Ketonal Sprint

Leaflet accompanying the packaging: patient information

Ketonal Sprint, 25 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.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• The doctor should be contacted if there is no improvement or if the patient feels worse:
• Adolescents:after 3 days of taking the medicine
• Adults:after 3 days of taking the medicine in case of fever or after 5 days in case of pain.

Table of contents of the leaflet

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

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

Ketonal Sprint 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 non-steroidal anti-inflammatory drugs (NSAIDs). Ketonal Sprint is used in adults and adolescents aged 16 years and older for the short-term symptomatic treatment of mild or moderate acute pain, such as: headache, toothache, painful menstruation, pain caused by minor sprains and strains. Adults:should consult a doctor if there is no improvement or if the patient feels worse after 3 days in case of fever or after 5 days in case of pain. Adolescents:if after 3 days of taking the medicine there is no improvement or if the patient feels worse, a doctor should be consulted.

2. Important information before taking Ketonal Sprint

When not to take Ketonal Sprint

• if the patient is allergic to ketoprofen, other non-steroidal 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, 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");

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 or history of recurrent peptic ulcer or bleeding (two or more separate, proven episodes of bleeding or ulceration); if the patient has a history of gastrointestinal bleeding, ulceration, or perforation of the gastrointestinal tract; if the patient has 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 (impaired kidney function); 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 Sprint, the patient should discuss the following with the doctor or pharmacist:

• if the patient has impaired kidney function, Ketonal Sprint should be administered with caution.
• if the patient has heart failure (a condition in which the heart is weakened), disorders of 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), 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 in the case of 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), confirmed 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 blood vessels in the brain), as the patient may be taking lysine salt of ketoprofen, like all NSAIDs, only after careful examination 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 diseases (e.g., if they have high blood pressure, diabetes, or high cholesterol, or if they smoke).

• if the patient has a history of (including family history of) hypertension and/or mild to moderate congestive heart failure, as close 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 hyperkalemia-inducing drugs (see "Other medicines and Ketonal Sprint"). In such cases, potassium levels should be monitored.
• if the patient has an infection - see "Infections" below.
• if the patient has a history of allergic symptoms, the medicine should be administered with caution.
• similarly to all non-steroidal medicines, ketoprofen administration 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 rest of the 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 Sprint").
• if the patient has vision disorders, such as blurred vision, they should contact a doctor, as treatment may need to be discontinued.
• 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 Sprint should be used with caution.

Infections
Ketonal Sprint may mask the symptoms of infection, such as fever and pain. Therefore, Ketonal Sprint may delay the use of appropriate infection treatment, which can 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 a 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 Sprint" and the paragraphs below regarding gastrointestinal and cardiovascular risks.)
Concomitant use of Ketonal Sprint with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
During the use of all pain-relieving medicines from the NSAID group, such as ketoprofen, gastrointestinal bleeding, ulceration, and perforation have been reported, sometimes with a fatal outcome. Such events can occur at any time during treatment, even without warning symptoms or a history of serious gastrointestinal events.
The risk of bleeding, ulceration, or perforation of the gastrointestinal tract is higher during the use of high doses. It is also higher in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in the elderly (see "When not to take Ketonal Sprint"). 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 acetylsalicylic acid in low doses or other medicines that increase the risk of gastrointestinal complications, may be advised by their doctor to take protective medicines (e.g., misoprostol or proton pump inhibitors) (see "Other medicines and Ketonal Sprint").
Care should be taken 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 (e.g., medicines used to treat depression), anticoagulants (blood-thinning medicines, such as warfarin), or antiplatelet agents, such as acetylsalicylic acid (see "Other medicines and Ketonal Sprint").
Elderly patients
The medicine should be used with caution, as elderly patients may experience more side effects, especially gastrointestinal side effects, which can be fatal. Treatment should be started with the lowest possible dose, and any unusual symptoms, especially at the beginning of treatment, should be reported.
Children and adolescents
The medicine should not be used in children and adolescents under the age of 16.
If the medicine is taken by an adolescent aged 16 or over, the doctor may perform more frequent check-ups. The patient should consult a doctor.
If the patient has a history of gastrointestinal diseases, they should be closely monitored for gastrointestinal disorders, especially gastrointestinal bleeding.
Treatment with Ketonal Sprint should be stopped immediatelyafter the first symptoms of gastrointestinal bleeding or ulceration appear.
Patients with active or a history of peptic ulcer disease:
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 first signs of a rash, mucosal lesions, or other symptoms of hypersensitivity, the medicinal product Ketonal Sprint should be discontinued and a doctor consulted.
If the patient has celiac disease (gluten intolerance), they can take Ketonal Sprint, as it does not contain gluten.
If the patient has diabetes, they can take Ketonal Sprint, as it does not affect low-calorie diets or diets with restricted carbohydrate intake.

Ketonal Sprint and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is not recommendedto take Ketonal Sprint 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: there may be an increased risk of toxic effects of methotrexate on the blood. There must be at least a 12-hour interval between discontinuing or starting ketoprofen treatment and administering methotrexate.
• hydantoin derivatives (e.g., phenytoin) and sulfonamides (e.g., certain antibiotics and other medicines): the toxic effect of these substances may be enhanced.

