Used to relieve or reduce various types of pain.
What is Axofen SR and what is it used for?
Axofen SR belongs to a group called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to relieve or reduce various types of pain.
Axofen SR is used to treat the following conditions:
• A chronic disease-causing joint pain, swelling, and deformity (rheumatoid arthritis)
• A disease (osteoarthritis) resulting from joint degeneration, also commonly known as arthritis (osteoarthritis)
• A chronic disease causing joint pain, swelling, and deformity (ankylosing spondylitis)
• Acute musculoskeletal pain
• Acute gouty arthritis
• Menstrual pain (dysmenorrhea)
Do not use Axofen SR if:
• You are sensitive to any ingredient of Axofen SR,
• You have experienced asthma, hives, or other allergic reactions after taking aspirin or other NSAIDs
• You have pain before or after coronary artery bypass surgery
• You have severe liver failure,
• You have severe kidney failure,
• You have severe heart failure,
• You currently have or have previously had peptic ulcer disease,
• You have a history of bleeding or perforation of the stomach or intestines caused by NSAID use,
• You have bleeding from the stomach or intestines, cerebral hemorrhage, or any other bleeding.
• You are in the last trimester of pregnancy (from 6 months).
Use Axofen SR with caution if:
• You have known heart or blood vessel (cardiovascular) disease. In this case, your doctor will use the lowest effective dose. Even if you have never experienced cardiovascular symptoms, you and your doctor should be cautious about such events; your doctor will inform you what to do in such a situation.
• You have high blood pressure (hypertension); your doctor will closely monitor your blood pressure at the start and during treatment with Axofen SR.
• You have fluid retention or swelling
• You have a significant disease with respiratory failure, edema, or liver enlargement due to pre-existing heart failure
• Inflammation, bleeding, and perforation in the stomach and intestines.
• You are elderly, have heart or vascular disease, are taking aspirin concurrently, or have ulcers, gastrointestinal bleeding, or disorders such as inflammatory disease
• You have pre-existing asthma,
• You have anemia or a blood clotting problem
• You are planning to become pregnant
• You have systemic lupus erythematosus (SLE) or other connective tissue disorders,
• You have heart failure, liver cirrhosis, nephrotic syndrome, or evident kidney disease.
• You have impaired kidney function; your doctor will prescribe a lower dose of flurbiprofen
• You develop skin rash, mucosal disorders, or any other signs of hypersensitivity. In this case, your doctor will stop the treatment.
• You have eye-related complaints. In this case, consult an ophthalmologist.
Do not use together with other similar analgesics.
A very rare and in some cases fatal type of skin disease associated with flurbiprofen may occur, called exfoliative dermatitis, inflammation around the eyes and skin characterized by swelling and redness (Stevens-Johnson syndrome), and serious skin reactions including toxic epidermal necrolysis. The risk of these events is highest at the beginning of treatment, most cases occurring within the first month.
If you have ever experienced these dangerous signs at any time in the past, even if they are not currently present, please consult your doctor.
Pregnancy:
- Consult your doctor or pharmacist before using the medicine.
- Do not take Axofen SR in late pregnancy (from 6 months). The medicine should not be used during pregnancy unless recommended by a doctor.
- If you discover that you are pregnant during treatment, consult your doctor or pharmacist immediately.
Breastfeeding:
Do not take Axofen SR during breastfeeding. Since flurbiprofen passes into breast milk, it may harm your baby.
Driving and using machines:
Axofen SR may cause some side effects such as dizziness, restlessness, tremor, and drowsiness. Therefore, if you experience these symptoms, avoid driving or operating machinery.
Important information about some ingredients of Axofen SR:
This pharmaceutical product contains sugar and sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Use with other medicines:
Some medicines that may interact with Axofen SR:
• ACE inhibitors and angiotensin II antagonists (used to treat high blood pressure)
• Aspirin (pain relievers, blood thinners)
• Anticoagulants (blood-thinning medicines)
• Beta-blockers (used to treat high blood pressure)
• Diuretics (water tablets)
• Corticosteroids (used to treat allergies and as hormone replacement)
• Zidovudine, ticlopidine, tacrolimus, and cyclosporine (used during organ transplantation)
• Lithium or selective serotonin reuptake inhibitors (psychiatric medicines)
• Methotrexate (used to treat cancer)
• Digoxin (used in heart failure)
• Oral hypoglycemic agents (used to treat diabetes)
• Quinolone antibiotics (used against some infections)
• Antiplatelet agents (used to treat thrombosis)
• Cimetidine, ranitidine, antacids (used for some stomach problems)
If you are taking these medicines, please inform your doctor. These medicines may interact with Axofen SR.
