6.5 mg vagitorium
prasterone
1. What Intrarosa is and what it is used for
Intrarosa contains the active substance prasterone.
What Intrarosa is used for
Intra-pink is used for postmenopausal women who have moderate to severe symptoms of genital atrophy. It is used to relieve vaginal symptoms after menopause, such as dryness or irritation. The symptoms are caused by a decrease in the amount of estrogen in the body. This is natural after menopause.
How Intrarosa works
Prasterone relieves symptoms and signs of genital atrophy by replacing the estrogen produced by the ovaries before menopause. The drug is inserted into the vagina and the hormone is thus released exactly where it is needed. This can relieve vaginal discomfort
2. What you need to know before using Intrarosa
Do not use Intrarosa
Hormone replacement therapy carries risks that must be taken into account when deciding to start or continue treatment.
There is only limited experience in treating women who have entered menopause early (due to ovarian failure or after surgery). If you enter menopause early, there may be other risks with taking hormone replacement therapy. Talk to your doctor about this.
Before you start (or start again) with hormone replacement therapy, your doctor will ask you questions about your and your family’s medical history. Your doctor may perform an examination, which includes an examination of your breasts and/or a gynecological examination, if necessary.
Once you have started taking Intrarosa, you should have regular medical check-ups (at least twice a year). Then talk to your doctor about the benefits and risks of continuing with Intrarosa.
Go for regular check-ups of the breasts according to the doctor’s recommendation.
Do not use Intrarosa
if any of the following apply to you – talk to your doctor before using Intrarosa if you are not sure:
- If you have or have ever had breast cancer , or you suspect you may have it.
- If you have cancer is sensitive to estrogen s , such as cancer of the womb lining (endometrium), or you are suspected of having it.
- If you have unexplained vaginal bleeding .
- If you have a severely thickened uterine lining ( endometrial hyperplasia ) that is not treated.
- If you have or have ever had a blood clot in a vein ( thrombosis ), e.g. in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ).
- If you have a blood clotting disorder (eg lack of protein C, protein S or antithrombin).
- If you have or have had a disease caused by blood clots in the arteries are, such as heart attack, stroke or angina.
- If you have or have ever had a liver disease and your liver function values have not returned to normal.
- If you have a rare, inherited blood disorder called porphyria .
- If you are allergic (hypersensitive) to prasterone or any of the other ingredients of Intrarosa (listed in section 6, other information).
If any of the above occur for the first time while you are taking Intrarosa, stop using the medicine immediately and contact your doctor.
Warnings and cautions
When you need to be especially careful with Intrarosa
Before starting treatment, tell your doctor if you have ever had any of the following problems, as these may come back or get worse when you use Intrarosa. In that case, you should go for more frequent medical check-ups:
- nodules ( fibroids ) in the uterus,
- uterine lining that grows outside the uterus ( endometriosis ) or severely thickened uterine lining ( endometrial hyperplasia ),
- increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”),
- increased risk of developing estrogen-sensitive cancer (eg if your mother , sister or grandmother / grandmother has had breast cancer),
- high blood pressure ,
- liver disease, e.g. a benign liver tumor,
- diabetes ,
- gallstones ,
- migraine or severe headache,
- a disease of the immune system that affects many organs in the body (systemic lupus erythematosus, SLE ),
- epilepsy ,
- asthma ,
- a disease affecting the eardrum and hearing (otosclerosis),
- very high blood fats ( triglycerides ),
- fluid retention due to heart or kidney problems.
Stop using Intrarosa and seek medical advice immediately
if you notice any of the following when taking hormone replacement therapy:
- any of the conditions mentioned in the section “Do not use Intrarosa”,
- yellowing of the skin or whites of the eyes (jaundice), which may be a sign of liver disease,
- if you become pregnant,
- severely high blood pressure (with symptoms such as headache, fatigue, dizziness),
- migraine-like headaches that occur for the first time
- signs that indicate a blood clot, for example
- painful swelling and redness of the legs,
- sudden chest pain,
- breathing difficulties.
For more information, see “Blood clots in a vein ( thrombosis )”.
Note: Intrarose is not a contraceptive. If it has been less than 12 months since your last period or if you are under 50, you may still need to use contraception to avoid getting pregnant. Consult your doctor.
Hormone replacement therapy and cancer
Intra-pink has not been studied in women who have or have previously had breast cancer.
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
If you take tablets with hormone replacement with estrogen alone for a long time, the risk of cancer of the uterine lining (endometrium) may increase. Intrarosa does not stimulate the growth of the endometrium, which has been shown by the fact that the uterine lining is thin (atrophied) in all women who have taken Intrarosa for one year in clinical trials.
It is unclear whether there is a risk with long-term (more than a year) use of Intrarosa. The uptake of Intrarosa into the blood is very low and therefore progestagen does not need to be added.
If you experience bleeding or spotting, there is usually nothing to worry about, but you should make an appointment with your doctor. It may be a sign that your uterine lining has become thicker.
The following risks apply to hormone replacement preparations that circulate in the blood. Intrarose, on the other hand, is used topically in the vagina and the uptake into the blood is very low. The conditions described below are unlikely to worsen or recur during treatment with Intrarosa, but you should contact your doctor if you are concerned.
Breast cancer
There is evidence to suggest that hormone replacement therapy with a combination of estrogen and progestagen, and possibly also estrogen-only drugs, increases the risk of breast cancer. How much the risk increases depends on how long you take hormone replacement therapy. The additional risk appears within a few years but returns to normal within a few years (maximum 5 years) after treatment has been discontinued.
- Check your breasts regularly. See a doctor if you notice any change such as
- pits in the skin,
- changes in the nipple,
- nodules that you can see or feel.
You should also go for the mammograms that are offered.
Ovarian cancer
Ovarian cancer is rare – much more rare than breast cancer. The use of estrogen-only hormone replacement therapy has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, about 2 women out of 2,000 aged 50 to 54 who do not take such treatment will be diagnosed with ovarian cancer over a 5-year period. For women who have taken hormone replacement therapy for 5 years, there will be about 3 cases per 2,000 users (ie 1 extra case).
Rare cases of ovarian and breast cancer have been reported in women treated with 6.5 mg prasterone for 52 weeks.
The effect of hormone replacement therapy on the heart and circulation
Intrarosa has not been studied in women who have previously had blood clots, uncontrolled high blood pressure, or heart disease.
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is about 1.3 to 3 times higher in women using hormone replacement therapy than in non-users, especially during the first year.
Blood clots can be serious, and if passed on to the lungs, they can cause chest pain, shortness of breath, fainting, and even death.
The risk of getting a blood clot in a vein increases with age and if any of the following applies to you. Tell your doctor if any of the following situations apply to you:
- You will not be able to walk 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 > 30 kg / m 2 ).
- You have problems with blood coagulation that require long-term treatment with a drug that prevents blood clots.
- If any of your close relatives have ever had a blood clot in their leg, lungs or any other organ.
- You have systemic lupus erythematosus ( SLE ).
- You have cancer.
If there is a sign of a blood clot, see “Stop using Intrarosa and see a doctor immediately”.
In clinical trials, deep vein thrombosis has not been seen with the use of prasterone applied to the vagina. One case of pulmonary embolism has occurred, which corresponds to a lower incidence with Intrarosa than with placebo.
Comparison
Among women in their 50s who do not take hormone replacement therapy, an average of 4 to 7 out of 1,000 would be expected to have a blood clot in a vein over a 5-year period.
Heart disease (heart attack) / high blood pressure
Women who take estrogen alone are not at increased risk of developing heart disease.
Stroke
The risk of having a stroke is about 1.5 times higher in women who use hormone replacement therapy than in non-users. The number of extra cases of stroke due to hormone replacement therapy increases with age.
No cases of stroke have been observed in clinical trials of Intrarosa.
Comparison
Among women in their 50s who do not take hormone replacement therapy, an average of 8 out of 1,000 would be expected to have a stroke over a 5-year period. Among women in their 50s who take hormone replacement therapy, there will be 11 cases among 1,000 users over a 5-year period (ie 3 extra cases).
Other permits
- Hormone replacement therapy does not prevent memory impairment. There is some evidence of a higher risk of impaired memory in women who start hormone replacement therapy after the age of 65. Consult your doctor.
- You can get a discharge from the vagina that is caused by the hard fat in the vagitorium melting, while the treatment itself leads to increased secretion . You do not need to stop using Intrarosa due to the discharge.
- Intra-pink can make condoms, pessaries and cervical pessaries worse.
- If you have a vaginal infection , you need to be treated with antibiotics before taking Intrarosa.
Children and young people
Intrarosa is only used for adult women.
Other medicines and Intrarosa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are no data on efficacy and safety in women already taking hormone therapy, e.g. androgen er or hormone replacement therapy ( estrogen alone or combined estrogen- progestagen).
The use of Intrarosa in combination with hormone replacement therapy ( estrogen-only or combined estrogen- progestagen) or vaginal estrogen is not recommended.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Intra-pink is only intended for postmenopausal women. If you become pregnant, stop using Intrarosa and contact your doctor.
Fertility
Intrarosa is not intended for fertile women. It is not known if this medicine affects fertility.
Driving and using machines
Intrarosa does not affect your ability to drive or use machines.
3. How to use Intrarosa
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will strive to prescribe the lowest possible dose for as short a time as possible to treat your symptoms. Talk to your doctor if you think dose one is too strong or not strong enough.
How much to use
Use one vagitorium a day, at bedtime.
How to use it
Insert the vagitorium into the vagina with one finger or with the applicator included in the package.
Carefully read the instructions at the end of the leaflet on how to use Intrarosa.
How long should it be used?
When you start taking Intrarosa, you should see a doctor at least twice a year to see if you need to continue treatment.
If you use more Intrarosa than you should
Vaginal rinsing is recommended.
If you forget to use Intrarosa
If you have forgotten to use a vagitorium, do so as soon as you remember. However, if it is time for the next dose in less than 8 hours, skip the forgotten vagitorium.
Do not use two vagitorias to compensate for a missed dose.
If you need surgery
If you are going to have surgery, you must tell the surgeon that you are taking Intrarosa. You may need to stop taking Intrarosa 4-6 weeks before the operation to reduce the risk of blood clots (see section 2, “Blood clots in a vein”). Ask your doctor when you can start taking Intrarosa again.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women who use hormone replacement therapy circulating in the blood than in non-users. These risks apply to a lesser extent to vaginally use estrogen treatments:
- breast cancer,
- ovarian cancer,
- blood clots in the veins of the legs or lungs (venous thromboembolism),
- stroke ,
- probably impaired memory of hormone replacement therapy begins after age 65.
More information on these side effects can be found in section 2.
The most common side effect in clinical trials was vaginal discharge. This is probably due to the hard fat in the vagitorium melting, at the same time as there is an expected increase in the number of vaginal secretions due to the treatment. You do not need to stop using Intrarosa due to the discharge.
The following side effects have also been reported:
- with the frequency “normal” (may affect up to 1 in 10 people): abnormal vaginal discharge (usually ASCUS or LGSIL), weight change (increase or decrease),
- with the frequency “uncommon” (may affect up to 1 in 100 people): benign polyps in the cervix or uterus, benign lumps in the breasts.
The following side effects have been reported with hormone therapy with estrogen but not with Intrarosa in clinical trials:
- gallbladder disease,
- various skin diseases:
- discoloration of the skin, especially on the face or neck in the form of ‘pregnancy spots’ (chloasma),
- sore red nodules in the skin (erythema nodosum),
- skin rash with target-like redness or sores (erythema multiforme).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Intrarosa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not freeze.
Medicines 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is prasterone. Each vagitorium contains 6.5 mg of prasterone.
- The only other ingredient is hard fat (adeps solidus).
What the medicine looks like and contents of the pack
Intrarosa is a white to off-white, conically tapering vagitorium, length about 28 mm and diameter about 9 mm at the widest point.
The applicator is made of LDPE and 1% dye (titanium dioxide).
It is available in blister packs containing 28 vagitoria and 6 applicators.
Marketing Authorization Holder and Manufacturer
Endoceutics SA
Rue Belliard 40
1040 Brussels
Belgium
Manufacturer
Basic Pharma Manufacturing BV
Mayor Lemmensstraat 352
6163 JT Geleen
Netherlands