LENZETTO 1.53 mg/dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet
2. What is Lenzetto and what is it used for
   1. Relief of symptoms occurring after menopause
3. Important information before using Lenzetto
   1. When not to use Lenzetto
   2. Warnings and precautions
   3. You should stop using Lenzetto and consult your doctor immediately
   4. HRT and cancer
   5. You should regularly examine your breasts. If you notice any changes, such as those listed below, you should consult your doctor:
   6. Effect of HRT on the heart and circulation
   7. Children
   8. Lenzetto and other medicines
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Lenzetto contains alcohol
4. How to use Lenzetto
   1. Do not apply Lenzetto to the breasts or areas around them.
   2. Before the first use of a new applicator, you should prepare the pump by
   3. Do not allow others to touch the area of skin where the spray has been applied until it has dried and, if necessary, cover it with clothing 2 minutes after application.
   4. Using more than the recommended dose of Lenzetto
   5. Missing a dose of Lenzetto
   6. Stopping Lenzetto
5. Possible side effects
   1. Reporting side effects
6. How to store Lenzetto
7. Contents of the packaging and other information
   1. What Lenzetto contains
   2. What Lenzetto looks like and what the packaging contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet: January 2024

Leaflet accompanying the packaging: patient information

Lenzetto, 1.53 mg/dose, transdermal spray, solution
Estradiol

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 your doctor or pharmacist. This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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. See section 4.

Table of contents of the leaflet

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

1. What is Lenzetto and what is it used for

Lenzetto is used in hormone replacement therapy (HRT). It contains the female hormone estrogen. Lenzetto is used in women after menopause, at least 6 months after the last natural menstrual period. Lenzetto may also be used in women who have had their ovaries removed, as this causes immediate menopause. Lenzetto is a spray that contains a small amount of the active substance called estradiol. After spraying directly onto the skin, the medicine passes through the skin into the bloodstream. Lenzetto is indicated for use:

Relief of symptoms occurring after menopause

During menopause, the amount of estrogen produced by the woman's body decreases. This can cause symptoms such as a feeling of heat on the face, neck, and chest (so-called hot flashes). Lenzetto reduces the severity of these symptoms caused by menopause. The doctor will prescribe Lenzetto to the patient only if the symptoms are significantly bothering her daily life. Lenzetto is indicated for the treatment of estrogen deficiency symptoms after menopause, when menstrual bleeding is no longer present. Estrogen deficiency symptoms include hot flashes (sudden surges of heat and sweating felt throughout the body), sleep disturbances, irritability, and vaginal dryness. There is limited experience with the use of the medicine in women over 65 years of age. Lenzetto is not a contraceptive.

2. Important information before using Lenzetto

Medical history and regular check-ups
Using Hormone Replacement Therapy (HRT) involves risks that should be considered when deciding to start or continue treatment. There is limited experience with the use of the medicine in women with premature menopause (caused by ovarian dysfunction or surgery). Using HRT in women with premature menopause may involve different risks than in women who have had a natural menopause. You should consult your doctor. Before starting or restarting HRT, your doctor will conduct a medical interview, including a family history. The doctor may decide to perform a physical examination. This may include a breast examination and, if necessary, a gynecological examination. After starting Lenzetto, you should have regular check-ups (at least once a year) and discuss with your doctor the assessment of the benefits and risks of using Lenzetto. According to your doctor's recommendations, you should have regular breast examinations.

When not to use Lenzetto

If any of the following points apply to you, or if you have any doubts, you should consult your doctor before starting Lenzetto. You should not use Lenzetto:

• if you have or have had breast cancer or if it is suspected;
• if you have or are suspected of having other estrogen-dependent tumors, such as endometrial cancer;
• if you have vaginal bleeding of unknown cause;
• if you have excessive thickening of the endometrium (endometrial hyperplasia) that is not being treated;
• if you have or have had deep vein thrombosis (thrombophlebitis) or pulmonary embolism;
• if you have or have had blood clotting disorders (such as protein C, protein S, or antithrombin deficiency);
• if you have or have recently had blood clots in the arteries, such as heart attack, stroke, or angina pectoris;
• if you have or have had liver function disorders, and liver function tests have not returned to normal;
• if you have a rare blood disorder (porphyria) that runs in your family;
• if you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6).

