Ketonal forte

Patient Information Leaflet

Warning! Keep this leaflet! The packaging information in a foreign language.
Ketonal forte, 100 mg, coated tablets
Ketoprofen
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of Contents

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

Ketonal forte contains the active substance ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic and analgesic properties.
Ketonal forte is used for symptomatic treatment of inflammatory, degenerative and metabolic rheumatic disorders, as well as for relief of certain 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 allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced asthma attack, bronchospasm, nasal mucosal swelling, skin reaction (skin swelling or itchy rash), or any other type of allergic reaction after taking ketoprofen or similar-acting medicines (such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs));
• if the patient has:
• severe heart failure,
• severe renal failure,
• severe hepatic failure,
• tendency to bleeding,
• active gastric or duodenal ulcer or 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, consult your 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);
• the patient suffers from asthma or inflammation of the nasal mucosa (rhinitis, nasal congestion, sneezing), chronic sinusitis, or nasal polyps;
• the patient currently has or has previously had heart, kidney, or liver disease;
• the patient currently has or has previously had high blood pressure (hypertension);
• the patient has peripheral arterial disease (circulatory disorders in legs or feet due to narrowing or blockage of arteries) or cerebrovascular disease;
• the patient has diabetes or high blood cholesterol levels;
• the patient has an infection - see below under the section titled "Infections";
• the patient smokes tobacco;
• the patient is elderly.

Non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal), which can 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 use Ketonal forte"), and in elderly patients.
If the patient experiences unusual gastrointestinal symptoms during treatment with Ketonal forte (especially bleeding), medical advice should be sought immediately.
Use of medicines such as Ketonal forte may be associated with a small increased risk of arterial thrombotic events (heart attack or stroke). This risk increases with prolonged use of high doses.
Very rarely, severe skin reactions (some potentially fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur during treatment with non-steroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of treatment. If the patient develops a rash, mucosal lesions, or any signs of hypersensitivity, the medicine should be discontinued immediately.
If the patient experiences visual disturbances (e.g. blurred vision) during treatment with Ketonal forte, the medicine should be discontinued and medical advice should be sought.
It is very important to use Ketonal forte at the lowest effective dose for the shortest duration necessary to relieve symptoms.
Higher doses and longer treatment durations than recommended should not be used.

Infections
Ketonal forte may mask signs of infection such as fever and pain. Therefore, Ketonal forte 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 existing infection and symptoms of infection persist or worsen, immediate medical consultation is required.

Use of Ketonal forte in children and adolescents
This medicine should not be used in children and adolescents under 15 years of age.

Ketonal forte and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

The following medicines should not be used together with Ketonal forte

• other painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g. acetylsalicylic acid, diclofenac, naproxen);
• anticoagulants (medicines that inhibit blood clotting), antiplatelet agents (medicines that inhibit platelet aggregation), and thrombolytics (medicines used to unblock blood vessels), such as acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, or edoxaban;
• nicorandil (a medicine used to treat ischemic heart disease);
• lithium (a medicine used to treat certain psychiatric disorders);
• methotrexate (a medicine used, among others, in the treatment of cancer) in doses exceeding 15 mg per week.

Ketonal forte and other medicines may affect each other's actions and the occurrence of adverse effects.
Therefore, always consult a doctor or pharmacist before using Ketonal forte together with other medicines such as:

• diuretics;
• methotrexate (a medicine used, among others, in the treatment of cancer) in doses less than 15 mg per week;
• antihypertensive medicines;
• 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);
• immunosuppressive medicines, e.g. after organ transplantation (cyclosporine and tacrolimus);
• antidiabetic medicines;
• antiepileptic medicines;
• medicines used for heart conditions (cardiac glycosides, beta-blockers);
• quinolone antibiotics;
• tenofovir (an antiretroviral medicine used to treat HIV infection and chronic viral hepatitis B).

If in any doubt, consult a doctor or pharmacist.

Ketonal forte with food and drink
Ketonal forte tablets should be taken with food, swallowed 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 baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ketonal forte if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketonal forte may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, Ketonal forte should not be used unless the doctor considers its use 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.
From the 20th week of pregnancy, Ketonal forte may lead to kidney function disorders in the unborn child if taken for longer than a few days. This may result in low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
It is not known whether ketoprofen passes into breast milk. Ketonal forte should not be given to women who are breastfeeding.

Effect on fertility
Ketonal forte may impair fertility. If the patient is planning pregnancy, has difficulty becoming pregnant, or is undergoing fertility investigations, she should inform her doctor. The doctor may consider discontinuing treatment with Ketonal forte.

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

Ketonal forte contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ketonal forte

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for oral administration. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Adults and adolescents over 15 years of age
The usual dose is 1 coated tablet once or, at most, twice daily (100 to 200 mg of ketoprofen per day).

Osteoarthritis and rheumatoid arthritis
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 doctor will carefully evaluate the risk-benefit ratio of treatment.
Tablets should be taken during meals, with at least 100 ml of water or milk.
The doctor may recommend concomitant use of agents that neutralize gastric hydrochloric acid to reduce the risk of harmful effects of ketoprofen on the gastrointestinal tract.

Elderly patients
As a general rule, treatment with ketoprofen in elderly patients should be initiated at the lowest available dose and continued with the lowest effective dose.
In elderly patients, the risk of severe adverse effects is higher.
If a patient feels that the effect of Ketonal forte is too strong or too weak, they should consult a doctor.

Taking more Ketonal forte than recommended
In case of overdose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, bloody vomiting, tarry stools, disturbances of consciousness, respiratory depression, convulsions, kidney dysfunction, and renal failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and initiate symptomatic and supportive treatment.

Missed dose of Ketonal forte
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 pain-relieving medicines such as Ketonal forte, particularly 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, discontinue taking the medicine immediately and seek medical advice from a doctor or the nearest hospital emergency department:

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• asthma attack
• burning sensation, persistent stomach pain (which may indicate gastric or duodenal ulceration).

Adverse reactions with unknown frequency:

• vomiting blood, severe abdominal pain, or tarry stools (these may be symptoms of gastrointestinal bleeding)
• formation of blisters, skin peeling or bleeding on the skin with or without itching, nodular rash (around lips, eyes, mouth, nose, genital organs, hands or feet), sometimes accompanied by flu-like symptoms. These may be symptoms of serious skin disorders requiring urgent medical attention.
• presence of blood in urine, changes in urine output, swelling of legs, ankles or feet (which may indicate serious kidney problems)
• chest pain or sudden severe headache (taking medicines such 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, drop in blood pressure (which may lead to shock), itching and rash. These may be symptoms of a severe allergic reaction.

If any of the following adverse reactions occur, consult a doctor as soon as possible:

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• numbness, tingling, pricking or burning sensation of the skin
• pale skin and feeling of fatigue, fainting or dizziness (these may be symptoms of anaemia due to red blood cell breakdown)
• yellowing of the skin or whites of the eyes (with increased liver enzyme activity and serum bilirubin concentration) – jaundice, which may indicate serious liver dysfunction.

Adverse reactions with unknown frequency:

• easier than usual bruising or persistent bleeding (these may be symptoms of serious blood disorders, e.g. reduced platelet count)
• worsening of Crohn's disease or ulcerative colitis
• photosensitivity (skin hypersensitivity to light)
• hair loss
• susceptibility to infections (which may indicate serious blood disorders, e.g. severe reduction in certain types of white blood cells – agranulocytosis)
• seizures.

Other adverse reactions
Very common (may occur in more than 1 in 10 people):
increased liver function test results.
Common (may occur in less than 1 in 10 people):
malaise, dyspepsia, nausea, abdominal pain, vomiting.
Uncommon (may occur in less than 1 in 100 people):
headache, dizziness, drowsiness, constipation, diarrhoea, flatulence, gastric mucosal inflammation, rash, itching, oedema.
Rare (may occur in less than 1 in 1,000 people):
tinnitus, oral mucosal inflammation, weight gain.
Very rare (may occur in less than 1 in 10,000 people):
enteropathy with perforation, ulceration, strictures and bleeding.
Adverse reactions 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 when lying down, swelling of feet or legs), hypertension, skin redness (vasodilation), vasculitis, nasal mucosal inflammation (rhinitis, nasal itching, sneezing or nasal congestion), pancreatitis, feeling of fatigue or malaise, angioedema (sudden swelling of face, limbs or joints without itching or pain), decreased sodium concentration in blood (hyponatraemia), increased potassium concentration in blood (hyperkalaemia); confusion, aseptic meningitis, drug eruption (acute generalised pustular rash).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ketonal forte

• Keep this medicine out of the 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 stated month.
• Store below 25°C in the original packaging.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Ketonal forte contains
The active substance is ketoprofen. One coated tablet contains 100 mg of ketoprofen.
Other ingredients are: maize starch, 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 contents of the pack
The coated tablets are light blue, round, biconvex.
The tablets are packed in a brown glass bottle with a plastic screw cap and a tamper-evident ring,
placed in a cardboard box.
The pack contains 20 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Croatia, 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.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Croatia, country of export: HR-H-834540447-01
Parallel import authorisation number: 138/24