Lutenil

Package Leaflet: Information for the Patient

Lutenyl

Nomegestrol acetate
5 mg, tablets

• Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lutenyl and what is it used for
• 2. Important information before taking Lutenyl
• 3. How to take Lutenyl
• 4. Possible side effects
• 5. How to store Lutenyl
• 6. Contents of the pack and other information
• 1. What is Lutenyl and what is it used for

Nomegestrol, the active substance in Lutenyl, is a 19-norprogesterone derivative used to balance progesterone deficiencies. The affinity of nomegestrol to progesterone receptors is 2.5 times higher than that of the natural hormone.
Administered from the 5th to the 25th day of the cycle in a dose of 5 mg per day, Lutenyl inhibits ovulation, reduces gonadotropin secretion, lowers estrogen levels in the blood, and prevents the secretion of natural progesterone. Pharmacokinetic studies have not shown complete anti-gonadotropic activity in all patients.
Nomegestrol acetate is rapidly absorbed, with a maximum concentration occurring 2 hours after administration, and a half-life of approximately 40 hours. It is mainly excreted through the intestines and partially with urine.

Indications for Use

In premenopausal women: menstrual disorders associated with reduced or absent progesterone secretion:

• menstrual disorders: scanty or infrequent menstruation, excessively frequent menstruation, absence of menstruation
• functional bleeding from the genital organs: uterine bleeding, menstrual bleeding, including bleeding associated with fibroids
• symptoms preceding or associated with menstruation: painful menstruation, premenstrual syndrome, periodic breast pain

In postmenopausal women: Lutenyl is used with estrogens (artificially induced cycles) in hormone replacement therapy

2. Important Information Before Taking Lutenyl

When Not to Take Lutenyl:

In case of doubts, consult a doctor.
If any of the above factors occur for the first time during treatment with Lutenyl, the patient should stop taking the medicine immediately and consult a doctor without delay.

Warnings and Precautions

Before starting treatment with Lutenyl, the patient should discuss it with their doctor or pharmacist.

• clinical trials have not shown complete anti-gonadotropic activity in all patients
• before starting treatment for certain indications, especially painful menstruation, uterine bleeding, and absence of menstruation, the doctor must determine if it is a functional disorder
• before starting treatment, it is necessary to check for breast and uterine (cervix and endometrium) tumors
• the patient should stop taking the medicine in case of: any visual disturbances (double vision, severe visual disturbances, retinal vessel damage), thrombosis or embolism, severe, atypical headache
• caution should be exercised in patients with cardiovascular diseases, unstable hypertension, diabetes, or porphyria.

Special precautions
The patient should have regular check-ups at regular intervals.
If the patient notices any changes in their breasts during treatment, they should inform their doctor immediately.
If any of the following diseases are diagnosed, the patient should be under close supervision. It should be considered that these diseases may recur or worsen during treatment with Lutenyl; in particular, these include:

• uterine fibroids
• endometriosis or previous cases of endometrial hyperplasia
• thromboembolic disorders in history or the presence of risk factors for their occurrence (see below)
• risk factors for estrogen-sensitive tumors, e.g., first-degree relatives with breast cancer
• hypertension
• liver dysfunction (e.g., liver adenoma)
• diabetes, regardless of whether it is accompanied by vascular changes or not
• gallstones
• migraine or severe headaches
• systemic immune system disease affecting many organs in the body (systemic lupus erythematosus)
• epilepsy
• asthma
• otosclerosis (ear disease leading to deafness).

The doctor will decide to discontinue treatment if contraindications occur, as well as in the following situations:

• jaundice or worsening liver function
• significant increase in blood pressure
• new migraine headache
• pregnancy

HTZ and Malignant Tumors

Endometrial Hyperplasia and Endometrial Cancer

The use of estrogen-only HTZ increases the risk of endometrial hyperplasia and endometrial cancer. The additional use of progestogen for at least 12 days of the cycle protects the patient from this increased risk.
In women with an intact uterus who do not use HTZ, endometrial cancer is diagnosed in approximately 5 out of 1,000 women between the ages of 50 and 65. In women between the ages of 50 and 65 with an intact uterus who use estrogen-only HTZ, endometrial cancer is diagnosed in 10-60 out of 1,000 women (i.e., 5-55 additional cases), depending on the dose and duration of treatment.

Breast Cancer

Studies suggest that the use of combined estrogen-progestogen HTZ, and possibly estrogen-only HTZ, increases the risk of breast cancer. The additional risk depends on the duration of HTZ use. The additional risk becomes apparent within a few years. However, it returns to normal within a few years (up to 5) after stopping treatment.
In women who used estrogen-only HTZ for 5 years, there was no or minimal risk of breast cancer.
Comparison
In women between the ages of 50 and 79 who do not use HTZ, approximately 16 out of 1,000 will be diagnosed with invasive breast cancer within 5 years. In women between the ages of 50 and 79 who use combined estrogen-progestogen HTZ for 5 years, there will be 0-9 additional cases per 1,000 patients using the therapy (i.e., 16-25 cases per 1,000).

Check Your Breasts Regularly. Consult a Doctor If You Notice Any Changes Such As:

• wrinkles on the skin,
• changes in the breast,
• any visible or palpable thickening.

Ovarian Cancer

According to some epidemiological studies, long-term (at least 5-10 years) use of estrogen alone in women who have had a hysterectomy may increase the risk of ovarian cancer. The risk associated with long-term use of combined estrogen-progestogen therapy is unknown.

Meningioma

The use of nomegestrol acetate has been associated with the development of usually benign tumors of the tissue layer between the brain and the skull (meningioma). This risk increases, especially with longer use (several months or years). If a meningioma is diagnosed in a patient, the doctor will discontinue treatment with Lutenyl (see "Do not take..."). If the patient notices any symptoms, such as changes in vision (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches that worsen over time, memory loss, seizures, weakness in the arms or legs, they should inform their doctor immediately.

Effect of HTZ on the Heart and Circulation

Vein Thrombosis

The risk of venous thrombosis is approximately 2-3 times higher in women using HTZ, especially in the first year of treatment, than in women who do not use it. If a thrombus enters the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of venous thrombosis increases with age and depends on the presence of the following factors. The patient should inform their doctor if any of the following situations occur:

• the patient is unable to walk for an extended period due to extensive surgery, injury, or illness
• the patient is obese (Body Mass Index, BMI >30 kg/m)
• the patient has coagulation disorders and requires long-term treatment with anticoagulant medication
• if the patient or any close relatives have had a thrombus in the lower limb, lung, or other organ
• the patient is pregnant and (or) postpartum
• the patient has systemic lupus erythematosus (SLE).

Coronary Artery Disease

There is no scientific evidence to support the beneficial effect of HTZ on the cardiovascular system. Two large clinical trials on the effect of combined estrogen-progestogen therapy indicate a possible increase in cardiovascular disease incidence during the first year of treatment and no overall benefit. There is limited data on the effect of other HTZ medications on cardiovascular disease incidence and mortality.

Stroke

The risk of ischemic stroke is higher in individuals using HTZ than in those who do not. The number of additional stroke cases due to HTZ use increases with age.
Comparison
In women between the ages of 50 and 59 who do not use HTZ, approximately 3 out of 1,000 will likely experience a stroke within 5 years. Among women between the ages of 50 and 59 who use HTZ, there will be 0-3 additional cases per 1,000 patients using the therapy, within 5 years.

Other Conditions

Due to fluid retention caused by estrogens, patients with kidney or heart function disorders require special supervision. Women with severe renal failure require close monitoring, as the concentration of nomegestrol in the blood may increase.
Women with previously diagnosed hypertriglyceridemia who are undergoing hormone replacement therapy require special supervision. There are isolated reports suggesting the possibility of pancreatitis following a significant increase in triglyceride levels in women treated with estrogen alone.
Estrogens increase the amount of thyroid-binding globulin (TBG), leading to an increase in the total amount of circulating thyroxine. The levels of other binding proteins present in the blood may also increase, such as corticosteroid-binding globulin and sex hormone-binding globulin, resulting in an increase in the blood levels of corticosteroids and sex hormones, respectively. The levels of free or biologically active hormones do not change.
The levels of other plasma proteins (substrate for angiotensin/renin, alpha-1 antitrypsin, ceruloplasmin) may also increase.
HTZ does not improve cognitive function (memory loss, perception disorders, attention disorders). There is evidence of an increased risk of dementia in women who started HTZ at an age above 65.

Lutenyl and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This includes the following medicines:

• medicines used to treat epilepsy(such as phenobarbital, phenytoin, and carbamazepine),
• medicines used to treat tuberculosis(such as rifampicin, rifabutin).

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Lutenyl should not be used during pregnancy or breastfeeding.

Driving and Using Machines

The medicine may cause visual disturbances (see sections 2 and 4).

Lutenyl Contains Lactose

The medicine should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome.

3. How to Take Lutenyl

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
Recommended dose
The average daily dose is 5 mg (1 tablet).
In premenopausal women, treatment usually lasts 10 days, from the 16th to the 25th day of the cycle.
In postmenopausal women, the dosage depends on the type of hormone replacement therapy used.
In continuous hormone replacement therapy, Lutenyl is used for 12 to 14 days of each cycle.
The dose and duration of treatment can be adjusted according to the indication and the patient's response to the medicine.

Overdose of Lutenyl

So far, no cases of overdose have been reported.

4. Possible Side Effects

Like all medicines, Lutenyl can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
very common (≥1/10); common (≥1/100 to <1>Metabolism and nutrition disorders
Frequency not known:
weight gain
Psychiatric disorders
Frequency not known:
insomnia
Eye disorders
Frequency not known:
visual disturbances
Vascular disorders
Frequency not known:
worsening of venous insufficiency of the lower limbs; occurrence of venous thromboembolism
Gastrointestinal disorders
Frequency not known:
gastrointestinal disturbances
Skin and subcutaneous tissue disorders
Frequency not known:
skin allergies, excessive hair growth
Reproductive system and breast disorders
Frequency not known:
menstrual disorders, absence of menstruation, intermenstrual bleeding
General disorders and administration site conditions
Frequency not known:
fever
The use of nomegestrol acetate has been associated with the development of usually benign tumors of the tissue layer between the brain and the skull (meningioma), especially with high doses and long-term use (several months or years) with a frequency of "rare" (see section 2 "Warnings and precautions").

Reporting Side Effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Lutenyl

• Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
• The batch number on the packaging is marked as "Lot".
• Store the medicine at a temperature below 25°C
• Store the medicine out of sight and reach of children.

6. Contents of the Pack and Other Information

What Lutenyl Contains

1 tablet contains:
active substance: 5 mg nomegestrol acetate
excipients:lactose, microcrystalline cellulose, glycerol palmate stearate, colloidal anhydrous silica

What Lutenyl Looks Like and Contents of the Pack

The medicine is in the form of oblong tablets with a score line on one side.
The pack contains 10 tablets

Marketing Authorization Holder

Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland
(logo of the marketing authorization holder)

Manufacturer

Laboratoires MACORS
22 Rue des Caillottes
89000 Auxerre
France
To obtain more detailed information, please contact the local representative of the marketing authorization holder at phone number: 22 307 71 66.
Date of last revision of the leaflet:January 2025