Ketonal forte

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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.
Indications for use include:

• 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 attacks, bronchospasm, nasal mucosal swelling, or skin reactions (such as 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 (so-called NSAIDs));
• if the patient has:
• severe heart failure,
• severe renal insufficiency,
• severe hepatic insufficiency,
• a tendency to bleeding,
• active gastric or duodenal ulcer, or has previously experienced gastrointestinal bleeding, ulceration, or perforation;

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

Warnings and precautions
Before starting treatment with Ketonal forte, consult a doctor or pharmacist if:

• the patient has previously suffered from gastrointestinal disorders (there is a risk of exacerbating ulcerative colitis or Crohn's disease);
• the patient has asthma or inflammation of the nasal mucosa (rhinitis, nasal obstruction, 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 heading "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 previous 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, particularly 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.
Taking medicines such as Ketonal forte may be associated with a small increased risk of arterial thromboembolic events (e.g. 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 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.
If the patient experiences visual disturbances (e.g. blurred vision) during treatment with Ketonal forte, the medicine should be discontinued and medical advice sought.
It is very important to take Ketonal forte at the lowest effective dose for the shortest duration necessary to relieve symptoms.
Do not use higher doses or longer treatment durations than recommended.

Infections
Ketonal forte may mask symptoms 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 is taking this medicine during an existing infection and symptoms of infection persist or worsen, immediate medical advice should be sought.
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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 with other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

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 coagulation), 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 cancer treatment) at 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 cancer treatment) at doses less than 15 mg per week;
• medicines that 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);
• 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 during meals, swallowed with at least half a glass of water or milk.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 disturbances in kidney and heart function in the unborn child. It may
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increase the tendency to bleeding in both mother and child and may delay or prolong labour.

During the first six 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 time.

From the 20th week of pregnancy, Ketonal forte may cause disturbances in kidney function in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, 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.

Effects 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 Ketonal forte.

Driving and operating machinery
Ketonal forte 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.

Ketonal forte contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Ketonal Forte

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your 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 your doctor immediately (see section 2).

Adults and adolescents aged above 15 years
The usual dose is 1 coated tablet once or, at most, 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 doctor will carefully evaluate the risk-benefit ratio of the treatment.

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Tablets should be taken during meals, with at least 100 ml of water or milk.
Your 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
In elderly patients, treatment with ketoprofen should generally be initiated at the lowest available dose, and therapy should continue with the lowest effective dose.
The risk of severe adverse effects is higher in elderly patients.
If the patient feels that the effect of Ketonal Forte is too strong or too weak, they should consult their doctor.

Taking more Ketonal Forte than recommended
If more than the recommended dose has been taken, consult your doctor or pharmacist immediately.
Symptoms of overdose may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, vomiting of blood, tarry stools, disturbances of consciousness, respiratory depression, seizures, impaired kidney function, and kidney failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and initiate symptomatic and supportive treatment.

Missing a dose of Ketonal Forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Taking anti-inflammatory and pain-relieving medicines, such as Ketonal forte, particularly 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 effects occur, stop taking the medicine and seek immediate medical advice from a doctor or the nearest hospital emergency department:
Rare adverse effects (may affect less than 1 in 1,000 people):

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

Adverse effects with unknown frequency:

• vomiting blood, severe abdominal pain, or tarry stools (which may be symptoms of gastrointestinal bleeding)
• formation of blisters, peeling of the skin, or bleeding within the skin with or without itching, nodular rash (affecting lips, eyes, mouth, nose, genital organs, hands or feet), sometimes with flu-like symptoms. These may be symptoms of serious skin disorders requiring urgent medical attention.
• presence of blood in urine, changes in the amount of urine passed, 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)

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• swelling of the face, lips or throat, causing difficulty in 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 effects occur, consult a doctor as soon as possible:
Rare adverse effects (may affect 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 (which may be symptoms of anaemia due to breakdown of red blood cells)
• 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 effects with unknown frequency

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

Other adverse effects
Very common (may affect more than 1 in 10 people):
increased liver function test results
Common (may affect less than 1 in 10 people):
malaise, dyspepsia, nausea, abdominal pain, vomiting
Uncommon (may affect less than 1 in 100 people):
headache, dizziness, drowsiness, constipation, diarrhoea, flatulence, gastritis, rash, itching, oedema
Rare (may affect less than 1 in 1,000 people):
tinnitus, stomatitis, weight gain
Very rare (may affect less than 1 in 10,000 people):
enteropathy with perforation, ulceration, strictures and bleeding
Adverse 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 when lying down, swelling of feet or legs), hypertension, skin redness (vasodilation), vasculitis, rhinitis (nasal congestion, nasal itching, sneezing or nasal obstruction), pancreatitis, feeling of fatigue or malaise, angioedema (sudden swelling of face, limbs or joints without itching or pain), decreased sodium concentration in blood (hyponatremia), increased potassium concentration in blood (hyperkalemia); confusion, aseptic meningitis, drug eruption (acute generalized exanthematous pustulosis).
Reporting of adverse effects
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If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ketonal forte

• Keep this medicine 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 specified 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 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 anhydrous silica,
talc, lactose monohydrate.
Coating: hypromellose, polyethylene glycol 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, and biconvex.
The tablets are packed in brown glass bottles with screw caps made of plastic and a tamper-evident ring, placed in a cardboard box.
The packs contain 20 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorization number in Croatia, country of export: HR-H-834540447-01
Parallel import licence number: 236/23
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