Dexak 50

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! 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 drug.

Table of contents of the leaflet:

• 1. What is Dexak 50 and what is it used for
• 2. Important information before taking Dexak 50
• 3. How to take 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 drugs called non-steroidal 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. post-operative pain, pain in the course of renal colic and pain in the lumbosacral area.

2. Important information before taking Dexak 50

When not to take Dexak 50:

• If the patient is allergic to dexketoprofen or any of the other ingredients

It is necessary to carefully read the contents of the leaflet before taking the drug as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 or pharmacist. See section 4.

of this drug (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 inside the nose caused by an allergy), hives (vesicular rash), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has had photosensitivity reactions in the past: photoallergic or phototoxic reactions (in particular, redness and/or blisters on the skin exposed to the sun) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);
• If the patient has gastric or duodenal ulcer disease or gastrointestinal bleeding or if they have had gastrointestinal bleeding or ulceration or perforation 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 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 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);
• If the patient has or has had other stomach or intestinal diseases;
• If the patient is taking other drugs that increase the risk of stomach ulcers and bleeding, such as oral steroids, certain antidepressants (SSRI group, e.g. serotonin reuptake inhibitors), or anticoagulant drugs such as warfarin. In such cases, the doctor should be consulted before taking the drug, as they may decide to administer an additional protective drug (e.g. misoprostol or drugs that inhibit stomach acid production);
• If the patient has heart problems, has had a stroke, or is suspected to be at risk of these conditions (e.g. due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the doctor should be consulted before taking Dexak 50. Taking such drugs as Dexak 50 may be associated with a slight increase in the risk of heart attack or stroke. This risk increases with long-term use of high doses of the drug. Higher doses and longer treatment periods than recommended should not be used;
• If the patient is elderly: there is an increased risk of side effects (see section 4). In this case, the doctor should be contacted immediately;
• If the patient has an allergy or has had allergy-related problems in the past;
• If the patient has kidney, liver, or heart function disorders (hypertension and/or heart failure), as well as fluid retention or if any of the above 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 infertility treatment);
• In women in 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 drug 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 drug during an infection and the symptoms of the infection persist or worsen, they should immediately consult their doctor.
It is recommended to avoid taking this drug during chickenpox.

Children and adolescents

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

Dexak 50 and other drugs

The doctor should be informed about all drugs currently being taken by the patient or recently taken, as well as any drugs the patient plans to take.
Certain drugs should not be taken at the same time as Dexak 50, and in the case of other drugs, the dosage may need to be changed due to concurrent use of Dexak 50.
The doctor, dentist, or pharmacist should always be informed if the patient is taking any of the following drugs 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 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
• 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 transplants
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve 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 selective serotonin reuptake inhibitor (SSRI) group
• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
• Beta-adrenergic blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed.

In case of any doubts related to taking Dexak 50, the doctor or pharmacist should be consulted.

Pregnancy, breastfeeding, and fertility

Dexak 50 should not be taken during the last three months of pregnancy or during breastfeeding.
If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor, as the use of Dexak 50 may be inappropriate in this situation.
Pregnant women or women planning to become pregnant should avoid taking this drug. The use of the drug during pregnancy must only be done under the doctor's recommendation.
Dexak 50 is not recommended for women planning pregnancy or undergoing infertility treatment.
Information on potential fertility effects can also be found in section 2, "Warnings and precautions".

Driving and operating machinery

Dexak 50 may cause dizziness and drowsiness and may therefore 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 machinery until the symptoms have resolved. In case of doubts, the doctor should be consulted.

Dexak 50 contains ethanol and sodium

Each ampoule of Dexak 50 contains 12.35% ethanol (alcohol) by volume, i.e. up to 200 mg per dose, equivalent to 5 ml of beer or 2.08 ml of wine per dose.
This may have a harmful effect on individuals with alcohol dependence.
This should be taken into account in pregnant women, breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, which means it can be considered "sodium-free".

3. How to take Dexak 50

This drug should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The smallest effective dose should be used for the shortest period necessary to alleviate the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the doctor should be consulted immediately (see section 2).
The doctor will inform the patient about the dosage 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) at intervals of 8 to 12 hours. If necessary, the dose can be repeated after 6 hours. The maximum daily dose should not be exceeded, 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 pain phase (no longer than 2 days). The doctor will use oral painkillers when possible.
In elderly patients with renal impairment and in patients with renal or liver disorders, the dose should not exceed 50 mg of Dexak 50 per day (equivalent to 1 ampoule of the drug).

Method of administration

The drug 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
Should not be used in children and adolescents under 18 years of age.

Overdose of Dexak 50

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

Missed dose of Dexak 50

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

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.
Possible side effects are listed below and are ranked according to their likelihood 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, hypotension, fever, blurred vision, dizziness (of labyrinthine origin), drowsiness, sleep disorders, headache, anemia, abdominal pain, constipation, indigestion, diarrhea, dryness of the oral mucosa, flushing, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare side effects (may affect up to 1 in 1000 people):

Gastric ulcer disease, bleeding, or perforation of the stomach, hypertension, fainting, slowed breathing rate, superficial vein inflammation due to blood clots (thrombophlebitis), irregular heartbeat (extrasystoles), accelerated heart rate, swelling of the limbs, swelling of the throat, abnormal sensations, feeling of increased body temperature, and tremors, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, pain in the kidney area, 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 syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath caused by bronchospasm, asthma, pancreatitis, allergic skin reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
The doctor should be informed if the patient observes any side effects, especially those related to the stomach or intestines (e.g. stomach pain, heartburn, or bleeding), if the patient has had similar side effects in the past due to long-term use of anti-inflammatory drugs, especially in the elderly.
If a skin rash or any mucosal lesions (e.g. in the mouth) or any symptoms of allergy occur, the doctor should be contacted immediately, and the treatment with Dexak 50 should be discontinued.
When taking 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 drugs as Dexak 50 may be associated with a slight increase in the risk of heart attack or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), the administration 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 the elderly, stomach ulcers, perforation, or bleeding from the stomach and/or duodenum may occur, in some cases with fatal outcomes.
After taking the drug, the following were observed: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral mucosal ulceration, exacerbation of colitis, and Crohn's disease. Less frequently, gastric mucosal inflammation was observed.
As with other NSAIDs, aseptic meningitis may occur, mainly 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 doctor should be informed immediately if symptoms of infection or worsening of the patient's condition occur while taking Dexak 50.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the drug.

5. How to store Dexak 50

The drug should be stored out of sight and reach of children.
The drug 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 drug 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).

Disposal

Drugs should not be thrown into the sewage system or household waste. The pharmacist should be asked how to dispose of unused drugs and what to do with 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 drug is dexketoprofen (in the form of dexketoprofen trometamol). Each ampoule contains 50 mg of dexketoprofen.
• Other ingredients are: 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 packaging contains

Dexak 50 is a solution for injection/infusion. The packaging contains 1, 5, 6, 10, 20, 50, or 100 ampoules made of brown glass (type I) in a blister pack, in a cardboard box, each containing 2 ml of clear and colorless solution.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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:

• A. Menarini Manufacturing Logistics and Services S.R.L., Via Sette Santi 3, 50131, Florence, Italy

Alfasigma S.p.A., Via Enrico Fermi, 1, Alanno, 65020, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Romania, the country of export:11193/2018/01
11193/2018/02
Parallel import authorization number:328/17
This medicinal product is authorized for sale 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: 20.09.2022
[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 administered 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 heparin, 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 drugs 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 infusion devices made of ethyl vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), or polyvinyl chloride (PVC).