Dekenor

PACKAGE LEAFLET

Package leaflet: Information for the patient

Dekenor, 25 mg, film-coated tablets
Dexketoprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3–4 days, you should consult your doctor.

Contents of the leaflet

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

1. What Dekenor is and what it is used for

Dekenor is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used in adults for the short-term treatment of mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), and toothache.

2. Important information before taking Dekenor

When not to take Dekenor

• If the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or has previously experienced asthma attacks, acute allergic rhinitis (a short-term inflammatory condition of the nose), nasal polyps (growths inside the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, tongue or breathing difficulties), or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has previously experienced photoallergic or phototoxic reactions (a specific type of redness and/or blistering of the skin due to exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient currently has an active peptic ulcer or gastrointestinal bleeding, or has previously experienced gastrointestinal bleeding, ulcers, or perforation;
• If the patient has chronic digestive problems (e.g. indigestion, heartburn);
• If the patient currently has or has previously had bleeding or perforation of the stomach or intestines due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) as painkillers;
• If the patient has chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal impairment, or severe liver function disorders;
• If the patient has a tendency to excessive bleeding or coagulation disorders;
• If the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or is breastfeeding.

Allergic reactions to dexketoprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, Dekenor should be discontinued immediately and medical help should be sought urgently from a doctor or emergency services.

Warnings and precautions

Before starting Dekenor, discuss with your doctor or pharmacist if:

• You have allergies or a history of allergic reactions.
• You have kidney, liver, or heart problems (hypertension and/or heart failure), fluid retention, or have experienced any of these conditions in the past.
• You are taking diuretics or are severely dehydrated with reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, or vomiting).
• You have heart problems, have had a stroke, or are at high risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). Discuss treatment with your doctor or pharmacist, as taking medicines like Dekenor may slightly increase the risk of heart attack ("myocardial infarction") or stroke. The risk increases with higher doses and longer treatment duration. Do not exceed the recommended dose or treatment duration.
• You are elderly: older individuals may be more susceptible to adverse effects (see section 4). If any occur, consult your doctor immediately.
• You are a woman with fertility problems (Dekenor may impair female fertility; therefore, women planning pregnancy or undergoing fertility investigations should not use this medicine).
• You have blood or blood cell production disorders.
• You have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue).
• You have a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• You have a history of other stomach or intestinal problems.
• You have an infection; see subsection "Infections" below.
• You are taking other medicines that increase the risk of peptic ulceration or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs – selective serotonin reuptake inhibitors), anticoagulants (e.g. warfarin), or antiplatelet drugs like aspirin. In such cases, consult your doctor before taking Dekenor. Your doctor may recommend additional protective treatment for the stomach (e.g. misoprostol or acid-reducing agents).
• You have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as this increases the risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Taking this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dekenor may mask symptoms of infection such as fever and pain. Therefore, Dekenor may delay appropriate treatment of infections, increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and symptoms persist or worsen, consult your doctor immediately.

Children and adolescents

Dekenor has not been studied in children and adolescents. Therefore, the safety of Dekenor in children and adolescents has not been established, and the medicine should not be used in this population.

Dekenor with other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including over-the-counter medicines, as well as any medicines you plan to take. Some medicines should not be used together, while others may require dose adjustments when used in combination.

Always inform your doctor, dentist, or pharmacist if you are taking or using any of the following medicines in addition to Dekenor:

Not recommended to be used together:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other anticoagulant drugs
• Lithium, used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive drug) when used in high doses of 15 mg/week or more
• Hydantoin derivatives, e.g. phenytoin, used to treat epilepsy
• Sulfamethoxazole, used to treat bacterial infections

Use together with caution:

• Angiotensin-converting enzyme (ACE) inhibitors, diuretics, and angiotensin II receptor antagonists, used to treat high blood pressure and heart problems
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Aminoglycoside antibiotics, used to treat bacterial infections
• Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide), used to treat diabetes
• Methotrexate when used in low doses (less than 15 mg/week)

Use together requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used to treat bacterial infections
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation
• Streptokinase and other thrombolytic or fibrinolytic drugs, used to dissolve blood clots
• Probenecid, used to treat gout
• Digoxin, used to treat chronic heart failure
• Mifepristone, used as an abortifacient (to terminate pregnancy)
• Selective serotonin reuptake inhibitors (SSRIs), antidepressants
• Antiplatelet drugs used to reduce platelet aggregation and prevent clot formation
• Beta-blockers, used to treat high blood pressure and heart conditions
• Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medicines together with Dekenor, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and effects on fertility

Do not use Dekenor during the last three months of pregnancy or while breastfeeding. Dekenor may cause kidney and heart problems in the unborn child, affect the tendency to bleeding in both mother and child, and delay or prolong labour.

If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist, as using Dekenor may not be appropriate.

