Kodak

Italy
Brand name Kodak
Form granules
Active substance / Dosage
KETOPROFEN LYSINE SALT
Prescription type Over-the-counter
ATC code
M01AE03
Registration number 044366
Manufacturer PHARMEG S.R.L.

Table of Contents

Patient Information Leaflet

KODIAK 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 advised.

  • 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice any improvement 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 taking 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 KODIAK is and what it is used for

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

2. What you need to know before taking KODIAK

Do not take KODIAK

  • 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 drugs), 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 (the heart's inability 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; 1/12
  • if you suffer from Crohn’s disease (intestinal inflammation) or ulcerative colitis (intestinal inflammation with ulcers);
  • if you have severe hepatic (reduced liver function due to cirrhosis or severe hepatitis) or renal (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 (a predisposition to bleeding) or other coagulation disorders, or if you have haemostatic disorders (difficulty in stopping bleeding);
  • if you are undergoing treatment with high-dose diuretics;
  • if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
  • if the person taking 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
Unwanted effects can be minimized by using the lowest effective dose for the shortest duration 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, including KODIAK, gastrointestinal bleeding, ulceration, and perforation—sometimes fatal—have been reported at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Patients with a prior history of these conditions are at higher risk (see “Do not take KODIAK”).
Report any abdominal signs or symptoms (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 “Other medicines and KODIAK”).
Elderly patients are at greater risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Immediately discontinue treatment with KODIAK 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 NSAID use (see “Possible side effects”). These reactions usually occur during the initial stages of treatment. Discontinue use of KODIAK if a skin rash, mucosal lesions, or any other signs of hypersensitivity (allergic reaction) appear.
Precautions
Consult your doctor or pharmacist before taking KODIAK:

  • If your kidneys do not function properly, as KODIAK should be used with caution in such cases. If you use KODIAK, 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 checks. 2/12
  • If you have an infection – see the section «Infections» below.
  • If you have liver disease or abnormal liver function tests, since 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 cardiac pumping function), confirmed 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 in the brain), as you should only take KODIAK after careful medical evaluation.
  • If you have risk factors for these conditions, such as high blood pressure, diabetes (a disease caused by high blood glucose levels), hyperlipidemia (elevated blood fat levels), or if you smoke.
  • If you have allergic manifestations or a history of 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 allergic reactions), chronic rhinitis (inflammation of the nasal mucosa), allergic rhinitis, chronic sinusitis, and/or nasal polyposis.
  • 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 KODIAK 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 KODIAK.
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 “Other medicines and KODIAK”). In such cases, potassium levels should be monitored periodically.
Infections
KODIAK may mask symptoms of infections such as fever and pain. Therefore, KODIAK could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to 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
KODIAK must not be administered to children and adolescents under 15 years of age.
Other medicines and KODIAK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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Use of KODIAK 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 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 used to prevent organ transplant rejection or for certain immune system disorders);
  • 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 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 KODIAK 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 used to prevent organ transplant rejection or for certain immune system disorders);
  • 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 sulfonamides (antibiotics used to treat bacterial infections);
  • Phenytoin (a medicine used to treat epilepsy);
  • Gemeprost (a medicine used for uterine examinations and surgical procedures).

It is not advisable to consume alcoholic beverages during treatment with KODIAK.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take KODIAK during the last three months of pregnancy, as it may harm the fetus or cause delivery complications.
It may cause kidney and heart problems in the fetus. It could affect your and your baby’s tendency to bleed and delay or prolong labor beyond expectations.
You should not take KODIAK during the first 6 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, KODIAK may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels 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 circulatory and respiratory disturbances in the newborn.
Breastfeeding
Do not take KODIAK while breastfeeding.
Fertility
KODIAK may cause fertility problems in women. Therefore, if you plan to become pregnant, 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 use of machines
After taking KODIAK, 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”).
KODIAK 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 due to the body’s inability to properly metabolize it.
This medicine contains lime flavor, lemon flavor, and frescofort flavor, 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 unwanted 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 KODIAK

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 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 KODIAK – Warnings and precautions”).

Use in patients with mild or moderate liver problems
If you have mild or 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 need to know before taking KODIAK – Do not take KODIAK”).

Use in patients with mild or moderate kidney problems
If you have mild or moderate kidney impairment, consult your doctor, who should 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 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 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 KODIAK than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital Emergency Department.
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, 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 in case of 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 blood purification technique) may be useful in removing the circulating medicine.

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 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 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 gastrointestinal in 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 intestinal gas), gastritis (inflammation of the stomach lining)
  • skin rash, pruritus (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 in the blood, caused by bleeding)
  • paraesthesia (numbness or tingling sensations)
  • blurred vision (see "Warnings and precautions")
  • tinnitus (persistent ringing or noise in the ear)
  • asthma (bronchial inflammation and narrowing of the airways)
  • stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion in the stomach or the first part of the intestine)
  • hepatitis (liver inflammation), 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) and 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 (reduction in haemoglobin in the blood caused by destruction of red blood cells), leucopenia (decreased white blood cell count), neutropenia (reduced number of 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 non-existent things), confusion, mood alterations, agitation, insomnia, seizures (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 (abnormal 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), 7/12

laryngospasm (narrowing of the larynx), acute respiratory failure (a 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 elderly patients; see "Warnings"), gastric ulcer (lesion in the stomach), oral ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melena (presence of digested blood in stools), haematemesis (vomiting blood), 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 (loss of hair and body hair), 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 (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), acute generalized exanthematous pustulosis (skin eruption with pus-filled lesions), dermatitis (skin irritation)
  • acute renal failure (reduced kidney function), tubulo-interstitial nephritis, nephritis and nephrotic syndrome (kidney inflammations), 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 production), 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 lymphatic vessels)
  • hyperkalaemia (increased potassium levels in blood), hyponatraemia (decreased sodium levels in blood).

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, 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.
Reporting side effects 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

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What KODIAK 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, lemon flavour, lime flavour, freshfort flavour, 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 the contents of the pack
KODIAK is presented as an oral granulate, homogeneous granules of white to pale yellow colour.
This medicine is available in packs of 12 sachets, 24 sachets or 30 sachets.
Marketing Authorization 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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