stomach and/or intestinal problems (e.g. peptic ulcers, perforation or blood loss 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 (for example misoprostol or medicines that block the production of acid in the stomach);
- suffer from 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 suffered from one of these conditions in the past. In these cases the doctor will have to keep her under close control;
- have hepatic porphyria (rare blood disease characterized by 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, some antidepressants (selective serotonin reuptake inhibitors) or agents that prevent blood clots such as aspirin or anticoagulants such as warfarin ( see paragraph “Other medicines and ILMOTASK”). In these cases, talk to your doctor before taking ILMOTASK because you may need to take an additional medicine to protect your stomach (for example misoprostol or medicines that block the production of acid in the stomach);
- 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, previous stroke or think you may be at risk for these conditions (for example if you have high blood pressure, suffer from diabetes, have high levels of cholesterol in your blood or is a smoker). ILMOTASK may be associated with a slightly increased risk of heart attack and stroke. This risk is more likely at high doses and for prolonged periods.
It must not exceed the recommended dose and duration of treatment;
- suffer from asthma associated with chronic allergic colds and/or nasal polyps;
- you have an infection - see "infections" paragraph below

As with other anti-inflammatories, ketoprofen can 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 exposure to the sun 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 appearance of side effects.

Infections

ILMOTASK can hide symptoms or signs of infections such as fever and pain. It is therefore possible that ILMOTASK 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.

Stop taking this medicine and contact your doctor immediately if

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

Children and adolescents
ILMOTASK must 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 blood loss from the stomach or intestines which may be life-threatening, particularly in elderly patients) may occur.

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

Stop taking ILMOTASK immediately and contact your doctor as soon as you notice a rash, any sores inside your mouth or on your genitals, or any signs of an allergic reaction.

The side effects that may occur with ILMOTASK 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, diarrhoea, excessive gastrointestinal gas production (flatulence), constipation (constipation), inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to accumulation of fluids (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 of the hands and feet (paraesthesia), blurred vision, ringing in the ear (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), stomach problems or intestine (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 lining the brain and spinal cord (aseptic meningitis), inflammation of the lymphatic 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 activity of the bone marrow (medullary aplasia), 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 alteration, hyperexcitability, insomnia, transient loss of consciousness (syncope), convulsions, taste disturbance (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), dizziness, swelling in the eyes due to fluid accumulation (periorbital edema), heart problems (heart failure), perception of your own heartbeat (palpitations), fast 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, rash rash (rash, maculopapular rash), inflammation of the skin (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), urticaria, swelling of the face, lips, mouth, tongue or throat which may cause difficulty breathing and swallowing (angioedema), rare skin condition with blistering and bleeding of the lips, eyes, mouth, nose and genitals (Stevens Johnson syndrome), severe skin disease (Lyell's syndrome, toxic epidermal necrolysis), worsening of colitis and Crohn's disease (chronic inflammatory bowel disease), bleeding and perforation of the stomach and intestine, stomach or duodenal ulcer, heartburn, stomach pain, damage to the lining of the stomach without perforation leading to bleeding (gastritis erosive), swelling of the mouth or tongue, inflammation of the pancreas, passing blood in the stool (melena), loss of blood when vomiting (haematemesis), kidney problems such as blood in the urine (haematuria), acute kidney failure, nephritis tubulointerstitial syndrome, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, renal function test abnormal, fluid retention, decreased urine output (oliguria), difficulty urinating (dysuria), chills, tiredness ( asthenia), swelling of the extremities (peripheral edema), swelling of the face (face edema).

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.