Feloran 100 mg. 30 tablets
The active substance of Feloran Actavis is diclofenac sodium. It belongs to the group of so-called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines relieve complaints induced articular and extra-inflammation, such as pain, redness, swelling and localized heat. They did not act on the cause of the disease changes and help for relief or elimination of their events. Feloran Actavis has anti-inflammatory and protivobolkov moderate and high temperature effect.
Feloran Actavis is used to treat:
• inflammatory and degenerative joint diseases - rheumatoid arthritis, ankylosing spondylitis, other mono- and polyarthritis; degenerative joint disease in active phase - osteoarthritis, particularly coxarthrosis, spondylarthrosis.
• extraarticular rheumatism - periarthritis, bursitis, tenosynovitis, fibrositis, myositis.
• Acute gouty arthritis.
• Pain and / or inflammatory conditions of non-rheumatic origin -posttravmatichna and postoperative pain or swelling, neuralgia, neuritis, lumboishialgii, bursitis, capsulitis, synovitis, tendonitis or tenosynovitis.
• painful and / or inflammatory conditions in gynecology such as dysmenorrhoea or adnexitis.
2. WHAT YOU NEED TO KNOW BEFORE Feloran Actavis
Feloran Actavis does not apply to:
• Allergy to the drug or to any of the excipients;
• ulcer of the stomach or duodenum;
• Data for bronchial asthma, urticaria or rhinitis, provoking from taking aspirin or other medicines from the group of NSAIDs.
In the application of this product, please note the following:
It should be noted that at each stage of treatment may occur bleeding of the gastrointestinal tract or ulcer / perforation, with or without warning symptoms or preceding claims. These complications are usually more frequent and have more serious consequences in the elderly. In these cases it is necessary to suspend the adoption of the product.
Like other NSAIDs, upon initial use of the product in rare cases can develop allergic reactions (incl. Anaphylactic / anaphylactoid reactions).
Like other NSAIDs, Feloran Actavis may mask the signs and symptoms of some infectious processes. Strict monitoring of patients with symptoms of gastrointestinal disorders or diseases (duodenal ulcer, ulcerative colitis, Crohn's disease) and patients with impaired hepatic function. Like other NSAIDs, prolonged treatment with Feloran Actavis may increase the values of one or more liver enzymes, so as a precautionary measure should be monitored for liver function.
For persistent or worsening of violations in liver function tests, if signs or symptoms of liver disease or other characteristics (eg. Eosinophilia, rash, etc.), The adoption of Feloran Actavis should be discontinued.
Caution should be exercised when using Feloran Actavis to patients with hepatic porphyria, since it can trigger an attack of the disease.
Caution should be exercised in patients with impaired renal and hepatic function, in elderly patients, patients treated with diuretics and patients before and after major surgery. In these cases, as a precaution when using Feloran Actavis is recommended to monitor renal function.
Like other NSAIDs, prolonged treatment with Feloran Actavis is recommended periodically to monitor the differential blood count.
Feloran Actavis, like other NSAIDs may temporarily inhibit platelet function. Therefore, patients with bleeding disorders should be monitored carefully. Caution is necessary in elderly patients, because of the peculiarities of this age. In elderly patients with low body weight or with comorbidities recommended use of the lowest effective dose.
Application of Feloran Actavis with food and drink:
It is desirable that the adoption of Feloran Actavis be done concomitantly or immediately after a meal. Avoid adopting Feloran Actavis together with alcohol, because of an increased risk of bleeding and ulceration of the gastrointestinal tract.
Before taking any medicine, consult your doctor or pharmacist.
Feloran Actavis should be used only when absolutely necessary during pregnancy, and only in the lowest effective doses. Not recommended for use Feloran Actavis in the second half of pregnancy, as it can prolong gestation and birth and damage the unborn child.
Before taking any medicine, consult your doctor or pharmacist.
Feloran Actavis is found in breast milk and may cause side effects in the newborn, therefore not recommended for use.
Driving and using machines
Patients in whom there is dizziness or other changes CNS, including hearing disorders should not drive or operate machinery.
Important information about some of the ingredients of Feloran Actavis
This medicinal product contains lactose as an excipient, which makes it unsuitable for patients with lactase intolerance. Due to the presence in its composition of wheat starch, this product can be dangerous for people with gluten intolerance (celiac disease).
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they have not been prescribed by your doctor.
Lithium, digoxin: Diclofenac may increase plasma concentrations of lithium or digoxin.
Diuretics (drugs that increase the flow of urine): Like other NSAIDs, diclofenac may decrease the effectiveness of diuretics. Concomitant use of potassium-sparing diuretics may lead to an increased content of potassium in the blood, thus requiring frequent monitoring.
NSAIDs (non-steroidal anti-inflammatory drugs): Co-administration with other NSAIDs may increase the incidence of adverse reactions.
Anticoagulants (products delaying the clotting process): concomitant administration with diclofenac may increase the risk of bleeding. Antidiabetics: When concomitant administration of diclofenac increases glucose-lowering effect. With more prolonged treatment with diclofenac may require adjustment of these drugs.
Methotrexate: Caution is recommended when administering NSAIDs at least 24 hours before or after treatment with methotrexate because its blood concentration may increase, resulting in increased toxicity.
Cyclosporine: You can increase the toxic effects of cyclosporine on the kidney.
Antibacterial agents of the quinolone family: In isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
Glucocorticoids: Increased risk of bleeding and gastrointestinal ulcerations.
Colchicine: Increased risk of gastrointestinal side effects ..
Products containing gold salts: Increased renal toxicity of the combination.
Antacids: increase the plasma concentration of diclofenac.
3. HOW TO TAKE Feloran Actavis
Always Feloran Actavis exactly as your doctor has instructed.
According to the complaints, the doctor will determine the appropriate treatment for your disease dose. The tablets are taken orally with a full glass of water (200 ml) during or immediately after a meal.
Recommended dose for adults:
Rheumatoid arthritis - the recommended starting dose is 6 to 8 tablets (150 to 200 mg) per day divided into three or four. After achieving a satisfactory effect, the dose may be reduced to the minimum effective, typically of 3-4 tablets (75-100 mg) per day divided into two or three doses.
Ankiloziragts spondylitis -4-6 tablets (100-150 mg) daily in three or four doses. After reaching effect dose is reduced to the minimum effective.
Other mono- and polyarthritis - orally 4-6 tablets (100 -150 mg) per day divided into three or four doses. After alleviation dose is reduced to the minimum effective.
Osteoarthritis -4-6 tablets (100-150 mg) per day divided into two or three doses. After alleviation dose is reduced to the minimum effective.
Extraarticular rheumatism (periarthritis, bursitis, tenosynovitis, fibrositis, myositis, gout) - 4-6 tablets (100-150 mg) daily in three or four doses. After alleviation dose is reduced to the minimum effective.
Pain syndrome of non-rheumatic origin (trauma, postoperative pain, neuralgia, neuritis, bursitis, capsulitis, sinuviti, tendinitis) - 4-6 tablets (100-150 mg) per day divided into three or four. After alleviation dose is reduced to the minimum effective. Dysmenorrhea (painful menstruagshtya) - titrated individually, as usually sufficient 2 to 6 tablets (50 to 150 mg) per day. Upon initiation of treatment should be applied 2 to 4 tablets (50 to 100 mg) daily, divided into two or three doses, and if necessary, the dose may be increased over several menstrual cycles up to a maximum 8 tablets (200 mg) per day three or four doses. Treatment should be initiated at the first signs and depending on the type and severity of clinical symptoms can last for several days.
Doses for children:
In children over 1 year of age should apply 0.5 - 2 mg / kg bw daily 2-3 accepts depending on the severity of the condition. For the treatment of juvenile rheumatoid arthritis, the dose may be increased to up to 3 mg / kg bw daily, divided into 3-4 doses.
If you have the impression that the effect of the application of Feloran Actavis is too strong or too weak, talk to your doctor or pharmacist.
If you used a larger dose than prescribed Feloran Actavis
When taking a higher dose than prescribed immediately consult a doctor!
Upon acceptance of a higher dose of the product can be prepared symptoms of the gastrointestinal tract, of the kidneys and central nervous system. One may observe severe stomach pains, nausea, vomiting, bleeding from the gastrointestinal tract, acute renal failure, convulsions and coma.
Treatment of overdose:
In the early hours take gastric lavage and inducing vomiting (only if there are no signs of bleeding!). Apply charcoal. Held supportive and symptomatic treatment if there are complications as very low blood pressure, kidney failure, seizures, bleeding, respiratory depression.
If symptoms of overdose, immediately contact a doctor!
If you forget to use Feloran Actavis
If you miss a dose, take it at the next regular intake without increasing the dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Feloran Actavis can cause side effects.
general feeling of malaise, fatigue and general weakness, increased or decreased appetite, change in taste, feeling of warmth and flushing; On the part of the gastrointestinal tract
Fairly rare (1-10%): stomach upset, nausea, vomiting, burning sensation, diarrhea, cramps, flatulence.
Rare (<1%), bleeding from the gastrointestinal tract, gastric or intestinal ulcer with or without bleeding or perforation.
Isolated cases (<0.001%), ulcers of the oral mucosa, inflammation and irritation of the tongue and esophagus, disorders in the lower part of the intestine by unspecific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis.
Central nervous system:
Headache, dizziness and, in isolated cases, sensory disturbances, memory disturbances, insomnia, irritability, depression, anxiety, nightmares, tremor, psychotic reactions. Sensory organs:
In single cases - visual disturbances, impaired hearing, tinnitus, taste perversion.
Rash, skin eruptions, urticaria. In isolated cases - bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyle (acute toxic epidermolysis), exfoliative dermatitis, alopecia, photosensitivity, purpura.
Edema, acute renal failure, urinary abnormalities such as blood and protein in the urine, interstitial nephritis, nephrotic syndrome, papillary necrosis.
Elevated liver enzymes, rarely hepatitis with or without jaundice, fulminant hepatitis rarely (with very rapid and severe course).
Isolated cases of changes in the blood - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.
Systemic anaphylactic / anaphylactoid reactions, allergic rhinitis, bronchospasm, asthma, angioedema, vasculitis, pneumonitis.
Rarely palpitations, chest pain, hypertension, arrhythmia, exacerbation of congestive heart failure.
If you notice any side effects not listed in this leaflet, please saobgtsete this doctor or pharmacist.
Keep out of reach of children! At temperatures below 25 ° C.
Do not use after the expiry date stated on the packaging! Shelf life: 5 (five) years from date of manufacture.