ILMOTASK 40 mg Гранулят

Содержание инструкции

1. ILMOTASK 40 mg granules
   1. What is ILMOTASK and what is it 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

ILMOTASK 40 mg granules

Lysine Ketoprofen

Read this leaflet carefully before you start taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.

Contents of this leaflet:

• 1. What ILMOTASK is and what it is used for
• 2. What you need to know before you take 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 is ILMOTASK and what is it 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 the age of 15 for the treatment
of acute mild to moderate 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 toany of the other ingredients of this medicine (listed in section 6);
• if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatorydrugs (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 nodules inside the nose (nasal polyps), a cold(acute rhinitis), allergic skin reactions such as urticaria or swelling of the face,lips, mouth, tongue or throat that can cause difficulty swallowing andbreathing (angioedema). In this case, an immediate allergic reaction may occur,which may be life-threatening;
• if you suffer from or have suffered from a problem with your stomach or intestines (active orrecurrent peptic ulcer), or digestive disorders;
• if you suffer from or have suffered from bleeding or perforation of the stomach and intestineseven following the use 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 insufficiency);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to ablood 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 section“Pregnancy, breastfeeding and fertility”);
• if the person who is going to take the medicine is a child or adolescent under 15years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking ILMOTASK .
Pay particular attention with ILMOTASK if:

• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and ILMOTASK”);
• you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestines, which may be life-threatening;
• you suffer from or have suffered in the past from problems with your stomach and/or intestines (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 (for example misoprostol or medicines that block acid production in the stomach);
• you suffer from a disease called systemic lupus erythematosus or a mixed connective tissue disease (immune system disorders affecting connective tissue);
• you suffer from allergies or have had allergic problems in the past;
• you have problems with your kidneys, liver or heart and have fluid retention, or have suffered from any of these conditions in the past. In these cases, your doctor will need to monitor you closely;
• you have hepatic porphyria (a rare blood disease characterized by altered activity of one of the liver enzymes), as the medicine may trigger an attack;
• you have suffered in the past from a chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• you are taking medicines that may increase the risk of peptic ulcer or bleeding, for example oral corticosteroids, some antidepressants (selective serotonin reuptake inhibitors) or agents that prevent blood clot formation such as aspirin or anticoagulants such as warfarin (see section “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 acid production in the stomach);
• you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility;
• you 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 cholesterol levels or are a smoker). ILMOTASK may be associated with a slight increase in the risk of

heart attack and stroke. This risk is more likely at high doses and for prolonged periods. Do not
exceed the recommended dose and duration of treatment;

• suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
• have an infection - see section "infections" below

As with other anti-inflammatory drugs, ketoprofen 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 exposure to the sun during treatment with this medicine because the 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.

Infections
ILMOTASK may mask the symptoms or signs of infections such as fever and pain. Therefore,
ILMOTASK 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 varicella. If you take this medicine
while you have an infection and the symptoms of the infection persist or worsen, contact
your doctor immediately.

Stop taking this medicine and contact your doctor immediately if

• you develop skin rashes, mucous membrane lesions or any other signs of hypersensitivity;
• you develop a severe skin reaction that may be fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• you develop eye problems (such as blurred vision);
• you have burning, bleeding or pain in your stomach.

Children and adolescents
ILMOTASK should not be given to children and adolescents under 15 years of
age.

Other medicines and ILMOTASK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Avoid taking this medicine if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs) and high doses of salicylates (more than 3 g per day);
• medicines used to slow down the blood clotting process (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
• lithium, used to treat depression or similar disorders;
• methotrexate at high doses (more than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• hydantoins, used for epilepsy;
• sulfonamides, used for bacterial infections.

If you are taking any of the following medicines, tell your doctor who will monitor you:

• corticosteroids, used for inflammation;
• ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
• methotrexate at low doses (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• pentoxifylline, used to treat chronic venous ulcers;
• zidovudine and tenofovir, used to treat AIDS;
• sulfonylureas, used for diabetes;
• thrombolytics, used for blood clotting problems;
• probenecid, used for gout;
• some antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
• cyclosporine and tacrolimus, used after a transplant or to treat immune system disorders;
• some antibiotics, used against infections caused by bacteria.

Your doctor will need to monitor you and may decide to reduce the dose of
ILMOTASK.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ILMOTASK during the last trimester of pregnancy as it may cause problems to
your baby and during labour.
The use of ILMOTASK is also not recommended during the first and second trimester of pregnancy, unless
strictly necessary.
Breastfeeding
Do not take ILMOTASK during breastfeeding.
Fertility
ILMOTASK may cause fertility problems in women. Therefore, if you are planning to become
pregnant, you should inform your doctor as this medicine may reduce fertility.
Stop treatment if you have fertility problems and intend to plan a pregnancy
or if you need to undergo fertility tests.

Driving and operating machinery
This medicine can cause dizziness, drowsiness or convulsions. If this happens to you, avoid
driving vehicles or using machinery.

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 disease that causes phenylalanine to build up because the body cannot dispose of it
correctly.

3. How to take ILMOTASK

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest period 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).

Use in adults and adolescents over 15 years of age
The recommended dose is 1 sachet, once only, or repeated 2-3 times a day, for more intense painful conditions.

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

Use in people with liver problems
If you suffer from 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 ILMOTASK - Do not take ILMOTASK”).

Use in people with mild or moderate kidney problems
If you have mild or 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 need to know
before taking ILMOTASK - Do not take ILMOTASK”).
Do not use ILMOTASK for prolonged periods without your doctor's advice and do not exceed the
recommended doses.
Limit the duration of therapy to overcome the painful episode.

Method of administration
ILMOTASK can be placed directly on the tongue. It dissolves with saliva; this allows
its use without water.
Take this medicine on a full stomach.
Take this medicine always using the minimum effective dose and for the shortest possible time
necessary to control the symptoms in order to reduce the occurrence of adverse effects.

If you take more ILMOTASK than you should
The most common symptoms of an overdose are as follows: lethargy, drowsiness, nausea, vomiting and
stomach pain.
Other symptoms may include headache, dizziness, confusion, loss of consciousness,
low blood pressure, respiratory depression, bluish discoloration of the skin and mucous membranes (cyanosis),
kidney failure, convulsions and coma.
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining medicine and its container to the hospital or to
the doctor so they know which medicine was taken.

If you forget to take ILMOTASK
If you forget to take a dose, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for a missed dose.
If you have any questions about the use of this medicine, ask 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. Gastrointestinal or intestinal discomfort (peptic ulcers, perforation or bleeding from the stomach or intestine which can be life-threatening, particularly in elderly patients) may occur.
Immediately inform your doctor if you notice the onset of side effects to the stomach and/or intestine (stomach pain, burning, bleeding), especially if you are an elderly patient.
Immediately stop taking ILMOTASK and consult your doctor as soon as you notice the onset of skin rash, any lesion inside the mouth or on the genitals, or any sign of an allergic reaction.
The side effects that can 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 production of gas in the gastrointestinal tract (flatulence), constipation, inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to fluid retention (edema), fatigue.

Rare(may affect up to 1 in 1,000 people)
Reduction in the number of red blood cells following bleeding (hemorrhagic anemia), tingling and numbness of hands and feet (paresthesia), blurred vision, ringing in the ear (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), problems with the stomach 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), reduced number of platelets (thrombocytopenia), reduced number of white blood cells (agranulocytosis), increased number of white blood cells (leukocytosis), reduced number of white blood cells (leukopenia), reduced number of neutrophils, a type of white blood cells (neutropenia), formation of numerous hemorrhagic spots on the skin due to a reduction in the number of platelets (thrombocytopenic purpura), reduced activity of the bone marrow (myelodysplasia), destruction of red blood cells (hemolytic anemia), reduced production of red blood cells (aplastic anemia), sudden allergic reaction potentially fatal (including anaphylactic shock), depression, seeing and hearing things that do not exist (hallucinations), mood alteration, hyperactivity, insomnia, transient loss of consciousness (syncope), convulsions, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), vertigo, swelling around the eyes due to fluid retention (periorbital edema), heart problems (heart failure), perception of one's heartbeat (palpitations), accelerated heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of blood vessels (vasculitis), swelling of the larynx, difficulty breathing (bronchospasm), common cold (rhinitis), shortness of breath (dyspnea), difficulty breathing due to contraction of the larynx (laryngospasm), acute respiratory failure, skin rash (exanthema, maculo-papular rash), skin inflammation (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema), rare skin condition with blisters and bleeding of 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 diseases), bleeding and perforation of the stomach and intestine, ulcer in the stomach or duodenum, heartburn, stomach pain, damage to the stomach lining without perforation resulting in bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, passing blood in the stool (melena), vomiting blood (hematemesis), kidney problems such as blood in the urine (hematuria), acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, fluid retention, decreased urine production (oliguria), difficulty urinating (dysuria), chills, fatigue (asthenia), swelling of the extremities (peripheral edema), swelling of the face (facial edema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ILMOTASK contains
The active ingredient is lysine ketoprofen.
Each sachet contains 40 mg of lysine ketoprofen (equivalent to 25 mg of ketoprofen).
The other ingredients are: mannitol, xylitol, lime flavour, lemon flavour, frescofort flavour,

aspartame, talc, basic butyl methacrylate copolymer, magnesium stearate, colloidal hydrated silica,
hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of ILMOTASK and contents of the pack
ILMOTASK is presented in the form of granules for oral use.
The pack contains 10 sachets, 12 sachets, 20 sachets, 24 sachets or 30
sachets

Marketing Authorisation Holder
Farmitalia s.r.l
Viale Alcide De Gasperi 165/B

• 95127- Catania

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