Velbienne mini

Leaflet accompanying the packaging: information for the user

Velbienne mini, 1 mg + 2 mg, film-coated tablets
Estradiol valerate and dienogest

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Table of contents of the leaflet

• 1. What is Velbienne mini and what is it used for
• 2. Important information before using Velbienne mini
• 3. How to use Velbienne mini
• 4. Possible side effects
• 5. How to store Velbienne mini
• 6. Contents of the packaging and other information

1. What is Velbienne mini and what is it used for

Velbienne mini is a medicine used for hormone replacement therapy (HRT).
for use in postmenopausal women, at least 12 months after their last natural menstrual period.

Relieve symptoms occurring after menopause

During menopause, the amount of estrogen produced by the woman's body decreases. This can
result in symptoms such as: a feeling of heat on the face, neck, and chest (so-called hot flashes). Velbienne mini relieves these symptoms (occurring after menopause). Velbienne mini is
prescribed only in cases where the symptoms significantly affect the patient's daily life.

2. Important information before using Velbienne mini

Medical history and regular check-ups

Using HRT is associated with a risk that should be considered when deciding to start or continue therapy.
Experience with the use of therapy in women with premature menopause (caused by ovarian failure or surgical procedures) is limited. In the case of women with premature menopause, the risk of using HRT may be different. You should consult a doctor.
Before starting (or reusing) HRT, the doctor will conduct a medical interview with the patient and their family. The doctor may perform a physical examination, including a breast examination and/or internal organs, if necessary.

• After starting Velbienne mini, you should regularly visit your doctor for check-ups (at least once a year). During these visits, you should discuss the benefits and risks of continuing to use Velbienne mini with your doctor.
• According to the doctor's recommendations, you should undergo regular breast examinations.

When not to use Velbienne mini

If any of the following points apply to the patient or if the patient has doubts about any of the following points, they should consult a doctorbefore using Velbienne mini.
Velbienne mini should not be used:

• if the patient currently has or has had breast canceror if there is a suspicion of it;
• if the patient has malignant tumor sensitive to estrogen, such as endometrial cancer (endometrium) or if there is a suspicion of it;
• if there is bleeding from the vagina of unknown cause;
• if there is untreated excessive thickening of the endometrium(endometrial hyperplasia);
• if the patient has or has had venous thromboembolic disease(deep vein thrombosis, e.g. of the lower limbs or lungs, e.g. pulmonary embolism);
• if the patient has blood coagulation disorders(such as protein C, protein S, or antithrombin deficiency);
• if the patient has or has recently had a disease caused by arterial thrombosis, such as heart attack, stroke, or angina pectoris;
• if the patient has or has had liver diseaseand liver function tests have not returned to normal,
• if the patient has a rare, inherited blood disorder called porphyria,
• if the patient is allergic to estradiol valerate, dienogest, or any of the other ingredients of this medicine (listed in point 6).

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If any of the above factors occur for the first time while using Velbienne mini, you should stop using the medicine and contact your doctor immediately.

Warnings and precautions

You should inform your doctor if you currently have or have had any of the following conditions, as they may recur or worsen during treatment with Velbienne mini .In such cases, you should be monitored more frequently:

• uterine fibroids,
• endometriosis or previous cases of endometrial hyperplasia,
• increased risk of thromboembolic disorders or a history of them (see "Thrombosis in the veins (thrombosis)"),
• increased risk of estrogen-sensitive tumors (e.g. if the patient's mother, sister, or grandmother had breast cancer),
• high blood pressure,
• liver function disorders, such as a benign liver tumor,
• diabetes,
• gallstones,
• migraine or severe headaches,
• an immune system disease that affects many organs in the body (systemic lupus erythematosus, SLE),

Systemic lupus erythematosus (SLE),

• epilepsy,
• asthma,
• a disease that affects the eardrum and hearing (otosclerosis),
• very high levels of fats (triglycerides) in the body,
• fluid retention due to heart or kidney problems,
• hereditary and acquired angioedema.

