Ilmotask

Package leaflet: Information for the patient

ILMOTASK 40 mg granules

Ketoprofen Lysine Salt
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after short periods of treatment.

Contents of this leaflet:

1. What ILMOTASK is and what it is used for
2. What you need to know before taking ILMOTASK
3. How to take ILMOTASK
4. Possible side effects
5. How to store ILMOTASK
6. Contents of the pack and other information

1. What ILMOTASK is and what it is used for

ILMOTASK contains the active substance ketoprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), used to treat pain and inflammation.
ILMOTASK is indicated in adults and adolescents over the age of 15 for the treatment of mild to moderate acute pain.

2. What you need to know before taking ILMOTASK

Do not take ILMOTASK

• 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 you have a history of hypersensitivity reactions (allergy) triggered by the use of ketoprofen or substances with a similar mechanism of action, for example acetylsalicylic acid or other NSAIDs (other anti-inflammatory medicines), such as asthma (bronchial inflammation and narrowing of the airways), bronchospasm (constriction of the bronchi), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes), or other allergic-type reactions;
• if you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways);
• if you have severe heart failure (inability of the heart to pump sufficient blood to meet the body's needs);
• if you suffer from gastritis (inflammation of the stomach lining);
• if you currently have a peptic ulcer (a lesion in the stomach or the first part of the intestine) or gastrointestinal bleeding, or if you have previously experienced recurrent peptic ulcer or bleeding (two or more distinct, documented episodes of bleeding or ulceration);
• if you have previously experienced gastrointestinal bleeding, ulceration, perforation, or chronic dyspepsia (indigestion);
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs;
• if you suffer from Crohn’s disease (inflammation of the intestine) or ulcerative colitis (inflammation of the intestine with ulcers);
• if you have severe liver (reduced liver function due to cirrhosis, severe hepatitis) or kidney (reduced kidney function) insufficiency;
• if you suffer from leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you suffer from haemorrhagic diathesis (predisposition to develop bleeding) or other coagulation disorders, or if you have haemostatic disorders (difficulty in stopping bleeding);
• if you are being treated with high doses of diuretics;
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the person to be treated is under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ILMOTASK.
Warnings
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section “How to take ILMOTASK” and the paragraphs below on gastrointestinal and cardiovascular risks).
Concomitant use of ILMOTASK with other anti-inflammatory medicines should be avoided.
During treatment with all NSAIDs, including ILMOTASK, gastrointestinal bleeding, ulceration, and perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Patients who have previously suffered from these conditions are at higher risk (see section “Do not take ILMOTASK”).
Report any signs or symptoms of abdominal discomfort (including gastrointestinal bleeding), even at the beginning of treatment.
Inform your doctor if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), anticoagulants (medicines that delay blood clotting), such as warfarin, selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid (see section “Other medicines and ILMOTASK”).
Elderly patients are at greater risk of developing adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.
Stop treatment with ILMOTASK immediately at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions (of the skin), some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with the use of NSAIDs (see section “Possible side effects”). These reactions usually occur during the initial stages of treatment. Discontinue use of ILMOTASK if a skin rash, mucosal lesions, or any other sign of hypersensitivity (allergic reaction) appears.
Precautions
Consult your doctor or pharmacist before taking ILMOTASK:

• If your kidneys do not function properly, as ILMOTASK should be used with caution in such cases. If you use ILMOTASK, your kidney function should be monitored, especially if you are elderly or are taking diuretics (medicines that lower blood pressure).
• If you have liver problems, you should undergo periodic check-ups.
• If you have an infection – see the section «Infections» below.
• If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pumping function), established ischemic heart disease (heart disease resulting from reduced blood flow due to narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the arteries and blood vessels of the brain), as you should only take ILMOTASK after careful evaluation by your doctor.
• If you have risk factors for these conditions, for example high blood pressure, diabetes (a disease caused by high levels of glucose in the blood), hyperlipidemia (high levels of fats in the blood), or if you smoke.
• If you have a history of allergic manifestations or previous allergies, as the medicine should be administered with caution.
• If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways) or allergic diathesis (predisposition to develop allergies), chronic rhinitis (inflammation of the nasal mucosa), allergic rhinitis (allergic inflammation of the nasal mucosa), chronic sinusitis, and/or nasal polyps.
• If you have hematopoietic disorders (affecting the formation and maturation of blood cells), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as ILMOTASK should be used with caution.
• If you have hepatic porphyria (a rare blood disorder characterized by altered activity of a liver enzyme), as the medicine could trigger an attack.

Some NSAIDs may be associated with an increased risk of arterial thrombotic events (e.g., heart attack or stroke). Currently, there are insufficient data to exclude a similar risk for ILMOTASK.
An increased risk of atrial fibrillation (a disturbance in the heart's rhythm) has been reported with the use of NSAIDs.
Hyperkalemia (increased potassium levels in the blood) may occur, especially if you have diabetes, renal insufficiency, and/or are taking medicines that may cause hyperkalemia (see section “Other medicines and ILMOTASK”). In such cases, potassium levels should be monitored periodically.
Infections
ILMOTASK may mask symptoms of infections such as fever and pain. Therefore, ILMOTASK may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and varicella-related bacterial skin infections. If you take this medicine while having an infection and symptoms persist or worsen, contact your doctor immediately.
Contact your doctor if you experience visual disturbances, such as blurred vision, as treatment must be discontinued.
Avoid exposure to sunlight during treatment with this medicine, as the skin may become more sensitive.
Children and adolescents
ILMOTASK must not be administered to children and adolescents under 15 years of age.
Other medicines and ILMOTASK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of ILMOTASK in combination with the following is not recommended:

• other anti-inflammatory medicines, such as NSAIDs, selective cyclooxygenase-2 inhibitors, and high doses of salicylates (more than 3 g per day);
• medicines that delay blood clotting, such as heparin and warfarin, and medicines that prevent platelet aggregation, such as ticlopidine and clopidogrel;
• lithium (a medicine used to treat manic-depressive psychosis);
• methotrexate at doses exceeding 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• hydantoins (used to treat epilepsy) and sulfonamides (such as certain antibiotics used to treat bacterial infections).

Caution is required when using ILMOTASK in combination with:

• potassium salts;
• potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
• NSAIDs (anti-inflammatory medicines);
• heparins (anticoagulants);
• cyclosporine and tacrolimus (medicines that prevent organ transplant rejection or are used to treat certain immune system diseases);
• trimethoprim (an antibiotic used for bacterial infections);
• tenofovir (a medicine used to treat certain viral infections);
• methotrexate at doses below 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• corticosteroids (medicines used to treat inflammatory conditions);
• pentoxifylline (a medicine used to improve blood circulation in the limbs);
• zidovudine (a medicine used to treat HIV);
• sulfonylureas (medicines used to treat diabetes);
• cardiac glycosides (medicines that act on the heart).

Consider the combination of ILMOTASK with:

• beta-blockers, ACE inhibitors, diuretics (medicines used to lower blood pressure);
• mifepristone (a medicine used for medical termination of pregnancy);
• intrauterine contraceptive devices;
• cyclosporine, tacrolimus (medicines that prevent organ transplant rejection and are used for certain immune system diseases);
• thrombolytics (medicines that help dissolve blood clots);
• ticlopidine and clopidogrel (medicines that prevent platelet aggregation);
• selective serotonin reuptake inhibitors (some antidepressants);
• probenecid (a medicine used to treat gout);
• quinolones and sulfamides (antibiotics used to treat bacterial infections);
• phenytoin (a medicine used to treat epilepsy);
• gemeprost (a medicine used for uterine examinations and surgical procedures).