Women who are pregnant or planning pregnancy should not use Dekenor. From the 20th week of pregnancy, Dekenor may cause kidney function disturbances in the unborn child if used for more than a few days. This may lead to reduced amniotic fluid surrounding the baby (oligohydramnios). If treatment longer than a few days is necessary, your doctor may recommend additional monitoring. Any treatment during pregnancy should only be carried out under medical supervision.

Dekenor is not recommended for women trying to conceive or undergoing fertility investigations. Information on potential effects on fertility is provided in section 2, "Warnings and precautions".

Driving and operating machinery

Dekenor may cause dizziness and fatigue, and therefore may slightly affect the ability to drive vehicles or operate machinery. If such symptoms occur, do not drive or operate machinery until symptoms have resolved. If in doubt, consult your doctor.

Dekenor contains sodium

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

3. How to take Dekenor

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is usually ½ tablet (12.5 mg) every 4–6 hours or 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).
If there is no improvement or if symptoms worsen within 3–4 days, consult your doctor. Your doctor will advise on how many tablets to take per day and for how long. The dose of Dekenor required depends on the type, severity, and duration of pain.
The lowest effective dose should be used for the shortest possible duration necessary to relieve symptoms. In case of infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
For elderly patients or in case of kidney or liver problems, treatment should be initiated with a total daily dose not exceeding 2 tablets (50 mg). In elderly patients, this dose may later be increased to the generally recommended dose (75 mg), provided Dekenor is well tolerated.
Method of administration
Swallow the tablet with a sufficient amount of water. The medicine should be taken with food, as this helps reduce the risk of gastrointestinal or intestinal adverse effects. However, in case of acute pain and the need for rapid relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), as this will facilitate easier absorption of the drug.
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
Taking more Dekenor than recommended
If you have taken too much of this medicine, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Remember to bring the medicine’s packaging or the enclosed leaflet with you.
Missing a dose of Dekenor
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time (according to section 3 "How to take Dekenor").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of possible adverse effects, classified according to their frequency of occurrence.

Common adverse effects (may occur in no more than 1 in 10 people):
Nausea and/or vomiting, abdominal pain mainly in the upper abdomen, diarrhoea, indigestion (dyspepsia).

Uncommon adverse effects (may occur in no more than 1 in 100 people):
Dizziness (sensation of spinning), drowsiness, sleep disturbances, nervousness, headache, palpitations, flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth, bloating, skin rash, fatigue, pain, feeling of heat and chills, general malaise (asthenia).

Rare adverse effects (may occur in no more than 1 in 1,000 people):
Peptic ulcer disease, ulcer perforation or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slowed breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), unusual sensations, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood test), liver cell damage (hepatitis), acute kidney failure.

Very rare adverse effects (may occur in no more than 1 in 10,000 people):
Anaphylactic shock (an allergic reaction which may also lead to fainting), open skin ulcers, in the mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to airway narrowing (bronchospasm), dyspnoea, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), reduced platelet count (thrombocytopenia).

Frequency not known: cannot be estimated from available data
Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Fixed drug eruption
An allergic skin reaction known as fixed drug eruption, which may include round or oval areas of redness and swelling of the skin, blister formation and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Fixed drug eruptions usually recur in the same location(s) upon re-administration of the drug.

Immediately inform a doctor if any gastrointestinal symptoms occur at the beginning of treatment (e.g. abdominal pain, heartburn or bleeding), and if the patient has previously experienced any such adverse effects from long-term use of anti-inflammatory medicines, especially in elderly patients.

Discontinue Dekenor immediately upon observation of any rash, or any changes inside the mouth or on genital organs, or any symptoms of allergy.

During therapy with non-steroidal anti-inflammatory drugs, fluid retention and oedema (particularly of the legs and ankles), as well as elevated blood pressure and heart failure have been reported.

Medicines such as Dekenor may be associated with a small increased risk of myocardial infarction ("heart attack") or cerebrovascular stroke.

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcer disease, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients. Following administration, nausea, vomiting, diarrhoea, bloating, constipation, dyspepsia, abdominal pain, melena, coffee-ground vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported.

Less frequently, inflammation of the gastric mucosa (gastritis) has been observed.

As with other NSAIDs, haematological reactions may occur (thrombocytopenia, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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.

By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Dekenor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Store below 30 °C.
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 Dekenor contains

• The active substance is dexketoprofen. Each coated tablet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).
• The other ingredients (excipients) are microcrystalline cellulose, sodium croscarmellose, maize starch, colloidal anhydrous silica, magnesium stearate in the tablet core, and hypromellose, macrogol 6000, propylene glycol, and titanium dioxide (E 171) in the coating. See section 2, "Dekenor contains sodium".

What Dekenor looks like and contents of the pack
White or almost white, round, biconvex coated tablets with a division line on one side of the tablet.
Dimensions: approximately 10 mm in diameter.
The tablet can be divided into equal doses.
Dekenor is available in packs containing 10 x 1, 20 x 1, 30 x 1, and 50 x 1 coated tablets in single-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500

This medicinal product is authorised in the European Economic Area countries under the following names: