Ketonal forte sr: detailed information

Package leaflet: Information for the patient

Ketonal forte SR, 100 mg, prolonged-release tablets
Ketoprofenum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Ketonal forte SR is and what it is used for
Important information before taking Ketonal forte SR
How to take Ketonal forte SR
Possible side effects
How to store Ketonal forte SR
Contents of the package and other information

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

Ketonal forte SR contains the active substance ketoprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (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

for relief of symptoms in long-term treatment:
- chronic inflammatory diseases in which the immune system attacks the joints, including the spine
- certain painful and disabling forms of osteoarthritis (cartilage degeneration leading to joint pain and movement difficulties)
for short-term treatment of pain flare-ups, including:
- structures surrounding the joints (tendinitis, tenosynovitis, periarthritis)
- joints (in cases of joint inflammation caused by microcrystal deposition or osteoarthritis)
- lower back (lumbago)
- pain due to nerve inflammation (e.g. sciatica)
- musculoskeletal system following 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 previously experienced an allergic reaction after taking acetylsalicylic acid or another pain-relieving medicine such as ketoprofen, ibuprofen, or diclofenac, e.g. asthma, breathing difficulties, nasal discharge with accompanying itching, swelling of the face, lips, tongue or throat, urticaria/rash, or other types of allergic reactions. Severe allergic reactions have been observed in these patients, rarely leading to death.
if the patient currently has gastric and/or duodenal ulcers or a history of gastrointestinal bleeding, ulceration, or perforation
if the patient has active bleeding from the stomach and/or intestine, bleeding in the brain, or any other active bleeding
if the patient has severe heart failure
in case of severely impaired liver or kidney function
during the last 3 months of pregnancy

Warnings and precautions
Before starting to take Ketonal forte SR, discuss this with your doctor or
pharmacist if:

the patient has ever had asthma associated with nasal polyps or chronic
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-relieving
medicines such as ketoprofen, ibuprofen, or diclofenac, known as nonsteroidal anti-inflammatory drugs (NSAIDs) (see "When not to take Ketonal forte SR" above).
the patient has gastrointestinal diseases known as ulcerative colitis or Crohn's disease.
the patient has or has had heart diseases, such as mild to moderate
congestive heart failure.
Symptoms of such heart failure include fluid accumulation in the lungs, abdominal cavity, arms, or legs. See also the section "When not to take Ketonal forte SR" above.
the patient has undergone coronary artery bypass graft surgery
the patient has mild or moderate kidney or liver disease, including abnormal results in certain liver or kidney function tests. See also the section "When not to take Ketonal forte SR" above.
the patient is experiencing fluid loss
the patient has or has had high blood pressure
the patient has vascular diseases in the arteries of the hands and/or legs or brain
the patient has diabetes or high cholesterol
the patient smokes tobacco
the patient has an infection – see below, section titled "Infections".
the patient is elderly

Elderly individuals are at increased risk of adverse effects from pain-relieving medicines such as ketoprofen, particularly gastrointestinal bleeding and/or intestinal perforation, which may be fatal. Therefore, elderly patients should carefully monitor for any unusual symptoms, especially gastrointestinal bleeding, particularly at the beginning of treatment. The doctor will also monitor the patient more closely.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not exceed the recommended dose or duration of treatment.

For all pain-relieving medicines such as ketoprofen, cases of gastrointestinal bleeding and/or ulceration, or perforation (with potentially fatal outcomes) have been reported. These effects may occur at any time during treatment, even without warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding and/or ulceration, or perforation increases with higher doses of the medicine. It is higher in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in elderly patients. See also section "When not to take Ketonal forte SR". The use of ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, especially when high doses are used. In patients with these risk factors, the doctor may recommend protective medications. This also applies when additional treatment with low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk is required.

Immediately discontinue use of Ketonal forte SR and inform your doctor if symptoms of gastrointestinal bleeding, ulceration, or perforation occur. See section 4 "Possible side effects".

The use of medicines such as Ketonal forte SR may be associated with a small increased risk of heart attack or stroke. This risk increases with higher doses and prolonged treatment. Do not use higher doses or longer treatment durations than recommended.

Inform your doctor or pharmacist if the patient has heart problems, has previously had a stroke, or is in a high-risk group for these conditions, e.g. if:

the patient has high blood pressure, diabetes, or high cholesterol, or
the patient smokes tobacco.

