Effex^® Tribulus (Tablets) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

G04BE (Drugs for the treatment of erectile dysfunction)

Active Substance

Tribulus terrestris (Grouping name)

Dosage Form

Effex® Tribulus

Film-coated tablets, 250 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brown in color, round, biconvex; the cross-section is light brown in color, and the presence of inclusions of brown, white, or yellowish-white color is allowed.

* extractant ethyl alcohol 70%.

Excipients: lactose, potato starch, microcrystalline cellulose, povidone K17, crospovidone, talc, colloidal silicon dioxide, calcium stearate.

Film coating composition: hypromellose (hydroxypropyl methylcellulose), macrogol 400 (polyethylene glycol 400), iron oxide red dye, titanium dioxide, polysorbate 80, iron oxide black dye, talc.

15 pcs. – blister packs (4) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with a stimulating effect on sexual activity and hypolipidemic action

Pharmacotherapeutic Group

Drugs used in urology; drugs for the treatment of erectile dysfunction

Pharmacological Action

Effex^® Tribulus is a herbal preparation obtained from the aerial part of Tribulus terrestris L., containing mainly furostanol-type steroid saponins.

It has a general tonic effect and stimulates some functions of the reproductive system. In men, it restores and improves sexual libido and prolongs erection time. It stimulates spermatogenesis, increasing the number of spermatozoa and their motility.

The mechanism of action of Tribulus terrestris extract is unknown. It is assumed that the predominant compound protodioscin is metabolized in the body to dehydroepiandrosterone (DHEA), which has a beneficial effect on immunity, cell membrane integrity, erectile function, and cholesterol metabolism.

It is known that cholesterol is the initial substance for the synthesis of all steroids, including DHEA, testosterone, and estradiol, which also explains the hypolipidemic effect of the drug.

Other active furostanol saponins that are part of the Tribulus terrestris extract probably modulate the effect of protodioscin.

The drug has a hypolipidemic effect, and in patients with lipoproteinemia, it reduces total cholesterol and low-density lipoproteins, without affecting serum triglyceride and high-density lipoprotein levels.

Pharmacokinetics

Pharmacological studies in humans have not been conducted. Tribulus terrestris dry contains a complex of biologically active substances, which makes it impossible to conduct pharmacokinetic studies.

Indications

For adults in complex therapy for

• Erectile dysfunction, incl. accompanied by decreased libido;
• Male infertility due to idiopathic oligoasthenoteratozoospermia (decrease in the quantity and quality of spermatozoa in the ejaculate), surgical intervention for varicocele (varicose veins of the spermatic cord of the testicle), immunological infertility;
• Dyslipidemia to reduce the level of total cholesterol.

ICD codes

Dosage Regimen

Orally, after meals.

For erectile dysfunction and infertility, 1-2 tablets 3 times/day. The duration of treatment is at least 90 days. The course of treatment can be repeated on the recommendation of a doctor.

For dyslipidemia to reduce the level of total cholesterol: 2 tablets 3 times/day. The course is at least 3 months. Repeated courses – on the recommendation of a doctor.

Children

Safety and efficacy in children aged 0 to 18 years have not been established. Data are not available.

Adverse Reactions

Allergic reactions are possible.

From the gastrointestinal tract – irritating effect on the gastric mucosa (nausea).

Contraindications

• Hypersensitivity to Tribulus terrestris herb extract or to any of the excipients included in the preparation;
• Prostatic hyperplasia;
• Severe cardiovascular diseases (stroke, myocardial infarction) within the last year;
• Severe, unstable and uncontrolled cardiovascular diseases (unstable angina, chronic heart failure with symptoms at rest, sick sinus syndrome or conduction disorders such as sinoatrial block, atrioventricular block II or III degree, bradycardia <50 beats/min);
• Renal diseases (severe renal failure (CrCl <25 ml/min or creatinine >180 µmol/l));
• Galactosemia, Lapp lactase deficiency or glucose-galactose malabsorption syndrome;
• Pregnancy (see section “Pregnancy and lactation”);
• Breastfeeding period (see section “Pregnancy and lactation”);
• Age under 18 years.

With caution: in patients with diabetes mellitus.

Use in Pregnancy and Lactation

Pregnancy

The use of the drug is not recommended during pregnancy.

Breastfeeding period

The use of the drug is not recommended during breastfeeding.

Fertility

Data are not available.

Pediatric Use

Contraindicated for use under the age of 18 years.

Special Precautions

If there is no effect while taking the drug for 1 month, the patient should consult a doctor. To avoid a possible irritating effect of the drug on the gastric mucosa, it is recommended to take the drug after meals.

Excipients

Patients with diabetes mellitus should take into account that each tablet contains lactose and starch.

Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this drug.

Effect on the ability to drive vehicles and mechanisms

The drug Effex^® Tribulus does not affect the ability to drive vehicles and work with mechanisms.

Overdose

No cases of drug overdose have been reported.

Symptoms when using the drug in doses exceeding the recommended ones, dyspeptic disorders (nausea, vomiting) may occur.

Treatment symptomatic.

Drug Interactions

The drug may enhance the effect of diuretics and potentiate the hypotensive effect of antihypertensive agents.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.