Dexketoprofen adamed

Package leaflet: Information for the user

Dexketoprofen Adamed, 50 mg/2 ml, solution for injection / infusion
Dexketoprofenum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Dexketoprofen Adamed is and what it is 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 Dexketoprofen Adamed is and what it is 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 oral administration is not appropriate, e.g. postoperative pain, renal colic (severe kidney pain), and lumbosacral pain.

2. Information before using Dexketoprofen Adamed

When not to use Dexketoprofen Adamed:

• 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 previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (blister-like rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of respiratory disturbances), or wheezing after taking acetylsalicylic acid or another NSAID;
• if the patient previously experienced photosensitivity reactions or phototoxic reactions (particularly redness and/or blistering of the 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 or bleeding from the stomach or intestines, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
• if the patient currently has or previously experienced bleeding from the stomach or intestines or perforation due to treatment with NSAID painkillers;
• if the patient has certain chronic gastrointestinal disorders (e.g. indigestion, 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 renal failure, or severe hepatic impairment;
• if the patient has a tendency to excessive bleeding or coagulation disorders;
• if the patient is significantly dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or insufficient fluid intake;
• if the patient is in the third trimester of pregnancy or breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting treatment with Dexketoprofen Adamed, consult a doctor or pharmacist:

• if the patient previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• if the patient has or has had other stomach or intestinal disorders;
• if the patient is taking other medicines that increase the risk of gastric or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI group, e.g. serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult a doctor before taking Dexketoprofen Adamed, who may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs that inhibit gastric acid production);
• if the patient has heart problems, has had a stroke, or is suspected of being at risk of such conditions (e.g. in case of high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult a doctor or pharmacist before using the medicine. Taking medicines such as Dexketoprofen Adamed 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;
• if the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
• if the patient has an allergy or has had an allergy in the past;
• if the patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of the above conditions occurred previously;
• in patients receiving diuretics or in patients who are dehydrated and have reduced blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
• in women experiencing fertility problems or undergoing infertility investigations (Dexketoprofen Adamed 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 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 and chronic nasal infections, 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, especially in patients allergic to acetylsalicylic acid and/or NSAIDs;
• if the patient has an infection – see below, section titled "Infections".

Infections
Dexketoprofen Adamed may mask symptoms of infection such as fever and pain. Therefore, Dexketoprofen Adamed 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 infection and infection symptoms persist or worsen, consult a doctor immediately.

Children and adolescents
Studies on the use of Dexketoprofen Adamed in children and adolescents have not been conducted. 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines. Some medicines should not be used together with Dexketoprofen Adamed, and for others, dosage adjustments may be necessary when used concomitantly with Dexketoprofen Adamed.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexketoprofen Adamed.

Not recommended to use simultaneously:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs
• Warfarin, heparin, or other antithrombotic drugs
• Lithium used to treat certain mood disorders
• Methotrexate (an anticancer or immunosuppressive drug) 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 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
• 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 disorders and in transplant patients
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used for medical termination of pregnancy
• Selective serotonin reuptake inhibitors (SSRI) antidepressants
• Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
• Beta-blockers used to treat high blood pressure and heart diseases
• Tenofovir, deferasirox, pemetrexed

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

Pregnancy, breastfeeding and fertility

Do not use Dexketoprofen Adamed during the last three months of pregnancy or while breastfeeding. If in doubt, consult a doctor.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult a doctor, as the use of Dexketoprofen Adamed may be inappropriate in such circumstances. Pregnant women or women planning pregnancy should avoid using this medicine. Use of the medicine at any stage of pregnancy must be strictly under medical supervision.
Use of Dexketoprofen Adamed is not recommended in women planning pregnancy or undergoing infertility investigations.

Do not take Dexketoprofen Adamed if you are in 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 6 months of pregnancy, Dexketoprofen Adamed should not be used unless the doctor considers its use 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 time. From week 20 of pregnancy, the medicine may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Driving and operating machinery
Dexketoprofen Adamed may cause dizziness and fatigue and therefore may slightly affect the ability to drive motor vehicles and operate machinery. If such symptoms occur, do not drive motor vehicles or operate mechanical equipment until symptoms resolve. If in doubt, consult a doctor.

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

3. How to use Dexketoprofen Adamed

This medicine will be administered to the patient by the attending physician or nurse intramuscularly (injected into the muscle) or intravenously (injected into a vein).
The physician will inform the patient about the dose of Dexketoprofen Adamed, which will depend on the type, severity, and duration of the patient's symptoms. Generally, the recommended dose is 1 vial (50 mg) of Dexketoprofen Adamed administered every 8 to 12 hours. If necessary, the dose may be repeated after 6 hours. Under no circumstances should the maximum daily dose of 150 mg of Dexketoprofen Adamed (3 vials) be exceeded.
Treatment with injections will be used only during the acute pain phase (for 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 kidney or liver disorders, the daily dose of Dexketoprofen Adamed should not exceed 50 mg (1 vial).
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a physician immediately (see section 2).
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 Dexketoprofen Adamed
If a higher than recommended dose of this medicine is used, contact a physician or pharmacist immediately or go to the emergency department of the nearest hospital. Remember to bring the medicine packaging or this leaflet with you.
Missed dose of Dexketoprofen Adamed
If a dose of the medicine is suspected to have been missed, inform the physician or nurse immediately.
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 are listed below, grouped according to their likelihood of occurrence.

Immediately inform a doctor if:

• The patient notices any adverse reactions affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if the patient has previously experienced similar adverse reactions due to long-term use of anti-inflammatory medicines, particularly in elderly patients.
• Signs of infection appear or worsen during treatment with Dexketoprofen Adamed.

Discontinue treatment with Dexketoprofen Adamed immediately upon observing any skin rash, mucosal lesions (e.g. inside the mouth), or any symptoms of allergy.

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

Uncommon adverse reactions: may affect up to 1 in 100 people
Vomiting blood, hypotension, fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, indigestion, diarrhoea, dryness of the oral mucosa, facial flushing, rash, dermatitis, itching, increased sweating, fatigue, pain, feeling of cold.

Rare adverse reactions: may affect up to 1 in 1,000 people
Gastric ulcer, gastrointestinal bleeding or perforation, hypertension, fainting, reduced respiratory rate, superficial thrombophlebitis (inflammation of surface veins due to blood clot), cardiac arrhythmia (extra beats), tachycardia, limb oedema, throat swelling, sensory disturbances, feeling of increased body temperature, tremors, tinnitus (ear ringing), 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), elevated blood sugar levels (hyperglycaemia), low blood sugar levels (hypoglycaemia), elevated blood levels of certain fats (hypertriglyceridaemia), increased excretion of ketone bodies (ketonuria) or protein (proteinuria) in urine, 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 or 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, reduced white blood cell count (neutropenia), reduced platelet count (thrombocytopenia).

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure have been reported.

Use of medicines such as Dexketoprofen Adamed may be associated with a small increased risk of myocardial infarction ("heart attack") or stroke.

In patients with systemic lupus erythematosus or mixed connective tissue disease (immunological disorders affecting connective tissue), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most commonly observed adverse reactions involved gastrointestinal disturbances. Particularly in elderly patients, gastric ulcer, perforation or bleeding from the stomach and (or) duodenum may occur, in some cases with fatal outcome.

After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, bloating, constipation, indigestion, lower abdominal pain, black tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastritis has been observed less frequently.

As with other NSAIDs, haematological reactions may occur (purpura, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow suppression).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dexketoprofen Adamed

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.
Unopened ampoules: store in the outer packaging to protect from light.
No special temperature requirements for storage of the medicine.
Stability after dilution: chemical and physical stability of diluted Dexketoprofen Adamed, 50 mg/2 ml, solution for injection/infusion, has been confirmed when stored at 2°C to 8°C for 24 hours.
If the medicine is not used immediately after dilution, the user is responsible for the storage period and conditions prior to use, and the storage period should not exceed 24 hours at 2°C to 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if the solution is not clear and colourless or if visible particles or contamination are observed. Dexketoprofen Adamed, 50 mg/2 ml, solution for injection/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 wastewater or 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 Dexketoprofen Adamed contains

• The active substance is dexketoprofen with tromethamine. Each 2 ml ampoule contains 73.80 mg of dexketoprofen with tromethamine, equivalent to 50 mg of dexketoprofen (INN).
• Other ingredients: alcohol (96% ethanol), sodium chloride, sodium hydroxide (for pH adjustment), 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 type I glass ampoules, each containing 2 ml of a clear, colourless
solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:
Poland Dexketoprofen Adamed
Slovakia DEXKETOPROFEN ADAMED 50 mg/2 ml
Czech Republic Dexketoprofen ADAMED
Portugal Dexcetoprofeno Sotex

7. INFORMATION INTENDED FOR MEDICAL PROFESSIONALS ONLY
The following information is intended exclusively for medical 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 lactate solution.
The diluted solution should be administered as a slow intravenous infusion lasting from 10 to
30 minutes. The solution must always be protected from direct daylight.
Intravenous bolus: if necessary, the contents of 1 ampoule (2 ml) of Dexketoprofen Adamed
may be administered as a slow intravenous bolus over no less than 15 seconds.
Due to the presence of ethanol, Dexketoprofen Adamed must not be administered directly into the spinal canal (intrathecally or epidurally).
Instructions for handling the medicinal product:
When administering Dexketoprofen Adamed as an intravenous bolus, the solution should
be injected immediately after withdrawal from the ampoule.
In case of intravenous infusion, the solution should be diluted under aseptic conditions and
protected from direct daylight.
Only clear and colourless solutions should be used.
Compatibility information:
Dexketoprofen Adamed has been shown to be compatible when mixed in small volumes
(e.g. in a syringe) with solutions for injection containing heparin, lidocaine, morphine,
and theophylline.
The solution for injection, when diluted as indicated, is a clear solution.
Dexketoprofen Adamed diluted in a volume of 100 ml of physiological 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 the diluted solution of the medicinal product
Dexketoprofen Adamed was stored in plastic bags or administration devices made of ethylene vinyl acetate (EVA), cellulose propionate (CP), low-density polyethylene (LDPE), and polyvinyl chloride (PVC).