Ketonal forte

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

Ketonal forte contains the active substance ketoprofen - a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic and analgesic effects.
Ketonal forte is used to treat symptomatic inflammatory, degenerative and metabolic rheumatic diseases and to alleviate some symptoms of pain syndromes.
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 allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
if the patient has experienced shortness of breath, asthma attack, swelling of the nasal mucosa or skin reaction (skin swelling or itching rash) or other allergic reaction after taking ketoprofen or similar acting drugs (such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (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").

• 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 had gastrointestinal diseases in the past (there is a risk of exacerbating the course of ulcerative colitis or Crohn's disease);
the patient has asthma or nasal mucosa inflammation (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 in the blood;
the patient has an infection - see below, section entitled "Infections".
the patient smokes;
the patient is elderly.
Nonsteroidal 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 symptoms or a history of serious gastrointestinal events.
The risk of bleeding, ulceration 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 take Ketonal forte") and in the elderly.
If unusual gastrointestinal symptoms occur in the patient during treatment with Ketonal forte (especially at the beginning of treatment), they should immediately inform their doctor.
Taking such drugs 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 drug.
During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of treatment, 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 symptoms of hypersensitivity, they should stop taking the drug.
If the patient experiences vision disturbances (e.g. blurred vision) during treatment with Ketonal forte, they should stop taking the drug and consult a doctor.
It is very important to take Ketonal forte in the smallest effective dose for the shortest necessary time to alleviate 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 during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Using Ketonal forte in children and adolescents

Do not use in children and adolescents under 15 years of age.

Ketonal forte and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

The following medicines should not be taken with Ketonal forte

other painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors (e.g. acetylsalicylic acid, diclofenac, naproxen);
anticoagulant medicines (blood thinning medicines), antiplatelet medicines (medicines that prevent blood clots) 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 coronary heart disease);
lithium (a medicine used to treat certain mental illnesses);
methotrexate (a medicine used to treat certain types of cancer) at a dose greater than 15 mg per week.
Ketonal forte and other medicines may interact with each other and affect each other's effects and side effects.
Therefore, always consult a doctor or pharmacist before taking Ketonal forte with other medicines, such as:
diuretics;
methotrexate (a medicine used to treat certain types of cancer) at 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 vascular disease);
probenecid (a medicine used to treat gout and high uric acid levels);
medicines that suppress the immune system, e.g. after organ transplantation (cyclosporin 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, consult a 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 a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ketonal forte 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 delayed or prolonged labor.
During the first 6 months of pregnancy, do not take Ketonal forte unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time.
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 child (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. Breastfeeding women should not be given 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 Ketonal forte.

Driving and using machines

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

Ketonal forte contains lactose 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 essentially "sodium-free".

3. How to take Ketonal Forte

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for oral administration. Use the smallest effective dose for the shortest necessary time to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during treatment, consult a 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, maximum 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, consult a doctor or pharmacist immediately.
After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, abdominal pain, bloody vomiting, 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

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult a 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 analgesic medicines, such as 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 following side effects occur, stop taking the medicine and consult a doctor or the nearest hospital emergency department immediately:

Rare side effects(may occur in less than 1 in 1000 people):
asthma attack
burning, persistent abdominal pain (which may indicate stomach or duodenal ulcer)
Side effects with unknown frequency:
bloody vomiting, severe abdominal pain or black stools (which may be symptoms of gastrointestinal bleeding)
blistering, skin peeling or bleeding in the skin with itching (or without), papular rash (on the lips, eyes, mouth, nose, genitals, hands or feet), sometimes with symptoms similar to flu. 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.

If the following side effects occur, consult a 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 and feeling of tiredness, fainting or dizziness (which may be symptoms of anemia due to red blood cell destruction)
yellowing of the skin or whites of the eyes (with increased liver enzyme activity and bilirubin levels in the blood) - jaundice, which may indicate serious liver problems

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
sensitivity to sunlight
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 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, stomach inflammation, rash, itching, swelling
Rare (may occur in less than 1 in 1000 people):
ringing in the ears, mouth inflammation, 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 disorders, 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, itching, sneezing or nasal congestion), pancreatitis, feeling of tiredness or malaise, angioedema (sudden swelling of the face, limbs or joints without itching or pain), decreased sodium levels in the blood (hyponatremia), increased potassium levels in the blood (hyperkalemia); confusion, aseptic meningitis, drug rash (acute generalized exanthematous pustulosis).

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell a 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: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ketonal forte

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Store in a temperature not exceeding 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. 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.
Other ingredients are: starch, povidone, magnesium stearate, colloidal silica, purified talc, lactose.
Coating: hypromellose, macrogol 400, indigo carmine (E132), talc, titanium dioxide (E171), carnauba wax.

What Ketonal forte looks like and what the pack contains

The coated tablets are light blue, round, biconvex.
The tablets are packed in orange glass bottles in a cardboard box or blisters of aluminum/PVC foil in a cardboard box.
The packs contain 20 or 30 coated tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Lek S.A.
ul. Domaniewska 50C
02-672 Warsaw
To obtain more detailed information, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

Date of last revision of the leaflet:

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