Auxilen

Patient Information Leaflet

Auxilen, 50 mg/2 mL, injection/infusion solution
Dexketoprofen
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This 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 a doctor or pharmacist immediately. See section 4.

Table of Contents

1. What Auxilen is and what it is used for
2. Important information before using Auxilen
3. How to use Auxilen
4. Possible side effects
5. How to store Auxilen
6. Contents of the pack and other information

1. What Auxilen is and what it is used for

Auxilen is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Auxilen 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. Important information before using Auxilen

When not to use Auxilen:

• If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• If the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient suffers from asthma or has previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (nodules inside the nose caused by allergy), urticaria (vesicular rash), 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) blistering of skin exposed to sunlight) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
• If the patient has gastric and (or) duodenal ulcer disease or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
• If the patient currently has or has previously experienced gastrointestinal bleeding and (or) perforation due to use of NSAIDs;
• If the patient has certain chronic gastrointestinal disorders (e.g. indigestion, heartburn);
• If the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe renal insufficiency, or severe hepatic dysfunction;
• If the patient has a marked tendency to bleed 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 breastfeeding.

Warnings and precautions
Before starting treatment with Auxilen, discuss the following with your doctor:

• If the patient has previously suffered from chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• If the patient currently has or has previously had other stomach or intestinal disorders;
• If the patient is taking other medicines that increase the risk of gastric and (or) duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, such as serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or antithrombotic agents such as warfarin. In such cases, consult your doctor before taking Auxilen. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs that inhibit gastric acid secretion);
• If the patient has heart disease, 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 this medicine. Use of medicines such as Auxilen may be associated with a small increased risk of myocardial infarction ("heart attack") or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended;
• If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately;
• If the patient has allergies or has previously experienced allergy-related problems;
• If 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 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 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 chickenpox; in exceptional cases, non-steroidal anti-inflammatory drugs may exacerbate the disease;
• 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 hypersensitive to acetylsalicylic acid and (or) NSAIDs.

Kounis syndrome
Allergic reactions to dexketoprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
If any of these symptoms occur, discontinue use of Auxilen immediately and contact your doctor or emergency services without delay.

Children and adolescents
The use of Auxilen has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established; therefore, Auxilen should not be used in children and adolescents.

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

Concomitant use not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs;
• Warfarin, heparin, or other anticoagulant drugs;
• Lithium, used in the treatment of certain mood disorders;
• Methotrexate, used in the treatment of rheumatoid arthritis and certain cancers;
• Hydantoin derivatives and phenytoin, used in the treatment of epilepsy;
• Sulfamethoxazole, used to treat bacterial infections.

Concomitant use requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used in the treatment of high blood pressure and heart disease;
• Pentoxifylline and oxpentifylline, 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;
• Chlorpropamide and glibenclamide, used in the treatment of diabetes.

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 organ transplantation;
• Streptokinase and other thrombolytic or fibrinolytic agents, i.e. drugs 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 (to terminate pregnancy);
• Selective serotonin reuptake inhibitors (SSRIs), antidepressant medicines;
• Antiplatelet drugs used to reduce platelet aggregation and prevent blood clot formation.

If you have any doubts about using Auxilen with other medicines, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using Auxilen.

This medicine must not be used during the last three months of pregnancy or during breastfeeding.

Auxilen must not be administered during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. 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.

During the first six months of pregnancy, Auxilen should not be used 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, Auxilen may cause kidney dysfunction in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the fetus (oligohydramnios). If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.

Dexketoprofen may impair fertility. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.

Driving and operating machinery

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

Auxilen contains ethanol and sodium

Each Auxilen ampoule contains 200 mg of ethanol, equivalent to 5 mL of beer or 2.08 mL of wine per dose.

This may cause harm in individuals with alcohol-related disorders.

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 medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Auxilen

This medicine should always be used as directed by the physician. If in doubt, consult the physician.

The physician will inform the patient about the appropriate dose of Auxilen, which will depend on the type, severity, and duration of the patient's symptoms. The recommended dose is 50 mg of dexketoprofen (1 vial of Auxilen) 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 Auxilen) must not be exceeded.

Auxilen is intended for short-term use and should only be used during the acute pain phase (no longer than 2 days). The physician will switch to oral pain medication as soon as possible.

In elderly patients with renal impairment, and in patients with renal or hepatic disorders, the daily dose of Auxilen must not exceed 50 mg (equivalent to 1 vial of Auxilen).

Route of administration
Auxilen may be administered intramuscularly or intravenously (technical details regarding intravenous administration are provided in the section intended for healthcare professionals).

When administering Auxilen intramuscularly, the solution should be injected immediately after opening the vial, by slow injection into the muscle.

Only clear and colourless solutions should be used.

Instructions for opening the vial:

1. Rotate the vial with the coloured dot facing upwards. If any solution is present in the upper part of the vial, gently tap the vial with a finger to bring the solution down to the lower part.
2. Use both hands to open the vial; holding the vial in one hand, remove the top part by twisting it in the direction opposite to the coloured dot (see figure below).

Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).

