Ketonal Duo

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

Ketonal DUO contains the active substance ketoprofen - a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic, and analgesic properties.
Ketonal DUO is available in a pharmaceutical form that differs from other capsules in the way the active substance is released. The capsules contain two types of pellets: 60% standard pellets (white) and 40% coated pellets (yellow). Ketoprofen is quickly released from the white pellets and slowly from the yellow pellets. This method ensures both immediate and prolonged release.
The indications for the use of Ketonal DUO are:
rheumatic diseases, including rheumatoid arthritis,
arthritis of other origin,
extra-articular inflammatory conditions, such as tendon sheath inflammation or painful shoulder syndrome,
degenerative joint and spine disease, with significant pain and significantly impaired patient mobility.

2. Important information before taking Ketonal DUO

When not to take Ketonal DUO

if you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
if you have ever had a breathing problem, an asthma attack, swelling of the nasal mucosa or a skin reaction (skin swelling or itching 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 you have:

• severe heart failure,
• severe kidney failure,
• severe liver failure,
• a tendency to bleed,
• active peptic ulcer disease of the stomach and/or duodenum or have had it in the past

gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract;
if you are in the third trimester of pregnancy (see below "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Before starting treatment with Ketonal DUO, discuss with your doctor or pharmacist if:
you have ever had gastrointestinal diseases (there is a risk of exacerbating the course of ulcerative colitis or Crohn's disease);
you have asthma or nasal mucosa inflammation (rhinitis, nasal congestion, sneezing),
chronic sinusitis or nasal polyps;
you currently have or have had heart, kidney, or liver disease;
you currently have or have had high blood pressure (hypertension);
you have peripheral arterial disease (circulatory disorders in the legs or feet due to narrowing or blockage of arteries) or cerebral vessels;
you have diabetes or high cholesterol levels in the blood;
you have an infection - see below, section entitled "Infections".
you smoke;
you are elderly.
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome), which may occur at any time during treatment, even without warning symptoms or severe gastrointestinal events in the past.
The risk of bleeding, ulceration, or perforation of the gastrointestinal tract is higher when using high doses of NSAIDs, in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation (see section "When not to take Ketonal DUO"), and in the elderly.
If you experience unusual gastrointestinal symptoms, especially bleeding, while taking Ketonal DUO (especially at the beginning of treatment), you should immediately inform your doctor.
Taking such medicines as Ketonal DUO may be associated with a slight increase in the risk of arterial thrombotic events (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 treatment, very rare but serious skin reactions (some with fatal outcome) may occur, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. If you develop a rash, changes in the mucous membranes, or any symptoms of hypersensitivity, you should discontinue the medicine.
If you experience vision disturbances (e.g., blurred vision) while taking Ketonal DUO, you should discontinue the medicine and consult your doctor.
It is very important to take Ketonal DUO in the smallest effective dose for the shortest duration necessary to relieve symptoms.
Do not take higher doses or longer treatment than recommended.
Infections
Ketonal DUO may mask the symptoms of an infection, such as fever and pain. Therefore, Ketonal DUO may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, you should immediately consult your doctor.

Using Ketonal DUO in children and adolescents

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

Ketonal DUO and other medicines

Tell your doctor about all the 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 DUO

other painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g., acetylsalicylic acid, diclofenac, naproxen);
anticoagulant medicines (blood thinners), antiplatelet agents (medicines that prevent blood clots), and thrombolytic agents (medicines used to dissolve blood clots), such as acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, edoxaban;
nicorandil (a medicine used to treat coronary artery disease);
lithium (a medicine used to treat certain mental illnesses);
methotrexate (a medicine used, among other things, to treat cancer) at a dose greater than 15 mg per week.
Ketonal DUO and other medicines may interact with each other, affecting their efficacy and the occurrence of side effects. Therefore, you should always consult your doctor or pharmacist before taking Ketonal DUO with other medicines, such as:
diuretics;
methotrexate (a medicine used, among other things, to treat cancer) at a dose 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 diseases);
pentoxifylline (a medicine used to treat muscle pain due to peripheral vascular disease);
probenecid (a medicine used to treat gout and increased uric acid levels);
medicines that suppress the immune system, e.g., after organ transplantation (cyclosporine and tacrolimus);
antidiabetic medicines;
antiepileptic medicines;
medicines used in heart diseases (digitalis glycosides, beta-blockers);
quinolone antibiotics;
tenofovir (an antiretroviral medicine used to treat HIV and chronic hepatitis B).
In case of any doubts, consult your doctor or pharmacist.

Ketonal DUO with food and drink

Ketonal DUO capsules should be taken during meals, with at least half a glass of water or milk.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Ketonal DUO if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Ketonal DUO may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and prolong labor.
In the first 6 months of pregnancy, do not take Ketonal DUO unless your 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 DUO may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
It is not known whether ketoprofen passes into breast milk. Breastfeeding women should not take Ketonal DUO.
Fertility
Ketonal DUO may make it more difficult to become pregnant. If you are planning to become pregnant, have problems becoming pregnant, or are undergoing fertility tests, you should inform your doctor. Your doctor may consider stopping Ketonal DUO treatment.

Driving and using machines

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

Ketonal DUO contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Ketonal DUO

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is intended for oral use. Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Adults and adolescents over 15 years of age
Usually, 1 capsule (150 mg of ketoprofen) is taken once a day.
The maximum daily dose of ketoprofen is 200 mg.
Before prescribing a dose of 200 mg per day, your doctor will carefully weigh the benefits and risks of treatment.
Take the medicine during meals, with at least 100 ml of water or milk.
Your doctor may recommend taking medicines that neutralize stomach acid at the same time to reduce the risk of harmful effects of ketoprofen 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 you feel that the effect of Ketonal DUO is too strong or too weak, talk to your doctor.

Taking a higher dose of Ketonal DUO than recommended

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.
After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, and abdominal pain, bloody vomiting, black stools, changes in consciousness, respiratory depression, seizures, kidney problems, and kidney failure.
In case of suspected significant overdose, your doctor may recommend gastric lavage and symptomatic and supportive treatment.

Missing a dose of Ketonal DUO

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketonal DUO can cause side effects, although not everybody gets them.
Taking anti-inflammatory and pain-relieving medicines like Ketonal DUO, especially in high doses and for a long time, may be associated with a small increased risk of heart attack or stroke.

If you experience any of the following side effects, stop taking the medicine and contact your doctor or the nearest hospital emergency department immediately:

Rare side effects(may affect up to 1 in 1000 people):
asthma attack
burning, persistent stomach 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, peeling, or bleeding of the skin, with or without itching, 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 DUO 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, 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 you experience any of the following side effects, contact your doctor as soon as possible:

Rare side effects(may affect up to 1 in 1000 people):
numbness, tingling, prickling, or burning sensation of the skin
pallor, fatigue, 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., agranulocytosis)
seizures

Other side effects

Very common (may affect more than 1 in 10 people):
increased liver function test results
Common (may affect up to 1 in 10 people):
malaise, nausea, vomiting, abdominal pain
Uncommon (may affect up to 1 in 100 people):
headache, dizziness, drowsiness, constipation, diarrhea, bloating, gastric inflammation, rash, itching, swelling
Rare (may affect up to 1 in 1000 people):
tinnitus, oral mucosa inflammation, weight gain
Very rare (may affect up to 1 in 10,000 people):
enteropathy with perforation, ulceration, or stenosis and bleeding
Side 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 the feet or ankles), hypertension, flushing (vasodilation), vasculitis, rhinitis (hay fever, nasal congestion, sneezing), pancreatitis, fatigue, or malaise, angioedema (sudden swelling of the face, limbs, or joints without itching or pain), hyponatremia (low sodium levels in the blood), hyperkalemia (high potassium levels in the blood); confusion, aseptic meningitis, drug rash (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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 DUO

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 below 25°C. Store in the original packaging.
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 DUO contains

The active substance of the medicine is ketoprofen. One prolonged-release hard capsule contains 150 mg of ketoprofen.
The other ingredients are:
Pellets:microcrystalline cellulose, lactose monohydrate, povidone, sodium croscarmellose, polysorbate 80.
Pellet coating: Eudragit RS 30D, Eudragit RL 30D, triethyl citrate, polysorbate 80, talc, yellow iron oxide (E172), anhydrous colloidal silica.
Capsule shell:gelatin, indigo carmine (E132), titanium dioxide (E171).

What Ketonal DUO looks like and contents of the pack

The capsules have a transparent body and a blue cap and contain white and yellow prolonged-release pellets.
PVC/TE/PVDC/Aluminum blisters in a cardboard box contain 30 capsules.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
To obtain more detailed information, please 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:06/2024
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