Ketonal fast

Package leaflet: Information for the patient

Ketonal Fast, 50 mg, granules for oral solution in sachet
Ketoprofenum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
See section 4.
Contents of the leaflet

1. What Ketonal Fast is and what it is used for
2. Important information before taking Ketonal Fast
3. How to take Ketonal Fast
4. Possible side effects
5. How to store Ketonal Fast
6. Contents of the package and other information

1. What Ketonal Fast is and what it is used for

Ketonal Fast contains the active substance ketoprofen in the form of ketoprofen lysine salt. It belongs to a group of medicines used to treat pain and inflammation, known as non-steroidal anti-inflammatory drugs (NSAIDs).
Ketonal Fast is used:

• in adults for symptomatic treatment of pain and inflammation in the following conditions:

• inflammation following injury

• painful inflammatory conditions of the oral cavity (including teeth), throat, nose, ears, urinary tract, and respiratory tract

• painful joint inflammation with damage to cartilage and underlying bone

• chronic inflammatory disease of immunological origin primarily affecting joints

• chronic inflammation of spinal joints

• rheumatic diseases involving periarticular tissues

• in adolescents aged 16 years and older for short-term and symptomatic treatment of pain and inflammation occurring with or without fever in conditions such as:

• disorders affecting bones and joints

• postoperative pain

• ear infection (otitis)

2. Important information before taking Ketonal Fast

When not to take Ketonal Fast

• if the patient is 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 the patient has a history of hypersensitivity reactions (allergy), such as bronchospasm, asthma attack, acute inflammation of the nasal mucosa, urticaria, nasal polyps, angioedema (swelling of the deep layers of the skin and subcutaneous tissue, which may also involve mucous membranes), or other types of allergic reactions caused by administration of ketoprofen or other substances with a similar mechanism of action (e.g. acetylsalicylic acid or other NSAIDs). In such patients, severe, rarely fatal, anaphylactic reactions have been reported (see section 4 "Possible side effects");
• if the patient suffers from bronchial asthma;
• if the patient has severe heart failure (the heart is unable to pump sufficient blood required by the body);
• if the patient currently has peptic ulcer disease or gastrointestinal bleeding, or if the patient has a history of recurrent peptic ulcer disease or gastrointestinal bleeding (two or more separate, documented episodes of bleeding or ulceration);
• if the patient has previously experienced gastrointestinal bleeding, ulceration, gastrointestinal perforation, or chronic dyspepsia;
• if the patient has previously experienced gastrointestinal bleeding or perforation due to prior treatment with NSAIDs;
• if the patient has leukopenia (low white blood cell count) or thrombocytopenia (low platelet count);
• if the patient has gastrointestinal disease such as ulcerative colitis or Crohn's disease;
• if the patient has inflammation of the gastric mucosa;
• if the patient has severe liver failure (liver cirrhosis, severe hepatitis, impaired liver function) or severe kidney failure (impaired kidney function);
• if the patient has a bleeding tendency (predisposition to bleeding) or other coagulation disorders;
• if the patient is undergoing intensive diuretic therapy;
• if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before using Ketonal Fast, discuss this with your doctor or pharmacist:

• if the patient has impaired kidney function, Ketonal Fast should be administered with caution.
• if the patient has heart failure (a condition in which the heart is weakened), impaired liver function such as liver cirrhosis (severe impairment of liver function), impaired kidney function such as nephropathy (degenerative kidney disease) or chronic kidney failure (impaired kidney function), if the patient is being treated with diuretics (medicines used to increase urine excretion), or if the patient may have low blood volume (hypovolemia), especially if the patient is elderly at the beginning of treatment, because kidney function must be closely monitored.
• as with all NSAIDs, this medicine may increase certain laboratory test results, such as blood urea nitrogen and plasma creatinine levels.
• if the patient has liver disease or abnormal liver function test results, because liver enzyme activity (aminotransferases) should be periodically assessed, especially during long-term treatment.
• as with other NSAIDs, this medicine may cause slight transient increases in certain liver parameters, as well as significant increases in SGPT/ALT (alanine aminotransferase) and SGOT/AST (aspartate aminotransferase) (liver enzymes) (see section 4 "Possible side effects"). In case of significant increases in these parameters, treatment should be discontinued. Rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported during ketoprofen use. During long-term treatment, liver and kidney function tests and blood morphology should be monitored.
• if the patient has undergone coronary artery bypass graft surgery (bypass surgery).
• if the patient has uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate pumping of blood by the heart), confirmed ischemic heart disease (heart disease occurring due to reduced blood flow caused by narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of arteries and blood vessels of the brain), because in such cases the patient may use ketoprofen lysine salt, like all NSAIDs, only after thorough evaluation by a doctor.
• if the patient has a history of heart disease or stroke ("cerebrovascular incident") or believes they may be at risk of developing these conditions (for example, if they have high blood pressure, diabetes, or high cholesterol levels, or if they smoke)
• if the patient has a history (including family history) of hypertension (high blood pressure) and/or mild to moderate congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate pumping of blood by the heart), appropriate monitoring and proper recommendations are necessary. Fluid retention and edema have been reported during NSAID treatment.
• medicines such as ketoprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular incident). The risk is more likely with high-dose and long-term treatment.
• increased risk of atrial fibrillation (abnormal heart rhythm) associated with NSAID use has been reported.
• hyperkalemia (increased potassium levels) may occur, especially if the patient has diabetes, kidney failure, and/or is being treated with medicines that promote hyperkalemia (see subsection "Other medicines and Ketonal Fast"). In such cases, potassium levels should be monitored.
• if the patient has an infection - see below, section titled "Infections"
• if the patient has or has had allergic symptoms in the past, the medicine should be administered with caution.
• as with all non-steroidal medicines, use of ketoprofen in patients with bronchial asthma or predisposition to allergies may trigger an asthma attack. If the patient has asthma associated with chronic inflammation of the nasal mucosa, chronic sinusitis, and/or nasal polyps, they are more likely to be allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may cause asthma attacks or bronchospasm, shock, and other allergic conditions, especially in individuals allergic to acetylsalicylic acid and/or NSAIDs (see subsection "When not to take Ketonal Fast").
• if the patient has visual disturbances, such as blurred vision, contact a doctor, as treatment should be discontinued.
• if the patient has hematopoietic disorders (which cause changes in blood cell formation and maturation), systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disease, because Ketonal Fast should be used cautiously in these cases.

Infections
Ketonal Fast may mask symptoms of infection, such as fever and pain. Therefore, Ketonal Fast may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and infection symptoms persist or worsen, immediate consultation with a doctor is necessary.
Warnings:
Side effects can be minimized by using the medicine at the lowest effective dose for the shortest duration necessary to control symptoms (see section "How to take Ketonal Fast" and paragraphs below regarding gastrointestinal and cardiovascular risks).
Concomitant use of Ketonal Fast with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
During use of all pain-relieving medicines from the NSAID group, such as ketoprofen, gastrointestinal bleeding, ulceration, and perforation have been reported, in some cases with fatal outcome. Such effects may occur at any time during treatment, even without warning symptoms or history of severe gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration, or perforation is higher when using high doses. It is also higher in patients with a history of peptic ulcer disease, especially complicated by bleeding or perforation, and in elderly patients (see also section "When not to take Ketonal Fast"). Use of ketoprofen, especially at high doses, may be associated with a higher risk of gastrointestinal toxicity.
Patients who fall under the above warnings, as well as patients who require concomitant use of low-dose acetylsalicylic acid or other medicines associated with increased risk of gastrointestinal complications, may be prescribed protective agents (e.g., misoprostol or proton pump inhibitors) by their doctor (see subsection "Other medicines and Ketonal Fast").
Caution should be exercised when taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), selective serotonin reuptake inhibitors (such as medicines used to treat depression), anticoagulants (blood-thinning medicines, such as warfarin), or antiplatelet medicines, such as acetylsalicylic acid (see subsection "Other medicines and Ketonal Fast").
Children and adolescents
Do not use in children and adolescents under 16 years of age.
In some patients in the pediatric and adolescent group treated with ketoprofen lysine salt, gastrointestinal bleeding, occasionally severe, and ulceration have been reported (see section 4 "Possible side effects"). Therefore, the product should be administered under strict medical supervision, with individual dose assessment.
If the patient has or has had gastrointestinal diseases in the past, they should be carefully monitored for gastrointestinal disturbances, especially gastrointestinal bleeding.
Treatment with Ketonal Fast should be discontinued immediately upon occurrence of first symptoms of gastrointestinal bleeding or ulceration.
Patients with active or past peptic ulcer disease:
Patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) should exercise caution, as these conditions may recur during NSAID use (see section 4 "Possible side effects").
Ketoprofen may be associated with a higher risk of severe gastrointestinal toxicity compared to other NSAIDs, especially at high doses.
Very rarely, after administration of pain-relieving medicines such as ketoprofen, severe skin reactions have been reported, with redness and blister formation, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4 "Possible side effects"). Most cases of these reactions occur within the first month of treatment. Ketonal Fast should be discontinued immediately upon first signs of rash, mucosal lesions, or other hypersensitivity symptoms, and a doctor should be consulted.
If the patient has celiac disease (gluten intolerance), they may take Ketonal Fast, as it does not contain gluten.
If the patient has diabetes, they may take Ketonal Fast, as it does not affect low-calorie diets or restricted diets.
Ketonal Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as medicines the patient plans to take.
It is not recommended to use Ketonal Fast if the patient is taking:

• other pain-relieving medicines, such as
• medicines similar to ketoprofen, e.g., ibuprofen, diclofenac, naproxen;
• acetylsalicylic acid at doses used to treat pain and inflammation or to reduce fever;
• medicines used to treat pain, inflammation, or rheumatic diseases, containing an active substance with a name ending in "-coxib";
• medicines used to inhibit blood clotting, platelet aggregation, or dissolve blood clots, such as acetylsalicylic acid, warfarin, clopidogrel, ticlopidine, heparin, dabigatran, apixaban, rivaroxaban, or edoxaban. NSAIDs may enhance the effect of these medicines (see subsection "Warnings and precautions"), increasing the risk of bleeding. If concomitant use cannot be avoided, the patient should be closely monitored.
• lithium (a medicine used to treat bipolar disorder). NSAIDs may increase lithium blood levels to toxic values.
• methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and certain cancers) at doses exceeding 15 mg/week: there may be an increased risk of methotrexate hematological toxicity. At least 12 hours must elapse between discontinuation or initiation of ketoprofen treatment and methotrexate administration.
• hydantoin derivatives (e.g., phenytoin) and sulfonamides (e.g., certain antibiotics and other medicines): the toxic effects of these substances may be intensified.

If concomitant use of Ketonal Fast and any of the listed medicines is necessary, the doctor should carefully monitor the patient's condition.
Ketonal Fast and other medicines may also interact and affect each other's action. Therefore, always consult a doctor or pharmacist before using Ketonal Fast together with other medicines, especially such as:

• medicines increasing urine excretion by the kidneys and used to reduce blood pressure (diuretics);
• methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and certain cancers) used at doses less than 15 mg/week: there may be an increased risk of methotrexate hematological toxicity. During the first few weeks of combined therapy, blood morphology should be monitored weekly. If the patient is elderly or has impaired kidney function, monitoring should be more frequent.
• medicines used to reduce high blood pressure, e.g., beta-blockers, diuretics, ACE inhibitors, and angiotensin II antagonists: the patient should be adequately hydrated before starting concomitant treatment, and kidney function monitoring should be considered after starting concomitant treatment (see subsection "Warnings and precautions"). NSAIDs may reduce the effectiveness of diuretics.
• cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels; however, no pharmacokinetic interactions between ketoprofen and active cardiac glycosides have been demonstrated.
• corticosteroids (medicines used to treat inflammatory conditions): there may be an increased risk of gastrointestinal ulceration or bleeding (see subsection "Warnings and precautions").
• pentoxifylline (a medicine used to improve blood circulation in the limbs): there may be an increased risk of bleeding. More frequent clinical monitoring may be necessary.
• tenofovir (a medicine used to treat certain viral infections): may increase the risk of kidney failure.
• zidovudine (a medicine used to treat HIV): there may be increased hematological toxicity with severe anemia. Blood tests should be performed after starting NSAID treatment.
• sulfonylurea derivatives (antidiabetic medicines, e.g., gliclazide): NSAIDs may enhance the hypoglycemic (glucose-lowering) effect of sulfonylurea derivatives.
• medicines that may increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim.
• nicorandil, used to prevent or reduce chest pain (angina pectoris) associated with certain heart diseases.

Combinations to consider:
antihypertensive medicines (beta-blockers, angiotensin-converting enzyme inhibitors, diuretics): NSAIDs may reduce the effectiveness of antihypertensive medicines.
mifepristone (a medicine used for medical termination of pregnancy): theoretically, contraceptive effectiveness may be reduced due to NSAID properties.
intrauterine contraceptive devices: device effectiveness may be reduced, which may lead to pregnancy.
cyclosporine, tacrolimus (medicines used after organ transplantation or to treat immune system disorders): increased risk of additional kidney toxicity, especially in elderly patients.
thrombolytic medicines (medicines facilitating removal of blood clots): increased risk of bleeding.
antiplatelet medicines (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs, e.g., certain antidepressants): increased risk of gastrointestinal bleeding.
probenecid (a medicine used to treat gout): concomitant use of probenecid may increase ketoprofen blood levels.
quinolone antibiotics: possible increased risk of seizures.
phenytoin and sulfonamides: dose reduction may be necessary.
gemeprost (a medicine used in gynecological surgery): reduced effectiveness.
Alcohol consumption should be avoided.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not use Ketonal Fast during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. This medicine may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labor.
Do not use Ketonal Fast during the first 6 months of pregnancy unless the doctor considers it absolutely necessary and recommended. If treatment is required during this period or when trying to conceive, the lowest dose for the shortest possible time should be used. If Ketonal Fast is used for longer than a few days after the 20th week of pregnancy, it may cause kidney function disorders in the unborn child. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Breastfeeding is not recommended during use of Ketonal Fast. It is not known whether ketoprofen passes into breast milk.
If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor. Medicines such as ketoprofen may make it more difficult to conceive.
Fertility
Use of NSAIDs, including Ketonal Fast, may reduce female fertility and is not recommended for women trying to conceive.
NSAIDs, including Ketonal Fast, should be discontinued if there are problems with conception or during fertility investigations.
Driving and operating machinery
Ketonal Fast generally does not affect the ability to drive or operate machinery. However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or visual disturbances, these activities should not be performed.
Ketonal Fast contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to take Ketonal Fast

This medicine should always be taken according to the recommendations of a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 16 years and older
One full divided sachet three times daily.
The lowest effective dose should be used for the shortest duration necessary to relieve
symptoms. If symptoms of an infection (such as fever and pain) persist or worsen,
medical advice should be sought immediately (see section 2).
Use in elderly patients
The dose should be determined by a doctor, who may consider reducing the usual dose. See "Warnings
and precautions" in section 2.
Use in patients with hepatic impairment
The lowest daily dose is recommended (see section "Warnings and precautions").
Use in patients with mild to moderate renal impairment
A reduced initial dose and maintenance treatment with the lowest effective dose are recommended.
Individual dose adjustment may be considered only after good drug tolerance has been established.
Urine volume and renal function should be monitored (see section "Warnings and precautions").
Ketonal Fast 50 mg, granules for oral solution, should not be used in patients with severe
hepatic or renal dysfunction (see section "When not to take Ketonal Fast").
Instructions for use

• Open the sachet along the line marked “half dose” to obtain the dose contained in one part of the sachet.
• Open the sachet along the line marked “full dose” to obtain the dose contained in the entire sachet.
• Pour the contents into a glass with approximately 100 ml of water.
• Stir thoroughly for about 30 seconds until the granules dissolve.
• The resulting oral solution should be taken immediately after preparation, during a meal.

Taking more Ketonal Fast than recommended
If more Ketonal Fast has been taken than recommended, seek immediate medical advice from a doctor or
go to the nearest hospital.
In most cases, symptoms of overdose are limited to lethargy, drowsiness, nausea,
vomiting, epigastric (upper abdominal) pain, abdominal pain, headache, dizziness, and
diarrhea.
In cases of severe overdose, low blood pressure, respiratory depression,
and gastrointestinal bleeding may occur.
The patient should be immediately transferred to a specialized center for symptomatic treatment.
There is no specific antidote in case of ketoprofen overdose.
In suspected significant overdose, recommended management includes gastric lavage in combination with symptomatic and supportive treatment. In cases of renal failure, hemodialysis may be useful in removing the drug from the body.
Missed dose of Ketonal Fast
If a dose of Ketonal Fast is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly observed adverse events are gastrointestinal.
The following adverse reactions have been observed during ketoprofen use in adults:

Frequent (may occur in up to 1 in 10 people):
dyspepsia (indigestion), nausea, abdominal pain, vomiting.

Uncommon (may occur in up to 1 in 100 people):
headache, central dizziness, peripheral dizziness, somnolence,
constipation, diarrhoea, flatulence (intestinal gas), gastritis, abdominal discomfort,
skin rash, pruritus (itching),
oedema (fluid accumulation causing swelling), fatigue, peripheral oedema,
chills.

Rare (may occur in up to 1 in 1000 people):
haemorrhagic anaemia (anaemia caused by blood loss),
paraesthesia (abnormal skin sensations, tingling),
blurred vision (see section "Warnings and precautions"),
tinnitus (ringing in the ears),
asthma,
stomatitis (oral ulceration), peptic ulcer (ulceration of the stomach or duodenum), colitis,
hepatitis, increased aminotransferase activity (liver enzymes), increased blood bilirubin levels (elevated serum bilirubin due to liver dysfunction), jaundice,
weight gain.

