Instructions for Omnic modified-release hard capsules 0.4 mg No. 30
Composition
active ingredient: tamsulosin hydrochloride;
1 capsule contains 0.4 mg of tamsulosin hydrochloride;
excipients: microcrystalline cellulose, acid methacrylate copolymer (type A), polysorbates, sodium lauryl sulfate, triacetin, calcium stearate, talc, capsule shell: gelatin, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
Dosage form
Modified-release capsules, hard.
Main physicochemical properties: oblong-shaped capsules (type 2) with an orange body and an olive-green cap, with black markings on the surface, the contents are a yellowish-white granular powder.
Pharmacotherapeutic group
Drugs used in benign prostatic hyperplasia. α1-adrenergic receptor antagonists. ATC code G04C A02.
Pharmacological properties
Pharmacodynamics
Omnic® selectively and competitively blocks postsynaptic α1-adrenoceptors, in particular α1A and α1D, located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra and an improvement in urine output. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced (difficulty starting urination, weakening of the urine stream, dribbling after urination, a feeling of incomplete bladder emptying, frequent urination, urge to urinate at night, urgency to urinate).
These effects persist for a long time with long-term treatment and significantly delay surgery or catheterization.
α1-adrenergic antagonists may lower blood pressure by reducing peripheral vascular tone. No clinically significant reduction in blood pressure was observed in studies of Omnic®.
Pharmacokinetics
Absorption: Tamsulosin is well absorbed from the gastrointestinal tract, and its bioavailability is almost 100%. Absorption of tamsulosin occurs somewhat more slowly after food intake. The same level of absorption is achieved when the patient takes Omnic® at the same time after a meal. The pharmacokinetics of tamsulosin is linear.
After taking a single dose of Omnic® after a meal, the peak concentration of tamsulosin in the blood plasma is reached after approximately 6 hours, and a stable concentration is observed on the fifth day after daily administration of the drug. Cmax is approximately two-thirds higher than that formed after taking a single dose.
Distribution: In men, tamsulosin is approximately 99% bound to plasma proteins. The volume of distribution of the drug is small (approximately 0.2 l/kg).
Metabolism: Tamsulosin hydrochloride is not subject to the first-pass effect and is slowly metabolized in the liver to form pharmacologically active metabolites that retain high selectivity for α1-adrenoceptors. Most of the active substance is present in the blood in unchanged form.
Elimination: Tamsulosin and its metabolites are excreted mainly in the urine. Approximately 9% of the dose remains as unchanged active substance.
After a single dose of Omnic® after a meal and at steady-state plasma concentrations, the half-lives are approximately 10 and 13 hours, respectively.
Indication
Treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia.
Contraindication
Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema, or to any of the excipients; history of orthostatic hypotension; severe hepatic impairment.
Interaction with other medicinal products and other types of interactions
Interaction studies have only been performed in adults.
No drug interactions have been observed with the simultaneous use of tamsulosin hydrochloride with atenolol, enalapril, nifedipine or theophylline. Simultaneous use with cimetidine increases, and with furosemide - decreases, the concentration of tamsulosin in the blood plasma, but since these levels remain within the normal range, there is no need for special dosage adjustment of tamsulosin.
In in vitro studies, diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin did not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin did not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone in human plasma.
However, diclofenac and warfarin may increase the elimination rate of tamsulosin.
Tamsulosin hydrochloride should not be administered in combination with strong CYP3A4 inhibitors in patients with poor CYP2D6 metabolism.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate CYP3A4 inhibitors.
Concomitant use of tamsulosin hydrochloride and paroxetine (a strong CYP2D6 inhibitor) leads to an increase in Cmax and AUC to 1.3 and 1.6, respectively, but this is not clinically significant.
Concomitant use with other α1-adrenergic blockers may enhance the hypotensive effect.
Application features
As with other α1-adrenergic blockers, in some cases, Omnic® may cause a decrease in blood pressure, which can sometimes lead to loss of consciousness. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the above symptoms disappear.
Before starting treatment with Omnic®, a medical examination should be performed to identify other concomitant diseases that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment, a rectal examination of the prostate gland and, if necessary, a test to determine the level of prostate-specific antigen (PSA) before starting and at regular intervals during treatment should be performed.
The drug should be prescribed with extreme caution to patients with severe renal insufficiency (creatinine clearance <10 ml/min), as clinical studies of the use of Omnic® in such patients have not been conducted.
Some patients who have taken or are taking tamsulosin have experienced atonic pupil syndrome (IFIS, a variant of pinhole pupil syndrome) during cataract and glaucoma surgery, which may lead to an increased number of complications during or after such surgery.
It is generally recommended that tamsulosin be discontinued 1 to 2 weeks before cataract and glaucoma surgery, but the benefit of discontinuing tamsulosin has not been clearly established. Atonic pupil syndrome has also been reported in patients who have discontinued tamsulosin for a long period prior to cataract surgery.
Patients undergoing elective cataract or glaucoma surgery should not be started on tamsulosin hydrochloride. In preparation for surgery, surgeons and ophthalmologists should inquire whether the patient has taken (or is taking) tamsulosin in order to prevent possible complications associated with IFIS.
Tamsulosin hydrochloride should not be administered in combination with strong CYP3A4 inhibitors in patients with poor CYP2D6 metabolism.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate CYP3A4 inhibitors (see Interactions with other medicinal products and other forms of interaction).
Cases of allergic reactions to tamsulosin have been reported in patients with a history of allergy to sulfonamides. Caution should be exercised when administering tamsulosin hydrochloride to patients with a history of allergy to sulfonamides.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect of the drug on the ability to drive or use machines have not been conducted. However, patients should be warned about the possibility of dizziness.
Use during pregnancy or breastfeeding
Omnic® is not indicated for use in women.
Fertility
Ejaculation disorders have been reported in short- and long-term clinical trials with tamsulosin. Cases of ejaculation disorders, retrograde ejaculation and insufficient ejaculation have been reported in the post-marketing period.
Method of administration and doses
Recommended dose for adults - 1 capsule daily after breakfast or after the first meal. The capsule should be swallowed whole, do not break or chew, as this will prevent the modified release of the active ingredient.
No dose adjustment is required for patients with renal impairment. No dose adjustment is required for patients with mild to moderate hepatic impairment (see also Contraindications).
Children
The drug should not be used in children.
The safety and efficacy of tamsulosin in children (under 18 years of age) have not been evaluated.
Overdose
Symptoms
Overdose with tamsulosin hydrochloride can potentially cause severe hypotensive effects. Severe hypotensive effects have been observed with varying degrees of overdose.
Treatment
In order to stop further absorption of the drug, vomiting can be induced artificially. In case of overdose of a significant amount of the drug, the patient should be washed with activated charcoal and low-osmotic laxatives, such as sodium sulfate.
Adverse reactions
| Body system | Common (>1/100, <1/10) | Uncommon (>1/1000, <1/100) | Rare (>1/10,000, <1/1,000) | Very rare (<1/10,000) | Unknown (cannot be estimated from available data) |
| Neurological disorders | Dizziness (1.3%)
| Headache | Faint | | |
| From the organs of vision | | | | | Blurred vision*, visual impairment* |
| From the heart | | Feeling of heart palpitations | | | |
| Vascular disorders | | Orthostatic hypotension | | | |
| Respiratory-mediastinal disorders | | Rhinitis | | | Nosebleed* |
| Gastrointestinal disorders | | Constipation, diarrhea, nausea, vomiting | | | Dry mouth* |
| Skin and mucous membrane disorders | | Rash, itching, hives | Angioedema | Stevens-Johnson syndrome | Erythema multiforme*, exfoliative dermatitis*, photosensitivity reaction* |
| Reproductive disorders | Ejaculation disorders, including retrograde ejaculation and ejaculatory failure | | | Priapism | |
| General disorders | | Asthenia | | | |
*Observed in the post-registration period
During post-marketing surveillance, cases of intraoperative iris instability (pinched pupil syndrome) during cataract and glaucoma surgery have been described in patients taking tamsulosin (see section "Special warnings and precautions for use").
Post-marketing experience: In addition to the above adverse reactions, cases of atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported. As these cases were reported spontaneously, the frequency of reports and the relationship to the use of tamsulosin cannot be reliably established.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister, 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Astellas Pharma Europe B.V.
Location of the manufacturer and its business address
Hogemat 2, 7942 JM Meppel, Netherlands.
