Ketokaps

Package leaflet: Information for the patient

Ketokaps
25 mg, soft capsules
Ketoprofenum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if you feel worse, you should contact your 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 pack 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 properties (it belongs to the group of non-steroidal anti-inflammatory
drugs – NSAIDs). The mechanism of action of ketoprofen probably involves inhibition of prostaglandin synthesis.

Indications
Ketokaps is indicated for symptomatic treatment of mild to moderate acute pain of various origins (e.g. muscular and musculoskeletal pain, headache, toothache, painful menstruation), as well as for pain and fever associated with common cold and influenza.

2. Important information before using Ketokaps

When not to use 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 previously experienced breathlessness, bronchial asthma attack, 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 (so-called 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 disease or has previously experienced gastrointestinal bleeding, ulceration or gastrointestinal perforation;
• if the patient has severe heart, liver or kidney failure;
• if the patient has a bleeding tendency (predisposition to bleeding).

Warnings and precautions
Before starting to use Ketokaps, discuss this with your doctor, pharmacist or nurse, especially if:

• the patient has had gastrointestinal disorders (gastric and/or duodenal ulcer disease, ulcerative colitis, Crohn's disease) – due to the risk of symptom exacerbation;
• the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulant medicines (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants) and antiplatelet medicines (such as acetylsalicylic acid);
• the patient has been diagnosed with bronchial asthma, chronic rhinitis, chronic sinusitis or nasal polyps – administration of ketoprofen may trigger an asthma attack or bronchospasm, particularly in individuals hypersensitive to acetylsalicylic acid or non-steroidal anti-inflammatory drugs;
• the patient has heart diseases (heart failure, ischaemic heart disease), peripheral arterial disease and/or cerebrovascular disease, has had a stroke or suspects an increased risk of cardiovascular disorders (e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking);
• the patient has kidney or liver disorders or fluid imbalance (e.g. dehydration due to diuretic use or following recent surgery) – use of the medicine may reduce renal blood flow leading to kidney function disorders, especially in elderly patients. Very rare cases of jaundice and hepatitis have been reported during ketoprofen treatment;
• the patient is elderly – in elderly patients, the risk of adverse effects (especially gastrointestinal bleeding and perforation) is higher, therefore they should exercise particular caution;
• the patient has an infection – see below, section titled "Infections".

Taking Ketokaps at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Concomitant use of Ketokaps with other medicines containing non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid or selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
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") and in elderly patients.
If unusual gastrointestinal symptoms, especially bleeding, occur during treatment (particularly at the beginning of treatment), the patient should stop taking the medicine immediately and inform their doctor 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 thrombotic events (heart attack or stroke). This risk increases with long-term use of high doses of the medicine. Doses higher than recommended or longer treatment duration than advised should not be used.
Use of NSAIDs, such as Ketokaps, may be associated with a small increased risk of atrial fibrillation.
During use of non-steroidal anti-inflammatory drugs (NSAIDs), especially at the beginning of treatment, severe skin reactions (some with potentially fatal outcome) may very rarely 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 immediately and the doctor informed without delay.
If visual disturbances (e.g. blurred vision) occur during treatment with Ketokaps, the patient should stop taking the medicine and consult a doctor.

Infections
Ketokaps may mask objective signs of infection, such as fever and pain. Therefore, Ketokaps may delay appropriate treatment of infection 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 existing infection and infection symptoms persist or worsen, immediate medical advice should be sought.

Children
Do not use in children under 12 years of age.

Ketokaps and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The following medicines should not be used together with Ketokaps:

• 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 medicines (medicines that inhibit platelet aggregation), thrombolytics (medicines used to unblock 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 greater than 15 mg per week.

Ketokaps and other medicines may interact with each other, therefore always consult your doctor or pharmacist before using Ketokaps together with other medicines. In particular, before taking Ketokaps, inform your doctor or pharmacist if you are taking any of the following medicines:

• 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 that lower blood pressure;
• medicines used to treat depression (so-called selective serotonin reuptake inhibitors, SSRI);
• corticosteroids (medicines used to treat pain, swelling, allergies, asthma, rheumatoid 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 disease (digitalis glycosides, beta-blockers, nicorandil);
• quinolone antibiotics.

If you have any doubts, consult your doctor or pharmacist.

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

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

Pregnancy
Ketokaps should not be taken during the last three 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 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 week 20 of pregnancy, Ketokaps may cause kidney function disorders 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 required, the doctor may recommend additional monitoring.

Breastfeeding
Use of Ketokaps in breastfeeding women is not recommended.

Effect on female fertility
Ketoprofen may make it more difficult to become pregnant. If the patient is planning pregnancy, has difficulty becoming pregnant or is undergoing fertility investigations, she should inform her doctor without delay. The doctor may decide to discontinue use of Ketokaps.

Driving and using machines
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
One capsule contains 52.5 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact their doctor before taking the medicine or giving it to the child.

3. How to use Ketokaps

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a 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 daily, every 6–8 hours.
Do not exceed the recommended maximum daily dose of 150 mg.

Adolescents aged 12 to 15 years:
The recommended dose is 1 capsule up to 3 times daily, every 6–8 hours.
Do not exceed the recommended daily dose.

The medicine is administered orally. The capsule should be swallowed whole (do not chew), with at least half a glass of water.

In some patients, it may be advisable to take medicines that neutralize or protect the gastric mucosa to reduce the risk of harmful effects of ketoprofen 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 adverse reactions is higher; therefore, it is recommended to use the lowest effective doses.

Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor.

Overdose of Ketokaps
If you take more than the recommended dose, 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
Do not take a double dose to make up for a missed dose.

If you have any further questions about 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 everybody will experience them.
THE MEDICINE MUST BE DISCONTINUED AND MEDICAL ADVICE MUST BE SOUGHT IMMEDIATELY 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 severe 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 a rash affecting the entire body, peeling, formation of blisters and shedding of skin sheets.

The use of anti-inflammatory and analgesic medicines such as Ketokaps, especially at high doses and over a long period, 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 dizziness, drowsiness;
• constipation, diarrhoea, flatulence, gastritis;
• rash, erythema, pruritus;
• oedema, fatigue.

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

• anaemia due to haemorrhage or bleeding;
• paraesthesia (sensory disturbances);
• visual disturbances (blurred vision);
• tinnitus (ringing in the ears);
• dyspnoea, possibility of asthma attack;
• stomatitis, gastric ulceration;
• hepatitis, increased aminotransferase activity, increased plasma bilirubin concentration due to hepatitis;
• weight gain.

Frequency unknown (frequency cannot be estimated from available data):

• agranulocytosis (decreased number of certain types of granulocytes in blood), thrombocytopenia (reduced number of platelets in blood), bone marrow suppression, haemolytic anaemia, leukopenia (reduced number of white blood cells in blood);
• anaphylactic reactions (including anaphylactic shock);
• depression, hallucinations, disorientation, mood disturbances;
• aseptic meningitis, convulsions, taste disturbances, dizziness (peripheral origin);
• heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis;
• bronchospasm (especially in patients with diagnosed 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 generalised exanthematous pustulosis;
• acute renal failure, particularly in patients with pre-existing renal impairment and/or in 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ketokaps

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 packaging. 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. Such practices help protect the environment.

6. Contents of the pack and other information

What Ketokaps contains

• The active substance is ketoprofen. Each capsule contains 25 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, purified water.

What Ketokaps looks like and contents of the pack
Ketokaps is oval, transparent soft capsules with a smooth, glossy surface, light yellow in colour, hermetically filled with liquid, approximately 11.40 mm x 7.45 mm in size.
One pack contains 30 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]