1 mg and 2 mg, coated tablets
estradiol valerate
What Progynon is and what it is used for
Progynon is a drug used for Hormone Replacement Therapy ( HRT ). It contains the female sex hormone estrogen. Progynon is used in women whose menstruation has stopped ( menopause ).
Progynon is used to:
Relieving symptoms during and after
menopause When menstruation ends ( menopause ), a woman’s estrogen decreases. It can cause problems such as sweating and hot flashes. Progynon relieves these symptoms after menopause. Progynon should only be used if the problems cause problems in daily life.
Progynon 2 mg only :
Preventing Osteoporosis
After menopause, some women develop osteoporosis. Discuss all possible options with your doctor.
If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Progynon to prevent osteoporosis after menopause.
What you need to know before you take Progynon
Do not use Progynon
Medical background and regular check
-ups The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask you about your own, and your family’s, medical background. Your doctor may do a general medical and gynecological examination, which also includes an examination of your breasts.
Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Perform regular examinations of the breasts according to the doctor’s recommendations.
Do not take Progynon
if any of the following apply to you. If you are not sure, talk to your doctor before taking Progynon.
Do not take Progynon:
- if you have or have had breast cancer or there is a suspicion that you may have it
- if you have or have had estrogen-dependent cancer, such as cancer of the uterine lining (endometrium) or there is a suspicion of such cancer
- if you have unexpected genital bleeding that has not been investigated by a doctor
- if you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it
- if you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ), or your lungs ( pulmonary embolism )
- if you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin)
- if you have or have recently had a disease caused by a blood clot in the arteries, such as a heart attack, stroke, or angina
- if you have or have had any liver disease and still have abnormal liver values
- if you have porphyria, a rare inherited blood disorder
- if you are allergic to estradiol valerate or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you the first time you use Progynon, stop taking Progynon and contact your doctor immediately.
Warnings and cautions
Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Progynon. Should this occur, have more frequent check-ups with a doctor.
- if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining)
- if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
- if a close relative has had breast cancer or other estrogen-dependent cancer
- high blood pressure
- liver disease e.g. liver adenoma (benign tumor )
- diabetes
- gallstone disease
- if you get a migraine or severe headache
- if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- epilepsy
- asthma
- otosclerosis (ossification of the middle ear leading to a hearing loss)
- hypertriglyceridemia (elevated blood lipids)
- fluid retention due to heart or kidney disease
- hereditary and acquired angioedema
You should contact a doctor immediately and discontinue treatment if any of the following occur:
- any of the things mentioned in the section “Do not take Progynon”
- if skin or whites of the eyes turn yellow (jaundice); it may be a sign of liver disease
- swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which may indicate angioedema
- if your blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)
- if you are having a migraine headache for the first time
- if you become pregnant
- if you get symptoms of a blood clot, such as
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties
For more information, see “Blood clots in a vein ( thrombosis )”.
Note: Progynon is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.
By taking progestogen as a supplement to estrogen for at least 12 days every 28-day cycle, you are protected against this extra risk. The doctor will prescribe the progestogen if you have your uterus left. If your uterus has undergone surgery ( hysterectomy ), you should consult your doctor if you can take the medicine without a progestogen.
For women with the uterus left who do not take HRT, an average of 5 out of 1,000 women aged 50-65 will be diagnosed with endometrial cancer.
For women aged 50 – 65 who have the uterus left and who take HRT with estrogen alone, between 10 and 60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5 and 55 extra cases), depending on the dose one and for how long it is taken.
Unexpected bleeding
You will have a bleeding once a month (so-called dropout bleeding) when you take Progynon. But if you get unexpected bleeding or splashing bleeding in addition to your monthly bleeding, and these:
- lasts longer than 6 months
- starts after you take Progynon for 6 months
- continues after you stop taking Progynon
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison
Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over 5 years.
In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4 – 8 extra cases).
Among women aged 50–59 who do not use HRT, an average of 27
of 1,000 to be diagnosed with breast cancer over 10 years.
In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- indentations or pits
- changes of the nipple
- nodules you can see or feel
You are also advised to go for the mammography examinations that you are called to. You must tell the nurse/healthcare professional who is performing the mammogram that you are taking HRT, as this medicine may increase the density (density) of your breasts, and it may affect the results of the mammogram. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much more rare than breast cancer. The use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2000 aged 50 to 54 who do not take HRT for 5 years. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 users (ie about 1 extra case).
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is 1.3 – 3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
You are more likely to get a blood clot in a vein as you get older and if any of the following apply to you. Tell your doctor if any of the following apply to you:
- you have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- you are severely overweight ( BMI over 30 kg / m 2 )
- you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- if a close relative has had a blood clot in the bone, lung or another organ you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of a blood clot are described in the section “You should contact a doctor immediately and stop the treatment”.
Comparison
For women in their 50s who do not take HRT, an average of 4 – 7 out of 1,000 people are expected to have a blood clot in a vein over 5 years.
For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9 – 12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).
For women in their 50s without a uterus who take estrogen alone for more than 5 years, 5 – 8 out of 1,000 users are expected to get a blood clot in a vein (ie 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attack.
For women over the age of 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take HRT.
For women without a uterus who take estrogen alone, there is no increased risk of developing heart disease.
Stroke
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
Comparison
For women in their 50s who do not take HRT, an average of 8 out of 1,000 people are expected to have a stroke over 5 years.
For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).
Other conditions
- Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Other medicines and Progynon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, (traditional) herbal medicines, and herbal medicines.
Some medicines can affect the way Progynon works, which can lead to irregular bleeding. The following applies:
- medicines used to treat epilepsy (eg barbiturates, phenytoin, primidone, carbamazepine, and possibly oxcarbazepine, topiramate, and felbamate)
- medicines used to treat tuberculosis (eg rifampicin, rifabutin)
- drugs used to treat HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir, nelfinavir)
- (traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum )
- drugs against hepatitis C virus ( HCV ) (such as the combination treatment ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as the treatment glekaprevir / pibrentasvir) may cause elevated liver function values in blood test results (increase in ALT liver enzyme) in women using combined hormonal contraceptives. Progynon contains estradiol instead of Ethinylestradiol. It is not known whether an increase in ALT liver enzyme may occur with the use of Progynon in combination with this HCV combination therapy. Your doctor will advise you.
- medicines used to treat fungal infections (eg griseofulvin, fluconazole , itraconazole, ketoconazole and voriconazole)
- drugs used to treat bacterial infections (eg clarithromycin, erythromycin )
- medicines used to treat certain heart diseases, high blood pressure (eg verapamil, diltiazem )
- grapefruit juice
Results from blood test analyze
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Progynon as it may affect the results of some tests.
Pregnancy and breastfeeding
Progynon is intended for women whose menstruation has stopped. If you become pregnant, stop taking Progynon and consult a doctor.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Progynon contains excipients
Progynon contains lactose monohydrate and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to take Progynon
Always take Progynon exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. Dose one should be determined by a doctor who adapts it individually for you. Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and you should use Progynon for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
Progynon is given as either continuous or cyclic treatment. Continuous treatment means that Progynon is used without interruption, while cyclic treatment means that Progynon is used for 3 weeks followed by a one-week break.
Continuous treatment
Take one tablet daily without interruption.
Cyclic treatment
Package containing tablet maps:
The package contains three maps, each containing 28 tablets of the active substance. Take one tablet a day for three weeks, then take a one-week break. The seven tablets left on the map can be saved. After seven tablet-free days, a new map begins. After three treatment periods, the saved tablets from the three blister cards can be used for the fourth month.
Jar of Progynon with 100 tablets:
Take Progynon for 21 days and take a break for seven days. In a cyclical treatment, it is important to note which day of the week the treatment should start again.
Women who still have regular bleeding should start treatment on the fifth day of bleeding. Patients without bleeding can start treatment at any time. Women switching from hormonal replacement therapy should start treatment the day after the end of the previous cycle.
Treatment with estrogen alone can lead to overstimulation of the uterine lining. To avoid this, it is recommended that women who have the uterus remain are given a supplement of corpus luteum hormone, a so-called progestogen hormone for 12-14 days every month or continuously.
During cyclic treatment, menstrual-like bleeding usually occurs two to four days after the end of progestogen treatment.
The tablets should be swallowed whole with some liquid at about the same time each day.
Symptom relief usually occurs during the first treatment cycle.
If you need surgery
If you are going to have surgery, tell your surgeon that you are taking Progynon. You may need to stop taking Progynon for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start taking Progynon again.
If you take more Progynon than you should
Overdose can cause nausea and vomiting and irregular bleeding. No specific treatment is necessary, but if you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Progynon
If you forget to take a tablet, you can take it as soon as possible within 12 hours from the usual time, otherwise, discard the forgotten tablet and take the next tablet, as usual, the next day. Do not take a double dose to make up for a forgotten tablet.
The risk of breakthrough bleeding or splashing bleeding may increase if a tablet is forgotten.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
The following diseases are more common in women who take HRT than in those who do not:
- Breast cancer
- Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- Ovarian cancer ( ovarian cancer )
- Blood clots in veins in bones or lungs (venous thromboembolism )
- Heart disease
- Stroke _
- Probable memory loss, if treatment with HRT is started after the age of 65
See section 2 for more information on these side effects.
Like all medicines, Progynon can cause side effects, although not everybody gets them. Most side effects occur during the first months of treatment and usually disappear with continued treatment.
Common (may affect up to 1 in 10 people):
Weight gain or loss, headache, abdominal pain, nausea, skin rash, itching, unforeseen bleeding from the abdomen including spotting.
Uncommon (may affect 1 in 100 people):
Hypersensitivity reactions, depression, dizziness, visual disturbances, palpitations, sour stomach, hives, erythema nodosum (characterized by painful reddish-purple bumps on the skin), pain in the breasts, tenderness in the breasts, and fluid accumulation.
Rare (may affect up to 1 in 1,000 people):
Anxiety, increased or decreased sex drive, migraines, problems wearing lenses, bloating, bloating, increased hair, acne, muscle cramps, painful menstruation, discharge, symptoms similar to PMS, breast enlargement, and fatigue.
Breakthrough bleeding/spotting may occur in some women during the first months of treatment. You should contact your doctor if the irregular bleeding lasts longer than a few months or if it starts to occur after a period of treatment, or if it continues after the end of treatment, as the cause may need to be investigated further.
The following side effects have been reported with other HRTs:
- The disease of the gallbladder
- Various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful reddish-purple bumps on the skin (erythema nodosum)
- annular redness or sore rash (erythema multiforme)
How to store Progynon
Keep out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Progynon 1 mg:
- The active substance is 1 mg estradiol valerate.
- The other ingredients are lactose monohydrate (47 mg), maize starch, povidone 25,000 and 700,000, talc, magnesium stearate, sucrose (34 mg), macrogol 6000, calcium carbonate, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), montan glycol wax.
The tablets are yellow, round, and have a diameter of 6.8 mm.
Progynon 2 mg:
- The active substance is 2 mg estradiol valerate.
- The other ingredients are lactose monohydrate (46 mg), corn starch, povidone 25,000 and 700,000, talc, magnesium stearate, sucrose (34 mg), macrogol 6000, calcium carbonate, montan glycol wax.
The tablets are white, round, and have a diameter of 6.8 mm.
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
| Progynon 1 m g:Bayer AG Müllerstraße 17813353 BerlinGermany Progynon 2 mg:Bayer Weimar GmbH & Co. KGDöbereinerstraße 2099427 WeimarGermany | Bayer Weimar GmbH and Co. KG Döbereinerstraße 2099427 Weimar Germany |