Dexketoprofen Adamed

Package Leaflet: Information for the User

Dexketoprofen Adamed, 50 mg/2 ml, Solution for Injection/Infusion

Dexketoprofen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Dexketoprofen Adamed and what is it used for

Dexketoprofen Adamed, 50 mg/2 ml, solution for injection/infusion is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat moderate to severe acute pain, when the use of tablets is not appropriate, e.g. post-operative pain, renal colic (severe kidney pain) and lower back pain.

2. Important information before using Dexketoprofen Adamed

When not to use Dexketoprofen Adamed:

• if the patient is allergic to dexketoprofen or 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 had asthma attacks in the past, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergies), urticaria (hives), angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) or wheezing after taking acetylsalicylic acid or other NSAIDs;
• if the patient has had hypersensitivity reactions to sunlight or phototoxic reactions (especially in the form of redness and/or blisters on the skin exposed to the sun) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);

a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood lipid levels);

• if the patient has stomach or duodenal ulcer disease or bleeding from the stomach or intestines or if they have had bleeding from the stomach or intestines, ulcers, or perforation in the past;
• if the patient has had bleeding from the stomach or intestines or perforation due to the use of pain-relieving drugs from the NSAID group;
• if the patient has certain chronic gastrointestinal diseases (e.g. dyspepsia, heartburn);
• if the patient has intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• if the patient has severe heart failure, moderate or severe kidney failure, or severe liver failure;
• if the patient has a tendency to bleed excessively or has coagulation disorders;
• if the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• if the patient is in the third trimester of pregnancy or breastfeeding (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting to take Dexketoprofen Adamed, discuss it with your doctor or pharmacist:

• if the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the past;
• if the patient has or has had other stomach or intestinal diseases;
• if the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, e.g. oral steroid medicines, certain antidepressants (SSRI group, e.g. serotonin reuptake inhibitors), medicines that prevent blood clots such as acetylsalicylic acid or anticoagulant medicines such as warfarin. In such cases, before taking Dexketoprofen Adamed, consult a doctor who may decide to administer an additional protective medicine (e.g. misoprostol or medicines that inhibit stomach acid production);
• if the patient has heart problems, has had a stroke, or is at risk of such disorders (e.g. in case of high blood pressure, diabetes, high cholesterol, or smoking). In such cases, before taking the medicine, consult a doctor or pharmacist. Taking such medicines as Dexketoprofen Adamed may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses and longer treatment than recommended;
• if the patient is elderly: there is an increased risk of side effects (see section 4). In such a case, contact your doctor immediately;
• if the patient has an allergy or has had an allergy in the past;
• if the patient has kidney, liver, or heart function disorders (hypertension and/or heart failure), as well as fluid retention or if any of these diseases have occurred in the patient in the past;
• in patients taking diuretics or in patients with decreased hydration and reduced blood volume due to excessive fluid loss (e.g. frequent urination, diarrhea, or vomiting);
• in women with fertility problems or undergoing infertility tests (Dexketoprofen Adamed may affect female fertility and is not recommended for women planning pregnancy or undergoing infertility tests);
• in women in the first and second trimester of pregnancy;
• if the patient has blood disorders 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 chickenpox, in rare cases, non-steroidal anti-inflammatory drugs may cause worsening of the disease;
• if the patient has asthma and chronic nasal infections, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs;
• if the patient has an infection - see below, section entitled "Infections".

Infections

Dexketoprofen Adamed may mask the symptoms of infection, such as fever and pain. Therefore, Dexketoprofen Adamed may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Children and adolescents

No studies have been conducted on the use of Dexketoprofen Adamed in children and adolescents. Therefore, the safety and efficacy of this medicine have not been established, and it should not be used in children and adolescents (under 18 years of age).

Dexketoprofen Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. Some medicines should not be taken at the same time as Dexketoprofen Adamed, and in the case of others, the dose may need to be changed due to simultaneous use of Dexketoprofen Adamed.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines at the same time as Dexketoprofen Adamed.

Concomitant use not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• Methotrexate (anticancer or immunosuppressive medicine) used in high 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, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease
• Pentoxifylline and oxypentifylline 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 or tacrolimus used to treat immune system diseases and in transplants
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used for pharmacological abortion
• Antidepressant medicines from the selective serotonin reuptake inhibitor (SSRI) group
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart disease
• Tenofovir, deferazirox, pemetrexed.

