Ketokaps Med

Leaflet attached to the packaging: patient information

Ketokaps Med

100 mg, soft capsules

Ketoprofen

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ketokaps Med and what is it used for
• 2. Important information before taking Ketokaps Med
• 3. How to take Ketokaps Med
• 4. Possible side effects
• 5. How to store Ketokaps Med
• 6. Package contents and other information

1. What is Ketokaps Med and what is it used for

Ketokaps Med contains the active substance ketoprofen. Ketoprofen is a medicine with anti-inflammatory, analgesic, and antipyretic effects (it belongs to the group of nonsteroidal anti-inflammatory drugs - NSAIDs). The mechanism of action of ketoprofen is probably based on the inhibition of prostaglandin synthesis.

Indications for use

Ketokaps Med is used for the symptomatic treatment of inflammatory, degenerative, and metabolic rheumatic diseases, as well as for the relief of certain pain syndromes, such as:

• rheumatoid arthritis,
• degenerative joint diseases (osteoarthritis), including those with severe pain and significantly impaired patient mobility,
• ankylosing spondylitis,
• painful menstruation,
• pains of various origins with moderate severity.

2. Important information before taking Ketokaps Med

When not to take Ketokaps Med

• if the patient is hypersensitive to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced dyspnea, bronchial asthma, nasal polyps, or skin reactions (skin edema or pruritic rash) or other types of allergic reactions after taking ketoprofen or similar-acting medicines (such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs));
• if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding, and fertility");
• if the patient has active gastric or duodenal ulcer or has had a history of gastrointestinal bleeding, ulceration, or perforation;
• if the patient has severe heart, liver, or kidney failure;
• if the patient has a bleeding disorder (tendency to bleed).

Warnings and precautions

Before starting treatment with Ketokaps Med, the patient should discuss it with their doctor, especially if:

• the patient has had gastrointestinal diseases (gastric or duodenal ulcer, ulcerative colitis, Crohn's disease) - due to the possibility of exacerbating symptoms;
• the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g., prednisolone), anticoagulants (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (e.g., acetylsalicylic acid);
• the patient has been diagnosed with asthma, chronic rhinitis, chronic sinusitis, or nasal polyps - administration of ketoprofen may cause an asthma attack, bronchospasm, especially in patients with hypersensitivity to acetylsalicylic acid or nonsteroidal anti-inflammatory drugs;
• the patient has heart diseases (heart failure, coronary heart disease), peripheral artery disease, and/or cerebrovascular disease, or has had a stroke or suspects an increased risk of cardiovascular diseases (e.g., high blood pressure, diabetes, increased cholesterol, smoking);
• the patient has kidney, liver, or water metabolism disorders (e.g., dehydration due to diuretic use or recent surgery) - taking the medicine may reduce renal blood flow, leading to kidney function disorders, especially in elderly patients. Very rare cases of jaundice and liver inflammation have been reported during ketoprofen treatment;
• the patient is elderly - elderly patients have a higher risk of adverse reactions (especially gastrointestinal bleeding and perforation), so they should be particularly cautious;
• the patient has an infection - see below, "Infections" section.

Taking Ketokaps Med in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of adverse reactions.
Concomitant use of Ketokaps Med with other medicines containing nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid or selective cyclooxygenase-2 inhibitors (COX-2), should be avoided.
Nonsteroidal 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 a history of severe gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration, or perforation is higher during treatment with high doses of NSAIDs, in patients with a history of ulcer disease, especially if complicated by bleeding or perforation (see "When not to take Ketokaps Med" section), and in the elderly.
If the patient experiences unusual gastrointestinal symptoms, especially bleeding, during treatment (especially at the beginning of treatment), they should stop taking the medicine and immediately consult a doctor.
Taking non-acetylsalicylic acid nonsteroidal anti-inflammatory drugs, such as ketoprofen, may be associated with a small increased risk of arterial thrombotic events (myocardial infarction or stroke). This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment.
Taking medicines like Ketokaps Med may be associated with a small increased risk of atrial fibrillation.
During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of treatment, very rare but severe skin reactions (some with fatal outcome) may occur, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. If the patient develops a rash, mucosal lesions, or any symptoms of hypersensitivity, they should stop taking the medicine.
If the patient experiences vision disturbances (e.g., blurred vision) while taking Ketokaps Med, they should stop taking the medicine and consult a doctor.
Infections
Ketokaps Med may mask the symptoms of infection, such as fever and pain. Therefore, Ketokaps Med may delay the use of appropriate infection treatment, potentially leading to 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 infection symptoms persist or worsen, they should immediately consult a doctor.

Children and adolescents

Ketokaps Med should not be used in children and adolescents under 15 years of age.

Ketokaps Med and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The following medicines should not be taken with Ketokaps Med:

• other painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g., acetylsalicylic acid, diclofenac, naproxen);
• anticoagulants (blood thinners), antiplatelet agents (platelet inhibitors), thrombolytics (medicines used to dissolve blood clots), direct factor Xa inhibitors, such as acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, edoxaban;
• lithium (a medicine used to treat certain mental illnesses);
• methotrexate (a medicine used to treat certain cancers) in a dose greater than 15 mg per week.

Ketokaps Med and other medicines may interact with each other, so the patient should always consult a doctor or pharmacist before taking Ketokaps Med with other medicines.
In particular, before taking Ketokaps Med, the patient should inform their doctor about taking any of the following medicines:

• medicines that may increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs), heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim;
• diuretics;
• methotrexate (a medicine used to treat certain cancers) in a dose less than 15 mg per week;
• medicines that lower blood pressure;
• medicines used to treat depression (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 artery disease);
• probenecid (a medicine used to treat gout and increased uric acid levels);
• tenofovir (a medicine used to treat certain viral infections);
• immunosuppressants (e.g., after organ transplantation) (cyclosporine and tacrolimus);
• antidiabetic medicines;
• antiepileptic medicines;
• medicines used to treat heart diseases (digitalis glycosides, beta-blockers, nicorandil);
• quinolone antibiotics.

In case of any doubts, the patient should consult a doctor or pharmacist.

Ketokaps Med with food and drink

The capsules are best taken with meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Ketokaps Med should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ketokaps Med may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be taken 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, Ketokaps Med may cause kidney function disorders 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 child (oligohydramnios) or narrowing of the arterial duct in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ketokaps Med is not recommended for use in breastfeeding women.
Female fertility
Ketoprofen may make it harder to get pregnant. If the patient is planning to get pregnant, has problems getting pregnant, or is undergoing fertility tests, they should inform their doctor. The doctor may decide to stop the use of Ketokaps Med.

Driving and using machines

Ketoprofen may cause dizziness, drowsiness, vision disturbances, and seizures in some patients. If these symptoms occur, the patient should not drive or operate machines.

Ketokaps Med contains sorbitol liquid, partially dehydrated, and cochineal red

One capsule contains 150 mg of sorbitol. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine. The sorbitol in the medicine may affect the bioavailability of other orally administered medicines.
Cochineal red may cause allergic reactions.

3. How to take Ketokaps Med

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The smallest effective dose should be taken for the shortest necessary period to relieve symptoms. If the patient has an infection and the infection symptoms (such as fever and pain) persist or worsen, they should immediately consult a doctor (see section 2).
Adults and adolescents over 15 years of age:
Usually, 1 capsule is taken 1 to 2 times a day (100 to 200 mg of ketoprofen per day).
Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
The recommended dose is 1 soft capsule, up to 2 times a day.
The maximum daily dose is 200 mg of ketoprofen. Before starting treatment with a dose of 200 mg per day, the doctor will carefully weigh the benefits and risks.
The medicine is taken orally. The capsule should be swallowed whole (not chewed), with at least half a glass of water.
The doctor may recommend taking medicines that neutralize or protect the stomach lining to reduce the risk of harmful effects of ketoprofen on the gastrointestinal tract.

Use in children and adolescents

Ketokaps Med should not be used in children and adolescents under 15 years of age.

Elderly patients

In elderly patients, the risk of adverse reactions is higher, so the smallest effective doses are recommended.

Overdose of Ketokaps Med

In case of overdose, the patient should immediately consult a doctor or pharmacist.
After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, abdominal pain, bleeding vomiting, black stools, disturbances of consciousness, respiratory depression, seizures, kidney function disorders, and kidney failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and symptomatic and supportive treatment.

Missed dose of Ketokaps Med

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 a doctor or pharmacist.

4. Possible side effects

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

STOP TAKING the medicine and consult a doctor immediately if the following occur:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, bleeding vomiting, or dark particles that resemble coffee grounds.
• symptoms of rare but severe allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, palpitations, decreased blood pressure leading to shock. These symptoms may occur even after the first use of the medicine. If any of these symptoms occur, the patient should immediately consult a doctor;
• severe skin reactions, such as a rash covering the whole body, exfoliation, blistering, and peeling of the skin.

Taking anti-inflammatory and analgesic medicines like Ketokaps Med, especially in high doses and for a long time, may be associated with a small increased risk of myocardial infarction or stroke.
Common (may affect up to 1 in 10 people):

• indigestion, nausea, abdominal pain, vomiting, asthenia, malaise.

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

• headache, dizziness (central origin), drowsiness;
• constipation, diarrhea, bloating, gastritis;
• rash, redness, itching;
• edema, fatigue.

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

• anemia caused by bleeding or blood loss;
• paresthesia (sensory disturbances);
• vision disturbances (blurred vision);
• tinnitus (ringing in the ears);
• shortness of breath, possible asthma attack;
• stomatitis, gastric ulceration;
• hepatitis, increased liver enzyme activity, increased bilirubin levels in the blood due to hepatitis;
• weight gain.

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

• agranulocytosis (decrease in the number of a certain type of granulocytes in the blood), thrombocytopenia (decrease in the number of platelets in the blood), bone marrow suppression, hemolytic anemia, leukopenia (decrease in the number of white blood cells in the blood);
• anaphylactic reactions (including anaphylactic shock);
• depression, hallucinations, disorientation, mood disturbances;
• aseptic meningitis, seizures, taste disturbances, dizziness (peripheral origin);
• heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis;
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid or other NSAIDs), rhinitis;
• worsening of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforation, pancreatitis;
• photosensitivity, alopecia, urticaria, angioedema, blistering eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis;
• acute kidney failure, especially in patients with pre-existing kidney function disorders and/or dehydration, tubulointerstitial nephritis, nephrotic syndrome, abnormal kidney function test results;
• hyponatremia, hyperkalemia.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 Ketokaps Med

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ketokaps Med contains

• The active substance of the medicine is ketoprofen. 1 capsule contains 100 mg of ketoprofen.
• The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, purified water, and capsule shell with the composition: gelatin, sorbitol liquid, partially dehydrated, cochineal red (E 124), purified water.

What Ketokaps Med looks like and contents of the pack

The medicine is in the form of elongated, transparent capsules with a smooth, shiny surface, red in color, tightly filled with a liquid, with dimensions of approximately 24.95 mm x 8.90 mm.
One package of the medicine contains 30 or 60 soft capsules in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: