Package leaflet: Information for the patient

Ketonal Active, 50 mg, hard capsules
Ketoprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

Ketonal Active capsules contain the active substance ketoprofen, a medicine with anti-inflammatory,
antipyretic and analgesic properties (belongs to the group of non-steroidal anti-inflammatory
drugs – NSAIDs).

Ketonal Active is used for short-term symptomatic treatment of mild to moderate acute pain, such as:

muscle pain,
bone and joint pain,
headache,
toothache,
painful menstruation,
pain caused by strains and sprains.

2. Important information before taking Ketonal Active

When not to take Ketonal Active: 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 asthma, bronchospasm, nasal mucosal swelling, skin reaction (manifested by 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 experienced gastrointestinal bleeding, ulceration, or perforation; if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding and effect on fertility").

Do not use Ketonal Active in children under 15 years of age.
Warnings and precautions Before taking Ketonal Active, 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, manifested, among others, by chronic diarrhoea); the patient suffers from asthma or inflammation of the nasal mucosa (rhinitis, nasal congestion, sneezing), chronic sinusitis, or nasal polyps; the patient has or has had heart, kidney, or liver disease; the patient has or has had high blood pressure (hypertension);

the patient has peripheral arterial disease (circulatory disorders in legs or feet caused by narrowing or blockage of arteries) or cerebral vascular 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 (over 65 years of age).

Non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration, or perforation—piercing of the stomach or intestinal wall (which may be fatal), which can occur at any time during treatment, even without warning symptoms or prior 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, especially complicated by bleeding or perforation (see section "When not to take Ketonal Active"), and in elderly patients.
If the patient experiences any gastrointestinal symptoms while taking Ketonal Active (especially at the beginning of treatment), medical advice should be sought immediately.
Taking medicines such as Ketonal Active may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses of the drug.
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 and a doctor consulted.
If visual disturbances (e.g. blurred vision) occur while taking Ketonal Active, treatment should be stopped and medical advice sought.
It is very important to take Ketonal Active at the lowest effective dose for the shortest duration necessary to relieve symptoms. Higher doses or longer treatment periods than recommended should not be used.
Infections
Ketonal Active may mask symptoms of infection such as fever and pain. Therefore, Ketonal Active 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 symptoms of infection persist or worsen, immediate medical consultation is required.
Children and adolescents
Do not use in individuals under 15 years of age.
Ketonal Active and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
The following medicines should not be taken together with Ketonal Active:
other painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors (e.g. acetylsalicylic acid, diclofenac, naproxen);
anticoagulants (medicines that inhibit blood clotting), e.g. dabigatran, apixaban, rivaroxaban, edoxaban;
antiplatelet agents (medicines that inhibit platelet aggregation);
thrombolytics (medicines used to unblock blood vessels), such as acetylsalicylic acid, heparin, warfarin, clopidogrel, or ticlopidine;
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 Active and other medicines may interact, affecting their action and increasing the risk of adverse effects. Therefore, always consult a doctor or pharmacist before using Ketonal Active together with other medicines such as:
diuretics (medicines that increase urine production);
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 hepatitis B virus infection).
If in doubt whether the patient is taking any of the medicines listed above, consult a doctor or pharmacist.
Ketonal Active with food and drink
Ketonal Active capsules should be taken during meals, swallowed with at least half a glass of water or milk.
Pregnancy, breastfeeding and effect on 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 taking this medicine.
Pregnancy
Do not take Ketonal Active if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketonal Active may cause kidney and heart function disorders 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 Active 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.
If Ketonal Active is taken for longer than a few days after the 20th week of pregnancy, it may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney disorders, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
It is not known whether ketoprofen passes into breast milk. Ketonal Active should not be given to breastfeeding women.
Effect on fertility
Ketonal Active may impair fertility. If the patient is planning pregnancy, has difficulty conceiving, or is undergoing fertility investigations, she should inform her doctor.
Driving and operating machinery
Ketonal Active may cause dizziness, drowsiness, visual disturbances, and convulsions in some patients. If such symptoms occur, driving vehicles or operating machinery should be avoided.
Ketonal Active contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact a doctor before taking this medicine.

