VAGIFEM 10 MICROGRAMMI Vaginal tablet

Зміст інструкції

1. Vagifem 10 microgrammes vaginal tablets
   1. What Vagifem is and what it is used for
   2. Cosa deve sapere prima di usare Vagifem
   3. How to use Vagifem
   4. Possible side effects
   5. How to store Vagifem
   6. Package Contents and Other Information

Vagifem 10 microgrammes vaginal tablets

estradiol

Read this leaflet carefully before you start to use 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, ‘Possible side effects’.

What is in this leaflet:

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

1. What Vagifem is and what it is used for

Vagifem 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.

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

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

Vagifem worksby replacing the estrogen normally produced by the ovaries. It is inserted into the vagina so that
the hormone is released when needed. This will relieve vaginal discomfort.
Experience in women over 65 years of age is limited.

2. Cosa deve sapere prima di usare Vagifem

Storia medica e controlli medici regolari
The use of HRT involves risks that must be considered when deciding whether to start or
continue taking it.
Experience in the treatment of 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 resuming) 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 gynecological examination, if necessary.
Once you have started treatment with Vagifem, 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 Vagifem.
Have your breasts monitored at regular intervals as recommended by your doctor.

Non usi Vagifem:
If you are in any of the following conditions. If you are unsure about any of the points below, talk to your doctor
before using Vagifem.
Do not use Vagifem if:

• If you are allergic(hypersensitive) to estradiolor any of the other ingredients of Vagifem (listed in section 6 ‘Contents of the pack and other information’).
• If you have or have had malignant breast canceror there is a suspicion of it.
• If you have or have had or there is a suspicion that you have a tumor sensitive to estrogens, 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 clotsin the veinsof the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have disorders of blood coagulation(thrombophilic disorders such as protein C, protein S or antithrombin deficiency).
• If you have a blood coagulation disorder(thrombophilic disorders, 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,a 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 blood disease of hereditary type called “ porphyria”.

If any of the above situations occur at the beginning of using Vagifem, stop taking it
and consult your doctor immediately.

Avvertenze e precauzioni
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 Vagifem. If so, your doctor may
need to see you more often for medical check-ups.

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

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

• Migraine headache that you have never had before
• Yellowing of the skin and eyes (jaundice). These may be signs of a liver disorder
• Swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, associated with difficulty breathing, which are indicative of angioedema
• Significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• Any condition listed above in the paragraph ‘ Do not use Vagifem’
• If you become pregnant
• If you notice signs of blood clots such as:
• swelling, pain or redness of the legs
• sudden chest pain
• difficulty breathing. For more information, see “Blood clots in a vein (thrombosis)”.

Note: Vagifem 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 contraceptives to prevent
pregnancy. Seek advice from your doctor.

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 Vagifem when used for repeated or prolonged use (more than one year). However, Vagifem has shown very low blood absorption and
therefore the addition of a progestin is therefore not necessary.
If you have vaginal bleeding or 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 for medicines of hormone replacement therapy (HRT) that circulate in the

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

very low. It is less likely that the conditions below will worsen or recur during

treatment with Vagifem, but you should talk to your doctor if you are concerned.

Breast cancer
Evidence suggests that the use of Vagifem 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 Vagifem 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 dimples
• changes to the nipple
• any lumps you feel or see.

In addition, it is recommended to join 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 use HRT, about 2 women out of 2,000 will be diagnosed with ovarian cancer within 5 years.
For women who use HRT for 5 years, there are about 3 cases per 2,000 users (i.e., about 1 case more).

Effect of HRT on heart and circulation
Blood clots in a blood vessel (thrombosis)
The risk of developing blood clots in a blood vesselis approximately 1.3-3 times higher in women
who use HRT compared to women who do not use it, especially during the first year of
treatment.
Blood clots are not always 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 if one or more of the following situations
apply to you. Tell your doctor in one of the following cases:

• 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 problems with blood clotting 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 Vagifem and consult your doctor
immediately”.

Comparative data
Among women aged 50 who do not use HRT, on average over a period of more than 5 years, a blood clot in a blood vessel could 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 who use 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 who use HRT compared to women who do not
use 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 use HRT, on average over a period of more than 5 years, 8 cases per
1,000 could be expected. For women aged 50 who use HRT for more than 5 years, 11 cases per

• 1,000 users are diagnosed (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 Vagifem
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription, herbal medicines or other natural products. However, Vagifem
is used for local treatment in the vagina and does not affect the use of other drugs. Vagifem may affect
other treatments applied vaginally.

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

Driving and using machines
No known effects.

3. How to use Vagifem

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 Vagifem 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 Vagifem.

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

• When using medicines to treat menopausal symptoms, it is recommended to use the lowest effective dose and use the medicine for the shortest possible time.
• Your doctor will aim to prescribe the lowest dose of Vagifem 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 only continue if the benefits are greater than the risks. Consult your doctor about this.

If you take more Vagifem than you should

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

If you forget to take Vagifem

• 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 Vagifem
Do not stop using Vagifem without consulting your doctor. Your 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, tell the surgeon that you are using Vagifem. It may be necessary to stop
using Vagifem 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 Vagifem again.
If you have any further questions on 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 frequently in women treated with medicines containing systemic TOS
circulating in the blood compared to women who do not use TOS. The aforementioned risks are to a lesser extent
related to treatments administered via the vaginal route such as Vagifem:

• ovarian carcinoma;
• blood clots in a blood vessel of the legs or lungs (venous thromboembolism);
• heart disorders;
• stroke;
• possible memory loss in women who start any type of TOS after the age of 65. For further information on these side effects, see paragraph 2 ‘What you need to know before using Vagifem’.

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)
• Rash
• Weight gain
• Hot flushes
• Hypertension.

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 alterations:
• discoloration of the skin, particularly on the face and neck, known as “pregnancy mask” (cloasma)
• painful reddish skin nodules (erythema nodosum)
• skin erythema 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 or pharmacist. 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 provide more information on the safety of this medicine.

5. How to store Vagifem

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date which is 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 waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
This medicine may pose risks to the aquatic environment.

6. Package Contents and Other Information

What Vagifem contains

• The active ingredient is estradiol 10 micrograms (as estradiol hemihydrate). Each vaginal tablet contains 10 micrograms of estradiol (as estradiol hemihydrate).
• The other ingredients are: hypromellose, lactose monohydrate, corn starch and magnesium stearate
• The film coating contains: hypromellose and macrogol 6000.

Description of Vagifem and package contents
Each white vaginal tablet is placed in a single-use applicator.
Vagifem is inscribed on one side with the writing NOVO 278.
Pack sizes:
18 vaginal tablets with applicators.
24 vaginal tablets with applicators.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency

INSTRUCTIONS FOR USE
How to use Vagifem

• 1. Remove one blister pack from the packaging. Open it at the end as shown in the image.

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

• 3. To release the tablet, gently press the button until you hear a click. The tablet is then immediately protected by the vaginal wall.

It will not fall out while standing or walking.

• 4. Remove the applicator and discard it.

© 2017
Novo Nordisk A/S