VELBIENNE Film-coated tablet (2022)

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1. Name of the medicinal product

Velbienne 1 mg/2 mg, film-coated tablet.

2. Qualitative and quantitative composition

Each film-coated tablet contains: estradiol valerate 1.0 mg (equivalent to 0.764 mg estradiol) and dienogest 2.0 mg. Excipients with known effect: each tablet contains 58.22 mg of lactose monohydrate. ...

3. Pharmaceutical form

Film-coated tablet. Tablets are light pink and rounded with a diameter of 6 mm approx.

4.1. Therapeutic indications

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with more than one year post menopause. Experience of treating women older than 65 years is limited.

4.2. Posology and method of administration

Posology How to start Velbienne 1 mg/2 mg Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined HRT product may start treatment at any time. Women ...

4.3. Contraindications

Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current ...

4.4. Special warnings and precautions for use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken ...

4.5. Interaction with other medicinal products and other forms of interaction

Note: The prescribing information of concomitant medication should be consulted to identify potential interactions. Effects of other medicinal products on Velbienne Substances increasing the clearance ...

4.6. Fertility, pregnancy and lactation

Pregnancy Velbienne is not indicated during pregnancy. If pregnancy occurs during medication with Velbienne, treatment should be withdrawn immediately. For dienogest no clinical data on exposed pregnancies ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use of machines have been observed in users of estradiol valerate 1 mg/dienogest ...

4.8. Undesirable effects

The following table (System Organ Class MedDRA v. 8.0) attributes frequencies to the undesirable effects of estradiol valerate 1 mg/dienogest 2 mg. These frequencies are based on the frequencies of adverse ...

4.9. Overdose

Acute toxicity studies indicated that, even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. Overdose may cause nausea and vomiting and ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations ATC code: G03FA Estradiol valerate The active ingredient, synthetic 17ß-estradiol, which is chemically and biologically ...

5.2. Pharmacokinetic properties

Estradiol valerate Absorption After oral administration estradiol valerate is completely absorbed. Cleavage to estradiol and valeric acid takes place during absorption by the intestinal mucosa or in the ...

5.3. Preclinical safety data

Estradiol valearate The toxicity profile of estradiol is well known. There are no preclinical data of relevance to the prescriber that are additional to those already included in other sections of the ...

6.1. List of excipients

Core: Lactose monohydrate Maize starch Pregelatinized maize starch Povidone K30 (E1201) Magnesium stearate (E572) Coating: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol/PEG 3350 ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

6.5. Nature and contents of container

Blister of PVC/PVDC/aluminium. Supplied in cartons containing 28, 3 28, or 6 28 coated tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Exeltis Healthcare S.L, Av. Miralcampo 7-Poligono Ind. Miralcampo 19200, Azuqueca de Henares, Guadalajara, Spain

8. Marketing authorization number(s)

RVG 118123

9. Date of first authorization / renewal of the authorization

Date of first authorization: 21 juni 2018 Renewal of the authorization: 6 december 2021

10. Date of revision of the text

17 april 2022