Ketoprex forte

Patient Information Leaflet

Ketoprex FORTE, 100 mg, coated tablets
Ketoprofenum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Ketoprex is and what it is used for

Ketoprex contains the active substance ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic and analgesic properties.
Ketoprex is indicated for the symptomatic treatment of inflammatory, degenerative and metabolic disorders of the musculoskeletal system, and for relief of pain syndromes such as:

• rheumatoid arthritis;
• acute flare-ups of osteoarthritis (degenerative joint disease);
• pain, especially inflammatory pain of various origins and moderate intensity.

2. Information before taking Ketoprex

When not to take Ketoprex

• if the patient is allergic to ketoprofen or to 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 the presence of active gastric or duodenal ulcer, gastrointestinal bleeding, gastrointestinal ulceration or perforation.
• in case of coagulation disorders and tendency to bleeding.
• in case of severe liver failure.
• in case of severe kidney failure.

This medicine should not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before using Ketoprex, consult a doctor or pharmacist if:

• the patient has previously suffered from gastrointestinal disorders (there is a risk of
  exacerbation of ulcerative colitis or Crohn’s disease,
  manifesting, among others, as chronic diarrhea);

• the patient suffers from asthma or nasal mucosal inflammation (rhinitis, nasal obstruction, 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 due to narrowing or blockage of arteries) or cerebral vascular 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 (with potentially
fatal outcome), which 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 of NSAIDs are used, in patients with a history of peptic ulcer disease, especially
complicated by bleeding or perforation (see section “When not to take Ketoprex”)
and in elderly patients.
If the patient experiences any gastrointestinal symptoms during treatment with 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 prolonged use of high doses
of the drug.
During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning
of therapy, severe skin reactions (some potentially fatal) may very rarely 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 medicine should be discontinued immediately and medical advice sought.
If visual disturbances (e.g. blurred vision) occur during treatment with Ketoprex, the medicine 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. Doses higher than recommended and longer treatment duration than advised should not be used.
Renal and/or liver function disorders
In patients with heart failure, nephrotic syndrome, and cirrhosis, in patients receiving diuretics, and in patients with chronic kidney 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 with a history of liver disease, periodic monitoring of aminotransferase activity should be performed, especially during long-term treatment. Rare cases of jaundice and hepatitis have been reported during treatment with ketoprofen.
Infections
Ketoprex may mask symptoms of infection such as fever and pain. Therefore, Ketoprex may delay the initiation of 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 ongoing infection and symptoms of infection 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 with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The following medicines should not be used 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 cancer treatment) 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 a doctor or pharmacist before using Ketoprex together with other medicines such as:

• medicines that increase blood potassium levels. 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, and trimethoprim, increased blood potassium levels may occur.
• diuretics (medicines that increase urine production);
• methotrexate (a medicine used, among others, in cancer treatment) 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);
• medicines that suppress the immune system, 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 medicines listed above, 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
Ketoprex should not be taken during 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 tendency to 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 should be used for the shortest possible duration.
If Ketoprex is taken for longer than a few days beyond the 20th week of pregnancy, it may cause narrowing of a blood vessel (ductus arteriosus) in the child’s heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for more 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 impair fertility. If the patient is planning pregnancy, has difficulty conceiving, or is undergoing fertility investigations, she should inform her doctor.
Driving and using machines
Ketoprex may cause dizziness, drowsiness, visual disturbances, and convulsions in some patients. If any of these symptoms occur, the patient should not drive or operate machinery.
Ketoprex FORTE 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 as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
This medicine is intended for oral administration. The lowest effective dose should be used for the
shortest necessary duration to relieve symptoms. If, during an infection, its symptoms (such as
fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Adults
The usual dose is 1 coated tablet once or up to twice daily (100 to 200 mg of ketoprofen per day).
Rheumatoid arthritis and osteoarthritis
Recommended dose: 1 tablet up to twice daily.
The maximum daily dose of ketoprofen is 200 mg.
Before prescribing a daily dose of 200 mg, the physician should carefully evaluate the benefit-risk
ratio of treatment.
Tablets should be taken during meals, with at least 100 mL of water or milk.
The physician may recommend concomitant use of drugs that neutralize gastric hydrochloric acid to
reduce the risk of harmful gastrointestinal effects of ketoprofen.
Pain associated with infections
No dosage adjustment is necessary.
During treatment with Ketoprex, the course of the underlying infection should be monitored,
as this medicine may mask signs of infection and promote the development of infections such as
community-acquired bacterial pneumonia and bacterial skin infections associated with varicella
(see section 2).
Patients with renal or hepatic impairment
In patients with impaired kidney or liver function, metabolism and (or) elimination of the drug may
be limited. The lowest effective dose should be used for the shortest possible duration.
Careful monitoring of kidney function is required at the beginning of treatment (see section 2).
In patients with abnormal liver function tests or a history of liver disease, periodic monitoring of
aminotransferase activity is necessary (see section 2).
Ketoprofen is contraindicated in patients with severe renal and (or) hepatic impairment (see
section 2).
Elderly patients
In elderly patients, treatment with ketoprofen should generally be initiated with the lowest available
dose, and therapy should be continued with the lowest effective dose.
In elderly patients, the risk of severe adverse effects is higher.
If the patient feels that the effect of Ketoprex is too strong or too weak, they should consult their
doctor.
Use in children and adolescents
This medicine should not be used in individuals under 18 years of age.
Overdose of Ketoprex
Symptoms observed after ingestion of an excessive dose 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 physician will provide symptomatic
treatment and initiate supportive measures to maintain vital functions.
Missed dose of 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.
Taking anti-inflammatory and analgesic medicines such as Ketoprex, especially at high doses and for prolonged periods, may be associated with a small increased risk of heart attack or stroke.
If any of the following adverse reactions occur, stop taking the medicine immediately
and seek urgent medical advice from your 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, low blood pressure (which may lead to shock), itching and rash. These may be symptoms of a severe allergic reaction (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 (these may be symptoms of gastrointestinal bleeding);
• blistering, peeling of the skin or bleeding within the skin with or without itching, nodular rash (around the lips, eyes, mouth, nose, genital organs, hands or feet), sometimes with flu-like symptoms. These may be symptoms of serious skin reactions (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis);
• presence of blood in the urine, changes in the amount of urine passed, 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, bloating, nausea, gastritis, vomiting
• irritation of the urinary tract, renal failure
• dream disturbances, 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 depigmentation, 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, tarry stools, occult blood in stools, pancreatitis, peptic ulcer, hypersalivation, ulcerative colitis, dry mouth
• presence of blood in urine, impotence, nephrotic syndrome, uterine bleeding, acute tubular necrosis, interstitial nephritis, renal failure syndrome
• agranulocytosis (reduction in number of certain types of granulocytes in blood), anaemia, coagulation disorders, haemolysis, thrombocytopenia (reduction in number of platelets in blood), rectal bleeding, purpura, purpuric rash
• cholestatic hepatitis, hepatitis, jaundice, serum bilirubin concentrations
• 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;
tel.: +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 FORTE

Keep this medicine out of 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer 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 100 mg of ketoprofen.
The other ingredients are:
Tablet core:
Microcrystalline cellulose
Sodium croscarmellose
Magnesium stearate
Anhydrous colloidal silica
Tablet coating:
Opadry TF Blue coating:
Polyvinyl alcohol
Calcium carbonate
Macrogol 3350
Talc
Indigo carmine – aluminium lake (E 132)

What Ketoprex looks like and contents of the pack
Blue, round, biconvex coated tablet with a diameter of approx. 8 mm.
Blister packs made of PVC/PVDC/Aluminium in a cardboard box.
The pack contains 10 coated tablets.

Marketing Authorisation Holder and Manufacturer
OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
Tel.: +48 14 680 32 00
{OLIMP Laboratories logo}