Vagirux
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Vagirux, 10 micrograms, vaginal tablets
Estradiolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents
- What Vagirux is and what it is used for
- What you need to know before using Vagirux
- How to use Vagirux
- Possible side effects
- How to store Vagirux
- Contents of the pack and other information
1. 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 by the woman's ovaries.
Vagirux belongs to a group of medicines known as local estrogen therapy administered vaginally.
Vagirux is used to relieve menopausal symptoms in the vagina, such as dryness or irritation. In medical terminology, this condition is known as "atrophic vaginitis". It is caused by a decrease in estrogen levels and occurs naturally after menopause.
Vagirux works by replacing the estrogen normally produced by the woman's ovaries. The medicine is administered vaginally, so the hormone is released exactly where it is needed. This may help relieve vaginal discomfort.
2. Important Information Before Using Vagirux
Medical History and Regular Check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when a woman decides whether to start or continue HRT.
Experience with treating women in premature menopause (due to ovarian failure or surgical intervention) is limited. If a woman experiences premature menopause, the risks associated with HRT may differ. Please discuss this with your doctor.
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Before starting (or restarting) HRT, your doctor should take a full medical and family history. Your doctor may decide to perform examinations such as a breast examination and/or a gynecological examination, if necessary.
If you start using Vagirux, you should consult your doctor at least once a year. During follow-up visits, you should discuss with your doctor the benefits and risks of continuing Vagirux treatment.
Women should undergo regular breast screening examinations as recommended by their doctor.
When Not to Use Vagirux
If any of the conditions listed below are present or you have any doubts related to them, you should speak with your doctor before starting Vagirux.
Do not use Vagirux if you:
- have been diagnosed with, have had in the past, or are suspected of having breast cancer;
- have been diagnosed with, have had in the past, or are suspected of having an estrogen-dependent tumor, such as endometrial cancer (cancer of the uterine lining);
- have unexplained vaginal bleeding;
- have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated;
- have been diagnosed with or have had in the past blood clots in the veins (thrombosis), e.g., in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
- have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
- currently have or recently had an arterial disease caused by blood clots, e.g., myocardial infarction, stroke, or angina pectoris;
- have been diagnosed with or have had in the past liver disease and liver function tests have not returned to normal;
- have been diagnosed with a rare inherited blood disorder - porphyria;
- are allergic to estradiol or any of the other ingredients of Vagirux (listed in section 6).
If any of the above conditions occur for the first time during treatment with Vagirux, stop using the medicine immediately and contact your doctor as soon as possible.
Warnings and Precautions
Before starting treatment, inform your doctor if you currently have or have had any of the following conditions in the past, as they may recur or worsen during treatment with Vagirux. In such cases, your doctor may decide that more frequent monitoring is necessary.
- Uterine fibroids;
- Presence of uterine lining tissue outside the uterus (endometriosis) or past history of excessive uterine lining growth (endometrial hyperplasia);
- Increased risk of blood clots (see "Blood clots in veins (venous thrombosis)");
- Increased risk of estrogen-dependent tumors (e.g., breast cancer in mother, sister, or grandmother);
- High blood pressure;
- Liver disease, e.g., benign liver tumor;
- Diabetes;
- Gallstones;
- Migraine or severe headaches;
- Systemic autoimmune disease affecting multiple organs - systemic lupus erythematosus;
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- Epilepsy;
- Asthma;
- A disease affecting the eardrum and hearing - otosclerosis;
- Very high levels of fats (triglycerides) in the blood;
- Fluid retention due to impaired heart or kidney function;
- Hereditary or acquired angioedema.
You should stop using Vagirux and contact your doctor immediately if any of the following conditions occur during HRT:
- Any of the conditions listed under "When Not to Use Vagirux" above;
- Yellowing of the skin or eyes (jaundice). These may be signs of liver disease;
- Swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives together with breathing difficulties, suggesting angioedema;
- Significant increase in blood pressure (symptoms may include headache, fatigue, and dizziness);
- A new onset of migraine headache;
- If you become pregnant;
- If you experience symptoms of blood clots such as:
- painful swelling and redness in the legs,
- sudden chest pain,
- difficulty breathing. For more information, see "Blood clots in veins (venous thrombosis)".
Note: Vagirux is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, additional contraception may be necessary. Please consult your doctor.
HRT and Cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Long-term use of oral HRT containing only estrogens may increase the risk of developing cancer of the uterine lining (endometrium).
It is not known whether a similar risk exists with repeated or prolonged (longer than one year) use of Vagirux. However, Vagirux is absorbed into the bloodstream to a very small extent, and therefore adding a progestogen is not necessary.
Bleeding or spotting is usually not a cause for concern, but you should consult your doctor. It may be a sign of endometrial thickening.
