Lenzetto

Package leaflet: Information for the user

Lenzetto, 1.53 mg/dose, transdermal spray, solution
Estradiolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms appear identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately.
See section 4.

Contents of the leaflet

1. What Lenzetto is and what it is 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 pack and other information

1. What Lenzetto is and what it is used for

Lenzetto is used in hormone replacement therapy (HRT). It contains the female hormone estrogen.
Lenzetto is intended for use in postmenopausal women, at least 6 months after the last natural menstrual period.

Lenzetto may also be used in women who have undergone surgical removal of the ovaries, as this causes immediate onset of menopause.

Lenzetto is formulated as a spray containing a small amount of the active substance called estradiol. When sprayed directly onto the skin, the medicine passes through the skin into the bloodstream.

Lenzetto is indicated for:
Relief of postmenopausal symptoms
During menopause, the amount of estrogen produced by a woman's body decreases. This may lead to symptoms such as sudden feelings of heat in the face, neck, and chest (known as hot flushes). Lenzetto reduces the severity of such menopausal symptoms. Your doctor will prescribe Lenzetto only if your symptoms significantly interfere with your daily life.

Lenzetto is indicated for the treatment of estrogen deficiency symptoms following menopause, when menstrual bleeding has ceased. Symptoms of estrogen deficiency include hot flushes (sudden episodes of flushing and sweating affecting the whole body), sleep disturbances, irritability, and vaginal dryness.

Experience with the use of Lenzetto in women over 65 years of age is limited.

Lenzetto is not a contraceptive medicine.

2. Important information before using Lenzetto

Medical history and regular check-ups
Hormone Replacement Therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience with the use of this medicine in women with premature menopause (due to ovarian dysfunction or surgical intervention) is limited. The risks associated with HRT in women with premature menopause may differ from those in women who have undergone natural menopause. Consult your doctor.
Before starting or restarting HRT, your doctor will take a medical and family history. Your doctor may decide to perform a physical examination, which may include a breast examination and (or), if necessary, a gynaecological examination.
After starting treatment with Lenzetto, you should have regular check-ups (at least once a year) and discuss with your doctor the benefit-risk balance of continuing Lenzetto treatment.
You should have regular breast examinations as recommended by your doctor.

When not to use Lenzetto
If any of the following apply to you, or if you have any doubts, consult your doctor before starting treatment with Lenzetto.
Do not use Lenzetto:

• if you have or have had breast cancer or there is suspicion of it;
• if you have or are suspected of having other estrogen-dependent tumours, such as cancer of the endometrium (lining of the womb);
• if you have vaginal bleeding of unknown cause;
• if you have excessive thickening of the lining of the womb (endometrial hyperplasia) that has not been treated;
• if you have or have ever had venous thromboembolic disease in the legs ( deep vein thrombosis ) or lungs ( pulmonary embolism );
• if you have blood clotting disorders (such as protein C deficiency, protein S deficiency or antithrombin deficiency );
• if you have or recently had arterial diseases caused by blood clots, such as heart attack, stroke or angina pectoris;
• if you have or have ever had liver function disorders and liver function test results have not returned to normal;
• if you have a rare inherited blood disorder (porphyria);
• if you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6).

If any of the above symptoms occur for the first time during treatment with Lenzetto, stop treatment immediately and contact your doctor.

Warnings and precautions
Before starting treatment with Lenzetto, discuss this with your doctor or pharmacist.
If any of the following conditions are currently present, have occurred in the past and (or) have worsened during treatment with Lenzetto, inform your doctor, as these conditions may recur or worsen. If so, consult your doctor about having more frequent check-ups:

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

Stop using Lenzetto and contact your doctor immediately
If you experience any of the following symptoms while taking hormone replacement therapy (HRT):

• any of the conditions listed in the section "When not to use Lenzetto";
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disorders;
• swelling of the face, tongue and (or) throat and (or) difficulty swallowing or hives, together with breathing difficulties, suggesting angioedema;
• significant increase in blood pressure (symptoms may include: headache, fatigue, dizziness);
• migraine-type headaches occurring for the first time;
• if you become pregnant;
• if you notice symptoms of blood clots, such as:
• painful swelling and redness in the legs,
• sudden chest pain,
• difficulty breathing.

For further information, see section: "Blood clots in the veins (thrombosis)".
Note: Lenzetto is not a contraceptive. If less than 12 months have passed since your last menstrual period, or if you are under 50 years of age, you may need to use an additional contraceptive method to prevent pregnancy. Consult your doctor.

HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Using HRT with estrogen-only medicines increases the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the endometrium.
This risk can be avoided by taking a progestagen together with estrogen for at least 12 days in each 28-day cycle. Therefore, your doctor will prescribe a progestagen separately for women with an intact uterus. If your uterus has been removed (hysterectomy), consult your doctor whether it is safe for you to use this medicine without taking a progestagen.
Among women with an intact uterus who do not use HRT, an average of 5 out of 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
Among women aged 50 to 65 with an intact uterus who use estrogen-only HRT products, 10 to 60 out of 1000 will be diagnosed with endometrial cancer (i.e. 5 to 55 additional cases), depending on the dose and duration of treatment.
Lenzetto contains a higher dose of estrogens than other estrogen-only medicines used for HRT. The risk of endometrial cancer associated with using Lenzetto in combination with a progestagen is unknown.

Unexpected bleeding
While using Lenzetto, you will have monthly bleeding (so-called withdrawal bleeding) if you are also taking progestagen in a sequential regimen. If you experience unexpected bleeding or spotting unrelated to monthly bleeding that:

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

Breast cancer
Available data confirm an increased risk of breast cancer with the use of hormone replacement therapy (HRT) containing either estrogen-progestagen combinations or estrogen-only products. This increased risk depends on the duration of HRT use. A higher risk becomes evident after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was used for more than 5 years.
Comparison
Among women aged 50 to 54 who do not use HRT, an average of 13 to 17 out of 1000 will be diagnosed with breast cancer within 5 years.
Among women aged 50 who start a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start a 5-year course of estrogen-progestagen HRT, the number of cases will be 21 per 1000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 out of 1000 women over 10 years.
Among women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year course of estrogen-progestagen HRT, the number of cases will be 48 per 1000 women (i.e. 21 additional cases).
You should regularly examine your breasts. If you notice any changes such as those listed below, consult your doctor:

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

Additionally, you are advised to participate in screening mammography programmes if offered. It is important to inform the nurse or radiographer that you are using HRT, as treatment may increase breast density, which can affect mammography results. With increased breast density, mammography may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of HRT with estrogen-only or combined estrogen-progestagen products is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in an average of about 2 out of 2000 women within 5 years.
Among women who have used HRT for 5 years, it will occur in about 3 out of 2000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of venous blood clots is approximately 1.3 to 3 times higher in women using HRT compared to women not using HRT, especially during the first year of treatment.
If a clot travels to the lungs, it may cause chest pain, shortness of breath, loss of consciousness, and even death.
The likelihood of venous blood clots increases with age and if any of the following situations apply to you. Inform your doctor if any of the following apply to you.

• if you are unable to walk for a prolonged period due to major surgery, injury or illness (see section 3 "If you need to undergo surgery"),
• if you are obese (BMI > 30 kg/m²),
• if you have a blood clotting disorder and require long-term anticoagulant therapy,
• if any of your close relatives have had a blood clot in the leg, lungs or another organ,
• if you have systemic lupus erythematosus (SLE),
• if you have cancer.

Symptoms of blood clots are listed in the section: "Signs requiring immediate discontinuation of Lenzetto and contact with your doctor".
Among women over 50 who do not use HRT, an average of 4 to 7 out of 1000 can be expected to develop venous blood clots within 5 years.
Among women over 50 who have used estrogen-progestagen HRT products for 5 years, there will be 9 to 12 cases per 1000 women (i.e. 5 additional cases).
Among women over 50 who have had a hysterectomy and have used estrogen-only HRT products for 5 years, there will be 5 to 8 cases per 1000 women (i.e. 1 additional case).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
In women over 60 years of age using HRT with estrogen-progestagen products, the risk of heart disease is slightly increased 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.

Stroke
The risk of stroke is approximately 1.5 times higher in women using HRT compared to women not using HRT. The increase in stroke cases due to HRT use is proportional to the age of the population.
Comparison: Among women over 50 who do not use HRT, stroke will occur in an average of 8 out of 1000 within 5 years. Among women over 50 using HRT, there will be about 11 stroke cases per 1000 within 5 years (i.e. 3 additional cases).

Other conditions
HRT does not protect against memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.

Children
Estradiol in aerosol form may be accidentally transferred from the patient's skin to others.
Avoid contact between other people, especially children, and the exposed area of the patient's skin. After the aerosol has dried, cover the area if necessary. If a child comes into contact with the area of skin sprayed with estradiol, wash the child's skin with soap and water as soon as possible. Due to estradiol transfer, young children may show unexpected signs of sexual development (e.g. breast budding). In most cases, these symptoms resolve once the child is no longer exposed to aerosol estradiol.
If you notice any signs or symptoms of puberty (breast development or other sexual changes) in a child who may have been accidentally exposed to aerosol estradiol, contact your doctor.

Lenzetto and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the action of Lenzetto, which 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 way some other medicines work:

• the epilepsy medicine (lamotrigine), as this may increase the frequency of seizures,
• combination treatment regimens for hepatitis C virus (HCV) infection with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause increased liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Lenzetto contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT liver enzyme activity may occur when Lenzetto is used simultaneously with such combination HCV treatment regimens.

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines, herbal remedies and natural products. Your doctor will provide appropriate advice.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are using Lenzetto, as this medicine may affect the results of certain tests.

Pregnancy and breastfeeding
Lenzetto is intended only for postmenopausal women. If you become pregnant, stop using Lenzetto immediately and contact your doctor.
Do not use Lenzetto during breastfeeding.

Driving and using machines
There are no data on the effects of Lenzetto on the ability to drive or operate machinery.

Lenzetto contains alcohol
This medicine contains 65.47 mg of alcohol (ethanol) per dose, equivalent to 72.74% v/v.
It may cause a burning sensation on damaged skin.
Alcohol-based liquids are flammable. Keep away from fire. During application of the aerosol 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 exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will aim to prescribe the lowest possible dose for the shortest possible duration needed
to relieve your symptoms. During treatment, your doctor may adjust the dose according to your
individual needs. If you feel the effect of the medicine is too strong or too weak, consult your doctor.
If you have not had a hysterectomy (surgical removal of the uterus), your doctor will prescribe tablets
containing another hormone called a progestagen to balance the effects of oestrogens on the
endometrium (lining of the uterus). Your doctor will explain how to take these tablets. Withdrawal
bleeding may occur towards the end of the progestagen treatment cycle (see section "Unexpected
bleeding").

If you need to undergo surgery
If you are planning to have surgery, inform your doctor that you are using Lenzetto. You may need to
stop using Lenzetto approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see
section 2. "Blood clots in veins"). Ask your doctor when you can start using Lenzetto again.

Where to apply Lenzetto
The spray should be applied to dry, healthy skin on the inner forearm. If this is not possible, apply the
spray to the inner thigh.
Do not apply Lenzetto to the breasts or areas of the body near the breasts.

How to use Lenzetto
Before first use of a new dispenser, prime the pump by spraying the medicine three times with the
cap closed: Hold the container vertically, as shown in Figure 1. Without removing the cap, press
the nozzle three times with your thumb or index finger.
The medicine is now ready for use.
Do not prime the dispenser before each use—only before the first use from a new container. If one
or more doses are missed, prime the dispenser according to the instructions in the section "Missed
dose of Lenzetto".

Ensure the skin where the medicine will be sprayed is healthy, clean, and dry.
Dosing instructions for Lenzetto.

