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WHAT SOFTENSIF IS AND WHAT IT IS USED FOR
Softensif belongs to a group of medicines called diuretics. Lowers blood pressure through the following mechanisms:
increases urine output (increases the excretion of sodium and chlorine from the body);
causes smooth muscle relaxation and dilation of blood vessels (effects due to the ability of indapamide to regulate the entry of calcium into cells);
enhances the formation of vasodilators in the kidneys and vascular wall.
It is used to treat high blood pressure (hypertension).
2. BEFORE YOU TAKE SOFTENSIF
Do not use Softensif
if you are allergic (hypersensitive) to the active substance indapamide or to any of the other ingredients of the product;
if you are hypersensitive to other sulphonamide-containing medicines;
in severe disorders of renal and hepatic function;
in hypokalaemia (low potassium levels).
Take special care with Softensif
Before starting treatment with Softensif, tell your doctor if you have any chronic illness, if you are hypersensitive to other medicines and foods, or if you are taking other medicines.
The product should be used with caution in:
Hypokalaemia, hyponatraemia (low levels of potassium and sodium in the blood) and other electrolyte or water disorders. Periodic monitoring of serum electrolytes is required, especially in risk groups of patients: the elderly, malnourished, taking many drugs, patients with ascites, edema, cardiovascular disease, heart failure, patients with changes in the electrocardiogram. Hypokalaemia in such patients is a predisposing factor for the occurrence of cardiac arrhythmias, including fatal seizures. This requires more frequent monitoring of serum potassium. The first test should be performed in the first week after starting treatment. If hypokalaemia is detected, it should be corrected.
Calcium. Urinary calcium excretion may be decreased and a transient increase in serum levels may be induced. Hypercalcaemia (increased levels of serum calcium) may be due to previously unrecognized hyperparathyroidism (a disease with increased parathyroid function). In this case, treatment should be discontinued until parathyroid function testing.
Blood sugar. Latent (latent) diabetes or increased insulin requirements in diabetics may occur during treatment with Softensif. Periodic blood sugar monitoring is required.
Uric acid. Serum uric acid levels may be increased in patients treated with Softensif. Therefore, periodic monitoring is required during treatment.
Renal function. Softensif, like other thiazide diuretics, should be used with caution in patients with mild renal impairment (they are ineffective in advanced renal failure). If progressive renal impairment is observed in patients treated with Softensif, treatment should be discontinued. Periodic monitoring of renal function is required.
Systemic lupus erythematosus (autoimmune disease). Thiazide diuretics, including Softensif, may exacerbate or activate systemic lupus erythematosus. Softensif can positive the results of doping control in athletes. The medicinal product may increase the sensitivity of the skin to sunlight, therefore prolonged sun exposure should be avoided.
Follow your doctor's instructions in case you are prescribed a diet low in salt but high in potassium (products high in potassium are: bananas, prunes, raisins, orange juice). Monitor your blood pressure regularly.
Taking other medications
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Combines not recommended
lithium products (for the treatment of mental illness) - increased risk of developing lithium intoxication;
non-antiarrhythmic medicinal products causing “torsales de pointes” (life-threatening heart rhythm disorder): astemizole and terfenadine (for the treatment of allergies), the antibiotic erythromycin intravenously, the anticancer medicine vincamine, bepridil (for the treatment of increased blood pressure ), pentamidine (antiparasitic product), sultopride (for the treatment of mental illness) - risk of recurrent heart rhythm disorders.
Combines that require special attention
systemic nonsteroidal anti-inflammatory drugs, carbenoxolone (protects the lining of the stomach) - risk of provoking acute renal failure in dehydrated patients;
other hypokalaemic compounds, such as the antifungal amphotericin B, laxatives (used to treat constipation) - risk of hypokalaemia (low potassium);
HOW TO TAKE SOFTENSIF
Always use Softensif exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
The usual dose is 1 tablet of 2.5 mg daily, taken orally, preferably in the morning on an empty stomach with plenty of water.
Patients with hepatic and renal impairment
The treating physician may reduce the dose and / or extend the dosing interval if necessary. In case of deterioration, Softensif treatment should be discontinued.
If you take more Softensif than you should
Strictly follow the prescribed treatment. Do not take more or less than the prescribed amount or at more frequent intervals.
In case of accidental intake of the drug in a dose significantly exceeding the prescribed by a doctor, seek medical help immediately!
In case of drug overdose, the following symptoms may occur: nausea; vomiting, weakness, water-electrolyte imbalance. In more severe cases - a sharp drop in blood pressure, respiratory depression.
Treatment of overdose is carried out in a hospital setting and is aimed primarily at removing gastric contents by induced vomiting, gastric tube and lavage and subsequent correction of disturbed water-electrolyte balance.
If you forget to take Softensif
Do not take a double dose to make up for a forgotten dose.
If you stop taking Softensif
Softensif normalizes blood pressure, but does not cure high blood pressure, so it is necessary to take the drug even if you feel well. Do not stop treatment without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Softensif can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Softensif: painful muscle contractions (cramps), headache, agitation or drowsiness, nervousness, feeling tense and anxious, irritability, dizziness, insomnia, depression, blurred vision, transient myopia, yellow vision, photosensitivity, orthostatic hypotension, palpitations, arrhythmias, nausea, dry mouth, loss of appetite, constipation or diarrhea, stomach discomfort, flu-like symptoms, runny nose, cough, frequent urination, polyuria (increased urination) nocturia (nocturnal urination), decreased sexual desire, congestive jaundice, pancreatitis, changes in liver function, rarely hepatitis (inflammation of the liver), changes in some blood parameters, especially in older patients. In hepatic impairment, thiazides and related dehydration drugs can cause hepatic encephalopathy (brain changes).
If such occurs, its application should be stopped immediately.
If the following symptoms occur, it is necessary to seek medical advice immediately: skin rash accompanied by itching, difficulty breathing, water-electrolyte disturbances.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SOFTENSIF
Store in the original package at a temperature below 25 ° C.
Keep out of reach of children.
Do not use Softensif after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Softensif contains
The active substance is: indapamide 2.5 mg in one film-coated tablet.
The other ingredients are: lactose monohydrate, wheat starch; cellulose, microcrystalline; povidone K 25, magnesium stearate.
Film-forming coating: peel off white 33 G28707 (hypromellose, titanium dioxide, lactose monohydrate, macrogol 3000, triacetin).
What Softensif looks like and contents of the pack
White to off-white, round, biconvex film-coated tablets 6 mm in diameter.
15 film-coated tablets in a blister of solid, colorless, clear PVC / aluminum foil. 2 blisters in a cardboard box, together with a leaflet.
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