DONAFLOR 50 mg /30 Mcg Vaginal Tablet

Зміст інструкції

1. DONAFLOR 50 mg + 30 micrograms vaginal tablets
   1. What is Donaflor and what is it used for
   2. Cosa deve sapere prima di usare Donaflor
   3. How to use Donaflor
   4. Possible side effects
   5. How to store Donaflor
   6. Contents of the pack and other information

DONAFLOR 50 mg + 30 micrograms vaginal tablets

Lactobacillus acidophilus and estriol

Read this leaflet carefully before you 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 their symptoms are the same as yours, as it could 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 Donaflor is and what it is used for
• 2. What you need to know before you use Donaflor
• 3. How to use Donaflor
• 4. Possible side effects
• 5. How to store Donaflor
• 6. Contents of the pack and other information

1. What is Donaflor and what is it used for

DONAFLOR belongs to a group of medicines called Vaginal Hormone Replacement Therapy (HRT).
It is used to relieve menopausal symptoms in the vagina such as dryness or irritation
which in medical terminology is described as “vaginal atrophy” and is determined by a decrease in the levels of
estrogen in your body. This happens naturally after menopause. DONAFLOR works by replacing the
estrogens normally produced in the ovaries of women. It is inserted into the vagina, so the hormone is
released where it is needed. This can reduce discomfort in the vagina.
Donaflor contains the active ingredients lactic acidophilus (which has a protective function towards the vagina) and estriol (a sex hormone).
Donaflor is used for:

• vaginal discharge of unknown origin (vaginal secretion) or mild or moderate cases of bacterial vaginal infection (bacterial vaginosis), when the use of antibiotic medicines is not entirely necessary.
• restoration of the vaginal bacterial flora (lactobacilli) after local and/or systemic treatment with antibiotic or chemotherapeutic medicines.
• inflammation of the vaginal mucosa due to estrogen sex hormone deficiency in menopause and post-menopause (atrophic vaginitis), or as concomitant treatment with systemic hormone replacement therapy. Donaflor can also be used as a preventive treatment for the recurrence of candida infections (a fungus).

2. Cosa deve sapere prima di usare Donaflor

Personal medical history and routine medical check-ups
The use of Hormone Replacement Therapy (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 (caused by ovarian insufficiency or
surgery) is limited. If you have premature menopause, the risks of using HRT may be different. Please, talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your medical history and family history. The doctor may decide to perform a clinical examination. This may include a breast exam and/or, if necessary, a pelvic exam.
Once you have started treatment with DONAFLOR, you should consult your doctor for regular check-ups
(at least once a year). During these check-ups, talk to your doctor about the benefits and risks of
continuing with DONAFLOR.
Undergo regular breast screening checks, as recommended by your doctor.

Do not use Donaflor
If any of the following conditions apply to you. If you are unsure about any of the points listed
below, talk to your doctor before taking Donaflor.
Do not take Donaflor:

• If you have or have ever had breast cancer, or if you suspect you have it;
• If you have a cancer that is sensitive to estrogens, such as cancer of the uterine lining (endometrium), or if you suspect you have it;
• If you have unexplained vaginal bleeding;
• If you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated;
• If you have or have ever had a blood clot in a vein (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 disease caused by blood clots in the arteries, such as heart attack (myocardial infarction), stroke or angina;
• If you have or have ever had liver disease and your liver function tests have not returned to normal;
• If you have a rare blood disease called "porphyria" that is inherited in the family;
• If you are allergic (hypersensitive) to estriol or any of the other ingredients of DONAFLOR (listed in section 6);
• If you have a severe purulent vaginal inflammation;
• If you are a young woman before reaching sexual maturity.

If any of the above conditions appear for the first time during the use of Donaflor,
stop using it immediately and consult your doctor immediately.

When to be particularly careful with Donaflor
Tell your doctor if you have ever had any of the following problems, before starting treatment, as these
may recur or worsen during therapy with Donaflor. In such cases, you should consult your doctor
more often for check-ups:

• fibroids inside the uterus
• growth of the uterine lining outside the uterus (endometriosis) or a history of excessive growth of the uterine lining (endometrial hyperplasia);
• increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)");
• increased risk of developing a cancer sensitive to estrogens (e.g. having a mother, sister or grandmother who has had breast cancer);
• high blood pressure;
• liver disease, such as benign liver tumor;
• diabetes;
• gallstones (biliary);
• migraine or severe headache;
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE);
• epilepsy;
• asthma;
• a disease that affects the eardrum and hearing (otosclerosis);
• a very high level of fats in the blood (triglycerides);
• fluid retention caused by heart or kidney problems;
• hereditary or acquired angioedema.

