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Lenzetto spray 8.1 ml.

Lenzetto is used for hormone replacement therapy (HRT). The lens contains the female hormone estrogen. The lens is used in menopausal women and for at least 6 months after their last normal cycle.

Quantity

What LENZETTO is and what it is used for

The lancet is used for hormone replacement therapy (HRT). The linseed contains female hormone from the estrogen group. Leningema is used in menopausal women and at least 6 months after their last normal cycle.

The lance can be used in women who have undergone surgery to remove the ovaries as this results in immediate menopause.

The lancet is an injection solution that contains small amounts of a drug called estradiol. When injected directly onto the skin, it passes through it into the bloodstream.

The lance is used to:

Relief of post-menopausal symptoms

During menopause, the amount of estrogen produced in the female organism decreases. This can cause symptoms such as burning sensation on the face, neck and chest ("hot flushes"). Leningema relieves these symptoms after menopause. Your lance will only be prescribed if your symptoms severely hamper your daily life.

The lancet is indicated for the treatment of symptoms of estrogen deficiency after menopause when menstruation has stopped. Symptoms of estrogen deficiency include warm waves (sudden heat and body sweats), sleeping problems, irritability and

dryness of the vagina.

Experience in treating women older than 65 years is limited.

Lancet is not a contraceptive.

2. What you need to know before using Lenzeto Medical history and regular check-ups

The use of HRT involves risks that should be considered when deciding whether to start or continue treatment.

Experience with treatment of premature menopausal women (due to insufficient ovarian function or surgery) is limited. If you have premature menopause, the risks of using HRT may be different. You need to consult your doctor.

Before you start (or resume) HRT, your doctor will ask for your medical history and that of your family. Your doctor may decide to have a physical examination. This may include breast and / or internal examination if necessary.

Once you start using Lancet, you should visit your doctor for regular check-ups (at least once a year). During these examinations, discuss with your doctor the benefits and risks of continuing with Lancet.

Regularly check your chest if recommended by your doctor.

Do not use Lancet if any of the following conditions apply to you. If you are not sure about any of the conditions below, talk to your doctor before you start using Lancet.

Do not use Lancet

- if you have, have had or suspect that you have breast cancer;

- if you have, have had or suspect that you have a cancer that is sensitive to

- oestrogens, such as uterine lining (endometrium);

- if you have unexplained vaginal bleeding

- if you have excessive growth of the uterine lining (endometrial hyperplasia) that has not been treated;

- if you have or have had a blood clot in a vein (thrombosis), for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism); if you have a blood coagulation disorder (eg protein C deficiency, protein S deficiency or antithrombin deficiency);

- if you have or have recently had a disease caused by the formation of blood clots in the arteries, eg heart attack, stroke or angina; if you have or have had liver disease and your liver function has not been normalized;

- if you have a rare blood disease called "porphyria" that is transmitted to the family (inheritance).

- if you are allergic (hypersensitive) to estradiol or any of the other ingredients of this medicine (described in section 6).

If any of the conditions listed above appear for the first time while using Lenca, stop using it immediately and consult your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before using Lancet.

Before using, tell your doctor if you have ever had any of the following problems, as they may be experiencing or getting worse during treatment with Leningrad. In this case, you should visit your doctor more often to perform check-ups: - Fibroids in the uterus;

- growth of the uterine lining outside the uterus (endometriosis) or excessive growth of the uterine lining (endometrial hyperplasia) in the past; increased risk of blood clots (see "Blood clots in a vein (thrombosis)");

- increased risk of developing estrogen sensitive cancer (for example, if you have a mother, nurse or grandmother who has had breast cancer); high blood pressure;

- hepatic disorder, such as a benign liver tumor; diabetes;

- gall stones; migraine or severe headache;

- a disease of the immune system that affects many organs in the body (systemic lupus

- erythematosus (SLE));

- epilepsy;

- asthma;

- a disease affecting the eardrum and hearing (otosclerosis);

- Very high blood fats (triglycerides);

- retention of fluid due to cardiac or renal disorders.

Stop using Lancet and go to your doctor immediately If you notice any of the following conditions when using HRT:

- any of the conditions listed under "Do not use Lancet";

- yellowing of the skin and whites of the eyes (jaundice). These may be signs of liver disease;

- a strong increase in blood pressure (symptoms may be headache, fatigue, dizziness);

- a migraine-like headache that occurs for the first time;

- if you become pregnant

- if you notice signs of a blood clot such as:

- painful swelling and reddening of the feet,

- sudden chest pain,

- difficulty in breathing,

- visual disturbances.

For more information, see "Blood clots in a vein (thrombosis)".

Note: Lancet is not a contraceptive. If you are less than 12 months old from your last menstrual cycle or you are under 50, you may need additional contraception to protect yourself from pregnancy. Ask your doctor for advice.

HRT and cancer

Excessive enlargement of the uterine lining (endometrial hyperplasia) and uterine mucosal cancer (endometrial cancer).

Using estrogen only with HRT may increase the risk of excessive uterine lining (endometrial hyperplasia) and uterine lining (endometrium).

Taking progestagen in addition to estrogen for at least 12 days in every 2 8-day cycle prevents you from this additional risk. In this case, your doctor will prescribe progestagen separately if you have a uterus. If your uterus has been removed (hysterectomy), discuss with your doctor whether you can safely take this product without progestagen.

An average of 5 out of 1,000 women who have uterus and do not use HRT »are diagnosed with endometrial cancer aged 50-65 years.

Between 10 and 60 women in 1,000 women aged 50 to 65 who have uterus and receive estrogen only HRT are diagnosed with endometrial cancer (ie between 5 and 55 additional cases) depending on the dose and duration of the treatment.

The lance contains a higher estrogen dose than other estrogen-only HRT products. The risk of endometrial cancer when using Lancet together with progestagen is unknown.

Unusual bleeding

You will have bleeding once a month (the so-called bleeding bleed) while using the Lancet if combined with a cyclically dosed progestagen product. But if you have unusual bleeding or drops of blood (spotting) besides your monthly bleeding, which: goes on after the first 6 months

start after you have used Lancet for more than 6 months after you have stopped using Lenzeta visit your doctor as soon as possible.

Breast cancer

Data suggest that the use of estrogen-progestagen combination therapy, and possibly estrogen-only HRT, increases the risk of breast cancer. The additional risk depends on how long you take HRT. The additional risk becomes clear within a few years.

However, after stopping treatment, it returns to normal levels within a few years (at most 5 years).

For women with a uterus who have received HRT with estrogen only for 5 years, there has been little or no increase in the risk of developing breast cancer.

An average of 9 to 14 per 1,000 women aged 50 to 79 who do not use HRT are diagnosed with breast cancer within 5 years. In women aged 50 to 79 who have been using HRT with estrogen-progestagen for 5 years, there are 13 to 20 cases per 1,000 patients (ie 4 to 6 cases).

Regularly check your chest. Visit your doctor if you notice any changes, such as:

- wrinkling of the skin changes the nipple of the breast

- any lumps that you can see or feel

In addition, we advise you to join mammography research programs if you are offered. In mammography, it is important to inform the nurse / health care professional who is conducting the X-ray examination that you are using HRT, as this medicine can increase breast density and thus affect the outcome of the mammogram. Mammography may not detect all lumps when breast density is increased.

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

On average, between 2 per 1,000 women aged 50 to 69 who do not take HRT have been diagnosed with ovarian cancer for 5 years. In women who have taken HRT for 5 years, between 2 and 3 cases per 1,000 patients (ie up to one additional case) have been diagnosed.

Effect of HRT on heart and blood circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3 times higher in women taking HRT than those who do not receive, especially during the first year of treatment.

Blood clots can be serious and if one of them reaches the lungs, it can cause chest pain, shortness of breath, loss of consciousness and even death.

The likelihood of getting a blood clot in the veins is greater as you age and if any of the following conditions apply to you. Tell your doctor if any of these conditions apply to you:

- if you can not walk for a long time because of a major surgery, trauma or illness (see also section 3 if you need surgery), - if you are significantly overweight (BMI> 30 kg / m2).

- if you have a blood coagulation problem that requires continued treatment with a medicine used to prevent blood clots.

