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Instructions

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Instruction for use: Veregen

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Active substance Camellia sinensis leaf extract

Composition

Composition per 1 g of ointment:

active substance: Camellia Chinese leaves extract dry * - 100 mg;

auxiliary substances: isopropyl myristate 350 mg; paraffin soft white (petrolatum white) - 295 mg; wax bee white - 200 mg; propylene glycol stearate (propylene glycol monopalmitostearate) - 50 mg; oleyl alcohol-5 mg

* Camellia Chinese leaves extract dry peeled with a content of 55 to 72% (-) -spigallocatasinchinagallate.

Composition and form of release

Ointment for external use

Description of dosage form

Homogeneous ointment from reddish-brown to brown, free from solid particles.

Pharmacological group

Herbal origin means.

Pharmacodynamics

Veregen® is a drug whose action is determined by biologically active substances (catechins), which is part of the active ingredient - the camellia of Chinese leaves of the extract of dry. The mechanism of action of the drug is not currently established.

Pharmacokinetics

No data available.

Indications

Treatment of external genital and perianal condylomas (genital warts) in immunocompetent patients aged 18 years.

Contraindications

Hypersensitivity to the active ingredient or auxiliary components of the drug;

Vaginal, urethral or anal application of ointment;

Application on mucous membranes;

Children and adolescents under 18 years of age (due to the lack of sufficient clinical data);

Dysfunction of the liver of severe severity (due to lack of sufficient data on efficacy and safety):

Immunosuppressive therapy.

pregnancy and lactation

The drug is not recommended for use in pregnancy (due to the lack of clinical data for use in this category of patients and the availability of the drug in the reprotoxic properties). Since no studies have been performed as to whether the components of the drug or its metabolites are excreted in breast milk, the use of the drug during breast-feeding is not recommended (it is impossible to exclude the risk of side effects in the child).

Dosing and Administration

The drug is intended for external use. It is applied 3 times a day. A single dose of ointment 250 mg (which roughly corresponds to a strip of ointment 0.5 cm long) should be evenly distributed to all external genital and perianal condylomas in such a way that each condyloma is covered with a thin layer of ointment. The daily dose of ointment is 750 mg. The drug is used until all warts disappear, but not more than 16 weeks (the maximum duration of treatment), even if new condylomas appear during treatment.

If the dose is missed, the treatment should be continued in accordance with the instructions for use.

It is recommended to wash your hands before and after applying the product.

It is not necessary to rinse off the remaining ointment before the next application.

It is necessary to wash off the remnants of the drug before sexual relations.

Women who use tampons need to insert a tampon before applying the ointment.

Side effects

Frequency of adverse reactions: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10000, <1/1000); very rarely (<1/10000).

General disorders and disorders at the site of administration

Local reactions at the site of application, erythema, erythema, itching, irritation / burning, pain, ulceration, puffiness, compaction, blisters

Local reactions at the site of application, such as exfoliation, discharge, bleeding, swelling

Local reactions at the site of application, such as discoloration, discomfort, dryness, erosion, cracks, hyperesthesia, numbness, scars, nodules, dermatitis, hypersensitivity, local necrosis, papules and eczema

Violations of the blood and lymphatic system

Inguinal lymphadenitis / lymphadenopathy

Infectious and parasitic diseases

Pyoderma, vulvitis, vaginal discharge, infections at the site of application, pustules at the site of application, genital herpes, staphylococcal infection, urethritis, vaginal candidiasis, vulvovaginitis

Disorders from the kidneys and urinary tract

Dysuria, urgent urination, pollakiuria

Violations of the genitals and mammary gland

Phimosis

Stenosis of the external opening of the urethra, balanitis, dyspareunia

Disturbances from the skin and subcutaneous tissues

Rash and papular rash

The maximum severity of local reactions is observed in the first weeks of treatment.

