SONIRID DUO SET OF PILLS 5MG + CAPSULES + 400MG

Indications

- treatment and control of symptoms of benign prostatic hyperplasia (BPH).

Dosage and administration

The drug Sonirid Duo contains Tamsulosin 400 μg in modified release capsules and 5 mg Finasteride in film-coated tablets.

Preparations are intended for daily use.

The daily dose of the drug Sonirid Duo includes 1 capsule with a modified release of tamsulosin 400 μg and 1 tablet, film-coated, finasteride 5 mg.

Tamsulosin 400 mcg, modified release capsules, must be taken at the same time of day, after a meal. Capsules should be swallowed whole, do not crush or chew, because this can disrupt the sustained release of the active ingredient.

For a full therapeutic effect, long-term use of the drug Sonirid Duo is necessary.

With the appearance of adverse reactions, you can transfer the patient to monotherapy with finasteride; however, it is recommended to return to the combined mode with increased severity of symptoms of BPH.

Adverse effects

Side effects are defined as: frequent (> 1/100 to <1/10); infrequent (> 1/1000 to <1/100); rare (> 1/10 000 to <1/1000); very rare (<1/10 000).

Undesirable reactions with tamsulosin monotherapy

Nervous system: frequent - dizziness; infrequent - headache; rare - fainting.

Cardiovascular: infrequent - postural hypotension, tachycardia.

Respiratory: infrequent - rhinitis.

Gastrointestinal: infrequent - constipation, diarrhea, nausea, vomiting.

On the part of the skin and subcutaneous fat: infrequent - rash, pruritus, urticaria; rare - angioedema.

From the reproductive system: infrequent - retrograde ejaculation; rare - priapism.

Adverse Reactions Monotherapy with Finasteride

Immune system: infrequent - hypersensitivity.

Special senses: infrequent - clouding of the lens.

From the digestive system: frequent - pain in the abdomen.

On the part of the skin and subcutaneous fat: infrequent - rash.

From the reproductive system and mammary glands: frequent - erectile dysfunction, impaired ejaculation, decreased ejaculate volume, decreased libido; infrequent - breast tenderness, increase in mammary glands, pain in the testicles.

During post-marketing surveillance, the following additional adverse reactions are described (data on the incidence of adverse reactions are not available): hypersensitivity reactions, including pruritus, urticaria, swelling of the lips and face.

Adverse reactions combined treatment

In patients receiving combined treatment (finasteride and α1-adrenergic blocker), described the same undesirable reactions that occur with the same frequency as with monotherapy with finasteride and α1-blocker. However, the following exceptions were identified: erectile dysfunction and impaired ejaculation were more frequent with combined treatment, while disease progression (including increased symptoms of BPH or the need for surgical treatment) was more common with monotherapy.

Contraindications

- the presence of postural hypotension in history;

- severe liver failure;

- impaired renal function (plasma creatinine concentration> 2 mg / dL);

- intolerance to galactose, lactase deficiency or glucose-galactose malabsorption;

- women and children;

- Hypersensitivity to active or auxiliary substances.

WITH caution: if there is a risk of obstructive uropathy; in diseases of the liver; when planning surgical treatment of cataracts.

Use during pregnancy and lactation

Sonirid Duo can not be used for women. Pregnant and women of reproductive age contact with crushed or compromised finasteride pills should be avoided, and contact with the seminal fluid of a man taking finasteride should be avoided (use a condom).

Application for violations of the liver

Contraindicated in severe liver failure. WITH caution in diseases of the liver.

Application for violations of kidney function

Contraindicated in impaired renal function (plasma creatinine concentration> 2 mg / dL).

Use in children

Contraindicated in children.

Use in elderly patients

In older patients, finasteride is slightly slower, but it has no clinical significance and does not require dose adjustment.

Special notes

When evaluating PSA, it is necessary to take into account the fact that PSA concentration decreases with treatment with finasteride. In most patients, PSA concentration decreases rapidly during the first month of treatment, and then stabilizes at a new baseline level. This post-therapeutic baseline is approximately equal to half the therapeutic value. Thus, in typical cases of treatment with finasterid for six months or more, PSA must be doubled to compare with normal values ​​in patients not taking finasteride. There were no other differences in standard laboratory values ​​between patients receiving placebo or finasteride.

Before starting treatment with Sonirid Duo, the patient should be examined to exclude the presence of other diseases that manifest the same symptoms as BPH. Before treatment, and regularly during treatment, a digital rectal examination and, if necessary, determination of PSA should be carried out.

Patients with a large amount of residual urine and / or severe difficulty urinating should be examined to detect obstructive uropathy.

Precautions when using tamsulosin

As with other α blockers.1-adrenoreceptors, during treatment with tamsulosin, blood pressure may decrease, which in rare cases leads to syncope. At the first signs of postural hypotension (for example, dizziness, weakness), the patient should be seated or placed until the symptoms disappear.

Intraoperative atonic iris syndrome (SAR, a variant of the small pupil syndrome) was observed during cataract surgery in some patients taking tamsulosin. Intraoperative SAR can increase the incidence of complications of the operation. It is not recommended to start treatment with tamsulosin in patients who are going to undergo cataract surgery. Termination of tamsulosin for 1-2 weeks before surgery usually reduces the risk, but the optimal time to stop taking it has not yet been established. In order to prevent the development of intraoperative atonic iris syndrome, the surgeon and ophthalmologists in the preoperative period should find out whether the patient has taken tamsulozin before or continues to take it. This will make it possible to take appropriate measures during planning and during surgery.

Precautions when using finasteride

Data on the possibility of entry of finasteride into the body during manual separation of the pill or during sexual intercourse upon contact with seminal fluid of a man taking finasteride is not available. In this regard, pregnant women and women of reproductive age are not recommended to share the pills with their hands, to avoid contact with the crushed or lost integrity tablets, and also to avoid contact with the seminal fluid of a man taking finasteride. Since the duration of the presence of finasteride in the seminal fluid of a man after stopping the drug is unknown, it is necessary to observe such precautions for 2 months after the end of treatment.

Finasteride pills contain lactose monohydrate. Patients with rare hereditary intolerance to galactose, lactase deficiency or impaired glucose-galactose absorption do not take the drug. Patients with lactose intolerance should take into account that the preparation contains 102.6 mg of lactose monohydrate.

Effect of finasteride on PSA concentration and diagnosis of prostate cancer

Before the start of treatment and periodically during treatment with finasteride, a digital rectal examination should be performed and, if necessary, the concentration of PSA should be determined. There is a significant coincidence of PSA concentrations in men with and without prostate cancer. Thus, in men with BPH, the PSA value, which is within the normal range due to the use of finasteride, does not exclude the presence of prostate cancer.The use of finasteride reduces the serum PSA concentration by approximately 50% in patients with BPH, even in the presence of prostate cancer. A decrease in the concentration of PSA is observed in the whole range of its values ​​and may be different in different patients. When assessing PSA, it is necessary to take into account that a decrease in plasma PSA in patients with BPH who take finasteride does not exclude the presence of prostate cancer. In patients taking finasteride for 6 months or more, PSA should be doubled to compare with normal values ​​in patients not taking finasteride. Such an adjustment preserves the sensitivity and specificity of determining the PSA index and makes it possible to diagnose prostate cancer.

With the ever-increasing PSA concentration in men taking finasteride, a thorough examination should be carried out. However, we cannot exclude the possibility of a violation of the dosing regimen specified in the instructions for use of finasteride.

Finasteride does not significantly reduce the proportion of free PSA and the ratio of free PSA to total; this indicator remains unchanged with finasteride treatment. When determining the proportion of free PSA for the diagnosis of prostate cancer correction is not required.

Influence on ability to drive motor transport and control mechanisms

No effects of finasteride have been identified.Especially such effects of tamsulosin were not investigated. However, you should consider the possibility of drowsiness, blurred vision, dizziness, fainting in some patients, and therefore they should temporarily refrain from driving and working with mechanisms with an increased risk of injury.

Overdose

No cases of simultaneous overdose with finasterid and tamsulosin have been described.

There is no clinical data on tamsulosin overdose. In theory, acute overdose with tamsulosin can cause hypotension, which can lead to cardiovascular disorders. To restore the blood pressure and heart rate of the patient, it is necessary to lay down, if necessary, plasma-substituting drugs and, depending on the condition of the patient, vasopressor drugs should be used. It is recommended to monitor the function of the kidneys. Dialysis is not indicated due to significant binding of tamsulosin to plasma proteins . To reduce the absorption of the drug, it is advisable to induce vomiting. Gastric lavage after ingestion of a large amount of the drug should be carried out together with the appointment of Activated carbon and osmotic laxative (for example, sodium sulfate).

Overdose finasteride: the use of a single dose of finasteride 400 mg and repeated intakes up to 80 mg / day for 3 months did not reveal undesirable reactions. With an overdose of specific treatment is not required.

Drug interaction

In in vitro studies of hepatic microsomal fractions (model of drug metabolism by the cytochrome P450 enzyme system), it was determined that tamsulosin does not enter into a pharmacokinetic interaction with finasteride during metabolism in the liver.

Additional tamsulosin interaction with other drugs and other types of interaction

No interaction was detected with the simultaneous use of tamsulosin and Atenolol , Enalapril , Nifedipine or theophylline.

Combined use with cimetidine can cause an increase in plasma tamsulosin concentration, while Furosemide causes its decrease. However, changing the dose of the drug is not required, because tamsulosin concentration remains in the normal range.

In vitro, diazepam, propranolol, trichloromethiazide, chlormadinone, Amitriptyline , Diclofenac , glibenclamide, Simvastatin and Warfarin do not alter the content of the free fraction of tamsulosin in human plasma.

Also tamsulosin does not change the content of the free fraction of diazepam, propranolol, trichloromethiazide and chlormadinone.

In in vitro studies of hepatic microsomal fractions (model of drug metabolism by cytochrome P450 enzyme system), no interaction with amitriptyline, Salbutamol , glibenclamide and finasteride was observed at the level of hepatic metabolism.

However, diclofenac and warfarin may increase the rate of elimination of tamsulosin.

Theoretically, there is a possibility that the combined use with tamsulosin may enhance the hypotensive effect of other drugs, such as general anesthesia or other α drugs.1-blockers.

Additional interactions with finasteride with other drugs and other types of interactions

No clinically significant interaction was found with the combined use of finasteride with the following drugs: warfarin, ACE inhibitors, α1-adrenoblockers, theophylline, Acetylsalicylic acid , Paracetamol , beta-blockers, diuretics, nitrates, slow Calcium channel blockers, anticonvulsants, NSAIDs , benzodiazepines, quinolones, histamine H blockers2-receptors, inhibitors of 3-hydroxy-3-methyl-glutaryl-coenzyme A-reductase (HMG-CoA).

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15 ° to 30 ° C.