If any of these symptoms occur for the first time while using Lenzetto, you should stop treatment and consult your doctor immediately.

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting Lenzetto. If any of the following conditions are present, have been present in the past, or have worsened while using Lenzetto, you should inform your doctor, as this may lead to recurrences or worsening of these conditions. If so, you should consult your doctor for more frequent check-ups:

• uterine fibroids;
• increased risk of excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer;
• increased risk of blood clots;
• increased risk of estrogen-dependent tumors (such as breast cancer that occurred in the mother, sister, or grandmother);
• high blood pressure;
• liver function disorders, such as liver tumors;
• diabetes;
• gallstones;
• migraine or severe headache;
• immune system disorders that affect multiple organs (systemic lupus erythematosus, SLE);
• epilepsy;
• asthma;
• disorders affecting the eardrum and hearing (otosclerosis);
• very high levels of fats in the blood (hypertriglyceridemia);
• fluid retention due to heart or kidney problems;
• hereditary and acquired angioedema.

You should stop using Lenzetto and consult your doctor immediately

If you notice any of the following symptoms while using hormone replacement therapy (HRT):

• any of the conditions listed in the "When not to use Lenzetto" section;
• yellowing of the skin and eyes (jaundice), which may be signs of liver problems;
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing, which may indicate angioedema;
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• migraine headaches that occur for the first time;
• if you become pregnant;
• if you notice symptoms of a blood clot, such as:
• painful swelling and redness of the legs,
• sudden chest pain,
• difficulty breathing.

For more information, see the "Blood clots in the veins (thrombosis)" section. Note:Lenzetto is not a contraceptive. If it has been less than 12 months since your last menstrual period, or if you are under 50 years old, you may need to use a contraceptive method to protect against pregnancy. You should consult your doctor.

HRT and cancer

Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer.
Using HRT that contains only estrogen increases the risk of excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. This risk can be avoided by also taking a progestogen for at least 12 days of each 28-day cycle. Therefore, if you have a uterus, your doctor will prescribe a progestogen separately. If you have had a hysterectomy (surgical removal of the uterus), you should consult your doctor to see if you can safely use this medicine without taking a progestogen. Among women with a uterus who do not use HRT, endometrial cancer is diagnosed in about 5 out of 1000 women between the ages of 50 and 65. Among women between the ages of 50 and 65 with a uterus who use HRT that contains only estrogen, endometrial cancer is diagnosed in 10 to 60 out of 1000 women (i.e., 5 to 55 more cases), depending on the dose and duration of treatment. Lenzetto contains a higher dose of estrogen than other medicines used for HRT that contain only estrogen. It is not known what the risk of endometrial cancer is when using Lenzetto with a progestogen. Unexpected bleedingWhile using Lenzetto, you will experience monthly bleeding (so-called withdrawal bleeding) if you are also taking progestogen sequentially. If you experience unexpected bleeding or spotting that is not related to your monthly bleeding, which

• continues despite 6 months of treatment;
• occurs for the first time after 6 months of using Lenzetto;
• continues despite stopping Lenzetto; you should see a doctor as soon as possible.

Breast cancerThe available data confirm an increased risk of breast cancer in women using hormone replacement therapy (HRT) in the form of combined estrogen and progestogen or estrogen-only therapy. This increased risk depends on the duration of HRT use. The increased risk is clearly visible after 3 years of HRT use. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years. Among women between the ages of 50 and 54 who do not use HRT, breast cancer is diagnosed in about 13 to 17 out of 1000 women over 5 years. In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1000 patients (i.e., 0 to 3 additional cases). Among women aged 50 who start 5-year combined estrogen and progestogen HRT, the number of cases will be 21 out of 1000 women (i.e., 4 to 8 additional cases). Among women between the ages of 50 and 59 who do not use HRT, breast cancer is diagnosed in about 27 out of 1000 women over 10 years. In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1000 patients (i.e., 7 additional cases). In women aged 50 who start 10-year combined estrogen and progestogen HRT, the number of cases will be 48 out of 1000 patients (i.e., 21 additional cases).

You should regularly examine your breasts. If you notice any changes, such as those listed below, you should consult your doctor:

• -dimpling of the breast skin,
• changes in the nipples,
• any visible or palpable lumps.

In addition, it is recommended that you participate in breast cancer screening programs if offered. It is essential to inform the nurse or person performing the mammography about HRT use, as treatment may cause an increase in breast density, which can affect the mammography result. In the case of increased breast density, mammography may not detect all lumps. Ovarian cancerOvarian cancer is rare - much rarer than breast cancer. Using HRT that contains only estrogen or a combination of estrogen and progestogen is associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer depends on age. For example, in women between the ages of 50 and 54 who do not use HRT, ovarian cancer is diagnosed in about 2 out of 2000 women over 5 years. In women who have taken HRT for 5 years, it occurs in about 3 out of 2000 women (i.e., up to 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in the veins (thrombosis)The risk of blood clots in the veins is about 1.3 to 3 times higher in women using HRT than in women not using HRT, especially during the first year of treatment. If a blood clot reaches the lungs, it can cause chest pain, shortness of breath, loss of consciousness, and even death. The likelihood of blood clots in the veins increases with age and if any of the following points apply to you:

• if you are unable to walk for a long time due to a serious operation, injury, or illness (see section 3 "If you need to have surgery"),
• if you are obese (BMI > 30 kg/m),
• if you have a blood clotting disorder and need long-term anticoagulant treatment,
• if any of your close relatives have had a blood clot in their leg, lung, or other organ,
• if you have systemic lupus erythematosus (SLE),
• if you have cancer.

The symptoms of a blood clot include, see the "Stop using Lenzetto and consult your doctor immediately" section. In a group of women over 50 who do not use HRT, blood clots in the veins are expected to occur in 4 to 7 out of 1000 women over 5 years. Among women over 50 who have used combined estrogen and progestogen HRT for 5 years, there will be 9 to 12 cases per 1000 women (i.e., 5 more cases). Among women over 50 who have had a hysterectomy and have used estrogen-only HRT for 5 years, there will be 5 to 8 cases per 1000 women (i.e., 1 more case). Heart disease (heart attack)There is no evidence that using HRT prevents heart attacks. In women over 60 who use combined estrogen and progestogen HRT, there is a slightly increased risk of heart disease compared to women not using HRT. The risk of heart disease does not increase in women who have had a hysterectomy and use estrogen-only HRT. StrokeThe risk of stroke is about 1.5 times higher in women using HRT than in women not using HRT. The increase in stroke risk due to HRT use is proportional to the age of the population. Comparison: In a group of women over 50 who do not use HRT, a stroke will occur in about 8 out of 1000 women over 5 years. Among women over 50 who use HRT, there will be about 11 strokes per 1000 women over 5 years (i.e., 3 more cases). Other conditionsHRT does not protect against memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after the age of 65. You should consult your doctor.

Children

Estradiol in the form of a spray can be accidentally transferred from the patient's skin to others. You should not allow others, especially children, to come into contact with the exposed area of the patient's skin and, if necessary, cover the area with clothing. If a child comes into contact with the area of the skin where estradiol has been sprayed, you should wash the child's skin with soap and water as soon as possible. Due to the transfer of estradiol, small children may exhibit unexpected signs of sexual maturation (e.g., breast budding). In most cases, these symptoms will resolve when the child is no longer exposed to the estradiol spray. If a child who may have been accidentally exposed to the estradiol spray shows any signs or symptoms of sexual maturation (breast development or other sexual changes), you should consult a doctor.