- if someone in your immediate family has ever had a blood clot in the leg, lung or other organ.

- if you have systemic lupus erythematosus (CJIE). if you have cancer.

If signs of a blood clot appear, see "Stop using Lancome and go to a doctor immediately."

An average of 4 to 7 out of 1,000 women over 50 years of age who do not use HRT are expected to have a blood clot in a vein within 5 years.

In women over 50 years of age who have used HRT with estrogen-progestagen for 5 years, there are 9 to 12 cases per 1,000 users (ie 5 additional cases).

For women over 50 years of age who have a uterus removed and have used estrogen only HRT for 5 years, there are 5 to 8 cases per 1,000 patients (ie 1 additional case).

Heart disease (heart attack)

There is no evidence that HRT prevents a heart attack.

There is a greater likelihood that women over 60 years of age receiving HRT with estrogen-progestagen will develop heart disease than women who do not take any HRT.

There is no increased risk of developing cardiac disease in women with uterus who are receiving estrogen only.

Stroke

The risk of getting a stroke is about 1.5 times higher for women, compared to those who do not. The number of additional stroke cases of HRT increases with age.

An average of 8 out of 1,000 women over 50 years of age who do not use HRT is expected to get a stroke within 5 years. In women over the age of 50 who have used HRT, there are 11 cases per 1,000 patients within 5 years (ie 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start to apply HRT after the age of 65. Consult your doctor.

Children

Estrogen in Leningo Spray can be accidentally transferred to other people from the skin where it is applied to other people. Do not allow other people, especially children, to touch the treatment site. If a child touches a part of the arm where the Leningo is sprayed, wash his skin with soap and water as quickly as possible. In young children who have accidentally been in contact with the place where Lancet has been injected, signs of unexpected puberty (such as breast development) may occur.

Contact your doctor immediately if you notice signs and symptoms (breast development or other sexual changes) in a child that may have occurred as a result of accidental contact with Lancet. In most cases, the breasts return to their normal condition if the child is not exposed to Lengzeth for a long time.

Pets

Do not allow a pet to lick or touch the hand where the Lancet is sprayed. Small animals can be particularly susceptible to estrogen in Lenzeto. Contact a veterinarian if your pet shows an increase in chest and / or swollen vulva or any other signs of illness.

Other drugs and Lanzetto

Tell your doctor if you are using, have recently used or are likely to use other medicines.

Some medicines can prevent Lenzeto effect. This can lead to irregular bleeding. This applies to the following medicines:

- medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)

- medicines for tuberculosis (such as rifampicin, rifabutin)

- medicines to treat HIV infection (such as nevirapine, ritonavir, nelfinavir or efavirenz)

- (traditional) herbal medicines containing St John's wort (Hypericum perforatum)

Ask your doctor or pharmacist for advice before using any medicine.

Laboratory researches

If you need a blood test, tell your doctor or the laboratory technician that you are using Lancet as this medicine may affect the results of some studies.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to get a problem, ask your doctor or pharmacist for advice before taking this medicine.

Leningema is only for use in postmenopausal women. If you become pregnant, stop using Lenzette immediately and contact your doctor.

Do not use Lance as you are breastfeeding.

Driving and using machines

Lancet has no influence on the ability to drive or use machines.

The linseed contains alcohol

Alcohol-based products are flammable. Avoid exposure to fire, flame or smoking until the spray dries.

3. How to use Lanzetto

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will try to prescribe the lowest dose to treat your symptoms as soon as possible as needed. During treatment, your doctor may adjust your dose according to your individual need. Talk to your doctor if you think this dose is too high or not enough.

If you have not had a hysterectomy, your doctor will give you tablets containing another hormone called a progestogen to compensate for the effect of estrogens on the lining of the uterus. Your doctor will tell you how to take these tablets. Removal of bleeding may occur at the end of the progestogen treatment period. (See section "Unusual bleeding").

Where to apply Lenzetto

The spray should be applied to the inside of the forearm.

Do not apply Lancet on the chest or in a place near the chest.

How to apply Lanzetto

Before you inject the first dose of a new container onto dry and healthy skin, the applicator should be prepared for use by spraying three times in the lid.

