Ketonal forte Sr

Leaflet attached to the packaging: patient information

Ketonal forte SR, 100 mg, prolonged-release tablets

Ketoprofen

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 any 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 SR and what is it used for
• 2. Important information before taking Ketonal forte SR
• 3. How to take Ketonal forte SR
• 4. Possible side effects
• 5. How to store Ketonal forte SR
• 6. Package contents and other information

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

Ketonal forte SR contains the active substance ketoprofen. It belongs to a group called non-steroidal anti-inflammatory drugs or NSAIDs. These medicines are used to reduce inflammation and relieve pain.
Ketonal forte SR is used in adults and adolescents aged 15 years and older

• to relieve symptoms in long-term treatment:
• in chronic inflammatory diseases where the immune system attacks the joints, including the spine
• certain painful and disabling arthroses (cartilage wear leading to joint pain and difficulty moving)
• as short-term pain relief, including:
• structures surrounding the joints (tendonitis, bursitis, periarticular inflammation)
• joints (in cases of arthritis caused by microcrystal deposition or arthrosis)
• lower back (lumbago)
• nerve pain (e.g., sciatica)
• musculoskeletal system after injury.

2. Important information before taking Ketonal forte SR

When not to take Ketonal forte SR

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had a previous allergic reaction after taking acetylsalicylic acid or a pain reliever, such as ketoprofen, ibuprofen, or diclofenac, e.g., asthma, breathing difficulties, nasal congestion with accompanying itching, swelling of the face, lips, tongue, or throat, hives/rash, or other types of allergic reactions. In these patients, severe allergic reactions have been observed, which can be life-threatening.
• if the patient has stomach or duodenal ulcers or has had bleeding from the stomach or intestines, their ulceration, or perforation
• if the patient has bleeding from the stomach or intestines, brain bleeding, or other active bleeding
• if the patient has severe heart failure
• in cases of severely impaired liver or kidney function
• during the last 3 months of pregnancy

Warnings and precautions

Before starting to take Ketonal forte SR, the patient should discuss it with their doctor or pharmacist if:
the patient has ever had asthmawith nasal polypsor long-term inflammation of the nose or sinuses (chronic rhinitis or sinusitis).
Taking this medicine may cause breathing difficulties or an asthma attack,
especially in patients who are allergic to acetylsalicylic acid or pain relievers
such as ketoprofen, ibuprofen, or diclofenac, called non-steroidal anti-inflammatory drugs (NSAIDs) (see "When not to take Ketonal forte SR" above).
the patient has gastrointestinal diseases called ulcerative colitisor Crohn's disease.
the patient has or has had heart disease, such as mild to moderate congestive heart failure
Symptoms of such heart failure include fluid accumulation in the lungs, abdominal organs, arms, or legs. See also "When not to take Ketonal forte SR" above.
the patient has had heart bypass surgery
the patient has mild or moderate kidney or liver disease, including changes in some liver or kidney function test results. See also "When not to take Ketonal forte SR" above.
the patient has fluid loss
the patient has or has had high blood pressure
the patient has vascular diseasesin the arteries of the hands and (or) feet or brain
the patient has diabetesor high cholesterol
the patient smokes
the patient has an infection- see below, section titled "Infections".
the patient is elderly
Elderly people are at increased risk of adverse reactions to pain relievers such as ketoprofen, particularly gastrointestinal bleeding and perforation, which can be fatal. Therefore, elderly people should be carefully monitored for the appearance of any unusual symptoms, especially gastrointestinal bleeding, especially when starting treatment.
The doctor will also monitor the patient more closely.
Adverse reactions can be minimized by using the smallest effective dose for the shortest duration necessary to control symptoms. Do not exceed the recommended dose or duration of treatment.
If the patient has heart problems, has had a stroke, or is at risk of these conditions, they should inform their doctor or pharmacist, e.g., if they:
have high blood pressure, diabetes, or high cholesterol or
smoke.
Severe skin reactionswith redness and blisters, some with a fatal outcome, have been reported very rarely in patients taking pain relievers such as ketoprofen.
See section 4 "Possible side effects". These reactions usually occur within the first month of treatment. The patient should stop taking Ketonal forte SR and inform their doctor immediately if they experience a skin rash, changes in the mucous membranes, or other signs of hypersensitivity.

Infections

Ketonal forte SR may mask the symptoms of an infection, such as fever and pain. As a result, Ketonal forte SR may delay the use of appropriate infection treatment, leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.

Children and adolescents

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

Ketonal forte SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is not recommendedto take Ketonal forte SR if the patient is taking:
any other pain reliever, e.g.

