Ketonal forte

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Ketonal Forte

100 mg, coated tablets

Ketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell 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 taking Ketonal Forte
• 3. How to take Ketonal Forte
• 4. Possible side effects
• 5. How to store Ketonal Forte
• 6. Contents of the pack 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 taking Ketonal Forte

When not to take 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 polyps, or skin reactions (such as hives or itching) after taking ketoprofen or similar-acting drugs (such as acetylsalicylic acid or other NSAIDs);
if the patient has:
severe heart failure,
severe renal failure,
severe liver failure,
a tendency to bleed,
active peptic ulcer disease or a history of gastrointestinal bleeding, ulceration, or perforation; if the patient is in the third trimester of pregnancy (see "Pregnancy, breastfeeding, and fertility" below).

• severe heart failure,
• severe renal failure,
• severe liver failure,
• tendency to bleed,
• active peptic ulcer disease or a history of gastrointestinal bleeding, ulceration, or perforation; if the patient is in the third trimester of pregnancy (see "Pregnancy, breastfeeding, and fertility" below).

Warnings and precautions

Before starting treatment with Ketonal Forte, the patient should discuss it with their doctor or pharmacist if they have:
a history of gastrointestinal disease (there is a risk of exacerbating ulcerative colitis or Crohn's disease);
asthma or nasal polyps (rhinitis, stuffy nose, sneezing),
chronic sinusitis or nasal polyps;
currently or have had heart, kidney, or liver disease;
currently or have had high blood pressure (hypertension);
peripheral arterial disease (circulatory problems in the legs or feet due to narrowed or blocked arteries) or cerebrovascular disease;
diabetes or high cholesterol;
an infection - see below, "Infections".
smoke;
are elderly.
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration, 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 gastrointestinal bleeding, ulceration, or perforation is higher when taking high doses of NSAIDs in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation (see "When not to take Ketonal Forte" above) and in the elderly.
If the patient experiences unusual gastrointestinal symptoms, especially bleeding, during treatment with 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 non-steroidal anti-inflammatory drugs (NSAIDs), especially at the start of treatment, very rare but serious skin reactions (some of which can be fatal) 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.
If the patient experiences vision disturbances (such as blurred vision) during treatment with Ketonal Forte, they should stop taking the medicine and consult their doctor.
It is very important to take Ketonal Forte in the smallest effective dose for the shortest time necessary to relieve symptoms.
Do not take 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 consequently 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 while an infection is present, 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 taken with Ketonal Forte

other painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors (e.g., acetylsalicylic acid, diclofenac, naproxen);
anticoagulant medicines (blood thinners), antiplatelet medicines (medicines that prevent blood clotting), and thrombolytic medicines (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 angina pectoris);
lithium (a medicine used to treat certain mental illnesses);
methotrexate (a medicine used to treat cancer and certain other conditions) in a dose greater than 15 mg per week.
Ketonal Forte and other medicines may interact with each other, affecting their efficacy and the risk 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 certain other conditions) in a dose less than 15 mg per week;
medicines that lower blood pressure;
medicines used to treat depression (such as selective serotonin reuptake inhibitors, SSRIs);
corticosteroids (medicines used to treat pain, swelling, allergies, asthma, rheumatoid 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);
medicines for diabetes;
medicines for epilepsy;
medicines for 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 taking this medicine.
Pregnancy
The medicine can be used in the first and second trimester of pregnancy only if the doctor considers it absolutely necessary.
Use in the third trimester of pregnancy is contraindicated.
Breastfeeding
Women who are breastfeeding should not take Ketonal Forte.
Fertility in women
Ketonal Forte may make it more difficult to become pregnant.
If the patient is planning a pregnancy, has problems becoming 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 and sodium

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

3. How to take Ketonal Forte

This medicine should always be taken exactly 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 take the smallest effective dose 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 twice a day (100 to 200 mg of ketoprofen per day).
Rheumatoid arthritis and osteoarthritisThe recommended dose is 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.
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 gastrointestinal side effects.
Elderly patients
In elderly patients, the general rule is to start treatment with the lowest 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, impaired consciousness, respiratory depression, seizures, kidney dysfunction, 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 taking 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 affect up to 1 in 1000 people):
bronchial asthma attack
burning sensation, persistent stomach pain (which may indicate stomach or duodenal ulcer)
Side effects with unknown frequency:
bloody 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, papular 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)
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 affect up to 1 in 1000 people):
numbness, tingling, prickling, or burning sensation of the skin
pallor, fatigue, dizziness, or fainting (which may be signs of anemia due to red blood cell destruction)
jaundice (which may indicate serious liver dysfunction)
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
increased sensitivity of the skin to light
hair loss
increased susceptibility to infections (which may indicate serious blood disorders, e.g., agranulocytosis)
seizures

Other side effects

Very common (may affect more than 1 in 10 people): increased liver function test results
Common (may affect up to 1 in 10 people):
malaise, nausea, vomiting, abdominal pain
Uncommon (may affect up to 1 in 100 people):
headache, dizziness, drowsiness, constipation, diarrhea, bloating, gastric inflammation, rash, itching, swelling
Rare (may affect up to 1 in 1000 people):
tinnitus, oral mucosal inflammation, weight gain
Very rare (may affect up to 1 in 10,000 people):
enteropathy with perforation, ulceration, or stenosis 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, vasculitis, rhinitis (runny nose, itchy nose, sneezing, or stuffy nose), 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 those not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, it is possible to gather more information 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.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines they no longer use.
This will help protect the environment.

6. Contents of the pack and other information

What Ketonal Forte contains

The active substance is ketoprofen.
One coated tablet contains 100 mg of ketoprofen.
The other ingredients are: corn starch, 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 pack

Brown glass bottle with a child-resistant cap, in a cardboard box.
Pack size: 20 coated tablets
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 29/930/95-C
Parallel import authorization number: 140/22
Date of leaflet approval: 22.03.2022
[Information about the trademark]