Sutrilneo

Sutrilneo

torasemide

Manufacturer:

Ferrer Internacional

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Contents
Torasemide.
Description
Each tablet of SUTRILNEO 5 mg and 10 mg contains 5 mg and 10 mg of torasemide.
Excipients/Inactive Ingredients: Guar gum, maize starch (gluten free), colloidal silicon dioxide, magnesium stearate and lactose.
Action
Torasemide is a diuretic medicine (increases the elimination of urine) that belongs to the group of medicines known as "Loop diuretics: sulphonamides, plain".
Indications/Uses
Torasemide is indicated for the treatment of: Essential hypertension (high blood pressure with no identifiable cause).
Oedema (fluid retention) caused by congestive heart failure, kidney or liver disease.
Dosage/Direction for Use
Always take SUTRILNEO exactly as what the doctor has said. The patient should check with the doctor or pharmacist if not sure.
Remember to take the medicine.
The doctor will tell the duration of the treatment with SUTRILNEO. Do not stop treatment earlier as the condition can get worse.
Torasemide tablets are taken for oral administration.
Tablets have to be taken with a sufficient quantity of liquid and have to be swallowed whole, not crushed or chewed. Tablets can be taken with or without a meal.
Adults: Hypertension: The usual starting dose is 5 milligrams once a day but the doctor may increase the dose to 10 milligrams once a day or prescribe an additional hypertensive.
Treatment of oedema associated with congestive heart failure, renal or hepatic disease: The usual starting dose is 5 to 20 milligrams once a day but the doctor can increase the dose by approximately doubling if necessary.
Older people: The dose shall be the same as in adults.
Children: There is no experience of use of torasemide in children; this is why its use is not recommended in this age group. Please inform the doctor or pharmacist if the effect of SUTRILNEO is too strong or too weak.
If the patient forgets to take SUTRILNEO: Do not take a double dose to make up for a forgotten dose.
Take the dose as soon as the patient remembers and at the usual time of the following day.
Overdosage
If the patient has taken more SUTRILNEO than they should, talk to the doctor or pharmacist immediately.
In case of overdose the patient may notice an increase in the amount of urine produced and drowsiness, confusion, weakness and dizziness may occur.
Contraindications
Patients allergic (hypersensitive) to torasemide, to sulphonylureas or any of the excipients of the medicine.
Patients suffering from anuria (absent production of urine).
Special Precautions
Patients suffering from any serious liver disease as the use of torasemide may precipitate coma state; with low blood sodium or potassium levels or low blood volume; with heart problems, specially if the patients are being treated with cardiac glycosides as this increases the risk of cardiac arrhythmias; with gout or diabetes; suffering from kidney failure or the patient have urinary problems; low blood pressure (hypotension).
Children, as safety and effectiveness of torasemide in children have not been established.
Important information about some of the ingredients of SUTRILNEO: This medicine contains lactose. Ask the doctor for advice before taking this medicine if the patient has been diagnosed with intolerance to certain sugars.
Driving and using machines: This medicine can alter the ability to drive and use machines, specially when taken in combination with alcohol.
Use In Pregnancy & Lactation
Pregnancy: Ask the doctor or pharmacist for advice before taking any medicine.
The use of torasemide is not recommended during pregnancy.
Breast-feeding: Ask the doctor or pharmacist for advice before taking any medicine.
It is not known whether torasemide can pass into breast milk, this is why the use is not recommended during breast-feeding.
Side Effects
Like all medicines SUTRILNEO can cause side effects, although not everybody gets them.
Adverse events that can occur with SUTRILNEO taking into account possibility of occurrence are the following: common (between 1 in 10 and 1 in 100 patients), uncommon (between 1 in 100 and 1 in 1000 patients), rare (fewer than 1 in 1000 patients) and very rare (fewer than 1 each 10000 patients): Nutrition and metabolism disorders: Uncommon: Increase of cholesterol values, increase of triglyceride values, increase of thirst sensation.
Nervous system disorders: Common: Dizziness, headache, drowsiness. Uncommon: Cramps in lower limbs.
Cardiac disorders: Uncommon: extrasystoles (cardiac rate disorder), palpitations (awareness of heartbeat), tachycardia (increase of heartbeat rate).
Vascular disorders: Uncommon: Facial flushing.
Respiratory disorders: Uncommon: Nose bleeds.
Gastrointestinal disorders: Common: Diarrhoea. Uncommon: Abdominal pain, flatulence.
Kidney and urinary disorders: Common: increased urinary frequency, increased urine volume, increase of night time urine production. Uncommon: Urinary urgency.
General disorders: Uncommon: Asthenia (exhaustion), thirst, weakness, weariness, hyperactivity (abnormal increase of activity), restlessness.
Laboratory tests: Uncommon: increase of platelet volume (a type of blood cells).
Nausea, vomiting, hyperglycemia (increase of glucose levels), hyperuricemia (increase of uric acid levels), hypokalemia (decrease of potassium levels), hypovolemia (decrease in the volume of circulating blood), hypotension (abnormal decrease of blood pressure), impotence, deep venous thrombosis (a type of formation of clots), cutaneous reaction (skin reaction) and syncope (abrupt loss of consciousness) could also occur. If the patient considers that any of the side effects he/she is suffering from is getting serious or if he/she notices any of the side effects not listed, please tell the doctor or pharmacist.
Drug Interactions
Please tell the doctor or pharmacist if they are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The patient should also tell the doctor if they are taking some of the following medicines which can interact with torasemide: Cardiac glycosides as digoxin (heart medicines): the effect of these medicines can be increased.
Aminoglycoside antibiotics and ethacrynic acid: they can increase the toxicity in the ear.
Lithium (antidepressant medicine), salicylates: their toxicity can be increased.
Non-steroidal anti-inflammatory medicines (e.g. ibuprofen, indomethacin), probenecid (antigout medicine), cholestyramine (medicine used to reduce cholesterol levels in the blood): they can decrease the effect of torasemide.
Storage
Do not store above 30°C.
Store in the original package to protect the product from moisture.
MIMS Class
ATC Classification
C03CA04 - torasemide ; Belongs to the class of high-ceiling sulfonamide diuretics.
Presentation/Packing
PR tab (white or whitish, round and biconvex prolonged-release, with "SN" engraved on one side) 5 mg x 15's, 30's. 10 mg x 15's, 30's.
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