Ketoprofen apteo med

Patient Information Leaflet: Instructions for the User

Ketoprofen APTEO MED
50 mg, coated tablets
Ketoprofenum
Please read this leaflet carefully 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 a
physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you have any questions, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if your condition worsens, contact your physician.

Table of Contents

1. What Ketoprofen is and what it is used for
2. Important information before taking Ketoprofen
3. How to take Ketoprofen
4. Possible side effects
5. How to store Ketoprofen
6. Contents of the pack and other information

1. What Ketoprofen is and what it is used for

Ketoprofen 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.
Ketoprofen is indicated for short-term symptomatic treatment of mild to moderate acute pain, such as:

• muscle pain,
• headache,
• toothache,
• bone and joint pain,
• painful menstruation,
• pain due to strains and sprains,
• lower back pain.

Ketoprofen is indicated for use in adults and adolescents over 15 years of age.
If there is no improvement after 5 days, or if your condition worsens, contact your physician.

2. Important information before using Ketoprofen

When not to use Ketoprofen

• if the patient has a diagnosed allergy to ketoprofen or any of the other ingredients of this
  medicine (listed in section 6), aspirin-induced asthma, or other hypersensitivity reactions following
  nonsteroidal anti-inflammatory drugs (NSAIDs). In such patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, rhinitis, urticaria, or other allergic-type reactions, severe, rarely fatal, anaphylactic reactions have been observed,

• if the patient has active gastric and/or duodenal ulcer disease, or has ever experienced gastrointestinal bleeding, ulcers, or perforations,

• if the patient has severe hepatic or renal insufficiency,

• if the patient has severe heart failure,

• if the patient has a bleeding disorder,

• if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Ketoprofen, inform your doctor if the patient has:

• bronchial asthma, chronic rhinitis, chronic sinusitis, nasal polyps. Administration of ketoprofen may trigger an asthma attack or bronchospasm, especially in individuals with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• ulcers or bleeding while concurrently taking oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (e.g., aspirin) and nicorandil. The use of Ketoprofen may increase the risk of gastrointestinal ulcers or bleeding in these patients;
• a history of gastrointestinal disorders (past history of gastric and/or duodenal ulcer, ulcerative colitis, Crohn's disease), due to the potential for exacerbation of the disease;
• photosensitivity or UV radiation sensitivity;
• heart disease (heart failure), liver disease (liver function disorders), or kidney disease (chronic kidney function disorders), and fluid balance disorders (e.g., dehydration due to diuretic use or following recent surgery). The use of Ketoprofen may reduce renal blood flow, leading to kidney function disturbances, especially in elderly patients. Kidney function should be closely monitored at the beginning of treatment in such patients. In patients with liver function disorders, the doctor may consider reducing the dose. Very rare cases of jaundice and hepatitis have been reported during ketoprofen treatment. The doctor may recommend appropriate tests;
• infection – see the section titled “Infections” below.

The use of ketoprofen, especially at high doses, may be associated with a higher risk of serious gastrointestinal toxicity compared to other NSAIDs.
In patients with diabetes, renal insufficiency, and/or those treated concomitantly with drugs that increase blood potassium levels, concurrent use of ketoprofen may lead to increased blood potassium concentration.

Infections
Ketoprofen may mask symptoms of infection such as fever and pain. Therefore, Ketoprofen 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 chickenpox. If the patient is taking this medicine during an ongoing infection and symptoms persist or worsen, immediate medical advice should be sought.

The use of nonsteroidal anti-inflammatory drugs other than acetylsalicylic acid, such as Ketoprofen, may be associated with a small increased risk of heart attack (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.

If 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 disease (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), the treatment should be discussed with a doctor or pharmacist. Patients with heart disease who develop edema and fluid retention should be appropriately monitored and treatment individually adjusted.

Inform the doctor if the patient has recently undergone coronary artery bypass grafting.

The use of drugs such as Ketoprofen may be associated with a small increased risk of atrial fibrillation.

If visual disturbances occur, discontinue the use of the medicine and contact a doctor.

During treatment, inform the doctor if any of the following occur:

• Signs of drug hypersensitivity, especially: dyspnea, urticaria, skin rash, mucosal damage, sudden facial and neck itching. In such cases, contact a doctor immediately, who will decide whether to discontinue the medicine.
• Signs of gastrointestinal bleeding, such as: vomiting blood, blood in stool, tarry stools. Gastrointestinal ulceration or perforation may occur. In such cases, contact a doctor immediately, who will decide whether to discontinue the medicine.
• Severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). In such cases, contact a doctor immediately, who will decide whether to discontinue the medicine. The highest risk of these disorders occurs at the beginning of treatment. In most cases, these skin reactions occur during the first month of treatment.

Patients with a history of severe gastrointestinal disorders, especially elderly individuals, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial phase of treatment.

Warning
Ketoprofen contains the nonsteroidal anti-inflammatory drug ketoprofen.
Concomitant use of other medicines containing nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid or selective cyclooxygenase-2 (COX-2) inhibitors, is not recommended. Always read the patient leaflet of any other concurrently used medicine to ensure it does not contain a nonsteroidal anti-inflammatory drug.

Use of Ketoprofen in children and adolescents
The use of Ketoprofen is not recommended in children and adolescents under 15 years of age.

Ketoprofen and other medicines
Inform the doctor about all medicines currently or recently used, as well as any medicines the patient plans to use, including those available without a prescription.

Do not use ketoprofen concomitantly with the following medicines:

• other nonsteroidal anti-inflammatory drugs (including selective COX-2 inhibitors) and high-dose salicylates. Concurrent use increases the risk of adverse effects (especially gastrointestinal ulceration and gastrointestinal bleeding).
• anticoagulants such as: heparin, vitamin K antagonists (e.g., warfarin), antiplatelet agents (e.g., clopidogrel, ticlopidine), thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., apixaban, rivaroxaban, edoxaban). Ketoprofen inhibits platelet aggregation and irritates the gastric mucosa, increasing the risk of bleeding, especially gastrointestinal bleeding. Concurrent use of these medicines with ketoprofen is not recommended. If such combination is necessary, closely monitor clinical symptoms and perform periodic laboratory tests. Do not use NSAID treatment for longer than a few days.
• lithium. Ketoprofen inhibits lithium excretion, increasing its blood concentration (even to toxic levels). Concomitant use of ketoprofen with lithium salts is not recommended. If such treatment is necessary, strictly follow the doctor's instructions and regularly perform appropriate tests as prescribed by the doctor during and after NSAID treatment.
• methotrexate (at doses greater than 15 mg per week). Concurrent use of high-dose methotrexate (greater than 15 mg per week) increases the likelihood of hematological toxicity.

Exercise caution when using ketoprofen concomitantly with the following medicines:

• medicines that increase blood potassium levels. In patients concurrently using potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, other NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, or trimethoprim, increased blood potassium levels may occur.
• diuretics, ACE inhibitors, and angiotensin II receptor blockers. Patients who will use these medicines concomitantly with ketoprofen should be adequately hydrated before starting treatment. After starting treatment, follow the doctor's recommendations regarding monitoring kidney function.
• methotrexate (at doses less than 15 mg per week). During the first weeks of concomitant use of ketoprofen and methotrexate at doses less than 15 mg per week, regular complete blood counts (CBC) as prescribed by the doctor should be performed.
• corticosteroids. Increased risk of gastrointestinal ulceration and bleeding.
• pentoxifylline. Increased risk of bleeding when used concomitantly with ketoprofen. Follow the doctor's advice when using these medicines together.
• tenofovir. Increased risk of renal failure when tenofovir disoproxil fumarate is used concomitantly with ketoprofen.
• nicorandil. Patients taking nicorandil and NSAIDs concomitantly have an increased risk of severe complications such as gastrointestinal ulceration, perforation, and bleeding.
• cardiac glycosides. Nonsteroidal anti-inflammatory drugs may exacerbate heart failure and increase blood levels of cardiac glycosides. Caution is advised, especially in patients with renal function disorders, as NSAIDs may impair kidney function and reduce renal clearance of cardiac glycosides.
• cyclosporine. Increased risk of nephrotoxic effects, especially in elderly patients.
• tacrolimus. Increased risk of nephrotoxic effects, especially in elderly patients.
• quinolone antibiotics. Patients using NSAIDs and quinolone antibiotics concomitantly have an increased risk of seizures.

Particular attention should be paid when using ketoprofen concomitantly with:

• antihypertensive medicines (β-adrenergic receptor blockers, angiotensin-converting enzyme inhibitors, diuretics) – risk of reduced effectiveness of these medicines (due to inhibition of vasodilatory prostaglandins by NSAIDs).
• thrombolytic agents – increased risk of bleeding.
• probenecid – reduced renal excretion of ketoprofen.
• selective serotonin reuptake inhibitors (SSRIs) – increased risk of gastrointestinal bleeding.