The consumption of alcoholic beverages is not recommended during treatment with ILMOTASK.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ILMOTASK during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery.
It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond the expected duration.
Do not use ILMOTASK during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, ILMOTASK may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Do not take the medicine close to delivery, as it may cause disturbances in the newborn’s circulation and respiration.
Breastfeeding
There is no available information on the excretion of ketoprofen in breast milk.
Ketoprofen is not recommended during breastfeeding.
Fertility
The use of NSAIDs, including ILMOTASK, may reduce female fertility and is therefore not recommended for women attempting to conceive.
Discontinue ILMOTASK if you have fertility problems or are undergoing fertility investigations.
Driving and using machines
After taking ILMOTASK, drowsiness, dizziness, seizures, and visual disturbances may occur. It is therefore recommended to avoid driving, operating machinery, or performing activities requiring particular alertness (see “Possible side effects”).
ILMOTASK contains aspartame
This medicine contains 10.56 mg of aspartame per dose (1 sachet), equivalent to 31.78 mg per maximum recommended daily dose (3 sachets).
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body's inability to properly metabolize it.
ILMOTASK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially “sodium-free”.
ILMOTASK contains benzyl alcohol
This medicine contains lime flavour, lemon flavour, and frescofort flavour, which in turn contain 0.00032 mg of benzyl alcohol per dose (1 sachet), equivalent to 0.00096 mg per maximum recommended daily dose (3 sachets).
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take ILMOTASK

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Use in adults and adolescents over 15 years of age
The recommended dose is 40 mg once daily (corresponding to 1 sachet), or repeated 2–3 times daily in cases of more severe pain.

Use in the elderly
If you are elderly, take the lowest possible daily dose (see section 2, "What you should know before taking ILMOTASK – Warnings and precautions").

Use in patients with liver problems
If you have mild to moderate liver impairment, take the lowest possible daily dose.
Do not take this medicine if you have severe liver problems (see section 2, "What you should know before taking ILMOTASK – Do not take ILMOTASK").

Use in patients with mild to moderate kidney problems
If you have mild to moderate kidney problems, consult your doctor, who will need to monitor you during treatment with this medicine.
Do not take this medicine if you have severe kidney problems (see section 2, "What you should know before taking ILMOTASK – Do not take ILMOTASK").

Use in children
The safety and efficacy of ILMOTASK have not yet been established.

Duration of treatment
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Do not use ILMOTASK for prolonged periods without medical advice and do not exceed the recommended doses.
Limit the duration of treatment to the resolution of the painful episode.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.

Method of administration
ILMOTASK can be placed directly on the tongue. It dissolves with saliva, allowing administration without water.
Take this medicine with food.
Always use the lowest effective dose for the shortest possible time needed to control symptoms, in order to reduce the risk of adverse effects.

If you take more ILMOTASK than you should
In case of accidental ingestion or overdose of ILMOTASK, contact your doctor immediately or go to the nearest hospital.
Overdose cases with ketoprofen doses up to 2.5 g have been reported. In most cases, symptoms were limited to lethargy, confusion, loss of consciousness, drowsiness, headache, dizziness, vertigo, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, and diarrhea. Gastrointestinal bleeding, hypotension (low blood pressure), respiratory depression, and cyanosis (bluish discoloration of the skin and mucous membranes) may also occur.
There are no specific antidotes for ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In cases of renal failure, haemodialysis (a technique for extracorporeal blood purification) may be useful in removing the circulating drug.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effects are of a gastrointestinal nature.
The following adverse reactions have been observed with the use of ketoprofen in adults:

Common (may affect up to 1 in 10 people)

• dyspepsia (indigestion), nausea, abdominal pain, vomiting.

Uncommon (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness;
• constipation, diarrhoea, flatulence (passing wind), gastritis (inflammation of the stomach lining);
• rash, itching, fatigue.

Rare (may affect up to 1 in 1,000 people)

• haemorrhagic anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen, caused by bleeding);
• paraesthesia (numbness or tingling sensations);
• blurred vision (see section “Warnings and precautions”);
• tinnitus (persistent ringing or noise in the ears);
• asthma (inflammation of the airways and narrowing of the bronchial tubes);
• stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (sores in the stomach or the first part of the intestine);
• hepatitis (inflammation of the liver), increased transaminases (elevated levels of certain enzymes indicating liver function), increased bilirubin (a substance indicating liver function);
• weight gain.

Very rare (may affect up to 1 in 10,000 people)

• facial oedema (swelling of the face) and erythema (redness of the skin)

Frequency not known (cannot be estimated from the available data)

• thrombocytopenia (reduced platelet count), agranulocytosis (severe reduction in a type of white blood cells), bone marrow failure (reduced production of blood cells by the bone marrow), haemolytic anaemia (reduction in haemoglobin in the blood caused by destruction of red blood cells), leucopenia (decrease in white blood cells), neutropenia (reduction in a type of white blood cells), aplastic anaemia (reduction in haemoglobin in the blood due to inadequate production of blood cells by the bone marrow), leucocytosis (increased white blood cell count), thrombocytopenic purpura (skin spots due to reduced platelet count);
• anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy);
• jaundice (yellowing of the skin and whites of the eyes);
• depression, hallucination (perception of things not present in reality), confusion, mood alterations, agitation, insomnia, convulsions (uncontrolled body movements), dizziness, dysgeusia (altered taste), tremor, dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital oedema (swelling around the eye), peripheral oedema;
• chills, asthenia (weakness);
• heart failure (inability of the heart to pump sufficient blood to meet the body's needs), atrial fibrillation (irregular heart rhythm), palpitations (awareness of heartbeat), tachycardia (increased heart rate), hypertension (high blood pressure), hypotension (low blood pressure);
• vasodilation (widening of blood vessels), vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels);
• bronchospasm (constriction of the bronchi), especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), dyspnoea (difficulty breathing), laryngeal oedema (swelling of the larynx due to fluid accumulation), laryngospasm (narrowing of the larynx), acute respiratory failure (one fatal case has been reported in an asthmatic patient sensitive to acetylsalicylic acid);
• exacerbation of colitis (worsening of intestinal inflammation), exacerbation of Crohn’s disease (worsening of intestinal inflammation), gastrointestinal haemorrhage (bleeding from the stomach or intestine), gastrointestinal perforation (sometimes fatal, particularly in the elderly; see section “Warnings”), gastric ulcer (lesion in the stomach), mouth ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, gastric pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melaena (presence of digested blood in stools), haematemesis (vomiting blood), abdominal discomfort, colitis, hyperchlorhydria (excess acid in the stomach), gastric pain (stomach ache), erosive gastritis (severe inflammation of the stomach lining), oedema of the tongue (swelling of the tongue);
• photosensitivity reactions (sensitivity to sunlight or UV lamps), alopecia (loss of hair and body hair), urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat which may cause breathing or swallowing difficulties), bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (serious skin reactions), oedema (fluid retention), exanthema (skin rash), maculopapular exanthema (skin rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), generalised exanthematous pustulosis (skin eruption with pustules), dermatitis (skin irritation);
• acute renal failure (reduced kidney function), tubulo-interstitial nephritis, nephritis and nephritic syndrome (inflammation of the kidneys), nephrotic syndrome (kidney disorder causing protein loss in urine), glomerulonephritis (inflammatory kidney disease), fluid/sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (serious kidney damage), oliguria (reduced urine output), abnormal kidney function tests, haematuria (presence of blood in urine);
• aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of the lymphatic vessels);
• hyperkalaemia (increased potassium levels in the blood), hyponatraemia (decreased sodium levels in the blood).

Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ILMOTASK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ILMOTASK contains
The active substance is ketoprofen lysine salt.
Each sachet contains 40 mg of ketoprofen lysine salt (equivalent to 25 mg of ketoprofen).
The other components are: mannitol, xylitol, lime flavour, lemon flavour, frescofort flavour (the flavour components contain benzyl alcohol), aspartame, talc, basic butylated methacrylate copolymer, magnesium stearate, hydrated colloidal silica, hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of ILMOTASK and contents of the pack
ILMOTASK is an oral granulate.
Pack sizes: 10, 12, 20, 24 or 30 sachets.

Marketing Authorization Holder
Farmitalia S.r.l
Via Pinciana 25
00198 Rome
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) – Italy