You should stop using Velbienne mini and contact your doctor immediately

If, while using HRT, you notice any of the following symptoms:

• any of the conditions listed in the "When not to use Velbienne mini" section;
• yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disease;
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing, which suggest the occurrence of angioedema;
• significant increase in blood pressure (possible symptoms include headaches, fatigue, dizziness);
• migraine-like headaches that occur for the first time;
• pregnancy;
• signs of thrombosis, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing. More information is available in the "Stop using Velbienne mini and contact your doctor immediately" section.

Note:Velbienne mini is not a contraceptive. If it has been less than 12 months since the last menstrual period or if the patient is under 50 years old, additional contraceptive measures may be necessary. You should consult a doctor.

HRT and malignant tumors

Excessive thickening of the endometrium (endometrial hyperplasia) and malignant tumor of the endometrium (endometrial cancer)

Using only estrogen HRT increases the risk of excessive thickening of the endometrium (endometrial hyperplasia) and malignant tumor of the endometrium (endometrial cancer). The presence of progestogen in Velbienne mini protects against this additional risk.

Irregular bleeding

Irregular bleeding or spotting may occur during the first 3 to 6 months of using Velbienne mini .However, if irregular bleeding:

• persists for more than 6 months;
• occurs when the patient has been using Velbienne mini for more than 6 months;
• persists after stopping Velbienne mini;

you should contact your doctor immediately.

Breast cancer

Evidence suggests that taking HRT in the form of a combination of estrogen and progestogen or estrogen alone increases the risk of breast cancer. This additional risk depends on how long the patient uses HRT. The additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
In the case of women aged 50 to 54 who do not use HRT, breast cancer will be diagnosed in approximately 13 to 17 out of 1,000 women over a period of 5 years.
In the case of women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1,000 patients (i.e. 0 to 3 additional cases).
In the case of women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 out of 1,000 patients (i.e. 4 to 8 additional cases).
In the case of women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in approximately 27 out of 1,000 women over a period of 10 years.
In the case of women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1,000 patients (i.e. 7 additional cases).
In the case of women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 out of 1,000 patients (i.e. 21 additional cases).
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You should regularly examine your breasts. You should contact your doctor if you notice any changes such as:

• indentations in the skin;
• changes in the breast;
• any visible or palpable thickening.

Regular mammograms are recommended. Before undergoing the examination, you should inform the healthcare staff or nurse about the use of the medicine, as HRT may increase breast density, which can affect the mammography result. In areas where breast density is increased, the mammogram may not detect all changes.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Using HRT that includes only estrogens or a combination of estrogens and progestogens is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed over a period of 5 years in approximately 2 out of 2,000 women. In women who have taken HRT for 5 years, it will occur in approximately 3 out of 2,000 women taking it (i.e. approximately 1 additional case).

Effect of HRT on the heart and circulation

Thrombosis in the veins (thrombosis)

The risk of developing venous thromboembolic diseaseis approximately 1.3 to 3 times higher in women using HRT, especially in the first year of treatment, than in women who do not use it.
Thrombosis can be dangerous. If a thrombus enters the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of thrombosis in the veins increases with age and depends on the presence of the following factors. You should inform your doctor if any of the following conditions apply to you:

• you are unable to walk for a long time due to extensive surgery, injury, or illness (see also point 3 "If surgery is necessary");
• you are obese (body mass index BMI > 30 kg/m);
• you have blood coagulation disorders and require long-term treatment with anticoagulant medication;
• any of your close relatives have had a thrombus in the lower limb, lung, or other organ;
• you have systemic lupus erythematosus (SLE);
• you have cancer.

Information about the symptoms of thrombosis can be found in the "Stop using Velbienne mini and contact your doctor immediately" section.
Comparison
In the case of women aged 50 to 59 who do not use HRT, a venous thrombus will occur in approximately 4 to 7 out of 1,000 women over a period of 5 years.
In women aged 50 to 59 who have used combined estrogen-progestogen HRT for more than 5 years, a venous thrombus will occur in 9 to 12 out of 1,000 women (i.e. 5 more cases).

Heart disease (myocardial infarction)

There is no scientific evidence to confirm that HRT can prevent myocardial infarctions.
Women over 60 years old who use combined estrogen-progestogen HRT are slightly more likely to develop heart disease than women who do not use HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in people using HRT than in those who do not use it. The number of additional cases of stroke caused by HRT increases with age.
Comparison
In the case of women aged 50 to 59 who do not use HRT, a stroke will occur in approximately 8 out of 1,000 women over a period of 5 years. In women aged 50 to 59 who use HRT, a stroke will occur in 11 out of 1,000 women over a period of 5 years (i.e. 3 more cases).

Other conditions

• HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at the age of 65 or older. You should consult a doctor.

Velbienne mini and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription, herbal medicines, or other natural products. Your doctor will advise you on the appropriate course of action.
Some medicines may affect the action of Velbienne mini .This may lead to irregular bleeding. This applies to the following medicines:

• Medicines used to treat epilepsy(such as barbiturates, phenytoin, primidone, carbamazepine, and possibly oxcarbazepine, topiramate, and felbamate);
• Medicines used to treat tuberculosis(such as rifampicin and rifabutin);
• Medicines used to treat HIV and hepatitis C virus(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as nevirapine, efavirenz, ritonavir, and nelfinavir);
• Herbal products containing St. John's Wort(Hypericum perforatum);
• Medicines used to treat fungal infections(such as griseofulvin, itraconazole, ketoconazole, voriconazole, fluconazole);
• Medicines used to treat bacterial infections(such as clarithromycin and erythromycin);
• Medicines used to treat certain heart diseases, high blood pressure(such as verapamil and diltiazem);
• Grapefruit juice.

HRT may affect the action of other medicines:

• A medicine used to treat epilepsy (lamotrigine), as it may increase the frequency of seizures;
• Medicines used to treat hepatitis C virus (medicines containing ombitasvir/paritaprevir/ritonavir with dasabuvir or without it, and glecaprevir/pibrentasvir), as they may cause liver function test abnormalities (elevation of liver enzyme ALT). Velbienne mini contains estradiol instead of ethinyl estradiol. It is not known whether the concomitant use of Velbienne mini with the aforementioned hepatitis C virus treatment medicines may also cause an elevation of liver enzyme ALT.

Lab tests

If a blood test is necessary, you should inform the laboratory staff about the use of Velbienne mini ,as it may affect the results of some tests.

Pregnancy and breastfeeding

Velbienne mini is intended for use only in postmenopausal women.
In the event of pregnancy, you should stop using the medicine and contact your doctor.

Driving and using machines

No effect of Velbienne mini on the ability to drive and use machines has been observed.

Important information about some of the ingredients of Velbienne mini

Velbienne mini contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Velbienne mini

Your doctor will prescribe the lowest possible dose necessary to treat your symptoms, for the shortest possible duration. If you think the effect of the medicine is too weak or too strong, you should inform your doctor.
This medicine should always be used according to the doctor's instructions. If you have any doubts, you should consult a doctor or pharmacist. Your doctor will decide how long you should take Velbienne mini.
The recommended dose is one tablet per day, which should be taken at the same time every day.
The tablet should be swallowed whole with water. Velbienne mini can be taken with or without food. The next calendar pack of the medicine should be started the day after finishing the current one.
You should not take breaks between packs.
If you have been using other HRT products: you should continue treatment until you have taken all the tablets from the current pack of the medicine. The first tablet of Velbienne mini should be taken the next day. You should not take a break between the previous medicine and Velbienne mini.
If you have been using HRT with a weekly break: the pack should be started the day after the break ends.
If you are starting HRT for the first time:you can start using Velbienne mini at any time.

Using a higher dose of Velbienne mini than recommended

If you take too much Velbienne mini, you may experience nausea, vomiting, or bleeding from the genital tract. There is no need to initiate any treatment, but if you have any doubts, you should contact your doctor or pharmacist.

Missing a dose of Velbienne mini

If you forget to take a tablet and it has been less than 24 hours since it was supposed to be taken, you should take it as soon as possible. The next tablet should be taken at the usual time.
If it has been more than 24 hours since the tablet was supposed to be taken, you should leave the missed tablet in the pack. The next tablets should be taken at the usual time every day. You should not take a double dose to make up for the missed dose.
Missing a tablet for several days may cause bleeding.