Please inform your doctor or pharmacist if you are currently taking or have recently taken any other medicines, whether prescribed or not.
Method of use:
Unless otherwise advised by your doctor: take once daily in the evening after meals with a glass of water.
Use in children:
Do not use in children under 12 years of age.
Use in the elderly:
Since elderly patients are at risk of serious side effects, the lowest dose should be prescribed.
Use in liver/kidney failure:
Long-term therapy has caused kidney damage in patients; therefore, Axofen SR should be used with caution in patients with severe liver and kidney failure.
However, it is not recommended for use in patients with severe kidney failure. If there are signs of kidney failure, it should be used with caution.
If you feel that the effect of Axofen SR is too weak or too strong, talk to your doctor or pharmacist.
If you use more Axofen SR than you should:
Most commonly, drowsiness, nausea, vomiting, and abdominal pain occur. In this case, appropriate treatment is required in a hospital emergency department. Activated charcoal may be useful within 4 hours of taking Axofen SR. Your doctor or pharmacist will assist you with this.
If you forget to take Axofen SR:
- Take it as soon as you remember. If it is time for your next dose, skip the extra dose and continue normal use.
- Do not take a double dose to make up for a missed dose, as it may be excessive for you. If you have missed more than one dose, inform your doctor.
Possible side effects:
If any of the following occur, stop using Axofen SR and immediately contact your doctor or the nearest emergency department:
Common:
• Rhinitis • Urinary tract infection • Changes in body weight • Restlessness (anxiety) • Depression • Insomnia • Nervousness • Amnesia • Dizziness • Headache • Increased reflexes • Drowsiness • Tremor • Visual changes • Tinnitus • Stomach pain • Constipation • Diarrhea • Dyspepsia • Flatulence • Gastrointestinal bleeding • Nausea • Vomiting • Skin rash • Asthenia • Fluid retention (such as ankle swelling) • Weakness (feeling unwell) • Increased liver enzymes.
Uncommon:
• Anemia • Hyperuricemia • Fluid retention • Confusion • Ataxia • Cerebrovascular ischemia • Paresthesia • Parosmia • Conjunctivitis • Heart failure • Vascular disorders • Vasodilation • Hypertension • Asthma • Epistaxis • Bronchospasm • Bloody diarrhea • Esophageal disease • Gastritis • Hematemesis • Peptic ulcer • Stomatitis • Gastrointestinal ulcer • Hepatitis • Angioedema • Eczema • Itching • Urticaria • Shivering • Hematuria • Kidney failure • Chills • Fever
• Changes in some test results (decrease in hemoglobin and hematocrit levels).
Rare:
• Serious allergic reactions (anaphylactic reactions) • Myocardial infarction • Gastrointestinal perforation • Glomerulonephritis • Renal papillary necrosis • Nephrotic syndrome.
Unknown:
• Inhibition of platelet aggregation
The following side effects are mainly derived from worldwide post-marketing experience and literature. Exact frequency is usually not possible to estimate:
- Anemia (aplastic anemia, hemolytic anemia), thrombocytopenia, neutropenia, allergic shock (anaphylaxis), colitis, exacerbation of inflammatory bowel disease, inflammation of the small intestine with loss of blood and protein, jaundice, exfoliative dermatitis, photosensitization, skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis), aseptic meningitis, interstitial nephritis.
If you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Storage conditions:
Keep Axofen SR in its packaging and out of reach of children.
Store below 25°C
Use according to the expiration date. Do not use after the expiry date stated on the package.
Dispensing conditions: Pharmaceutical product group – III, available without prescription.
Marketing authorization holder:
İlko İlaç San. ve Tic. A.Ş.
Veysel Karani Mah. Çolakoğlu Sok. No:10 34885 Sancaktepe / İstanbul - Turkey
Manufacturer:
İlko İlaç San. ve Ticaret A.Ş.
3.Organize Sanayi Bölgesi Kuddusi Cad. 23. Sok. No:1 Selçuklu / Konya - Turkey
