Ketolek

Package Leaflet: Information for the Patient

KETOLEK, 50 mg, hard capsules

Ketoprofen

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Ketolek and what is it used for

Ketolek contains the active substance ketoprofen, an anti-inflammatory, antipyretic, and analgesic (belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs)).

• NSAIDs.

Ketolek is used for short-term, symptomatic treatment of mild to moderate pain of various origins, e.g., muscle pain, bone and joint pain, headache.

2. Important information before taking Ketolek

When not to take Ketolek:

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had bronchial asthma, asthma attacks, nasal polyps, or other allergic reactions after taking ketoprofen, acetylsalicylic acid, or other NSAIDs. Such patients have reported severe, sometimes life-threatening anaphylactic reactions (see section 4),
• if the patient has ever had skin hypersensitivity reactions to light (photoallergic or phototoxic reactions) when taking ketoprofen or fibrates (lipid-lowering drugs),
• if the patient has unexplained blood disorders (blood system disorders),
• if the patient has an active peptic ulcer (gastric and/or duodenal ulcer) or a history of gastrointestinal bleeding, ulcers, or perforation,
• if the patient has bleeding disorders,
• if the patient has cerebral bleeding or other active bleeding,
• if the patient has severe heart failure,
• if the patient has severe liver or kidney disorders,
• during the last three months of pregnancy.

Warnings and precautions

Before starting to take Ketolek, the patient should discuss it with their doctor or pharmacist.

The patient should inform their pharmacist or doctor if they have an infection - see below, section "Infections".

The "Warnings and precautions" section contains information on when the patient can take Ketolek only under certain conditions (i.e., at longer intervals between doses or in smaller doses, with concurrent monitoring of organ function). However, even in such cases, special caution is required.

This section also applies to patients who have experienced the situations described below in the past.

For further information, the patient should contact their doctor or pharmacist.

Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects.

Gastrointestinal effects (stomach and intestines)

The patient should avoid taking Ketolek at the same time as other NSAIDs (including selective cyclooxygenase-2 inhibitors).

Elderly patients

During NSAID treatment, the risk of side effects, especially gastrointestinal bleeding or perforation, which can be fatal, is higher in elderly patients. Therefore, elderly patients require special medical care.

Gastrointestinal bleeding, ulcers, and perforations

Gastrointestinal bleeding, ulcers, or perforations, which can be fatal, have been reported for all NSAIDs, at any time during treatment, with or without warning symptoms or a history of gastrointestinal events.

Epidemiological data indicate that ketoprofen use may be associated with an increased, compared to other NSAIDs, toxic effect on the gastrointestinal tract, especially at higher doses.

The risk of gastrointestinal bleeding, ulcers, or perforations increases with the dose of NSAIDs in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section 2 "When not to take Ketolek"), and in elderly patients. In elderly patients, treatment should therefore be started with the lowest available dose.

It is recommended to consider concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) in these patients, as well as in patients requiring concurrent treatment with low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal side effects.

Patient monitoring

Patient monitoring is required for patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as NSAIDs may exacerbate these conditions (see section 4 "Possible side effects").

Cardiovascular and cerebrovascular effects

Taking medicines like Ketolek may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher with prolonged use of high doses of the medicine. Higher doses and longer treatment periods than recommended should not be used.

In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss their treatment with their doctor or pharmacist.

Cautious use is recommended in patients with hypertension and/or mild to moderate heart failure in their medical history, as fluid retention and edema have been reported in association with NSAID treatment.

Skin reactions

Very rare cases of serious, sometimes life-threatening skin reactions - with redness and blisters - have been reported during NSAID treatment (including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell's syndrome); see section 4 "Possible side effects"). The risk of these reactions is likely higher at the beginning of treatment, as most cases occurred within the first month of treatment. In case of the first symptoms of skin rash, mucosal lesions, and other signs of hypersensitivity, the patient should immediately stop taking Ketolek and consult their doctor.

Photoallergic reactions caused by NSAIDs are well-known side effects of these drugs and are most commonly attributed to UV radiation. Ketoprofen increases the risk of photoallergic contact dermatitis. Sometimes, symptoms may first appear after a latency period of hypersensitivity. The disappearance of skin symptoms after discontinuation of the medicine may take several months. In case of a photoallergic reaction in patients taking Ketolek, the medicine should be discontinued, and the patient should consult their doctor.

