Progyneova 1 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Progynova 1 mg coated tablets
Estradiol valerate
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
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Package leaflet:
- What Progynova is and what it is used for
- What you need to know before taking Progynova
- How to take Progynova
- Possible side effects
- How to store Progynova
- Contents of the pack and other information
1. What Progynova is and what it is used for
Progynova is a hormonal medicine.
This medicine is indicated in hormone replacement therapy (HRT) for:
the treatment of menopausal symptoms (the period of time when reproductive function and menstruation cease in a woman), whether natural or surgically induced (castration), e.g. hot flushes, night sweats, urogenital disorders (atrophic vaginitis).
If you still have your uterus, treatment with oestrogens, such as Progynova, must always be accompanied by sequential administration of a progestogen.
Progynova must not be used to prevent heart disease or to enhance intellectual capacity.
Progynova is not a contraceptive and does not restore fertility.
2. What you need to know before starting Progynova
Follow carefully all instructions given by your doctor.
Read the following information before using Progynova.
Medical history and regular check-ups
Hormone replacement therapy (HRT) involves risks that must be considered when deciding whether to start or continue treatment.
Experience with HRT in women with premature menopause (due to ovarian insufficiency or surgical intervention) is limited. If you have premature menopause, the risks of using HRT may differ. Consult your doctor.
Before starting (or resuming) HRT, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast examination and/or an internal examination, if necessary.
Once treatment with Progynova has started, you should visit your doctor for regular check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Progynova.
Regular breast examinations should be performed as recommended by your doctor.
Do not take Progynova
if any of the following apply to you. If you are unsure about any of the following points, consult your doctor before taking Progynova. Do not take Progynova:
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If you are pregnant or suspect you may be pregnant, or if you are breastfeeding.
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If you have or have had breast cancer or suspect you may have it.
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If you have known or suspected premalignant lesions influenced by sex hormones.
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If you have or suspect you have a cancer dependent on estrogen action, such as cancer of the inner lining of the uterus (endometrium).
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If you have abnormal vaginal bleeding.
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If you have excessive thickening of the inner lining of the uterus (endometrial hyperplasia) that is not being treated.
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If you have or have had a blood clot in a vein (thrombosis), e.g., in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
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If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
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If you have or have recently had a disease caused by blood clots in the arteries (arterial thrombosis), (e.g., angina pectoris, myocardial infarction, stroke).
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If you have or have had any liver disorder, and liver function tests have not returned to normal.
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If you have a rare inherited blood disorder called "porphyria" passed from parent to child.
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If you have sickle cell anemia (a blood disorder).
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If you are allergic to estradiol valerate or to any of the other components of this medicine (listed in section 6).
If any of these conditions occur for the first time while you are taking Progynova, stop treatment immediately and consult your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Progynova.
Visit your doctor regularly, at least once a year. Discuss with your doctor at each visit whether you need dose adjustments or continuation of treatment. Your doctor will assess whether you are at increased risk of thrombosis due to a combination of risk factors or a single high-risk factor. If multiple risk factors are present, the risk may be greater than the simple addition of two individual risks. If the risk is too high, your doctor will not prescribe HRT.
For the treatment of menopausal symptoms, HRT should only be initiated when symptoms affect a woman's quality of life. In all cases, a careful annual assessment of risks and benefits should be performed, and HRT should only continue while benefits outweigh risks. The lowest effective dose and shortest possible duration of treatment should always be considered.
When to take special precautions with Progynova
Inform your doctor if you have ever had any of the following conditions before starting treatment, as they may recur or worsen during treatment with Progynova. If so, you should visit your doctor more frequently for check-ups:
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Gynecological disorders such as irregular, frequent, or persistent uterine bleeding, fibroids (a type of uterine tumor), endometriosis (presence of uterine lining tissue outside its normal location), or history of endometrial hyperplasia (abnormal proliferation of cells lining the inside of the uterus).
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Increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)").
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Increased risk of developing an estrogen-dependent cancer (e.g., having a mother, sister, or grandmother who had breast cancer).
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Changes or abnormalities in the breasts.
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High levels of certain fats (triglycerides) in the blood or a family history of this condition due to the risk of developing pancreatitis (inflammation of the pancreas).
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Fluid retention due to heart or kidney problems.
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High blood pressure.
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Liver disorders, such as a benign liver tumor.
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Kidney disorders.
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Diabetes.
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Gallstones.
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Migraines or severe headaches.
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An autoimmune disease affecting multiple organs called systemic lupus erythematosus (SLE).
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Epilepsy.
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Multiple sclerosis (a nervous system disorder).
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Asthma.
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Pruritus (itching).
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Otosclerosis (abnormal bone growth in the ear), a condition affecting the eardrum and ear.
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Chorea minor (a nervous system disorder).
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Hypercalcemia (calcium concentration in blood above normal levels).
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Hereditary and acquired angioedema.
Take special care not to exceed the recommended doses.
During HRT treatment, certain serious conditions may occur more frequently, such as blood clots (thrombosis) and certain types of tumors.
Stop taking Progynova and contact your doctor immediately
If you experience any of the following conditions while taking HRT:
- Any of the conditions listed in the section "Do not take Progynova",
- Yellowing of the skin or whites of the eyes (jaundice). This may be a sign of liver disease,
- Swelling of the face, tongue, or throat and difficulty swallowing or hives accompanied by breathing difficulties, suggesting angioedema,
- A significant increase in blood pressure (symptoms may include headache, fatigue, dizziness),
- Migraine-type headaches when occurring for the first time,
- If you become pregnant,
- If you notice signs of a blood clot, such as:
- Painful swelling and redness in the legs,
- Sudden chest pain,
- Difficulty breathing.
For more information, see "Blood clots in a vein (thrombosis)"
Note: Progynova is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years old, you may still need to use an additional contraceptive method to prevent pregnancy. Seek advice from your doctor.
HRT and cancer
Excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer)
Estrogen-only HRT increases the risk of excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer).
Taking a progestogen in addition to estrogen for at least 12 days per 28-day cycle protects against this increased risk. If you still have your uterus, your doctor will prescribe another hormone, a progestogen, to reduce the risk of uterine cancer.
If you no longer have a uterus (you have had a hysterectomy), consult your doctor about the safe use of this medicine without a progestogen.
In women with an intact uterus who are not using HRT, an average of 5 out of 1,000 women aged 50 to 65 will be diagnosed with endometrial cancer. In women with an intact uterus who use estrogen-only HRT, between 10 and 60 out of 1,000 women aged 50 to 65 will be diagnosed with endometrial cancer (i.e., between 5 and 55 additional cases), depending on the dose and duration of treatment.
Unexpected bleeding
You will have a monthly menstrual bleed (also called withdrawal bleeding) while taking Progynova. However, if you experience unexpected bleeding or spotting in addition to your menstrual period that:
- Continues beyond the first 6 months;
- Begins after having taken Progynova for more than 6 months;
- Continues after stopping Progynova;
consult your doctor as soon as possible.
Breast cancer
Available data show that the use of hormone replacement therapy (HRT), either combined estrogen-progestogen or estrogen-only, increases the risk of breast cancer. The additional risk depends on how long you use HRT. The additional risk becomes apparent after 3 years of use. After stopping HRT, the additional risk decreases over time, but may persist for 10 years or more if HRT was used for more than 5 years.
Your doctor will advise you on how to detect abnormalities in your breasts and will perform periodic checks during treatment.
For women without a uterus who are using estrogen-only HRT for 5 years, there is little or no increase in the risk of breast cancer.
Comparison
In women aged 50 to 54 years not using HRT, an average of 13 to 17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.
In women aged 50 who start estrogen-only HRT for 5 years, there will be between 16 and 17 cases per 1,000 users (i.e., between 0 and 3 additional cases).
In women aged 50 who start combined estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 users (i.e., 4–8 additional cases).
In women aged 50 to 59 years not taking HRT, an average of 27 cases of breast cancer will be diagnosed per 1,000 women over a 10-year period.
In women aged 50 who start estrogen-only HRT for more than 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases).
In women aged 50 who start combined estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e., 21 additional cases).
Check your breasts regularly. Consult your doctor if you notice any changes such as:
- Dimpling of the skin
- Changes in the nipple
- Any lump you can see or feel
In addition, you are advised to participate in screening mammography programs when offered. For screening mammograms, it is important to inform the nurse/healthcare professional performing the X-ray that you are using HRT, as these medicines can increase breast density, which may affect the mammogram result. Increased breast density may make it harder for a mammogram to detect all lumps.
Ovarian cancer
Ovarian cancer occurs less frequently than breast cancer. The use of HRT, either estrogen-only or combined estrogen-progestogen, has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years not on HRT, about 2 cases of ovarian cancer are observed per 2,000 women over a 5-year period. In women on HRT for 5 years, about 3 cases per 2,000 patients are observed (i.e., about 1 additional case).
Effects of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of developing blood clots in veins is approximately 1.3 to 3 times higher in HRT users compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.
Your risk of developing a blood clot in the veins increases with age and if any of the following apply to you. Inform your doctor if any of these situations apply to you:
- You cannot walk for a prolonged period due to major surgery, injury, or illness (see also section 3, If you need to undergo surgery)
- You have severe overweight (Body Mass Index >30 kg/m²)
- You have a blood clotting disorder requiring long-term treatment to prevent blood clots
- A close relative has had a blood clot in the leg, lung, or any other organ
- You have systemic lupus erythematosus (SLE)
- You have cancer.
For symptoms of a blood clot, see "Stop taking Progynova and contact your doctor immediately."
Comparison
In women in their fifties not taking HRT, an average of 4 to 7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period.
In women in their fifties who have taken combined estrogen-progestogen HRT for 5 years, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases).
For women in their fifties without a uterus who have taken estrogen-only HRT for 5 years, there will be 5 to 8 cases per 1,000 users (i.e., 1 additional case).
Blood clots also occur, although much less frequently, in the arteries of the heart (myocardial infarction, angina pectoris), in cerebral arteries (cerebral thrombosis – stroke), or in the eyes (vision loss or double vision).
Coronary heart disease (heart attack)
HRT has not been shown to prevent heart attacks.
Women over 60 years of age using combined estrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking HRT.
The risk of developing cardiovascular disease does not increase in women without a uterus who take estrogen-only therapy.
Stroke
The risk of stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT increases with age.
Comparison
In women in their fifties not taking HRT, an average of 8 out of 1,000 are expected to have a stroke over a 5-year period. For women in their fifties taking HRT, there will be 11 cases per 1,000 users over a 5-year period (i.e., 3 additional cases).
Liver tumors
Rarely, liver tumors have been observed after the use of hormonal substances such as those contained in Progynova.
Other diseases
Inform your doctor if you have impaired kidney or heart function. Estrogens may cause fluid retention, and therefore patients with impaired kidney function should be carefully monitored.
If you are diabetic, you should be closely monitored during HRT treatment, as it may affect carbohydrate metabolism (peripheral insulin resistance and glucose tolerance).
If you have a uterine fibroid (a type of uterine tumor), it may increase in size under the influence of estrogens. In such cases, treatment should be discontinued.
If you experience a recurrence of endometriosis (a disorder of reproductive organ tissue), treatment discontinuation is recommended.
If you have a prolactinoma (a non-cancerous tumor causing increased secretion of the hormone prolactin), close medical supervision is required (including periodic measurement of prolactin levels).
If you develop chloasma (irregularly bordered yellowish-brown skin patches, mainly on the face) during HRT treatment, especially if you have a history of chloasma during pregnancy, you should avoid exposure to sunlight or ultraviolet rays while on treatment.
You should discuss with your doctor possible alternative treatments for your specific condition and how long treatment should last. This should be reviewed periodically during treatment.
Hormone replacement therapy does not prevent memory loss. There is some evidence of greater memory loss in women who begin using HRT after age 65. Seek advice from your doctor.
In women with hereditary angioedema (swelling or allergic-type edema usually appearing on the face), exogenous estrogens such as those in Progynova may induce or worsen symptoms.
Progynova is not a contraceptive and should not be used as such; it also does not restore fertility.
To prevent pregnancy, non-hormonal contraceptive measures should be used when necessary (except rhythm and temperature methods). If there are signs suggesting pregnancy, tablet intake should be stopped until pregnancy is ruled out (see section "Pregnancy and Lactation").
Laboratory tests
If you need a blood test, inform your doctor or laboratory staff that you are taking Progynova, as it may alter the results of certain laboratory tests or analyses.
Pregnancy and lactation
If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Progynova is indicated only in postmenopausal women. Do not use Progynova if you are pregnant or wish to become pregnant. If pregnancy occurs during treatment with Progynova, treatment must be stopped immediately.
Do not use Progynova if you are breastfeeding. Small amounts of sex hormones may pass into breast milk.
Use of Progynova with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, herbal remedies, or other natural products.
Some medicines may interfere with the effect of Progynova. This may cause irregular bleeding. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. This applies to the following medicines:
- Antiepileptic medicines (e.g., barbiturates, phenytoin, primidone, carbamazepine, and possibly oxcarbazepine, topiramate, and felbamate)
- Medicines for tuberculosis (e.g., rifampicin and rifabutin)
- Medicines for HIV and hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir, nelfinavir)
- Herbal preparations containing St. John's wort (Hypericum perforatum). The effect of these preparations persists for up to two weeks after discontinuation.
- Medicines for fungal infections (e.g., griseofulvin, fluconazole, itraconazole, ketoconazole, and voriconazole)
- Medicines for bacterial infections (e.g., clarithromycin and erythromycin)
- Medicines for certain heart conditions and high blood pressure (such as verapamil, diltiazem)
- Grapefruit juice
HRT may affect the function of other medicines:
- An antiepileptic medicine (lamotrigine), as it could increase seizure frequency.
- Medicines for hepatitis C virus (HCV) (e.g., HCV combination regimens ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in liver function blood tests (increase in liver enzyme ALT) in women using HRT containing ethinylestradiol. Progynova contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT can occur when Progynova is used with these HCV combination regimens.
- Certain substances (e.g., paracetamol) may increase the amount of circulating estradiol in the blood and thus enhance its effect.
- In specific cases, requirements for oral antidiabetics or insulin may vary due to effects on glucose tolerance.
Note that these instructions may also apply if other medicines are taken before or after taking Progynova.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor will advise you accordingly.
Driving and using machines
No effects on the ability to drive or use machines have been observed in users of Progynova.
Progynova contains lactose and sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Progynova
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor should always consider administering the lowest effective dose and the shortest possible duration of treatment. If you feel that the effect of Progynova is too strong or too weak, inform your doctor or pharmacist.
Remember to take your medicine.
- Adult women, including elderly women.
If you have undergone hysterectomy (partial or total removal of the uterus), you may start treatment at any time.
If you still have an intact uterus and are still experiencing menstrual cycles, treatment should begin within the first 5 days of the onset of menstruation, combining Progynova with a progestogen (see below “Combined regimen”).
If you do not have menstrual periods, your periods are very infrequent, or you are in the postmenopausal period, treatment may be started at any time by combining Progynova with a progestogen (see below “Combined regimen”), provided that pregnancy has been ruled out.
Dosage
Unless otherwise directed by your doctor, treatment is initiated by taking two Progynova 1 mg tablets daily, without chewing, after a meal. After a certain period of time, your doctor may reduce the dose to one 1 mg tablet daily.
After 6 months of treatment, you are advised to interrupt the medication to assess whether symptoms persist.
Administration
After each 20-day treatment cycle, a break from taking the coated tablets may be taken, usually lasting one week or less (cyclic HRT), or the coated tablets may be continued without interruption (continuous HRT). In the latter case, a new pack should be started immediately after finishing the previous one.
Combined regimen:
If you have an intact uterus, it is recommended to concomitantly use an appropriate progestogen for 10–14 days every 4 weeks (sequential combined HRT), or with each coated tablet containing estrogen (continuous combined HRT).
Your doctor should provide appropriate prescriptions to facilitate and ensure proper adherence to the recommended combined regimen.
The tablets should be taken without chewing, with some liquid.
The time of day at which you take the tablet is not critical, but once you have chosen a specific time, you should maintain it every day.
Adding a progestogen is not recommended in hysterectomized women, unless there is a prior diagnosis of endometriosis.
Switching from other HRT treatments (cyclic, continuous sequential, or continuous combined regimens):
If you are switching from another HRT treatment, you should complete your current treatment cycle before starting Progynova.
If you feel that the effect of Progynova is too strong or too weak, inform your doctor or pharmacist.
Children and adolescents
Progynova is not indicated for use in children and adolescents.
Special populations
Elderly patients
There are no data suggesting a need for dosage adjustment in elderly patients.
Patients with hepatic impairment
Progynova has not been specifically studied in patients with hepatic impairment. Progynova is contraindicated in women with severe liver disease (see section “Do not take Progynova”).
Patients with renal impairment
Progynova has not been specifically studied in patients with renal impairment.
If you take more Progynova than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
Overdose may cause nausea, vomiting, and irregular bleeding. Specific treatment is not usually required, but you should consult your doctor if you are concerned.
If you forget to take Progynova
Do not take a double dose to make up for a missed dose.
If you forget to take a tablet and less than 24 hours have passed, take the missed tablet as soon as possible and continue with your next tablet at the usual time. If treatment is interrupted for a longer period, irregular bleeding may occur.
If you stop taking Progynova
Your doctor will determine the duration of your treatment. Do not stop treatment prematurely, as it may not achieve the desired effect.
If you need surgery
If you are scheduled for surgery, inform your surgeon that you are taking Progynova. You may need to stop taking Progynova for 4 to 6 weeks before the procedure to reduce the risk of blood clot formation (see also section 2 “Blood clots in a vein”). Ask your doctor when you can resume treatment with Progynova.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following diseases occur more frequently in women using HRT compared to women who do not take HRT:
- breast cancer
- abnormal growth or cancer of the inner lining of the uterus (endometrial hyperplasia or cancer)
- ovarian cancer
- blood clots in the veins of the legs or lungs (venous thromboembolism)
- coronary heart disease
- stroke
- possible memory loss if HRT is started after the age of 65.
For more information about these adverse effects, see section 2.
In addition to the adverse effects listed in the section "Warnings and precautions", the following possible adverse effects have been reported in users of different oral HRT preparations, listed according to the part of the body affected and their frequency of occurrence.
- Frequent adverse effects (may affect up to 1 in 10 people):
Weight gain, weight loss
Headache
Abdominal pain, nausea
Skin rash, pruritus (itching)
Vaginal bleeding including spotting
- Uncommon adverse effects (may affect up to 1 in 100 people):
Hypersensitivity reaction (allergic reaction)
Depressed mood
Dizziness
Visual disturbances
Palpitations
Dyspepsia (indigestion)
Erythema nodosum (skin inflammation with the appearance of nodules, usually located in the legs)
Urticaria
Breast pain, breast tenderness
Edema (fluid retention)
- Rare adverse effects (may affect up to 1 in 1,000 people):
Anxiety, increased libido (sexual desire), decreased libido
Migraine
Intolerance to contact lenses
Swelling, vomiting
Hirsutism (excessive hair growth), acne
Muscle cramps
Dysmenorrhea (painful menstruation), vaginal discharge, premenstrual-like syndrome, breast enlargement
Fatigue
In women with hereditary angioedema (swelling or allergic-type edema usually affecting the face), exogenous estrogens such as those contained in Progynova may induce or worsen symptoms (see "Warnings and precautions").
The following adverse effects have been reported with other HRT medicines:
- Gallbladder disease.
- Subcutaneous and skin disorders:
- skin discoloration, especially on the face or neck, known as "pregnancy mask" (chloasma) (skin patches),
- skin rash with red lesions resembling targets or sores (erythema multiforme) (a type of skin inflammation),
- painful red skin nodules (erythema nodosum) (a type of skin inflammation with the appearance of nodules on the legs),
- vascular purpura (red spots on the skin).
- Probable dementia in women over 65 years of age (see section "Warnings and precautions").
Reporting of adverse effects:
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Progynova
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use Progynova after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Progynova
- The active substance is estradiol valerate.
Each coated tablet contains 1 mg of estradiol valerate.
- The other components are: monohydrate lactose, corn starch, povidone 25,000, talc, magnesium stearate, sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, glycol waxes, 85% glycerol (E-422), titanium dioxide (E-171), yellow iron oxide (E-172).
Appearance of the product and contents of the pack
Progynova is presented in a box containing one blister with 20 beige coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3 - 5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20
99427 Weimar
Germany
or
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
Date of latest revision of this leaflet: September 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.