Stop treatment with Donaflor and consult your doctor immediately
If you notice any of the following conditions during Hormone Replacement Therapy (HRT) with Donaflor:

• any of the conditions mentioned in the "Do not use Donaflor" section;
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease;
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives accompanied by difficulty breathing, which are indicative of angioedema
• a sharp increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• migraine-type headache that occurs for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful and reddened swelling of the legs;
• sudden chest pain;
• difficulty breathing. For more information, see "Blood clots in a vein (thrombosis)"

Note: Donaflor 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, you still need to use additional contraception to prevent pregnancy. Talk
to your doctor for advice.
Hormone Replacement Therapy (HRT) and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining
(endometrial carcinoma)
Prolonged use of estrogen-only HRT tablets may increase the risk of developing
cancer of the uterine lining (endometrium).
It is not certain whether there is a similar risk with Donaflor when used for repeated or long-term
treatments (more than one year). However, Donaflor has shown to have very low absorption into the blood, so
the addition of a progestin is not necessary.
If you experience bleeding or spotting, there is usually no cause for concern, but you should make an appointment
to consult your doctor. It may be a sign that your uterine lining (endometrium) has
become thicker.
The following risks apply to Hormone Replacement Therapy (HRT) medications that circulate in
the blood. However, Donaflor is intended for local treatment in the vagina and absorption into the blood is very
low. It is less likely that the conditions mentioned below will worsen or recur during
treatment with Donaflor, but you should consult your doctor if you are concerned.
Breast cancer
Evidence suggests that the use of Donaflor does not increase the risk of breast cancer in women who have not had breast cancer in the past. It is not known whether Donaflor can be used safely in
women who have had breast cancer in the past.
Check your breasts regularly. See your doctor if you notice changes such as:

• skin dimpling;
• changes in the nipple;
• any lumps you can see or feel. You are also advised to participate in screening mammography programs when offered.

Ovarian cancer
Ovarian cancer is rare, much rarer than breast cancer. The use of estrogen-only hormone replacement therapy (HRT) 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 to 54 who are not taking
hormone replacement therapy (HRT), about 2 out of 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have taken hormone replacement therapy for 5 years, there will be about 3
cases per 1000 users (i.e. about 1 additional case).
Effect of Hormone Replacement Therapy (HRT) on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is approximately 1.3 to 3 times higher in users of hormone replacement therapy
compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one of them reaches the lungs, it can cause chest pain,
shortness of breath, fainting or even death.
A blood clot is more likely to occur when you get older and if one of the following
conditions applies to you. Tell your doctor if any of these situations apply to you:

• you are unable to walk for a long period due to surgery, injury or serious illness (see also section 3, If you are going to have surgery);
• you are severely overweight (BMI >30 kg/m );
• you have a blood clotting problem that requires long-term treatment with a medication used to prevent blood clots from forming;
• someone in your close family has ever had a blood clot in the leg, lung or another organ;
• you suffer from systemic lupus erythematosus (SLE);
• you have cancer.

For symptoms of a blood clot, see "Stop using Donaflor and consult your doctor immediately".

Comparison
Considering women in their fifties who are not taking hormone replacement therapy, on average, over a
period of 5 years, 4 to 7 out of 1000 are expected to develop a blood clot in a vein.
For women in their fifties who are taking estrogen-only hormone replacement therapy for more than 5 years, there will be 5 to 8 cases per 1000 users (i.e. 1 additional case).
Heart disease (heart attack)
For women taking estrogen-only therapy, there is no increased risk of developing
heart disease.
Stroke
The risk of developing a stroke is approximately 1.5 times higher in users of hormone replacement therapy
(HRT) compared to non-users. The number of additional stroke cases due to the use of HRT will increase with
age.

Comparison
Considering women in their fifties who are not taking hormone replacement therapy (HRT), in
average, 8 out of 1000 are expected to have a stroke in a 5-year period. For women in their fifties who
are taking hormone replacement therapy (HRT), there will be 11 cases per 1000 users, in a
5-year period (i.e. 3 additional cases).
Other conditions

• Hormone replacement therapy does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start using HRT after the age of 65. Talk to your doctor for advice.

Other medicines and Donaflor
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including over-the-counter medicines, herbal medicines or other natural products, and if you are
using other vaginal treatments applied locally.
Do not use vaginal cleansers or douches during treatment with Donaflor.
Concomitant treatment with anti-infectives (e.g. local or systemic antibiotics) may lead to a reduction
of the effect of Donaflor.

Donaflor with food, drinks and alcohol
Due to the topical use and action of Donaflor, no interactions with food, drinks and alcohol are expected.

Pregnancy, breastfeeding and fertility
If you become pregnant, stop taking Donaflor and contact your doctor. Donaflor is contraindicated in
pregnancy and breastfeeding (see section: Stop treatment with Donaflor and
consult your doctor immediately)
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Donaflor does not impair or negligibly impairs the ability to drive vehicles or operate machinery

3. How to use Donaflor

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist. The doctor will aim to prescribe the minimum dose to treat the symptoms and for the
shortest possible time. Talk to your doctor if you think this dose is too strong or not strong enough.
Vaginal discharge, vaginal infections, therapy for restoring vaginal bacterial flora:
the recommended dose is:

• 1-2 vaginal tablets per day for 6-12 days.

Stop treatment during menstruation and resume treatment immediately afterwards.
Inflammation of the vaginal mucosa (atrophic vaginitis), vaginal secretion in post menopause:
the recommended dose is:

• 1 vaginal tablet per day for the first week, followed by a maintenance dose of 1 vaginal tablet once or twice a week.

Use in children and adolescents
Donaflor should not be used in young women who have not reached sexual maturity.

Route of administration
For vaginal use.
The vaginal tablets should be inserted deep into the vagina in the evening before going to bed. It is
best to perform the insertion in a lying position with your legs slightly bent.
If the vagina is very dry, before being inserted, the vaginal tablets can be moistened with
a little water to favor their disintegration.
Tablets not completely dissolved:
Donaflor contains components that do not dissolve completely; residues of the tablet may
rarely be found in underwear. This does not affect the effectiveness of the medicine.

If you take more Donaflor than you should
In case of accidental use of an excessive dose of Donaflor, inform your doctor immediately or go to
the nearest hospital.

If you are going to have surgery
If you are going to have surgery, inform the surgeon that you are using Donaflor. It may
be necessary to stop using Donaflor approximately 4-6 weeks before the surgery to reduce the
risk of a blood clot (see paragraph 2, Blood clots in a vein). Ask your doctor
when you can start using Donaflor again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects, listed according to frequency, have been observed with Donaflor:

Uncommon side effects(may affect up to 1 in 100 people):

• Sensation of mild stinging or burning pain (immediately after administration)

Rare side effects(may affect up to 1 in 1000 people):

• Vulvovaginal itching
• Allergic reaction with redness and itching

In one case, allergy to the lyophilized lactobacillus contained in Donaflor was found.
In incorrect use of the medicine, after oral ingestion, isolated cases of adverse events have been reported
such as vomiting (1), diarrhea (1), increased menstruation (1) and heartburn (1).
The following diseases are reported more frequently in women who use medicines for hormone replacement
therapy circulating in the blood compared to women who do not use hormone replacement therapy.
These risks are less common with treatments administered vaginally such as Donaflor:

• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• stroke;
• probable memory loss if hormone replacement therapy is started over the age of 65. For further information on these side effects, see paragraph 2.

The following side effects have been reported with other HRT:

• gallbladder disease
• various skin disorders:
• discoloration of the skin, especially on the face or neck, known as “chloasma” or “pregnancy spots”;
• painful reddish skin nodules (erythema nodosum);
• skin rash with redness or target-shaped 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 Donaflor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C) in the original packaging to protect the medicine from light and
humidity.
Storing Donaflor at room temperature during the treatment period (1-2 weeks) does not
affect the effectiveness of the product.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Donaflor contains

• The active ingredients are Lactobacillus acidophilus ATCC 4356: 50.0 mg of lyophilized substance containing at least 100 million live bacteria and estriol 30 micrograms.
• The other components are lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, disodium phosphate.

Description of the appearance of Donaflor and contents of the pack
Vaginal tablets. Packs of 6 and 12 vaginal tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Exeltis Italia s.r.l. – Via Lombardia, 2/a – 20068 Peschiera Borromeo (MI) - Italy
Manufacturer:
Haupt Pharma Amareg GmbH – Donaustaufer Strasse 378; DE-93055 Regensburg, Germany