Infections

Ketolek may mask the symptoms of an infection, such as fever and pain. Therefore, Ketolek may delay the use of appropriate infection treatment and consequently lead to an 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 during an infection, and the symptoms of the infection persist or worsen, they should immediately consult their doctor.

Other information

Ketolek should only be used after careful consideration of the benefit-to-risk ratio in cases of specific congenital blood production disorders (acquired porphyria).

At the beginning of treatment in patients with heart failure, liver cirrhosis, and nephrotic syndrome, in patients taking diuretics, in patients with chronic kidney failure, especially in elderly patients, renal function should be carefully monitored. In such patients, the administration of ketoprofen may cause a decrease in renal blood flow due to the inhibition of prostaglandin synthesis and lead to renal function disorders.

In the following cases, close medical supervision is required:

• in patients with pre-existing kidney damage,
• in patients with liver function disorders,
• in patients immediately after major surgery,
• in patients with allergies (e.g., skin reactions to other medicines, asthma, hay fever), chronic rhinitis, chronic respiratory diseases with airway obstruction,
• in patients taking potent diuretics,
• in patients taking NSAIDs or other painkillers,
• in patients with blood coagulation disorders and taking anticoagulant medicines.

Severe hypersensitivity reactions (e.g., anaphylactic shock) are very rare.

In case of the first symptoms of severe hypersensitivity reactions after taking Ketolek, the patient should stop taking the medicine. Depending on the symptoms, any medical intervention must be performed by a specialist.

If vision disturbances occur, such as blurred vision, treatment should be discontinued.

Ketoprofen, the active substance of Ketolek, may temporarily inhibit platelet aggregation.

Patient monitoring is required for patients with blood coagulation disorders.

If the patient is taking anticoagulant medicines (blood thinners) or medicines that lower blood sugar levels, they should be closely monitored for blood sugar and coagulation levels.

Like other NSAIDs, ketoprofen may mask the symptoms of infectious diseases.

In patients with abnormal liver function test results or a history of liver disease, liver enzyme activity should be periodically monitored.

Rare cases of jaundice and liver inflammation associated with ketoprofen use have been reported.

During prolonged use of Ketolek, regular monitoring of liver enzyme activity, kidney function, and blood morphology is required.

The patient should inform their doctor or dentist about taking Ketolek before surgery.

In patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, there is a higher risk of hypersensitivity to acetylsalicylic acid and/or NSAIDs. Taking this medicine may cause asthma attacks or bronchial spasms, especially in patients allergic to acetylsalicylic acid or NSAIDs (see section 2 "When not to take Ketolek").

During long-term use of painkillers, headaches may occur, which should not be treated by increasing the dose of the medicine. If frequent headaches occur despite treatment with Ketolek, the patient should consult their doctor.

Essentially, habitual use of painkillers, especially when taking several painkillers at the same time, may lead to permanent kidney damage, including kidney failure (analgesic nephropathy).

Children and adolescents

Ketolek should not be used in patients under 15 years of age.

Ketolek 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.

In particular, this applies to:

• digoxin (used to strengthen heart muscle) - concurrent use of Ketolek and digoxin may increase the risk of heart failure and lead to an increase in digoxin serum levels. Monitoring of digoxin serum levels is recommended.
• medicines containing phenytoin (used to treat epilepsy) or lithium (used to treat mental disorders) - concurrent use of Ketolek with these medicines may increase their serum levels, sometimes leading to toxic lithium serum levels due to decreased renal lithium excretion. Close monitoring of lithium serum levels and phenytoin serum levels is recommended.
• diuretic medicines (urine-producing), beta-adrenergic blockers, and medicines used to treat high blood pressure - Ketolek may weaken the effect of these medicines.
• angiotensin-converting enzyme inhibitors (medicines used to treat heart failure and high blood pressure) - taking Ketolek may weaken their effect. Additionally, concurrent use of these medicines may increase the risk of kidney function disorders.
• potassium-sparing diuretics (a group of diuretic medicines) - concurrent use of Ketolek may lead to an increase in potassium levels in the blood. Potassium levels in the blood should be monitored.
• other NSAIDs (including selective cyclooxygenase-2 inhibitors) or corticosteroids - concurrent use with Ketolek increases the risk of ulcers or gastrointestinal bleeding.
• antiplatelet agents (inhibiting or reducing blood clotting), such as acetylsalicylic acid, and certain antidepressants (selective serotonin reuptake inhibitors - SSRIs), which may increase the risk of gastrointestinal bleeding.
• methotrexate (a medicine used to treat cancer and autoimmune diseases) - administration of Ketolek within 24 hours before or after methotrexate administration may lead to increased levels of this medicine and increase its side effects.
• cyclosporine and tacrolimus - concurrent use of Ketolek with these medicines may increase the risk of additive kidney toxicity, especially in elderly patients.
• medicines containing probenecid and sulfinpyrazone (used to treat gout) - these medicines may delay the excretion of ketoprofen. This may lead to excessive accumulation of Ketolek in the body and increase the frequency and severity of side effects.
• anticoagulant medicines (blood thinners), such as warfarin - NSAIDs may increase the effect of these medicines.
• oral antidiabetic medicines (used to treat diabetes) - to date, clinical studies have not shown interactions between ketoprofen and these medicines. Nevertheless, it is recommended to monitor blood sugar levels during concurrent treatment.
• loop diuretics (used to treat high blood pressure) - concurrent use of these medicines may increase the frequency of kidney function disorders.
• antacids, which may decrease the absorption of ketoprofen in the intestine.
• pentoxifylline (a medicine used to treat intermittent claudication) - concurrent use of pentoxifylline with Ketolek may increase the risk of bleeding.
• antibiotics (medicines used to treat bacterial infections) - administration of antibiotics, such as quinolone derivatives, may increase the risk of seizures.
• thrombolytic agents (medicines that prevent blood clot formation) - Ketolek increases the effect of these medicines.

