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Auxilen 50 mg / 2 ml. 5 ampules


Auxilen is an analgesic from a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Auxilen is used to treat acute, moderate to severe pain when taking tablets is not appropriate, such as post-operative pain, renal colic (severe kidney pain) and back pain.


What Auxilen is and what it is used for

Auxilen is an analgesic from a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Auxilen is used to treat acute, moderate to severe pain when taking tablets is not appropriate, such as pain after surgery, renal colic (severe pain in the kidneys) and back pain.

2. What you need to know before you take Auxilen

Do not use Auxylene and tell your doctor:

if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);

if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

if you have asthma or have suffered from asthma attacks, acute allergic rhinitis (inflammation of the nasal mucosa for a short time), nasal polyps (nose formations due to allergies), urgikaria (skin rash), angioedema (swelling of the face, eyes, lips) , or tongue, or respiratory failure), or wheezing after taking aspirin or other NSAIDs;

if you are photoallergic or phototoxic (especially a specific type of redness or blistering of the skin under the influence of sunlight) while taking ketoprofen (PSPVS) or fibrates (medicines used to reduce the level of fat in the blood);

if you have or have had a peptic ulcer, stomach or intestinal bleeding before or have had chronic digestive disorders in the past (eg indigestion, heartburn, perforation);

if you have had stomach or intestinal bleeding or perforation as a result of previous use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;

if you have chronic digestive problems (eg indigestion, heartburn);

if you have an intestinal disorder with chronic inflammation (Crohn's disease or ulcerative colitis);

if you suffer from severe heart failure, moderate to severe renal impairment or severe hepatic impairment;

if you have bleeding or clotting disorders;

if you are severely dehydrated (you have lost a lot of fluid in your body) due to vomiting, diarrhea or insufficient fluid intake;

if you are pregnant in the third trimester or breast-feeding.

Warnings and precautions

Talk to your doctor before taking Auxilen

if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

if you have suffered or are suffering from other stomach or intestinal problems;

if you are taking other medicines that increase the risk of a heel ulcer or bleeding, e.g. oral steroids, some antidepressants (such as SSR1, ie selective serotonin reuptake inhibitors), substances that prevent blood clots such as acetylsalicylic acid or anticoagulants such as warfarin. In these cases, tell your doctor before taking Auxylene, who may advise you to take additional medicines that protect your stomach (eg misoprostol or medicines that block the formation of stomach acid);

If you have heart problems, have had a stroke, or think you may be at risk for these conditions (eg if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist. . Medicines such as Auxylene may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. Each risk increases with higher doses or prolonged treatment. Do not exceed the recommended dose and duration of treatment;

if you are elderly, as you may be more prone to side effects (see section 4). If any side effects occur, consult your doctor immediately;

if you have allergies or have had allergic reactions in the past;

if you have kidney, liver or heart problems (hypertension and / or heart failure), as well as fluid retention, or if you have suffered from any of these disorders in the past;

if you are taking diuretics or are dehydrated and have reduced blood volume due to excessive fluid loss (eg frequent urination, diarrhea or vomiting);

if you are in the first or second trimester of pregnancy;

if you suffer from a disorder in the formation of blood or the formation of blood cells;

if you suffer from systemic lupus erythematosus or mixed connective tissue disease (disorders of the immune system that affect the connective tissue);

if you have chickenpox (measles), as NSAIDs can make the infection worse;

if you suffer from asthma in combination with chronic rhinitis, chronic sinusitis and / or nasal polyposis, which suggest that you have a higher risk of allergy to acetylsalicylic acid and / or non-steroidal anti-inflammatory drugs (NSAIDs) than the general population. Taking this medicine may cause an asthma attack or bronchospasm, especially in patients allergic to acetylsalicylic acid and

Application method:

Auxylene can be administered intramuscularly or intravenously (technical details of intravenous administration are given in the section "Information for healthcare professionals").

When Auxilen is administered intramuscularly, the solution should be administered immediately after withdrawal from the ampoule as a slow injection deep into the muscle.

Only clear and transparent solutions should be used.

Instructions for opening the ampoule:

1) Turn the ampoule upside down. If there is any liquid in the top of the ampoule, gently touch it with your finger to transfer the contents to the bottom of the ampoule.

2) Use both hands to open the ampoule, holding the bottom of the ampoule with one hand and break off the top of the ampoule with the other in the opposite direction to the colored dot (see picture).

Use in children and adolescents

This medicine should not be taken by children and adolescents (under 18 years of age).

If you take more Auxylene than you should

If you take more than the prescribed dose, tell your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Take the pack with this leaflet with you.

If you forget to take Auxilen

Do not take a double dose to make up for a forgotten dose. Use the next dose when prescribed (see section 3 “How to take Auxylene”).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are described below according to the frequency of their occurrence.

Common side effects: affects less than 1 in 10 people

Nausea and / or vomiting, pain at the injection site, injection site reactions, e.g. inflammation, bruising or bleeding.

Uncommon side effects: affects less than 1 in 100 people

Vomiting blood, low blood pressure, high fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anemia, abdominal pain, constipation, digestive problems, diarrhea, dry mouth, redness of the skin, skin rash, dermatitis, itching , increased sweating, fatigue, pain, feeling cold.

Rare side effects: affects less than 1 in 1,000 people

Peptic ulcer, hemorrhage from peptic ulcer or perforation of peptic ulcer, high blood pressure, nausea, slow breathing, inflammation of a superficial vein due to a blood clot (superficial thrombophlebitis), isolated heart skip (extrasystole), rapid periphera, rapid heartbeat laryngeal edema, abnormal sensations, abnormal sensation of fever and chills, tinnitus, itchy rash, jaundice, acne, back pain, kidney pain, frequent urination, menstrual disorders, prostate problems, muscle stiffness, joint stiffness , muscle cramps, abnormal liver tests (determined by blood tests), elevated blood sugar (hyperglycaemia), low blood sugar (hypoglycaemia), elevated blood triglycerides (hypertriglyceridaemia), tingling sensation and other feelings of tingling (paresthesia), ketone bodies in the urine (ketonuria), abnormal liver function tests (blood tests) edema), proteinuria (proteinuria), liver cell damage (hepatitis), acute renal failure.

Very rare side effects: affects less than 1 in 10,000 people

Anaphylactic reaction (hypersensitivity reaction that may lead to loss of consciousness), ulceration of the skin, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyell's syndrome), swelling of the face or swelling of the lips and throat (angioedema) ), difficulty breathing due to narrowing of the airways (bronchospasm), shallow breathing, inflammation of the pancreas, sensitive skin, skin sensitivity to light, itching, kidney problems, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you experience any stomach / intestinal side effects at the start of treatment (eg stomach pain, heartburn or bleeding), if you have previously had any of the side effects due to long-term use of anti-inflammatory medicines, and especially if you have in old age.

Stop using Auxylene as soon as possible after you notice a skin rash or mucosal lesion (eg mucous membranes in the mouth) or any signs of allergy.

Fluid retention and edema (especially of the ankles and legs), high blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs.

Medicines such as Auxylene may be associated with a slightly increased risk of heart attack

How to store Auxylene

This medicine does not require any special storage conditions. Store in the original package in order to protect from light. Do not freeze.

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Auxylene is for single use only and any unused amount should be discarded.

Do not use this medicine if you notice that the solution is not clear and transparent and if there are signs of impaired quality (eg particles).

Chemical and physical in-use stability has been observed in 0.9% sodium chloride solution, 5% glucose and lactated Ringer's solution for 18 hours at 25 ° C and 2-8 ° C, provided it is adequately protected from natural daylight. .

From a microbiological point of view, unless the opening / dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Auxylene contains

The active substance is dexketoprofen trometamol.

1 ml of solution contains dexketoprofen trometamol, which corresponds to 25 mg dexketoprofen.

One ampoule (2 ml) contains dexketoprofen trometamol, which corresponds to 50 mg dexketoprofen.

The other ingredients are sodium chloride, ethanol 96%, sodium hydroxide (for pH adjustment), water for injections.

What Auxilen looks like and contents of the pack

Clear colorless solution, without visible particles.

Auxylene is produced in 2 ml dark glass ampoules Type I. Package size: 1, 5, 25 or 100 ampoules.

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