PAUDIEN 1 mg/2 mg Coated Tablet

Зміст інструкції

1. Paudien 1 mg/2 mg tablets
   1. What is Paudien and what is it used for
   2. What you need to know before taking Paudien
   3. How to take Paudien
   4. Possible side effects
   5. How to store Paudien
   6. Contents of the pack and other information

Paudien 1 mg/2 mg tablets

estradiol valerate / dienogest
Generic medicine

Read this leaflet carefully before you start taking 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 Paudien is and what it is used for
• 2. What you need to know before you take Paudien
• 3. How to take Paudien
• 4. Possible side effects
• 5. How to store Paudien
• 6. Contents of the pack and other information

1. What is Paudien and what is it used for

Paudien is indicated as Hormone Replacement Therapy (HRT).
It contains two types of female hormones: an estrogen and a progestin.
Paudien is used in postmenopausal women with at least 1 year since their last menstruation.
Paudien is used for:

Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by a woman's body decreases.
This can cause symptoms such as heat in the face, neck and chest ("hot flashes"). Paudien relieves these
symptoms after menopause. Paudien will be prescribed to you if the symptoms seriously interfere with your
daily life.

2. What you need to know before taking Paudien

Medical history and regular check-ups
The use of HRT involves risks that must be taken into consideration when deciding whether to start
taking it or continuing with it.
Experience in the treatment of women with premature menopause (due to ovarian insufficiency or
surgery) is limited.
If you have premature menopause, the risks of using HRT may be different. Talk to your
doctor.
Before starting (or restarting) HRT, your doctor will ask about your medical history and that of your family.
The doctor may decide to have you undergo a physical examination. This may include a breast exam and/or
a pelvic exam, if necessary.
Once you have started Paudien, you should see your doctor for regular check-ups (at least once
a year). During these check-ups, discuss with your doctor the benefits and risks of continuing with Paudien.
Undergo regular breast screenings, as recommended by your doctor.

Do not take Paudien
If any of the following conditions apply to you. If you have any doubts about any of the points below,
consult your doctor before taking Paudien.
Do not take Paudien if

• you have or have ever had breast cancer, or if you suspect you have it;
• you have a cancer that is sensitive to estrogen, such as cancer of the uterine lining (endometrium), or if you suspect you have it;
• you have unexplained vaginal bleeding;
• you have an excessive thickening of the uterine lining(endometrial hyperplasia) that has not been treated;
• you have or have had a blood clot in a vein(thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• you have a blood clotting disorder(such as protein C, protein S or antithrombin deficiency);
• you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, strokeor angina;
• you have or have had a liver diseaseand if liver function tests have not returned to normal values;
• you suffer from a rare blood disordercalled "porphyria" that is inherited;
• you are allergicto valerate estradiol, dienogest or any of the other ingredients of Paudien (listed in section 6).

If any of the conditions listed above appear for the first time while taking Paudien, stop taking it
immediately and consult your doctor immediately.

Warnings and precautions
Tell your doctor if you have ever had any of the following problems, before starting treatment, as
these may return or worsen during treatment with Paudien. In such cases, you should see your
doctor more often for check-ups:

• fibroids in the uterus;
• growth of the outer lining of the uterus (endometriosis) or a history of abnormal growth of the uterine lining (endometrial hyperplasia);
• increased risk of developing blood clots (see section 2 "Blood clots in veins (thrombosis)");
• increased risk of developing a cancer sensitive to estrogen (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 headaches;
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE);
• epilepsy;
• asthma;
• a disease affecting the eardrum and hearing (otosclerosis);
• very high levels of fats in the blood (triglycerides);
• fluid retention caused by kidney or heart problems;
• hereditary and acquired angioedema.

Stop taking Paudien and consult your doctor immediately
If you notice any of the following diseases or conditions while taking HRT:

• any of the conditions in section 2 "Do not take Paudien";
• yellowing of the skin or the white 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, along with difficulty breathing, which are indicative of angioedema;
• a sharp increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• headaches similar to migraines that occur for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful and red swelling of the legs,
• sudden chest pain,
• difficulty breathing. For more information, see section 2 "Blood clots in veins (thrombosis)". Note: Paudien 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 may still need to use additional contraception to prevent pregnancy. Talk to your doctor.

HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the
uterine lining (endometrial cancer)
Taking HRT based only on estrogen increases the risk of excessive thickening of the
uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial
cancer).
The progestin in Paudien protects against this additional risk.

Irregular bleeding
You may experience irregular bleeding or spotting (breakthrough bleeding) during the first 3-6 months of taking
Paudien.
However, if irregular bleeding:

• continues for more than the first 6 months,
• starts after taking Paudien for more than 6 months,
• continues after stopping Paudien, consult your doctor as soon as possible.

Breast cancer
Evidence shows that taking hormone replacement therapy (HRT) based on estrogen and
combined progestins or estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk appears within 3 years
of use. After stopping HRT, the additional risk will decrease over time, but this risk
may persist for 10 years or more if HRT is used for more than 5 years.
Comparison
In women aged between 50 and 54 who are not taking HRT, breast cancer will be
diagnosed in an average of 13-17 women out of 1000 over a 5-year period.
In women aged 50 who start taking HRT based on estrogen alone for a period of 5 years,
16-17 cases will occur out of 1000 users (i.e. 0-3 additional cases).
In women aged 50 who start taking HRT based on combined estrogen and progestin for 5
years, there will be 21 cases out of 1000 users (i.e. 4 to 8 additional cases).
In women aged between 50 and 59 who are not taking HRT, breast cancer will be
diagnosed in an average of 27 women out of 1000 over a 10-year period.
In women aged 50 who start taking HRT based on estrogen alone for 10 years, there will be 34 cases out of 1000 users (i.e. 7 additional cases).
In women aged 50 who start taking HRT based on combined estrogen and progestin for
10 years, there will be 48 cases out of 1000 users (i.e. 21 additional cases).

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

• skin dimpling;
• changes in the nipple;
• lumps that can be seen or felt.

In addition, we recommend that you participate in breast screening programs when offered. For breast screening, it is important to inform the nurse / doctor professional
performing the X-ray that you are using HRT, as this medicine may increase the density of your breast which
may affect the mammogram result. When breast density is increased, mammography may
not detect all lumps.

Ovarian cancer
Ovarian cancer is rare, much rarer than breast cancer. The use of estrogen-only or estro-progestin-based therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54
years who are not taking HRT, about 2 women out of 2000 will be diagnosed with ovarian cancer
within 5 years. For women who are taking HRT for 5 years, there will be about 3 cases out of 2000
women treated (i.e., about 1 additional case).

Effect of HRT on heart and circulation
Blood clots in veins (thrombosis)
The risk of blood clots in the veinsis 1.3 to 3 times higher in users of HRT compared to
non-users, especially during the first year of use.
Blood clots can be serious and, if one migrates to the lungs, can cause chest pain,
difficulty breathing, fainting or even death.
You are more likely to have a blood clot in the veins as 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 time due to surgery, injury or illness (see also section 3 "If you need surgery");
• you are severely overweight (BMI >30 kg/m);
• you have blood clotting problems that require long-term treatment with a drug used to prevent blood clots;
• one of your close relatives has ever had a blood clot in the leg, lung or another organ;
• you suffer from systemic lupus erythematosus (SLE);
• you have cancer. For signs of a blood clot, see “Stop taking Paudien and consult your doctor immediately”.

Comparison
Considering women around 50 years of age who are not taking HRT, on average, over a period of
5 years, 4 to 7 out of 1000 may develop a blood clot in a vein.
For women around 50 years of age who have been taking estroprogestinic HRT for more than 5 years, there will be 9 to
12 cases out of 1000 users (i.e. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attack.
Women over the age of 60 who use estroprogestinic HRT are slightly more likely to
develop heart disease than those who do not use HRT.

Stroke
The risk of stroke is approximately 1.5 times higher in users of HRT compared to non-users. The
number of additional cases of stroke due to HRT use increases with age.
Comparison
Considering women around 50 years of age who are not taking HRT, on average, 8 out of 1000 are expected
to have a stroke over a 5-year period. For women around 50 years of age who are taking HRT, there will be 11
cases in 1000 users in 5 years (i.e. 3 additional cases).

Other conditions
HRT 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. Ask your doctor for advice.

Other medicines and Paudien
Tell your doctor or pharmacist if you are taking or have recently taken or may take
any other medicines.
Some medicines can interfere with the effect of Paudien. This may lead to irregular bleeding. This applies to the following medicines:

• Medicines for epilepsy(such as barbiturates, phenytoin, primidone, carbamazepine and possibly also oxcarbazepine, topiramate and felbamate).
• Medicines for tuberculosis(such as rifampicin, rifabutin).
• Medicines for HIV and Hepatitis C infection(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir).
• Herbal remedies containing St. John's wort(Hypericum perforatum).
• Medicines for the treatment of fungal infections(such as griseofulvin, itraconazole, ketoconazole, voriconazole and fluconazole).
• Medicines for the treatment of bacterial infections(such as clarithromycin and erythromycin).
• Medicines for the treatment of certain heart conditionsor high blood pressure (such as verapamil and diltiazem).
• Grapefruit juice.
• Medicines for hepatitis C virus (HCV) (such as the combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir and a regimen with glecaprevir/pibrentasvir) can cause an increase in liver function test results (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Paudien contains valerate estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Paudien with this HCV combination regimen. Your doctor will advise you. Laboratory testsIf you need to have blood tests, tell your doctor or laboratory personnel that you are taking Paudien, as this medicine may affect the results of some tests. Pregnancy and breastfeedingPaudien is only used for postmenopausal women. If you become pregnant, stop taking Paudien and contact your doctor. Driving and using machinesNo effects on the ability to drive and operate machinery have been observed. Paudien contains lactoseIf you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Paudien

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you have any doubts.
The doctor will prescribe the lowest dose to treat your symptoms for the shortest possible time. Consult
your doctor if you think this dose is too strong or not strong enough.

