Flexo 1g/2ml

FLEXO® 1g/2ml 2ml solution for IM injection in ampoule №1 is used as an intramuscular injection. Sterile · Active ingredient: Each 2ml ampoule contains 1g etofenamate. · Excipients: Medium-chain triglycerides Read this patient leaflet carefully and completely before using the medicine, as it contains important information for you. · Keep this leaflet. You may need to read it again. · If you have additional questions, contact your doctor or pharmacist. · This medicine has been prescribed for you only. Do not pass it on to others. · When taking the medicine, report to your doctor that you are taking this medication when you are in the hospital or visiting a doctor. · Follow exactly what is written in this leaflet. Do not take a higher or lower dose than recommended. In this leaflet: 1. What is FLEXO® and what is it used for 2. What you need to know before taking FLEXO® 3. How to take FLEXO® 4. Possible side effects 5. How to store FLEXO® 1. What is FLEXO® and what is it used for FLEXO® is presented in colorless glass ampoules containing 2 ml of a clear and viscous solution for intramuscular injection. It is available in packs of 1 or 3 ampoules. FLEXO® contains etofenamate as the active ingredient. Etofenamate is an active substance belonging to the group of non-steroidal analgesic/anti-rheumatic agents and has anti-inflammatory, pain-relieving (analgesic) properties. It is used to treat the following conditions: • Degenerative joint disease, joint arthritis (osteoarthritis) • Rheumatic disease associated with joint inflammation (rheumatoid arthritis) • Rheumatic disease associated with spinal fusion and limited mobility in the spinal joints (ankylosing spondylitis) • Joint inflammation characterized by severe, sudden pain in an inflamed joint, usually starting in the big toe of the lower limb, causing severe pain, tenderness, redness, and swelling in the joints (acute gouty arthritis) • Musculoskeletal pain • Inflammation, swelling, and soft tissue damage observed after surgery (post-operative pain) • Menstrual pain (dysmenorrhea) Note: The injectable solution is only used in cases where topical application of etofenamate is not beneficial or appropriate. Treatment should generally be limited to a single injection. Due to the slow release of the active ingredient, FLEXO® is not suitable for conditions requiring a rapid effect. After using FLEXO®, due to the slow release of active ingredients from the oily formulation, the duration of action may be extended up to 24 hours. 2. What you need to know before taking FLEXO® Consult your doctor or pharmacist before taking any medicine. Do not take FLEXO® in the following conditions Cardiovascular risk: NSAIDs or painkillers can increase the risk of serious cardiovascular thrombotic events associated with heart attack and stroke, which can be fatal. This risk may increase with prolonged use. Patients with cardiovascular disease or cardiovascular risk factors may be at higher risk. FLEXO® is not used to treat pain during preparation for coronary artery bypass surgery. Gastrointestinal risk: NSAIDs or painkillers increase the risk of serious side effects on the stomach or intestines, including bleeding, ulceration, and perforation of the stomach or intestine, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at increased risk of serious gastrointestinal events. • If you are hypersensitive to etofenamate or any of the ingredients of FLEXO®. • If you have a history of asthma, shortness of breath, runny nose, hives, or allergic-type reactions associated with the use of aspirin or other non-steroidal anti-inflammatory drugs. • If you have or have ever had a stomach or intestinal ulcer or bleeding. • If you are scheduled for surgery on the blood vessels supplying the heart (coronary arteries). • If you are taking medications that prevent blood clots or thin the blood (anticoagulants or antiplatelets). • If you have severe heart failure. • If you have liver or kidney failure. • If you are in the late stages of pregnancy (after the sixth month). • If you are breastfeeding. • If you are under 18 years of age. Take special precautions when using FLEXO® in the following conditions Conditions where FLEXO® should only be used after careful risk-benefit assessment. • If you have porphyria, it may be induced (an inherited or acquired disorder of the production of a substance that gives blood its color; exacerbation of this disease can be caused by certain substances). Conditions where FLEXO® should only be used under careful medical monitoring: • If you have a history of gastrointestinal bleeding or perforation with NSAIDs or painkillers. • If you have active peptic ulcer or duodenal ulcer or a history of it (one or two episodes of confirmed ulcer or bleeding). • If you have or have had inflammatory bowel disease (ulcerative colitis, Crohn's disease). • If you have heart or blood vessel disorders. • If you have high blood pressure (hypertension). • If you have heart disease or swelling problems. • If you have had a stroke. • If you have had surgery. • If you are over 65 years of age or are debilitated. Please