Ketonal Fast

Leaflet accompanying the packaging: patient information

Ketonal Fast, 50 mg, granules for oral solution, in a sachet

Ketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.
See section 4.

Table of contents of the leaflet

• 1. What is Ketonal Fast and what is it 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 packaging and other information

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

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

• In adultsfor the symptomatic treatment of inflammatory painin the following conditions:
• inflammation after injury
• painful inflammatory conditions in the mouth (including teeth), throat, nose, ears, urinary tract, and respiratory tract
• painful joint inflammation with cartilage and underlying bone damage
• chronic inflammatory disease of immunological origin affecting mainly the joints
• long-term inflammation of the spine
• rheumatic diseases affecting tissues outside the joints
• In adolescents from 16 years of agefor the symptomatic and short-term treatment of painand inflammationwith or without fever in conditions such as:
• -bone and joint diseases
• -post-operative pain
• -ear inflammation

2. Important information before taking Ketonal Fast

When not to take Ketonal Fast

• if the patient is allergic to ketoprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or 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 rhinitis, urticaria, nasal polyps, or angioedema (swelling of the deep layers of the skin and subcutaneous tissue, which can also affect the mucous membranes) or other types of allergic reactions caused by the administration of ketoprofen or other substances with a similar mechanism of action (e.g., acetylsalicylic acid or other NSAIDs). In such patients, severe, sometimes fatal, anaphylactic reactions have been reported (see section 4 "Possible side effects")

acetylsalicylic acid or other NSAIDs). Such patients have reported severe, sometimes fatal, anaphylactic reactions (see section 4 "Possible side effects")

• if the patient has asthma;
• if the patient has severe heart failure (heart failure that is not adequately controlled with treatment);
• if the patient has a current peptic ulcer or bleeding, or if the patient has had a recurrent peptic ulcer or bleeding (two or more separate, proven episodes of bleeding or ulceration);
• if the patient has had a history of gastrointestinal bleeding, ulceration, or perforation, or if the patient has had a history of gastrointestinal bleeding or perforation due to previous NSAID treatment;
• if the patient has leukopenia (low white blood cell count) or thrombocytopenia (low platelet count);
• if the patient has a gastrointestinal disease, such as ulcerative colitis or Crohn's disease;
• if the patient has gastritis;
• if the patient has severe liver failure (liver cirrhosis, severe hepatitis, impaired liver function) or severe kidney failure (renal impairment);
• if the patient has a bleeding disorder (tendency to bleed) or other coagulation disorders;
• if the patient is undergoing intensive diuretic treatment;
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before taking Ketonal Fast, the patient should discuss it with their 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 nephrotic syndrome (a degenerative disease of the kidneys), or chronic kidney failure (impaired kidney function), or if the patient is being treated with diuretics (medicines used to increase urine production) or if the patient may have low blood volume (hypovolemia), especially if the patient is elderly at the start of treatment, as kidney function must be closely monitored.
• similarly to all NSAIDs, this medicine may increase the values of certain laboratory test results, such as urea and creatinine levels in the blood.
• if the patient has liver disease or abnormal liver function test results, as periodic evaluation of aminotransferase (liver enzyme) activity is recommended, especially during long-term treatment.
• similarly to other NSAIDs, this medicine may cause minor, 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 the event of a significant increase in these parameters, treatment should be discontinued. During ketoprofen treatment, rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported. During long-term treatment, liver and kidney function tests and blood morphology should be performed.
• if the patient has undergone coronary artery bypass grafting (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 blood pumping by the heart), proven ischemic heart disease (heart disease that occurs as a result of reduced blood flow caused by coronary artery narrowing), peripheral arterial disease, and (or) cerebrovascular disease (disease of the arteries and blood vessels of the brain), as the patient may be taking lysine salt of ketoprofen, like all NSAIDs, only after a thorough medical examination.
• if the patient has a history of heart disease or stroke ("cerebrovascular incident")

or if the patient believes they may be at risk of developing these diseases (e.g., if they have high blood pressure, diabetes, or high cholesterol, or if they smoke)

• if the patient has a 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 blood pumping by the heart), careful monitoring and appropriate recommendations are necessary. During NSAID treatment, fluid retention and edema have been reported.
• medicines like 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 doses and long-term treatment
• increased risk of atrial fibrillation (change in heart rhythm) associated with NSAID use has been reported.
• hyperkalemia (elevated potassium levels) may occur, especially if the patient has diabetes, kidney failure, and (or) is being treated with medications that promote hyperkalemia (see "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 a history of allergic symptoms, the medicine should be administered with caution.
• similarly to all nonsteroidal medicines, ketoprofen use in patients with asthma or a predisposition to allergies may trigger an asthma attack. If the patient has asthma associated with chronic rhinitis, 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 "When not to take Ketonal Fast").
• if the patient has visual disturbances, such as blurred vision, they should contact their doctor, as treatment discontinuation may be necessary.
• if the patient has hematopoietic disorders (which affect the production and maturation of blood cells), systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disease, Ketonal Fast should be used with caution.

Infections
Ketonal Fast may mask the symptoms of infection, such as fever and pain. Therefore, Ketonal Fast may delay the use of appropriate infection treatment, which may lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
Warnings:
Side effects can be reduced by using the medicine in the smallest effective dose for the shortest possible treatment period necessary to control the symptoms (see "How to take Ketonal Fast" and the paragraphs below regarding gastrointestinal and cardiovascular risks.)
Avoid concomitant use of Ketonal Fast with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
During the use of all pain-relieving medicines, including all NSAIDs, such as ketoprofen, gastrointestinal bleeding, ulcers, and perforationhave been reported, sometimes with fatal outcomes. These events can occur at any time during treatment, even without warning signs or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, or perforation is higher during the use of high doses. It is also higher in patients with a history of peptic ulcers, especially if complicated by bleeding or perforation, and in the elderly (see also "When not to take Ketonal Fast"). The use of ketoprofen, especially in high doses, may be associated with a higher risk of toxic effects on the gastrointestinal tract.
Patients who are at risk, as well as those who require concomitant use of low-dose acetylsalicylic acid or other medicines that increase the risk of gastrointestinal complications, should be advised by their doctor to take protective measures (e.g., misoprostol or proton pump inhibitors) (see "Other medicines and Ketonal Fast").
Avoid taking medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), selective serotonin reuptake inhibitors (e.g., antidepressants), anticoagulants (blood-thinning medicines, such as warfarin), or antiplatelet agents, such as acetylsalicylic acid (see "Other medicines and Ketonal Fast").

Children and adolescents

Do not use the medicine in children and adolescents under 16 years of age.
In some pediatric patients treated with lysine salt of ketoprofen, gastrointestinal bleeding and ulcers have been reported, occasionally with a severe course, and gastrointestinal perforation (see section 4 "Possible side effects"). Therefore, the product should be administered under close medical supervision, and the doctor will individually assess the dosage.
If the patient has a history of gastrointestinal diseases, they should be closely monitored for gastrointestinal disorders, especially gastrointestinal bleeding.
Discontinuetreatment with Ketonal Fast immediately if the patient experiences the first symptoms of gastrointestinal bleeding or ulcers.
Patients with active or a history of peptic ulcers:
Patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) should be cautious, as these conditions may recur during NSAID use (see section 4 "Possible side effects").
Ketoprofen may be associated with a higher risk of severe toxic effects on the gastrointestinal tract compared to other NSAIDs, especially in high doses.
Very rarely, after the use of pain-relieving medicines, such as ketoprofen, severeskin reactionshave been reported, with redness and blistering, 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. Immediately after the appearance of the first signs of a rash, mucosal lesions, or other symptoms of hypersensitivity, Ketonal Fast should be discontinued and a doctor consulted.
If the patient has celiac disease (gluten intolerance), they can take Ketonal Fast, as it does not contain gluten.
If the patient has diabetes, they can take Ketonal Fast, as it does not affect low-calorie diets or diets with restricted carbohydrate intake.

Ketonal Fast and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Do not takeKetonal Fast if the patient is taking:

• other pain-relieving medicines, such as
• medicines similar to ketoprofen, e.g., ibuprofen, diclofenac, naproxen;
• acetylsalicylic acid in 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 prevent blood clotting, platelet aggregation, or to 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 "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 manic-depressive psychosis). NSAIDs may increase lithium levels in the blood to toxic values.
• methotrexate (a medicine used to treat certain autoimmune diseases and certain cancers) in doses greater than 15 mg/week: may increase the risk of toxic effects of methotrexate on the blood. There should be at least a 12-hour interval between discontinuation or initiation of ketoprofen treatment and methotrexate administration.
• hydantoin derivatives (e.g., phenytoin) and sulfonamides (e.g., certain antibiotics and other medicines): may increase the toxic effects of these substances.

If concomitant use of Ketonal Fast and any of these medicines is necessary, the doctor should closely monitor the patient's condition.
Ketonal Fast and other medicines may also interact with each other. Therefore, always consult a doctor or pharmacist before taking Ketonal Fast with other medicines, especially:

• diuretics (medicines used to increase urine production and reduce blood pressure);
• methotrexate (a medicine used to treat certain autoimmune diseases and certain cancers) in doses less than 15 mg/week: may increase the toxic effect of methotrexate on the blood. During the first few weeks of combination therapy, weekly blood morphology tests should be performed. If the patient is elderly or has impaired kidney function, more frequent tests should be performed.
• medicines used to reduce high blood pressure, such as beta-blockers, diuretics, ACE inhibitors, and angiotensin II antagonists: the patient should be properly hydrated before starting concomitant treatment, and kidney function should be considered after starting concomitant treatment (see "Warnings and precautions"). NSAIDs may reduce the effect of diuretics.
• cardiac glycosides: NSAIDs may increase the risk of heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels; however, no pharmacokinetic interactions have been found between ketoprofen and active glycosides.
• corticosteroids (medicines used to treat inflammatory conditions): may increase the risk of gastrointestinal ulcers or bleeding (see "Warnings and precautions")
• pentoxifylline (a medicine used to improve blood circulation in the limbs): may increase the 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): may increase the toxic effect on the blood, with severe anemia. After starting NSAID treatment, blood tests should be performed.
• sulfonylurea derivatives (oral hypoglycemic medicines, e.g., gliclazide): NSAIDs may enhance the hypoglycemic effect (lowering blood glucose levels) of sulfonylurea derivatives
• medicines that may increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim.
• nicorandil, used to prevent or reduce chest pain (angina pectoris) in certain heart diseases.

Combinations to consider:
antihypertensive medicines (beta-blockers, ACE inhibitors, diuretics): NSAIDs may reduce the effect of antihypertensive medicines.
mifepristone (a medicine used for voluntary termination of pregnancy): the effectiveness of the contraceptive method may be reduced due to the properties of NSAIDs.
intrauterine contraceptive devices: the effectiveness of the device 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 toxic effects on the kidneys, especially in the elderly.
thrombolytic medicines (medicines that facilitate the 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 levels in the blood.
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 fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine .
Pregnancy
Do not use Ketonal Fast in 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 risk of bleeding in the mother and child and prolong labor.
Do not use Ketonal Fast in the first 6 months of pregnancy, unless the doctor considers it absolutely necessary and recommends it. If the patient requires treatment during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. If Ketonal Fast is used for more than a few days from the 20th week of pregnancy, it may cause kidney function disorders in the unborn child. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ketonal Fast is not recommended during breastfeeding. It is not known whether ketoprofen passes into breast milk.
If the patient plans to become pregnant or is having trouble conceiving, they should inform their doctor. Medicines like ketoprofen may make it harder to become pregnant.
Fertility
The use of NSAIDs, including Ketonal Fast, may reduce female fertility and is not recommended in women trying to conceive.
NSAIDs, including Ketonal Fast, should be discontinued if the patient is having trouble conceiving or during fertility testing.

Driving and using machines

Ketonal Fast does not affect the ability to drive or use machines. However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or visual disturbances, they should not perform these activities.

Ketonal Fast contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is essentially "sodium-free".

3. How to take Ketonal Fast

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

Adults and adolescents from 16 years of age

One whole double-chambered sachet three times a day.
Use the smallest effective dose for the shortest possible treatment period necessary to control the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Use in the elderly

The dose is determined by the doctor, who may consider reducing the usual dose. See "Warnings and precautions" in section 2.

Use in patients with liver failure

The recommended daily dose is the smallest (see "Warnings and precautions").

Use in patients with mild to moderate kidney failure

The initial dose should be reduced, and the maintenance dose should be the smallest effective dose. Individual dose adjustment can be considered only after good tolerance of the medicine has been established.
Urinary output and kidney function should be monitored (see "Warnings and precautions").
Do not use Ketonal Fast, 50 mg, granules for oral solution, if the patient has severe liver and kidney function disorders (see "When not to take Ketonal Fast").

Method of administration

• 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 "whole dose" to obtain the dose contained in the whole sachet.
• Pour the contents into a glass with approximately 100 ml of water.
• Stir well for about 30 seconds until the granules dissolve.
• The resulting oral solution should be taken immediately after preparation, during a meal.

Overdose of Ketonal Fast

In case of overdose, consult a doctor or go to the nearest hospital immediately.
In most cases, symptoms of overdose are limited to lethargy, drowsiness, nausea, vomiting, and abdominal pain (upper abdomen), stomach pain, headache, dizziness, and diarrhea.
In cases of severe overdose, low blood pressure, respiratory depression, and gastrointestinal bleeding have been observed.
The patient should be taken to a specialized center immediately to initiate symptomatic treatment.
There is no specific antidote in case of ketoprofen overdose.
In case of suspected significant overdose, the recommended treatment includes gastric lavage in combination with symptomatic and supportive treatment. In case of kidney failure, hemodialysis may be useful in removing the medicine from the body.

Missed dose of Ketonal Fast

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should not take the missed dose. Do not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketonal Fast can cause side effects, although not everybody gets them.
The most common side effects are related to the gastrointestinal tract.
The following side effects have been reported in adults taking ketoprofen:
Common (may affect up to 1 in 10 people):
indigestion (poor digestion), nausea, abdominal pain, vomiting.
Uncommon (may affect up to 1 in 100 people):
headache, dizziness, drowsiness
constipation, diarrhea, bloating (gas in the intestines), gastritis, abdominal discomfort
skin rash, itching
edema (fluid accumulation causing swelling), fatigue, peripheral edema
chills
Rare (may affect up to 1 in 1,000 people):
hemorrhagic anemia (anemia caused by blood loss)
paresthesia (abnormal sensations on the skin, tingling)
blurred vision (see "Warnings and precautions")
tinnitus (ringing in the ears)
asthma
stomatitis (mouth ulcers), peptic ulcer (stomach or duodenal ulcer), colitis (inflammation of the colon)
hepatitis (inflammation of the liver), increased aminotransferase (liver enzyme) activity, increased bilirubin levels in the blood (elevated bilirubin levels in the serum due to liver function disorders), jaundice
weight gain.
Very rare (may affect up to 1 in 10,000 people)
dykinesia (movement disorder), fainting
hypotension (low blood pressure)
angioedema (swelling of the deep layers of the skin and subcutaneous tissue)
hematuria (blood in the urine)
asthenia (physical weakness), facial edema.
Frequency not known (cannot be estimated from the available data):
thrombocytopenia (low platelet count), agranulocytosis (significant decrease in white blood cell count), bone marrow failure (decreased production of blood cells), hemolytic anemia (anemia caused by abnormal red blood cell destruction), neutropenia (decreased count of neutrophil white blood cells);
aplastic anemia (anemia caused by insufficient production of blood cells in the bone marrow); leukocytosis (elevated white blood cell count), thrombocytopenic purpura; leukopenia (low white blood cell count)
anaphylactic reactions (including anaphylactic shock); hypersensitivity.
depression, hallucinations, confusion, mood changes, agitation, insomnia. In a pediatric patient who took a dose twice the recommended dose in the product characteristics, anxiety and behavioral disorders also occurred.
seizures
changes in taste perception
tremors, hyperkinesia
heart failure (heart weakness), atrial fibrillation (heart rhythm disorder), palpitations, tachycardia (rapid heart rate)
hypertension (high blood pressure), vasodilation, vasculitis (inflammation of blood vessels or lymphatic vessels) (including leukocytoclastic vasculitis)
bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnea (difficulty breathing), laryngospasm, acute respiratory failure (reported in a single case with a fatal outcome in a patient with asthma and hypersensitivity to acetylsalicylic acid).
gastralgia (stomach pain), exacerbation of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforation of the gastrointestinal tract (sometimes fatal, especially in the elderly), heartburn, gastric ulcer, duodenal ulcer, oral edema, pancreatitis, erosive gastritis, gastrointestinal hemorrhage or melena (digested blood in the stool), hyperchlorhydria (excess of hydrochloric acid in the stomach), abdominal pain, tongue edema
photosensitivity (sensitivity to sunlight or UV lamps), alopecia (hair loss), urticaria, angioedema, blistering eruptions, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis (severe skin reactions), erythema (redness of the skin), rash, rash with small bumps, purpura, acute generalized exanthematous pustulosis (rash with pustules), dermatitis
acute kidney failure, tubulointerstitial nephritis, nephritis or nephrotic syndrome, kidney failure, fluid and (or) sodium retention with possible edema, acute tubular necrosis (kidney cell damage), renal papillary necrosis (kidney damage), oliguria (reduced urine production), abnormal kidney function test results
periorbital edema (swelling around the eyes)
aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord not caused by bacteria)
lymphangitis (inflammation of the lymphatic vessels)
hyperkalemia (elevated potassium levels in the blood), hyponatremia (low sodium levels in the blood).
Medicines, including Ketonal Fast, may be associated (especially with high doses and long-term treatment) with an increased risk of arterial thrombotic events (blood clots in blood vessels), such as heart attack (myocardial infarction) or stroke (cerebrovascular incident) (see section 2 "Important information before taking Ketonal Fast").
Following the recommendations in the leaflet accompanying the packaging reduces the risk of side effects.

Blood tests

Blood test results may indicate liver or kidney function disorders.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ketonal Fast

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

6. Contents of the packaging and other information

What Ketonal Fast contains

• The active substance is ketoprofen. Each sachet contains 50 mg of ketoprofen in the form of ketoprofen lysinate (80 mg).
• The other ingredients are: mannitol (E 421), povidone K30, peppermint flavor (contains maltodextrin and gum arabic), sodium chloride, sodium saccharin, colloidal anhydrous silica.

What Ketonal Fast looks like and contents of the pack

White or yellowish granules.
The medicine is packaged in double-chambered sachets made of paper/Aluminum/PE, in a cardboard box.
Pack sizes: 30 double-chambered sachets.

Marketing authorization 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 more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet: 03/2025
Logo of the marketing authorization holder