The container should behave exactly as shown in Figure 1. With the lid closed, press the button down three times with a thumb or forefinger.

Now the drug is ready for use.

Do not prepare the applicator before each dose but only once before you start using a new container.

Make sure the skin where you want to spray the medicine is clean and dry.

To apply the daily dose, remove the plastic cover, hold the container upright and place the surface of the conical tip on the skin.

It may be necessary to move your hand or the conical tip of the container to the hand so that the cone sticks to the skin and there is no distance between it and the dry and healthy skin.

Press the down button once.

If a second injection is required, move the cone on the arm so that it is up to the place where you have already injected. Press the down button once.

If a third injection is required, move the cone again on the arm and press the down button once.

If the second or third injection can not fit on the same inner part of the forearm, or if you have trouble inserting the cone on the inside of the forearm as shown in Figure 3, or if you have difficulty applying the forearm, it may also to spray the spray on the other inner part of the forearm or on the inner surface of the foot.

Always replace the lid of the container after using Lancet.

Allow the spray to dry for at least 2 minutes before putting on a garment and at least 60 minutes before bathing or washing. If sprays have spread on other surfaces of your skin, for example on the hands, immediately wash the area with soap and water.

The lancet should not be applied to injured or damaged skin.

Do not massage or rub your skin into a skin.

Do not allow other people to touch the site of the skin where you have the spray, at least 60 minutes afterwards. If another person (especially children

Pets

Do not allow a pet to lick or touch the hand where the Lancet is sprayed. Small animals can be particularly susceptible to estrogen in Lenzeto. Contact a veterinarian if your pet shows an increase in chest and / or swollen vulva or any other signs of illness.

Other drugs and Lanzetto

Tell your doctor if you are using, have recently used or are likely to use other medicines.

Some medicines can prevent Lenzeto effect. This can lead to irregular bleeding. This applies to the following medicines:

- medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)

- medicines for tuberculosis (such as rifampicin, rifabutin)

- medicines to treat HIV infection (such as nevirapine, ritonavir, nelfinavir or efavirenz)

- (traditional) herbal medicines containing St John's wort (Hypericum perforatum)

Ask your doctor or pharmacist for advice before using any medicine.

Laboratory researches

If you need a blood test, tell your doctor or the laboratory technician that you are using Lancet as this medicine may affect the results of some studies.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to get a problem, ask your doctor or pharmacist for advice before taking this medicine.

Leningema is only for use in postmenopausal women. If you become pregnant, stop using Lenzette immediately and contact your doctor.

Do not use Lance as you are breastfeeding.

Driving and using machines

Lancet has no influence on the ability to drive or use machines.

The linseed contains alcohol

Alcohol-based products are flammable. Avoid exposure to fire, flame or smoking until the spray dries.

3. How to use Lanzetto

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will try to prescribe the lowest dose to treat your symptoms as soon as possible as needed. During treatment, your doctor may adjust your dose according to your individual need. Talk to your doctor if you think this dose is too high or not enough.

If you have not had a hysterectomy, your doctor will give you tablets containing another hormone called a progestogen to compensate for the effect of estrogens on the lining of the uterus. Your doctor will tell you how to take these tablets. Removal of bleeding may occur at the end of the progestogen treatment period. (See section "Unusual bleeding").

Where to apply Lenzetto

The spray should be applied to the inside of the forearm.

Do not apply Lancet on the chest or in a place near the chest.

How to apply Lanzetto

Before you inject the first dose of a new container onto dry and healthy skin, the applicator should be prepared for use by spraying three times in the lid.

The container should behave exactly as shown in Figure 1. With the lid closed, press the button down three times with a thumb or forefinger.

Now the drug is ready for use.

Do not prepare the applicator before each dose but only once before you start using a new container.

Make sure the skin where you want to spray the medicine is clean and dry.

To apply the daily dose, remove the plastic cover, hold the container upright and place the surface of the conical tip on the skin.

It may be necessary to move your hand or the conical tip of the container to the hand so that the cone sticks to the skin and there is no distance between it and the dry and healthy skin.