Ketonal forte

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ketonal forte, 100 mg, coated tablets

Ketoprofen

Before using the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ketonal forte and what is it used for
• 2. Important information before using Ketonal forte
• 3. How to use Ketonal forte
• 4. Possible side effects
• 5. How to store Ketonal forte
• 6. Contents of the packaging and other information

1. What is Ketonal forte and what is it used for

Ketonal forte contains the active substance ketoprofen - a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic, and analgesic effects.
Ketonal forte is used to treat symptomatic inflammatory, degenerative, and metabolic rheumatic diseases, as well as to alleviate some symptoms of pain syndromes.
The indications for use are:

• rheumatoid arthritis;
• osteoarthritis (degenerative joint disease);
• painful menstruation;
• moderate pain.

2. Important information before using Ketonal forte

When not to use Ketonal forte

• 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 shortness of breath, asthma, nasal congestion, or skin reactions (such as hives or itching) after using ketoprofen or similar-acting medicines (such as acetylsalicylic acid or other NSAIDs);
• if the patient has:
• severe heart failure,
• severe kidney failure,
• severe liver failure,
• a tendency to bleeding,
• active peptic ulcer disease or a history of gastrointestinal bleeding, ulcers, or perforation;

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• if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Ketonal forte, the patient should discuss it with their doctor or pharmacist if:

• the patient has a history of gastrointestinal diseases (there is a risk of exacerbating ulcerative colitis or Crohn's disease);
• the patient has asthma or nasal congestion (rhinitis, nasal congestion, sneezing), chronic sinusitis, or nasal polyps;
• the patient currently has or has had heart, kidney, or liver disease;
• the patient currently has or has had high blood pressure (hypertension);
• the patient has peripheral arterial disease (circulatory disorders in the legs or feet due to narrowing or blockage of arteries) or cerebral vessels;
• the patient has diabetes or high cholesterol levels;
• the patient has an infection - see below, section "Infections".
• the patient smokes;
• the patient is elderly.

NSAIDs may cause gastrointestinal bleeding, ulcers, or perforation (which can be fatal), which can occur at any time during treatment, even without warning signs or a history of serious gastrointestinal events.
The risk of bleeding, ulcers, or perforation in the gastrointestinal tract is higher when using high doses of NSAIDs in patients with a history of ulcer disease, especially if complicated by bleeding or perforation (see section "When not to use Ketonal forte"), and in the elderly.
If the patient experiences unusual gastrointestinal symptoms, especially bleeding, while taking Ketonal forte (especially at the start of treatment), they should immediately inform their doctor.
Taking such medicines as Ketonal forte may be associated with a small increased risk of arterial thrombotic events (heart attack or stroke).
This risk increases with long-term use of high doses of the medicine.
During treatment with NSAIDs, including Ketonal forte, very rare but serious skin reactions (some with a fatal outcome) can occur, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. If the patient develops a rash, mucosal lesions, or any signs of hypersensitivity, they should stop taking the medicine and consult their doctor.
If the patient experiences vision disturbances (e.g., blurred vision), they should stop taking the medicine and consult their doctor.
It is essential to use Ketonal forte at the lowest effective dose for the shortest duration necessary to alleviate symptoms.
The patient should not exceed the recommended dose or duration of treatment.
Infections
Ketonal forte may mask the symptoms of an infection, such as fever and pain. Therefore, Ketonal forte 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 related to chickenpox. If the patient is taking this medicine while having an infection, and the infection symptoms persist or worsen, they should consult their doctor immediately.
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Using Ketonal forte in children and adolescents

The medicine should not be used in children and adolescents under 15 years of age.

Ketonal forte and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The following medicines should not be used with Ketonal forte

• other painkillers, such as NSAIDs, including selective cyclooxygenase-2 inhibitors (e.g., acetylsalicylic acid, diclofenac, naproxen);
• anticoagulants (medicines that prevent blood clotting), antiplatelet agents (medicines that prevent platelet aggregation), and thrombolytic agents (medicines used to dissolve blood clots), such as acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, or edoxaban;
• nicorandil (a medicine used to treat coronary artery disease);
• lithium (a medicine used to treat certain mental illnesses);
• methotrexate (a medicine used to treat cancer and other diseases) in a dose higher than 15 mg per week.

Ketonal forte and other medicines may interact with each other, affecting their efficacy and the occurrence of side effects.
Therefore, the patient should always consult their doctor or pharmacist before taking Ketonal forte with other medicines, such as:

• diuretics;
• methotrexate (a medicine used to treat cancer and other diseases) in a dose lower than 15 mg per week;
• medicines that lower blood pressure;
• medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs);
• corticosteroids (medicines used to treat pain, swelling, allergies, asthma, rheumatic diseases, and skin diseases);
• pentoxifylline (a medicine used to treat muscle pain due to peripheral artery disease);
• probenecid (a medicine used to treat gout and high uric acid levels);
• immunosuppressants (e.g., after organ transplantation, cyclosporine, and tacrolimus);
• antidiabetic medicines;
• antiepileptic medicines;
• medicines used to treat heart conditions (digitalis glycosides, beta-blockers);
• quinolone antibiotics;
• tenofovir (an antiretroviral medicine used to treat HIV and chronic hepatitis B).

In case of any doubts, the patient should consult their doctor or pharmacist.

Ketonal forte with food and drink

The patient should take Ketonal forte tablets during meals, with at least half a glass of water or milk.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should not take Ketonal forte if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketonal forte may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and the child and prolong labor.
In the first 6 months of pregnancy, the patient should not use Ketonal forte unless their doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, the patient should use the lowest effective dose for the shortest possible duration.
From the 20th week of pregnancy, Ketonal forte may cause kidney problems in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
It is not known whether ketoprofen passes into breast milk. Women who are breastfeeding should not take Ketonal forte.
Fertility
Ketonal forte may make it more difficult to conceive. If the patient is planning a pregnancy, has problems conceiving, or is undergoing fertility tests, they should inform their doctor. The doctor may consider stopping the use of Ketonal forte.

Driving and using machines

Ketonal forte may cause dizziness, drowsiness, vision disturbances, and seizures in some patients. If these symptoms occur, the patient should not drive or operate machinery.

Ketonal forte contains lactose monohydrate and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to use Ketonal Forte

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for oral administration. The patient should use the lowest effective dose for the shortest duration necessary to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
Adults and adolescents over 15 years of age
Usually, 1 coated tablet is taken once or twice a day (100 to 200 mg of ketoprofen per day).
Rheumatoid arthritis and osteoarthritis
Recommended dose: 1 tablet, up to 2 times a day.
The maximum daily dose of ketoprofen is 200 mg.
Before prescribing a dose of 200 mg per day, the doctor will carefully weigh the benefits and risks of treatment.
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The patient should take the tablets during meals, with at least 100 ml of water or milk.
The doctor may recommend taking antacids to reduce the risk of ketoprofen's harmful effects on the gastrointestinal tract.
Elderly patients
In elderly patients, the general rule is to start treatment with the lowest available dose and continue with the lowest effective dose.
In elderly patients, the risk of serious side effects is higher.
If the patient feels that the effect of Ketonal forte is too strong or too weak, they should consult their doctor.

Taking a higher dose of Ketonal forte than recommended

In case of an overdose, the patient should immediately consult their doctor or pharmacist.
After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, abdominal pain, bleeding, black stools, impaired consciousness, respiratory depression, seizures, kidney problems, and kidney failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and symptomatic and supportive treatment.

Missing a dose of Ketonal forte

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketonal forte can cause side effects, although not everybody gets them.
Taking anti-inflammatory and pain-relieving medicines like Ketonal forte, especially in high doses and for a long time, may be associated with a small increased risk of heart attack or stroke.

If the patient experiences any of the following side effects, they should stop taking the medicine and immediately consult their doctor or the nearest hospital emergency department:

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

• asthma attack
• burning, persistent abdominal pain (which may indicate stomach or duodenal ulcers)

Side effects with unknown frequency:

• bleeding vomiting, severe abdominal pain, or black stools (which may be signs of gastrointestinal bleeding)
• blistering, peeling, or bleeding of the skin, with or without itching, rash (on the lips, eyes, mouth, nose, genitals, hands, or feet), sometimes with flu-like symptoms. These may be signs of serious skin disorders requiring immediate medical attention.
• blood in the urine, changes in urine output, swelling of the feet, ankles, or hands (which may indicate serious kidney problems)
• chest pain or sudden severe headache (taking such medicines as Ketonal forte may be associated with a small increased risk of heart attack or stroke)

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• swelling of the face, lips, or throat, causing difficulty swallowing or breathing, with wheezing, chest tightness, rapid heartbeat, decreased blood pressure (which may lead to shock), itching, and rash. These may be signs of a severe allergic reaction.

If the patient experiences any of the following side effects, they should consult their doctor as soon as possible:

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

• numbness, tingling, prickling, or burning of the skin
• pallor, fatigue, dizziness, or fainting (which may be signs of anemia due to red blood cell destruction)
• jaundice (yellowing of the skin or whites of the eyes, with increased liver enzyme activity and bilirubin levels in the blood)

Side effects with unknown frequency:

• easy bruising or prolonged bleeding (which may be signs of serious blood disorders, e.g., decreased platelet count)
• worsening of Crohn's disease or ulcerative colitis
• photosensitivity
• hair loss
• infections (which may indicate serious blood disorders, e.g., agranulocytosis)
• seizures

Other side effects

Very common (may occur in more than 1 in 10 people):
increased liver enzyme test results
Common (may occur in less than 1 in 10 people):
malaise, nausea, vomiting, abdominal pain
Uncommon (may occur in less than 1 in 100 people):
headache, dizziness, drowsiness, constipation, diarrhea, bloating, gastric inflammation, rash, itching, swelling
Rare (may occur in less than 1 in 1000 people):
tinnitus, oral mucosal inflammation, weight gain
Very rare (may occur in less than 1 in 10,000 people):
enteropathy with perforation, ulcers, or narrowing and bleeding
Side effects with unknown frequency (frequency cannot be estimated from available data):
mood changes, taste disturbances, heart failure (with symptoms such as shortness of breath, difficulty breathing while lying down, swelling of the feet or ankles), hypertension, flushing, vasculitis, rhinitis (runny nose, itching, sneezing, or nasal congestion), pancreatitis, fatigue, or malaise, angioedema (sudden swelling of the face, limbs, or joints without itching or pain), hyponatremia (low sodium levels in the blood), hyperkalemia (high potassium levels in the blood); confusion, aseptic meningitis, drug rash (acute generalized exanthematous pustulosis).

Reporting side effects

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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ketonal forte

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
• The medicine should be stored at a temperature below 25°C in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ketonal forte contains

The active substance is ketoprofen. One coated tablet contains 100 mg of ketoprofen.
The other ingredients are: cornstarch, povidone, magnesium stearate, colloidal silica, talc, lactose monohydrate.
Coating:hypromellose, macrogol 400, indigo carmine (E 132), talc, titanium dioxide (E 171), carnauba wax.

What Ketonal forte looks like and contents of the packaging

The coated tablets are light blue, round, and biconvex.
The tablets are packaged in brown glass bottles with a plastic cap and a ring seal, in a cardboard box.
The packaging contains 20 coated tablets.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Croatia, the country of export:

Sandoz d.o.o., Maksimirska 120, 10000 Zagreb, Croatia

Manufacturer:

Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, Slovenia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Croatian marketing authorization number: HR-H-834540447-01

Parallel import authorization number: 236/23

Date of leaflet approval: 19.10.2023

[Information about the trademark]
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