The risks described below apply to HRT medicines that enter the bloodstream. Vagirux is applied locally into the vagina and is absorbed into the blood to a very small extent. It is less likely that the conditions listed below will worsen or recur during Vagirux use; however, if in doubt, consult your doctor.
Breast Cancer
Data indicate that using Vagirux does not increase the risk of breast cancer in women who have never had breast cancer before. It is not known whether Vagirux can be safely used in women who have had breast cancer.
You should regularly examine your breasts. Contact your doctor if you notice any of the following changes:
- Dimpling of the skin,
- Changes in the nipple,
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- Presence of lumps that are visible or palpable.
Additionally, screening mammograms are recommended as advised by your doctor.
Ovarian Cancer
Ovarian cancer is rare—much rarer than breast cancer. Estrogen-only HRT is associated with a slightly increased risk of ovarian cancer.
Comparison
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2000 women over a 5-year period. Among women who have used HRT for 5 years, it occurs in about 3 out of 2000 women (i.e., about 1 additional case).
Effects of HRT on the Heart and Circulation
Blood Clots in the Veins (Venous Thrombosis)
The risk of blood clots in the veins is 1.3 to 3 times higher in women using HRT compared to non-users, especially during the first year of use.
Blood clots can have serious consequences and, if they travel to the lungs, may cause chest pain, shortness of breath, loss of consciousness, or even death.
The risk of venous blood clots is higher if you are older or if any of the following situations apply to you. Inform your doctor if any of the following apply to you:
- you are unable to walk for a prolonged period due to major surgery, injury, or illness (see also section 3, "If Surgery is Planned");
- you are significantly overweight (BMI > 30 kg/m²);
- you have a history of thromboembolic disorders requiring long-term anticoagulant therapy;
- you or a close family member have had blood clots in the legs, lungs, or other organs in the past;
- you have systemic lupus erythematosus;
- you have been diagnosed with cancer.
If you experience symptoms of blood clots, see "You should stop using Vagirux and contact your doctor immediately."
Comparison
Among women aged 50 to 59 who do not use HRT, the number of venous blood clot cases over 5 years is estimated at 4 to 7 per 1000 women.
Among women aged 50 to 59 using estrogen-only HRT for more than 5 years, the number of cases is 5 to 8 per 1000 women (i.e., 1 additional case).
Heart Disease (Heart Attack)
Women using estrogen-only HRT do not have an increased risk of developing heart disease.
Stroke
The risk of stroke is about 1.5 times higher in women using HRT compared to non-users. The number of additional stroke cases caused by HRT use increases with age.
Comparison
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Among women aged 50 to 59 who do not use HRT, the number of stroke cases over 5 years is estimated at an average of 8 per 1000 women. Among women aged 50 to 59 using HRT, the number of cases over 5 years is 11 per 1000 women (i.e., 3 additional cases).
Other Conditions
HRT does not prevent memory loss. The risk of probable memory loss may be somewhat higher in women who start HRT after the age of 65. Please consult your doctor.
Vagirux and Other Medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal remedies, or other natural products.
The likelihood of interactions with other medicines is low because Vagirux is applied locally into the vagina. However, Vagirux may affect other local treatments applied vaginally.
Pregnancy and Breastfeeding
Vagirux is intended for use only in postmenopausal women. If you become pregnant, stop using the medicine and contact your doctor.
Driving and Operating Machinery
It is not known whether Vagirux affects the ability to drive or operate machinery.
3. How to use Vagirux
This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
How to use Vagirux
- Treatment with Vagirux may be started on any day.
- For vaginal use only. Do not take the tablets by mouth.
- A vaginal tablet should be placed into the vagina using the applicator.
The “INSTRUCTIONS FOR USE” at the end of this leaflet provide detailed guidance. The instructions must be read carefully before using Vagirux.
The vaginal tablet applicator is intended for repeated use up to 24 times for one patient (one tablet per application). After this, the applicator should be discarded with household waste. Do not use applicators showing visible signs of damage.
What dose to use
- For the first 2 weeks, use one vaginal tablet once daily.
- Afterwards, use one vaginal tablet twice a week. Maintain a 3–4 day interval between doses.
General information about treatment of menopausal symptoms
- Your doctor will determine the lowest effective dose of Vagirux for the shortest possible duration needed to treat your symptoms. Consult your doctor if the prescribed dose seems too high or insufficient.
- Treatment should continue only if the benefits outweigh the risks. Discuss this with your doctor.
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If you use more Vagirux than prescribed
- If you use more Vagirux than recommended, contact your doctor or pharmacist.
- Vagirux is intended for local, intravaginal use. The dose of estradiol is so low that a large number of tablets would have to be used to reach the dose usually administered orally.
If you forget to use a dose of Vagirux
- If you miss a dose, use the missed tablet as soon as possible.