3. How to take Ketonal Active

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for oral use. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended dose
Adults and adolescents over 15 years of age
1 capsule three times daily (every 8 hours).
The capsules should be taken during meals, with at least half a glass of water or milk. Antacids may be taken simultaneously, which may help reduce the risk of gastrointestinal adverse effects.
Do not use this medicine for longer than 5 days without consulting a doctor.
If symptoms worsen or do not improve after 5 days, contact your doctor.
Elderly patients
Caution is required in elderly patients due to an increased risk of severe adverse effects. If nonsteroidal anti-inflammatory drugs (NSAIDs) are necessary, the lowest effective dose should be used.
Use in children and adolescents
This medicine should not be used in individuals under 15 years of age.
Taking more than the recommended dose of Ketonal Active
If more than the recommended dose has been taken, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, haematemesis (vomiting blood), melaena (black, tarry stools), 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 Active
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Taking anti-inflammatory and pain-relieving medicines such as Ketonal Active, especially at high doses and for prolonged periods, may be associated with a small increased risk of heart attack or stroke.
If any of the following side effects occur, stop taking the medicine immediately
and seek urgent medical advice from a doctor or the nearest hospital emergency department:

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 (anaphylactic reaction);
bronchial asthma attack;
burning sensation, persistent stomach pain (which may indicate ulceration of the stomach or duodenum);
vomiting blood, severe abdominal pain or tarry (black) stools (these may be symptoms of gastrointestinal bleeding);
formation of blisters, peeling of the skin or bleeding within the skin with itching (or without), nodular rash (around lips, eyes, mouth, nose, genital organs, hands or feet), sometimes with flu-like symptoms. These may be symptoms of serious skin reactions (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis);
blood in the urine, changes in the amount of urine passed, swelling of legs, ankles or feet (which may indicate serious kidney problems).

The following side effects may occur during treatment with Ketonal Active:
Very common (may affect more than 1 in 10 people):

changes in liver function laboratory tests (increased liver function test results).

Common (may affect up to 1 in 10 people):

malaise, physical weakness (asthenia);
indigestion, nausea, abdominal pain, vomiting.

Uncommon (may affect up to 1 in 100 people):

headache, dizziness, drowsiness;
constipation, diarrhoea, flatulence, inflammation of the stomach lining;
allergic reactions, rash, itching;
oedema (fluid retention).

Rare (may affect up to 1 in 1000 people):

anaemia due to haemorrhage or bleeding;
numbness, tingling, pricking or burning sensation of the skin (paraesthesia);
visual disturbances (blurred vision);
tinnitus;
bronchial asthma attack;
inflammation of the oral mucosa, gastric ulceration, hepatitis;
weight gain.

Very rare (may affect up to 1 in 10,000 people):

enteropathy (intestinal disorders) with perforation, ulceration or strictures and bleeding;
severe liver dysfunction with jaundice (yellowing of the skin or whites of the eyes) and inflammation.

Side effects with unknown frequency (frequency cannot be estimated from available data):

agranulocytosis (reduced number or complete absence of certain white blood cells (granulocytes), which may increase susceptibility to infections);
thrombocytopenia (reduced number of platelets, which may increase susceptibility to bleeding and bruising);
bone marrow suppression, haemolytic anaemia (caused by excessive breakdown of red blood cells), leukopenia (reduced number of white blood cells);
anaphylactic reactions (including anaphylactic shock - see beginning of this section);
angioedema (sudden swelling of the face, limbs or joints without itching or pain);
decreased sodium concentration in blood (hyponatremia), increased potassium concentration in blood (hyperkalemia);
confusion, mood changes;
aseptic meningitis, taste disturbances, convulsions;
heart failure (with symptoms such as shortness of breath, difficulty breathing when lying down, swelling of feet or legs);
hypertension, skin redness (vasodilation), vasculitis;
bronchospasm (especially in patients hypersensitive to acetylsalicylic acid and other NSAIDs), inflammation of the nasal mucosa (rhinitis, nasal itching, sneezing or nasal congestion);
exacerbation of symptoms of chronic bowel diseases (colitis or Crohn's disease), gastrointestinal bleeding and perforation (see beginning of this section), pancreatitis;
photosensitivity, alopecia, urticaria, blistering skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (see beginning of this section), acute generalized exanthematous pustulosis;
serious kidney dysfunction (see beginning of this section);
feeling of fatigue. Use of medicines such as ketoprofen may be associated with a small increased risk of heart attack or stroke.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Ketonal Active

Keep this 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 stated month.
Store below 25 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ketonal Active contains
The active substance is ketoprofen. One hard capsule contains 50 mg of ketoprofen.
The other ingredients are: monohydrate lactose, magnesium stearate, anhydrous colloidal silicon dioxide.
Capsule shell: gelatin, titanium dioxide (E 171), patent blue (E 131).

What Ketonal Active looks like and contents of the pack
Ketonal Active is a white-blue, opaque capsule containing a yellowish-white powder in free-flowing or agglomerated form.
The medicine is packed in amber glass bottles closed with an LDPE cap, placed in a cardboard box.
The pack contains 10, 20 or 30 capsules.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
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 Warsaw
tel. +48 22 209 70 00