Lenzetto and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Some medicines may affect the action of Lenzetto. This may lead to irregular bleeding. These include:

• medicines used to treat epilepsy(such as phenobarbital, phenytoin, and carbamazepine),
• medicines used to treat tuberculosis(such as rifampicin, rifabutin),
• medicines used to treat HIV infection(such as nevirapine, efavirenz, ritonavir, and nelfinavir),
• herbal products containing St. John's Wort(Hypericum perforatum).

HRT may affect the action of other medicines:

• an antiepileptic drug (lamotrigine), as it may increase the frequency of seizures,
• medicines used to treat hepatitis C(such as a treatment regimen using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and a treatment regimen using glecaprevir/pibrentasvir) may cause an increase in liver function test results in the blood (increased activity of the liver enzyme ALT) in women using combined hormonal contraceptives containing ethinyl estradiol. Lenzetto contains estradiol instead of ethinyl estradiol. It is not known whether increased liver enzyme ALT activity may occur when using Lenzetto with such a hepatitis C treatment regimen.

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any over-the-counter medicines, herbal medicines, and natural products. Your doctor will provide you with appropriate instructions. Laboratory testsIf a blood test is necessary, you should inform your doctor or laboratory staff about Lenzetto use, as this medicine may affect the results of some tests.

Pregnancy and breastfeeding

Lenzetto is intended only for women after menopause. If you become pregnant, you should stop using Lenzetto immediately and consult your doctor. You should not use Lenzetto while breastfeeding.

Driving and using machines

There is no data on the effect of Lenzetto on the ability to drive and use machines.

Lenzetto contains alcohol

This medicine contains 65.47 mg of alcohol (ethanol) per dose, which is equivalent to 72.74% v/v. It may cause burning on damaged skin. Alcohol-based liquids are flammable. Keep away from fire. When applying the spray to the skin, avoid open flames, lit cigarettes, or certain hot devices (e.g., hair dryers) until the applied dose has dried.

3. How to use Lenzetto

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. Your doctor will try to prescribe the lowest possible dose for the shortest possible time to relieve your symptoms. During treatment, your doctor may adjust the dosage based on your individual needs. If you think the effect of the medicine is too strong or too weak with the prescribed dose, you should consult your doctor. If you have not had a hysterectomy, your doctor will prescribe progestogen tablets to balance the effects of estrogen on the endometrium. Your doctor will explain how to take these tablets. At the end of the progestogen treatment, you may experience withdrawal bleeding (see the "Unexpected bleeding" section). If you need to have surgeryIf you are planning to have surgery, you should tell your doctor about Lenzetto use. There may be a need to stop using Lenzetto about 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2 "Blood clots in the veins"). You should ask your doctor when you can restart Lenzetto. Where to apply LenzettoThe spray should be applied to dry, healthy skin on the inner surface of the forearm. If this is not possible, the spray can be applied to the inner surface of the thigh.

Do not apply Lenzetto to the breasts or areas around them.

How to use Lenzetto

Before the first use of a new applicator, you should prepare the pump by

spraying the medicine three times with the cap closed:Hold the container upright, as shown in Figure 1. Without removing the cap, press the thumb or index finger on the button three times. The medicine is now ready to use. The applicator should only be prepared before the first use of a new container, not before each use. If you miss one or more doses, you should prepare the applicator according to the instructions in the "Missing a dose of Lenzetto" section.

Make sure the skin where the medicine will be sprayed is healthy, clean, and dry.
How to dose the medicine.

To administer the daily dose, remove the plastic cap, hold the container upright, and place the plastic applicator tip flat against the skin surface (Fig. 2). You may need to move your arm or move the applicator outlet along your arm so that it fits snugly against the skin and there are no gaps between the applicator outlet and the skin. Press the button once. Before releasing, press it all the way downand hold. If you need to spray again, move the applicator outlet along your arm so that it is outside the area where you previously sprayed the medicine. Press the button once. If you need to spray for the third time, move the applicator outlet along your arm and press the button once.

If you cannot spray the second or third time on the same inner surface of the forearm, you can apply the medicine to the other forearm. If you have problems placing the applicator tip on the inner surface of the forearm, as shown in Figure 3, or if you have difficulty applying the medicine to the forearm, you can also apply it to the inner surface of the thigh.

After using Lenzetto, always close the container with the cap (Fig. 4). If you use the medicine as directed, each spray will deliver the same amount of active substance to the skin, regardless of differences in the shape or appearance of the solution on the skin. The sprayed medicine should be left to dry for at least 2minutes before dressing and at least 60minutes before bathing or showering. If Lenzetto gets on other areas of skin, such as your hands, wash the skin in that area with soap and water immediately. Do not apply Lenzetto to damaged or injured skin. Do not rub or massage Lenzetto into the skin surface.

Do not allow others to touch the area of skin where the spray has been applied until it has dried and, if necessary, cover it with clothing 2 minutes after application.

What dose of Lenzetto should you use
Your doctor will likely recommend starting treatment with the lowest dose (one spray per day). You should discuss with your doctor what dose of Lenzetto is suitable for you. If necessary, your doctor may increase the dose to two sprays per day. The maximum daily dose is 3 sprays.
How often should you use Lenzetto
You should perform the total number of sprays (doses) prescribed by your doctor every day at the same time.
How long to use Lenzetto
Every 3-6 months, you should discuss with your doctor how long to use Lenzetto. Lenzetto should only be used for as long as symptoms related to menopause persist. Other useful informationSunscreens may change the absorption of estrogens in Lenzetto. You should avoid using sunscreens on the skin areas where you plan to apply Lenzetto. However, if you need to use sunscreens, you should apply them to the skin at least 1 hour before using Lenzetto. Lenzetto should be used with caution in extreme temperature conditions, such as saunas or sunbathing. There is limited data indicating that the rate and extent of Lenzetto absorption may be reduced in overweight and obese women. You should discuss this with your doctor. During treatment, your doctor may adjust the dose to your individual needs.

Using more than the recommended dose of Lenzetto

If you use more Lenzetto than recommended or if a child accidentally uses the medicine, you should consult your doctor or go to the hospital for advice on the risks and actions to take. If you use more Lenzetto than recommended, you may experience nausea, vomiting, and irregular bleeding.

Missing a dose of Lenzetto

If you miss a dose of Lenzetto at the usual time, you should use it as soon as possible, and then use it as you normally would. If it is almost time for your next dose, you should wait and use the next dose as usual. If you miss one or more doses, you will need to prepare the applicator with a single priming spray with the cap closed. Do not use a double dose to make up for a missed dose. If you miss a dose, you may experience an increased risk of irregular bleeding and spotting. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

Stopping Lenzetto

Your doctor will also explain how to stop using this medicine after treatment is completed. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenzetto can cause side effects, although not everybody gets them. Women using HRT are more likely to report the following conditions than women not using HRT:

• breast cancer;
• abnormal growth or cancer of the endometrium (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• gallbladder disease;
• high blood pressure;
• liver function disorders;
• high blood sugar;
• possible memory loss if HRT is started after the age of 65.

For more information on these side effects, see section 2. Some side effects can be serious. The following symptoms require immediate medical attention:

• sudden chest pain;
• chest pain that spreads to the arm or neck;
• difficulty breathing;
• painful swelling and redness of the legs;
• yellowing of the eyes and face (jaundice);
• unexpected vaginal bleeding (irregular bleeding) or spotting after using Lenzetto for some time or after stopping treatment;
• changes in the breasts, including dimpling of the skin, changes in the nipples, or any lumps that can be seen or felt;
• painful menstruation;
• dizziness and fainting;
• changes in speech;
• changes in vision;
• unexplained headaches resembling migraines.

If any side effect worsens or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist. After using Lenzetto, the following side effects have been reported: Common side effects(may affect up to 1 in 10 people) Headache, abdominal pain, nausea, rash, itching (pruritus), irregular bleeding from the uterus or vaginal bleeding, including spotting, breast tenderness, breast pain, weight gain or weight loss. Uncommon side effects(may affect up to 1 in 100 people) Allergic reactions, depressed mood, insomnia (difficulty sleeping), dizziness (feeling of dizziness or "spinning"), vision disturbances, palpitations (feeling of heartbeat), diarrhea, dyspepsia (indigestion), high blood pressure, erythema multiforme (characterized by painful red nodules on the skin), hives (generalized or localized rash or nodules), skin irritation, fluid retention (edema), muscle pain, breast discoloration, nipple discharge, endometrial polyps or cervical polyps, endometrial hyperplasia, ovarian cyst, vaginal infection (vaginitis), increased liver enzyme activity and cholesterol levels in the blood, axillary pain. Rare side effects(may affect up to 1 in 1000 people) Anxiety, decreased or increased sexual desire, migraines, intolerance to contact lenses, bloating, vomiting, excessive hair growth on the body, acne, muscle cramps, painful menstruation, premenstrual syndrome, breast enlargement, fatigue. After Lenzetto has been marketed, the following other side effectshave been reported, with a frequency of "unknown" (frequency cannot be estimated from available data): hair loss (alopecia), chloasma (golden-brown pigmentation spots, so-called "pregnancy spots" especially on the face), skin discoloration. After using other HRT medicines, the following side effects have been reported:Severe allergic reaction that causes swelling of the face or throat (angioedema), anaphylactic and/or anaphylactoid reactions (severe allergic reaction that causes difficulty breathing or dizziness), glucose intolerance, depression, mood disorders, irritability, worsening of chorea (a condition characterized by involuntary movements), worsening of epilepsy, dementia, worsening of asthma, gallbladder disease, jaundice, pancreatitis, benign tumor of the smooth muscle of the uterus, skin disorders, skin discoloration, especially on the face or neck, known as "pregnancy spots" (chloasma), painful red nodules on the skin (erythema nodosum); rash in the shape of target-like red patches or ulcers (erythema multiforme), bleeding changes (purpura), hair loss, joint pain, nipple discharge, breast lumps, increased size of benign tumors of the smooth muscle of the uterus, changes in the shedding of the inner lining of the cervix, vaginal infection (vaginitis), fungal infection of the vagina (vaginal thrush), low calcium levels in the blood.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenzetto

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The medicine should be used within 56 days of first use. Do not store in the refrigerator or freeze the medicine. Do not store above 25°C. The medicine contains ethanol, which is a flammable substance. Keep away from heaters, open flames, and other ignition sources. 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 Lenzetto contains

• The active substance is estradiol (in the form of estradiol hemihydrate). Each dose contains 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).
• The other ingredients are octyl salicylate and ethanol 96%.

What Lenzetto looks like and what the packaging contains

Lenzetto is a transdermal spray solution containing estradiol and octyl salicylate in ethanol. It is equipped with a dosing pump. Lenzetto is available in a plastic container with a plastic coating. Inside, there is a glass container. Each package contains one container, which contains 6.5 ml of solution and allows for 56 doses of 90 microliters. You should mark the number of sprays performed in the table on the packaging. Each dose contains 1.53 mg of estradiol. Do not use the Lenzetto container for more than the marked number of sprays on the label, even if the container is not completely empty. Packaging size: One plastic container, 6.5 ml (56 doses). Three plastic containers, 3 x 6.5 ml (3 x 56 doses). Not all packaging sizes may be available.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o. ul. ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki

Manufacturer:

Gedeon Richter România S.A. Cuza Vodă street 99-105 Târgu-Mureş 540306 Romania Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary For more information on this medicine, you should contact: GEDEON RICHTER POLSKA Sp. z o.o. Medical Department ul. ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Tel. +48 (22)755 96 48 [email protected]

Date of last revision of the leaflet: January 2024

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