In case of any doubts related to the use of Dexketoprofen Adamed, consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Do not use Dexketoprofen Adamed in the last three months of pregnancy or during breastfeeding. In case of doubts, consult a doctor.
If the patient is pregnant, suspects she may be pregnant, or plans to have a child, she should consult a doctor, as the use of Dexketoprofen Adamed may be inappropriate in this situation. Pregnant women or women planning to become pregnant should avoid using this medicine. The use of the medicine during pregnancy must be done only according to the doctor's recommendation.
Dexketoprofen Adamed is not recommended for women planning pregnancy or undergoing infertility tests.
Do not take Dexketoprofen Adamed if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.During the first 6 months of pregnancy, do not use Dexketoprofen Adamed, unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or while trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, the medicine may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Driving and using machines

Dexketoprofen Adamed may cause dizziness and fatigue, and therefore may slightly affect the ability to drive vehicles and operate machinery. If such symptoms are observed, do not drive vehicles or operate machinery until the symptoms have resolved. In case of doubts, consult a doctor.

Dexketoprofen Adamed contains ethanol and sodium

Dexketoprofen Adamed contains 200 mg of alcohol (ethanol), in each ampoule, which is equivalent to 100mg/ml. The amount of alcohol in this medicine is equivalent to 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, i.e. the medicine is considered "sodium-free".
Excipients (other ingredients of this medicine) may rarely cause allergic reactions (hypersensitivity) and bronchospasm.

3. How to use Dexketoprofen Adamed

This medicine will be administered to the patient by a doctor or nurse intramuscularly (injected into a muscle) or intravenously (injected into a vein).
The doctor will inform the patient about the size of the dose of Dexketoprofen Adamed, which will depend on the type, severity, and duration of symptoms in the patient. Generally, the recommended dose is 1 ampoule (50 mg) of Dexketoprofen Adamed administered every 8 to 12 hours. If necessary, the dose can be repeated after 6 hours. In no case should the maximum daily dose be exceeded, which is 150 mg of Dexketoprofen Adamed (3 ampoules).
Treatment with injection (injection) will be used only in the acute pain phase (not longer than 2 days). The doctor will use oral pain-relieving medicines as soon as possible.
In elderly patients with kidney failure and in patients with kidney or liver disorders, do not exceed the dose of 50 mg of Dexketoprofen Adamed per day (1 ampoule).
Use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during the use of this medicine, consult a doctor immediately (see section 2).

Use in children and adolescents

Do not use this medicine in children and adolescents (under 18 years of age).

Using a higher dose of Dexketoprofen Adamed than recommended

In case of using a higher dose of this medicine than recommended, immediately inform a doctor or pharmacist or go to the emergency department of the nearest hospital. Remember to take the package or this package leaflet with you.

Missing a dose of Dexketoprofen Adamed

In case of suspected missing a dose of the medicine, immediately inform a doctor or nurse.
In case of any further doubts related to the use of this medicine, consult a 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 listed below, grouped by frequency of occurrence.

Inform your doctor immediately:

• If you notice any side effects related to the stomach or intestines (e.g. stomach pain, heartburn, or bleeding) at the beginning of treatment, especially if you have had similar side effects in the past due to long-term use of anti-inflammatory medicines, especially in elderly patients.
• If the symptoms of an infection worsen or persist while taking Dexketoprofen Adamed.

Stop using Dexketoprofen Adamed immediately if you noticea skin rash or any mucosal lesions (e.g. in the mouth) or any signs of an allergic reaction.

Frequent side effects: may occur in up to 1 in 10 people

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

Uncommon side effects: may occur in up to 1 in 100 people

Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disorders, headache, anemia, abdominal pain, constipation, indigestion, diarrhea, dry mouth, facial flushing, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare side effects: may occur in up to 1 in 1,000 people

Stomach ulcers, stomach bleeding, or perforation, high blood pressure, fainting, slow breathing rate, superficial vein inflammation due to blood clots (thrombophlebitis), irregular heartbeat (extrasystoles), rapid heartbeat, swelling of the limbs, throat swelling, sensory disturbances, feeling of increased body temperature, and tremors, ringing in the ears (tinnitus), itching rash, jaundice, acne, back pain, kidney pain, increased urination, menstrual disorders, benign prostatic hyperplasia, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function tests (blood tests), high blood sugar levels (hyperglycemia), low blood sugar levels (hypoglycemia), high blood levels of certain fats (hypertriglyceridemia), increased excretion of ketone bodies (ketonuria) or protein (proteinuria) in the urine, liver cell damage (hepatitis), acute kidney failure.

Very rare side effects: may occur in up to 1 in 10,000 people

Anaphylactic reactions (acute allergic reactions that can lead to anaphylactic shock), skin ulcers, ulcers of the lips, eyes, and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath due to bronchospasm (bronchospasm), shortness of breath, pancreatitis, allergic skin reactions, and sun sensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
During the use of non-steroidal anti-inflammatory drugs, fluid retention, and swelling (especially of the ankles and feet), increased blood pressure, and heart failure have been reported.
Taking such medicines as Dexketoprofen Adamed may be associated with a slight increase in the 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), the use of anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.
The most commonly observed side effects were related to gastrointestinal disorders.
Especially in elderly patients, stomach ulcers, perforation, or bleeding from the stomach and/or duodenum may occur, in some cases with a fatal outcome.
After using the medicine, the following were observed: nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, worsening of colitis, and Crohn's disease. Less often, stomach inflammation was observed.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Dexketoprofen Adamed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the stated month.
Unopened ampoules: store in the outer packaging to protect from light.
No special storage temperature instructions for the medicine.
Shelf life after dilution: the chemical and physical stability of the diluted Dexketoprofen Adamed solution, 50 mg/2 ml, solution for injection/infusion, stored at a temperature of 2°C to 8°C for 24 hours, has been confirmed.
If the medicine is not used immediately after dilution, the user is responsible for the storage period and conditions before use, and the storage period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution was done in controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear and colorless or contains visible impurities (e.g. particles). Dexketoprofen Adamed, 50 mg/2 ml, solution for injection/infusion, is intended for single use only and should be used immediately after opening. Unused solution should be discarded (see "Disposal" below).

Disposal

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed and how to handle used needles and syringes. This will help protect the environment.

6. Contents of the pack and other information

What Dexketoprofen Adamed contains

• The active substance of the medicine is dexketoprofen trometamol. Each 2 ml ampoule contains 73.80 mg of dexketoprofen trometamol, which corresponds to 50 mg of dexketoprofen (INN).
• The other ingredients are: ethanol 96%, sodium chloride, sodium hydroxide (to adjust pH), sodium metabisulfite, and water for injections.

What Dexketoprofen Adamed looks like and contents of the pack

Dexketoprofen Adamed is a solution for injection or infusion. The pack contains 5 or 10 ampoules made of type I glass, each containing 2 ml of a clear and colorless solution.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Dexketoprofen Adamed
Slovakia
DEXKETOPROFEN ADAMED 50 mg/2 ml
Czech Republic
Dexketoprofen ADAMED
Portugal
Dexcetoprofeno Sotex
Date of last revision of the package leaflet: 05.2023
-----------------------------------------------------------------------------------------------------------------

7. INFORMATION INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS

MEDICAL

The following information is intended exclusively for healthcare professionals.

Intravenous administration:

Intravenous infusion:dilute the contents of 1 ampoule (2 ml) of Dexketoprofen Adamed in a volume of 30 ml to 100 ml of sodium chloride solution, 5% glucose solution, or Ringer's solution with lactate.
The diluted solution should be administered as a slow intravenous infusion over 10 to 30 minutes. The solution should always be protected from natural daylight.
Intravenous bolus:if necessary, the contents of 1 ampoule (2 ml) of Dexketoprofen Adamed can be administered as a slow intravenous bolus over a period of not less than 15 seconds.

Due to the ethanol content, it is contraindicated to use Dexketoprofen Adamed directly into the spinal canal (intrathecally or epidurally).

Instructions for handling the medicinal product:

When administering the medicinal product Dexketoprofen Adamed as an intravenous bolus, the solution should be injected immediately after withdrawal from the ampoule.
In the case of intravenous infusion, the solution should be diluted under aseptic conditions and protected from natural daylight.
Only use a clear and colorless solution.

Compatibility information:

It has been shown that Dexketoprofen Adamed is compatible when mixed (e.g. in a syringe) with heparin, lidocaine, morphine, and theophylline solutions for injection.
The solution for injection diluted as indicated is a clear solution.
Dexketoprofen Adamed diluted of sodium chloride solution or glucose solution is compatible with the following medicines in the form of solutions for injection: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.
No absorption of the active substance was observed when the diluted solution of the medicinal product Dexketoprofen Adamed was stored in plastic bags or devices for administration made of ethyl vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), and polyvinyl chloride (PVC).