Package leaflet: Information for the patient

Ketoprex MAX, 50 mg, coated tablets
Ketoprofenum
Please read carefully the entire leaflet before taking 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
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.
If there is no improvement after 5 days, or if you feel worse, consult a doctor.

Table of contents

What Ketoprex is and what it is used for
Important information before taking Ketoprex
How to take Ketoprex
Possible side effects
How to store Ketoprex
Contents of the pack and other information

1. What Ketoprex is and what it is used for

Ketoprex contains the active substance ketoprofen, a medicine with anti-inflammatory,
antipyretic and analgesic properties (belongs to the group of non-steroidal anti-inflammatory
drugs – NSAIDs).

Ketoprex is used for short-term symptomatic treatment of mild to moderate acute pain, such as:

musculoskeletal pain,
headache,
dental pain,
painful menstruation.

If there is no improvement after 5 days, or if you feel worse, consult a doctor.

2. Information before taking Ketoprex

When not to take Ketoprex

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 hypersensitivity reactions such as bronchospasm, asthma attack, rhinitis, urticaria, or other types of allergic reactions after taking ketoprofen, salicylates (including acetylsalicylic acid) or other nonsteroidal anti-inflammatory drugs (NSAIDs).
during the third trimester of pregnancy.
in case of severe heart failure.
in case of active peptic ulcer or (and) duodenal ulcer, gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract.
in case of coagulation disorders or tendency to bleeding.
in case of severe liver failure.
in case of severe renal failure.

Do not use this medicine in children and adolescents under 18 years of age.
Warnings and precautions
Before using Ketoprex, consult your doctor or pharmacist if:

the patient has previously suffered from gastrointestinal disorders (there is a risk of exacerbating ulcerative colitis or Crohn's disease, manifested, among others, by chronic diarrhea);
the patient suffers from asthma or rhinitis (nasal congestion, runny nose, sneezing), chronic sinusitis, or nasal polyps;
the patient has or has had heart, kidney, or liver disease;
the patient has or has had high blood pressure (hypertension);
the patient suffers from peripheral arterial disease (circulatory disorders in legs or feet caused by narrowing or blockage of arteries) or cerebrovascular disease;
the patient has diabetes or high blood cholesterol levels;
the patient has an infection – see below (section "Infections");
the patient smokes tobacco;
the patient is elderly (over 65 years of age).

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration, or perforation—punching a hole in the wall of the stomach or intestine (which may be fatal), which can occur at any time during treatment, even without warning symptoms or previous serious 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, especially complicated by bleeding or perforation (see section "When not to take Ketoprex"), and in elderly patients.
If the patient experiences any gastrointestinal symptoms while taking Ketoprex (especially at the beginning of treatment), medical advice should be sought immediately.
Taking medicines such as Ketoprex may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses of the drug.
During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of therapy, very rare but severe skin reactions (some potentially fatal) 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, the drug should be discontinued and medical advice sought.
If visual disturbances (e.g. blurred vision) occur during treatment with Ketoprex, the drug should be discontinued and medical advice sought.
It is very important to take Ketoprex at the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not use higher doses or longer treatment duration than recommended.
Renal and/or liver function disorders
In patients with heart failure, nephrotic syndrome, renal cirrhosis, those receiving diuretics, or patients with chronic renal failure, especially if elderly, careful monitoring of kidney function is required at the beginning of treatment. Administration of Ketoprex to these patients may lead to worsening of renal function.
In patients with abnormal liver function test results or a history of liver disease, periodic monitoring of aminotransferase activity is recommended, especially during long-term treatment. Rare cases of jaundice and hepatitis have been reported during ketoprofen treatment.
Infections
Ketoprex may mask symptoms of infection such as fever and pain. Therefore, Ketoprex 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 takes this medicine during an ongoing infection and symptoms persist or worsen, immediate medical consultation is required.
Children and adolescents
Ketoprex should not be used in children and adolescents under 18 years of age.
Ketoprex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The following medicines should not be taken together with Ketoprex :

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), e.g. dabigatran, apixaban, rivaroxaban, edoxaban;
antiplatelet agents (medicines that inhibit platelet aggregation);
thrombolytics (medicines used to unblock blood vessels), such as acetylsalicylic acid, heparin, warfarin, clopidogrel or ticlopidine;
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.

Ketoprex and other medicines may interact with each other, affecting their efficacy and increasing the risk of adverse effects. Therefore, always consult your doctor or pharmacist before taking Ketoprex together with other medicines such as:

medicines that increase potassium levels in blood. In patients taking potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, other NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, or trimethoprim, increased blood potassium levels may occur.
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 used to 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);
immunosuppressants (e.g. after organ transplantation: cyclosporine and tacrolimus);
antidiabetic medicines;
antiepileptic medicines;
medicines used for heart conditions (digitalis glycosides, beta-blockers);
quinolone antibiotics;
tenofovir (an antiretroviral medicine used to treat HIV infection and chronic viral hepatitis B).

If in doubt whether the patient is taking any of the listed medicines, consult a doctor or pharmacist.
Taking Ketoprex with food and drink
Ketoprex should be taken 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 her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ketoprex if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Ketoprex may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor.
During the first six months of pregnancy, Ketoprex should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used.
If Ketoprex is taken for more than a few days after the 20th week of pregnancy, it may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
It is not known whether ketoprofen passes into breast milk. Ketoprex should not be given to breastfeeding women.
Effect on fertility
Ketoprex may make it more difficult to become pregnant. If the patient is planning pregnancy, has difficulty becoming pregnant, or is undergoing fertility investigations, she should inform her doctor.
Driving and operating machinery
Ketoprex may cause dizziness, drowsiness, visual disturbances, and convulsions in some patients. If these symptoms occur, do not drive or operate machinery.
Ketoprex MAX contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Ketoprex

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended dose
Adults
1 tablet up to 3 times daily (every 8 hours, maximum 3 tablets per day).
Ketoprex should be taken during meals, swallowed with at least half a glass of water or milk. Antacids may be taken simultaneously, which may help reduce the risk of gastrointestinal adverse effects.
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 your doctor.
Pain associated with infection
No dose adjustment is necessary.
If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Patients with impaired kidney or liver function
In patients with impaired renal or hepatic function, metabolism and (or) elimination of the drug may be reduced. The lowest effective dose for the shortest possible duration should be used.
In patients with impaired renal function, renal function should be monitored at the beginning of treatment (see section 2).
In patients with impaired liver function, abnormal liver function tests, or a history of liver disease, periodic monitoring of aminotransferase activity is recommended (see section 2).
Ketoprofen is contraindicated in patients with severe renal and (or) hepatic insufficiency (see section 2).
Elderly patients
Caution is required in elderly patients due to increased risk of severe adverse effects. If non-steroidal anti-inflammatory drugs (NSAIDs) are necessary, the lowest effective dose should be used.
Use in children and adolescents
This medicine should not be used in individuals under 18 years of age.
Taking more Ketoprex than recommended
Symptoms observed after overdose of ketoprofen include lethargy, drowsiness, nausea, vomiting, and epigastric pain. There is no specific antidote. In case of overdose, seek immediate medical advice from a doctor or pharmacist. The doctor will provide symptomatic treatment and initiate supportive therapy to maintain vital functions.
If you forget to take Ketoprex
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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.
The use of anti-inflammatory and pain-relieving medicines such as Ketoprex, especially at high doses and over long periods, may be associated with a small increased risk of heart attack or stroke.
If any of the following adverse reactions occur, the medicine must be discontinued immediately
and you should seek urgent medical advice from a doctor or the nearest hospital emergency department:

swelling of the face, lips or throat causing difficulty in swallowing or breathing, wheezing or chest tightness, rapid heartbeat, reduced blood pressure (which may lead to shock), itching and rash. These may be symptoms of a severe allergic (anaphylactic) reaction;
asthma attack;
burning sensation, persistent stomach pain (which may indicate gastric or duodenal ulceration);
vomiting blood, severe abdominal pain or tarry (black) stools (which may indicate gastrointestinal bleeding);
blistering, skin peeling or bleeding on the skin with or without itching, nodular rash (around the lips, eyes, mouth, nose, genitals, hands or feet), sometimes accompanied by flu-like symptoms. These may be symptoms of serious skin reactions (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis);
blood in the urine, changes in urine volume, swelling of the legs, ankles or feet (which may indicate serious kidney problems).

The following adverse reactions may occur during treatment with Ketoprex:
Very common (may affect more than 1 in 10 people):

changes in liver function laboratory parameters (increased liver function test results)
dyspepsia

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

rash
abdominal pain, anorexia, constipation, diarrhoea, flatulence, nausea, gastritis, vomiting
urinary tract irritation, renal failure
sleep disorder, dizziness, somnolence, headache, insomnia, nervousness, malaise
depression
visual disturbances
tinnitus

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

myocardial infarction, arrhythmia, heart failure, tachycardia, palpitations
oedema, hypertension, peripheral vascular disease, vasodilation
alopecia, vesicular rash, eczema, hyperhidrosis, erythema multiforme, exfoliative dermatitis, onycholysis, pruritus, skin discoloration, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
worsening of diabetes, gynaecomastia, hyponatraemia, increased thirst, weight gain, weight loss
atrophy of the oral mucosa, taste disturbances, belching, gastritis, gastrointestinal bleeding, gastrointestinal perforation, gastric ulcers, haematemesis, increased appetite, melena, occult blood in stool, pancreatitis, peptic ulcer, hypersalivation, ulcerative colitis, dry mouth
presence of blood in urine, impotence, nephrotic syndrome, uterine bleeding, acute tubular disease, interstitial nephritis, renal failure syndrome
agranulocytosis (reduced number of certain types of granulocytes in the blood), anaemia, coagulation disorders, haemolysis, thrombocytopenia (reduced number of platelets in the blood), rectal bleeding, purpura, purpuric rash
cholestatic hepatitis, hepatitis, jaundice, elevated serum bilirubin levels
skin hypersensitivity reactions, anaphylactic shock
sepsis
amnesia, aseptic meningitis, chills, malaise, dysphoria, migraine, nightmares, sensory disturbances, dizziness
personality disorders, hallucinations, dysphoria
muscle pain
conjunctivitis, dry eye syndrome, eye pain, retinal haemorrhage, retinal pigmentary changes
hearing disturbances
bronchospasm, dyspnoea, epistaxis, haemoptysis, laryngeal oedema, pharyngitis, rhinitis

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):

coronary thrombosis
stroke
gastrointestinal inflammation

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ketoprex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines should 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 Ketoprex contains
The active substance is ketoprofen. Each coated tablet contains 50 mg of ketoprofen.
The other ingredients are:
Tablet core:
Microcrystalline cellulose
Sodium croscarmellose
Magnesium stearate
Colloidal anhydrous silica
Tablet coating:
Opadry TF White coating:
Polyvinyl alcohol
Calcium carbonate
Macrogol 3350
Talc

What Ketoprex looks like and contents of the pack
White or almost white, round, biconvex coated tablet with a diameter of approx. 6 mm.
Blister packs made of PVC/PVDC/Aluminium in a cardboard carton.
The pack contains 20 coated tablets.

Marketing authorisation holder and manufacturer
OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
Tel.: +48 14 680 32 00
{Logo Olimp Laboratories}