Use of a higher than recommended dose of Auxilen
If an overdose is suspected, inform a physician or pharmacist, or go immediately to the nearest hospital emergency department. Remember to bring the medicine’s packaging or this patient leaflet with you.

Missed dose of Auxilen
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 Auxilen").

If you have any further doubts regarding the use of this medicine, consult your physician 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 patients):
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 patients):
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, indigestion, 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 patients):
Peptic ulcer, bleeding or perforation of gastric ulcer, high blood pressure, fainting, slowed breathing rate, superficial thrombophlebitis (inflammation of surface veins due to blood clot), extrasystoles (irregular heartbeats), rapid heartbeat, limb swelling, throat swelling, abnormal sensations, feeling of increased body temperature, tremors, ringing in the ears (tinnitus), 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 levels (hyperglycaemia), low blood sugar levels (hypoglycaemia), elevated levels of certain fats in the blood (hypertriglyceridaemia), prickling sensation like pins and needles, numbness, or other tingling sensations (paraesthesia), 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 patients):
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 caused by constriction of respiratory muscles (bronchospasm), shortness of breath, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
Frequency unknown: cannot be estimated from available data
Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
Fixed drug eruption
An allergic skin reaction known as fixed drug eruption, which may include round or oval areas of redness and swelling of the skin, blister formation and itching. Skin darkening in affected areas may also occur, which may persist after healing. Fixed drug eruptions usually recur in the same location(s) upon re-exposure to the medicine.
Patients should inform their doctor if they experience any adverse gastrointestinal symptoms 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.
Auxilen should be discontinued immediately if a skin rash or any change in mucous membranes (e.g. inside the mouth) occurs, or if any allergic symptoms appear.
During administration of non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure may occur.
Use of medicines such as Auxilen may be associated with a small increased risk of heart attack ("myocardial infarction") or 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.
Patients should immediately inform their doctor if signs of infection occur or if their condition worsens during treatment with Auxilen.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist.
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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Auxilen

No special storage instructions are required. Store in the original
packaging to protect from light. Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
The medicine Auxilen is intended for single use; any unused portions of the solution
should be discarded.
Do not use this medicine if the patient notices that the solution is not clear and colourless, or if
there are visible signs of contamination (e.g. particles).
It has been demonstrated that the solution diluted in 0.9% sodium chloride, 5% glucose, and Ringer's lactate,
maintains chemical stability for 18 hours when stored at 25°C and 2-8°C,
provided it is protected from daylight.
From a microbiological standpoint, unless the dilution method excludes the risk of microbiological contamination,
the product should be used immediately. If not used immediately, the responsibility for
storage duration and conditions lies with the user.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist
how to dispose of medicines no longer in use. This practice helps protect the
environment.

6. Contents of the packaging and other information

What Auxilen contains

• The active substance is dexketoprofen. 1 mL of solution contains dexketoprofen trometamol equivalent to 25 mg of dexketoprofen. One ampoule (2 mL) contains dexketoprofen trometamol equivalent to 50 mg of dexketoprofen.
• The other ingredients are: sodium chloride, 96% ethanol, sodium hydroxide (for pH adjustment), water for injections.

What Auxilen looks like and contents of the pack
A clear, colourless solution free from visible particles.
Auxilen is supplied in ampoules made of coloured type I glass, each containing 2 mL.
Pack contents: 1, 5, 6, 10, 25 or 100 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia   Dexketoprofen Kalceks
Latvia    Dexketoprofen Kalceks 50 mg/2 ml solution for injection/infusion
Lithuania  Dexketoprofen Kalceks 50 mg/2 ml injekcinis ir infuzinis tirpalas
Romania   Xedofen 50 mg/2 ml solution for injection/infusion
Bulgaria   Auxilen 50 mg/2 ml инжекционен/инфузионен разтвор
Ireland   Morsadex 50 mg/2 ml solution for injection/infusion
Poland    Auxilen
Austria   Auxilen 50 mg/2 ml Injektions-/Infusionslösung
Germany  Dexketoprofen Ethypharm Kalceks 50 mg Injektions-/Infusionslösung
Spain    Auxilen 50 mg/2 ml solución inyectable y para perfusión EFG

Information intended exclusively for medical professionals:

Intravenous administration:
Intravenous infusion: dilute the contents of 1 ampoule (2 mL) of Auxilen in 30 mL to 100 mL of 0.9% sodium chloride solution, 5% glucose solution, or Ringer's lactate 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 Auxilen may be administered as a slow intravenous bolus over a period of not less than 15 seconds.
Due to its ethanol content, Auxilen must not be administered directly into the spinal canal (intrathecally or epidurally).

Instructions for handling the medicinal product:
When administering Auxilen as an intravenous bolus, the solution should be injected immediately after withdrawal from the tinted ampoule.
In the case of intravenous infusion, the solution should be diluted under aseptic conditions and protected from daylight.
Only clear and colorless solutions should be used.

Compatibility information:
Auxilen 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 injectable solution, when diluted as indicated, is a clear solution. Auxilen diluted in a volume of 100 mL of 0.9% sodium chloride solution or 5% 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 Auxilen were stored in plastic bags or devices made of ethylene-vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), and polyvinyl chloride (PVC).