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

• diuretics (medicines that increase urine production) used to reduce blood pressure.
• methotrexate (a medicine used to treat certain autoimmune diseases and certain cancers) in doses less than 15 mg/week: there may be an increased toxic effect of methotrexate on the blood. During the first few weeks of combination treatment, 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, such as beta-blockers, diuretics, ACE inhibitors, and angiotensin II antagonists: the patient should be properly hydrated before starting combination treatment, and kidney function should be considered after starting combination treatment (see "Warnings and precautions"). NSAIDs may weaken the effect of diuretics.
• digitalis glycosides: NSAIDs may increase the risk of heart failure, reduce the glomerular filtration rate, and increase digitalis glycoside levels; however, no pharmacokinetic interactions have been demonstrated between ketoprofen and active digitalis glycosides.
• corticosteroids (medicines used to treat inflammatory conditions): there may be an increased risk of gastrointestinal ulceration or bleeding (see "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): there may be an increased risk of kidney failure.
• zidovudine (a medicine used to treat HIV): there may be an increased 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 receptor 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 weaken 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): the 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 agents (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.
diphenylhydantoin 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 a doctor or pharmacist before taking this medicine .
Pregnancy
Ketonal Sprint should not be taken 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 also increase the risk of bleeding in the mother and child and prolong labor.
Ketonal Sprint should not be taken during 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 Sprint 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 levels of amniotic fluid surrounding the child (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
Breastfeeding is not recommended during treatment with Ketonal Sprint. It is not known whether ketoprofen passes into breast milk.
If the patient is planning to conceive or is having trouble conceiving, they should inform their doctor. Medicines like ketoprofen may make it harder to conceive.
Fertility
The use of NSAIDs, including Ketonal Sprint, may reduce female fertility and is not recommended in women trying to conceive.
NSAIDs, including Ketonal Sprint, should be discontinued if there are problems conceiving or during fertility testing.

Driving and using machines

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

Ketonal Sprint 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 Sprint

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The recommended dose is:
Adults and adolescents aged 16 and over
One sachet up to three times a day.
There should be at least an 8-hour interval between doses.
The smallest effective dose should be used for the shortest possible time necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the doctor should be consulted immediately (see section 2).

Use in the elderly

The dose should be 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 smallest daily dose is recommended (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. Urine output and kidney function should be monitored (see "Warnings and precautions").

Method of administration

• Open the sachet
• Pour the contents into a glass of water, using approximately 50 ml of water for each sachet used.
• Mix well for about 30 seconds until the granules are dissolved.
• The resulting oral solution should be taken immediately after preparation, during a meal.

Duration of treatment

Adults: the doctor should be consulted if there is no improvement or if the patient feels worse after 3 days of taking the medicine in case of fever or after 5 days in case of pain.
Adolescents: the doctor should be consulted if after 3 days of taking the medicine there is no improvement or if the patient feels worse.

Taking a higher dose of Ketonal Sprint than recommended

In case of overdose, the patient should immediately consult a doctor or go to the nearest hospital.
In most cases, symptoms of overdose are limited to lethargy, drowsiness, nausea, vomiting, abdominal 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 receive 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.

Missing a dose of Ketonal Sprint

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

4. Possible side effects

Like all medicines, Ketonal Sprint can cause side effects, although not everybody gets them.
The most common adverse events are related to the gastrointestinal tract.
The following side effects have been reported in adults during ketoprofen treatment:
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 (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 ulceration), peptic ulcer disease, colitis
hepatitis, increased 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)
dyskinesia (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 breakdown of red blood cells), neutropenia (decreased count of 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 patient from the pediatric population who took a dose twice as high as recommended in the product characteristics, anxiety and behavioral disorders also occurred.
seizures
changes in taste
tremors, hyperkinesia
heart failure (weakened heart), atrial fibrillation (heart rhythm disorder), palpitations, tachycardia (rapid heart rate)
hypertension (high blood pressure), vasodilation, vasculitis (inflammation of blood vessels or lymphatic vessels)
bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnea (difficulty breathing), bronchial spasm, 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 pain, angioedema (swelling of the mouth)
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 papules, purpura, acute generalized exanthematous pustulosis (rash with pustules)
acute kidney failure, tubulointerstitial nephritis, nephritic syndrome, nephrotic syndrome, kidney failure, fluid retention and (or) sodium retention with possible edema, acute tubular necrosis (kidney cell damage), renal papillary necrosis (kidney tissue damage), oliguria (reduced urine output), abnormal kidney function test results
periorbital edema (swelling around the eyes)
aseptic meningitis (inflammation of the membranes surrounding the brain, 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 Sprint, 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 Sprint").
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 side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety 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 Sprint

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging and sachet after EXP. The expiration date refers to the last day of the month stated.
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. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Ketonal Sprint contains

• The active substance is ketoprofen. Each sachet contains 25 mg of ketoprofen in the form of ketoprofen lysinate (40 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 Sprint looks like and contents of the pack

White or yellowish granules.
The medicine is packaged in paper/Aluminum/PE sachets, in a cardboard box.
Pack sizes: 12 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
Marketing authorization holder's logo