Lutenil

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lutenyl

5 mg, tablets
Nomegestrol acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 for progesterone receptors is 2.5 times higher than that of the natural hormone.
Administered from the 5th to the 25th day of the cycle at a dose of 5 mg per day, Lutenyl inhibits ovulation, reduces gonadotropin secretion, lowers circulating estrogen levels, 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

In premenopausal women: menstrual disorders related to reduced or absent progesterone secretion:

• menstrual disorders: scant or infrequent menstruation, excessive 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: spontaneous 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:

• if the patient is allergic to nomegestrol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has undiagnosed vaginal bleeding,
• if the patient has a history of idiopathic venous thrombosis or active venous thromboembolic disease (deep vein thrombosis, pulmonary embolism),
• if the patient has active or a history of arterial thrombotic diseases (e.g., myocardial infarction),
• if the patient has severe liver dysfunction, current or a history of,
• if the patient has been diagnosed with a meningioma (usually a benign brain tumor). In case of doubt, consult your doctor. If any of the above factors occur for the first time while taking Lutenyl, stop taking the medicine immediately and consult your doctor.

Warnings and precautions

Before starting Lutenyl, discuss it with your 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, check for breast and uterine (cervix and endometrium) tumors;
• stop taking the medicine if you experience: any vision disorders (double vision, severe vision disturbances, retinal vessel damage), thrombosis, or embolism, severe, unusual headache;
• exercise caution in cases of cardiovascular disease, unstable hypertension, diabetes, or porphyria.

Special precautions
In regular intervals, the patient should undergo a control examination.
If during treatment the patient observes any changes in the breasts, they should immediately inform their doctor.
In the event that any of the following diseases have been diagnosed, occurred in the past, and (or) worsened during pregnancy or previous hormonal treatment, the patient should be under close surveillance. It should be considered that these diseases may recur or worsen during Lutenyl treatment; in particular, these include:

• uterine fibroids,
• endometriosis or previous cases of endometrial hyperplasia,
• thromboembolic disorders in the history or the existence of factors increasing the risk of 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 lupus erythematosus (a disease affecting many organs in the body),
• epilepsy,
• asthma,
• otosclerosis (a disease leading to hearing loss).

The doctor will decide to stop 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.

Hormone Replacement Therapy (HRT) and Malignant Tumors

Endometrial Hyperplasia and Endometrial Cancer

The use of estrogen-only HRT increases the risk of endometrial hyperplasia and endometrial cancer. The addition of a progestogen for at least 12 days of the cycle protects against this increased risk.
In women with an intact uterus who do not use HRT, endometrial cancer is diagnosed in approximately 5 out of 1000 women between the ages of 50 and 65. In women with an intact uterus taking estrogen-only HRT, between 10 and 60 out of 1000 women will be diagnosed with endometrial cancer (i.e., 5 to 55 additional cases), depending on the dose and duration of treatment.

Breast Cancer

Studies suggest that the use of combined estrogen-progestogen HRT, and possibly estrogen-only HRT, increases the risk of breast cancer. The additional risk depends on the duration of HRT. The additional risk becomes apparent within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
In women who have taken estrogen-only HRT for 5 years, there is little or no risk of breast cancer.
Comparison
In women aged 50-79 who do not take HRT, approximately 16 out of 1000 will be diagnosed with invasive breast cancer within 5 years. In women aged 50-79 taking combined estrogen-progestogen HRT for 5 years, there will be between 16 and 25 cases per 1000 women (i.e., 0 to 9 additional cases).

Regular Breast Examinations

Regular breast examinations should be performed. If any changes occur, such as:

• skin dimpling,
• breast changes,
• 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

During nomegestrol treatment, meningiomas (usually benign brain tumors) have been reported (see section 4 "Possible side effects"). If a meningioma is diagnosed, nomegestrol treatment should be discontinued.

Effect of HRT on the Heart and Circulation

Vein Thrombosis

The risk of venous thrombosis is approximately 2-3 times higher in women taking HRT, especially in the first year of treatment, than in women not taking HRT. 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. Inform your 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/m2),
• the patient has coagulation disorders and requires long-term treatment with anticoagulant medication,
• if the patient or a close relative has 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 HRT on the cardiovascular system. Two large clinical trials on the effect of combined (estrogen and progestogen) therapy indicate a possible increase in cardiovascular disease during the first year of treatment and no overall benefit. There is limited data on the effect of other HRT medications on morbidity and mortality due to cardiovascular disease.

Stroke

The risk of ischemic stroke is higher in individuals taking HRT than in those who do not. The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-59 who do not take HRT, approximately 3 out of 1000 will experience a stroke within 5 years. Among women aged 50-59 taking HRT, there will be between 0 and 3 additional cases per 1000 women treated, within 5 years.

Other Conditions

Due to fluid retention caused by estrogens, patients with kidney or heart dysfunction require special supervision. Women with severe renal impairment require close monitoring due to the possible increase in circulating nomegestrol levels.
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 total 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 increased 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 be increased.
HRT does not improve cognitive function (memory loss, perception disorders, attention disorders). There is evidence of an increased risk of dementia in women who start HRT after the age of 65.

Lutenyl and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This includes:

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

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Lutenyl should not be taken during pregnancy or breastfeeding.

Driving and Using Machines

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

Lutenyl Contains Lactose Monohydrate

The medicine should not be taken by patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

3. How to Take Lutenyl

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your 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, dosing depends on the type of hormone replacement therapy used.
In continuous hormone replacement therapy, Lutenyl is taken 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>Metabolic and Nutritional Disorders
Frequency not known:
weight gain
Psychiatric Disorders
Frequency not known:
insomnia
Eye Disorders
Frequency not known:
vision 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
After long-term (several years) use of nomegestrol at doses of 3.75 mg or 5 mg per day or higher, meningiomas (usually benign brain tumors) have been reported (see section "When not to take nomegestrol").

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to Store Lutenyl

Keep the medicine out of the 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.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Lutenyl Contains

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

What Lutenyl Looks Like and Contents of the Pack

The medicine is in the form of elongated tablets with a score line on one side.
The pack contains 10 tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in France, Country of Export:

THERAMEX Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1 D01 YE64
Ireland

Manufacturer:

Delpharm Lille S.A.S, Parc d’Activites Roubaix-Est, 22 rue de Toufflers - CS 50070, 59452 Lys-Lez-Lannoy, France
Laboratoires Macors, rue des Caillottes, ZI Plaine des Isles, 89000 Auxerre, France
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in France, Country of Export:326 611-2
326 612-9
3400932661121
3400932661299
Parallel Import Authorization Number:564/12
Date of Leaflet Approval: 06.09.2022
[Information about the trademark]