Dekenor

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: patient information

Dekenor, 25 mg, coated tablets

Dexketoprofen

It is essential to carefully read the contents of the leaflet 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 or pharmacist.

• The leaflet should be kept to be able to read it again if necessary.
• 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 or pharmacist. See section 4.
• If after 3-4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Dekenor and what is it 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 is Dekenor and what is it used for

Dekenor is a pain-relieving 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, 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 had asthma attacks in the past, severe allergic rhinitis (short-term inflammation of the nose), nasal polyps (growths in the nose caused by allergy), hives (rash on the skin), angioedema (swelling of the face, eyes, lips, tongue, or respiratory problems) or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has had photoallergic or phototoxic reactions (a particular type of redness and/or blistering of the skin due to exposure to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood fat levels);
• If the patient has active stomach or intestinal ulcers/bleeding, or has had stomach or intestinal bleeding, ulcers, or perforation in the past;
• If the patient has chronic gastrointestinal problems (e.g., indigestion, heartburn);
• If the patient has had stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs as painkillers;

or intestinal ulcers/bleeding as a result of taking non-steroidal anti-inflammatory drugs as painkillers;

• If the patient has intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney failure, or severe liver dysfunction;
• If the patient has a tendency to bleed excessively or has bleeding disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Dekenor, the patient should discuss it with their doctor or pharmacist

• In case of allergies or a history of allergies.
• In case of kidney, liver, or heart problems (high blood pressure and/or heart failure), as well as fluid retention or a history of these conditions.
• In case of taking diuretics or in case of severe dehydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting).
• In case of heart problems, a history of stroke, or suspected high risk of these conditions (e.g., high blood pressure, diabetes, or high cholesterol, or smoking), the patient should discuss treatment with their doctor or pharmacist: taking medicines like Dekenor may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk increases with increasing doses and duration of treatment. The recommended dose should not be exceeded, nor should the treatment period be prolonged.
• In the case of elderly patients: elderly patients may be more prone to side effects (see section 4). If any occur, they should immediately consult their doctor.
• In the case of women with fertility problems (Dekenor may affect female fertility, so women planning a pregnancy or undergoing fertility tests should not take it).
• In case of blood production and blood cell disorders.
• In case of systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue).
• In case of a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• In case of a history of other stomach or intestinal problems.
• In case of infections, see "Infections" below.
• In case of taking other medicines that increase the risk of stomach ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, or selective serotonin reuptake inhibitors), anticoagulants such as aspirin or warfarin. In these cases, before taking Dekenor, the patient should consult their doctor: the doctor may recommend taking an additional medicine to protect the stomach (e.g., misoprostol or medicines that reduce stomach acid production).
• In case of asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, there is a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.

Infections
Dekenor may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Dekenor may delay proper treatment of the infection, which may lead to increased risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections in chickenpox. If the patient is taking this medicine during an infection, and the symptoms persist or worsen, they should immediately consult their doctor.

Children and adolescents

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

Dekenor 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, including those available without a prescription. There are certain medicines that should not be taken together, and others whose doses may need to be changed when taken in certain combinations.
The patient should always inform their doctor, dentist, or pharmacist about the use or taking of any of the following medicines, in addition to Dekenor:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant medicines
• Lithium, used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive medicine), used in high doses of 15 mg/week
• Hydantoin derivatives, such as phenytoin, used to treat epilepsy
• Sulfamethoxazole, used to treat bacterial infections

Concomitant use that requires caution:

• ACE inhibitors, diuretics, and angiotensin II receptor antagonists, used to treat high blood pressure and heart problems
• Pentoxifylline and oxypentifylline, 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, used in low doses, less than 15 mg/week

Concomitant use that requires special consideration:

• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine or tacrolimus, used to treat immune system diseases and organ transplants
• Streptokinase and other thrombolytic or fibrinolytic medicines, such as medicines used to dissolve blood clots
• Probenecid, used to treat gout
• Digoxin, used to treat chronic heart failure
• Mifepristone, used as an abortifacient (intended to terminate pregnancy)
• Antidepressants from the SSRI group (selective serotonin reuptake inhibitors)
• Antiplatelet medicines used to limit platelet aggregation and blood clot formation
• Beta-adrenergic blockers, used to treat high blood pressure and heart disease
• Tenofovir, deferiprone, pemetrexed

In case of any doubts about taking other medicines with Dekenor, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Dekenor should not be used during the last three months of pregnancy or during breastfeeding.
Dekenor may cause kidney and heart problems in the unborn child, as well as affect the tendency to bleed in the mother and child, and may delay or prolong labor.
If the patient is pregnant, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist, as the use of Dekenor may be inappropriate in this situation.
Women planning a pregnancy and pregnant women should not take Dekenor. From the 20th week of pregnancy, Dekenor 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). If treatment is necessary for a longer period, the doctor may recommend additional monitoring. Treatment initiated at any stage of pregnancy should only be done according to the doctor's recommendations.
Dekenor is not recommended for women trying to conceive or during fertility testing. Information on potential fertility effects can be found in section 2, "Warnings and precautions".

Driving and using machines

Dekenor may cause dizziness and fatigue, and therefore may slightly affect the ability to drive vehicles and operate machinery. If such symptoms are observed, the patient should not drive vehicles or operate machinery until the symptoms have resolved. In case of doubts, the patient should consult their doctor.

Dekenor contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine 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 a doctor or pharmacist. In case of doubts, the patient should consult their 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 more than 3 tablets per day (75 mg).
If after 3-4 days there is no improvement or the symptoms worsen, the patient should consult their doctor. The doctor will recommend how many tablets to take per day and for how long. The dose of Dekenor to be taken depends on the type, severity, and duration of the pain.
The smallest effective dose should be used for the shortest possible period necessary to relieve the symptoms. In case of infections, the patient should immediately consult their doctor if the symptoms (such as fever and pain) persist or worsen (see section 2).
In the case of elderly patients or in case of kidney or liver problems, treatment should be started with a total daily dose not exceeding 2 tablets (50 mg). In the case of elderly patients, this dose may be increased later to the generally recommended dose (75 mg), provided that Dekenor is well tolerated.
Method of administration
The tablet should be swallowed, washed down with a sufficient amount of water. The medicine should be taken with food, as this helps to reduce the risk of stomach or intestinal side effects. However, in case of acute pain and the need for quick relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), as this will facilitate the absorption of the medicine.

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years of age).

Taking a higher dose of Dekenor than recommended

In case of taking too much of this medicine, the patient should immediately inform their doctor or pharmacist, or go to the emergency room of the nearest hospital. The patient should remember to take the packaging of this medicine or the attached leaflet with them.

Missing a dose of Dekenor

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose at the usual time (as described in section 3 "How to take Dekenor").
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, Dekenor can cause side effects, although not everybody gets them.
The following is a list of possible side effects, according to their frequency.

Common side effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, stomach pain mainly in the upper abdomen, diarrhea, digestive problems (indigestion).

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

Dizziness (feeling of spinning), drowsiness, sleep disturbances, nervousness, headache, palpitations, flushing, stomach inflammation (gastritis), constipation, dry mouth, bloating, skin rash, fatigue, pain, feeling of heat and chills, general malaise (weakness).

Rare side effects (may affect up to 1 in 1,000 people):

Ulcers, perforation, or bleeding from ulcers (which may manifest as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral edema (e.g., swollen ankles), throat edema, loss of appetite (anorexia), unusual sensations, itching rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver test results (blood test), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people):

Anaphylactic shock (an allergic reaction that can also lead to fainting), open sores on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or edema of the lips and throat (angioedema), shortness of breath due to bronchial constriction (bronchospasm), dyspnea, 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), decreased platelet count in the blood (thrombocytopenia).
The patient should immediately inform their doctor if they notice any gastrointestinal symptoms at the start of treatment (e.g., stomach pain, heartburn, or bleeding) and if they have had such side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
Dekenor should be discontinued immediately if a rash or any changes in the mouth or genital areas occur, or if any signs of an allergic reaction appear.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the legs and ankles) have been reported, as well as increased blood pressure and heart failure.
Medicines like Dekenor may be associated with a small increased risk of heart attack ("myocardial infarction") or 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. Ulcers, perforation, or bleeding from the gastrointestinal tract may occur, sometimes fatal, especially in elderly patients. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, black stools, coffee ground vomiting, oral ulceration, exacerbation of colitis and Crohn's disease have been reported. Less frequently, stomach inflammation (gastritis) has been observed. As with other NSAIDs, hematologic reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, as well as agranulocytosis and bone marrow hypoplasia) may occur.

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
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dekenor

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
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 pack and other information

What Dekenor contains

• The active substance is dexketoprofen. Each coated tablet contains 25 mg of dexketoprofen (in the form of dexketoprofen trometamol).
• The other ingredients (excipients) are microcrystalline cellulose, sodium croscarmellose, cornstarch, anhydrous colloidal 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 score line on one side of the tablet.
Dimensions: diameter approximately 10 mm.
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 authorization 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
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 18.01.2023