What it is and what it is used for

for

What Nalvee is Nalvee contains a medicine called 'dydrogesterone'. Dydrogesterone is an artificially produced hormone. It is very similar to the hormone 'progesterone', which is produced in the body. Medicines like Nalvee are called 'progestogens'. What Nalvee is used for Nalvee can be used alone or in combination with an estrogen. Whether you also take an estrogen depends on the symptoms for which you are taking Nalvee. Nalvee is used: − In the context of progesterone deficiencies • to relieve painful periods • to relieve the symptoms of endometriosis (a problem caused by growth of the womb lining outside the womb) • for the treatment of menstrual irregularities • to relieve the symptoms of premenstrual syndrome (PMS) −

To treat the symptoms of menopause in the context of a hormone replacement therapy (HRT) as an adjunct to estrogen treatment in women with uterus • These symptoms vary from woman to woman • They may include hot flashes, night sweats, sleep disturbances, vaginal dryness and urological problems

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To re-start periods that have stopped before the menopause (amenorrhoea)

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To stop or prevent unusually heavy or long periods (often due to the start of the menopause)

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How Nalvee works There is usually a balanced amount of the natural hormone progesterone and estrogen (the other main female hormone) in the body. If your body does not make enough progesterone, Nalvee compensates for this and restore the balance. Your doctor may prescribe an estrogen along with Nalvee. Whether he actually does this depends on the reason you are taking Nalvee. Some women taking estrogen alone in HRT may experience an unusual thickening of the womb lining. This can also be the case if your uterus has been removed but you have been diagnosed with endometriosis (a build-up of womb lining outside the uterus). Taking dydrogesterone for part of your monthly cycle helps to prevent a build-up of your womb lining. 2.

What you need to know before you take it

e Nalvee

Do not take Nalvee if you are allergic to dydrogesterone or any of the other ingredients of this medicine (listed in section 6) if you have a tumour condition that can be aggravated by progestogens, or are suspected of having – e.g. a brain tumour called a "meningioma" if you have vaginal bleeding of unknown cause if you suffer from severe acute and chronic liver diseases as well as disorders in the metabolism of bile pigments (e.g. Dubin-Johnson syndrome, Rotor syndrome) if you suffer or have suffered from liver tumours if you suffer from phlebitis with formation of a blood clot (thrombophlebitis) if you suffer from blood clot formation (thrombosis) or acute blockage of a blood vessel by a blood clot carried with the bloodstream (thromboembolic diseases) If any of the above applies to you, do not take Nalvee. If you are not sure, talk to your doctor or pharmacist before taking Nalvee. If you are taking Nalvee together with an estrogen, for example as part of HRT, please also read the 'Do not take' section of the package leaflet you will receive with the estrogen-containing medicine. Warnings and precautions Talk to your doctor or pharmacist before taking Nalvee. Special caution is required when taking Nalvee, if you have high blood pressure or develop high blood pressure while taking Nalvee. If you need to take Nalvee for unusual bleeding, your doctor will find the cause of the bleeding before you start taking this medicine. If unusual vaginal bleeding or spotting occurs while taking Nalvee, it is usually nothing to worry about. Such bleeding is especially likely during the first months. However, make an appointment to see your doctor straight away if bleeding or spotting: carries on for more than a few months starts after you have been on treatment for a while carries on even after you have stopped treatment This may be a sign that your womb lining has become thicker. Your doctor will look into the cause of the bleeding or spotting and may do a test to rule out the possibility that you have cancer of the womb lining. Talk to your doctor or pharmacist before taking Nalvee if one of the following conditions applies to you: 2/9

depression liver problems a rare blood disorder that runs in the family (is congenital) called porphyria jaundice and/or itching caused by bile stasis If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Nalvee. It is especially important to inform them if the above symptoms have ever worsened during pregnancy or with previous hormone treatment. Your doctor may monitor you more closely during treatment. If the symptoms worsen or reappear while taking Nalvee, your doctor will probably stop the treatment. Higher doses should be used with caution in the case of stroke (also in the history) Nalvee and HRT As well as the benefits, HRT also has some risks that you and your doctor need to consider when deciding whether to take these medications. If you are taking Nalvee along with estrogen as part of HRT, the following information is important to you. Please also read the package leaflet you will receive with your prescribed estrogen medicine. Early menopause There is limited experience with the treatment of women with early menopause (due to a failure of the ovaries' function or their surgical removal). In younger women the level of risk is low. This means that the benefit-risk ratio for younger women taking HRT for early menopause may be better than for older women. Medical examinations Before starting (or resuming) a HRT your doctor will take your own medical history and that of your family. Your doctor will decide whether a physical examination is necessary. This may include a breast examination and/or an abdominal examination if necessary. Before and during treatment, your doctor may use screening methods such as a mammogram (breast X-ray). Your doctor will tell you how often to have these tests. Once you start taking Nalvee, you should see your doctor for regular check-ups (at least once a year). Endometrial cancer and endometrial hyperplasia Women who have a uterus who use an estrogen-only therapy for a long time have an increased risk for: endometrial cancer (cancer of the uterine lining) endometrial hyperplasia (an unusual enlargement of the lining of the uterus) Taking Nalvee with the estrogen (for at least 12 days per month – or 28-day cycle or continuous estrogen-progestogen combination therapy) may prevent this additional risk. Breast cancer The available data show that the use of hormone replacement therapy (HRT) with a combination of estrogen and progestogen or the use of estrogens alone for HRT increase the risk of breast cancer. This additional risk depends on the length of time the HRT is taken and can be seen after about 3 (1-4) years of use. After stopping HRT, the additional risk decreases over time, but the risk may persist for up to 10 years or more if you have been taking HRT for longer than 5 years. Be sure to: you go for regular breast screening – your doctor tells you how often to go you check your breasts regularly and monitor these changes: retractions (dimples) in the skin nipple changes lumps you can see or feel If you notice any changes, see your doctor right away.

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Ovarian cancer Ovarian cancer is rare – much rarer than breast cancer. Taking HRT containing estrogen alone or a combination of estrogen and progestogen is associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer changes with age. For example, approximately 2 out of 2 000 women aged 50 to 54 years who do not take HRT will be diagnosed with ovarian cancer within a 5-year period. For women who have taken HRT for 5 years, there will be approximately 3 cases per 2 000 users (i.e. approximately 1 extra case). Blood clots (thromboses) For women using HRT, the risk of developing blood clots in the veins (thromboses) is up to 1.3 to 3 times higher compared to non-users. There is an increased risk especially in the first year of HRT. You are more likely to develop a blood clot if: you are older you have cancer you are very overweight you are taking estrogens you are pregnant or have recently given birth you (or a close relative) have had a previous blood clot, including in your leg or lungs you have been immobile for a long time because of a major surgery, injury or illness (see also information under "Surgery") you have a condition called systemic lupus erythematosus (SLE) – a specific autoimmune disorder that causes, among others, joint pain, skin rashes and fever If any of the above applies to you (or if you are unsure), talk to your doctor about whether HRT is appropriate for you. If you notice painful swelling in your legs, sudden chest pain or difficulty breathing: see a doctor right away stop using your HRT medication until your doctor allows it again These may be signs of a blood clot. If you are taking medicines used to prevent blood clots (anticoagulants) – such as warfarin, phenprocoumon, tell your doctor or pharmacist. Your doctor will pay special attention to assessing the benefits and risks of a HRT. Surgery If you have planned surgery, tell your doctor before surgery that you are taking HRT. Do this well in advance of surgery. You will probably need to stop taking HRT several weeks before surgery. Under certain circumstances, you may need some other treatment before and after surgery. Your doctor will tell you when you can start taking HRT again. Heart disease There is no evidence that HRT provides protection against heart disease. Women who take estrogenprogestogen HRT are slightly more likely to develop heart disease than women who do not take any HRT. The risk of heart disease also increases with age. The number of additional cases of heart disease due to estrogen- progestogen HRT use is very low in healthy women shortly after menopause. The number of additional cases increases with age. If you feel chest pain that spreads into your arm or neck: see a doctor right away do not take HRT anymore until your doctor says you can This pain may be a sign of a heart attack.

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Stroke Combined estrogen-progestogen or estrogen-only HRT increases the risk of stroke. This risk is up to 1.5 times higher than for non-users. The risk for women taking HRT compared to those not taking it does not change with age or time since menopause. However, as the risk of stroke depends on age, the overall risk of stroke for women taking HRT will increase with age. If you experience a severe, unexplained/unusually strong headache or migraine (which may also be associated with visual disturbance): see a doctor right away do not take HRT again until your doctor says you can This may an early warning sign of a stroke. Other medicines and Nalvee Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription or herbal medicines. Especially tell your doctor or pharmacist if you are taking any of the medicines listed below. These medicines may reduce the effect of Nalvee, causing bleeding or spotting: herbal preparations containing St. John's Wort, sage or ginkgo biloba medicines to treat convulsions (epilepsy) – such as phenobarbital, carbamazepine, phenytoin medicines to treat infections – such as rifampicin, rifabutin, nevirapine, efavirenz medicines to treat HIV infection (AIDS) – such as ritonavir, nelfinavir If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine. Nalvee with food and drink Nalvee can be taken regardless of meals. Children and adolescents There is no use for Nalvee in children before their first menstrual period. It is not known how safe or effective Nalvee is in adolescents aged 12 to 18 years. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Nalvee is not authorised for use in pregnancy. Children of mothers who have taken a certain type of progestogen may be at increased risk of hypospadias (a birth defect of the penis affecting the urethra). However, this increased risk has not yet been confirmed. So far, there is no evidence that taking dydrogesterone during pregnancy is harmful. Dydrogesterone tablets have been used by more than 10 million pregnant women. If you are pregnant, consult your doctor before taking Nalvee. See your doctor if you become pregnant or think you may be pregnant. He or she will explain the benefits and risks of taking Nalvee in pregnancy. Breast-feeding If you are breastfeeding, do not take Nalvee. It is not known whether Nalvee passes into breast milk and affects the baby. Studies with other progestogens show that small amounts of these drugs pass into breast milk. Fertility There is no evidence that dydrogesterone reduces your fertility when taken as recommended by your doctor. 5/9

Driving and using machines You may feel a little sleepy or feel slightly dizzy after taking Nalvee. It will be more likely within the first few hours after taking it than later. If this happens, do not drive or use any tools or operate machinery. Wait to see how Nalvee affects you before driving, using tools, or operating machinery. Nalvee contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3.

How to take Nalvee

Always take this medicine exactly as your doctor told you. Check with your doctor or pharmacist if you are not sure. Your doctor will adjust the dose to suit you.

How to take it

this product Take each tablet with water. You can take the tablets regardless of meals. If you have to take more than one tablet, spread the use evenly throughout the day. For example, take one tablet in the morning and one in the evening. Try to take the tablets at the same time each day. This will ensure a steady amount of medicine in your body. At the same time, this will help you not to forget to take the tablets. Posology The number of tablets you take and the days you take them and the total duration of therapy will depend on the reason you are being treated for. If you have natural periods so far, day 1 of your cycle is when you start bleeding. If you no longer have natural periods, your doctor will decide with you when to determine day 1 of your cycle and when to start taking the tablets. To relieve painful periods Cycle days 5 to 25: Take 2 tablets a day. To relieve the symptoms of endometriosis Take 2 to 3 tablets a day. You will either be asked to take your tablets: On every day of your cycle or only on cycle days 5 to 25. For the treatment of irregular periods Take 2 tablets a day. Do this from the second half of your cycle until the first day of your next cycle. The starting day and number of days you take your tablets for will depend on the length of your cycle. To relieve the symptoms of pre-menstrual syndrome Take 2 tablets a day. Do this from the second half of your cycle until the first day of your next cycle. The starting day and number of days you take your tablets for will depend on the length of your cycle. Your doctor may decide to give you a higher dose. For the treatment of symptoms of menopause (HRT) If you are taking "continuous sequential" HRT (e.g. taking an estrogen tablet or having an estrogen patch or estrogen gel throughout your cycle) • take 1 tablet a day and only during the last 14 days of each 28-day cycle. If you are taking "cyclic" HRT (e.g. you take an estrogen tablet or use an estrogen patch or estrogen gel for 21 days of the cycle, followed by 7 days without medication) 6/9

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• take 1 tablet per day and only during the last 12 to 14 days of estrogen treatment. If necessary, your doctor may increase the dose to 2 tablets a day.

For menstrual bleeding that is unusually heavy or happens between periods When treatment is started to stop bleeding: Take 2 tablets a day Do this for five to seven days. For continuous treatment: Take 2 tablets a day Do this during the second half of your cycle. The starting day and number of days you take your tablets for will depend on the length of your cycle. To re-start periods that have stopped before the menopause Take 2 tablets a day. Do this for fourteen days during the second half of your expected cycle. The starting day of days you take your tablets for will depend on the length of your cycle. If you take more Nalvee than you should If you (or someone else) have taken too many Nalvee tablets, it is unlikely to harm you seriously. However, if you are worried, contact your doctor for advice. If you forget to take Nalvee Take the missed tablet as soon as you remember. However, if more than 12 hours have passed after the regular intake time, skip the forgotten tablet and take your next tablet at your next usual intake time. Do not take the double dose to make up for a forgotten tablet. If you miss an intake, bleeding or spotting may occur. If you stop taking Nalvee Do not stop taking Nalvee without first consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine. Side effects when taking Nalvee alone Treatment with Nalvee may cause symptoms similar to those experienced in the early stages of pregnancy, such as loss of appetite, stomach pressure, nausea, oedema and weight gain, nervous restlessness, dizziness, worsening of mood and calf cramps. These symptoms disappear when the treatment is stopped. If you notice any of the following side effects, stop taking Nalvee and see a doctor right away liver problems – symptoms may include yellowing of the skin or whites of the eyes (jaundice), feeling weak, a general discomfort or abdominal pain (may affect up to 1 in 100 people) allergic reactions – symptoms may include difficulty breathing or reactions affecting the whole body such as nausea, vomiting, diarrhoea or low blood pressure (may affect up to 1 in 1 000 people) swelling of the face and throat that may cause difficulty breathing (may affect up to 1 in 1 000 people)

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Other side effects seen when taking Nalvee alone Common (may affect up to 1 in 10 people) migraine, headache nausea sensitive or painful breasts irregular, extraordinary heavy or painful menstrual periods missed menstrual period, prolonged menstrual period or bleeding less frequently than normal Uncommon (may affect up to 1 in 100 people) weight gain dizziness depressed mood vomiting allergic skin reactions – such as rash, itching or hives Rare (may affect up to 1 in 1 000 people) drowsiness swelling of the breasts a certain type of anaemia caused by the destruction of red blood cells swelling caused by fluid retention in the tissue, often in the lower legs or ankles an increase in the size of progestogen-dependent tumours (such as meningioma) In younger patients, side effects are expected to be similar to those in adults.

Possible side effects

when taking Nalvee together with estrogen (estrogen-progestogen HRT) If you are taking Nalvee with estrogen, please also read the information in the package leaflet you will receive with your prescribed estrogen-containing medicine. See section 2 "What you need to know before you take Nalvee" of this package leaflet for more information about the side effects listed above. If you notice any of the following side effects, stop taking Nalvee and see your doctor right away Painful swelling in your leg, sudden chest pain, or difficulty breathing. These may be signs of a blood clot. Chest pain that shoots up into the arm or neck. This may be a sign of a heart attack or a coronary artery disease. A severe, unexplained headache or migraine (with or without visual disturbances). These can be signs of a stroke. See a doctor immediately if you notice changes such as dimples on the skin of your breasts, nipple changes, or lumps that you can see or feel. These changes may be signs of breast cancer disease. Other side effects that may occur when taking Nalvee together with the use of an estrogen include excessive thickening or cancer of the uterine lining and ovarian cancer. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below. The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.

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5.

How to store it

Nalvee

Keep this medicine out of the sight and reach of children. Do not this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. This medicinal product does not require any special storage condition. 6.

Contents of the pack and other information

What Nalvee contains The active substance is dydrogesterone. One film-coated tablet contains 10 mg of dydrogesterone. The other excipients of the tablet's core are lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica and magnesium stearate. Other excipients in the coating layer are: hypromellose, macrogol and titanium dioxide. What Nalvee looks like and contents of the pack The film-coated tablets are white, round, biconvex marked with "L1" on one side without marking on the other side. The tablets are packed in blister packs consisting polyvinyl chloride (PVC) coated polyvinylidene chloride (PVDC) blisters heat-sealed aluminium (Alu) foil. The blister pack contains 10, 20 and 28 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Hungary Manufacturer CYNDEA PHARMA, S.L. Polígono Industrial Emiliano Revilla Sanz. Avenida de Ágreda, 31, Ólvega 42110 Soria, Spain This leaflet was last revised in 07/2024.

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