Stopping the use of Velbienne mini

Menopausal symptoms, including hot flashes, sleep disturbances, nervousness, dizziness, or vaginal dryness, may recur. After stopping Velbienne mini, bone loss will resume. If you want to stop therapy with Velbienne mini, you should consult a doctor or pharmacist.

If surgery is necessary

Before surgery, you should inform the surgeon about the use of Velbienne mini .It may be necessary to stop using Velbienne mini approximately 4 to 6 weeks before surgery to reduce the risk of thrombosis (see point 2 "Thrombosis in the veins (thrombosis)"). You should consult a doctor about when you can start using Velbienne mini again.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Velbienne mini can cause side effects, although not everybody gets them.
The following diseases occur more frequently in women using HRT than in those who do not use it:

• breast cancer;
• abnormal growth or malignant tumor of the endometrium (endometrial hyperplasia or endometrial cancer);
• ovarian cancer;
• thrombosis in the veins of the lower limbs or lungs (thromboembolic disorders);
• heart disease;
• stroke;
• risk of memory loss, if HRT is started at the age of 65 or older.

More information about the above side effects can be found in point 2.
The following side effects are associated with the use of Velbienne mini:
In the first few months of therapy with Velbienne mini, irregular bleeding may occur. It usually has a temporary character and disappears as treatment continues. If bleeding does not stop, you should contact your doctor.
Frequent(may occur in less than 1 in 10 people):

• headache,
• nausea,
• breast tenderness, vaginal bleeding, hot flashes.

Uncommon(may occur in less than 1 in 100 people):

• weight gain,
• drowsiness, nervousness, loss of appetite leading to weight loss, aggression, depression, insomnia, decreased libido, inability to achieve orgasm,
• dizziness, migraine, overactivity, tingling sensation,
• high blood pressure, venous thrombosis (leg pain) (see also point 2 "Thrombosis in the veins (thrombosis)"), phlebitis, nosebleeds,
• bloating, abdominal pain, constipation, diarrhea, dry mouth, vomiting,
• gallbladder pain,
• increased sweating, acne, itching, dry skin with red, flaky areas (psoriasis),
• muscle pain, leg cramps,
• disorders of the endometrium, painful menstruation, itching of the genitals, vaginal thrush,
• fatigue, generalized fluid retention, facial swelling,
• edema.

Other HRTs have been reported to have the following side effects:

• gallbladder disease
• skin disorders:
• skin discoloration, especially on the face or neck (chloasma);
• painful red nodules on the skin (erythema nodosum);
• a rash with blisters or redness resembling a target (erythema multiforme).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Velbienne mini

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date". The expiry date refers to the last day of the month.
Velbienne mini should be stored in its original packaging to protect it from light.
Velbienne mini does not require special storage temperatures.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Velbienne mini contains

The active substances of Velbienne mini are estradiol valerate and dienogest. One tablet contains 1.0 mg of estradiol valerate (which corresponds to 0.764 mg of estradiol) and 2.0 mg of dienogest.
The other ingredients are: lactose monohydrate, corn starch, corn starch paste, povidone K30, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), iron oxide black (E172).

What Velbienne mini looks like and contents of the pack

Velbienne mini is a round, pink, film-coated tablet.
Velbienne mini is available in packs containing 28, 3x28, and 6x28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warszawa
e-mail: [email protected]
Manufacturer
Laboratorios León Farma S.A.
La Vallina s/n, Pol. Ind. Navatejera,
Villaquilambre-24193 León
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Estradiol Valeraat 1 mg / Dienogest 2 mg Laboratorios León Farma film-coated tablets
Germany:
Velbienne 1 mg / 2 mg film-coated tablets
Austria:
Velbienne 1 mg / 2 mg film-coated tablets
Slovakia: VELBIENNE 2 mg/1 mg film-coated tablets
Estonia:
VELBIENNE 2 mg + 1 mg film-coated tablets
Lithuania:
VELBIENNE 2 mg/1 mg film-coated tablets
Poland:
Velbienne mini
Latvia:
Velbienne 2 mg/1 mg film-coated tablets
France: CLIFEMME 1mg / 2mg, film-coated tablet,
Portugal: Clifemme 2 mg + 1 mg, film-coated tablets
Date of last revision of the leaflet:29.04.2024