Ketonal forte

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Ketonal forte, 100 mg, coated tablets

Ketoprofen

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform their doctor or pharmacist. 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 for the symptomatic treatment of inflammatory, degenerative, and metabolic rheumatic diseases, as well as for the relief of certain 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, bronchial asthma, nasal congestion, or skin reactions (such as hives or itching) or other allergic reactions 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,
• tendency to bleeding,
• active peptic ulcer disease of the stomach and/or duodenum or has had a history of gastrointestinal bleeding, ulceration, or perforation;
• 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 the course of 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, the section entitled "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 symptoms 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 peptic ulcer disease, especially if complicated by bleeding or perforation (see "When not to use Ketonal forte") and in the elderly.
If unusual gastrointestinal symptoms occur in the patient, especially bleeding, during treatment with Ketonal forte (especially at the beginning 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) 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, 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 very important to use Ketonal forte in the smallest effective dose for the shortest time necessary to relieve symptoms.
Do not use higher doses or longer treatment than recommended.
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 and lead to an 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 during an infection and the symptoms of the infection persist or worsen, they should immediately consult their doctor.

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 certain cancers) in a dose greater than 15 mg per week.

Ketonal forte and other medicines may interact with each other and affect each other's efficacy and side effects.
Therefore, the patient should always consult their doctor or pharmacist before using Ketonal forte with other medicines, such as:

• diuretics;
• methotrexate (a medicine used to treat certain cancers) in a dose less 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);
• medicines that suppress the immune system, 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

Ketonal forte tablets 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Ketonal forte should not be used if the patient is 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 child and cause prolonged or delayed labor.
In the first 6 months of pregnancy, Ketonal forte should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Ketonal forte may cause kidney problems in the unborn child if used for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child'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 be given Ketonal forte.
Fertility
Ketonal forte may make it harder to get pregnant. If the patient is planning to get pregnant, has problems getting pregnant, 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

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

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 use. The smallest effective dose should be used for the shortest time necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during treatment, the patient should immediately consult their doctor (see section 2).
Adults and adolescents over 15 years of age
Usually, 1 coated tablet is taken once or up to twice a day (100-200 mg of ketoprofen per day).
Rheumatoid arthritis and osteoarthritis
Recommended dose: 1 tablet up to twice 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.
Tablets should be taken 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 smallest available dose and continue with the smallest 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 taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, abdominal pain, bloody vomiting, black stools, disturbances of 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.

In case of the following side effects, the patient 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):

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

Side effects with unknown frequency:

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

In case of the following side effects, the patient 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 sensation of the skin
• pallor, fatigue, fainting, or dizziness (which may be symptoms of anemia due to red blood cell destruction)
• jaundice (which may indicate serious liver problems, with increased liver enzyme activity and bilirubin levels in the blood).

Side effects with unknown frequency

• easy bruising or prolonged bleeding (which may be symptoms of serious blood disorders, e.g., decreased platelet count)
• worsening of Crohn's disease or ulcerative colitis
• increased sensitivity of the skin to light
• hair loss
• increased susceptibility to infections (which may indicate serious blood disorders, e.g., significant decrease in the number of a certain type of white blood cell - 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, gastritis, rash, itching, swelling.
Rare (may occur in less than 1 in 1000 people):
tinnitus, oral mucositis, weight gain.
Very rare (may occur in less than 1 in 10,000 people):
enteropathy with perforation, ulceration, or narrowing and bleeding.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
mood changes, taste disturbances, heart failure (with symptoms such as shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles), hypertension, flushing (vasodilation), vasculitis, rhinitis (runny nose, nasal 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

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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,
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ketonal forte

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Store in 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.
Other ingredients are: cornstarch, povidone, magnesium stearate, colloidal anhydrous 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 what the packaging contains

The coated tablets are light blue, round, and biconvex.
The tablets are packaged in a brown glass bottle 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 contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Croatia, the country of export:HR-H-834540447-01

Parallel import authorization number: 138/24

Date of leaflet approval: 28.03.2024

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