Dekenor

Patient Information Leaflet

Dekenor 50 mg/2 mL solution for injection/infusion
Dexketoprofen
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dekenor is and what it is used for
2. Important information before using Dekenor
3. How to use 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 a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used in the treatment of moderate to severe acute pain when oral administration is not appropriate, such as postoperative pain, renal colic pain (severe kidney pain), and lumbosacral pain.

2. Important information before using Dekenor

When not to use Dekenor:

• If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• If the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nodules inside the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, tongue, or a combination of respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has gastric or duodenal ulcer disease or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
• If the patient has chronic digestive problems (e.g. indigestion, heartburn);
• If the patient currently has or has previously had gastrointestinal bleeding or perforation due to use of NSAIDs;
• 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 failure, or severe hepatic failure;
• If the patient has a tendency to excessive bleeding or coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhoea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

During treatment with dexketoprofen, allergic reactions have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue Dekenor immediately and contact a doctor or emergency services without delay.

Warnings and precautions
Before starting treatment with Dekenor, discuss with your doctor, pharmacist, or nurse if:

• The patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• The patient has or has had other stomach or intestinal disorders;
• The patient is taking other medicines that increase the risk of gastric or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, such as serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or antithrombotic agents such as warfarin. In such cases, consult your doctor before taking Dekenor, who may decide to prescribe a protective agent (e.g. misoprostol or acid-reducing agents);
• The patient has heart disease, history of stroke, or suspicion of being in a high-risk group for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult your doctor before use. Medicines such as Dekenor 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 exceed the recommended dose or duration of treatment;
• The patient is elderly: there is an increased risk of adverse reactions (see section 4). In such cases, contact your doctor promptly;
• The patient has allergies or a history of allergic symptoms;
• The patient has kidney, liver, or heart dysfunction (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred previously;
• The patient is receiving diuretics or has reduced hydration and blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
• Women experiencing difficulty conceiving (Dekenor may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment);
• Women in the first or second trimester of pregnancy;
• The patient has blood cell or blood formation disorders;
• The patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• The patient has infections; see section "Infections" below;
• The patient has asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps; the risk of hypersensitivity to acetylsalicylic acid and/or NSAIDs is higher than in the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients hypersensitive to acetylsalicylic acid and/or NSAIDs.

Infections
Dekenor may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an infection and symptoms persist or worsen, consult a doctor immediately.
Use of this medicine during chickenpox is not recommended.

Children and adolescents
The use of Dekenor has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore Dekenor should not be used in children and adolescents.

Dekenor with other medicines
Inform your doctor about all medicines currently or recently taken, including those obtained without a prescription.
Some medicines should not be used together with Dekenor, and others may require dose adjustment when used concomitantly. Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dekenor:

Not recommended for concomitant use:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other anticoagulant drugs
• Lithium used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive agent) at high doses of 15 mg per week
• Hydantoin derivatives and phenytoin used to treat epilepsy
• Sulfamethoxazole used to treat bacterial infections

Concomitant use requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart disease
• Pentoxifylline and oxypentifylline used to treat ulcers in chronic venous insufficiency
• 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 at low doses, below 15 mg per week

Concomitant use requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system disorders and in organ transplantation
• Streptokinase and other thrombolytic or fibrinolytic agents (medicines 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) used as antidepressants
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferasirox, pemetrexed

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

Pregnancy, breastfeeding, and effect on fertility
Do not use Dekenor during the last three months of pregnancy or while breastfeeding.
Consult your doctor.
Dekenor may cause kidney and heart problems in the unborn child, affect bleeding tendency 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 Dekenor may not be appropriate in these circumstances.
Pregnant women or women planning pregnancy should avoid using this medicine.
Use of Dekenor at any stage of pregnancy must only occur under medical supervision.
From week 20 of pregnancy, Dekenor may cause kidney dysfunction in the unborn child if used for more than a few days. This may lead to reduced amniotic fluid volume surrounding the fetus (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the fetal heart. If treatment longer than a few days is necessary, your doctor may recommend additional monitoring.
Dekenor is not recommended for women planning pregnancy or undergoing infertility diagnosis.
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 mechanical equipment until symptoms resolve. If in doubt, consult your doctor.

Dekenor contains ethanol
This medicine contains 12% v/v ethanol (alcohol), i.e. up to 200 mg per dose, equivalent to 5 mL of beer or 2.08 mL of wine per dose. This may be harmful in patients with alcohol-related disease.
This should be considered in pregnant women, breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains less than 1 mmol sodium (23 mg) per dose, meaning it can be considered "sodium-free."

3. How to use Dekenor

This medicine should always be taken as directed by a physician. If in doubt, consult a doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The physician will determine the appropriate dose of Dekenor based on the type, severity, and duration of the patient's symptoms. The recommended dose is 1 ampoule (50 mg) of Dekenor every 8 to 12 hours. If necessary, the dose may be repeated after 6 hours. The maximum daily dose of 150 mg of Dekenor (3 ampoules) must not be exceeded.
The use of injections is intended for short-term treatment only and should be used solely during episodes of acute pain (no longer than 2 days). The physician will switch to oral pain medication as soon as possible.
In elderly patients with renal impairment and in patients with kidney or liver disorders, the daily dose of Dekenor must not exceed 50 mg (equivalent to 1 ampoule of the medicine).
Method of administration:
Dekenor may be administered intramuscularly or intravenously. A detailed description of intravenous administration is provided in the section intended exclusively for healthcare professionals.
When administering Dekenor intramuscularly, the solution should be injected immediately after opening the ampoule, by slow deep intramuscular injection.
Only clear, colourless solutions should be used.
Children and adolescents
Do not use this medicine in children and adolescents (under 18 years of age).
Accidental overdose of Dekenor
If an overdose of Dekenor is suspected, inform a doctor or nurse immediately.
Missed dose of Dekenor
As this medicine is administered under strict medical supervision, missing a dose is unlikely. However, if a dose is missed, inform the doctor or nurse.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, grouped according to their likelihood of occurrence.

Common side effects (may occur in up to 1 in 10 people):
Nausea and/or vomiting, pain at the injection site, reactions at the injection site such as inflammation, bruising or bleeding.

Uncommon side effects (may occur in up to 1 in 100 people):
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, indigestion, diarrhoea, dryness of the oral mucosa, facial flushing, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare side effects (may occur in up to 1 in 1,000 people):
Stomach ulcer, bleeding or perforation of the stomach ulcer, high blood pressure, fainting, slowed breathing rate, superficial vein inflammation due to blood clot (thrombophlebitis), irregular heart rhythm (extra beats), rapid heartbeat, limb swelling, throat swelling, abnormal sensations, feeling of increased body temperature and tremors, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, kidney area pain, increased urination, menstrual disorders, benign prostatic hyperplasia, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function test results (blood tests), high blood sugar levels (hyperglycaemia), low blood sugar levels (hypoglycaemia), high levels of certain fats in the blood (hypertriglyceridaemia), increased excretion in urine of so-called ketone bodies (ketonuria) or protein (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (may occur in up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin, lip, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath caused by constriction of respiratory muscles (bronchospasm), shortness of breath, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, reduced number of white blood cells (neutropenia), reduced number of platelets (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 may persist after healing. Fixed drug eruptions usually recur in the same location(s) upon re-exposure to the medicine.

If you notice any gastrointestinal side effects (e.g. stomach pain, heartburn or bleeding) at the beginning of treatment, or if you have previously experienced similar side effects due to long-term use of anti-inflammatory medicines, especially in elderly patients, you should inform your doctor.

If a skin rash or any mucosal lesion (e.g. inside the mouth) or any symptoms of allergy occur, you should immediately stop using Dekenor.

During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (particularly of ankles and legs), increased blood pressure and heart failure may occur.

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

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

The most commonly observed side effects involved gastrointestinal disorders. Particularly in elderly patients, gastric or duodenal ulcer, perforation or gastrointestinal bleeding may occur, in some cases with fatal outcome.

After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, lower abdominal pain, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Less frequently observed was inflammation of the gastric mucosa.

You should immediately inform your doctor if signs of infection occur or if your condition worsens during treatment with Dekenor.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dekenor

The medicine should be stored in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
There are no special requirements regarding the storage temperature of the medicinal product.
It has been demonstrated that, after dilution according to the recommendations provided in the section
"Information for healthcare professionals only", the diluted solution remains chemically stable for 24 hours
when stored at 25°C, provided it is protected from daylight.
From a microbiological standpoint, unless the dilution method excludes the risk of microbiological contamination,
the product should be used immediately. If the product is not used immediately, the responsibility for the storage duration and conditions lies with the user.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Dekenor contains

• The active substance is dexketoprofen. Each 2 mL ampoule of injection/infusion solution contains 50 mg of dexketoprofen (as dexketoprofen trometamol).
• Other components of the medicine are sodium chloride, ethanol (96%), sodium hydroxide (for pH adjustment), and water for injections. See section 2 "Dekenor contains ethanol and sodium".

What Dekenor looks like and contents of the pack
Dekenor injection/infusion solution is a colourless solution, practically free from particles
(pH: 7.0–8.0; osmolarity: 270–328 mOsmol/L).
Dekenor is available in cartons containing 1, 5 or 10 ampoules of injection/infusion solution.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information on the names of medicinal products in other European Economic Area countries, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500

Information intended exclusively for healthcare professionals:

Dekenor 50 mg/2 mL solution for injection/infusion
Dexketoprofen
Intravenous administration:
Intravenous infusion: dilute the contents of 1 ampoule (2 mL) of Dekenor in 30 mL to 100 mL of physiological saline, 5% glucose solution, or ingera solution. The diluted solution should be administered as a slow intravenous infusion over a period of 10 to 30 minutes. The solution must always be protected from daylight.
Intravenous bolus: if necessary, the contents of 1 ampoule (2 mL) of Dekenor may be administered as a slow intravenous bolus over no less than 15 seconds.
Due to its ethanol content, Dekenor must not be administered directly into the spinal canal (intrathecally or epidurally).

Instructions for handling the medicinal product:
When administering Dekenor as an intravenous bolus, the solution should be injected immediately after withdrawal from the colored ampoule.
In case of intravenous infusion, the solution should be diluted under aseptic conditions and protected from daylight.
Only clear, colorless solutions should be used.

Compatibility information:
Dekenor has been shown to be compatible when mixed in small volumes (e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine, and theophylline.
The diluted injection solution is a clear solution. Dekenor diluted in a volume of 100 mL of normal saline or glucose solution is compatible with the following drugs in injectable form: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.

No adsorption of the active substance was observed when diluted solutions of the medicinal product Dekenor were stored in plastic bags or administration devices made of ethylene vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), or polyvinyl chloride (PVC).