In case of any doubts about taking any of the above-mentioned medicines, the patient should consult their doctor or pharmacist.

Using Ketolek with food, drinks, and alcohol

Ketolek should be swallowed whole (not chewed), with a large amount of liquid, during or after a meal.

The patient should not drink alcohol while taking Ketolek.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Ketolek should not be used if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It 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.

During the first six months of pregnancy, Ketolek should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketolek may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring.

Breastfeeding

There is no data on the penetration of ketoprofen into breast milk. Ketolek is not recommended for use in breastfeeding women.

Female fertility

Ketolek may make it more difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Since higher doses of Ketolek may cause side effects related to the central nervous system (e.g., fatigue, dizziness), reaction ability may be impaired in individual cases, and the ability to drive vehicles and operate machines may be disrupted. This applies especially when consuming alcohol.

The patient should be informed about the possibility of drowsiness, dizziness, or seizures and advised not to drive vehicles or operate machines if such symptoms occur.

Ketolek contains lactose

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

3. How to take Ketolek

This medicine should always be taken exactly as described in this leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

The medicine is intended for oral administration.

The patient should use the smallest effective dose for the shortest necessary period to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during treatment, the patient should immediately consult their doctor (see section 2).

Recommended dose

Adults and adolescents over 15 years of age

1 capsule every 8 hours.

How to take the capsules

Ketolek should be swallowed whole (not chewed), with a large amount of liquid, during or after a meal.

Duration of treatment

The medicine should not be used for more than 5 days without consulting a doctor.

If the symptoms worsen or do not improve after 5 days, the patient should contact their doctor.

Elderly patients

In elderly patients, caution is required due to the increased risk of severe side effects. If it is necessary to take NSAIDs, the patient should consult their doctor or pharmacist.

Patients with liver and kidney disorders

In patients with liver and kidney disorders, caution is required due to the increased risk of severe side effects. If it is necessary to take NSAIDs, the patient should consult their doctor or pharmacist.

Use in children and adolescents

Ketolek is not recommended for use in children and adolescents under 15 years of age.

Overdose of Ketolek

As symptoms of overdose, central nervous system disorders may occur, such as headache, dizziness, lethargy, drowsiness, confusion, and loss of consciousness, as well as abdominal pain and nausea and vomiting. Additionally, hypotension, respiratory depression, and cyanosis (blue discoloration of the skin and mucous membranes) may occur.

There is no specific antidote.

In case of suspected overdose, the patient should inform their doctor. The doctor, considering the severity of the poisoning, will decide on the necessary preventive measures.

Missed dose of Ketolek

The patient should not take a double dose to make up for a missed dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketolek can cause side effects, although not everybody gets them.

Regarding the listed side effects of the medicine, it should be remembered that they are mainly dose-dependent and may vary between individual patients.

The most common side effects are related to the gastrointestinal tract. Ulcers of the gastrointestinal tract (peptic ulcer), perforation, or bleeding - sometimes fatal - may occur, especially in elderly patients (see section 2 "Warnings and precautions").

Nausea, vomiting, diarrhea, flatulence (passing gas), constipation, indigestion, abdominal pain, black stools (melena), and bloody vomiting have been reported after taking Ketolek.

