SUMMARY OF PRODUCT CHARACTERISTICS

1. TRADE NAME OF THE MEDICINAL PRODUCT

ADENOPROSIN 150 mg rectal suppositories

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2.1. General description

ADENOPROSIN is a medicine, the active substance of which is an active complex, obtained from the larvae of the insect Lymantria dispar.

2.2 Qualitative and quantitative composition

1 suppository contains the active complex ADENOPROSIN^® – 150 mg, in terms of total protein 29 mg.

The other ingredients are excipients with known effect.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suppositories.

Description of the medicine

Cylinder-conic form from yellow to brown colour suppository. It is allowed heterogeneity of the hue in the form of inclusions of a darker colour.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

ADENOPROSIN is recommended for men in the treatment of the following conditions:

• benign prostatic hyperplasia (BPH);
• chronic prostatitis (in complex treatment);
• chronic pelvic pain syndrome;
• conditions after prostate surgery.

4.2  Posology and method of administration

Dosage

ADENOPROSIN is administered as 1 suppository daily.

Children and adolescents

Suppositories are unsuitable for children and adolescents aged less than 18 years.

Method of administration

Rectal, preferably evening at one and the same hour. It is recommended to administer the suppositories after defecation or enema. After administration of the suppository it is recommended to find the patient lying down for a period of 30-40 minutes.

The duration of treatment is 1 to 3 months depending on the intensity of inflammatory processes of the prostate, the degree and symptoms of manifestation of the prostate adenoma and their associations. If necessary, the cure may be repeated.

4.3  Contraindications

Acute urinary retention, hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

This is not the case.

4.5 Interaction with other medicinal products and other forms of interaction

The cases of clinically significant drug interaction of ADENOPROSIN 150 mg rectal suppositories with other drugs have not been reported.

4.6 Fertility, pregnancy and lactation

ADENOPROSIN should not be used by women.

4.7 Effects on ability to drive and use machines

ADENOPROSIN has no influence on the ability to drive and use machines.

4.8 Side effects

Side effects associated with ADENOPROSIN therapy, reported by system organ class and frequency.

The following terms and frequencies are applied: very common (1/10), common (1/100 to <1/10), uncommon (1/1000 to <1/100), rare (1/10,000 to <1/1000), and very rare (<1/10,000). Where frequency can not be estimated from clinical trials data, it is recorded as “Not known”.

Gastrointestinal disorders: rare – diarrhea or frequent stools.

General disorders and administration site conditions: not known – anal pruritus.

Reporting side effects

Reporting suspected side effects after authorization of the medicine is important. This allows the benefit/ risk ratio of the medicine to be monitored further. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system available on the official website of the Agency for Medicines and Medical Devices at the following web address: www.amed.md or e-mail: farmacovigilenta@amed.md

4.9 Overdose

Cases of overdose have not been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Genito urinary system and sex hormones. Urologicals. Other urologicals., ATC code: G04BX

Mechanism of action

The active substance of ADENOPROSIN is a biomass from larvae of certain insect species (Lymantria dispar), which have antioxidant, vasoprotective, anti-inflammatory and immunomodulatory action.

Biologically active compounds of the drug reduce the formation of phospholipase A2 and the release of arachidonic acid by decreasing the synthesis of prostaglandins and leukotrienes (inhibits 5-lipoxygenase). The medicine reduces vascular permeability and prostate edema, improves prostatic microcirculation, induces apoptosis of cells, thus reducing the size of the hyperplastic prostate. By pathogenetic and non-specific mechanisms, ADENOPROSIN improves urodynamic parameters (increases urine flow rate, reduces urine time, reduces residual urine) and the overall status of patients with benign prostatic hyperplasia (HBP) and chronic prostatitis (reduces index of chronic prostatitis, reduces leukocyte content in prostatic secretions, improves uniformity of prostate ecto-structure).

The drug also regulates the tone and peristalsis of the lower urinary segments, making micturitions more efficient with diminishing the frequency, especially of the night, reducing the dysuria, feeling of incomplete bladder emptying and tension during urination. The antioxidant action is determined by the water-soluble antioxidant compounds of the preparation and is manifested by the inhibition of lipid peroxidation.

5.2 Pharmacokinetic properties

Given that ADENOPROSIN possesses a complex action on the macro-organism, determined by the cumulative effect of the biologically active substances of the extract from larvae of certain insect species (Lymantria dispar), it is not possible to perform pharmacokinetic studies at this time.

5.3 Preclinical safety data

Acute, sub-chronic and chronic experiments on mice, rats and dogs from preclinical studies have shown that the medicine does not influence:

• general condition and behavior of animals,
• increasing body mass,
• parameters of peripheral circulation, including biochemical parameters,
• indicators of metabolism of proteins, lipids and carbohydrates,
• male testosterone level,
• males breeding function.

The drug does not cause pathological changes at macroscopic level and histological changes of internal organs, does not present teratogenic, carcinogenic and embryotoxic properties.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Solid semi-synthetic glycerides (Hard fat)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 months

6.4 Special precautions for storage

Store below 25°C. Do not freeze. Store in the original package, in order to protect from light and moisture.

Keep out of the reach and sight of children.

6.5  Nature and contents of container

Primary packaging. PVC/PE contour cell package (blister) containing 5 suppositories.

Secondary packaging. Each 2 blisters with the package leaflet are packed in individual cardboard boxes from the “chrome” group according to GOST 7933-89 or “chrome-plated” according to ТU 13 – 0281020 – 97 – 90 or according to ST “Leaflets for the pharmaceutical industry” “Imprimart” , Chisinau Moldova.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

S.C. BIOTEHNOS S.A.

3-5 Gorunului street, Otopeni,

Ilfov district, code 075100 Romania

Phone: +4(031) 710 24 02

Fax: +4(031)710.24.00

E-mail: office@biotehnos.com

8. MARKETING AUTHORISATION NUMBER(S)

24817

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31.07.2018

10. DATE OF REVISION OF THE TEXT

July 2018