Ketokaps med

Package leaflet: Information for the patient

Ketokaps Med
100 mg, soft capsules
Ketoprofenum
Please read all of this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Ketokaps Med is and what it is 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. Contents of the pack and other information

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

Ketokaps Med contains the active substance ketoprofen. Ketoprofen is a medicine with anti-inflammatory, analgesic, and antipyretic properties (it belongs to the group of non-steroidal anti-inflammatory drugs – NSAIDs). The mechanism of action of ketoprofen is likely due to inhibition of prostaglandin synthesis.
Indications
Ketokaps Med is used for symptomatic treatment of inflammatory, degenerative, and metabolic rheumatic disorders, as well as for relief of certain pain syndromes, such as:

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

2. Important information before using Ketokaps Med

When not to use Ketokaps Med

• 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 (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 (NSAIDs));
• if the patient is in the third trimester of pregnancy (see below "Pregnancy, breastfeeding and effects on fertility");
• if the patient has active peptic ulcer disease of the stomach and/or duodenum or has previously experienced gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract;
• if the patient has severe heart, liver or kidney failure;
• if the patient has a bleeding tendency (bleeding diathesis).

Warnings and precautions
Before starting treatment with Ketokaps Med, discuss this with your doctor, especially if:

• the patient has had gastrointestinal disorders (peptic ulcer disease of the stomach and/or duodenum, ulcerative colitis, Crohn's disease) – due to the risk of worsening 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 (such as acetylsalicylic acid);
• the patient has been diagnosed with asthma, chronic rhinitis, chronic sinusitis, or nasal polyps – administration of ketoprofen may trigger an asthma attack or bronchospasm, especially in individuals hypersensitive to acetylsalicylic acid or non-steroidal anti-inflammatory drugs;
• the patient has heart disease (heart failure, ischemic heart disease), peripheral arterial disease and/or cerebrovascular disease, has had a stroke, or suspects an increased risk of cardiovascular diseases (e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking);
• the patient has kidney or liver disease or fluid balance disorders (e.g. dehydration due to diuretic therapy or following recent surgery) – use of the medicine may reduce renal blood flow, leading to impaired kidney function, especially in elderly patients. Very rare cases of jaundice and hepatitis have been reported during treatment with ketoprofen;
• the patient is elderly – elderly patients have a higher risk of adverse effects (especially gastrointestinal bleeding and perforation), so they should exercise particular caution;
• the patient has an infection – see below, the section titled "Infections".

Taking Ketokaps Med at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Avoid concomitant use of Ketokaps Med with other medicines containing non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid or selective cyclooxygenase-2 (COX-2) inhibitors.
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal bleeding, ulceration or perforation (with potentially 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 when high doses of NSAIDs are used, in patients with a history of peptic ulcer disease, especially complicated by bleeding or perforation (see section "When not to use Ketokaps Med"), and in elderly patients.
If the patient experiences unusual gastrointestinal symptoms during treatment (especially bleeding), the medicine should be discontinued immediately and the doctor should be informed without delay.
Use of non-steroidal anti-inflammatory drugs other than acetylsalicylic acid, such as ketoprofen, may be associated with a small increased risk of arterial thromboembolic events (e.g. myocardial infarction or stroke). This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.
Use of NSAIDs, such as Ketokaps Med, may be associated with a small increased risk of atrial fibrillation.
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.
If the patient experiences visual disturbances (e.g. blurred vision) during treatment with Ketokaps Med, the medicine should be discontinued and medical advice sought.

Infections
Ketokaps Med may mask objective signs of infection such as fever and pain. Therefore, Ketokaps Med 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 varicella. If the patient is taking this medicine during an infection and symptoms persist or worsen, immediate medical consultation is required.

Children and adolescents
Do not use in children and adolescents under 15 years of age.

Ketokaps Med and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

The following medicines should not be used together with Ketokaps Med:

• other painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (e.g. acetylsalicylic acid, diclofenac, naproxen);
• anticoagulants (medicines that inhibit blood clotting), antiplatelet agents (medicines that inhibit platelet aggregation), thrombolytics (medicines used to clear blood vessels), direct factor Xa inhibitors, for example: acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, edoxaban;
• lithium (a medicine used in the treatment of certain psychiatric disorders);
• methotrexate (a medicine used, among others, in cancer treatment) at doses exceeding 15 mg per week.

Ketokaps Med and other medicines may interact and affect each other's action. Therefore, always consult a doctor or pharmacist before using Ketokaps Med together with other medicines.
In particular, before taking Ketokaps Med, inform the doctor if any of the following medicines are being used:

• medicines that may increase blood potassium levels, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim;
• diuretics;
• methotrexate (a medicine used, among others, in cancer treatment) at doses less than 15 mg per week;
• medicines used to lower blood pressure;
• medicines used to treat depression (so-called selective serotonin reuptake inhibitors, SSRIs);
• corticosteroids (medicines used to treat pain, swelling, allergies, asthma, rheumatic 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);
• tenofovir (a medicine used to treat certain viral infections);
• medicines that suppress immune system function, e.g. after organ transplantation (cyclosporine and tacrolimus);
• antidiabetic medicines;
• antiepileptic medicines;
• medicines used for heart conditions (digitalis glycosides, beta-blockers, nicorandil);
• quinolone antibiotics.

If in doubt, consult a doctor or pharmacist.

Ketokaps Med with food and drink
Capsules should preferably be taken with food.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ketokaps Med 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 problems 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 6 months of pregnancy, the medicine 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. From the 20th week of pregnancy, Ketokaps Med may cause kidney dysfunction in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Use of Ketokaps Med in breastfeeding women is not recommended.

Effect on female fertility
Ketoprofen may impair fertility. If the patient is planning pregnancy, has difficulty conceiving, or is undergoing fertility investigations, she should inform her doctor. The doctor may decide to discontinue treatment with Ketokaps Med.

Driving and operating machinery
Ketoprofen may cause dizziness, drowsiness, visual disturbances and convulsions in some patients. If any of these symptoms occur, do not drive or operate machinery.

The medicine contains liquid sorbitol, partially dehydrated, and carmine red
One capsule contains 150 mg of sorbitol. Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child) or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot metabolize fructose, the patient should contact a doctor before taking the medicine. Sorbitol contained in the medicine may affect the bioavailability of other medicines taken simultaneously by oral route.
Carmine red may cause allergic reactions.

3. How to use Ketokaps Med

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Adults and adolescents above 15 years of age:
The usual dose is one capsule once or twice daily (100 to 200 mg of ketoprofen per day).

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
The recommended dose is one soft capsule, up to twice daily.
The maximum daily dose is 200 mg of ketoprofen. Before initiating treatment with a daily dose of 200 mg, the doctor will carefully evaluate the risk-benefit ratio.

The medicine should be taken orally. Swallow the capsule whole (do not chew), with at least half a glass of water.

The doctor may recommend concomitant use of drugs that neutralize or protect the gastric mucosa to reduce the risk of harmful gastrointestinal effects of ketoprofen.

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

Elderly patients
In elderly patients, the risk of adverse reactions is higher; therefore, the use of the lowest effective doses is recommended.

Taking more than the recommended dose of Ketokaps Med
In case of an overdose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, vomiting of blood, tarry stools, disturbances of consciousness, respiratory depression, convulsions, renal dysfunction, and kidney failure.
In case of suspected significant overdose, the doctor may recommend gastric lavage and initiate symptomatic and supportive treatment.

Missed dose of Ketokaps Med
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
THE MEDICINE MUST BE DISCONTINUED AND IMMEDIATE MEDICAL ADVICE SOUGHT IF
ANY OF THE FOLLOWING OCCUR:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure leading to shock. Symptoms may occur even after the first dose of the medicine. If any of these symptoms occur, contact a doctor immediately;
• Severe skin reactions, such as rash affecting the whole body, skin peeling, formation of blisters and shedding of skin sheets.

Taking anti-inflammatory and pain-relieving medicines such as Ketokaps Med, especially at high doses and for prolonged periods, may be associated with a small increased risk of heart attack or stroke.
Common (may affect up to 1 in 10 people):

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

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

• Central dizziness and vertigo, drowsiness;
• Constipation, diarrhoea, flatulence, gastritis;
• Rash, erythema, pruritus;
• Oedema, fatigue.

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

• Anaemia caused by haemorrhage or bleeding;
• Paraesthesia (abnormal sensations);
• Visual disturbances (blurred vision);
• Tinnitus (ringing in the ears);
• Dyspnoea, possible asthma attack;
• Stomatitis, gastric ulceration;
• Hepatitis, increased aminotransferase activity, increased bilirubin concentration in plasma due to hepatitis;
• Weight gain.

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

• Agranulocytosis (reduced number of certain types of granulocytes in blood), thrombocytopenia (reduced platelet count in blood), bone marrow suppression, haemolytic anaemia, leukopenia (reduced white blood cell count);
• Anaphylactic reactions (including anaphylactic shock);
• Depression, hallucinations, disorientation, mood disorders;
• Aseptic meningitis, convulsions, taste disturbances, peripheral vertigo;
• Heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis;
• Bronchospasm (especially in patients diagnosed with hypersensitivity to acetylsalicylic acid or other NSAIDs), rhinitis;
• Exacerbation of colitis and Crohn's disease, gastrointestinal bleeding, perforations, pancreatitis;
• Photosensitivity, alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis;
• Acute renal failure, especially in patients with pre-existing kidney dysfunction and/or dehydrated patients, tubulointerstitial nephritis, nephrotic syndrome, abnormal kidney function test results;
• Hyponatraemia, hyperkalaemia.

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

5. How to store Ketokaps Med

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must 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 Ketokaps Med contains

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

What Ketokaps Med looks like and contents of the pack
Ketokaps Med consists of elongated, transparent capsules with a smooth, glossy surface, red in colour, hermetically filled with liquid, measuring approximately 24.95 mm x 8.90 mm.
One pack contains 30 or 60 soft capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product Information
tel.: 22 742 00 22
e-mail: [email protected]