KETOFLIX 50 mg Granulate

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ketoflix, 50 mg, granules for oral solution, in a sachet
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ketoflix and what is it used for
4. Important information before taking Ketoflix
   1. When not to take Ketoflix
   2. Warnings and precautions
   3. Infections
   4. Children and adolescents
   5. Ketoflix and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ketoflix contains sodium
5. How to take Ketoflix
   1. Use in elderly patients
   2. Liver function disorders
   3. Method of administration
   4. Duration of treatment
   5. Overdose of Ketoflix
   6. Missed dose of Ketoflix
6. Possible side effects
   1. Frequency not known
   2. Frequency not known
   3. Very rare
   4. Frequency not known
   5. Blood tests
   6. Reporting side effects
7. How to store Ketoflix
8. Contents of the packaging and other information
   1. What Ketoflix contains
   2. What Ketoflix looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Ketoflix, 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.

• This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• Consult a doctor if there is no improvement or 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 Ketoflix and what is it used for
• 2. Important information before taking Ketoflix
• 3. How to take Ketoflix
• 4. Possible side effects
• 5. How to store Ketoflix
• 6. Contents of the packaging and other information

1. What is Ketoflix and what is it used for

Ketoflix contains the active substance ketoprofen in the form of ketoprofen lysinate. It belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs).
Ketoflix is used in adults and adolescents from 16 years of age for short-term symptomatic treatment of mild or moderate acute pain, such as:

• headache
• toothache
• menstrual cramps
• pain caused by minor sprains and strains

2. Important information before taking Ketoflix

When not to take Ketoflix

• if the patient is hypersensitive to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced an allergic reaction after taking acetylsalicylic acid or other painkillers, such as ketoprofen, ibuprofen, or diclofenac, such as:
• asthma attack, difficulty breathing
• swelling of the face, lips, tongue, or throat
• hives, itching, runny nose, and watery discharge from the nose, nasal polyps
• other types of allergic reactions. Such patients have been reported to have severe, sometimes fatal, severe allergic reactions.
• if the patient has asthma;
• if the patient has stomach or duodenal ulcers or has had bleeding, ulcers, or perforation of the gastrointestinal tract in the past;
• if the patient has had perforation of the gastrointestinal tract or bleeding after previous treatment with non-steroidal anti-inflammatory drugs;
• if the patient has gastrointestinal disease, such as ulcerative colitis or Crohn's disease;
• if the patient has inflammation of the stomach lining;
• if the patient has severe heart failure;
• if the patient has severe liver failure (liver cirrhosis, severe hepatitis);
• if the patient has severe kidney problems;
• if the patient is undergoing intensive diuretic therapy;
• if the patient has a tendency to bleeding;
• if the patient has leukopenia (decreased white blood cell count) and thrombocytopenia (decreased platelet count);
• if the patient has hemostasis disorders;
• if the patient has severe blood clotting disorders;
• if the patient is in the third trimester of pregnancy (see "Pregnancy, breastfeeding, and fertility");

Ketoflix should not be taken without a clear doctor's recommendation if the patient has an increased risk of complications related to the stomach, e.g., if the patient is elderly or taking certain other medications, such as anticoagulants, antiplatelet agents, corticosteroids, other non-steroidal anti-inflammatory drugs, or selective serotonin reuptake inhibitors (SSRIs), see also below "Warnings and precautions" and "Ketoflix and other medicines".

Warnings and precautions

Before taking Ketoflix, the patient should discuss it with their doctor or pharmacist if they:

• have asthmacombined with long-term inflammation of the nasal mucosa or sinuses and (or) nasal polyps;
• have or have had heart disease, such as mild or moderate congestive heart failure. Symptoms include fluid accumulation in the lungs, abdominal organs, arms, or legs. See also "When not to take Ketoflix".
• have mild or moderate kidney or liver disease, including changes in liver function test results or kidney function tests. See also above "When not to take Ketoflix".
• are taking diuretics (medicines that increase urine production);
• have low blood volume (hypovolemia)
• have or have had high blood pressure;
• have vascular diseasein the hands and (or) feet or brain;
• suffer from diabetesor have high cholesterollevels in the blood;
• smoke;
• have a history of allergies or have had allergic symptoms in the past;
• have vision disturbances, such as blurred vision;
• have hematopoietic disorders that affect blood cell production and maturation, systemic lupus erythematosus (an immune system disease), or mixed connective tissue disease;
• are elderly. Elderly patients are at increased risk of adverse reactions associated with the use of painkillers, such as ketoprofen, especially gastrointestinal bleeding and perforation, which can be fatal.

Therefore, elderly patients should report any unusual symptoms, especially gastrointestinal bleeding, especially at the start of treatment. The doctor will also closely monitor the patient's condition.

• have symptoms of infection - see below, section titled "Infections".

As with most non-steroidal anti-inflammatory drugs, it may sometimes happen that there is an increase in liver enzyme activity, an increase in bilirubin levels, or other liver function indicators in the blood, as well as an increase in serum creatinine or urea levels in the blood, and abnormal results of other laboratory tests.
Most of these disorders are minor and transient. If they increase or persist, ketoprofen administration should be discontinued.
Hyperkalemia may occur, especially in patients with diabetes or during concomitant therapy that may also affect potassium levels. In such cases, regular monitoring of potassium levels is recommended.
Concomitant use of Ketoflix with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
During treatment with all painkillers, such as ketoprofen, gastrointestinal bleeding, ulcers, and perforation have been reported, in some cases with a fatal outcome. Such reactions can occur at any time during treatment, even without warning signs or severe gastrointestinal events in the history.
The risk of bleeding, ulcers, or perforation of the gastrointestinal tract is higher when using high doses. It is also higher in patients with a history of stomach ulcers, especially if complicated by bleeding or perforation, and in elderly patients (see "When not to take Ketoflix"). Taking ketoprofen, especially in high doses, may be associated with a higher risk of toxic effects on the gastrointestinal tract.
Patients who are at risk of the above warnings, as well as patients who need to take acetylsalicylic acid in low doses or other medications associated with an increased risk of gastrointestinal complications, may be advised by their doctor to take protective medications.
If the patient experiences symptoms of gastrointestinal bleeding, ulcers, or perforation, they should immediately stop taking Ketoflix and consult a doctor. See section 4 "Possible side effects".
Caution should be exercised if the patient is taking medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids (medications used to treat inflammatory conditions), selective serotonin reuptake inhibitors (such as medications used to treat depression), anticoagulants (blood-thinning medications, such as warfarin), or antiplatelet agents, such as acetylsalicylic acid (see "Ketoflix and other medicines"). The risk of gastrointestinal bleeding is increased in patients with low body weight.
Taking such medications as Ketoflix may be associated with a slightly increased riskof heart attack or stroke. This risk increases with long-term use of high doses of the medication. The recommended dose should not be exceeded, and treatment should not be prolonged. The patient should inform their doctor or pharmacist if they have heart disease, have had a stroke, or are at risk of these conditions, e.g., due to:

• high blood pressure, diabetes, or high cholesterol levels in the blood
• smoking.

During treatment with painkillers, such as ketoprofen, very rare serious skin reactionswith redness and blistering (some with a potentially fatal outcome) have been reported. See section 4 "Possible side effects". Most of these occurred within the first month of treatment.
If the patient develops a skin rash, changes in the mucous membranes, or other symptoms of hypersensitivity, they should immediately stop taking Ketoflix and consult a doctor.
Side effects can be minimized by using the medication in the smallest effective dose for the shortest duration necessary to relieve symptoms. Do not take higher doses or longer treatment than recommended.

Infections

Ketoflix may mask symptoms of infection, such as fever and pain. As a result, Ketoflix may delay the use of appropriate infection treatment, potentially leading 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 medication during an infection, and the infection symptoms persist or worsen, they should immediately consult a doctor.

Children and adolescents

The medication should not be taken by children and adolescents under 16 years of age.
If the medication is taken by a patient over 16 years of age, the doctor may perform more frequent check-ups.

Ketoflix and other medicines

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
It is not recommendedto take Ketoflix if the patient is taking:

• other painkillers, such as
• medications similar to ketoprofen, e.g., ibuprofen, diclofenac, naproxen
• acetylsalicylic acid in doses used to treat pain and inflammation or to reduce fever
• medications used to treat pain, inflammation, or rheumatic diseases, containing an active substance ending in "-coxib"
• medications used to prevent blood clotting, platelet aggregation, or dissolve blood clots, such as acetylsalicylic acid, warfarin, clopidogrel, ticlopidine, heparin;
• lithium - a medication used to treat depression and mental illnesses;
• methotrexate used to treat cancer and certain autoimmune diseases in a dose of 15 mg per week or higher. It is recommended to wait at least 12 hours between stopping or starting ketoprofen treatment and administering methotrexate; certain medications used to treat epilepsy, such as phenytoin;
• sulfonamides, which are components of certain diuretics or used to treat bacterial infections.

If concomitant use of Ketoflix and any of the above medications is necessary, the doctor should closely monitor the patient's condition.
Ketoflix and other medications may also interact with each other. Therefore, the patient should always consult their doctor or pharmacist before taking Ketoflix with other medications, especially:

• medications that may increase potassium levels, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs, heparin, cyclosporine, tacrolimus, and trimethoprim;
• Tenofovir - a medication used to treat certain viral infections;
• medications that increase urine production through the kidneys and are used to lower blood pressure (diuretics);
• methotrexate used to treat cancer, severe arthritis, and skin diseases, psoriasis, in a dose less than 15 mg per week;

and

• medications used to lower high blood pressure, containing an active substance ending in "-pril" or "-sartan" (e.g., losartan) or "-olol";
• medications used to treat depression, so-called selective serotonin reuptake inhibitors;
• corticosteroids used to treat inflammation, allergies, prevent organ rejection, such as cortisone;
• pentoxifylline - a medication used to treat muscle pain due to vascular disease in the hands and (or) feet;
• probenecid - a medication used to treat gout and high uric acid levels in the blood;
• cyclosporine and tacrolimus - medications used to suppress the immune system, e.g., after organ transplantation;
• medications used to dissolve blood clots;
• zidovudine, a medication used to treat HIV infection;
• digitalis glycosides: non-steroidal anti-inflammatory drugs may worsen heart failure, reduce glomerular filtration rate, and increase digitalis glycoside levels; however, no pharmacokinetic interaction has been demonstrated between ketoprofen and active digitalis glycosides;
• medications used to treat diabetes, such as glibenclamide or glimepiride;
• Mifepristone (a medication used to terminate pregnancy medically).
• Intrauterine contraception: the effectiveness of the device may be reduced, leading to pregnancy;
• Antiplatelet agents (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs): there is an increased risk of gastrointestinal bleeding;
• Phenytoin and sulfonamides: it may be necessary to reduce the dosage of phenytoin or sulfonamides;
• Quinolone antibiotics - patients taking non-steroidal anti-inflammatory drugs and quinolones may be at increased risk of seizures;
• it is recommended to avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

Do not take Ketoflix in the last 3 months of pregnancy.
It is recommended to avoid taking Ketoflix in the first 6 months of pregnancy, unless the doctor considers it absolutely necessary.
It is not recommended to breastfeed while taking Ketoflix. It is not known whether ketoprofen passes into breast milk.
If the patient plans to become pregnant or is having trouble getting pregnant, they should inform their doctor. Medications like ketoprofen may make it harder to get pregnant.

Driving and using machines

Ketoflix generally does not affect the ability to drive or operate machinery.
However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or vision disturbances, they should not perform these activities.

Ketoflix contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per sachet, which means the medication is considered "sodium-free".

3. How to take Ketoflix

This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose is:
Adults and adolescents from 16 years of age
Half a divided sachet to three times a day or one whole divided sachet to two times a day.
There should be at least an 8-hour interval between doses.
Side effects can be minimized by using the medication in the smallest effective dose for the shortest duration necessary to relieve symptoms. Do not take higher doses or longer treatment than recommended.

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.

Liver function disorders

In patients with mild or moderate liver function disorders, the doctor may reduce the dose.
Ketoflix should not be taken by patients with severe liver function disorders.

Method of administration

• Open the sachet along the line marked "half dose" to obtain the dose contained in one part of the sachet (25 mg).
• Open the sachet along the line marked "full dose" to obtain the dose contained in the entire sachet (50 mg).
• Pour the contents into a glass with about 100 ml of water.
• Mix well for about 30 seconds until the granules dissolve.
• The resulting oral solution should be taken immediately after preparation, during a meal.

Duration of treatment

Adults: consult a doctor if there is no improvement or the patient feels worse after 3 days of taking the medication in case of fever or after 5 days in case of pain.
Adolescents: consult a doctor if there is no improvement or the patient feels worse after 3 days of taking the medication.

Overdose of Ketoflix

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.

Missed dose of Ketoflix

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, they should not take the missed dose. Do not take a double dose to make up for the missed dose.
In case of further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Ketoflix can cause side effects, although not everybody gets them.
If the following side effects occur, stop taking the medication and consult a doctor or the nearest hospital immediately:
Rare(may occur in less than 1 in 1000 people)

• asthma attack
• burning, persistent stomach pain with a feeling of hunger. These symptoms may indicate stomach or duodenal ulcers.