Very rare (may occur in up to 1 in 10,000 people):
dyskinesia (movement disorder), loss of consciousness,
hypotension (low blood pressure),
laryngeal oedema (swelling of the larynx),
haematuria (blood in urine),
asthenia (physical weakness), facial oedema.

Frequency not known (cannot be estimated from available data):
thrombocytopenia (reduced number of blood platelets), agranulocytosis (severe reduction in white blood cells), bone marrow failure (reduced blood cell production), haemolytic anaemia (anaemia caused by abnormal destruction of red blood cells), neutropenia (reduced number of neutrophil granulocytes); aplastic anaemia (anaemia due to insufficient blood cell production in the bone marrow); leukocytosis (increased number of white blood cells in blood), thrombocytopenic purpura; leukopenia (reduced number of white blood cells),
anaphylactic reactions (including anaphylactic shock); hypersensitivity,
depression, hallucinations, confusion, mood swings, restlessness, insomnia. In a paediatric patient who received a dose twice the recommended dose stated in the product characteristics, anxiety and behavioural disturbances were also observed,
seizures,
taste disturbances,
tremor, hyperkinesia,
heart failure (weakening of the heart), atrial fibrillation (heart rhythm disorder), palpitations, tachycardia (increased heart rate),
hypertension (high blood pressure), vasodilation, vasculitis (inflammation of blood or lymphatic vessels) (including leukocytoclastic vasculitis),
bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea (difficulty breathing), laryngospasm, acute respiratory failure (a single fatal case has been reported in a patient with asthma and hypersensitivity to acetylsalicylic acid).
gastralgia (stomach pain), exacerbation of colitis and Crohn's disease, gastrointestinal bleeding, gastrointestinal perforation (sometimes fatal, particularly in elderly patients), heartburn, gastric ulcer, duodenal ulcer, oral oedema, pancreatitis, erosive gastritis, haematemesis or melaena (black, tarry stools due to digested blood), hyperchlorhydria (excess hydrochloric acid in gastric juice), abdominal pain, lingual oedema,
photosensitivity (sensitivity to sunlight or UV lamps), alopecia (hair loss), urticaria, angioedema, vesicular eruptions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (severe skin reactions), erythema (skin redness), exanthema (rash), maculopapular rash, purpura, acute generalised exanthematous pustulosis (rash with pustule formation), dermatitis,
acute renal failure, tubulointerstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerulonephritis, water and/or sodium retention with possible oedema, acute tubular necrosis (damage to renal tubular cells), renal papillary necrosis (damage to renal papillae), oliguria (reduced urine output), abnormal kidney function test results,
periorbital oedema (swelling around the eyes),
aseptic meningitis (inflammation of the membranes surrounding the brain not caused by bacteria),
lymphangitis (inflammation of lymphatic vessels),
hyperkalaemia (increased potassium levels in blood), hyponatraemia (decreased sodium levels in blood).

Medicines, including Ketonal Fast, especially when used in high doses and for long-term treatment, may be associated with an increased risk of arterial thromboembolic events (formation of blood clots in blood vessels), such as myocardial infarction (heart attack) or stroke (cerebrovascular incident) (see section 2 "Important information before taking Ketonal Fast").

Following the recommendations provided in the package leaflet reduces the risk of adverse reactions.

Blood tests
Blood test results may indicate impaired liver or kidney function.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921301; fax: +48 22 4921309; website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ketonal Fast

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box and sachet after EXP. The expiry date refers to the last day of the stated month.
The oral solution obtained after dissolving the powder should be used immediately.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ketonal Fast contains

• The active substance is ketoprofen. Each sachet contains 50 mg of ketoprofen in the form of ketoprofen lysine salt (80 mg).
• Other ingredients: mannitol (E 421), povidone K30, peppermint flavour (containing maltodextrin and acacia gum), sodium chloride, sodium saccharin, colloidal anhydrous silica.

What Ketonal Fast looks like and contents of the pack
White or yellowish granules.
The medicine is packed in dual-compartment sachets made of paper/aluminium/PE, placed in a cardboard box.
Pack sizes: 30 dual-compartment sachets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano 43
24041 Brembate (BG), Italy
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For further information about the medicine and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Logo of the Marketing Authorisation Holder