Ketoflix

Patient Information Leaflet

Ketoflix
50 mg, hard capsules
Ketoprofen
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents

1. What Ketoflix is and what it is used for
2. What you need to know 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. Ketoprofen is a non-steroidal anti-inflammatory
drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties.

Ketoflix is used for short-term symptomatic treatment of mild to moderate acute pain of various
origin, such as muscular pain, musculoskeletal pain, and headache.
Ketoflix is intended for use in adolescents over 15 years of age and adults.

2. Important information before using Ketoflix

When not to use 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 asthma attack, bronchospasm, nasal mucosal swelling, skin reaction (skin swelling or itchy rash), or any other type of allergic reaction after taking ketoprofen or similarly acting medicines (such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (so-called NSAIDs));
• if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding and fertility");
• if the patient has active gastric or duodenal ulcer or has previously experienced gastrointestinal bleeding, gastrointestinal ulceration or perforation;
• if the patient has severe heart, liver or kidney failure;
• if the patient has a bleeding tendency (bleeding diathesis);
• if the patient is under 15 years of age.

Warnings and precautions
Before starting to use Ketoflix, consult a doctor, pharmacist or nurse, especially if:

• the patient has a history of gastrointestinal disorders (gastric or duodenal ulcer, ulcerative colitis, Crohn's disease) – due to the possibility of worsening symptoms;
• the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet drugs (such as acetylsalicylic acid);
• the patient has been diagnosed with asthma, chronic rhinitis, chronic sinusitis, or nasal polyps – administration of ketoprofen may trigger an asthma attack or bronchospasm, particularly in individuals with hypersensitivity to acetylsalicylic acid or nonsteroidal anti-inflammatory drugs;
• the patient has heart disease (heart failure, ischemic heart disease), peripheral arterial disease and/or cerebrovascular disease, has had a stroke, or suspects having an increased risk of cardiovascular disorders (e.g. high blood pressure, diabetes, elevated cholesterol, smoking);
• the patient has kidney or liver disease or fluid imbalance (e.g. dehydration due to diuretic use or after recent surgery) – use of the medicine may reduce renal blood flow, leading to kidney function impairment, especially in elderly patients. Very rare cases of jaundice and hepatitis have been reported during ketoprofen treatment;
• the patient is elderly – elderly patients have a higher risk of adverse effects (especially gastrointestinal bleeding and perforation), so they should exercise particular caution;
• the patient has an infection – see below, section titled "Infections".

Taking Ketoflix at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Avoid concomitant use of Ketoflix with other medicines containing nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid or selective cyclooxygenase-2 (COX-2) inhibitors.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration or perforation (with potentially fatal outcome), which may occur at any time during treatment, even without warning symptoms or history of severe gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher when high doses of NSAIDs are used, in patients with a history of peptic ulcer disease, especially complicated by bleeding or perforation (see section "When not to use Ketoflix"), and in elderly patients.
If the patient experiences unusual gastrointestinal symptoms during treatment (especially bleeding), discontinue use of the medicine immediately and inform the doctor without delay.
Taking nonsteroidal anti-inflammatory drugs other than acetylsalicylic acid, such as ketoprofen, may be associated with a small increased risk of arterial thrombotic events (heart attack or stroke). This risk increases with prolonged use of high doses of the medicine. Do not use higher doses or longer treatment duration than recommended.
Use of NSAIDs such as Ketoflix may be associated with a small increased risk of atrial fibrillation.
During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of therapy, very rare but severe skin reactions (some with potentially fatal outcomes) may occur, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient develops a rash, mucosal lesions or any signs of hypersensitivity, discontinue the medicine immediately and consult a doctor without delay.
If the patient experiences visual disturbances (e.g. blurred vision) during treatment with Ketoflix, discontinue use of the medicine and consult a doctor.

Infections
Ketoflix may mask objective signs 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 varicella. If the patient takes this medicine during an existing infection and symptoms persist or worsen, seek immediate medical advice.

Children and adolescents
Do not use this medicine in children and adolescents under 15 years of age.

Ketoflix and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
The following medicines should not be used together with Ketoflix:

• other painkillers such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g. acetylsalicylic acid, diclofenac, naproxen);
• anticoagulants (medicines that inhibit blood clotting), antiplatelet agents (medicines that inhibit platelet aggregation), thrombolytics (medicines used to unblock blood vessels), direct factor Xa inhibitors, for example: acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, edoxaban;
• lithium (a medicine used in the treatment of certain psychiatric disorders);
• methotrexate (a medicine used, among others, in the treatment of cancer) at doses exceeding 15 mg per week.

Ketoflix and other medicines may interact with each other. Therefore, always consult a doctor or pharmacist before using Ketoflix together with other medicines.
In particular, before taking Ketoflix, inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines that may increase blood potassium levels, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs), heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim;
• diuretics (medicines that increase urine production);
• methotrexate (a medicine used, among others, in the treatment of cancer) at doses less than 15 mg per week;
• medicines that lower blood pressure;
• medicines used to treat depression (so-called selective serotonin reuptake inhibitors, SSRIs);
• corticosteroids (medicines used to treat pain, swelling, allergies, asthma, rheumatoid diseases and skin disorders);
• pentoxifylline (a medicine used to treat muscle pain due to peripheral vascular disease);
• probenecid (a medicine used to treat gout and elevated uric acid levels);
• tenofovir (a medicine used to treat certain viral infections);
• medicines that suppress immune system function, e.g. after organ transplantation (cyclosporine and tacrolimus);
• antidiabetic medicines;
• antiepileptic medicines;
• medicines used for heart disease (digitalis glycosides, beta-blockers, nicorandil);
• quinolone antibiotics;
• medicines that neutralize gastric acid may reduce ketoprofen absorption in the intestine.

If in doubt, consult a doctor or pharmacist.

Ketoflix with food and drink
Take the capsules preferably during meals, with at least half a glass of water or milk.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use Ketoflix during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Ketoflix may cause kidney and heart problems in the unborn child. It may also increase the tendency to bleeding in both mother and child and delay or prolong labor.
Do not use Ketoflix during the first six months of pregnancy unless the doctor considers it absolutely necessary.
If treatment is required during this period or during attempts to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ketoflix may cause kidney function disturbances in the unborn child if used 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 for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Use of Ketoflix in breastfeeding women is not recommended.

Effect on female fertility
Ketoprofen may impair conception. If the patient is planning pregnancy, has difficulty conceiving, or is undergoing fertility testing, she should inform her doctor. The doctor may decide to discontinue treatment with Ketoflix.

Driving and operating machinery
Ketoprofen may cause dizziness, drowsiness, visual disturbances and convulsions in some patients. If any of these symptoms occur, do not drive or operate machinery.

Ketoflix contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Ketoflix

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 15 years of age:
The recommended dose is 1 capsule up to 3 times daily, every 6 to 8 hours.
Do not exceed the recommended maximum daily dose of 3 capsules (150 mg).
The medicine is for oral use. The capsule should be swallowed whole (do not chew) with at least half a glass of water. It is best to take the capsules during meals.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
In some patients, it may be advisable to take medicines that neutralize or protect the gastric mucosa to reduce the risk of harmful effects of ketoprofen on the gastrointestinal tract.

Use in children and adolescents
Ketoflix should not be used in children and adolescents under 15 years of age.

Elderly patients
In elderly patients, the risk of adverse reactions is higher; therefore, the use of the lowest effective doses is recommended.

Patients with hepatic or renal impairment
Caution is required in patients with impaired liver or kidney function due to an increased risk of severe adverse reactions. If nonsteroidal anti-inflammatory drugs must be used, consult a doctor or pharmacist.

Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor.
If symptoms worsen or do not improve after 5 days, contact a doctor.

Overdose of Ketoflix
In case of overdose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, haematemesis (vomiting blood), melena (black, tarry stools), disturbances of consciousness, respiratory depression, renal dysfunction, and renal failure.
In suspected significant overdose, the doctor may recommend gastric lavage and initiate symptomatic and supportive treatment.

Missed dose of Ketoflix
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
STOP TAKING THE MEDICINE and contact a doctor immediately if any of the following occur:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting blood or dark particles resembling coffee grounds;
• Symptoms of rare but serious allergic reactions such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately;
• Severe skin reactions, such as rash affecting the whole body, peeling, formation of blisters and shedding of skin sheets.

Taking anti-inflammatory and pain-relieving medicines such as Ketoflix, especially at high doses and for prolonged periods, may be associated with a small increased risk of heart attack or stroke.

Common (may affect up to 1 in 10 people):

• Dyspepsia, nausea, abdominal pain, vomiting, asthenia, malaise.

Uncommon (may affect up to 1 in 100 people):

• Central dizziness and vertigo, drowsiness;
• Constipation, diarrhoea, flatulence, gastritis;
• Rash, erythema, pruritus;
• Oedema, fatigue.

Rare (may affect up to 1 in 1,000 people):

• Anaemia due to haemorrhage or bleeding;
• Paraesthesia (sensory disturbances);
• Visual disturbances (blurred vision);
• Tinnitus (ringing in the ears);
• Dyspnoea, possibility of asthma attack;
• Stomatitis, gastric ulceration;
• Hepatitis, increased aminotransferase activity, increased plasma bilirubin concentration due to liver inflammation;
• Weight gain.

Very rare (may affect up to 1 in 10,000 people):

• Severe liver dysfunction with jaundice and inflammatory state.

Frequency not known (frequency cannot be estimated from available data):

• Agranulocytosis (reduction in number of certain granulocytes in blood), thrombocytopenia (reduction in number of platelets in blood), bone marrow suppression, haemolytic anaemia, leukopenia (reduction in number of leukocytes in blood);
• Anaphylactic reactions (including anaphylactic shock);
• Depression, hallucinations, disorientation, mood disturbances;
• Aseptic meningitis, convulsions, taste disturbances, peripheral vertigo;
• Heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis;
• Bronchospasm (especially in patients diagnosed with hypersensitivity to acetylsalicylic acid or other NSAIDs), rhinitis;
• Exacerbation of colitis and Crohn's disease, gastrointestinal bleeding, perforations, pancreatitis;
• Photosensitivity, alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (severe skin reactions), erythema (skin redness), acute generalised exanthematous pustulosis, dermatitis;
• Acute renal failure, especially in patients with pre-existing kidney dysfunction and/or in dehydrated patients, tubulointerstitial nephritis, nephrotic syndrome, abnormal kidney function test results;
• Hyponatraemia (low sodium levels in blood), hyperkalaemia (high potassium levels in blood).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ketoflix

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Ketoflix contains

• The active substance is ketoprofen. One capsule contains 50 mg of ketoprofen.
• The other ingredients are: monohydrate lactose, magnesium stearate, anhydrous colloidal silicon dioxide.
  Capsule composition: cap: gelatin, titanium dioxide (E 171), patent blue (E 131); body: gelatin, titanium dioxide (E 171)

What Ketoflix looks like and contents of the pack
Ketoflix is in the form of hard capsules with a blue cap and a white body, containing a white or
almost white powder mixture.
One pack contains 10, 20 or 30 hard capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

The most up-to-date approved information [Summary of Product Characteristics and Patient Leaflet] for this medicinal product is available by scanning the QR code located on the outer packaging using a smartphone or other device. The same information is also available at the following URL: https://www.biofarm.pl/fileadmin/ulotki/Ketoflix__QR.PDF.