Ketoprofen may reduce the effectiveness of hormonal contraceptives.

During long-term use of ketoprofen, regular blood tests, liver function tests, and kidney function tests should be performed.

Pregnancy, breastfeeding, and fertility

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

The use of Ketoprofen during the last three months of pregnancy is contraindicated, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart dysfunction in the unborn child. It may affect bleeding tendency in both mother and child and may result in delayed or prolonged labor.

Ketoprofen should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. Ketoprofen use for longer than a few days after the 20th week of pregnancy may cause kidney dysfunction in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
If the patient is breastfeeding, she should consult a doctor before using this medicine. Ketoprofen is not recommended for use in breastfeeding women. There are no data on the passage of ketoprofen into breast milk.

Effect on fertility
In women taking ketoprofen long-term, secondary anovulatory infertility may occur. Ketoprofen, like other NSAIDs, may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
If dizziness, drowsiness, or seizures occur during ketoprofen use, the patient should refrain from driving and operating machinery until the doctor confirms it is safe to perform these activities.

Ketoprofen contains lactose, tartrazine (E 102), cochineal red (E 124), and sodium

Lactose
If the patient has previously been diagnosed with carbohydrate intolerance, he or she should consult a doctor before taking this medicine.

Tartrazine (E 102) and cochineal red (E 124)
This medicine may cause allergic reactions.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Ketoprofen

This medicine should always be used according to the doctor's instructions. If in doubt, consult your
doctor.
The maximum daily dose is 150 mg. Higher doses are not recommended.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
If there is no improvement after 5 days, or if the patient feels worse, contact the doctor.

Dosage and method of administration
Adults and adolescents over 15 years of age
1 coated tablet every 8 hours.
The interval between doses should not be less than 8 hours.
Tablets should be taken with food, swallowed whole with a glass of water. Do not chew the tablet.
In case of mild gastrointestinal discomfort, it may be advisable to use agents that neutralize gastric acid or protect the gastric mucosa. Aluminum-containing compounds with neutralizing action do not reduce ketoprofen absorption.

Use of a higher than recommended dose of Ketoprofen
Symptoms observed after taking an overdose of ketoprofen include: lethargy, drowsiness, nausea, vomiting, and abdominal pain. In cases of severe overdose, arterial hypotension, respiratory depression, and gastrointestinal bleeding may occur.
There is no specific antidote.
In case of ingestion of a higher than recommended dose, contact a doctor immediately.
The doctor will initiate symptomatic treatment and supportive measures to maintain vital functions.

Missed dose of Ketoprofen
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone experiences them.

Common (may affect up to 1 in 10 patients):

• Dyspepsia, nausea, abdominal pain, vomiting

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

• Central origin headache and dizziness, drowsiness
• Constipation, diarrhoea, flatulence, gastritis
• Rash, redness, itching
• Oedema, fatigue

Rare (may affect up to 1 in 1,000 patients):

• Anaemia caused by haemorrhage or bleeding
• Paraesthesia (sensory disturbances)
• Visual disturbances (blurred vision)
• Tinnitus
• Dyspnoea, possible occurrence of asthma attack
• Stomatitis, gastric ulceration
• Hepatitis, increased aminotransferase activity, increased plasma bilirubin concentration 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 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, peripheral dizziness
• 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, blistering skin 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ketoprofen APTEO MED

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ketoprofen contains

• The active substance is ketoprofen. Each coated tablet contains 50 mg of ketoprofen.
• The other ingredients are: Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, magnesium stearate, anhydrous colloidal silicon dioxide; Tablet coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000, talc, tartrazine (E 102), carmine red (E 124).

What Ketoprofen looks like and contents of the pack
Ketoprofen APTEO MED tablets are biconvex, light yellow coated tablets with a diameter of 8 mm,
imprinted with the code "Kp 50" on one side and a break line on the other side.
The break line is intended only to facilitate tablet swallowing by allowing it to be broken, and does not indicate division into two equal doses.
The tablets are packed in PVC/Aluminum blisters and cardboard boxes. The pack contains 10 or 20 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240

Manufacturer:
AC HELCOR S.R.L.
Str. Dr. Victor Babes nr. 62, Loc. Baia Mare
430083 Municipiul Baia Mare
Jud. Maramures
Romania