Serious skin reactions such as redness and blistering, some of which have been fatal, have very rarely been reported with pain-relieving medicines such as ketoprofen. See section 4 "Possible side effects". These reactions usually occur within the first month of treatment. Immediately discontinue taking Ketonal forte SR and inform your doctor if a skin rash, mucosal lesions, or other signs of hypersensitivity occur.

Infections
Ketonal forte SR may mask symptoms of infection such as fever and pain. Therefore, Ketonal forte SR 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 ongoing infection and infection symptoms persist or worsen, seek immediate medical advice.

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

Ketonal forte SR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

It is not recommended to take Ketonal forte SR if the patient is using:

any other pain-relieving medicine, e.g.
- medicines similar to ketoprofen, such as ibuprofen, diclofenac, naproxen
- acetylsalicylic acid at doses used to treat pain and inflammation or to reduce fever
- medicines used to treat pain, inflammation, or rheumatism with active substances ending in “-coxib”
medicines that inhibit blood clotting or dissolve blood clots, such as warfarin, clopidogrel, ticlopidine, heparin, dabigatran, apixaban, rivaroxaban, or edoxaban
lithium, used to treat depression and psychiatric disorders
methotrexate, used in cancer treatment, at doses of 15 mg per week or higher
pemetrexed, used in cancer treatment

If co-administration of Ketonal forte SR with any of the above medicines is necessary, the doctor should closely monitor the patient's condition.

Ketonal Fast and other medicines may also interact with each other. Therefore, always consult your doctor or pharmacist before using Ketonal forte SR together with other medicines, especially with:

acetylsalicylic acid at doses used for preventing blood clots (50–375 mg per day)
medicines that increase water excretion by the kidneys and lower blood pressure (diuretics)
methotrexate used in the treatment of cancer, severe rheumatoid arthritis, or psoriasis, at doses less than 0.2 mg/kg per week (approximately less than 15 mg per week in adults)
medicines used to lower high blood pressure containing active substances ending in “-pril” or “-sartan” (e.g. losartan) or “-olol”
cardiac glycosides such as digoxin, used to control heart rate or treat heart failure
medicines used for depression, known as selective serotonin reuptake inhibitors (SSRIs)
corticosteroids used to treat inflammation, allergies, or prevent organ transplant rejection, such as cortisone
pentoxifylline – a medicine used to treat muscle pain due to vascular disease in the hands and/or legs
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
deferasirox, used to reduce iron levels in the blood
medicines used to dissolve blood clots
tenofovir – a medicine used in certain viral infections
medicines that may increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs), heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim
nicorandil – used to prevent or reduce chest pain (angina pectoris) associated with certain heart diseases.

Pregnancy, breastfeeding, and effects on fertility
Do not use Ketonal forte SR 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 both the mother and the child and may delay or prolong labor.

During the first 6 months of pregnancy, Ketonal forte SR should not be used unless the doctor considers it absolutely necessary. From week 20 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 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 is not recommended during treatment with Ketonal forte SR. It is not known whether ketoprofen passes into breast milk.

If the patient is planning pregnancy or has difficulty becoming pregnant, she should inform her doctor. Medicines such as ketoprofen may make it more difficult to become pregnant.

Driving and operating machinery
Ketonal forte SR generally does not affect the ability to drive or operate machinery. However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or visual disturbances, driving or operating machinery should be avoided.

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

Ketonal forte SR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Ketonal forte SR

This medicine should always be taken according to the doctor's or pharmacist's instructions.
If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 15 years and older
The dose required depends on the condition being treated.
It is 1 to 2 tablets per day (100 to 200 mg per day).
The tablets should be taken in one or two divided doses, as directed by the doctor.
Use the lowest effective dose 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).
Your doctor will inform you how long you should take the tablets.
Use in elderly patients
The doctor will determine the dose and may consider reducing the doses mentioned above. See section 2 "Warnings and precautions".
Liver or kidney function disorders
In patients with mild to moderate liver or kidney impairment, the doctor may reduce the dose.
Ketonal forte SR must not be used in patients with severe liver or kidney impairment.
Method of administration
Oral use.
The prolonged-release tablets should be swallowed whole with a glass of water, preferably during a meal or at least with food.
The tablets may be divided into equal doses. However, the tablets must not be broken, chewed or crushed further.
Taking more Ketonal forte SR than recommended
Seek immediate medical advice or go to the nearest hospital.
In most cases, symptoms of overdose are limited to lethargy, drowsiness, nausea, vomiting and epigastric pain.
Missed dose of Ketonal forte SR
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed one.
If you have any further doubts about using 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.
If any of the following adverse effects occur, you must stop taking the medicine
and immediately contact a doctor or go to the nearest hospital:

Rare (may affect fewer than 1 in 1,000 people)
asthma attack;
burning sensation, persistent stomach pain with feeling of emptiness and hunger. These symptoms may indicate gastric or duodenal ulceration or intestinal inflammation (colitis);
Frequency unknown
vomiting blood, severe abdominal pain, or tarry (black) stools (symptoms of gastrointestinal bleeding or perforation);
blistering, peeling of the skin, presence of blisters or bleeding on the skin with itchy, nodular rash (or without rash), affecting lips, eyes, mouth, nose, genital organs, hands or feet. At the same time, symptoms resembling influenza may occur. These may be symptoms of serious skin reactions requiring immediate treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis;
bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs);
bone marrow failure;
bullous dermatosis;
serious kidney function disorders;
fluid retention, which may cause swelling of hands or feet;
chest pain (symptom of heart attack) or sudden severe headache, nausea, dizziness, numbness, difficulty or inability to speak, paralysis (symptoms of stroke). Use of medicines such as 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 caused by a serious blood disorder called agranulocytosis;
seizures.

You must stop taking Ketonal forte SR and inform your doctor as soon as possible
if any of the following adverse effects occur:

Rare (may affect fewer than 1 in 1,000 people)
unusual skin sensations such as numbness, tingling, pricking, burning skin, or a "crawling" sensation on the skin;
pale skin, feeling of fatigue, fainting or dizziness, possibly due to red blood cell deficiency caused by bleeding;
blurred vision;
yellowing of the skin or whites of the eyes, which may indicate liver function disorders.
Frequency unknown
easier than usual bruising or prolonged bleeding; these may be symptoms of a serious blood disorder such as low platelet count;
decreased number of red blood cells, which may cause pale-yellow skin tone, weakness or shortness of breath (hemolytic anemia);
decreased number of white blood cells, which may increase the likelihood of infections;
worsening of a bowel disease called Crohn's disease or ulcerative colitis;
skin reaction to sunlight or UV radiation.

Other adverse effects may occur with the following frequency:
Common (may affect fewer than 1 in 10 people):

indigestion, abdominal pain;
nausea, vomiting.

Uncommon (may affect fewer than 1 in 100 people):

inflammation of the stomach lining;
constipation, diarrhoea, flatulence;
skin rash, itching;
fluid retention, which may cause swelling of hands or feet;
headache, dizziness or drowsiness;
feeling of fatigue or malaise;

Rare (may affect fewer than 1 in 1,000 people):

ringing in the ears;
weight gain;
pain and inflammation in the mouth.

Frequency unknown

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

Blood tests
Blood test results may indicate liver or kidney function disorders.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ketonal forte SR
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Ketonal forte SR contains
The active substance is ketoprofen.
Each prolonged-release tablet contains 100 mg of ketoprofen.
The other ingredients are:
White layer
Sodium carboxymethyl starch (type A)
Microcrystalline cellulose
Lactose monohydrate
Colloidal hydrated silica
Magnesium stearate
Light yellow layer
Hypromellose 100 mPa·s
Calcium hydrogen phosphate dihydrate
Yellow iron oxide (E 172)
Colloidal hydrated silica
Magnesium stearate

What Ketonal forte SR looks like and contents of the pack
Prolonged-release tablets.
A two-layered, oval, biconvex tablet measuring 15.1 mm x 7.6 mm, with a score 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 contain specks.
The tablet can be divided into two equal doses.
The medicine is packed in opaque, white PVC/Aluminum blisters and cardboard boxes.
Pack sizes:
Blister packs containing 20, 20x1 prolonged-release tablets.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
Poland

Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d,
9220 Lendava,
Slovenia

For more detailed information on this medicine, please contact the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
Poland
Tel: 22 209 70 00

This medicine is authorised for sale in the European Economic Area under the following names:
Hungary: Ketonal 100 mg tablete s produljenim oslobađanjem
Czech Republic: Ketonal Prolong
France: KETOPROFENE SANDOZ LP 100 mg, comprimé sécable à libération prolongée
Italy: Ketodipil
Poland: Ketonal forte SR
Romania: Ketonal DUO 100 mg comprimate cu eliberare prelungită