Blissel

Blissel is indicated for the treatment of symptoms of vaginal atrophy associated with estrogen deficiency in postmenopausal women.

Features of application

For the treatment of postmenopausal symptoms, topical estrogen therapy should only be initiated if symptoms that negatively affect quality of life occur.

In all cases, the risks and benefits should be carefully assessed at least once a year, and hormone replacement therapy (HRT) should be used only as long as the benefits outweigh the risks.

Blissel, vaginal gel, 50 mcg/g, should not be combined with estrogen preparations for systemic treatment, as there are no studies on the safety and risks associated with the estrogen concentration achieved with combined treatment.

The intravaginal applicator, which consists of a disposable cannula and a reusable plunger, may cause minor local damage, especially in women with severe vaginal atrophy.

Medical examination / further treatment

A complete personal and family history should be taken before starting or resuming/recommencing estriol treatment. A physical examination (including pelvic and breast examination) should be performed taking into account the patient's medical history, contraindications and warnings regarding the use of the drug. During the course of treatment, it is recommended to conduct periodic medical examinations of the patient, the frequency and nature of which depend on individual characteristics. Women should be informed about the changes in the mammary glands that they should report to their doctor or nurse.

It is recommended to perform examinations, including mammography, in accordance with current screening practices, which are adjusted to the clinical needs of the individual patient. In the presence of vaginal infections, they should be treated prior to initiation of therapy with Blissel, vaginal gel, 50 mcg/g.

Conditions that require medical supervision

If the following conditions are present or if they were observed earlier and/or worsened during pregnancy or previous hormonal therapy, the patient should be closely monitored, as these conditions may recur or worsen during treatment with Vaginal Gel:

- leiomyoma (uterine fibroids) or endometriosis;

- risk factors for thromboembolic disorders;

- risk factors for estrogen-dependent tumors, such as a family history of breast cancer in relatives of the 1st line;

- hypertension;

- liver disease (e.g. hepatoadenoma);

- diabetes mellitus with or without diabetic angiopathy;

- cholelithiasis;

- migraine or severe headache;

- systemic lupus erythematosus (SLE);

- history of endometrial hyperplasia;

- epilepsy

- asthma;

- otosclerosis.

Reasons for immediate discontinuation of treatment

Therapy should be discontinued immediately if any of the contraindications are identified, as well as in the following situations:

- jaundice or deterioration of liver function;

- significant increase in blood pressure;

- a new migraine headache attack;

- pregnancy.

Warnings about excipients

Blissel Vaginal Gel, 50 mcg/g contains sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (possibly delayed).

Interaction with other medicinal products and other types of interactions

No interaction studies have been conducted between Blissel Vaginal Gel 50 mcg/g and other medicinal products. Due to its topical application and minimal systemic absorption, it is unlikely that any clinically significant drug interaction with Blissel will occur. However, the possibility of interaction with other topical medicinal products for vaginal use should be considered.

• active ingredient: estriol;
• 1 g of vaginal gel contains 50 mcg of estriol;
• excipients: polycarbophyll, carbopol 971P, glycerin, sodium methylparahydroxybenzoate (E 219), sodium propylparahydroxybenzoate (E 217), hydrochloric acid, sodium hydroxide, purified water.

For intravaginal use.

The medicine is administered into the vagina using an applicator consisting of a disposable cannula with a filling mark and a reusable piston, carefully following the “Instructions for Use” below. It is advisable to administer the drug at bedtime.

One dose (cannula filled to the mark) contains 1 g of gel, which corresponds to 50 mcg of estriol.

Treatment can be started at any time after the onset of vaginal atrophy.

Initial treatment. One dose of vaginal gel daily for 3 weeks.

As maintenance treatment. One dose of vaginal gel twice a week is recommended. A doctor should assess the need for continuation of treatment after 12 weeks.
For the initial and continued treatment of postmenopausal symptoms, the lowest effective dose should be used for the shortest possible duration (see the full Instructions for medical use of Blissel).

It is not recommended to use progestogen-containing medicinal products together with vaginal medicinal products containing estrogen, in which systemic estrogen exposure remains within the normal postmenopausal range (see the full Instructions for medical use of Blissel).

If you miss a dose, it should be administered as soon as you remember, if no more than 12 hours have passed since the scheduled dose. If more than 12 hours have passed, the missed dose should not be administered, and treatment should be continued as usual.

Instruction for use

1. Remove the cap from the tube, turn it over, and use the sharp protrusion on the cap to open the tube (pierce the seal on the tube).

2. Remove one disposable cannula and a reusable plunger from the package. Insert the plunger as far as it will go into the cannula. Screw the cannula onto the neck of the tube.

3. Squeeze the tube, filling the applicator with gel until the piston stops at the filling mark.

4. Unscrew the cannula from the tube and close the tube cap.

5. To administer the gel, lie on your back with your knees bent in a spread position, gently insert the open end of the applicator deep into the vagina and slowly press the plunger until it is completely empty, then pull it out.

6. Pull the plunger out of the cannula, discard the cannula, and rinse the plunger with clean, warm water so that it can be used for future applications.

• Established, past or suspected breast cancer.
• Established or suspected estrogen-dependent malignancies (e.g. endometrial cancer).
• Vaginal bleeding of uncertain etiology.
• Untreated endometrial hyperplasia.
• Previous idiopathic or existing venous thromboembolism (deep vein thrombosis, pulmonary embolism).
• Active or recent arterial thromboembolism (e.g. angina pectoris, myocardial infarction).
• Established thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency).
• Acute liver disease or history of liver disease until liver function tests return to normal.
• Hypersensitivity to the active substance or to any excipient.
• Porphyria.

Use during pregnancy or lactation

Fertility

There are no data on the effect of the drug on fertility. 

Pregnancy

The drug should not be used during pregnancy. If a woman becomes pregnant during treatment, therapy should be discontinued immediately. 
There are no clinical data on the effect of estriol on pregnancy. So far, the results of most epidemiological studies on unintentional fetal exposure to estrogens do not indicate the presence of teratogenic or fetotoxic effects. 

Breast-feeding period 

The medicine should not be used during breastfeeding. 

Ability to influence the reaction rate when driving or using other mechanisms

Blissel Vaginal Gel, 50 mcg/g does not affect the ability to drive vehicles or use other machinery.

Children

The medicine is not intended for use in children.

Overdose

Estriol toxicity is very low, so an overdose of Blissel Vaginal Gel 50 mcg/g is unlikely with intravaginal administration. Symptoms that may occur in the event of accidental ingestion of a high dose include nausea, vomiting, and vaginal bleeding in women. No specific antidote is known. If necessary, symptomatic treatment is required. 

Adverse reactions

Adverse reactions are usually reported in 3-10% of patients treated. At the beginning of treatment, when the vaginal mucosa is still atrophic, local irritation in the form of heat and/or itching may occur. For adverse reactions identified in clinical trials of Blissel, vaginal gel, 50 mcg/g, see the full Instruction for medical use of Blissel.

10 g of vaginal gel in an aluminum tube with a cap, 1 aluminum tube with a cap, complete with 1 blister containing 10 disposable cannulas and 1 reusable plunger, in a cardboard box.

Registration certificate No. UA/20229/01/01

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children.

ITALPHARMACO, S.A., S/San Rafael 3, Pol. Ind. Alcobendas, Alcobendas, Madrid, 28108, Spain.