ETODIN FORT 400 mg. 14 tablets
The active substance in ETODIN Fort etodolac, which belongs to the group of nonsteroidal anti-inflammatory products in the group of derivatives of acetic acid.
ETODIN FORT tablets is indicated for the symptomatic treatment of:
- Rheumatic diseases like rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis
- Osteoarthritis pain and difficulty in movement
- Short and long-term treatment of osteoarthritis
- For the relief of mild and moderate pain (inflammation of the soft tissues, muscle pain, toothache and postoperative dental interventions, dysmenorrhea (painful menstruation), headache)
2. BEFORE YOU TAKE FORT ETODIN
Do not take ETODIN FORT
- If you are allergic (hypersensitive) to etodolac or any of the other ingredients of ETODIN FORT. An allergic reaction may be recognized as a: rash, itching, redness of the skin or difficulty breathing.
- If you have a history of peptic ulcer or active peptic ulceration
- If you suffer from severe heart disease that can cause fatigue, shortness of breath, swelling of ankles and others.
- If you develop asthma, rhinitis (inflammation of the nose, sneezing, runny nose and / or nasal) or urticaria (allergic skin reaction, which is characterized by a rise above the surrounding skin with redness and itching) during treatment with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) because of the possibility of developing a cross-reaction.
Take special care with ETODIN FORT
- If you receive anticoagulation (anti-clotting drugs), should be monitored for gastrointestinal symptoms and treatment should be stopped if bleeding occurs.
- If you suffer from heart disease, which can cause fatigue, shortness of breath, swelling of ankles, etc .; cirrhosis or inflammation of the kidneys, which can cause swelling of the ankles or high blood pressure; if you take diuretics (water resources); if you have chronic renal and hepatic failure have renal and liver function be monitored at the start of treatment.
- Drugs such as ETODIN FORT may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
- If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist .
Use in children and adolescents
ETODIN film-coated tablets can be used in children and adolescents aged between 6 and 16 years.
Use in elderly patients
In elderly patients do not need dose adjustment.
In adults with chronic kidney and liver failure at the beginning of treatment should be monitored renal and hepatic function.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Since ETODIN is highly bound to plasma proteins is needed dosage adjustment of other co-administered medications (anticoagulants), which also have a high degree of binding to plasma proteins.
FORT ETODIN can accelerate the effects of oral anticoagulants and heparin (anticoagulant medication), causing bleeding.
ETODIN FORT may lead to an enhanced hypoglycaemic effects of sulfa.
As ETODIN FORT may induce an increase of the concentration of lithium (for mental disorders, depression) in the plasma during the co-administration of these two drugs lithium plasma levels should be monitored.
ETODIN FORT may increase the hematologic toxicity of methotrexate (used in malignancies, and also in psoriasis and rheumatoid arthritis).
ETODIN FORT may reduce the effectiveness of diuretics.
ETODIN FORT may enhance the effects of the following medicines: ticlopidine (to prevent thrombosis), other NSAIDs, phenytoin (for seizures, epilepsy).
Use of ETODIN FORT with food and drink
FORT ETODIN of action is not affected by intake of food and drink.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Before taking ETODIN FORT it is important to tell your doctor if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed.
Do not take ETODIN FORT if you attempt to get pregnant because etodolac can lead to reversible inhibition of fertility.
There are no data on the safety during pregnancy in humans. ETODIN FORT film-coated tablets should not be administered during pregnancy.
Safety ETODIN FORT tablets during lactation has not been studied and its use in lactating mothers should be avoided.
Driving and using machines
No studies on the effects on ability to drive and use machines.
Important information about some of the ingredients of ETODIN FORT
ETODIN FORT contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FORT ETODIN
Always take ETODIN FORT exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
The recommended daily dose of ETODIN FORT film is 400-1200 mg.
ETODIN FORT film-apply 2 times (morning and evening) one tablet daily.
In acute pain conditions ETODIN FORT tablets can be given at shorter intervals.
The maximum daily dose is 1,200 mg. In patients weighing 60 kg or less, the total daily dose of ETODIN FORT film should not exceed 20 mg / kg.
The recommended daily dose in the treatment of juvenile rheumatoid arthritis in children aged between 6 and 16 years is as follows:
20-30 kg: 400 mg once daily
31-45 kg: 600 mg once daily
46-60 kg: 800 mg once daily
> 60 kg: 1000 mg once daily
If you take more dose FORT ETODIN
If you take more dose ETODIN FORT immediately visit the nearest hospital and take your medicine or its container with you or contact your doctor.
Do not exceed the recommended dose and duration of treatment.
If you forget to take ETODIN FORT
If you forget to take ETODIN FORT take the tablet as soon as you remember unless it is very close to the next dose. If this happens, skip the intake and take the next tablet as you follow the prescribed treatment.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking ETODIN FORT
Do not stop treatment before you have completed the full course of treatment even though you feel better. You may not have cured completely and some of the symptoms to recur.
If you have any further questions on the use of this product, ask
Your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ETODIN FORT can cause side effects, although not everybody gets them.
Gastro - intestinal disorders:
May occur nausea, pain in the upper abdomen, diarrhea, bloating and constipation. These effects are usually mild and transient. It may have seen the development of ulcers and / or gastrointestinal bleeding.
Skin and subcutaneous tissue (skin rash, pruritus, urticaria)
Respiratory, thoracic and mediastinal (occurring in the middle of the chest cavity) disorders (asthma attacks in patients with asthma, allergic rhinitis)
Patients who develop allergic reactions to aspirin or other NSAIDs
Violations of the liver:
May appear mild and transient increases in liver function tests.
May occur headache, dizziness and fatigue.
Cardiac and vascular disorders:
Drugs such as ETODIN FORT may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
If any of the side effects gets serious, or you notice other effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FORT ETODIN
Keep out of reach of children.
Store in the original container.
Do not use ETODIN FORT after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. ADDITIONAL INFORMATION
What FORT ETODIN
- The active substance is etodolac. Each tablet contains 400 mg of etodolac
- The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica, colloidal anhydrous, povidone, magnesium stearate
The composition of the film coating: hypromellose, titanium dioxide, iron oxide red, macrogol
FORT ETODIN looks like and contents of the pack
The film-coated tablets are oblong, light pink, scored on one side.
2 or number 14 film-coated tablets are packaged in blister.
In a cardboard box placed one blister number 2 or 14 tablets, or two blister packs of 14 pieces tablets.