10 microgram vaginal tablets
estradiol
What Vagirux is and what it is used for
Vagirux contains estradiol.
- Estradiol is a female sex hormone.
- It belongs to a group of hormones called estrogens.
- It is identical to the estradiol produced in the woman’s ovaries.
Varilux is part of a drug group called hormone replacement therapy ( HRT ) and is for vaginal use.
Varilux is used to relieve discomfort in the vagina after menopause (when menstruation stops in conjunction with menopause) such as dryness or irritation. The medical term for this is vaginal atrophy. It is caused by falling estrogen levels in the body, which is natural after menopause.
Varilux works by replacing the estrogen that is normally produced in the woman’s ovaries. The medicine is introduced into the vagina so that the hormone it is released where it is needed. This can relieve discomfort in the vagina.
The estradiol contained in Vagirux may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Vagirux
Medical background and regular medical check-ups
There are risks to using HRT. These must be taken into account when deciding whether a woman should start treatment or continue with ongoing treatment.
Experience in treating women whose menstruation has stopped prematurely (due to ovarian failure or surgery) is limited. If your period has stopped prematurely, the risks of using HRT may be different. Talk to your doctor about this.
Before starting HRT (or resuming treatment), your doctor will ask questions about your own and your family’s medical history. The doctor may perform a general medical and gynecological examination, which also includes an examination of the breasts.
Once you have started Vagirux, you should go for regular medical check-ups, at least once a year. At these checks, you can discuss the benefits and risks of continuing with Vagirux with your doctor.
Get regular mammograms as recommended by your doctor.
Do not use Vagirux
if any of the following apply to you. Talk to your doctor before using Vagirux if you are unsure about any of the points below.
Do not use Vagirux:
- if you have or have had breast cancer or are suspected of having it.
- if you have or have had estrogen-dependent cancer, for example, cancer of the lining of the womb (endometrium), or if it is suspected that you have it.
- if you have unexpected bleeding from the abdomen.
- if you have a severely thickened lining of the uterus ( endometrial hyperplasia ) that is not treated.
- if you have or have 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 coagulation disorder (e.g. protein C, protein S or antithrombin deficiency).
- if you have or have previously had a disease caused by blood clots in the arteries, e.g. heart attack, stroke, or angina pectoris.
- if you have or have had liver disease and your liver values are still abnormal.
- if you have porphyria, a rare inherited blood disorder.
- if you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you for the first time while using Vagirux, stop using Vagirux immediately and contact your doctor immediately.
Warnings and precautions
Tell the doctor, before starting treatment, if you have or have had any of the following problems as these may return or get worse during treatment with Vagirux. If this should occur, you should go for more frequent medical check-ups.
- Fibroids in the uterus.
- Endometrial lining that grows outside the uterus ( endometriosis ) or you have previously had greatly thickened endometrial lining ( endometrial hyperplasia ).
- Increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”).
- Increased risk of getting estrogen-dependent cancer (e.g. if mother, sister, or grandmother/grandmother has had breast cancer).
- High blood pressure.
- Liver disease, e.g. benign liver tumor.
- Diabetes.
- Gallstones.
- Migraine or severe headache.
- A disease of the immune system that attacks many organs in the body (systemic lupus erythematosus ( SLE ).
- Epilepsy.
- Asthma.
- A disease affecting the eardrum and hearing (otosclerosis).
- Hypertriglyceridemia (elevated level of blood fats).
- Fluid retention is caused by heart or kidney disease.
- Hereditary and acquired angioedema.
Stop using Vagirux immediately and consult a doctor
If any of the following occurs while you are using HRT:
- Any of the conditions mentioned above in the “Do not use Vagirux” section.
- The skin or the whites of the eyes become yellow (jaundice). It may indicate liver disease.
- swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, along with difficulty breathing which may indicate angioedema.
- Your blood pressure rises sharply (symptoms may be headache, fatigue, or dizziness).
- Migraine-like headache that occurs for the first time.
- You get pregnant.
- You get symptoms of 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 )” below.
Please note: Vagirux is not a contraceptive. If it has been less than 12 months since your last period or you are under the age of 50, you may still need to use contraception to prevent pregnancy. Consult your doctor about this.
HRT and cancer
Strong thickening of the lining of the uterus ( endometrial hyperplasia ) and cancer of the lining of the uterus (endometrial cancer)
Long-term use of estrogen-only HRT tablets can increase the risk of cancer of the lining of the uterus (endometrium).
It is unclear whether there is a similar risk with Vagirux when used for repeated treatment or long-term treatment (more than a year). However, Vagirux is absorbed into the blood to a very small extent and therefore no addition of the progestin is needed.
If you experience a breakthrough or spotting, it is usually nothing to worry about, but you should contact your doctor. It could be a sign that your endometrium has thickened.
The following risks apply to hormone replacement preparations ( HRT ) that circulate in the blood. However, Vagirux is intended for local treatment in the vagina and is only absorbed into the blood to a very small extent. It is less likely that the conditions mentioned below would worsen or recur during treatment with Vagirux, but you should see a doctor if you are concerned.
Breast cancer
Data suggest that the use of Vagirux does not increase the risk of breast cancer in women who have not had breast cancer before. It is unknown whether Vagirux can be used safely in women who have had breast cancer in the past.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- indentations or dimples in the skin
- nipple changes
- knots that you can see or feel.
It is also recommended that you undergo a mammogram examination when you are called.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Comparison
The risk of ovarian cancer varies with age. Out of 2,000 women aged 50 to 54 who do not take HRT, about 2 will develop ovarian cancer over 5 years. For women who have taken HRT for 5 years, it is about 3 cases per 2,000 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 about 1.3–3 times higher for women who take HRT than for women 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.
The likelihood of getting a blood clot in a vein is higher if you are older and if you have any of the following problems. Tell your doctor if any of these situations apply to you:
- you cannot walk for a longer period due to a major operation, injury or illness (see also section 3, “If you have to have an operation”)
- you are severely overweight ( BMI over 30 kg/m 2 )
- you have a blood coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- a close relative has ever had a blood clot in a leg, lung, or another organ.
- you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of blood clots are described in the section “Stop using Vagirux immediately and consult a doctor”.
Comparison
Among women in their 50s who do not take HRT, an average of 4–7 in 1,000 are expected to develop a blood clot in a vein over 5 years.
Among women in their 50s taking estrogen-only HRT for more than 5 years, 5–8 cases are expected per 1,000 users (ie 1 extra case).
Heart disease (heart attack)
Women treated with estrogen alone have no increased risk of developing heart disease.
Stroke _
The risk of stroke is about 1.5 times higher in women who take HRT than in women who do not. The number of extra cases of stroke due to HRT use increases with age.
Comparison
Among women in their 50s who do not take HRT, an average of 8 in 1,000 are expected to have a stroke over 5 years. Among women in their 50s taking HRT for more than 5 years, 11 cases are expected per 1,000 users (ie 3 extra cases).
Other conditions
HRT use does not prevent memory loss. The risk of memory loss appears to be slightly higher in women who start using HRT after the age of 65. Consult your doctor about this.
Other medicines and Vagirux
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking other medicines, including over-the-counter medicines and herbal remedies.
However, since Vagirux is used for local treatment in the vagina, it is unlikely that Vagirux will affect the effectiveness of other medicines. Varilux may affect the effectiveness of other treatments given vaginally.
Pregnancy and breastfeeding
Varilux is only intended for women whose menstruation has stopped. If you should become pregnant, stop using Vagirux and consult a doctor.
Driving ability and use of machinery
How to use Vagirux
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Use of this medicine
- You can start Vagirux on any day that suits you.
- For vaginal use only. Do not take the tablet by mouth.
- The vaginal tablet is inserted into the vagina with the applicator.
“DIRECTIONS FOR USE” at the end of this leaflet shows how Vagirux should be used. Read the instructions for use carefully before using Vagirux.
The applicator is intended to be used a maximum of 24 times for the same patient (one tablet per time). The applicator must then be thrown in the household waste. Do not use an applicator that shows signs of damage.
How much to use
- Use 1 vaginal tablet daily for the first 2 weeks.
- Then use 1 vaginal tablet 2 times a week with 3 or 4 days between each dose.
General information about the treatment of menopausal symptoms
- Your doctor will aim to prescribe the lowest dose of Vagirux for the shortest possible time to treat your symptoms. Talk to your doctor if you think the dose seems too high or too low.
- Treatment should only be continued if the benefits outweigh the risks. Talk to your doctor about this.
If you have used too much Vagirux
- If you have used too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
- Varilux is intended for local treatment in the vagina. The dose of estradiol is so low that a large amount of tablets is required to reach the dose normally used in treatment taken by mouth.
If you forget to use Vagirux
- If you forget a dose, take it as soon as you remember.
- Do not take a double dose to make up for a missed dose.
If you stop using Vagirux
Do not stop treatment with Vagirux without talking to your doctor. The doctor will explain what happens if you stop the treatment and inform you about other treatment options.
If you have to have surgery
If you are going to have surgery, you must inform the operating doctor that you are using Vagirux. You may need to stop Vagirux about 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, “Blood clots in a vein – thrombosis”). Ask the doctor when it is appropriate to start using Vagirux again.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are more common in women who use HRT medicines that circulate in the blood than in women who do not use HRT. The risks are lower for drugs taken vaginally, such as Vagirux:
- ovarian cancer (ovarian cancer)
- blood clots in veins in legs or lungs (venous thromboembolism )
- stroke _
- probable memory loss if treatment with HRT is started after the age of 65.
More information about these side effects can be found in section 2 “What you need to know before using Vagirux”.
Common – may affect up to 1 in 10 users:
- Headache.
- Stomach pain.
- Bleeding or discharge from the vagina, discomfort in the vagina.
Uncommon – may affect up to 1 in 100 users:
- Fungal infection in the vagina
- Nausea.
- Rash.
- Weight gain.
- Heatwave.
- High blood pressure.
Very rare – may affect up to 1 in 10,000 users:
- Diarrhea.
- Fluid retention.
- Worsening of migraines.
- General hypersensitivity (eg anaphylactic reaction/shock).
The following side effects have been reported with systemic treatment with estrogen:
- Gallbladder disease.
- Various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful red-purple bumps on the skin (erythema nodosum)
- ring-shaped reddening or ulcerated rash (erythema multiforme).
How to store Vagirux
Keep this medicine out of the sight and reach of children.
Store the blisters in the outer carton. Light sensitive.
Use before the expiry date which is stated on the carton and blister pack after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
This medicine may be a risk to the aquatic environment.
Contents of the packaging and other information
Contents declaration
- The active substance is estradiol. Each vaginal tablet contains estradiol hemihydrate corresponding to 10 micrograms of estradiol.
- Other ingredients are hypromellose, lactose monohydrate, corn starch, and magnesium stearate. The film coating contains hypromellose and macrogol.
Appearance and package sizes of the medicine
The vaginal tablets are white, round, film-coated tablets marked with “E” on one side. The diameter of the tablet is approximately 6 mm.
Package sizes:
18 vaginal tablets per blister with a reusable applicator.
24 vaginal tablets per blister with a reusable applicator.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út Ut 19-21
1103 Budapest
Hungary
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary