Ketoflix

Package leaflet: Information for the patient

Ketoflix, 50 mg, granules for oral solution in sachet
Ketoprofenum
Please read this 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 the physician or pharmacist.
• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Contact your doctor if symptoms do not improve or if you feel worse:
  • adolescents: after 3 days of treatment
  • adults: after 3 days of treatment for fever or after 5 days for pain.

Table of contents

1. What Ketoflix is and what it is 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 pack and other information

1. What Ketoflix is and what it is used for

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

• headache
• toothache
• painful menstruation
• pain due to minor strains and sprains

2. Important information before taking Ketoflix

When not to take Ketoflix

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction after taking acetylsalicylic acid or another pain-relieving medicine, such as ketoprofen, ibuprofen, or diclofenac, such as:
• asthma attack, difficulty breathing
• swelling of the face, lips, tongue, or throat
• hives, itchy nose, watery nasal discharge, nasal polyps
• other types of allergic reactions. Severe, rarely fatal, allergic reactions have been reported in such patients.
• if the patient suffers from asthma;
• if the patient has a peptic ulcer of the stomach and/or duodenum or has previously experienced gastrointestinal bleeding, ulceration, or perforation;
• if the patient has previously experienced gastrointestinal perforation or bleeding during earlier treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has a gastrointestinal disorder such as ulcerative colitis or Crohn's disease;
• if the patient has inflammation of the gastric mucosa;
• if the patient has severe heart failure;
• if the patient has severe liver dysfunction (liver cirrhosis, severe hepatitis);
• if the patient has severe kidney function disorders;
• if the patient is undergoing intensive diuretic therapy;
• if the patient has a tendency to bleed;
• if the patient has leukopenia (reduced white blood cell count) and thrombocytopenia (reduced platelet count);
• if the patient has coagulation 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 used without a clear recommendation from a doctor if the patient has an increased risk of gastrointestinal complications, for example, if the patient is elderly or is taking certain other medicines 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, discuss with your doctor or pharmacist if the patient:

• has asthma in combination with chronic inflammation of the nasal mucosa or sinuses and/or nasal polyps;
• has or has had heart disease, such as mild or moderate congestive heart failure. Symptoms include fluid accumulation in the lungs, abdominal cavity, arms, or legs. See also "When not to take Ketoflix".
• has mild or moderate kidney or liver disease, including abnormal results in certain liver or kidney function tests. See also above "When not to take Ketoflix".
• is taking diuretics (medicines that increase urine production);
• has low blood volume (hypovolemia);
• has or has had high blood pressure;
• has vascular diseases in the arms and/or legs or in the brain;
• has diabetes or has high cholesterol levels in the blood;
• smokes tobacco;
• has allergy symptoms or has had allergy symptoms in the past;
• has vision disorders, such as blurred vision;
• has hematopoietic disorders affecting blood cell formation and maturation, systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disease;
• is elderly. In elderly patients, there is an increased risk of adverse effects associated with the use of pain-relieving medicines such as ketoprofen, especially gastrointestinal bleeding and perforation, which may be fatal.

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

• has symptoms of infection – see below, section titled "Infections".

As with most non-steroidal anti-inflammatory drugs, increases in aminotransferase activity, elevated bilirubin levels, or other liver function markers in serum, as well as increased serum creatinine or blood urea nitrogen levels, and abnormal results in other laboratory tests may occasionally occur. Most of these abnormalities are mild and transient. If such abnormalities increase or persist, ketoprofen administration should be discontinued.

Hyperkalemia may occur, especially in patients with diabetes or during concomitant treatment 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.

When using any pain-relieving medicine such as ketoprofen, gastrointestinal bleeding, ulceration, and perforation have been reported, sometimes with fatal outcomes. These events may occur at any time during treatment, even without warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulceration, or perforation is higher when high doses are used. It is also higher in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in elderly patients (see section "When not to take Ketoflix"). Use of ketoprofen, especially at high doses, may be associated with an increased risk of gastrointestinal toxicity.

For patients with the above warnings, and for those requiring concomitant use of low-dose acetylsalicylic acid or other medicines associated with an increased risk of gastrointestinal complications, the doctor may recommend protective medicines.

If the patient experiences symptoms of gastrointestinal bleeding, ulceration, or perforation, Ketoflix should be discontinued immediately and medical advice sought. See section 4 "Possible side effects".

Caution is advised if the patient is 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 thinners, 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 medicines such as Ketoflix may be associated with a slight increase in the risk of heart attack or stroke. This risk increases with long-term use of high doses. The recommended dose should not be exceeded, nor should treatment be prolonged. Inform your doctor or pharmacist if you have heart disease, have had a stroke, or are at risk of such events, for example, in case of:

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

When using pain-relieving medicines such as ketoprofen, serious skin reactions with redness and blistering (some with potentially fatal outcomes) have been very rarely reported. See section 4 "Possible side effects". Most of these occurred within the first month of treatment.