consult your doctor if any of the above applies to you, at any time, even in the past. Taking FLEXO® with food and drink Interaction with food and drink is not observed, depending on the method of use. Pregnancy Before taking medication, consult your doctor or pharmacist. FLEXO® should not be used after the sixth month of pregnancy. Also, do not take FLEXO® after this period unless your doctor tells you to. If you discover you are pregnant during treatment, contact your doctor or pharmacist immediately. Breastfeeding Before taking medication, consult your doctor or pharmacist. Do not take FLEXO® during breastfeeding. Driving and using machinery FLEXO® may affect concentration, especially at the beginning of treatment and when increasing the dose. Refrain from driving and operating machinery while using FLEXO®. Use with other medicines Do not take FLEXO® with the following medicines: · Aspirin and other NSAIDs. FLEXO® should be used with caution with the following preparations: · Angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure). · Furosemide and diuretics (water pills). · Antihypertensive agents (drugs that lower high blood pressure). · Lithium (used to treat mania and depression). · Methotrexate (used for rheumatoid arthritis, and sometimes cancer). · Medications that prevent blood clots or thin the blood, such as warfarin and similar preparations. · Digoxin (used to treat heart failure). · Phenytoin (used to treat epilepsy). · Corticosteroids (a group of drugs used for many conditions, including inflammation, allergies, and organ transplantation). · Potassium-sparing diuretics. · Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression). · Probenecid or sulfinpyrazone (used to lower uric acid levels in the blood). · Alcohol. · Cyclosporine (used to prevent tissue rejection). · Antidiabetic drugs (used to lower blood sugar levels). Please inform your doctor or pharmacist about any prescription or over-the-counter medications you are currently taking or have recently taken. 3. How to take FLEXO® Instructions for proper use and frequency/dosage Your doctor will determine the dose of FLEXO® based on your condition and prescribe it for you. The usual dose is one ampoule of FLEXO® by deep intramuscular injection. If continuation of treatment with etofenamate is considered, your doctor may tell you that after taking the FLEXO® ampoule, you can continue treatment with FLEXO® gel or FLEXO® spray, which can be used topically. Method and route of administration: The FLEXO® ampoule is intended for intramuscular injection. After breaking the ampoule, the solution for injection is drawn into a syringe and administered as a deep intramuscular injection with a sufficiently long needle. Before injecting the solution, the plunger of the syringe is slightly pulled back to ensure that the needle is not in a blood vessel. Due to the possibility of anaphylactic reactions (sudden onset of severe allergy), monitoring for at least 1 hour may be necessary after FLEXO® injection. Special age groups Use in children: Since there is no experience with the use of etofenamate in children and adolescents, FLEXO® should not be used in patients under 18 years of age. Use in the elderly (65 years and older): FLEXO® should be used with caution in elderly patients due to possible side effects. Special conditions of use: Renal/hepatic insufficiency: Do not use FLEXO® if you have kidney or liver problems. Consult your doctor or pharmacist if you have the impression that the effect of FLEXO® is too strong or too weak. If you take more FLEXO® than you should Consult your doctor or pharmacist if you take more FLEXO® than you should. If you take more FLEXO® than recommended, the side effects of the preparation and their severity may increase. If an overdose of FLEXO® is used, central nervous system effects may occur, including headache, dizziness, drowsiness, and confusion, as well as symptoms such as nausea, vomiting, and abdominal pain. In addition, gastrointestinal bleeding, liver and kidney dysfunction may occur. Your doctor and pharmacist can help you with these symptoms. If you forget to take FLEXO® Do not take a double dose to compensate for a missed dose. Effects that may occur upon discontinuation of FLEXO® treatment. The development of any effect is unlikely. 4. Possible side effects Like all medicines, side effects can occur in individuals who are sensitive to the ingredients of FLEXO®. Very common (>1/10) May occur in at least 1 in 10 patients. Common (≥1/100 to <1/10) May occur in less than 1 in 10 patients, but more than 1 in 100 patients. Uncommon (≥1/1000 to <1/100) May occur in less than 1 in 100 patients, but more than 1 in 1000 patients. Rare (≥1/10,000 to <1/1000) May occur in less than 1 in 1000 patients, but more than 1 in 10,000 patients. Very rare (<10,000) May occur in less than 1 in 10,000 patients. Unknown: Cannot be estimated based on available data. Stop taking FLEXO® and inform your doctor immediately or go to the emergency department of the nearest hospital if any of the following events occur: · Severe forms of skin reactions (Stevens-Johnson syndrome, Lyell's syndrome). · Severe hypersensitivity reactions are likely and may include the following: When any symptom similar to a severe allergic reaction develops, swelling of the face, tongue, and throat, skin rash, shortness of breath, difficulty breathing, laryngeal edema, leading to narrowing of the airways, difficulty breathing, leading to an asthma attack, increased heart rate, decreased blood pressure, leading to potentially fatal shock, fever or shock. These reactions can occur after the first use of the drug. These are very serious side effects. If you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Please note that the following side effects are dose-dependent and may vary between individuals. The most frequently reported side effects relate to the digestive system. Gastric or intestinal ulcers (peptic ulcers), perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, vomiting blood, mouth ulcers, exacerbation of colitis and Crohn's disease. Gastritis has been described less frequently. In general, the risk of gastrointestinal bleeding depends on the duration of NSAID treatment and the dose used. Swelling, high blood pressure, and heart failure have been described in association with NSAID treatment. Medications such as FLEXO® may be associated with a slightly increased risk of heart attack (myocardial infarction or stroke). Side effects observed during intramuscular injection of etofenamate: Frequent side effects: Gastrointestinal symptoms such as nausea, vomiting, diarrhea, and mild gastrointestinal blood loss, which in exceptional cases can lead to anemia. Uncommon side effects: Headache, agitation, irritability, fatigue, dizziness, and drowsiness. Digestive system disorders, bloating, abdominal cramps, loss of appetite, stomach and duodenal ulcers (sometimes associated with bleeding and perforation). Hypersensitivity reactions, such as skin rash and itching. Increased liver enzymes in the blood (serum transaminases). Rare side effects: Blood production disorders. Hematopoietic disorders (anemia, leukopenia, agranulocytosis, thrombocytopenia). Initial symptoms include fever, sore throat, superficial oral lesions, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. Regular monitoring of blood counts is necessary for patients undergoing long-term treatment. Vomiting blood, blood in stool, or bloody diarrhea. Urticaria and/or hair loss. Liver damage (hepatitis with or without jaundice, very rarely fulminant and rarely without prodromal symptoms). Therefore, periodic monitoring of patients' liver function is necessary. Edema (peripheral edema) may develop, especially in patients with high blood pressure (hypertension) or impaired kidney function. Very rare side effects: Palpitations, chest pain, high blood pressure, and circulatory collapse. Heart failure. Hemolytic anemia. Sensory disturbances, taste disturbances, ringing in the ears and temporary hearing damage, memory loss, disorientation, convulsions, anxiety, nightmares, tremors, depression, and other psychotic reactions. Inflammation of the oral mucosa, damage to the tongue, esophagus, complaints in the lower abdomen (e.g., hemorrhagic colitis or exacerbation of Crohn's disease/ulcerative colitis) and constipation. Visual disturbances (blurred vision and/or double vision). Skin rash with fluid-filled blisters, eczema, redness, photosensitivity, flushing (also allergic purpura). In sporadic cases: damage to kidney tissue, which may be accompanied by acute kidney failure (interstitial nephritis, papillary necrosis), protein in the urine (proteinuria) and/or blood in the urine (hematuria). Nephrotic syndrome has been described in isolated cases. Therefore, kidney function should be checked regularly. Pancreatitis has been described in isolated cases. Inflammation of the lungs and blood vessels related to allergy has been described in isolated cases. Inflammation related to infection may worsen with the use of non-steroidal anti-inflammatory drugs in isolated cases (development of necrotizing fasciitis). This is likely related to the use of non-steroidal anti-inflammatory drugs. Therefore, consult your doctor immediately if you experience symptoms related to a new infection or worsening of existing symptoms while using FLEXO®. Evaluation of antibiotic or anti-infective therapy should be carried out. After intramuscular administration, less common local side effects may develop at the injection site (burning sensation) or tissue damage (such as sterile abscess formation, necrosis of fatty tissue or skin). For the above-mentioned side effects, please consider the suggestions listed. If you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Reporting suspected adverse reactions after drug authorization is very important. It allows for continuous monitoring of the benefit/risk balance of the medicinal product. 5. How to store FLEXO® Store FLEXO® out of reach and sight of children, in the original packaging. Store at room temperature, not exceeding 25°C. Protect from light. Dispensing category: Pharmaceutical product group III, available without prescription.