To administer the daily dose, remove the plastic cap, hold the container vertically, and place the
plastic applicator tip flat against the skin surface (Fig. 2).
You may need to move your arm or adjust the applicator nozzle along the arm to ensure it lies flat
against the skin with no gaps between the nozzle and the skin.
Press the nozzle once. Before releasing, press it fully down and hold.
If a second spray is needed, move the applicator nozzle along the arm to an area outside the
previously sprayed region. Press the nozzle once.
If a third spray is needed, move the applicator nozzle further along the arm and press the nozzle once.

If the second or third spray cannot be applied to the same inner forearm, the medicine may be
applied to the other forearm. If you have difficulty placing the applicator tip on the inner forearm as
shown in Figure 3, or if you have difficulty applying the medicine to the forearm, the medicine may
also be applied to the inner thigh.

After using Lenzetto, always replace the cap on the container (Fig. 4).
If you use Lenzetto as directed, each spray delivers the same amount of active substance to the
skin, regardless of differences in the appearance or shape of the solution on the skin.
Allow the sprayed medicine to dry for at least 2 minutes before dressing and for at least 60 minutes
before bathing or showering. If Lenzetto accidentally comes into contact with other skin areas, such
as the hands, wash the area immediately with soap and water.
Do not use Lenzetto on damaged or injured skin.
Do not massage or rub Lenzetto into the skin.
Do not allow other people to touch the area of skin where the spray has been applied until it is
completely dry, and if necessary, cover the area with clothing for 2 minutes after application. If
another person (especially a child) accidentally touches the skin area where Lenzetto has been
sprayed, instruct them to wash the area with soap and water immediately.

What dose of Lenzetto should be used
Your doctor will likely recommend starting treatment with the lowest dose (one spray per day).
Discuss with your doctor which dose is appropriate for you. If necessary, your doctor may increase
the dose to two sprays per day. The maximum daily dose is 3 sprays.

How often to use Lenzetto
The total number of sprays (dose(s)) prescribed by your doctor should be administered daily at the
same time.

Duration of treatment with Lenzetto
Every 3 to 6 months, discuss with your doctor how long you should continue using Lenzetto. Use
Lenzetto only as long as needed to relieve menopausal symptoms.

Other useful information
Sunscreen products may alter the absorption of oestrogens in Lenzetto. Avoid applying sunscreen to
the areas of skin where you intend to spray Lenzetto. However, if sunscreen is needed, apply it at
least 1 hour before using Lenzetto.
Use Lenzetto with caution in extreme temperature conditions, such as sauna use or sunbathing.
Limited data suggest that the rate and extent of absorption of Lenzetto may be reduced in
overweight and obese women. Discuss this with your doctor. During treatment, your doctor may
adjust the dose according to your individual needs.

Using more than the recommended dose of Lenzetto
If you use more than the recommended dose of Lenzetto or if the medicine is accidentally used by a
child, contact your doctor or go to a hospital for advice on the risks and actions to take.
If you use more than the recommended dose of Lenzetto, you may experience nausea, vomiting, and
intermenstrual bleeding (irregular vaginal bleeding).

Missed dose of Lenzetto
If you miss a dose of Lenzetto at the usual time, apply it as soon as possible, then continue as usual.
If it is nearly time for your next dose, wait and take the next dose at the usual time. If one or more
doses are missed, one priming spray with the cap closed is required. Do not use a double dose to
make up for a missed dose. Missing a dose may increase the likelihood of intermenstrual bleeding or
spotting.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Stopping Lenzetto
Your doctor will also explain how to stop using this medicine after treatment ends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
In women using HRT compared to women not using HRT, the following conditions have been reported more frequently:

• breast cancer;
• abnormal growth or cancer of the womb lining (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 levels;
• possible memory loss if HRT is started by a woman aged over 65 years. For more information about the above side effects, see section 2.

Some side effects may be serious.
The following symptoms require immediate medical attention:

• sudden chest pain;
• chest pain spreading to the arm or neck;
• difficulty breathing;
• painful swelling and redness of the legs;
• yellowing of the eyes and face (jaundice);
• unexpected vaginal bleeding (intermenstrual bleeding) or spotting after using Lenzetto for some time or after stopping treatment;
• changes in the breasts, including skin indentation, changes in the nipples, lumps that the woman can see or feel;
• painful periods;
• dizziness and fainting;
• changes in speech;
• changes in vision;
• unexplained headaches resembling migraine.

