Proflosin caps. kish.rastv.prolong. 0.4mg 30 pc

Description

Composition
Active substance:
1 capsule contains: tamsulosin hydrochloride – 0.40 mg ;.
Excipients:
Microcrystalline Cellulose – 276.90 mg; methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30% – 16.50 mg; triethyl citrate – 1.65 mg; talc – 16.5 mg Purified Water – 12.48 mg. Sheath: methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30% – 21.63 mg; talc – 8.65 mg; triethyl citrate – 2.16 mg.
Capsule
Capsule Shell: iron oxide red dye, E 172 – 0.0239 mg of titanium dioxide, E 171 – 0.530 mg Yellow iron oxide coloring E 172 – 0,258 mg gelatine – 38.938 mg. Cap capsules: indigo, E132 – 0.00152 mg, black iron oxide coloring E 172 – 0.0107 mg of titanium dioxide, E 171 – 0.356 mg Yellow iron oxide coloring E 172 – 0,114 mg gelatine – 23.889 mg .
Description:
Enteric sustained-release capsules
The contents of capsules (pellets, enteric coated).
Product form:
Capsules enteric sustained-release 0.4 mg. 10 capsules in blister PVC / PE / PVDC and aluminum foil. 1, 3 or 10 blisters together with instructions for medical application is placed in a cardboard box.
Contraindications
Hypersensitivity to tamsulosin or other components of the formulation; orthostatic hypotension (including history); severe liver failure.
Precautions chronic renal failure (creatinine clearance less than 10 mL / min); hypotension.
Precautions chronic renal failure (creatinine clearance less than 10 mL / min); hypotension.
Dosage
0.4 mg
Indications
Benign prostatic hyperplasia (treatment dizuricheskih disorders).
Interaction with other drugs
Tamsulosin does not interact with atenolol, enalapril, nifedipine and theophylline. While the use of cimetidine was a slight increase in the concentration of tamsulosin in blood plasma; furosemide – reduction in the concentration, however this does not require dose adjustments Proflosina drug as the drug concentration is within the normal range. Diclofenac and warfarin may increase the rate of excretion of tamsulosin. Simultaneous with the appointment of tamsulosin with other alpha1-adrenergic blockers may lead to lower blood pressure.
Overdose
Overdoses while taking the drug was not observed up to the present time. However, theoretically there is potential for a sharp decrease in blood pressure and tachycardia, which may require appropriate measures. For recovery of blood pressure (including orthostatic hypotension when) and heart rate of the patient to normal values ​​is necessary to lay. Hemodialysis impractical because tamsulosin has high affinity for plasma proteins. To prevent further absorption of tamsulosin expedient gastric lavage, activated charcoal or osmotic laxatives (e.g., sodium sulfate).
pharmachologic effect
Pharmacological group:
Alpha1 – blocker.
Pharmacodynamics:
Tamsulosin selectively and competitively blocks postsynaptic alpha1-adrenergic receptors located in the smooth muscle of the prostate, bladder neck and prostatic urethra. This leads to a reduction in smooth muscle tone of the prostate, bladder neck, prostatic urethra and improve urine flow. Alpha-adrenergic blockers can reduce blood pressure (BP) by decreasing peripheral vascular resistance. However, during clinical studies with tamsulosin in patients with normal blood pressure levels, clinically significant reductions in blood pressure were observed.
Pharmacokinetics:
Suction
After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. Absorption of tamsulosin slows down somewhat after a meal. After a single dose of the drug into a dose of 0.4 mg maximum concentration (Cmax) of tamsulosin in plasma achieved after approximately 6 hours. Distribution
Communication with plasma proteins – about 99%, volume of distribution is small – 0.2 l / kg. Metabolism
Tamsulosin is not subjected to the effect of “first pass” and slowly metabolised in the liver to form the less active metabolites. Most of tamsulosin present in the blood in unchanged form. The experiment revealed the ability of tamsulosin slightly induce the activity of microsomal liver enzymes. breeding
Tamsulosin and its metabolites are excreted mainly in urine, 9% of the drug appears unchanged. The half-life (T1 / 2) of tamsulosin is about 10 hours (single dose after meal), when taken regularly – 13 hours.
Conditions of supply of pharmacies
On prescription.
side effects
Possible side effects when using the drug are listed below in descending frequency of occurrence: often (1/100) infrequently (1/1000), rare (1/10000), very rarely (
Other: in some cases – the development of iris syndrome, atonic (narrow pupil syndrome) during cataract surgery, fatigue, rhinitis.
special instructions
At the first signs of orthostatic hypotension (dizziness, weakness) the patient must sit or lay. Before starting therapy with Proflosina should be excluded if the patient has diseases and conditions that can determine the symptoms, similar to those of benign prostatic hyperplasia. Before starting treatment and regularly during therapy should be performed digital rectal examination and, if necessary, to determine the concentration of prostate specific antigen (PSA). In case of angioedema, stop therapy with Proflosina. Re-appointment of the drug is contraindicated. When surgery for cataracts in patients receiving the drug may develop iris syndrome, atonic, it is necessary to consider surgery to preoperative patient preparation and conduct of operations. Effects on ability to drive a vehicle and other complex mechanisms need to be cautious when driving and activities potentially hazardous activities that require high concentration and speed of psychomotor reactions, due to the fact that the possible development of vertigo.
Storage conditions
At a temperature of not higher than 30 C. Keep out of reach of children !.
Dosing and Administration
Inside, 1 capsule 1 once a day after breakfast or the first meal. The capsule should be swallowed whole without chewing, drinking plenty of water. The capsule can not be divided into parts or crush, as this may affect the release rate of the active ingredient. Duration of application is not limited.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist