VAGIRUX 10 MICROGRAMS Vaginal tablet

Зміст інструкції

1. Vagirux 10 micrograms vaginal tablets
   1. What is Vagirux and what is it used for
   2. What you need to know before using Vagirux
   3. How to use Vagirux
   4. Possible side effects
   5. How to store Vagirux
   6. Content of the pack and other information

Vagirux 10 micrograms vaginal tablets

estradiol

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Vagirux is and what it is used for
• 2. What you need to know before you use Vagirux
• 3. How to use Vagirux
• 4. Possible side effects
• 5. How to store Vagirux
• 6. Contents of the pack and other information

1. What is Vagirux and what is it used for

Vagirux contains estradiol:

• Estradiol is a female sex hormone.
• It belongs to a group of hormones called estrogens.
• It is exactly the same estradiol produced by the ovaries.

Vagirux belongs to a group of medicines for Vaginal Hormone Replacement Therapy (HRT).

Vagirux is usedto relieve the symptoms of menopause such as vaginal irritation or dryness. In
medical terms this is known as “atrophic vaginitis”. It is caused by a decrease in the levels of
estrogen in the body. This happens naturally after menopause.

Vagirux worksby replacing the estrogen normally produced by a woman's ovaries. It is inserted
into the vagina so that the hormone is released where it is needed. This will relieve vaginal discomfort.

2. What you need to know before using Vagirux

Medical history and regular medical check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue taking it.
Experience in treating women with premature menopause (due to ovarian failure or surgical treatment) is limited. If you have premature menopause, the risk when using HRT may be different. Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast exam or a pelvic exam, if necessary.
Once you have started treatment with Vagirux, you should see your doctor for check-up visits at least once a year. During these check-up visits, discuss with your doctor the benefits and risks of continuing treatment with Vagirux.
Have your breasts monitored at regular intervals as recommended by your doctor.

Do not use Vagirux:
If you are in any of the following conditions. If you are unsure about any of the points below, talk to your doctorbefore using Vagirux.
Do not use Vagirux if:

• If you have or have had breast canceror there is a suspicion of it.
• If you have or have had or there is a suspicion that you have an estrogen-sensitive tumor, such as a tumor of the uterine lining (endometrium) or there is a suspicion of it.
• If you have unexplained vaginal bleeding.
• If you have an excessive growth of the uterine lining(endometrial hyperplasia) that has not been treated.
• If you have or have had blood clots inside the veins(thrombosis) such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a blood clotting disorder(such as protein C, protein S or antithrombin deficiency).
• If you have or have recently had a disorder caused by clots in the arteries, such as a heart attack, stroke or angina.
• If you have or have had a liver disorderand your liver function tests have not returned to normal
• If you have a rare hereditary blood disease called “porphyria”.
• If you are allergic to estradiolor any of the other ingredients of this medicine (listed in section 6).

If any of the above situations occur for the first time while using Vagirux, stop taking it and consult your doctor immediately.

Warnings and precautions
Before starting treatment, talk to your doctor if you are or have been in the conditions listed below, because these may return or worsen during treatment with Vagirux. If so, your doctor may need to see you more often for medical check-ups.

• Fibroids of the uterus;
• Growth of the uterine lining outside the uterus (endometriosis) or a history of excessive growth of the uterine lining (endometrial hyperplasia);
• Increased formation of blood clots (see “Blood clots inside a vein (thrombosis)”;
• Increased incidence of estrogen-dependent tumor (such as having a mother, sister or grandmother who has had breast cancer);
• High blood pressure;
• Liver disorder such as a benign liver tumor;
• Diabetes;
• Gallstones;
• Migraine or severe headache;
• An autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE);
• Epilepsy,
• Asthma,
• A disease of the middle ear and hearing (otosclerosis);
• A very high level of fats in the blood (triglycerides);
• Fluid retention due to heart or kidney problems.

Stop using Vagirux and consult your doctor immediately:
If you notice any of the following situations when using HRT:

• Any condition listed above in the paragraph ‘Do not use Vagirux’;
• Yellowing of the skin and eyes (jaundice). These may be signs of a liver disorder;
• Significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• Migraine-type headache that you have never had before;
• If you become pregnant;
• If you notice signs of blood clots such as:
• painful swelling and redness of the legs,
• sudden chest pain,
• difficulty breathing. For more information, see “Blood clots inside a vein (thrombosis)”.

Note:Vagirux is not a contraceptive. If less than 12 months have passed since your last menstrual period or you are under 50 years of age, you still need to use additional contraception to prevent pregnancy. Ask your doctor for advice.

HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and uterine lining cancer (endometrial cancer)
Long-term estrogen-only treatment may increase the risk of developing tumors of the uterine lining (endometrium).
It is not certain whether there is a similar risk with Vagirux when used for repeated or prolonged use (more than one year). However, Vagirux has shown very low absorption into the blood and therefore the addition of a progestin is therefore not necessary.
If you have vaginal bleedingor spotting, it is usually nothing to worry about, but you should make an appointment with your doctor. It may be a sign of thickening of the endometrium.

The following risks occur with HRT (hormone replacement therapy) medicines that circulate in the

blood. However, Vagirux is used for local treatment in the vagina and absorption into the blood is

very low. It is less likely that the conditions indicated below will worsen or recur during treatment with Vagirux, however contact your doctor if you have any doubts.

Breast cancer
Evidence suggests that the use of Vagirux does not increase the risk of breast cancer in women who have not had this type of cancer in the past. It is not known whether Vagirux can be used safely in women who have had breast cancer in the past.

Check your breasts regularly. Contact your doctor if you notice any changes such as:

• skin dimpling;
• changes in the nipple;
• any lumps you see or feel.

In addition, it is recommended to participate in breast screening programs when they are offered.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only therapy has been associated with a slight increase in the risk of ovarian cancer.

Comparative data
The risk of ovarian cancer varies depending on age. For example, in women aged 50-54 who do not take HRT, about 2 women out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who take HRT for 5 years, there are about 3 cases per 2,000 users (i.e., about 1 additional case).

Effect of HRT on heart and circulation
Blood clots in a blood vessel (thrombosis)
The risk of blood clot formation in a blood vesselis approximately 1.3-3 times higher in women taking HRT compared to women who are not taking it, particularly during the first year of treatment.
Blood clots can be serious, but if one reaches the lungs, it can cause chest pain, shortness of breath, collapse or even death.
You are more likely to have a blood clot in the blood vessels as you get older and if one or more of the following situations apply to you. Tell your doctor if any of the following apply:

• if you cannot walk or must be immobilized for a long time due to surgery, trauma or illness (see also section 3, ‘If you are to be operated on’)
• if you are excessively overweight (BMI > 30 kg/m)
• if you have had blood clotting problems for which you have needed long-term treatment with a medicine used to prevent blood clots
• if you or a family member has had a blood clot in the legs, lungs or other organ in the past
• if you suffer from systemic lupus erythematosus (SLE)
• if you have cancer. For signs of blood clots, see “Stop using Vagirux and consult your doctor immediately”.

Comparative data
Among women aged 50 who do not take HRT, on average over a period of more than 5 years, a blood clot in a blood vessel may be expected in 4 to 7 cases per 1,000 women.
In women aged 50 who use estrogen-only HRT for 5 years, 5 to 8 cases are diagnosed per 1,000 users (one additional case).

Heart disease (heart attack)
In women using estrogen-only HRT, there is no increase in the risk of developing heart disease.

Stroke
The risk of having a stroke is approximately 1.5 times higher in women taking HRT compared to women who are not taking it. The number of additional cases of stroke due to HRT use increases in relation to increasing age.

Comparative data
Among women aged 50 who do not take HRT, on average over a period of more than 5 years, 8 cases per 1,000 may be expected. For women aged 50 who use HRT for more than 5 years, 11 cases are diagnosed per 1,000 users (3 additional cases).

Other conditions
HRT has no preventive effect on memory loss. The risk of probable memory loss may be slightly higher in women who start any type of HRT after age 65. Talk to your doctor.

Other medicines and Vagirux
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including over-the-counter medicines, herbal medicines or other natural products.
However, Vagirux is used for local treatment in the vagina and does not affect the use of other drugs.
Vagirux may affect other treatments applied vaginally.

Pregnancy and breastfeeding
Vagirux is only indicated for postmenopausal women. If you become pregnant, stop Vagirux and contact your doctor.

Driving and using machines
No known effects.

3. How to use Vagirux

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Use of this medicine

• You can start treatment with Vagirux on any day that is most convenient for you.
• Insert the vaginal tablet into the vagina with the applicator.

The ‘INSTRUCTIONS FOR USE’ at the end of the leaflet will show you how to do this. Read
the instructions carefully before using Vagirux.
The vaginal tablet applicator is intended for multiple use up to 24 times for a single
patient (one tablet per application). Afterwards, dispose of the applicator through household waste. Do not use applicators that show obvious signs of damage.

How much to use

• Use one vaginal tablet every day for the first 2 weeks.
• Then use one vaginal tablet twice a week. Allow 3 or 4 days to pass between each dose.

General information on the treatment of menopausal symptoms

• Your doctor will aim to prescribe the lowest dose of Vagirux to treat your symptoms and for the shortest possible time. Talk to your doctor if you think this dose is too high or not strong enough.
• Treatment should continue only if the benefits are greater than the risks. Discuss this with your doctor.

If you take more Vagirux than you should

• If you have taken more Vagirux than you should, consult your doctor or pharmacist.
• Vagirux is for local internal treatment of the vagina. The estradiol dosage is so low that a considerable number of tablets would need to be taken to reach the dosage normally taken with oral treatment.

If you forget to take Vagirux

• If you have forgotten a dose, take the medicine as soon as you remember.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Vagirux
Do not stop using Vagirux without consulting your doctor. The doctor will explain the effects
of stopping treatment and discuss other treatment options with you.

If you are to be operated on
If you are about to be operated on, inform the surgeon that you are using Vagirux. It may be necessary
to stop using Vagirux 4 to 6 weeks before the operation to avoid the risk of
blood clots (see section 2, Blood clots in a blood vessel). Ask your doctor
when you can start using Vagirux again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions are reported more often in women using hormone replacement therapy (HRT) that
circulates in the blood compared to women who do not use HRT. The aforementioned risks are less
relevant for treatments administered via the vaginal route such as Vagirux:

• ovarian cancer;
• blood clots in a blood vessel of the legs or lungs (venous thromboembolism);
• stroke;
• possible memory loss in women who start any type of HRT after the age of 65.

For more information on these side effects, see section 2 ‘What you need to know before
using Vagirux’.

Common: may affect more than 1 in 10 people

• Headache
• Stomach pain
• Vaginal bleeding, discharge and discomfort.

Uncommon: may affect more than 1 in 100 people

• Genital fungal infections
• Feeling unwell (nausea)
• Skin rash
• Weight gain
• Hot flushes
• High blood pressure

Very rare: may affect more than 1 in 10,000 people

• Diarrhoea
• Fluid retention
• Worsening of migraine
• Generalised hypersensitivity (e.g. anaphylactic reactions/shock).

The following side effects have been reported with systemic estrogenic treatment:

• Cholelithiasis
• Various skin changes:
• skin discolouration, particularly on the face and neck, known as “pregnancy mask” (chloasma)
• painful, reddish skin nodules (erythema nodosum)
• skin redness with redness and sores (erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can
help to provide more information on the safety of this medicine.

5. How to store Vagirux

Keep this medicine out of the sight and reach of children.
Keep the blister in the outer cardboard packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging label and on the
blister after SCAD. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. These measures will help protect the environment.
This medicine may pose risks to the aquatic environment.

6. Content of the pack and other information

What Vagirux contains

• The active ingredient is estradiol. Each vaginal tablet contains estradiol hydrate equivalent to 10 micrograms of estradiol.
• The other ingredients are: hypromellose, lactose monohydrate, corn starch and magnesium stearate. The film coating contains: hypromellose and macrogol.

Description of the appearance of Vagirux and content of the pack
The vaginal tablets are white, round, film-coated tablets with an “E” imprinted on one
side. The diameter of the tablet is approximately 6 mm.
Packs:
18 vaginal tablets with a multi-use applicator.
24 vaginal tablets with a multi-use applicator.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21.
Budapest H-1103
Hungary

Manufacturer:
Haupt Pharma Münster GmbH (Member of the Aenova Group)
Schleebrüggenkamp 15
48159 Münster
Germany
Gedeon Richter Plc.
Gyömrői út 19-21.
Budapest H-1103
Hungary
This medicinal product is authorised in the Member States of the EEA under the following denominations:
AT Rewellfem 10 Mikrogramm Vaginaltabletten
CZ Vagirux
DK Rewellfem
EE Vagirux
ES Vagirux 10 microgram vaginal tablets
FI Vagirux
HR Vagirux 10 mikrograma tablete za rodnicu
HU Vagirux 10 mikrogramm hüvelytabletta
IE Vagirux
IS Rewellfem
IT Vagirux
LI Rewellfem
LT VAGIRUX 10 mikrogramų makšties tabletės
LV Vagirux 10 mikrogrami vaginālās tabletes
MT Vagirux 10 microgram vaginal tablets
NO Vagirux
PL Vagirux
PT Vagirux
RO ESTRADIOL RICHTER 10 micrograme comprimate vaginale
SE Vagirux
SI Vagirux 10 mikrogramov vaginalne tablete
SK Vagirux 10 mikrogramov vaginálne tablety
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INSTRUCTIONS FOR USE

How to use Vagirux

• 1. Remove the applicator from the packaging. Open the end as shown in the figure.

• 2. While holding the tube, pull the plunger of the applicator back until it stops. Press a vaginal tablet from the separate blister and place it firmly in the holder (wide end) of the applicator tube.

• 3. Carefully insert the applicator into the vagina. Stop when you meet resistance (8-10 cm).

• 4. To release the tablet, carefully press the button until it stops.

The tablet is thus immediately protected by the vaginal wall.
It will not fall out while standing or walking

• 5. After each use, before subsequent use, clean the applicator according to the following cleaning procedure:
• Remove the plunger from the applicator.
• Clean the tube and plunger with mild soap and rinse thoroughly with warm tap water. Rinse the inside and outside surface of the tube.
• If necessary, remove large amounts of residual water from both the tube and the plunger by briefly shaking them.
• Dry both the tube and the plunger in the air on a clean surface (e.g. a paper towel).
• Reinsert the plunger into the applicator tube for subsequent uses.
• 6. Use the applicator until the pack is empty (18 or 24 times). Afterwards, dispose of it in household waste.