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Dexofen 2 ml. 1 ampule

Product Code: Dexofen 2 ml. 1 ampule
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What is Dexofen Injection What it is used for

Dexfen injection is an analgesic medicine from the group of so-called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used to treat acute, moderate to severe pain when taking tablets is inappropriate, such as pain after surgery, renal colic (severe kidney pain), back pain.

2. What you need to know before using Dexofen Injection

Do not use Dexofen Injection if:

• are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (see section 6);

• are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;

• have asthma or suffer from asthma attacks, acute allergic rhinitis (inflammation of the nasal mucosa for a short period of time), polyps in the nose (nasal congestion due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, tongue or respiratory insufficiency) or chest swelling after taking aspirin or other non-steroidal anti-inflammatory drugs;

• you have had photosensitive or phototoxic reactions (a specific reaction to skin redness and / or blistering after exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or (medicines used to lower fat in blood);

• have peptic ulcer / stomach or intestinal bleeding, or have previously suffered from stomach or intestinal bleeding, ulcer or perforation;

• now or before you have had gastrointestinal or intestinal bleeding or perforation as a result of previous administration of non-steroidal anti-inflammatory drugs (NSAIDs)

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

• you have chronic inflammation of the gut (Crohn's disease or ulcerative colitis);

• suffer from severe heart failure, moderate or severe kidney problems or serious liver problems;

• you have bleeding or clotting disorders;

• you suffer from severe dehydration (you have lost a lot of body fluids) as a result of vomiting, diarrhea or insufficient fluid intake;

• you are pregnant in a third trimester or you are breast-feeding.

Warnings and precautions

Talk to your doctor before using Dexofen Injection if:

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

• now or before you have suffered from other stomach or intestinal problems;

• take other medicines that increase the risk of peptic ulcer or bleeding, oral steroids, some antidepressants (SSRI type, ie selective serotonin reuptake inhibitors), substances that prevent blood clots such as aspirin or anticoagulants such as warfarin. In such cases, tell your doctor before using Dexfen injection, which may advise you to take additional gastric (eg misoprostol or medicines that block gastric acid production);

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

• You are elderly because you may be more prone to side effects (see section 4). If any of the side effects occur, talk to your doctor immediately.

• you have an allergy or have had an allergic event in the past;

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

• Take diuretics or are dehydrated and have a reduced blood volume due to excessive fluid loss (eg urination, diarrhea or vomiting);

• You are a woman who has a problem with conception (Dexofen injector may impair reproductive capacity, so you should not take it if you are trying to become pregnant or doing infertility research);
you are pregnant in the first or second trimester;

• you suffer from impaired blood flow or abnormal blood cell formation;

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

• you have chicken pox, as NSAIDs can extremely worsen this infectious disease;

• you suffer from asthma combined with chronic rhinitis, chronic sinusitis and / or polyps in your nose because you have an increased risk of allergy to acetylsalicylic acid and / or NSAIDs compared to the rest of your population. The use of these medicines may cause asthma attacks or bronchospasm, especially in patients who are allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

Dexfen injection has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.

Other Drugs and Dexhofen Injection

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines should not be taken with others or dose changes are needed if they are taken at the same time.

Always tell your doctor, dentist or pharmacist if you are taking or using any of the following medicines at the same time as:

Combinations that are not recommended:

• acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs;

• warfarin, heparin or other anti-caking medicines;

• lithium used to treat certain mood disorders;

• methotrexate used in rheumatoid arthritis or cancer;

• hydantoin and phenytoin used in epilepsy;

• sulfamethoxazole used in bacterial infections.

Combinations requiring special precautions:

• ACE inhibitors, diuretics, beta-blockers and angiotensin-II antagonists used in high blood pressure and heart disease;

• pentoxifylline and oxpentifylline used to treat chronic venous ulcers;

• zidovudine used to treat viral infections;

• aminoglycoside antibiotics used to treat bacterial infections;

• chlorpropamide and glibenclamide used in diabetes.

Combinations to be applied with caution:

• quinolone antibiotics (eg ciprofloxacin, levofloxacin) used in bacterial infections;

• ciclosporin or tacrolimus, used in the treatment of immune system diseases and organ transplantation;

• Streptokinase and other thrombolytic or fibrinolytic drugs, i. E. medicines to break down blood clots;

• probenecid used in gout;

• digoxin used in the treatment of chronic heart failure;

• mifepristone used to induce abortion (to stop pregnancy);

• selective serotonin reuptake inhibitor (SSRIs) antidepressants;

• antiplatelet agents used to suppress platelet aggregation and blood clotting.

If you have any doubts about taking other medicines with Dexofen, talk to your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

Do not use Dexfen inject during the last three months of pregnancy or while you are breast-feeding. Ask your doctor for advice.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine because Dexfen may not be suitable for you;

The use of Dexofen should be avoided by women who are planning pregnancy or are already pregnant. Treatment at any time during pregnancy should only take place under medical supervision.

Using Dexofen is not recommended if you are trying to become pregnant or during infertility research.

Driving and using machines

Dexfen injection may slightly affect your ability to drive and use machines due to the potential for dizziness or drowsiness as undesirable effects. If you notice such effects, do not drive or use machines until these symptoms resolve. Ask your doctor for advice.

The dexfen injector contains ethanol

Each ampoule of Dexofen Injection contains 200 mg of ethanol equivalent to 5 ml of beer or 2.08 ml of wine per dose. It is harmful to people suffering from alcoholism.

This should be considered in pregnant and breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, ie essentially "sodium-free".
How to use Dexofen Injection

Always use this medicine exactly as you have told your doctor. If you are not sure, ask your doctor.

Your doctor will tell you what dose of Dexfen injection you need depending on the type, severity and duration of the complaints. The recommended dose is usually 1 ampoule (50 mg) of a dexfen injection every 8-12 hours. If necessary, the injection may be repeated after 6 hours. Do not exceed a total daily dose of 150 mg Dexofen Injection (3 ampoules).

Use injection treatment only during the acute period (for example, not more than two days). If possible, go to oral pain medication.

Elderly patients with impaired renal function and patients with renal or hepatic impairment should not exceed a total daily dose of 50 mg of Dexofen (1 ampoule).

Application method

The dexfen injection can be administered intramuscularly or intravenously (technical details of intravenous administration are given in the section "Information for medical specialists"). When administering Dexfen injected intramuscularly, the solution should be given as soon as it is withdrawn from the colored ampoule as a slow injection deep into the muscle. Only clear and transparent solutions should be used.

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years of age). If you have used more than the required dose of Dexofen Injection

If you have used a large amount of this medicine, tell your doctor or pharmacist or go to the emergency room of the nearest hospital. Please be sure to take the medicine pack or this leaflet with you.

If you forget to use Dexofen Injection

Do not take a double dose to make up for the missed dose. Apply the next regular dose according to the instructions (see section 3 "How to use Dexofen Injection"). If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.

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 everyone gets them.

Possible side effects are listed below according to their incidence.

Common side effects: can affect up to 10 people in X.

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

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

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

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

Peptic ulcer, peptic ulcer hemorrhage or peptic ulcer perforation, high blood pressure, loss of consciousness, delayed breathing, inflammation of the surface vein as a result of a blood clot (surface thrombophlebitis), isolated heart rhythm (extrasystole), rapid heartbeat, peripheral edema, edema of the larynx, abnormal sensations, feeling of chills and chills, tinnitus, itchy rash, jaundice, acne, back pain, kidney pain, frequent urination, menstrual disorders, prostate problems, muscular cramps, abnormal liver function tests (blood tests), elevated blood glucose (hyperglycaemia), decreased blood sugar (hypoglycaemia), increased triglycerides in the blood (hypertriglyceridemia), ketone bodies urine (ketonuria), urinary protein (proteinuria), hepatic impairment (hepatitis), acute renal failure.

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

Anaphylactic reaction (a hypersensitivity reaction that may lead to loss of consciousness), skin, mouth, eye and genital ulceration (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of the lips and throat (angioedema ), shortness of breath due to spasm of the respiratory tract (bronchospasm), superficial breathing, pancreatitis, skin sensitization or skin hypersensitivity to light, renal impairment, decreased white blood cell count (neutropenia), reduced number of platelets (thrombocytopenia).

Tell your doctor immediately if you notice stomach and / or intestinal side effects at the beginning of treatment (eg stomach pain, heartburn or bleeding) if you have previously suffered from any of the side effects due to prolonged use of anti-inflammatory medicines, especially if you are elderly.

Stop using Dexfen injection as much as possible
How to store Dexofen Injection

Keep out of the reach and sight of children.

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

Keep ampoules in the carton to protect from light!

Do not use this medicine if you notice that the solution is not clear and transparent and if there are signs of poor quality (eg particles). The dexfen injection is for single use only after opening and should be used immediately after opening the ampoule. Destroy any unused product (please see disposal instructions below).


Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the package and additional information

What contains each ampoule of 2 ml of Dexofen Injection

The active substance is dexketoprofen trometamol (73,80 mg) corresponding to dexketoprofen (INN) 50 mg.

The other ingredients are alcohol (ethanol), sodium chloride, sodium hydroxide and water for injections.

What Dexfen injector looks like and contents of the pack

Dexfen injection is an injection / infusion solution. Supplied in packs containing 5, 10 or 50 Type I glass ampoules each containing 2 ml clear and clear solution Not all pack sizes may be marketed.







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