KODIAK 40 mg Granules

Зміст інструкції

1. KODIAK 40 mg granules
   1. What is KODIAK and what is it used for
   2. What you need to know before you take KODIAK
   3. How to take KODIAK
   4. Possible side effects
   5. How to store KODIAK
   6. Contents of the pack and other information

KODIAK 40 mg granules

Ketoprofene Lysine Salt

Read this leaflet carefully before 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What is KODIAK and what is it used for

KODIAK contains the active ingredient ketoprofen, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
KODIAK is indicated in adults and adolescents over 15 years of age for the treatment of
acute mild to moderate pain.

2. What you need to know before you take KODIAK

Do not take KODIAK

• if you are allergic to ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you have a history of hypersensitivity (allergy) reactions triggered by the use of ketoprofen or substances with a similar mechanism of action, for example acetylsalicylic acid or other NSAIDs (other anti-inflammatory drugs) such as asthma (bronchial inflammation and narrowing of the airways), bronchospasm (constriction of the bronchi), allergic rhinitis (inflammation of the nasal mucosa of an allergic nature), 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 (the heart's inability to pump an adequate amount of 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 of the stomach or the first part of the intestine) or bleeding, or if you have suffered in the past from bleeding or a recurrent peptic ulcer (two or more distinct episodes, proven bleeding or ulceration);
• if you have previously suffered from gastrointestinal bleeding (bleeding from the stomach or intestine), ulceration, perforation or chronic dyspepsia (difficult digestion);
• if you have a history of gastrointestinal bleeding or perforation resulting from previous therapy with NSAIDs; 1/12
• 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) failure;
• if you suffer from leukopenia (reduction in the number of white blood cells) or thrombocytopenia (reduction in the number of platelets);
• if you suffer from a hemorrhagic diathesis (predisposition to the development of bleeding) and other bleeding disorders or if you have hemostatic disorders (difficulty stopping bleeding);
• if you are taking a high dose of diuretics;
• if you are in the last three months of pregnancy or 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 KODIAK.

Warnings
Adverse effects can be minimized by using the lowest effective dose and for the shortest possible duration of treatment necessary to control symptoms (see “How to take
KODIAK” and the sections below on gastrointestinal and cardiovascular risks).
Concomitant use of KODIAK with other anti-inflammatory drugs should be avoided.
During treatment with all NSAIDs, such as KODIAK, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which may be fatal. Patients who have previously suffered from these conditions are at greater risk (see “Do not take KODIAK”).
Report any signs or symptoms of abdominal discomfort (including gastrointestinal bleeding) even
at the beginning of treatment.
Tell 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 states),
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 “Other medicines and KODIAK”).
The elderly are more exposed to the risk of developing adverse reactions to NSAIDs, especially
bleeding and gastrointestinal perforation, which may be fatal.

Immediately stop treatment with KODIAK at the first signs of gastrointestinal bleeding or ulceration.
Serious skin (skin) reactions, some of which are 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”). The reaction usually occurs in the early stages of
treatment. Stop using KODIAK if you develop a rash, lesions of the mucous membranes or any other sign of hypersensitivity (allergic reaction).

Precautions

Ask your doctor or pharmacist for advice before takingKODIAK:

• If your kidneys do not function well, because in this case KODIAK must be taken with caution. If you use KODIAK, you must monitor your kidneys, especially if you are elderly or are taking diuretics (medicines that lower blood pressure).
• If you have liver problems, you should have periodic checks. 2/12
• If you have an infection - see paragraph «infections» below.
• If you have liver disease or if you have altered liver function tests, as liver enzyme levels (transaminases) should be assessed periodically, particularly with 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 that occurs following a reduction in 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 must take KODIAK only after careful evaluation by your doctor.
• If you have risk factors for these conditions, for example if you have high blood pressure, diabetes (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 suffered from allergies in the past, as the medicine must be administered with caution.
• If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways) or with an allergic disposition (predisposition to the onset of allergy), chronic rhinitis (inflammation of the nasal mucosa) and allergic rhinitis (inflammation of the nasal mucosa of an allergic nature), chronic sinusitis and/or nasal polyposis.
• If you are affected by hematopoietic alterations (which modify the formation and maturation of blood cells), systemic lupus erythematosus (an autoimmune disease) or mixed connective tissue diseases, as KODIAK must be used with caution.
• If you have hepatic porphyria (a rare blood disease characterized by an alteration in the 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). There is currently insufficient data to exclude a similar risk for
KODIAK.
An increased risk of atrial fibrillation (alteration of the heart rate) has been reported
associated with the use of NSAIDs.
Hyperkalemia (increased amount of potassium in the blood) may occur, especially if you suffer from
diabetes, kidney failure and/or are taking medicines that can cause hyperkalemia (see
“Other medicines and KODIAK”). In these circumstances, potassium levels should be monitored
periodically.
Infections
KODIAK can mask the symptoms of infections such as fever and pain. It is therefore possible that KODIAK
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, see your doctor immediately.
See your doctor if you experience visual disturbances, such as blurred vision, as it is necessary
to stop treatment.
Avoid exposure to the sun during treatment with this medicine as the skin may become more
sensitive.

