Dexak 50

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dexak 50 (Tador Inject)
50 mg/2 ml, solution for injection / for infusion
Dexketoprofen
Dexak 50 and Tador Inject are different trade names for the same medicinal product.
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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

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, pain due to renal colic, and lumbosacral region pain.

2. Important 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 nonsteroidal anti-inflammatory drugs (NSAIDs);
• If the patient has asthma or has previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal lining), nasal polyps (growths inside the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue or throat, or a combination of respiratory disorders), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly in the form of redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient has gastric or duodenal peptic 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 the use of pain-relieving NSAIDs;
• If the patient has inflammatory bowel diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal insufficiency, or severe hepatic insufficiency;
• 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 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 (SSRI-class drugs, such as serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid, or antithrombotic drugs 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 drugs that inhibit gastric acid production);
• The patient has heart problems, a history of stroke, or suspicion of being in a high-risk group for these conditions (e.g. in case of high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult a doctor before using Dexak 50. Use of 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 has previously experienced allergic reactions;
• The patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), or fluid retention, or if any of these conditions have occurred previously;
• In patients receiving diuretic therapy, or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
• In women experiencing fertility problems or undergoing infertility investigations (Dexak 50 may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment);
• In women during the first and second trimesters of pregnancy;
• If the patient has blood cell or blood formation 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 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. Administration of this medicine may trigger asthma attacks
  or bronchospasm, particularly 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 ongoing infection and 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 taken or recently taken, as well as any medicines the patient plans to take.
Some medicines should not be used simultaneously with Dexak 50, while for others, dosage adjustments may be necessary when used concomitantly with Dexak 50. Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together 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
  • High-dose methotrexate (an anticancer or immunosuppressive drug) at 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 diseases
  • 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
  • Low-dose methotrexate (less than 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 drugs (used to dissolve blood clots)
  • Probenecid used to treat gout
  • Digoxin used to treat chronic heart failure
  • Mifepristone used as an abortion-inducing agent (to terminate pregnancy)
  • Selective serotonin reuptake inhibitor (SSRI) 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 diseases
  • Tenofovir, deferasirox, pemetrexed.

If you have any doubts regarding the use of Dexak 50, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and effects on fertility
Dexak 50 should not be used during the last three months of pregnancy or during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor, as Dexak 50 may be inappropriate in such circumstances.
Women who are pregnant or planning pregnancy should avoid using this medicine. Use of this medicine at any stage of pregnancy must be strictly under medical supervision.
Dexak 50 is not recommended for women planning pregnancy or undergoing infertility diagnosis.
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 negligible effect on the ability to drive vehicles or operate machinery. If such symptoms occur, do not drive or operate mechanical equipment until symptoms resolve. In case of doubt, consult a doctor.

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 cause harm in individuals with alcohol-related disease.
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 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 symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The doctor will determine the appropriate 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 ampoule of Dexak 50) administered 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 ampoules of Dexak 50) must not be exceeded.
Dexak 50 is intended for short-term use only and should be used solely during episodes of acute pain (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 ampoule).
Method of administration
The medicine may 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 ampoule, 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 a higher than recommended dose of Dexak 50
In case of suspected overdose, inform a doctor or pharmacist or go immediately 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 administer a double dose to make up for a missed dose. The next dose should be given according to the prescribed dosing schedule (see section 3 "How to use Dexak 50").
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

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

Common adverse effects (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 effects (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 of cold.

Rare adverse effects (may affect up to 1 in 1,000 people):
Peptic ulcer, bleeding or perforation of gastric ulcer, 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 (ear ringing), 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 (hyperglycaemia), low blood sugar (hypoglycaemia), high blood levels of certain fats (hypertriglyceridaemia), increased excretion in urine of so-called ketone bodies (ketonuria) or protein (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare adverse effects (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 area ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to 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).

If, at the beginning of treatment, the patient experiences any adverse effects related to the stomach or intestines (e.g. stomach pain, heartburn or bleeding), or if the patient has previously experienced similar adverse effects due to long-term use of anti-inflammatory drugs, particularly in elderly patients, the doctor should be informed.

If a skin rash or any mucosal lesion (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, fluid retention and oedema (particularly of ankles and legs) may occur, as well as increased blood pressure and heart failure.

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 (immune system disorders affecting connective tissue), administration of anti-inflammatory drugs may rarely cause fever, headache and neck stiffness.

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

After administration of the drug, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, lower abdominal pain, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. 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 and haemolytic anaemia, rarely agranulocytosis and impaired bone marrow function) may also occur.

If signs of infection or worsening of the patient's condition occur during treatment with Dexak 50, the doctor should be informed immediately.

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

5. How to store Dexak 50

Keep this medicine out of the 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 the original packaging to protect them from light.
Do not use this medicine if the solution is not clear and colourless or if visible signs of contamination are present (e.g. particles).
Dexak 50 solution for injection / for infusion is intended for single use only and should be used immediately after opening.
Any unused solution must be discarded (see section “Disposal” below).

Disposal
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required and how to dispose of used needles and syringes. This will help protect the environment.

6. Contents of the packaging and other information

What Dexak 50 contains

• The active substance is dexketoprofen (in the form of dexketoprofen with tromethamine). Each ampoule contains 50 mg of dexketoprofen.
• Other ingredients: 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 / for infusion. The packaging contains 1, 5, 6, 10, 20, 50 or
100 amber glass ampoules (type I) in a blister pack, in 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:
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 Authorisation Number in Romania, country of export: 11193/2018/01
11193/2018/02
Parallel Import Authorisation Number: 328/17
This medicinal product is authorised for sale in the European Economic Area countries under the following trade 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 for healthcare professionals only
Intravenous administration:
Intravenous infusion ("drip"): dilute the contents of 1 ampoule (2 ml) of Dexak 50 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 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 coloured ampoule.
For intravenous infusion, the solution must 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 diluted injection solution 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 was 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), or polyvinyl chloride (PVC).