If the patient develops a skin rash, mucosal changes, or other signs of hypersensitivity, Ketoflix should be discontinued immediately and medical advice sought.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Doses higher than recommended and longer treatment durations should not be used.

Infections

Ketoflix may mask symptoms of infection, such as fever and pain. Therefore, Ketoflix may delay appropriate treatment of infection and consequently increase the 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 existing infection and symptoms persist or worsen, medical advice should be sought immediately.

Children and adolescents

The medicine should not be used in children and adolescents under 16 years of age.

If the medicine is taken by a patient aged 16 years or older, the doctor may perform more frequent control examinations.

Ketoflix and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

It is not recommended to use Ketoflix 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;
• lithium – a medicine used to treat depression and psychiatric disorders;
• methotrexate used to treat cancer and certain autoimmune diseases at a dose of 15 mg per week or higher. At least 12 hours should elapse between stopping or starting ketoprofen treatment and methotrexate administration;
• certain medicines used to treat epilepsy, such as phenytoin;
• sulfonamide medicines, which are components of certain diuretics or used to treat bacterial infections.

If concomitant use of Ketoflix and any of the listed medicines is necessary, the doctor should carefully monitor the patient's condition.

Ketoflix and other medicines may also interact and affect each other's actions. Therefore, always consult your doctor or pharmacist before using Ketoflix together with other medicines, especially such as:

• medicines 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 medicine used to treat certain viral infections;
• medicines that increase urine excretion by the kidneys and are used to lower blood pressure (diuretics);
• methotrexate used to treat cancer, severe arthritis, and skin disease psoriasis, at a dose less than 15 mg per week;
• medicines used to lower high blood pressure containing an active substance with a name ending in “-pryl” or “-sartan” (e.g. losartan) or “-olol”;
• medicines used to treat depression, so-called selective serotonin reuptake inhibitors;
• corticosteroids used to treat inflammation, allergies, or prevent organ transplant rejection, such as cortisone;
• pentoxifylline – a medicine used to treat muscle pain due to vascular disease in the arms and/or legs;
• probenecid – a medicine used to treat gout and high uric acid levels in the blood;
• cyclosporine and tacrolimus – medicines used to suppress immune system function, e.g. after organ transplantation;
• medicines used to dissolve blood clots;
• zidovudine, a medicine used to treat HIV infection;
• cardiac glycosides: non-steroidal anti-inflammatory drugs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels; however, no pharmacokinetic interaction between ketoprofen and active glycosides has been demonstrated;
• medicines used to treat diabetes, such as glibenclamide or glimepiride;
• Mifepristone (a medicine used to terminate pregnancy pharmacologically);
• Intrauterine contraception: device effectiveness may be reduced, potentially leading to pregnancy;
• Antiplatelet agents (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding;
• Phenytoin and sulfonamides: dosage reduction of phenytoin or sulfonamides may be necessary;
• Quinolone antibiotics – patients taking non-steroidal anti-inflammatory drugs and quinolones may be at increased risk of seizures;
• alcohol consumption should be avoided.

Pregnancy, breastfeeding and fertility

Do not use Ketoflix during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketoflix may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor.

Avoid using Ketoflix during the first 6 months of pregnancy unless the doctor considers it absolutely necessary.

If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ketoflix may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding is not recommended during treatment with Ketoflix. It is not known whether ketoprofen passes into breast milk.

If the patient plans pregnancy or has difficulty conceiving, she should inform her doctor.

Medicines such as ketoprofen may impair fertility.

Driving and operating machinery

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, these activities should not be performed.

Ketoflix 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 Ketoflix

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended dose:
Adults and adolescents aged 16 years and older
Half a dual-compartment sachet three times daily or one whole dual-compartment sachet twice daily.
At least an 8-hour interval should be maintained between doses.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not use higher doses or longer treatment durations 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.

Hepatic impairment
In patients with mild to moderate hepatic impairment, the doctor may reduce the dose.
Ketoflix must not be used in patients with severe hepatic impairment.

Instructions for use

• 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).
• Empty the contents into a glass containing approximately 100 ml of water.
• Mix thoroughly 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 if the patient feels worse after 3 days of treatment for fever or after 5 days for pain.
Adolescents: consult a doctor if there is no improvement or if the patient feels worse after 3 days of treatment.

Accidental overdose of Ketoflix
If more medicine 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, and epigastric pain.

Missed dose of Ketoflix
If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop taking the medicine immediately
and consult a doctor or go to the nearest hospital without delay:
Rare (may occur in fewer than 1 in 1,000 people)

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

Frequency not known

• vomiting blood, severe abdominal pain, or tarry (black) stools (signs of gastrointestinal bleeding or perforation)
• formation of blisters, peeling of the skin, or bleeding within the skin with an itchy, nodular rash (or without rash) affecting the lips, eyes, oral cavity, nose, genital organs, hands or feet, sometimes with flu-like symptoms. These may be signs of serious skin reactions (i.e. Stevens-Johnson syndrome and toxic epidermal necrolysis), which require urgent treatment
• presence of blood in the urine, changes in urine volume, swelling, especially in the legs, ankles or feet, which may indicate serious kidney disorders
• chest pain (symptom of heart attack) or sudden severe headache, nausea, dizziness, numbness, difficulty or inability to speak, paralysis (symptoms of stroke). Use of medicines such as Ketoflix may be associated with a small 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, drop in blood pressure leading to shock
• itching and rash
• laryngospasm causing breathing difficulties
• increased susceptibility to infections, possibly due to a serious blood disorder called agranulocytosis
• seizures

If any of the following adverse effects occur in the patient, immediately inform the doctor:
Rare (may occur in fewer than 1 in 1,000 people)

• unusual skin sensations such as numbness, tingling, pricking, burning skin or chills
• pale skin, feeling of fatigue, faintness or dizziness, possibly due to red blood cell deficiency caused by bleeding
• blurred vision
• yellowing of the skin or whites of the eyes, which may indicate liver function disorders

Frequency not known

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

Other adverse effects may occur with the following frequencies:
Common (may occur in fewer than 1 in 10 people):

• indigestion, abdominal pain
• nausea, vomiting

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

• inflammation of the stomach lining
• constipation, diarrhea, flatulence
• 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 fewer than 1 in 1,000 people):

• ringing in the ears
• weight gain
• ulceration and inflammation of the oral cavity
• hemorrhagic anemia (anemia due to blood loss)
• paresthesia (abnormal skin sensation, tingling)
• blurred vision
• asthma, peptic ulcer disease (gastric or duodenal ulcers), colitis, hepatitis, increased aminotransferase activity (liver enzymes), elevated bilirubin levels in blood

Very rare

• dyskinesia (movement disorders), fainting
• hypotension (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 legs
• palpitations
• high or low blood pressure
• skin redness due to blood vessel dilation
• rapid heartbeat
• mood changes
• restlessness
• difficulty falling asleep
• altered taste perception
• heartburn
• periorbital edema
• runny nose, itching, sneezing and nasal congestion
• hair loss
• urticaria, redness and inflammation of the skin, raised rash
• thrombocytopenia (reduced platelet count), agranulocytosis (marked reduction in white blood cells), hemolytic anemia (anemia caused by abnormal destruction of red blood cells); neutropenia (reduced number of white blood cells - neutrophils); aplastic anemia (due to abnormal bone marrow function); leukocytosis (increased number of leukocytes in blood), thrombocytopenic purpura
• anaphylactic reactions (including anaphylactic shock)
• seizures
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs)
• photosensitivity (reaction to exposure to sunlight or UV lamps), urticaria, angioedema, vesicular eruptions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (severe skin reactions), erythema (skin redness), rash, maculopapular rash, purpura, acute generalized exanthematous pustulosis, dermatitis
• acute kidney failure, interstitial nephritis, nephritis or nephrotic syndrome, glomerulonephritis, water/sodium retention with possible edema, acute tubular necrosis (damage to renal tubular cells), renal papillary necrosis (damage to renal papillae), oliguria (reduced urine output), symptoms of impaired kidney function
• lymphangitis (inflammation of lymphatic vessels)
• hyperkalemia (increased potassium levels in blood)
• hyponatremia (decreased sodium levels in blood)
• aseptic meningitis, lymphangitis
• stomach pain

Blood tests
Blood test results may indicate impaired liver or kidney function.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting of adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ketoflix

Keep this medicine out of the 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 specified 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Ketoflix contains
The active substance is ketoprofen. Each sachet contains 50 mg of ketoprofen in the form of ketoprofen
with lysine (80 mg).
Other ingredients: mannitol (E 421), povidone K30, mint flavour (containing natural flavourings, maltodextrin and gum arabic (E 414)), sodium chloride, sodium saccharin (E 954), anhydrous colloidal silicon dioxide.

What Ketoflix looks like and contents of the pack
White or yellowish granules.
The medicine is packed in double-layered paper/aluminium/PE sachets, placed in a cardboard box.
Pack contains 2, 6, 8, 10, 12 or 20 double-layered sachets.
One double-layered sachet contains 2 g of granules for oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +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
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