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

Other medicines and KODIAK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
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The use of KODIAK in combination with the following is not recommended:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors and high doses of salicylates (greater than 3 g per day);
• Medicines used to slow down the blood clotting process 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 (greater than 15 mg per week), a medicine used in the treatment of some autoimmune diseases and some cancers;
• Hydantoins (used to treat epilepsy) and sulfonamides (such as some antibiotics used to treat infections caused by bacteria).

Caution is required when using KODIAK in combination with:

• Potassium salts;
• Potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
• NSAIDs (anti-inflammatory drugs);
• Heparins (anticoagulants);
• Cyclosporine and tacrolimus (medicines that prevent rejection after organ transplantation or that are used for some autoimmune diseases);
• Trimethoprim (an antibiotic used for infections caused by bacteria);
• Tenofovir (a medicine used in the treatment of some viral infections);
• Low-dose methotrexate, less than 15 mg per week (a medicine indicated in the treatment of some autoimmune diseases and some cancers);
• Corticosteroids (medicines used to treat inflammatory states);
• 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 association of KODIAK with:

• Beta-blockers, ACE inhibitors, diuretics (medicines used to lower blood pressure);
• Mifepristone (a medicine used for medical abortion);
• Intrauterine contraceptive devices;
• Cyclosporine, tacrolimus (medicines that prevent rejection after organ transplantation and are used for some autoimmune 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 infections caused by bacteria);
• Diphenylhydantoin (a medicine used to treat epilepsy);
• Gemeprost (a medicine used for investigations and surgical interventions on the uterus).

It is not advisable to consume alcoholic beverages during treatment with KODIAK.

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 KODIAK during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth.
It can cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected.
You should not take KODIAK in the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If treatment is needed during this period or during attempts to
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conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, KODIAK can cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Do not take the medicine close to delivery, as it can cause changes in the circulation and breathing of the newborn.
Breastfeeding
Do not take KODIAK while breastfeeding.
Fertility
KODIAK can cause fertility problems in women. Therefore, if you are planning to become pregnant, you should inform your doctor because this medicine may reduce fertility.
Stop treatment if you have fertility problems and intend to plan a pregnancy or if you need to undergo tests for fertility.

Driving and operating machinery
Following the administration of KODIAK, drowsiness, dizziness, convulsions and visual disturbances may occur, it is recommended to avoid driving, using machinery or performing activities that require particular attention (see “Possible side effects”).

KODIAK contains aspartame, benzyl alcohol and sodium
This medicine contains 10.56 mg of aspartameper dose (1 sachet) equivalent to 31.78 mg per maximum daily dose (3 sachets).
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease that causes a build-up of phenylalanine because the body cannot eliminate it
correctly.
This medicine contains lime flavour, lemon flavour, freshfort flavour, which in turn contain 0.00032 mg of benzyl alcoholper dose (1 sachet) equivalent to 0.00096 mg per maximum daily
dose (3 sachets). Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist if you are pregnant or breastfeeding, if you have a liver or kidney condition. This is
because large amounts of benzyl alcohol can accumulate in the body and cause undesirable effects (such as metabolic acidosis).

This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially “sodium-free”.

3. How to take KODIAK

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.

Use in adults and adolescents over 15 years of age
The recommended dose is 40 mg per day (corresponding to 1 sachet), once, or repeated 2-3 times
a day, in 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 KODIAK - Warnings and precautions”).

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

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 KODIAK - Do not take KODIAK”).

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

Duration of treatment
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).
Do not use for prolonged periods without consulting your doctor and do not exceed the recommended doses.
Limit the duration of therapy to overcoming the painful episode.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.

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

If you take more KODIAK than you should
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately notify
your doctor or go to the Emergency Room of the nearest hospital.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most
cases, symptoms were observed and limited to lethargy, confusion, loss of consciousness, drowsiness, headache,
dizziness, vertigo, nausea, vomiting, epigastric pain (in the upper part of the abdomen), abdominal pain
and diarrhea.
Gastrointestinal bleeding, hypotension (lowering of blood pressure),
respiratory depression and cyanosis (bluish discoloration of the skin and mucous membranes) can also occur.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose
gastric lavage and symptomatic and supportive treatment are recommended.
In case of renal insufficiency, hemodialysis (extracorporeal blood purification technique) may be
useful to remove the medicine in circulation.

If you forget to take KODIAK
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 the missed dose.
If you have any doubts about the use of 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.
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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 (difficult digestion), nausea, abdominal pain and vomiting.

Uncommon(may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence (passage of intestinal gas), gastritis (inflammation of the stomach lining)
• skin rash, itching, fatigue.

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

• haemorrhagic anaemia (reduction of haemoglobin in the blood, a substance that carries oxygen in the blood caused by bleeding)
• paresthesia (sensation of numbness, tingling)
• blurred vision (see “Warnings and precautions”)
• tinnitus (persistent perception of noises in the ear)
• asthma (bronchial inflammation and narrowing of the airways)
• stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion of the stomach or the first part of the intestine)
• hepatitis (inflammation of the liver), increased transaminases (increase in some enzymes that indicate liver function), increased bilirubin (a substance that indicates liver function)
• weight gain.

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

• edema (swelling) of the face and erythema (redness of the skin).

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

• thrombocytopenia (reduction in the number of platelets), agranulocytosis (severe reduction in the number of a type of white blood cells), bone marrow failure (reduction in the production of blood cells by the bone marrow), haemolytic anaemia (reduction of haemoglobin in the blood, a substance that carries oxygen in the blood, caused by the destruction of red blood cells), leucopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of a type of white blood cells), aplastic anaemia (reduction of haemoglobin in the blood, a substance that carries oxygen in the blood, caused by insufficient production of blood cells by the bone marrow), leucocytosis (increase in the number of white blood cells), thrombocytopenic purpura (presence of spots on the skin due to a reduction in the number of platelets)
• anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy)
• jaundice (yellowing of the skin and the white part of the eyes)
• depression, hallucination (perception of things that do not exist in reality), confused state, altered mood, agitation, insomnia, convulsions (uncontrolled movements of the body), vertigo, dysgeusia (altered taste), tremor, dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital edema (swelling around the eye), peripheral edema.
• chills, asthenia (weakness)
• heart failure (inability of the heart to pump the adequate amount of blood needed by the body), atrial fibrillation (alteration of the heart rhythm), palpitations (perception of the heartbeat), tachycardia (increase in the number of heartbeats), hypertension (high blood pressure), hypotension (low blood pressure)
• vasodilation (dilation of blood vessels), vasculitis (inflammation of the vessels), including leucocytoclastic vasculitis (inflammation of small vessels)
• bronchospasm (constriction of the bronchi), especially in patients with established hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), dyspnoea (difficulty breathing), laryngeal edema (swelling of the throat due to fluid accumulation), 7/12

laryngospasm (constriction of the larynx), acute respiratory failure (a case has been reported, with fatal outcome, in an asthmatic patient sensitive to acetylsalicylic acid)

• exacerbation of colitis (worsening of inflammation of the intestine), exacerbation of Crohn's disease (worsening of inflammation of the intestine), gastrointestinal bleeding (bleeding of the stomach or intestine), gastrointestinal perforation (sometimes fatal, particularly in the elderly, see “Warnings”), gastric ulcer (lesion of the stomach), oral ulceration, duodenal ulcer (lesion of the first part of the intestine), duodenal perforation, heartburn, edema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melena (presence of digested blood in the stool), haematemesis (vomiting of blood), abdominal discomfort, colitis, hyperchlorhydria (excess of acid in the stomach), gastric pain (stomach ache), erosive gastritis (severe inflammation of the stomach lining), edema 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 that can cause difficulty in breathing and swallowing), blistering reactions including Stevens Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (severe skin reactions), edema (fluid retention), exanthem (skin rash), maculopapular rash (rash with patches), purpura (bruise-like spots on the skin due to abnormal blood accumulation), acute generalized pustulosis (rash with the formation of pustules), dermatitis (skin irritation)
• acute renal failure (reduction of kidney function), tubulo-interstitial nephritis, nephritis and nephritic syndrome (kidney inflammations), nephrotic syndrome (kidney alteration that involves a loss of proteins with urine), glomerulonephritis (inflammatory kidney disease), fluid/sodium retention with possible edema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (decreased urine production), abnormal renal function test, hematuria (presence of blood in the urine)
• aseptic meningitis (inflammation of the membranes surrounding the brain not caused by infections), lymphangitis (inflammation of the lymphatic vessels)
• hyperkalaemia (increased amount of potassium in the blood), hyponatremia (decreased amount of sodium in the blood).

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 KODIAK

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.
This medicine does not require any special storage conditions.
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

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What KODIAK contains
The active ingredient is ketoprofen lysine salt.
Each sachet contains 40 mg of ketoprofen lysine salt (equivalent to 25 mg of ketoprofen).
The other ingredients are: mannitol, xylitol, lemon aroma, lime aroma, frescofort aroma, aspartame,
talc, basic butyl methacrylate copolymer, magnesium stearate, hydrated colloidal silica, hypromellose,
stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of KODIAK and contents of the pack
KODIAK is presented in the form of granules for oral use, homogeneous granules from white to light yellow
in colour.
This medicinal product is available in packs of 12 sachets, 24 sachets or 30 sachets.

Marketing Authorisation Holder
Pharmeg S.r.l. - Via Dei Giardini, 34 – 85033 Episcopia (PZ)

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