Dexak 50

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Dexak 50 (Tador Inject)

50 mg/2 ml, solution for injection/infusion
Dexketoprofen
Dexak 50 and Tador Inject are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 reliever belonging to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of moderate and severe acute pain when oral administration is not appropriate, e.g., postoperative pain, pain in the course of renal colic, and pain in the lumbosacral area.

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 nonsteroidal 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 inside the nose caused by allergy), hives (blistering rash), or angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) after taking acetylsalicylic acid or another NSAID;
• If the patient has had hypersensitivity reactions to sunlight: photoallergic or phototoxic reactions (in particular, redness and/or blisters on the skin exposed to the sun) while taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);
• If the patient has stomach or duodenal ulcers or bleeding from the stomach or intestines, or if they have had bleeding from the stomach or intestines, ulcers, or perforation in the past;
• If the patient has certain chronic gastrointestinal diseases (e.g., indigestion, heartburn);
• If the patient has had bleeding from the stomach or intestines or perforation due to the use of painkillers 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 kidney failure, or severe liver failure;
• 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 and bleeding, such as oral steroids, certain antidepressants (SSRI, e.g., serotonin reuptake inhibitors), or anticoagulant medicines such as acetylsalicylic acid or warfarin. In such cases, the doctor may decide to prescribe an additional protective medicine (e.g., misoprostol or medicines that reduce 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 take higher doses or use the medicine for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In such cases, the patient should contact their doctor immediately;
• If the patient has allergies or has had allergy problems in the past;
• If the patient has kidney, liver, or heart problems (high blood pressure and/or heart failure), as well as fluid retention or if the patient has had any of these problems in the past;
• For patients taking diuretics or patients who are dehydrated and have reduced blood volume due to excessive fluid loss (e.g., frequent urination, diarrhea, or vomiting);
• For women having trouble getting pregnant or undergoing infertility tests (Dexak 50 may affect female fertility and is not recommended for women planning to become pregnant or undergoing fertility treatment);
• For women in the first and second trimesters of pregnancy;
• If the patient has blood disorders or blood cell problems;
• 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 titled "Infections";
• If the patient has asthma and chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of hypersensitivity 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 and consequently 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.
Certain medicines should not be taken at the same time as Dexak 50, and for others, 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:

• Not recommended for concurrent use:
• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines.
• Warfarin, heparin, or other anticoagulant medicines.
• Lithium used to treat certain mood disorders.
• Methotrexate (anticancer or immunosuppressive medicine) used in high doses of 15 mg per week.
• Hydantoin derivatives and phenytoin used to treat epilepsy.
• Sulfamethoxazole used to treat bacterial infections.
• Concurrent 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 (chlorpropamide and glibenclamide) used to treat diabetes.
• Methotrexate used in low doses, below 15 mg per week.
• Concurrent 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 transplants.
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e., medicines 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).
• Selective serotonin reuptake inhibitor (SSRI) antidepressants.
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation.
• Beta-blockers used to treat high blood pressure and heart disease.
• Tenofovir, deferasirox, pemetrexed.

In case of any doubts about taking Dexak 50, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Dexak 50 should not be used in the last three months of pregnancy or during breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor, as the use of Dexak 50 may be inappropriate in this situation.
Women who are pregnant or planning to become pregnant should avoid using this medicine. The use of this medicine during pregnancy should only be done under the doctor's recommendation.
Dexak 50 is not recommended for women planning to become pregnant or undergoing fertility treatment.
Information on the potential impact on fertility can also be found in section 2, "Warnings and precautions".

Driving and using machines

Dexak 50 may cause dizziness and fatigue, and therefore, it may have a minor impact on the ability to drive vehicles and operate machinery. If such symptoms are observed, the patient should not drive vehicles or operate moving 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% w/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 taken as directed 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 duration necessary to relieve the symptoms. 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 in the acute phase of pain (no longer than 2 days). The doctor will switch to oral painkillers as soon as possible.
For elderly patients with kidney failure and patients with kidney or liver disorders, the dose should not exceed 50 mg of Dexak 50 per day (equivalent 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

Dexak 50 should not be used in children and adolescents under 18 years of age.

Using a higher dose of Dexak 50 than recommended

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.
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 about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexak 50 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, such as 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 labyrinthine 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, bleeding, or perforation of stomach ulcers, high blood pressure, fainting, slow breathing rate, superficial thrombophlebitis (vein inflammation due to blood clots), irregular heartbeat (extra beats), 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 levels of certain fats in the blood (hypertriglyceridemia), increased excretion of ketone bodies or protein 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 hypersensitivity reactions that can lead to anaphylactic shock), skin ulcers, ulcers of the lips, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath caused by bronchospasm, asthma, pancreatitis, hypersensitivity reactions of the skin and hypersensitivity to sunlight, 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 medicines, especially if they are elderly.
If the patient experiences a skin rash or any mucosal lesions (e.g., in the mouth) or any signs of allergy, they should immediately consult their doctor, who will discontinue the treatment with Dexak 50.
When using nonsteroidal 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 medicines 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 bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes.
After using the medicine, the following were observed: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, mouth ulcers, worsening of colitis, and Crohn's disease. Less frequently, stomach inflammation was observed.
As with other NSAIDs, aseptic meningitis may occur, especially in patients with systemic lupus erythematosus or mixed connective tissue disease, as well as hematologic reactions (thrombocytopenic purpura, aplastic anemia, and hemolytic anemia, rarely agranulocytosis and bone marrow failure).
The patient should immediately inform their doctor if they experience any 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, 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
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.
The medicine should not be used after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
The ampoules should be stored in the original packaging to protect them from light. The medicine should not be used if the solution is not clear and colorless and signs of contamination are visible (e.g., particles). Dexak 50 solution for injection/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 thrown into the sewage system or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed and how to handle 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 what the package contains

Dexak 50 is a solution for injection/infusion. The package contains 5 ampoules made of brown glass (type I), in a blister pack, in a cardboard box, each containing 2 ml of a clear and colorless solution.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturer:

Menarini Manufacturing Logistics and Services S.R.L.
Via Sette Santi, 3
50131 Florence, Italy
Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (Pescara), Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romanian marketing authorization number: 11193/2018/01

Parallel import authorization number: 82/18

This medicinal product 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
Date of leaflet approval:20.02.2023
[Information about the trademark]

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 Dexak 50 as an intravenous bolus, the solution should be injected immediately after withdrawal from the colored ampoule.
When administering as an 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 injection solutions.
The diluted solution is a clear solution. Dexak 50 diluted of normal saline or glucose solution is compatible with the following medicines in injection solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.
No absorption of the active substance was observed when diluted solutions of Dexak 50 were stored in plastic bags or devices for administration made of ethylene-vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), and polyvinyl chloride (PVC).