• Take 1 tablet every day, preferably at the same time.
• Swallow the tablet whole with a glass of water.
• You can take Paudien with or without food.
• Start the calendar pack of tablets the day after you have finished the current calendar pack.
• Do not make a break between packs.

If you are taking other TOS preparations
Continue until you have finished your current pack and have taken all the tablets for that month.
Take the first Paudien tablet the next day. Do not make a break between the old
tablets and the Paudien tablets.

If you are using a TOS treatment with a one-week break
Start the day after the treatment-free period.

If this is your first TOS treatment
You can start the Paudien tablets at any time.

If you take more Paudien than you should
If you have taken too many Paudien tablets by mistake, you may feel unwell, be sick, or have
bleeding similar to a period. No treatment is necessary, but if you are worried
consult your doctor or pharmacist.

If you forget to take Paudien
If you have forgotten to take the tablet at the usual time, and it is less than 24 hours late, take one
tablet as soon as possible. Take the next tablet at the usual time.
If it is more than 24 hours late, leave out the forgotten tablet in the pack. Continue to
take the rest of the tablets at the usual time each day. Do not take a double dose to
make up for the forgotten tablet. If you have forgotten to take the tablet for several days
you may experience bleeding.

If you stop taking Paudien
You may start to feel your usual menopausal symptoms again, which can include hot flushes,
sleep problems, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist
if you want to stop taking Paudien.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Paudien. You may
need to stop taking Paudien 4 to 6 weeks before
the operation to reduce the risk of a blood clot (see section 2 "Blood clots in
veins (thrombosis)"). Ask your doctor when you can start taking Paudien 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 everyone will experience them.

The following diseases are reported more frequently in women using HRT compared to women
who do not use HRT:

• breast cancer;
• abnormal growth or cancer of the uterine lining (hyperplasia or endometrial cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT was started over the age of 65. For more information on these undesirable effects, see paragraph 2. The following undesirable effects may occur during treatment with Paudien.

Bleeding similar to menstruation is unexpected during the first few months of treatment with
Paudien. It is usually temporary and normally disappears with continued treatment. If this does
not happen, contact your doctor.

Common(may affect up to 1 in 10 people)

• headache
• malaise
• breast pain, hot flushes, vaginal bleeding

Uncommon(may affect up to 1 in 100 people)

• weight gain
• fatigue, loss of appetite leading to weight loss, aggressive reaction, difficulty sleeping, drowsiness, nervousness, inability to achieve orgasm, decreased sexual activity
• migraine, feeling of dizziness, tingling, hyperactivity
• venous blood clots (pain in the legs) (see also paragraph 2 "Blood clots in veins [thrombosis]"), inflammation of the veins, high blood pressure, nosebleeds
• abdominal pain, diarrhea, general feeling of being unwell, constipation, flatulence, dry mouth
• liver pain
• dry skin with scaly red patches called psoriasis, acne, itching, increased sweating, dry skin
• muscle pain, leg cramps
• problems with the uterine lining, vaginal candidiasis, painful menstruation, genital itching
• tiredness, generalized fluid accumulation in the tissue, facial swelling.

The following undesirable effects have been reported with other HRT:

• gallbladder disease;
• various skin disorders:
• skin discoloration, especially of the face or neck, known as "pregnancy mask" (chloasma),
• red and painful skin nodules (erythema nodosum),
• skin rash with red or blistering areas (erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the system
http://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 Paudien

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the carton and blister after Exp.. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paudien contains

• The active ingredients are 1 mg of estradiol valerate and 2 mg of dienogest.
• The other ingredients are iron oxide, lactose monohydrate, magnesium stearate, corn starch, povidone, anhydrous colloidal silica. Description of the appearance of Paudien and contents of the pack:Paudien tablets are red, round, with a diameter of 6mm. They are dispensed in calendar packs containing 28,3 x 28 or 6 x 28 tablets. Not all pack sizes may be marketed. Marketing Authorisation HolderFarmitalia SRL - Viale A. De Gasperi 165/B - 95127 CATANIA (CT) ManufacturerDr. Kade Pharmazeutische Fabrik GmbH Rigistraβe 2 12277 Berlin (Germany)

This medicinal product is authorised in the member states of the European Economic Area with the following names:
Germany Ladivella 1 mg/2 mg Tablets
Netherlands LaFleur 1 mg/2 mg tablets
Belgium Laclimella 1 mg/2 mg tablets
Luxembourg Laclimella 1 mg/2 mg tablets
Italy Paudien 1 mg/2 mg tablets