• medicines similar to ketoprofen, such as ibuprofen, diclofenac, naproxen
• acetylsalicylic acid in doses used to treat pain and inflammation or to lower fever
• medicines used to treat pain, inflammation, or rheumatism with active substance names ending in "coxib"

blood thinners or clot dissolvers, such as warfarin, clopidogrel, ticlopidine, heparin, dabigatran, apixaban, rivaroxaban, or edoxaban
lithium, used to treat depression and mental disorders
methotrexate, used to treat cancer, in doses of 15 mg per week or higher
pemetrexed, used to treat cancer
If it is necessary to take Ketonal forte SR with the above-mentioned medicines, the doctor should closely monitor the patient's condition.
Ketonal Fast and other medicines may also interact with each other. Therefore, the patient should always consult their doctor or pharmacist before taking Ketonal forte SR with other medicines, especially those such as:
acetylsalicylic acid in doses that prevent blood clotting (50-375 mg per day)
medicines that increase water excretion through the kidneys and lower blood pressure (diuretics)
methotrexate used to treat cancer, severe arthritis, and skin disease, psoriasis, in a dose of less than 15 mg per week
medicines used to lower high blood pressure containing an active substance with a name ending in "-pril" or "-sartan" (e.g., losartan) or "-olol"
digitalis glycosides, such as digoxin, used to control heart rate or treat heart failure;
medicines used in depression, called selective serotonin reuptake inhibitors
corticosteroids used to treat inflammation, allergies, prevent transplant rejection, such as cortisone;
pentoxifylline - a medicine used to treat muscle pain due to vascular disease in the hands and (or) feet
probenecid - a medicine used to treat gout and high uric acid levels in the blood;
cyclosporine and tacrolimus - medicines used to suppress the immune system, e.g., after organ transplantation;
deferazirox, used to reduce the amount of iron in the blood
medicines used to dissolve blood clots
tenofovir - a medicine used in certain viral infections
medicines that can increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim
nicorandil, used to prevent or reduce chest pain (angina pectoris) in certain heart diseases.

Pregnancy, breastfeeding, and fertility

Ketonal forte SR should not be taken 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 SR may cause kidney and heart problems in the unborn child.
It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.
In the first 6 months of pregnancy, Ketonal forte SR should not be taken unless the doctor considers it absolutely necessary. From the 20th week of pregnancy, Ketonal forte SR may cause kidney problems in the unborn child if taken for more than a few days.
It may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding is not recommended while taking Ketonal forte SR. It is not known whether ketoprofen passes into breast milk.
If the patient plans to become pregnant or is having trouble getting pregnant, they should inform their doctor. Medicines like ketoprofen may make it harder to get pregnant.

Driving and using machines

Ketonal forte SR does not normally affect the ability to drive or use machines. However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or vision disturbances, they should not drive or operate machines.

Ketonal forte SR contains lactose

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

Ketonal forte SR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ketonal forte SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The recommended dose is:

Adults and adolescents aged 15 years and older

The dose to be taken depends on the disease being treated.
This is 1 to 2 tablets per day(100 to 200 mg per day).
Tablets should be taken in 1 or 2 doses, as directed by the doctor.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection and the infection symptoms persist or worsen, they should consult their doctor immediately (see section 2).
The doctor will inform the patient how long to take the tablets.

Use in elderly patients

The dose will be determined by the doctor, who will consider reducing the above doses. See section 2 "Warnings and precautions".

Liver or kidney impairment

In patients with mild or moderate liver or kidney impairment, the doctor may reduce the dose.
Ketonal forte SR should not be taken by patients with severe liver or kidney impairment.

Method of administration

Oral administration.
Prolonged-release tablets should be swallowed, washed down with a glass of water, preferably during a meal or at least with a snack.
Tablets can be divided into two equal doses. However, tablets should not be further broken, chewed, or crushed.

Taking a higher dose of Ketonal forte SR than recommended

The patient should immediately consult their doctor or go to the nearest hospital.
In most cases, symptoms of overdose are limited to lethargy, drowsiness, nausea, vomiting, and abdominal pain.

Missing a dose of Ketonal forte SR

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should not take the missed dose. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketonal forte SR can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking the medicineand immediately consult their doctor or the nearest hospital:

• Rare(may occur in less than 1 in 1000 people)
• asthma attack;
• burning, persistent stomach pain with a feeling of hunger. These symptoms may indicate stomach or duodenal ulceration or inflammation of the intestine (colitis)
• Frequency not known
• vomiting blood, severe abdominal pain, or black stools (symptoms of gastrointestinal bleeding or perforation);
• the formation of blisters, peeling of the skin, the presence of pustules, or bleeding on the skin with an itchy, lumpy rash (or without it), affecting the lips, eyes, mouth, nose, genitals, hands, or feet. At the same time, symptoms similar to the flu may occur. These may be symptoms of severe skin reactions, requiring immediate treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis.
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs)
• bone marrow failure
• bullous dermatosis
• severe kidney problems
• fluid retention, which can cause swelling of the hands or feet
• chest pain (symptom of a heart attack) or sudden severe headache, nausea, dizziness, numbness, or difficulty speaking, paralysis (symptoms of a stroke). Taking medicines like Ketonal Fast may be associated with a small increased risk of heart attack or stroke. See "Warnings and precautions" in section 2;
• symptoms of severe allergic reactions, such as:
• swelling of the face, lips, mouth, or throat, causing wheezing or difficulty swallowing or breathing, chest tightness, rapid heartbeat, decreased blood pressure leading to shock;
• increased susceptibility to infections, which may be due to a serious blood disorder, called agranulocytosis;
• seizures.

The patient should stop taking Ketonal forte SR and consult their doctor as soon as possible if they experience any of the following side effects:

• Rare(may occur in less than 1 in 1000 people)
• unusual skin sensations, such as numbness, tingling, prickling, burning of the skin, or a feeling of "crawling" on the skin;
• pale skin, feeling of tiredness, fainting, or dizziness, probably caused by a lack of red blood cells due to bleeding;
• blurred vision;
• yellowing of the skin or whites of the eyes, which may indicate liver problems.
• Frequency not known
• easier than usual bruising or prolonged bleeding; These may be symptoms of a serious blood disorder, such as a low platelet count;
• reduced red blood cell count, which may cause pale yellow skin, weakness, or shortness of breath (hemolytic anemia);
• reduced white blood cell count, which may increase the risk of infection;
• worsening of a bowel disease called Crohn's disease or ulcerative colitis;
• skin reaction to sunlight or UV radiation.

Other side effects may occur with the following frequency:
Common(may occur in less than 1 in 10 people):

• indigestion, abdominal pain;
• nausea, vomiting.

Uncommon(may occur in less than 1 in 100 people):

• gastritis;
• constipation, diarrhea, gas;
• skin rash, itching;
• fluid retention, which can cause swelling of the hands or feet;
• headache, dizziness, or drowsiness;
• feeling of tiredness or malaise;

Rare(may occur in less than 1 in 1000 people):

• ringing in the ears;
• weight gain;
• mouth inflammation and ulcers.

Frequency not known

• heart failure with symptoms such as shortness of breath, difficulty breathing when lying down, swelling of the feet or legs;
• high blood pressure;
• redness of the skin due to dilation of blood vessels;
• mood changes;
• confusion;
• changes in taste;
• feeling of dizziness or "spinning"
• runny nose, itching, sneezing, and nasal congestion;
• hair loss;
• hives, redness, and inflammation of the skin, blistering rash;
• low sodium levels in the blood, which can cause fatigue and confusion, muscle twitching, seizures, and coma
• high potassium levels in the blood, which can cause irregular heartbeat
• aseptic meningitis (meningitis with possible symptoms such as stiff neck, headache, fever, nausea, vomiting)
• vasculitis, often with skin rash (including leukocytoclastic vasculitis)
• pancreatitis, which causes severe abdominal and back pain.

Blood tests

Blood test results may indicate liver or kidney problems.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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
phone: +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 SR

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
This medicine does not require special storage conditions.
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. Package contents and other information

What Ketonal forte SR contains

The active substance of the medicine is ketoprofen
Each prolonged-release tablet contains 100 mg of ketoprofen
The other ingredients are:
White layer
Sodium carboxymethylcellulose (type A)
Microcrystalline cellulose
Lactose monohydrate
Hydrated colloidal silica
Magnesium stearate
Light yellow layer
Hypromellose 100 mPa·s
Calcium hydrogen phosphate dihydrate
Yellow iron oxide (E 172)
Hydrated colloidal silica
Magnesium stearate

What Ketonal forte SR looks like and contents of the pack

Prolonged-release tablets.
A two-layer, oval, biconvex tablet with dimensions of 15.1 mm x 7.6 mm with a dividing line on both sides. One side of the tablet is white (layer containing 50 mg of ketoprofen with immediate release), and the other side is light yellow (layer containing 50 mg of ketoprofen with prolonged release). The tablet may have spots.
The tablet can be divided into two equal doses.
The medicine is packaged in non-transparent, white PVC/Aluminum blisters and a cardboard box.
Pack sizes:
Blisters containing 20, 20x1 prolonged-release tablets.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw

Manufacturer

Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d,
9220 Lendava,
Slovenia
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary
Ketonal 100 mg prolonged-release tablets
Czech Republic
Ketonal Prolong
France
KETOPROFENE SANDOZ LP 100 mg, prolonged-release tablet
Italy
Ketodipil
Poland
Ketonal forte SR
Romania
Ketonal DUO 100 mg prolonged-release tablets
Date of last revision of the leaflet:08/2024