Edema, high blood pressure, and heart failure have been reported in association with NSAID treatment.

Taking medicines like Ketolek may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

The following side effects have been reported in association with ketoprofen use in adults:

Very common (may affect more than 1 in 10 patients)

Gastrointestinal disorders, such as nausea, vomiting, heartburn, abdominal pain, flatulence, constipation, or diarrhea, as well as minor gastrointestinal bleeding, which may occasionally cause anemia.

Common (may affect up to 1 in 10 patients)

Hypersensitivity reactions in the form of skin rash and itching, insomnia, excitement, irritability, headache, dizziness, fatigue, indigestion, abdominal pain, ulcers of the gastrointestinal tract with bleeding and perforation in some cases, peripheral edema (swelling of the arms or legs), especially in patients with high blood pressure.

Uncommon (may affect up to 1 in 100 patients)

Drowsiness, vision disturbances (see section 2 "Warnings and precautions"), tinnitus (ringing in the ears), vomiting blood, black stools, oral mucosal inflammation, gastritis.

If the patient experiences moderate to severe abdominal pain, vomiting blood, blood in the stool, and/or black stools, they should stop taking Ketolek and immediately contact their doctor.

Kidney function disorders, hypersensitivity to light, rash, itching, edema, fluid retention, and abnormal kidney function test results.

Decreased urine production, fluid retention, and general malaise may be symptoms of kidney function disorders or even kidney failure.

Rare (may affect up to 1 in 1,000 patients)

Hemolytic anemia, paresthesia, asthma, liver inflammation, increased liver enzyme activity, increased bilirubin levels in the blood due to liver disorders, weight gain.

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

Cases of worsening infectious conditions (e.g., development of necrotizing fasciitis) have been reported in association with NSAID use, including Ketolek. Therefore, the patient should immediately contact their doctor if they experience or notice worsening symptoms of infection (e.g., redness, swelling, overheating, pain, fever) while taking Ketolek.

Hemolytic anemia (caused by accelerated breakdown of red blood cells), blood system disorders (aplastic anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding under the skin. In such cases, the patient should immediately stop taking Ketolek and contact their doctor. The patient should not treat these symptoms with painkillers or antipyretics.

During long-term treatment, the patient should regularly have their blood morphology monitored.

Severe hypersensitivity reactions. The symptoms include: facial edema, tongue edema, internal laryngeal edema with airway constriction, shortness of breath, palpitations, decreased blood pressure, and even life-threatening anaphylactic shock.

The patient should immediately consult their doctor if they experience the onset of these symptoms, which may occur after the first dose of Ketolek.

Heart failure, myocardial infarction, high blood pressure, pancreatitis, intestinal stricture, liver damage (especially during long-term treatment), hair loss (alopecia), severe skin reactions, e.g., skin rash with redness and blisters (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome)), kidney damage (papillary necrosis), especially during long-term treatment, as well as increased uric acid levels.

After several months of taking the medicine without complications, the skin may become sensitive to light, showing signs of redness, itching, blistering, and nodules on areas of skin exposed to sunlight or artificial UV light (e.g., solarium).

Frequency not known (frequency cannot be estimated from the available data)

Bone marrow failure, mood changes, confusion, seizures, taste disorders, aseptic meningitis, vasodilation, bronchial spasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), nasal mucosal inflammation, worsening of ulcerative colitis and Crohn's disease, urticaria, angioedema, abnormal kidney function test results.

The patient should regularly have their kidney function monitored.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ketolek

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiration date stated on the blister pack and carton after EXP. The expiration date refers to the last day of the month stated.

The medicine should not be stored at temperatures above 25°C.

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. Contents of the pack and other information

What Ketolek contains

The active substance of the medicine is ketoprofen.

Each capsule contains 50 mg of ketoprofen.

The other ingredients are:

Lactose monohydrate, magnesium stearate, anhydrous colloidal silica.

Capsule shell:

Body: gelatin, titanium dioxide (E 171).

Caps: gelatin, iron oxide, black (E 172), erythrosine (E 127), indigo carmine (E 132), titanium dioxide (E 171).

What Ketolek looks like and contents of the pack

Ketolek is a hard gelatin capsule with an opaque, blue-violet cap and a white body, filled with a grayish-white powder.

Ketolek is available in PVC/PVDC/Aluminum blisters in packs of 10 or 20 capsules in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.

ul. Dolna 21

05-092 Łomianki

tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Date of last revision of the leaflet: