Intrarosa 6,5 mg ovulos
Introduction
Product Information for the User
Intrarosa 6.5 mg Vaginal Inserts
prasterona
Read this entire product information carefully before starting to use this medication, as it contains important information for you.
- Keep this product information, as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed to you alone and should not be given to others even if they have the same symptoms as you, as it may harm them.
- If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this product information. See section 4.
1. What is Intrarosa and what is it used for
Intrarosa contains the active ingredient prasterona.
What Intrarosa is used for
Intrarosa is used to treat postmenopausal women with vulvar and vaginal atrophy and moderate to severe symptoms. It is used for the relief of menopausal symptoms that affect the vagina, such as dryness or irritation. The cause is a decrease in estrogen levels in the body. This occurs naturally after menopause.
How Intrarosa works
Prasterona corrects the symptoms and signs of vulvar and vaginal atrophy by replacing the estrogens that the ovaries of women normally produce before menopause. It is introduced into the vagina, so that the hormone is released where it is needed. This may relieve vaginal discomfort.
2. What you need to know before starting to use Intrarosa
The use of hormone replacement therapy (HRT) is associated with risks that should be considered before deciding to start or continue using this therapy.
The experience in treating women with premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of using HRT may be different. Consult your doctor.
Before starting (or resuming) HRT, your doctor will ask you about your medical history and that of your family. Your doctor may decide that you need a physical examination, which may include a breast examination and/or an internal examination, if necessary.
Once you have started taking Intrarosa, you should visit your doctor for regular check-ups (at least every 6 months). In these check-ups, you can discuss with your doctor the benefits and risks of continuing with Intrarosa.
You should attend regularly for breast examinations, as recommended by your doctor.
Do not use Intrarosa:
if you meet any of the following conditions. If you are unsure about any of the following points, consult your doctor before using Intrarosa,
- If you have or have hadbreast cancer, or suspect that you may have it;
- If you have or have hadcancer sensitive to estrogens, such as endometrial cancer, or suspect that you may have it;
- If you have anyunexplained vaginal bleeding;
- If you have anexcessive thickening of the uterine lining(endometrial hyperplasia) that is not being treated;
- If you have or have had a blood clot in a vein (thrombosis), either in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
- If you have anycoagulation disorder, such as protein C deficiency, protein S deficiency, or antithrombin deficiency;
- If you have or have had recently a disease caused by blood clots in the arteries, such as a heart attack, a stroke, or angina pectoris.
- If you have or have had aliver diseaseand your liver function tests have not yet normalized;
- If you have a rare hereditary blood disorder calledporphyria;
- If you areallergictoprasteroneor to any of the other ingredients of this medication (listed in section 6 "Packaging and additional information").
If any of these conditions appear for the first time while you are using Intrarosa, stop treatment and consult your doctor immediately.
Adverse reactions and precautions
When to be especially careful with Intrarosa
Inform your doctor if you have ever had any of the following problems, before starting treatment, as they may recur or worsen during treatment with Intrarosa. If so, you should visit your doctor more frequently for check-ups:
- uterine fibroids;
- growth of the uterine lining outside the uterus (endometriosis) or history of excessive thickening of the uterine lining (endometrial hyperplasia);
- history of blood clots (see "Blood clots in a vein (thrombosis)");
- increased risk of developing cancer sensitive to estrogens (such as having had a mother, sister, or grandmother with breast cancer);
- high blood pressure;
- liver disorders, such as a benign liver tumor;
- diabetes;
- gallstones;
- migraines or severe headaches;
- a systemic autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE);
- epilepsy;
- asthma;
- a disease that affects the eardrum and hearing (otosclerosis);
- very high levels of fat in the blood (triglycerides);
- fluid retention due to heart or kidney problems.
Stop taking Intrarosa and see your doctor immediately
If you notice any of the following symptoms while using HRT:
- any of the conditions mentioned in the section "Do not use Intrarosa";
- yellowing of the skin or the white of the eyes (jaundice). This may be a sign of liver disease;
- if you become pregnant;
- a sudden increase in blood pressure (with symptoms such as headache, fatigue, dizziness);
- migraine-type headaches, which may occur for the first time;
- if you notice symptoms of a blood clot, such as:
- swelling with pain and redness of the legs;
- sudden pain in the chest;
- difficulty breathing.
See "Blood clots in a vein (thrombosis)" for more information.
Note:Intrarosa is not a contraceptive. If it has been less than 12 months since your last menstrual period or if you are under 50 years old, you may need to continue using other contraceptive methods to avoid becoming pregnant. Ask your doctor.
HRT and cancer
Intrarosa has not been studied in women with a current or past diagnosis of cancer.
Endometrial hyperplasia and endometrial cancer
The prolonged administration of HRT with only estrogens in tablets may increase the risk of developing endometrial cancer. Intrarosa does not stimulate the growth of the endometrium, as shown by the atrophy of the uterine lining in all women treated with Intrarosa for one year in clinical trials.
It is not clear if there is any risk when Intrarosa is used for long-term treatment (more than one year). However, it has been shown that the absorption of Intrarosa into the bloodstream is very small, so it is not necessary to add a progestogen.
If you experience bleeding or spotting, it is usually not a cause for concern, but you should schedule a visit with your doctor. It may be a sign that the endometrium has thickened.
The following risks are related to the HRT medications that circulate in the bloodstream. However, Intrarosa is used for the local treatment of the vagina and the absorption into the bloodstream is very small. It is less likely that the conditions mentioned below will worsen or recur during treatment with Intrarosa, but you should see your doctor if you are concerned.
Breast cancer
The available data indicate that HRT that combines estrogens and progestogens, and possibly also HRT with only estrogens, increases the risk of breast cancer. The additional risk depends on the duration of HRT. The increased risk becomes apparent after a few years of HRT. However, it returns to normal within a few years (up to 5) after stopping treatment.
- Examine your breasts regularly. Visit your doctor if you notice any changes, such as:
- lumps in the skin;
- changes in the nipples;
- any lump that you can see or feel.
In addition, we recommend that you follow screening programs with mammograms when offered.
Ovarian cancer
Ovarian cancer is rare, much rarer than breast cancer. The use of HRT with only estrogens has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not receive HRT, about 2 cases of ovarian cancer will be diagnosed per 2000 women over a 5-year period. In women who have received HRT for 5 years, about 3 cases will be diagnosed per 2000 HRT users (i.e., about 1 additional case).
There have been rare cases of ovarian cancer and breast cancer in women treated with 6.5 mg of prasterone for 52 weeks.
Effect of HRT on the heart and circulation
Intrarosa has not been studied in women with a history of thromboembolic diseases, uncontrolled high blood pressure, or heart disease.
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is approximately 1.3 to 3 times higher in HRT users compared to non-users, especially in the first year of treatment.
Blood clots can be serious and if one of them reaches the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.
The likelihood of developing blood clots will be higher with increasing age and if any of the following factors are present. If any of these situations may apply to you, inform your doctor:
- you are unable to walk for a long time due to a major surgical intervention, injury, or illness (see also section 3, If you need to undergo surgery);
- you have significant obesity (BMI > 30 kg/m2);
- you have a coagulation disorder that requires long-term treatment with medication to prevent blood clots;
- any close relative has had a blood clot in the legs, lungs, or other organs;
- you have systemic lupus erythematosus (SLE);
- you have cancer.
See "Blood clots in a vein (thrombosis)" for more information on symptoms.
In clinical trials, no deep vein thrombosis was observed with prasterone intravaginally, and the only case of pulmonary embolism observed indicates a lower incidence with Intrarosa than in the placebo group.
Comparison
It is estimated that, over a 5-year period, an average of 4 to 7 out of every 1000 women around the age of 50 who do not receive HRT will develop a blood clot in a vein.
Heart disease (myocardial infarction)/High blood pressure
HRT with only estrogens does not increase the risk of heart disease.
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.
No cases of stroke were observed in clinical trials with Intrarosa.
Comparison
It is estimated that, over a 5-year period, an average of 8 out of every 1000 women around the age of 50 who do not receive HRT will suffer a stroke. In women around the age of 50 who are receiving HRT, the number of cases will be 11 per 1000 users over a 5-year period (i.e., 3 additional cases).
Other conditions
- HRT does not prevent memory loss. There are some indications of a higher risk of memory loss in women who started using HRT after the age of 65. Ask your doctor.
- You may experience vaginal discharge due to the "fat base" melting, and this is added to the increased vaginal secretions due to treatment. If vaginal discharge occurs, it is not necessary to interrupt Intrarosa administration.
- Intrarosa may alter latex condoms, diaphragms, and cervical caps.
- If you have a vaginal infection, you will need to receive a course of antibiotics before taking Intrarosa.
Children and adolescents
Intrarosa is only used in adult women.
Other medications and Intrarosa
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
No data are available on efficacy and safety in women currently treated with hormone replacement therapy, such as androgens, HRT (estrogens alone or combined with progestogens), or treatment with androgens.
It is not recommended to use Intrarosa in combination with HRT (treatment with only estrogens, estrogens-progestogens, or treatment with androgens) or with vaginal estrogens.
Pregnancy, breastfeeding, and fertility
Pregnancy and breastfeeding
Intrarosa should only be used in postmenopausal women. If you become pregnant, stop taking Intrarosa and consult your doctor.
Fertility
Intrarosa is contraindicated in fertile women. It is not known if this medication affects fertility.
Driving and operating machinery
Intrarosa does not generally affect the ability to drive or operate machinery.
3. How to use Intrarosa
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Your doctor will try to prescribe the lowest dose to treat your symptoms for the shortest period necessary. Talk to your doctor if you think this dose is excessive or insufficient.
How much to use
Use one insert once a day, at bedtime.
How to use Intrarosa
Insert the insert into the vagina with your finger or with an applicator provided in the packaging.
Read the usage instructions for Intrarosa carefully at the end of the leaflet before using this medication.
For how long to use
Once started, visit your doctor at least every 6 months to check if you need to continue using Intrarosa.
If you use more Intrarosa than you should
A vaginal douche is recommended.
If you forgot to use Intrarosa
If you forgot to use an insert, insert one as soon as you remember. However, if there are less than 8 hours until the next dose, skip the missed insert.
Do not use two inserts to make up for the missed dose.
If you need to undergo surgery
If you are going to undergo surgery, inform the surgeon that you are using Intrarosa. You may need to stop using Intrarosa between 4 and 6 weeks before the operation to reduce the risk of a blood clot (see section 2, "Blood clots in a vein (thrombosis)"). Ask your doctor when you can start using Intrarosa again.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people may experience them.
The following diseases are observed more frequently in women using THS medications that circulate in the blood, compared to women who do not use THS. These risks apply less to treatments with administered vaginal estrogens:
- breast cancer;
- ovarian cancer;
- blood clots in the veins of the legs or lungs (venous thromboembolism);
- stroke;
- probable memory loss if THS is initiated at an age of over 65 years.
For more information on these adverse effects, consult section 2.
The adverse effect reported most frequently in clinical studies was vaginal discharge. This is probably due to the fact that the hard fat melts and this is added to the expected increase in vaginal secretions caused by treatment. Vaginal discharge does not require interrupting the administration of Intrarosa.
The following adverse effects were also reported:
- frequent (may affect up to 1 in 10 people): abnormal vaginal cytology (in most cases, ASCUS or LGSIL), weight fluctuations (increase or decrease);
- infrequent (may affect up to 1 in 100 people): benign cervical or uterine polyps, benign breast mass.
The following adverse effects have been reported with THS containing estrogens, but not with Intrarosa, during clinical trials:
- gallbladder disease
- various skin disorders:
- skin pigmentation, especially on the face and neck, known as"mask of pregnancy" (cloasma)
- red and painful skin nodules (erythema nodular)
- eruption with ulcers or redness in the form of a target (erythema multiforme)
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es
By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Intrarosa
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and the blister pack after EXP. The expiration date is the last day of the month indicated.
Store below 30 °C.
Do not freeze.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Intrarosa
- The active ingredient is prasterone. Each ovule contains 6.5 mg of prasterone.
- The other component is hard fat (adeps solidus).
Appearance of the product and contents of the pack
Intrarosa is a white or off-white, bullet-shaped ovule, approximately 28 mm in length and 9 mm in diameter at its widest point.
The applicator is made of LDPE and contains 1% titanium dioxide as a colourant.
It is presented in blister packs containing 28 ovules with 6 applicators.
Marketing authorisation holder
Endoceutics S.A.
Rue Belliard 40
1040 Brussels
Belgium
Responsible person
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
Netherlands
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder: Belgium/Belgium/Belgium, Luxembourg/Luxembourg, Netherlands Theramex Belgium BVBA Tel: + 32 (0) 28088080 |
Germany, Austria Theramex Germany GmbH Tel: + 49 (0) 32 2122 490 37 |
Spain Theramex Ireland Limited Tel: + 34 911 143 487 |
France Theramex France S.A.S. Tel: + 33 (0) 800100350 |
Italy Theramex Italy S.r.l. Tel: + 39 02 81480024 |
Poland Theramex Poland sp. z o.o. Tel.: + 48 (0) 22 30 77 166 |
Portugal Tecnimede - Sociedade Técnico-Medicinal, S.A. Tel: + 351 210 414 100 |
United Kingdom (Northern Ireland), Ireland, Malta Theramex UK Limited Tel: + 44 (0) 3330096795 |
Denmark, Iceland, Norway,Finland,Sweden Avia Pharma AB Sweden/Sweden/Suomi Tel: + 46 (0) 8 544 900 22 Czech Republic,Estonia,Greece,Croatia,Republic of Cyprus, Latvia,Lithuania,Hungary, Romania, Slovenia,Slovak Republic Theramex Ireland Limited Tel:/Τηλ:+ 353 (0) 15138855 Date of the last revision of this summary of product characteristics 12/2023. Other sources of information Further detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu. Instructions for use of Intrarosa How to use Intrarosa
Before starting
A.Using the applicator |
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