Patient Information Leaflet

KETODOTASK 40 mg granules

Ketoprofen Lysine Salt
Please read all of 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 told you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

What KETODOTASK is and what it is used for
What you need to know before taking KETODOTASK
How to take KETODOTASK
Possible side effects
How to store KETODOTASK
Contents of the pack and other information

1. What KETODOTASK is and what it is used for

KETODOTASK 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.
KETODOTASK 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 KETODOTASK

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 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 the adequate amount of blood required by the body's needs);
if you suffer from gastritis (inflammation of the stomach mucosa);
if you currently have a peptic ulcer (a lesion of the stomach or the first part of the intestine) or gastrointestinal bleeding, or if you have previously suffered from recurrent peptic ulcer or bleeding (two or more distinct, confirmed episodes of bleeding or ulceration);
if you have previously suffered from gastrointestinal bleeding (bleeding of the stomach or intestine), ulceration, perforation, or chronic dyspepsia (difficult digestion);
if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs;
if you suffer from Crohn's disease (intestinal inflammation) or ulcerative colitis (intestinal inflammation 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 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.
Warnings
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see “How to take KETODOTASK” and the sections below on gastrointestinal and cardiovascular risks).
Concomitant use of KETODOTASK with other anti-inflammatory medicines should be avoided.
During treatment with all NSAIDs, including KETODOTASK, 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 “Do not take KETODOTASK”).
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 such as acetylsalicylic acid (see “Other medicines and KETODOTASK”).
Elderly patients are at increased risk of developing adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.
Stop treatment with KETODOTASK immediately at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions, 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 “Possible side effects”). These reactions usually occur during the initial stages of treatment. Discontinue use of KETODOTASK if a skin rash, mucosal lesions, or any other sign of hypersensitivity (allergic reaction) appear.
Precautions
Consult your doctor or pharmacist before taking KETODOTASK:

If your kidneys do not function properly, as KETODOTASK should be used with caution in such cases. If you use KETODOTASK, 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 have liver disease or abnormal liver function tests, as transaminase levels (liver enzymes) should be periodically assessed, particularly during long-term therapy.
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 take KETODOTASK only 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 blood glucose levels), hyperlipidemia (high levels of fats in the blood), or if you smoke.
If you have allergic manifestations or have previously suffered from allergies, as the medicine should be administered with caution.
If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways), 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 polyposis.
If you have hematopoietic disorders (altering the formation and maturation of blood cells), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as KETODOTASK should be used with caution.
If you have hepatic porphyria (a rare blood disorder characterized by altered activity of one of the liver enzymes), 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 KETODOTASK.
An increased risk of atrial fibrillation (alteration 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, kidney failure, and/or are taking medicines that may cause hyperkalemia (see “Other medicines and KETODOTASK”). In these circumstances, potassium levels should be monitored periodically.
Infections
KETODOTASK may mask symptoms of infections such as fever and pain. Therefore, KETODOTASK may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Consult 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
KETODOTASK must not be administered to children and adolescents under 15 years of age.
Other medicines and KETODOTASK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use of KETODOTASK in combination with the following is not recommended:

Other non-steroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase-2 inhibitors, and high doses of salicylates (more than 3 g per day);
Medicines used to slow down 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;
High-dose methotrexate (more than 15 mg per week), a medicine used in 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 KETODOTASK 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 used for certain immune system diseases);
Trimethoprim (an antibiotic used for bacterial infections);
Tenofovir (a medicine used to treat certain viral infections);
Low-dose methotrexate, less than 15 mg per 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 acting on the heart).

Consider the combination of KETODOTASK 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 or used for certain immune system diseases);
Thrombolytics (medicines that facilitate the dissolution of 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 sulfonamides (antibiotics used to treat bacterial infections);
Phenytoin (a medicine used to treat epilepsy);
Gemeprost (a medicine used for uterine examinations and surgical procedures).
Alcoholic beverages are not recommended during treatment with KETODOTASK.
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 KETODOTASK during the last three months of pregnancy, as it may harm the fetus or cause problems 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.
You should not take KETODOTASK 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 the 20th week of pregnancy, KETODOTASK 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 causing 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
Do not take KETODOTASK during breastfeeding.
Fertility
KETODOTASK may cause fertility problems in women. Therefore, if you plan to start a pregnancy, you should inform your doctor, as this medicine may reduce fertility.
Discontinue treatment if you have fertility problems and plan to conceive, or if you are undergoing fertility tests.
Driving and using machines
After taking KETODOTASK, drowsiness, dizziness, seizures, and visual disturbances may occur. It is therefore recommended to avoid driving, operating machinery, or performing activities requiring special alertness (see “Possible side effects”).
KETODOTASK contains aspartame, benzyl alcohol, and sodium
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 because the body cannot properly eliminate it.
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, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take KETODOTASK

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, 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 intense pain.

Use in elderly patients
If you are elderly, take the lowest possible daily dose (see section 2, “What you need to know before taking KETODOTASK – Warnings and precautions”).

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

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

Use in children
The safety and efficacy of KETODOTASK 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, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not use this medicine 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
Place the medicine 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 KETODOTASK than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital Emergency Department.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms have been limited to lethargy, confusion, loss of consciousness, drowsiness, headache, vertigo, dizziness, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, and diarrhoea.
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 case of renal failure, haemodialysis (a technique for extracorporeal blood purification) may be useful to remove the circulating medicine.

If you forget to take KETODOTASK
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The most commonly observed adverse 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, and 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, pruritus (itching), fatigue.

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

haemorrhagic anaemia (reduced haemoglobin in the blood, the substance that carries oxygen, caused by bleeding)
paraesthesia (numbness, tingling sensations)
blurred vision (see “Warnings and precautions”)
tinnitus (persistent ringing or noise in the ears)
asthma (inflammation of the airways and narrowing of the bronchi)
stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion 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), erythema (redness of the skin).

Frequency not known (frequency 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 (reduced haemoglobin in the blood due to destruction of red blood cells), leucopenia (reduced white blood cell count), neutropenia (reduced number of a type of white blood cells), aplastic anaemia (reduced haemoglobin in the blood due to inadequate production of blood cells by the bone marrow), leukocytosis (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 changes, 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)
vasodilatation (widening of blood vessels), vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels)
bronchospasm (constriction of the bronchi), particularly 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 throat 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, especially in the elderly; see “Warnings”), gastric ulcer (lesion in the stomach), oral ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, pyrosis (heartburn), abdominal discomfort, colitis, hyperchlorhydria (excess stomach acid), 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 (hair loss), urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing), bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (severe skin reactions), fluid retention (oedema), rash, maculopapular rash (rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), acute generalised exanthematous pustulosis (skin eruption with pustules), dermatitis (skin irritation)
acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritis and nephritic syndrome (inflammation of the kidneys), nephrotic syndrome (kidney disorder causing protein loss in urine), glomerulonephritis (inflammatory kidney disease), fluid and sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (reduced urine output), abnormal kidney function tests, haematuria (blood in the 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).

Following the instructions provided in this leaflet helps reduce the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store KETODOTASK

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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What KETODOTASK 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, freshfort flavour, aspartame, talc,
basic butylated methacrylate copolymer, magnesium stearate, hydrated colloidal silica, hypromellose, stearic
acid, povidone, sodium lauryl sulfate.

Description of the appearance of KETODOTASK and contents of the pack
KETODOTASK is presented as an oral granulate, homogeneous granules of white to pale yellow colour.
This medicinal product is available in packs of 12 sachets, 24 sachets or 30 sachets.

Marketing Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto De’ Stampi - Rozzano (MI)

Ketodotask