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 (Viaxal)
50 mg/2 ml
solution for injection/infusion
Dexketoprofenum
Dexak 50 and Viaxal are different trade names of the same medicinal product.
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Dexak 50 is and what it is used for
2. What you need to know 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 associated with renal colic, and lumbosacral 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 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 mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue 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 manifesting as 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 has gastric or duodenal ulcer disease and/or bleeding from the stomach or intestines, or if there has been previous 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 failure, or severe hepatic failure;
• If the patient has a tendency to excessive bleeding or 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 breastfeeding.

Warnings and precautions
Before starting treatment with Dexak 50, consult your 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 bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, such as selective serotonin reuptake inhibitors), anticoagulants like acetylsalicylic acid or antithrombotic agents such as warfarin. In such cases, consult your 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 at risk for these conditions (e.g. due to high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult your 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 your doctor immediately;
• The patient has allergies or has previously experienced allergy-related problems;
• The patient has kidney, liver, or heart dysfunction (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 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 in women planning pregnancy or undergoing infertility treatment);
• In women during the first and second trimesters of pregnancy;
• If the patient has blood cell formation 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 the section below titled “Infections”;
• If the patient has asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of hypersensitivity 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 existing 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; therefore, Dexak 50 should not be used in children and adolescents.

Dexak 50 with other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines should not be used simultaneously with Dexak 50, while others may require dose adjustments when taken concurrently with Dexak 50. 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 medicines.
  • Lithium used in the treatment of certain mood disorders.
  • High-dose methotrexate (an anticancer or immunosuppressive agent) at doses of 15 mg per week.
  • Hydantoin derivatives and phenytoin used in the treatment of epilepsy.
  • Sulfamethoxazole used in the treatment of bacterial infections.

• Concomitant use requiring caution:

  • ACE inhibitors, diuretics, and angiotensin II antagonists used in the treatment of high blood pressure and heart diseases.
  • Pentoxifylline and oxypentifylline used in the treatment of ulcers in chronic venous insufficiency.
  • Zidovudine used in the treatment of viral infections.
  • Aminoglycoside antibiotics used in the treatment of bacterial infections.
  • Sulfonylurea derivatives (chlorpropamide and glibenclamide) used in the treatment of diabetes.
  • Low-dose methotrexate, below 15 mg per week.

• Concomitant use requiring special consideration:

  • Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used in the treatment of bacterial infections.
  • Cyclosporine and tacrolimus used in the treatment of immune system disorders and in transplant patients.
  • Streptokinase and other thrombolytic or fibrinolytic agents, i.e. medicines used to dissolve blood clots.
  • Probenecid used in the treatment of gout.
  • Digoxin used in the treatment of chronic heart failure.
  • Mifepristone used as an abortion-inducing agent (pregnancy-terminating).
  • Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants.
  • Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
  • Beta-adrenergic blocking agents (beta-blockers) used in the treatment of high blood pressure and heart diseases.
  • Tenofovir, deferiprone, pemetrexed.

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

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Dexak 50 must 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 tendency to bleeding in both mother and child and may delay or prolong labour. Dexak 50 should not be used during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Dexak 50, if taken for longer than a few days, may cause: impaired kidney function in the unborn child – this may lead to reduced amniotic fluid volume surrounding the fetus (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the fetal heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
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 slight influence on the ability to drive vehicles and operate machinery. If such symptoms occur, do not drive or operate mechanical equipment until symptoms resolve. In case of doubt, consult your doctor.

Dexak 50 contains ethanol and sodium
Each ampoule of Dexak 50 medicinal product 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 be harmful in patients 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 according to the instructions given by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Your doctor will determine the appropriate dose of Dexak 50 based on the type, severity, and duration of your 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. Do not exceed the maximum daily dose of 150 mg of dexketoprofen (3 ampoules of Dexak 50).
Dexak 50 is intended for short-term use only and should be used solely during the acute phase of pain (no longer than 2 days). Your 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 dose should not exceed 50 mg of Dexak 50 per day (equivalent to 1 ampoule of the medicine).
Method of administration:
This medicine may be administered intramuscularly (injected into the muscle) or intravenously (injected into the 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
If you suspect an overdose, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Remember to bring the medicine packaging or patient leaflet with you.
Missed dose of Dexak 50
Do not take 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 experience them.
The possible adverse reactions listed below are categorized according to their likelihood of occurrence.

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

Uncommon adverse reactions (may affect up to 1 in 100 people):
Vomiting blood, hypotension (low blood pressure), fever, blurred vision, vertigo (vestibular 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 reactions (may affect up to 1 in 1,000 people):
Peptic ulcer, gastrointestinal bleeding or perforation, hypertension (high blood pressure), fainting, slow breathing rate, superficial thrombophlebitis (inflammation of surface veins due to blood clot), extrasystoles (irregular heart rhythm), tachycardia (rapid heartbeat), limb oedema, throat swelling, abnormal sensations, feeling of increased body temperature, tremors, tinnitus (ringing in the ears), itchy rash, jaundice, acne, back pain, kidney area pain, 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), elevated levels of certain fats in the blood (hypertriglyceridaemia), increased excretion in urine of so-called ketone bodies (ketonuria) or protein (proteinuria), liver cell damage (hepatitis), acute kidney 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), shortness of breath due to bronchial muscle spasm (bronchospasm), dyspnoea, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Patients should inform their doctor immediately 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. This particularly applies to elderly patients.

If a skin rash or any mucosal lesion (e.g. inside the mouth) or any allergic symptoms occur, patients should immediately consult a doctor, who will discontinue treatment with Dexak 50 without delay.

Fluid retention and oedema (particularly of the ankles and legs), increased blood pressure, and heart failure may occur during administration of non-steroidal anti-inflammatory drugs.

Use of medicines 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 frequently observed adverse reactions involved gastrointestinal disturbances. Particularly in elderly patients, gastric or duodenal ulceration, perforation, or gastrointestinal bleeding may occur, in some cases with fatal outcome.

After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, lower abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease. Gastritis (inflammation of the stomach lining) has been 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 may also occur (purpura, aplastic anaemia, haemolytic anaemia, and rarely agranulocytosis and bone marrow suppression).

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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

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 outer carton and on the ampoule.
The expiry date refers to the last day of the stated month.
Store the ampoules in the outer packaging to protect 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 or 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 required, as well as used needles and syringes. This will help protect the environment.

6. Contents of the pack 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: alcohol (96% ethanol; see section 2, Dexak 50 contains ethanol and sodium), 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 5 ampoules made of brown glass (type I), in a blister, packed in a cardboard box. Each ampoule contains 2 ml of a clear, colourless solution.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Laboratorios Menarini SA
Alfonso XII, 587
08918 Badalona, Spain

Manufacturer:
A. Menarini Manufacturing Logistics and Services Srl
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 Greece, the country of export: 58337/12-9-2008
Parallel Import Licence Number: 381/21
This medicinal product is authorised 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 for healthcare professionals only

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 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 injection over no less than 15 seconds.

Due to its ethanol content, Dexak 50 must not be administered directly into the intrathecal or epidural space.

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.
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 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).