If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.
The following side effects have been reported with the use of Lenzetto:

Common side effects (may occur in up to 1 in 10 people)
Headache, abdominal pain, nausea, rash, itching (pruritus), irregular uterine bleeding or vaginal bleeding, including spotting, breast tenderness, breast pain, weight gain or weight loss.

Uncommon side effects (may occur in up to 1 in 100 people)
Hypersensitivity reactions, depressed mood, insomnia (difficulty sleeping), dizziness (feeling dizzy or "spinning"), visual disturbances, palpitations (awareness of heartbeat), diarrhoea, dyspepsia (indigestion), high blood pressure, erythema nodosum (characterized by painful red nodules on the skin), urticaria (generalized or localized rash or hives), skin irritation, fluid retention (oedema), muscle pain, breast pigmentation, breast discharge, polyps (small-sized) in the uterus or cervix, endometrial hyperplasia, ovarian cyst, genital tract infection (vaginitis), increased liver enzyme activity and blood cholesterol levels, pain in the armpit area.

Rare side effects (may occur in up to 1 in 1000 people)
Anxiety, decreased or increased libido, migraine, contact lens intolerance, bloating, vomiting, hirsutism (excessive hair growth), acne, muscle cramps, painful menstruation, premenstrual syndrome, breast enlargement, fatigue.

Since the marketing of Lenzetto, other side effects have been reported with a frequency of "not known" (frequency cannot be estimated from available data): hair loss (alopecia), chloasma (golden-brown pigmented patches, so-called "pregnancy mask", particularly on the face), skin pigmentation.

The following side effects have been reported with other HRT medicines:

Severe allergic reaction causing facial or throat swelling (angioedema), anaphylactic and/or anaphylactoid reactions (severe allergic reaction causing breathing difficulties or dizziness), glucose intolerance, depression, mood disorders, irritability, worsening of chorea (Huntington's chorea), worsening of epilepsy, dementia, worsening of asthma, gallbladder disease, yellowing of the skin (jaundice), pancreatitis, benign smooth muscle tumours of the uterus, skin disorders, skin pigmentation, particularly on the face or neck, known as "pregnancy mask" (chloasma), painful red nodules on the skin (erythema nodosum), discoid erythematous or ulcerative skin rash (erythema multiforme), haemorrhagic skin lesions (purpura), hair loss, joint pain, milk discharge from the breasts, breast lumps, enlargement of benign uterine smooth muscle tumours, changes in cervical epithelial exfoliation, vaginitis, fungal vaginal infection (vaginal candidiasis), abnormally low blood calcium levels.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 helps provide more information on the safety of this medicine.

5. How to store Lenzetto

Keep this medicine 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 stated month.
Use the medicine within 56 days of first use.
Do not store in a refrigerator or freeze the medicine.
Do not store at temperatures above 25°C.
This medicine contains ethanol, which is a flammable substance. Store away from radiators, open flames, and other sources of ignition.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 96% ethanol.

What Lenzetto looks like and contents of the pack
Lenzetto is a transdermal aerosol containing a solution of estradiol and octyl salicylate in ethanol. It is equipped with a metering pump.
Lenzetto is available in a plastic container with a plastic coating. Inside is a glass vial. Each pack contains one vial containing 6.5 ml of solution, allowing for 56 doses of 90 microliters each. You should mark the number of administered sprays in the table on the packaging.
Each dose contains 1.53 mg of estradiol.
Do not use the Lenzetto container for more sprays than indicated on the label, even if the container is not completely empty.
Pack size:
One plastic container, 6.5 ml (56 doses).
Three plastic containers, 3 x 6.5 ml (3 x 56 doses).
Not all pack sizes may be marketed.
Marketing Authorisation 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 further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
((logo of the marketing authorisation holder))
((pharmacode))