Disorders from the liver and biliary tract: the literature describes cases of hepatotoxicity when administered orally with high doses of green tea extract. In studies of the drug Veregen®, an ointment of 10%, undesirable effects on liver function have not been established. On cases of identifying side effects from the liver and bile ducts, please inform the organization that accepts customer claims.

Overdose

Cases of drug overdose are unknown.

At casual oral reception the symptomatic treatment is shown. There is no specific antidote.

Interaction

Studies of the interaction of the Vereten® ointment with other drugs have not been conducted. Do not use other external medicines and methods of treating genital warts simultaneously, including sedentary baths, external use of preparations containing zinc or vitamin E, etc. It should avoid the use of high doses of green leaf extract (including in food additives).

special instructions

Avoid contact with eyes, nostrils, lips and horn.

Do not apply ointment on open wounds, damaged or inflamed skin. It is not recommended to prescribe the drug Vereten® after any recently transferred

surgical operations or drug therapy until complete healing of the skin.

It is not permissible to use the drug Veregen® for the treatment of urethral, intravaginal, cervical, rectal or intranatal condylomas. Patients with genital warts in the vulva should use the ointment with caution, since treatment in this area often causes skin reactions of severe severity.

Avoid accidental application of the ointment in the vagina. If you accidentally get the drug Vereten® in the vagina, immediately wash off the ointment with warm water and mild soap.

Male patients who have not been circumcised who undergo treatment for genital warts should daily stretch and rinse the foreskin to prevent phimosis. At the first signs of the appearance of strictures (for example, ulcers, densification or increasing difficulty in stretching the foreskin), treatment should be discontinued.

During treatment, the appearance of new warts.

Condoms should be used until the complete cure for all genital warts, as the drug Veregen® does not contribute to the elimination of HPV (human papilloma virus) and does not prevent the infection of others.

The drug "Veregen" can reduce the protective function of condoms and vaginal diaphragms. In this regard, before using condoms and sexual contacts, it is necessary to wash off the ointment from the treated areas. Additional methods of contraception should be provided.

In case of infection of the patient's sexual partner, simultaneous treatment of the partner is recommended to prevent re-infection of the latter.

Do not expose the treated area of the skin to sunlight or UV irradiation, as the drug was not tested under these conditions.

Avoid the use of an occlusive dressing.

After application, the ointment can leave stains on clothing and bedding.

When treating very often, local skin reactions of mild severity, such as erythema, pruritus, irritation (mainly burning), pain and swelling at the site of application, which should not lead to withdrawal of the drug. Symptoms of the reactions must pass after the first pedal treatment.

Interruption of treatment can be shown in the case of the development of intense local skin reactions, causing unbearable discomfort, increasing the severity

or associated with enlarged lymph nodes. Treatment with Veregen® can be resumed after a reduction in skin reactions.

In case of local skin reaction with the appearance of blisters, the patient should consult a doctor to exclude herpes genitalia.

The efficacy and safety of patients taking immunosuppressants have not been studied. Such patients should not use Veregen®.

No studies have been conducted to study the efficacy and safety of treatment lasting more than 16 weeks or conducting several courses of treatment.

Patients with severe liver damage (for example, a clinically significant increase in hepatic enzyme activity, increased bilirubin, an increase in INR (an international normalized ratio) should not use the drug because of insufficient data on safety studies.The drug Veregen® contains propileglycol monopalmitostearate, which can cause skin irritation, and isopropyl myristate, which can cause irritation and skin allergy.

Children

Clinical studies of the efficacy and safety of the drug in children have not been conducted.

The ability to influence the reaction rate when driving or working with other machinery

The study of the influence of the drug Veregen ® on the ability to drive and other mechanisms was not carried out. It is believed that the effect of the drug on these processes is absent or insignificant.

Form of issue

Ointment for external use 10%.

For 15 or 30 grams in aluminum tubes with a cap screwed from high-density polyethylene. Each tube, together with instructions for use, is placed in a cardboard pack.

Storage conditions

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years. After opening the tube, store it for no more than 6 weeks. Do not use after expiry date.

Conditions of leave from pharmacies

prescription

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