Dexak 50

Leaflet accompanying the packaging: information for the user

Dexak 50

Dexketoprofen

50 mg/2 ml

Solution for injection or infusion

Read the leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dexak 50 and what is it used for
• 2. Important information before using Dexak 50
• 3. How to use Dexak 50
• 4. Possible side effects
• 5. How to store Dexak 50
• 6. Package contents and other information

1. What is Dexak 50 and what is it used for

Dexak 50 is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of moderate to severe acute pain when oral administration is not appropriate, e.g. post-operative pain, renal colic pain, and lower back pain.

2. Important information before using Dexak 50

When not to use Dexak 50:

• 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, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (growths in the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has had hypersensitivity reactions to sunlight in the past: photoallergic or phototoxic reactions (especially in the form of redness and/or blisters on the skin exposed to the sun) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if they have had gastrointestinal bleeding or ulcers in the past;
• If the patient has certain chronic gastrointestinal diseases (e.g. indigestion, heartburn);
• If the patient has had gastrointestinal bleeding or perforation due to the use of pain-relieving drugs from the NSAID group;
• 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 renal impairment, or severe liver impairment;
• If the patient has a tendency to bleed excessively or has coagulation 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 Dexak 50, the patient should discuss it with their doctor or pharmacist:

• If the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the past;
• If the patient has or has had other stomach or intestinal diseases;
• If the patient is taking other medicines that increase the risk of stomach ulcers or gastrointestinal bleeding, such as oral steroids, certain antidepressants (SSRI drugs, e.g. serotonin reuptake inhibitors), or anticoagulant drugs such as acetylsalicylic acid or warfarin. In such cases, the doctor may decide to administer an additional protective medicine (e.g. misoprostol or drugs that inhibit stomach acid production);
• If the patient has heart problems, has had a stroke, or is at risk of these conditions (e.g. due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor before taking Dexak 50. Taking such medicines as Dexak 50 may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses of the medicine. The patient should not exceed the recommended dose and duration of treatment;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such a case, the patient should contact their doctor immediately;
• If the patient has an allergy or has had allergy problems in the past;
• If the patient has kidney, liver, or heart disorders (hypertension and/or heart failure), as well as fluid retention or if any of these problems have occurred in the patient in the past;
• In patients taking diuretics or in patients with decreased hydration and reduced blood volume due to excessive fluid loss (e.g. frequent urination, diarrhea, or vomiting);
• In women with fertility problems or undergoing infertility tests (Dexak 50 may affect female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
• In women during the first and second trimester of pregnancy;
• If the patient has blood disorders or blood cell disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has an infection - see below, section entitled "Infections";
• If the patient has asthma and chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Administration of this medicine may cause

asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections

Dexak 50 may mask the symptoms of infection, such as fever and pain. Therefore, Dexak 50 may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
It is recommended to avoid using this medicine during chickenpox.

Children and adolescents

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

Dexak 50 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines should not be taken at the same time as Dexak 50, and in the case of other medicines, the dose may need to be changed due to concurrent use of Dexak 50.
The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines with Dexak 50:

• Concomitant use not recommended:
• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other anticoagulant drugs
• Lithium used to treat certain mood disorders
• Methotrexate (anticancer or immunosuppressive drug) used in 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 chronic venous insufficiency ulcers
• Zidovudine used to treat viral infections
• Aminoglycoside antibiotics used to treat bacterial infections
• Sulfonylurea derivatives (chlorpropamide and glibenclamide) used to treat diabetes
• Methotrexate used in 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 diseases and in transplants
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as an abortifacient (to induce abortion)
• Antidepressant drugs from the SSRI group (selective serotonin reuptake inhibitors)
• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed.

In case of any doubts related to the use of Dexak 50, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Dexak 50 should not be used during the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn child.
It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, Dexak 50 should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Dexak 50, if taken for more than a few days, may cause: kidney problems in the unborn child - this may lead to decreased amniotic fluid around the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Dexak 50 is not recommended for women planning pregnancy or undergoing fertility treatment.
Information on potential fertility effects can also be found in section 2, "Warnings and precautions".

Driving and using machines

Dexak 50 may cause dizziness and drowsiness, and therefore may have a minor influence on 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.

Dexak 50 contains ethanol and sodium

This medicine contains 200 mg of alcohol (ethanol) in each 2 ml ampoule, which is equivalent to 3 mg/kg/dose (10% v/v). The amount of alcohol in one ampoule (2 ml) of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose unit, which means it can be considered "sodium-free".

3. How to use Dexak 50

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest possible time. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The doctor will inform the patient about the dose of Dexak 50, which will depend on the type, severity, and duration of the symptoms. The recommended dose is 50 mg of dexketoprofen (1 ampoule of Dexak 50) every 8 to 12 hours. If necessary, the dose can be repeated after 6 hours. The patient should not exceed the maximum daily dose, which is 150 mg of dexketoprofen (3 ampoules of Dexak 50).
Dexak 50 is intended for short-term use and should only be used during the acute pain phase (no longer than 2 days). The doctor will switch to oral pain-relieving medicines as soon as possible.
In elderly patients with renal impairment and in patients with kidney or liver disorders, the dose should not exceed 50 mg of Dexak 50 per day (which corresponds to 1 ampoule of the medicine).

Method of administration:

The medicine can be administered intramuscularly (injected into a muscle) or intravenously (injected into a vein). A detailed description of intravenous administration can be found in section 7.
When administering Dexak 50 intramuscularly, the solution should be injected immediately after opening the ampoule, by slow injection deep into the muscle.
Only clear and colorless solutions should be used.
Children and adolescents
Do not use in children and adolescents under 18 years of age.

Overdose of Dexak 50

In case of suspected overdose, the patient should inform their doctor or pharmacist or go to the emergency department of the nearest hospital. The patient should remember to take the medicine packaging or patient leaflet with them.

Missed dose of Dexak 50

The patient should not take a double dose to make up for a missed dose. The next dose should be taken according to the dosing schedule (see section 3 "How to use Dexak 50").
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

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

Nausea and/or vomiting, pain at the injection site, reactions at the injection site, e.g. inflammation, bruising, or bleeding.

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

Vomiting blood, low blood pressure, fever, blurred vision, dizziness (of vestibular origin), drowsiness, sleep disorders, headache, anemia, abdominal pain, constipation, indigestion, diarrhea, dry mouth, facial flushing, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

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

Stomach ulcers, gastrointestinal bleeding, or perforation, high blood pressure, fainting, slow breathing rate, superficial thrombophlebitis (vein inflammation due to blood clots), irregular heartbeat (extrasystoles), rapid heartbeat, swelling of limbs, throat swelling, abnormal sensations, feeling of increased body temperature, and tremors, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, kidney pain, increased urination, menstrual disorders, benign prostatic hyperplasia, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function tests (blood tests), high blood sugar levels (hyperglycemia), low blood sugar levels (hypoglycemia), high blood levels of certain fats (hypertriglyceridemia), increased excretion of ketone bodies (ketonuria) or protein (proteinuria) in the urine, liver cell damage (hepatitis), acute kidney failure.

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

Anaphylactic reactions (acute allergic reactions that can lead to anaphylactic shock), skin ulcers, ulcers of the lips, eyes, and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath caused by bronchospasm, shortness of breath, pancreatitis, skin allergy reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

The patient should inform their doctor if they notice any side effects, especially those related to the stomach or intestines (e.g. stomach pain, heartburn, or bleeding), if they have had similar side effects in the past due to long-term use of anti-inflammatory drugs, especially in elderly patients.
If a skin rash or any mucous membrane lesions (e.g. in the mouth) or any signs of allergy occur, the patient should immediately consult their doctor, who will discontinue treatment with Dexak 50.
When using non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure.
Taking such medicines as Dexak 50 may be associated with a small increased risk of heart attack or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the use of anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.
The most commonly observed side effects were related to the stomach and intestines. Especially in elderly patients, stomach ulcers, perforation, or gastrointestinal bleeding may occur, in some cases with fatal outcomes.
After using the medicine, the following have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bleeding vomiting, oral ulcerative stomatitis, exacerbation of colitis, and Crohn's disease. Less commonly, stomach inflammation has been observed.
As with other NSAIDs, aseptic meningitis (especially in patients with systemic lupus erythematosus or mixed connective tissue disease) and hematologic reactions (thrombocytopenic purpura, aplastic anemia, and hemolytic anemia, rarely agranulocytosis, and bone marrow failure) may occur.
The patient should immediately inform their doctor if they experience signs of infection or worsening of their condition while taking Dexak 50.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Dexak 50

The medicine should be stored out of sight and reach of children!
Do not use this medicine after the expiry date stated on the carton and ampoule.
The expiry date refers to the last day of the month.
Ampoules should be stored in the outer packaging to protect them from light. Do not use this medicine if the solution is not clear and colorless and signs of contamination are visible (e.g. particles). Dexak 50 solution for injection or infusion is intended for single use only and should be used immediately after opening. Unused solution should be discarded (see "Disposal" below).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use and how to dispose of used needles and syringes. This will help protect the environment.

6. Package contents and other information

What Dexak 50 contains

• The active substance of the medicine is dexketoprofen (in the form of dexketoprofen trometamol). Each ampoule contains 50 mg of dexketoprofen.
• Other ingredients are: alcohol (ethanol 96%, see section 2, Dexak 50 contains ethanol), sodium chloride, sodium hydroxide, and water for injections.

What Dexak 50 looks like and contents of the pack

Dexak 50 is a solution for injection or infusion. The pack contains 1, 5, 6, 10, 20, 50, or 100 ampoules made of colored glass type I, each containing 2 ml of clear and colorless solution. Not all pack sizes may be marketed.

Marketing authorization holder

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Sette Santi, 3 50131 Florence Italy or

Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (Pescara)
Italy
or
Zambon S.p.A.
via della Chimica, 9
36100 Vicenza
Italy

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

Spain (RMS), Belgium, Finland, France, Italy, Luxembourg, Portugal: Ketesse
Cyprus, Greece: Nosatel
Austria, Czech Republic: Dexoket
Estonia, Latvia, Lithuania: Dolmen
Germany: Sympal
Hungary: Ketodex forte
Ireland, Malta: Keral
Poland: Dexak 50
Slovakia: Dexadol
Slovenia: Menadex
Netherlands: Stadium
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01
Date of last revision of the leaflet: 08/2024

7. Information intended for healthcare professionals only

Intravenous administration:

Intravenous ("drip") infusion:the contents of 1 ampoule (2 ml) of Dexak 50 should be diluted in a volume of 30 ml to 100 ml of sodium chloride solution, 5% glucose solution, or Ringer's solution.
The diluted solution should be administered as a slow intravenous infusion over a period of 10 minutes to 30 minutes. The solution should always be protected from daylight.
Intravenous bolus (injection into a vein):if necessary, the contents of 1 ampoule (2 ml) of Dexak 50 can be administered as a slow intravenous bolus over a period of not less than 15 seconds.

Due to the ethanol content, Dexak 50 should not be administered directly into the spinal canal (intrathecally or epidurally).

Instructions for handling the medicinal product:

When administering the medicinal product Dexak 50 as an intravenous bolus, the solution should be injected immediately after withdrawal from the colored ampoule.
In the case of intravenous infusion, the solution should be diluted under aseptic conditions and protected from daylight.
Only clear and colorless solutions should be used.

Compatibility information:

It has been shown that Dexak 50 is compatible when mixed (e.g. in a syringe) with sodium chloride, lidocaine, morphine, and theophylline solutions.
The diluted solution is a clear solution. Dexak 50 diluted of normal saline or glucose solution is compatible with the following medicines in the form of injection solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.
No absorption of the active substance was observed when diluted solutions of the medicinal product Dexak 50 were stored in plastic bags or devices for administration made of ethyl vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), and polyvinyl chloride (PVC).