Ketonal duo

Package leaflet: Information for the patient

Ketonal DUO, 150 mg, prolonged-release hard capsules
Ketoprofenum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ketonal DUO is and what it is used for
2. Important information before taking Ketonal DUO
3. How to take Ketonal DUO
4. Possible side effects
5. How to store Ketonal DUO
6. Contents of the pack and other information

1. What Ketonal DUO is and what it is 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 by 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 rapidly released from the white pellets and slowly from the yellow pellets. This formulation ensures both immediate and prolonged release.
Ketonal DUO is indicated for:
rheumatic diseases, including rheumatoid arthritis,
joint inflammation of other origins,
extra-articular inflammatory conditions such as tenosynovitis or painful shoulder syndrome,
osteoarticular and spinal degenerative disease associated with severe pain and significantly impaired patient mobility.

2. Information before using Ketonal DUO

When not to use Ketonal DUO
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 breathlessness, bronchial asthma attack, mucosal swelling
of the nose, skin reaction (skin swelling or itchy rash), or any other type of allergic
reaction after taking ketoprofen or similarly 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 failure,
• severe hepatic failure,
• tendency to bleeding,
• active gastric or duodenal ulcer or has previously had 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 to use Ketonal DUO, consult a doctor or pharmacist if:
the patient has previously had gastrointestinal disorders (there is a risk of exacerbation of ulcerative colitis or Crohn's disease);
the patient has asthma or inflammation of the nasal mucosa (rhinitis, nasal congestion, 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, section titled "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 a history of 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 disease, especially complicated by bleeding or perforation (see section "When not to use Ketonal DUO"), and in elderly patients.

If the patient experiences unusual gastrointestinal symptoms while taking Ketonal DUO (especially at the beginning of treatment), such as bleeding, medical advice should be sought immediately.

Taking medicines such as Ketonal DUO 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.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of therapy, very rare but severe skin reactions (some potentially fatal) may 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) while taking Ketonal DUO, treatment should be stopped and medical advice should be sought.

It is very important to take Ketonal DUO at the lowest effective dose for the shortest duration necessary to relieve symptoms.

Do not use higher doses or longer treatment duration than recommended.

Infections
Ketonal DUO may mask symptoms of infection such as fever and pain. Therefore, Ketonal DUO 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 takes this medicine during an existing infection and infection symptoms persist or worsen, immediate medical consultation is required.

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

Ketonal DUO and other medicines
Tell the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.

The following medicines should not be used together with Ketonal DUO
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 clotting), 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, 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 DUO and other medicines may affect each other's actions and increase the risk of adverse effects. Therefore, always consult a doctor or pharmacist before using Ketonal DUO 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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ketonal DUO if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketonal DUO may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.

During the first six months of pregnancy, Ketonal DUO should not be used unless the doctor considers it 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 DUO may cause kidney problems 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 for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
It is not known whether ketoprofen passes into breast milk. Ketonal DUO should not be given to women who are breastfeeding.

Effect on fertility
Ketonal DUO 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 DUO.

Driving and operating machinery
Ketonal DUO may cause dizziness, drowsiness, visual disturbances, and convulsions in some patients. If these symptoms occur, do not drive or operate machinery.

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

3. How to use Ketonal DUO

This medicine should be used as directed by a physician. If in doubt, consult a
doctor or pharmacist.
This medicine is intended for oral administration. The lowest effective dose should be used for the
shortest necessary duration to relieve symptoms. If, during an infection, its symptoms (such as
fever and pain) persist or worsen, consult a doctor immediately (see
section 2).
Adults and adolescents over 15 years of age
The usual dose is 1 capsule (150 mg of ketoprofen) per day.
The maximum daily dose of ketoprofen is 200 mg.
Before prescribing a daily dose of 200 mg, the doctor will carefully evaluate the benefit-risk ratio of treatment.
The medicine should be taken during meals, with at least 100 ml of water or milk.
The doctor may recommend that the patient take antacids concurrently to reduce the risk of ketoprofen's harmful effects on the gastrointestinal tract.
Elderly patients
In elderly patients, treatment with ketoprofen should generally begin with the lowest available dose, continuing with the lowest effective dose.
In elderly patients, the risk of severe adverse effects is higher.
If the patient feels that the effect of Ketonal DUO is too strong or too weak, they should
consult a doctor.
Taking more than the recommended dose of Ketonal DUO
If an overdose is taken, seek immediate medical advice from a doctor or
pharmacist.
After an overdose, the following may occur: lethargy, drowsiness, nausea, vomiting, and epigastric pain, haematemesis, melaena, disturbances of consciousness, respiratory depression, convulsions, renal dysfunction, and renal failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and initiate symptomatic and supportive treatment.
Missed dose of Ketonal DUO
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Taking anti-inflammatory and pain-relieving medicines such as Ketonal DUO, especially at high doses and over long periods, may be associated with a small increased risk of heart attack or stroke.
If any of the following adverse reactions occur, stop taking the medicine immediately and consult a doctor or go to the nearest hospital emergency department:
Rare adverse reactions (may affect fewer than 1 in 1,000 people):
asthma attack
burning sensation, persistent stomach pain (which may indicate gastric or duodenal ulceration)
Adverse reactions with unknown frequency:
vomiting blood, severe abdominal pain or tarry stools (may be symptoms of gastrointestinal bleeding)
formation of blisters, peeling of the skin or bleeding in the skin with or without itching, nodular rash (around lips, eyes, mouth, nose, genital organs, hands or feet), sometimes accompanied by 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 (may indicate serious kidney problems)
chest pain or sudden severe headache (taking medicines such 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 in swallowing or breathing, 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 reactions occur, consult a doctor as soon as possible:
Rare adverse reactions (may affect fewer than 1 in 1,000 people):
numbness, tingling, pricking or burning sensation of the skin
pallor of the skin and feeling of fatigue, faintness or dizziness (may be symptoms of anaemia due to red blood cell breakdown)
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 reactions with unknown frequency:
bruising more easily than usual or persistent bleeding (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
increased susceptibility to infections (may indicate serious blood disorders, e.g. marked reduction in certain white blood cells – agranulocytosis)
seizures
Other adverse reactions
Very common (may affect more than 1 in 10 people):
increased liver function test results
Common (may affect fewer than 1 in 10 people):
malaise, dyspepsia, nausea, abdominal pain, vomiting
Uncommon (may affect fewer than 1 in 100 people):
headache, dizziness, somnolence, constipation, diarrhoea, flatulence, gastritis, rash, itching, oedema
Rare (may affect fewer than 1 in 1,000 people):
tinnitus, stomatitis, weight gain
Very rare (may affect fewer than 1 in 10,000 people):
enteropathy with perforation, ulceration, stenosis and bleeding
Adverse reactions 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 (hyponatraemia), increased potassium concentration in blood (hyperkalaemia); confusion, aseptic meningitis, drug eruption (acute generalised exanthematous pustulosis).
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ketonal Duo

Keep this medicine out of 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 stated month.
Store below 25°C. Store 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Ketonal DUO contains
The active substance is ketoprofen. One prolonged-release hard capsule contains
150 mg of ketoprofen.
The other ingredients are:
Pellets: microcrystalline cellulose, monohydrate lactose, povidone, sodium croscarmellose,
polysorbate 80.
Pellet coating: Eudragit RS 30D, Eudragit RL 30D, triethyl citrate, polysorbate 80, talc, yellow iron oxide (E172), anhydrous colloidal silicon dioxide.
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.
The pack consists of blisters made of PVC/TE/PVDC/Aluminium in a cardboard box containing 30 capsules.

Marketing Authorisation 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

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. +48 22 209 70 00