Frequency not known

• vomiting blood, severe abdominal pain, or black, tarry stools (symptoms of gastrointestinal bleeding or perforation)
• blisters, skin peeling, or bleeding in the skin with itching, lumpy rash (or without it) on the lips, eyes, mouth, nose, genitals, hands, or feet, sometimes with flu-like symptoms. These may be symptoms of serious skin reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis), which require urgent treatment
• blood in the urine, changes in urine output, swelling, especially of the feet, ankles, or hands, which may indicate serious kidney problems
• chest pain (symptom of a heart attack) or sudden severe headache, nausea, dizziness, numbness, or difficulty speaking (symptoms of a stroke). Taking medications like Ketoflix may be associated with a slightly increased risk of heart attack or stroke. See "Warnings and precautions" in section 2.
• symptoms of severe allergic reactions, such as:
• swelling of the face, lips, mouth, throat, or larynx, causing wheezing or difficulty swallowing or breathing
• chest tightness, rapid heartbeat, decreased blood pressure leading to shock
• itching and rash
• laryngeal spasm, which causes difficulty breathing
• increased susceptibility to infections, which may be due to a serious blood disorder, so-called agranulocytosis
• seizures

If the patient experiences any of the following side effects, they should immediatelytell their doctor:
Rare(may occur in less than 1 in 1000 people)

• unusual skin sensations, such as numbness, tingling, prickling, or burning of the skin
• pallor, feeling of fatigue, fainting, or dizziness, possibly due to anemia caused by blood loss
• blurred vision
• jaundice or yellowing of the whites of the eyes, which may indicate liver function disorders

Frequency not known

• easy bruising or prolonged bleeding. These may be symptoms of a serious blood disorder, such as a low platelet count.
• worsening of a bowel disease called Crohn's disease or ulcerative colitis
• skin reaction to sunlight or UV radiation

Other side effects may occur with the following frequency:
Common(may occur in less than 1 in 10 people):

• indigestion, abdominal pain
• nausea, vomiting

Uncommon(may occur in less than 1 in 100 people):

• gastritis
• constipation, diarrhea, gas
• skin rash, itching
• fluid retention, which may cause swelling of the hands or feet
• headache, dizziness, or drowsiness
• feeling of fatigue or malaise, chills

Rare(may occur in less than 1 in 1000 people):

• ringing in the ears
• weight gain
• mouth ulcers
• hemorrhagic anemia (anemia due to blood loss)
• paresthesia (abnormal skin sensation)
• blurred vision
• asthma, stomach ulcers (stomach or duodenal ulcers), liver inflammation, increased liver enzyme activity, elevated bilirubin levels in the blood

Very rare

• movement disorders, fainting
• low blood pressure
• laryngeal edema
• hematuria
• physical weakness, facial swelling

Frequency not known

• heart failure with symptoms such as shortness of breath, difficulty breathing when lying down, swelling of the feet or hands
• palpitations
• high or low blood pressure
• skin redness due to dilated blood vessels
• rapid heartbeat
• mood changes
• restlessness
• difficulty sleeping
• changes in taste
• heartburn
• swelling around the eyes
• runny nose, itching, sneezing, and nasal congestion
• hair loss
• hives, redness, and skin inflammation, raised rash
• thrombocytopenia (low platelet count), agranulocytosis (significant decrease in white blood cell count), hemolytic anemia (anemia due to abnormal red blood cell destruction); neutropenia (decrease in neutrophil count); aplastic anemia (due to abnormal bone marrow function); leukocytosis (elevated white blood cell count); thrombocytopenic purpura
• anaphylactic reactions (including anaphylactic shock)
• seizures
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs)
• photosensitivity (reaction to sun exposure or UV radiation), hives, angioedema, blistering eruptions, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis (severe skin reactions), erythema (skin redness), rash, lumpy rash, purpura, acute generalized exanthematous pustulosis, skin inflammation
• acute kidney failure, interstitial nephritis, kidney inflammation, or nephrotic syndrome, glomerulonephritis, fluid retention/sodium retention with possible swelling, acute tubular necrosis (kidney tubule cell damage), renal papillary necrosis (kidney papilla damage) oliguria (decreased urine output), symptoms of abnormal kidney function
• vasculitis (inflammation of blood vessels)
• hyperkalemia (elevated potassium levels in the blood)
• hyponatremia (low sodium levels in the blood)
• aseptic meningitis, vasculitis
• abdominal pain

Blood tests

Blood test results may indicate liver or kidney function disorders.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +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 can help gather more information on the safety of the medication.

5. How to store Ketoflix

Store the medication out of sight and reach of children.
Do not take this medication after the expiration date stated on the packaging and sachet after EXP. The expiration date refers to the last day of the specified month.
The oral solution obtained after dissolving the powder should be used immediately.
There are no special recommendations for storage conditions.
Medications should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Ketoflix 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 natural flavoring preparations, maltodextrin, and gum arabic (E 414)), sodium chloride, sodium saccharin (E 954), colloidal anhydrous silica.

What Ketoflix looks like and contents of the packaging

White or yellowish granules.
The medication is packaged in divided sachets of paper/Aluminum/PE, in a cardboard box.
The packaging contains 2, 6, 8, 10, 12, or 20 divided sachets.
One divided sachet contains 2 g of granules for oral solution.
Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]

Manufacturer

Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano 43
24041 Brembate (BG), Italy

Date of last revision of the leaflet:

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