Dexak 50

Package leaflet: Information for the user

Warning! Keep this 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 of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Dexak 50 is and what it is 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. Contents of the pack and other information

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

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

2. Information before using Dexak 50

When not to use Dexak 50:

• If the patient is allergic to dexketoprofen or to 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 previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nodules inside the nose caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or throat), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (especially 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 currently has gastric or duodenal ulcer disease and/or gastrointestinal bleeding, or if they have previously experienced gastrointestinal bleeding, ulceration, or perforation;
• If the patient has certain chronic gastrointestinal disorders (e.g. indigestion, heartburn);
• If the patient currently has or has previously had gastrointestinal bleeding or perforation due to use of pain-relieving NSAIDs;
• If the patient has inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
• If the patient has a tendency to bleed excessively or has coagulation disorders;
• If the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting treatment with Dexak 50, consult a doctor or pharmacist if:

• The patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• The patient currently has or has previously had other stomach or intestinal disorders;
• The patient is taking other medicines that increase the risk of gastric or duodenal ulceration or gastrointestinal bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, such as selective serotonin reuptake inhibitors), antithrombotic agents such as acetylsalicylic acid, or anticoagulants such as warfarin. In such cases, consult a doctor before taking this medicine. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or a medicine that inhibits gastric acid secretion);
• The patient has heart problems, a history of stroke, or is suspected of being at risk for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult a doctor before using Dexak 50. Medicines such as Dexak 50 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 use higher doses or longer treatment duration than recommended;
• The patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
• The patient has allergies or a history of allergic reactions;
• The patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred previously;
• In patients receiving diuretics or in patients with reduced hydration and reduced blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
• In women experiencing fertility problems or undergoing fertility investigations (Dexak 50 may impair female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
• In women during the first and second trimesters of pregnancy;
• If the patient has blood cell formation disorders or blood cell abnormalities;
• 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 under the section titled “Infections”;
• If the patient has asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the general population. Taking this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexak 50 may mask symptoms of infection such as fever and pain. Therefore, Dexak 50 may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore Dexak 50 should not be used in children and adolescents.

Dexak 50 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
Some medicines should not be used together with Dexak 50, while others may require dose adjustments when taken concurrently. Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexak 50:

• Not recommended for concomitant use:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs.

• Warfarin, heparin, or other anticoagulant drugs.

• Lithium used in the treatment of certain mood disorders.

• Methotrexate (an anticancer or immunosuppressive drug) used in high doses of 15 mg per week.

• Hydantoin derivatives and phenytoin used in the treatment of 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 conditions.

• Pentoxifylline and oxpentifylline 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 in the treatment of immune system disorders and in transplant patients.

• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots.

• Probenecid used in the treatment of gout.

• Digoxin used to treat chronic heart failure.

• Mifepristone used as an abortion-inducing agent (pregnancy termination).

• Selective serotonin reuptake inhibitors (SSRIs), a class of antidepressants.

• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation.

• Beta-adrenergic blocking agents (beta-blockers) used to treat high blood pressure and heart conditions.

• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking Dexak 50, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and effects on fertility
Do not use Dexak 50 during the last three months of pregnancy or while breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor, as using Dexak 50 in these circumstances may be inappropriate.
Women who are pregnant or planning pregnancy should avoid using this medicine. Use during any stage of pregnancy must only occur under a doctor’s guidance.
Dexak 50 is not recommended for women planning pregnancy or undergoing fertility investigations.
Information on potential effects on fertility is also provided in section 2, “Warnings and precautions”.

Driving and operating machinery
Dexak 50 may cause dizziness and fatigue and therefore may have a minor or slight influence on the ability to drive vehicles or operate machinery. If such symptoms occur, do not drive or operate mechanical equipment until symptoms subside.
If in doubt, consult your doctor.

Dexak 50 contains ethanol and sodium
This medicine contains 200 mg of alcohol (ethanol) in each 2 ml ampoule, 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 cause noticeable effects.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose unit, meaning it can be considered “sodium-free”.

3. How to use Dexak 50

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).

The doctor will determine the dose of Dexak 50 based on the type, severity, and duration of the patient's symptoms. The recommended dose is 50 mg of dexketoprofen (1 vial of Dexak 50) every 8 to 12 hours. If necessary, the dose may be repeated after 6 hours. The maximum daily dose of 150 mg of dexketoprofen (3 vials of Dexak 50) must not be exceeded.

Dexak 50 is intended for short-term use only and should be used solely during acute pain episodes (no longer than 2 days). The doctor 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 should not exceed 50 mg of Dexak 50 (equivalent to 1 vial of the medicine).

Method of administration:
This medicine can be administered intramuscularly (injected into the muscle) or intravenously (injected into a vein). A detailed description of intravenous administration is provided in section 7.

When administering Dexak 50 intramuscularly, the solution should be injected immediately after opening the vial, by slow deep intramuscular injection.

Only clear, colourless solutions should be used.

Children and adolescents
Do not use in children and adolescents under 18 years of age.

Use of more than the recommended dose of Dexak 50
If an overdose is suspected, inform a doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Remember to bring the medicine packaging or patient leaflet with you.

Missed dose of Dexak 50
Do not use a double dose to make up for a missed dose. The next dose should be administered according to the prescribed dosing schedule (see section 3 "How to use Dexak 50").

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will get them.
The possible adverse reactions listed below are categorized according to the likelihood of their occurrence.

Common adverse reactions (may affect up to 1 in 10 people):
Nausea and (or) vomiting, pain at injection site, reactions at injection site such as inflammation, bruising or bleeding.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Vomiting blood, hypotension, fever, blurred vision, vertigo (of labyrinthine origin), drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, dyspepsia, diarrhoea, dryness of the oral mucosa, facial flushing, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare adverse reactions (may affect up to 1 in 1,000 people):
Peptic ulcer, gastrointestinal bleeding or perforation, hypertension, fainting, reduced respiratory rate, superficial thrombophlebitis (inflammation of superficial veins due to blood clot), cardiac arrhythmia (extra beats), tachycardia, limb oedema, throat swelling, abnormal sensations, feeling of increased body temperature and tremors, tinnitus (ringing in the ears), itchy rash, jaundice, acne, back pain, renal area pain, increased urination, menstrual disorders, benign prostatic hyperplasia, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function tests (blood tests), hyperglycaemia, hypoglycaemia, hypertriglyceridaemia, increased excretion in urine of ketone bodies (ketonuria) or protein (proteinuria), liver cell damage (hepatitis), acute renal failure.

Very rare adverse reactions (may affect 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), dyspnoea caused by bronchial muscle spasm (bronchospasm), shortness of breath, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Patients should inform their doctor if they experience any adverse reactions affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if they have previously experienced similar adverse reactions due to long-term use of anti-inflammatory drugs, particularly in elderly patients.

If a skin rash, any mucosal lesions (e.g. inside the mouth), or any allergic symptoms occur, the patient should immediately consult a doctor, who will promptly discontinue treatment with Dexak 50.

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

Use of drugs such as Dexak 50 may be associated with a small increased risk of myocardial infarction ("heart attack") or cerebrovascular events (stroke).

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

The most commonly observed adverse reactions involved gastrointestinal disorders. Particularly in elderly patients, peptic ulcer disease, perforation or bleeding from the stomach and (or) duodenum may occur, in some cases with fatal outcome.

After administration of the medicine, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, lower abdominal pain, tarry stools, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis was observed less frequently.

As with other NSAIDs, aseptic meningitis may occur, particularly in patients with systemic lupus erythematosus or mixed connective tissue disease. Haematological reactions (purpura, aplastic anaemia, haemolytic anaemia, rarely agranulocytosis and bone marrow suppression) may also occur.

Patients should immediately inform their doctor if symptoms of infection occur or if their condition worsens during treatment with Dexak 50.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexak 50

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store the ampoules in their original packaging to protect them from light. Do not use this medicine if the solution is not clear and colourless or if there are visible signs of contamination (e.g. particles).
Dexak 50 solution for injection/infusion is intended for single use only and should be used immediately after opening. Any unused solution must be discarded (see section "Disposal" below).
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use and how to dispose of used needles and syringes. This will help protect the environment.

6. Contents of the package and other information

What Dexak 50 contains

• The active substance is dexketoprofen (as 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/infusion. The pack contains 5 ampoules made of
brown glass (type I), in a blister pack, inside a cardboard box, each containing 2 ml
of a clear, colourless solution.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Romania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Romania, country of export: 11193/2018/01
Parallel Import Authorisation Number: 82/18
This medicinal product is authorised for marketing 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
7. Information intended exclusively for medical professionals
Intravenous administration:
Intravenous infusion (drip): dilute the contents of 1 ampoule (2 ml) of Dexak 50 in 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 to 30 minutes. The solution must always be protected from daylight.
Intravenous bolus (injection into a vein): if necessary, the contents of 1 ampoule (2 ml) of Dexak 50 may be administered as a slow intravenous bolus over no less than 15 seconds.
Due to the ethanol content, Dexak 50 must 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 tinted ampoule.
When administering as an intravenous infusion, the solution should be diluted under aseptic conditions and protected from daylight.
Only clear, colourless solutions should be used.
Compatibility information:
Dexak 50 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 solution for injection, when diluted as indicated, is a clear solution. Dexak 50 diluted in a volume of 100 ml of normal saline or glucose solution is compatible with the following injectable solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
No adsorption of the active substance has been observed when diluted solutions of Dexak 50 were stored in plastic bags or administration devices made of ethylene vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE) and polyvinyl chloride (PVC).