- Do not use a double dose to make up for a missed dose.
Stopping Vagirux treatment
Do not stop treatment with Vagirux without consulting your doctor. Your doctor will explain the consequences of stopping treatment and discuss other possible treatment options.
If surgery is planned
If you are scheduled for surgery, inform the surgeon that you are using Vagirux. It may be necessary to stop using Vagirux 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, “Blood clots in the veins (venous thrombosis)”). Before restarting Vagirux, consult your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In women using hormone replacement therapy (HRT), the following diseases have been reported more frequently compared to women not using HRT. These risks are less relevant for medicines administered vaginally, such as Vagirux:
- ovarian cancer;
- blood clots in the legs or lungs (venous thromboembolic disease);
- stroke;
- possible memory loss, if HRT was initiated after the age of 65.
For further information, see section 2, "Important information before using Vagirux".
Common: may affect less than 1 in 10 women
- headache;
- abdominal pain;
- vaginal bleeding, discharge or discomfort.
Uncommon: may affect less than 1 in 100 women
- fungal infections of the genital organs;
- malaise (nausea);
- rash;
- weight gain;
- hot flushes;
- hypertension.
Very rare: may affect less than 1 in 10,000 women
- diarrhoea;
- fluid retention;
- worsening of migraine;
- generalized hypersensitivity (e.g. anaphylactic reaction/anaphylactic shock).
The following adverse reactions have been reported during systemic estrogen therapy:
- gallstones;
- various skin disorders:
- skin discolouration, especially on the face or neck, known as chloasma (melasma);
- painful red nodules on the skin (erythema nodosum);
- rash with characteristic redness or pain (erythema multiforme).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Vagirux
Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. This medicine may pose a risk to the aquatic environment.
6. Contents of the package and other information
What Vagirux contains
- The active substance is estradiol. Each vaginal tablet contains 10 micrograms of estradiol (as estradiol hemihydrate).
- The other ingredients are: hypromellose, lactose monohydrate, corn starch, and magnesium stearate. The tablet coating: hypromellose and macrogol.
What Vagirux looks like and contents of the pack
The vaginal tablets are white, round, film-coated, with the letter “E” engraved on one side, approximately 6 mm in diameter.
Pack sizes:
18 vaginal tablets in a PVC/PVDC/Aluminium blister pack and one reusable vaginal applicator in a protective foil, packed in a cardboard box.
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For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Gedeon Richter Plc., Gyömrői út 19-21., Budapest H-1103, Hungary
Manufacturer:
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
Gedeon Richter Plc., Gyömrői út 19-21., Budapest H-1103, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Greece, country of export: 20658/12-03-2021
Parallel import licence number: 252/23
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary Vagirux 10 mikrogramm hüvelytabletta
Austria Rewellfem 10 Mikrogramm Vaginaltabletten
Liechtenstein Rewellfem
Czech Republic Vagirux
Slovakia Vagirux 10 mikrogramov vaginálne tablety
Denmark Rewellfem
Iceland Rewellfem
Norway Vagirux
Finland Vagirux
Sweden Vagirux
Estonia VAGIRUX
Latvia Vagirux 10 mikrogrami vaginālās tabletes
Lithuania VAGIRUX 10 mikrogramų makšties tabletės
Croatia Vagirux 10 mikrograma tablete za rodnicu
Slovenia Vagirux 10 mikrogramov vaginalne tablete
Ireland Vagirux
Malta Vagirux 10 microgram vaginal tablets
Spain Vagirux 10 microgram vaginal tablets
Italy Vagirux
Poland Vagirux
Portugal Formyra
Romania ESTRADIOL RICHTER 10 micrograme comprimate vaginale
INSTRUCTIONS FOR USE
How to use Vagirux
- Remove the protective foil from the applicator. Open from the side indicated in the illustration.
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- Holding the tube, pull the plunger of the applicator until it stops. Take one vaginal tablet out of the individual blister and place it firmly into the holder (the wider end) of the applicator tube.
- Gently insert the applicator into the vagina until resistance is felt (8–10 cm).
- To release the tablet, press the plunger until resistance is felt. The tablet will immediately adhere to the vaginal wall. The tablet will not fall out when standing or walking.
- After each use, and before the next use, clean the applicator according to the cleaning instructions below:
- Remove the plunger from the applicator.
- Clean both the tube and the plunger with mild soap and thoroughly rinse with warm tap water. Rinse both the inner and outer surfaces of the tube.
- If necessary, remove excess water from both the tube and the plunger by shaking them briefly.
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- Air-dry both the tube and the plunger on a clean surface (e.g., on a paper towel).
- Reinsert the plunger into the applicator tube for future use.
- The applicator should be used until the pack is empty (18 times), then disposed of with household waste.
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