Ketokaps Max

Leaflet attached to the packaging: patient information

Ketokaps Max

50 mg, soft capsules

Ketoprofen

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

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.

• 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 Ketokaps Max and what is it used for
• 2. Important information before taking Ketokaps Max
• 3. How to take Ketokaps Max
• 4. Possible side effects
• 5. How to store Ketokaps Max
• 6. Contents of the pack and other information

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

Ketokaps Max 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 Max is used for the symptomatic treatment of acute pain of various origins (e.g., muscle and bone pain, headache, toothache, painful menstruation) of mild to moderate severity.

2. Important information before taking Ketokaps Max

When not to take Ketokaps Max

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced shortness of breath, asthma, nasal congestion, or skin reactions (skin swelling or itching rash) after taking ketoprofen or similar-acting medicines (such as acetylsalicylic acid or other NSAIDs);
• if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding, and fertility");
• if the patient has active stomach or duodenal ulcers or has had bleeding, ulcers, or perforation of the digestive tract;
• 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 Max, the patient should discuss it with their doctor, pharmacist, or nurse, especially if:

• the patient has had gastrointestinal diseases (stomach or duodenal ulcers, ulcerative colitis, Crohn's disease) - due to the risk of worsening symptoms;
• the patient is taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (e.g., acetylsalicylic acid);
• the patient has asthma, chronic rhinitis, chronic sinusitis, or nasal polyps - ketoprofen may cause an asthma attack, bronchospasm, especially in people with hypersensitivity to acetylsalicylic acid or NSAIDs;
• the patient has heart diseases (heart failure, coronary artery 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, high cholesterol, smoking);
• the patient has kidney, liver, or water balance disorders (e.g., dehydration due to diuretics 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 side effects (especially gastrointestinal bleeding and perforation), so they should be cautious;
• the patient has an infection - see below, "Infections" section.

Taking Ketokaps Max in the smallest effective dose for the shortest necessary period reduces the risk of side effects. It is recommended to avoid concomitant use of Ketokaps Max with other medicines containing NSAIDs, including acetylsalicylic acid or selective COX-2 inhibitors. NSAIDs may cause gastrointestinal bleeding, ulcers, or perforation (which can be fatal), which can occur at any time during treatment, even without warning signs or a history of severe gastrointestinal events. The risk of gastrointestinal bleeding, ulcers, or perforation is higher when using high doses of NSAIDs, in patients with a history of ulcers, especially if complicated by bleeding or perforation (see "When not to take Ketokaps Max" section), and in elderly patients. If unusual gastrointestinal symptoms occur, especially bleeding, the patient should stop taking the medicine and consult their doctor immediately. Taking non-acetylsalicylic acid NSAIDs, such as ketoprofen, 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 of the medicine. The patient should not exceed the recommended dose and duration of treatment. Taking NSAIDs, such as Ketokaps Max, may be associated with a small increased risk of atrial fibrillation. During NSAID treatment, especially at the beginning of treatment, very rare but serious skin reactions (some with fatal outcomes) may occur, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. If a rash, mucosal lesions, or any signs of hypersensitivity occur, the patient should stop taking the medicine and consult their doctor immediately. If the patient experiences vision disturbances (e.g., blurred vision), they should stop taking the medicine and consult their doctor. Infections Ketokaps Max may mask the symptoms of an infection, such as fever and pain. Therefore, Ketokaps Max 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 related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

Children and adolescents

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

Ketokaps Max 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. The following medicines should not be taken with Ketokaps Max:

• other painkillers, such as NSAIDs, including selective COX-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 cancer) in doses greater than 15 mg per week.

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

• medicines that may increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim;
• diuretics;
• methotrexate (a medicine used to treat cancer) in doses 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 high uric acid levels);
• tenofovir (a medicine used to treat certain viral infections);
• immunosuppressants, such as 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 their doctor or pharmacist.

Ketokaps Max with food and drink

The capsules should be taken with meals.

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 Do not take Ketokaps Max if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Ketokaps Max may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first 6 months of pregnancy, the medicine 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 dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketokaps Max may cause kidney problems in the unborn baby 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, the doctor may recommend additional monitoring. Breastfeeding The use of Ketokaps Max is not recommended in breastfeeding women. Fertility in women Ketoprofen may make it harder to get pregnant. If the patient is planning a pregnancy, has problems getting pregnant, or is undergoing fertility tests, they should inform their doctor. The doctor may decide to stop the use of Ketokaps Max.

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 machinery.

Ketokaps Max contains sorbitol liquid, partially dehydrated, and carmine red

The medicine contains 67.5 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If the patient has been diagnosed with intolerance to some sugars or has a rare genetic disorder called hereditary fructose intolerance, they should consult their doctor before taking the medicine. Sorbitol in the medicine may affect the bioavailability of other orally administered medicines. Carmine red may cause allergic reactions.

3. How to take Ketokaps Max

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Adults and adolescents over 15 years of age: The recommended dose is 1 capsule 1 to 3 times a day, every 6 to 8 hours. The maximum recommended daily dose is 3 capsules (150 mg). The medicine is taken orally. The capsule should be swallowed whole (not chewed), with at least half a glass of water. The patient should use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2). In some patients, it may be necessary to take medicines that neutralize or protect the stomach lining to reduce the risk of harmful effects of ketoprofen on the digestive tract.

Use in children and adolescents

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

Elderly patients

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

Duration of treatment

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

Overdose of Ketokaps Max

In case of overdose, the patient should immediately consult their doctor or pharmacist. After an overdose, the following symptoms may occur: lethargy, drowsiness, nausea, vomiting, abdominal pain, bloody 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 Max

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, Ketokaps Max 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, bloody vomiting, or coffee ground-like particles;
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, palpitations, or a drop in 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 their doctor;
• serious skin reactions, such as a rash covering the whole body, exfoliative dermatitis, blistering, and peeling of the skin.

Taking painkillers and anti-inflammatory medicines, such as Ketokaps Max, especially in high doses and for a long time, may be associated with a small increased risk of heart attack 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 due to bleeding or blood loss;
• paresthesia (sensory disturbances);
• vision disturbances (blurred vision);
• tinnitus (ringing in the ears);
• shortness of breath, possible asthma attack;
• stomatitis, gastric ulcer;
• 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 leukocytes 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 NSAIDs), rhinitis;
• worsening of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforation, pancreatitis;
• photosensitivity, alopecia, urticaria, angioedema, blistering skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis;
• acute kidney failure, especially in patients with pre-existing kidney disorders and/or dehydration, interstitial nephritis, nephrotic syndrome, abnormal kidney function test results;
• hyponatremia, hyperkalemia.

Reporting side effects

If the patient experiences any side effects, including those 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 Ketokaps Max

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. Contents of the pack and other information

What Ketokaps Max contains

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

What Ketokaps Max looks like and contents of the pack

The medicine is in the form of oval, transparent capsules with a smooth, shiny surface, red in color, tightly filled with a liquid, approximately 15.35 mm x 8.70 mm in size. One pack of the medicine contains 10 or 20 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: