Ketokaps

Leaflet attached to the packaging: patient information

Ketokaps

25 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 directed 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 and what is it used for
• 2. Important information before taking Ketokaps
• 3. How to take Ketokaps
• 4. Possible side effects
• 5. How to store Ketokaps
• 6. Contents of the packaging and other information

1. What is Ketokaps and what is it used for

Ketokaps contains the active substance ketoprofen. Ketoprofen is a medicine with anti-inflammatory, analgesic, and antipyretic effects (belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs))

• NSAIDs). The mechanism of action of ketoprofen is probably based on the inhibition of prostaglandin synthesis.

Indications for use

Ketokaps 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, as well as pain and fever in the course of a cold or flu.

2. Important information before taking Ketokaps

When not to take Ketokaps

• 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 polyps, or skin reactions (skin rash or itching) 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 "Pregnancy, breastfeeding, and fertility" below);
• if the patient has active stomach or duodenal ulcers or has had a history of gastrointestinal bleeding, ulcers, 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, 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 exacerbating 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 nonsteroidal anti-inflammatory drugs (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 in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects.
Concomitant use of Ketokaps 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, ulcers, or perforation (with possible fatal outcome), which may occur at any time during treatment, even without warning signs or severe gastrointestinal events in the past.
The risk of gastrointestinal bleeding, ulcers, or perforation is higher during treatment with high doses of NSAIDs, in patients with a history of ulcers, especially if complicated by bleeding or perforation (see "When not to take Ketokaps" section), and in the elderly.
If unusual gastrointestinal symptoms occur, especially bleeding, the patient should stop taking the medicine and consult a doctor immediately.
Taking nonsteroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid, 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 take higher doses or use the medicine for longer than recommended.
Taking medicines like Ketokaps may be associated with a small increased risk of atrial fibrillation.
Rare but serious skin reactions (some with fatal outcome), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported during treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of treatment. If a rash, mucosal lesions, or any signs of hypersensitivity occur, the patient should stop taking the medicine and consult a doctor immediately.
If the patient experiences vision disturbances (e.g., blurred vision), they should stop taking the medicine and consult a doctor.
Infections
Ketokaps may mask the signs of infection, such as fever and pain. Therefore, Ketokaps 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 a doctor immediately.

Children

Ketokaps should not be used in children under 12 years of age.

Ketokaps 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:

• other pain relievers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g., acetylsalicylic acid, diclofenac, naproxen);
• anticoagulant medicines (blood thinners), antiplatelet agents (medicines that prevent blood clots), thrombolytic medicines (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 doses greater than 15 mg per week.

Ketokaps and other medicines may interact with each other, so the patient should always consult their doctor or pharmacist before taking Ketokaps with other medicines. In particular, before taking Ketokaps, the patient should inform their doctor or pharmacist 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 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 those used 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 their doctor or pharmacist.

Ketokaps 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 their doctor or pharmacist before taking this medicine.
Pregnancy
Ketokaps 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 may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and the child and cause 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 possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketokaps 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 child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ketokaps is not recommended for use in breastfeeding women.
Female fertility
Ketoprofen may make it more difficult to become pregnant. If the patient is planning a pregnancy, has problems becoming pregnant, or is undergoing fertility tests, they should inform their doctor. The doctor may decide to stop the use of Ketokaps.

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 contains liquid sorbitol, partially dehydrated

One capsule contains 52.5 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 body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

3. How to take Ketokaps

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The smallest effective dose should be taken for the shortest necessary period to alleviate 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).
Adults and adolescents over 15 years of age:
The recommended dose is 1-2 capsules (25-50 mg) up to 3 times a day, every 6-8 hours.
The maximum recommended daily dose should not be exceeded, which is 150 mg.
Adolescents from 12 to 15 years of age:
The recommended dose is 1 capsule up to 3 times a day, every 6-8 hours.
The recommended daily dose should not be exceeded.
The medicine is taken orally. The capsule should be swallowed whole (not chewed), with at least half a glass of water.
In some patients, it may be beneficial to take medicines that neutralize or protect the stomach lining to reduce the risk of ketoprofen's harmful effects on the gastrointestinal tract.

Use in children

Ketokaps should not be used in children under 12 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 taken for more than 5 days without consulting a doctor.

Taking a higher dose of Ketokaps than recommended

In case of taking a higher dose of the medicine than recommended, 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.

Missing a dose of Ketokaps

A double dose should not be taken 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 can cause side effects, although not everybody gets them.

THE PATIENT SHOULD STOP TAKING THE MEDICINE AND IMMEDIATELY CONSULT THEIR DOCTOR IF THEY EXPERIENCE:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, bloody vomiting, or coffee ground-like particles;
• 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, and 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;

severe skin reactions, such as a rash covering the entire body, peeling, blistering, and shedding of the skin.

Taking pain relievers and anti-inflammatory medicines like Ketokaps, 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 1,000 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 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 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 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 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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 will help to gather more information on the safety of this medicine.

5. How to store Ketokaps

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 packaging and other information

What Ketokaps contains

• The active substance of the medicine is ketoprofen. One capsule contains 25 mg of ketoprofen.
• The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, purified water, and the capsule shell contains: gelatin, liquid sorbitol, partially dehydrated, purified water.

What Ketokaps looks like and contents of the packaging

The medicine is in the form of oval, transparent capsules with a smooth, shiny surface, light yellow in color, tightly filled with a liquid, with dimensions of approximately 11.40 mm x 7.45 mm.
One packaging of the medicine contains 30 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, Żmigrodzka 242 E

Information about the medicine

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: