BIJUVA 1 mg/100 mg Miękkie Kapsułki

Treść ulotki

1. BIJUVA 1 mg/100 mg soft capsules
   1. What is BIJUVA and what it is used for
   2. What you need to know before taking BIJUVA
   3. How to take BIJUVA
   4. Possible side effects
   5. How to store BIJUVA
   6. Contents of the pack and other information

BIJUVA 1 mg/100 mg soft capsules

estradiol/progesterone

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

1. What is BIJUVA and what it is used for

BIJUVA is a Hormone Replacement Therapy (HRT).
It contains two types of female hormones, an estrogen and a progestin. BIJUVA is used in women in
postmenopause with at least 12 months (1 year) since the last natural menstruation.

Relief of symptoms that appear after menopause
During menopause, the amount of estrogen produced by a woman's body decreases. This
can cause symptoms such as flushing of the face, neck and chest ("hot flashes"). BIJUVA
is able to relieve these symptoms after menopause.
BIJUVA will be prescribed to you only if your symptoms are such as to prevent you from leading a normal life
daily.

2. What you need to know before taking BIJUVA

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in treating premature menopause (due to ovarian dysfunction or surgery) is limited. If you are in early menopause, the risk associated with HRT may be of different relevance. Consult your doctor.
Before starting (or restarting) treatment with HRT, your doctor will ask you about your personal and family medical history. Your doctor may decide to perform a medical examination, which may include a breast exam and/or a pelvic exam, if necessary.
Once you have started therapy with BIJUVA, you should have regular medical check-ups (at least once a year). During these check-ups, you can discuss the risks and benefits of continuing therapy with BIJUVA with your doctor.
Undergo regular mammographic screening, as recommended by your doctor.

Do not take BIJUVA:
if any of the following conditions apply to you. If you have any doubts about any of the points below, consult your doctorbefore taking BIJUVA.
Do not take BIJUVA

• If you are allergic to estradiol hemihydrate or progesterone or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had in the past breast cancer, or if you suspect you may have it.
• If you have a hormone-sensitive cancer, such as cancer of the lining of the uterus (endometrium), or if you suspect you may have it.
• If you experience unexplained vaginal bleeding.
• If you suffer from excessive thickening of the lining of the uterus(endometrial hyperplasia) that has not been treated.
• If you have or have been treated in the past for a blood clot (thrombus) in a vein(thrombosis), for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you suffer from blood clotting disorders(e.g. deficiency of protein C, protein S or antithrombin).
• If you suffer from or have recently suffered from a disease caused by the presence of blood clots in the arteries, such as heart attack, strokeor angina.
• If you have or have had liver diseaseand your liver function tests have not returned to normal.
• If you suffer from a rare blood disease called “porphyria”, which is passed down through families (inherited). If any of the above conditions occur for the first time during the use of BIJUVA, stop therapy immediately and consult your doctor.

Warnings and precautions
Tell your doctor if you suffer from or have ever suffered from any of the following conditions before starting treatment, as these problems may recur or worsen during treatment with BIJUVA. In this case, you should have more frequent medical check-ups:
uterine fibroids;
growth of uterine lining outside the uterus (endometriosis) or a history of abnormal growth of the uterine lining (endometrial hyperplasia);
increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)“);
increased risk of developing cancers whose growth is sensitive to estrogens (such as having a mother, sister or grandmother who has suffered from breast cancer);
high blood pressure;
liver disorders, 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 that affects the eardrum and hearing (otosclerosis);
very high levels of fats in the blood (triglycerides);
fluid retention due to heart or kidney problems;
hereditary and acquired angioedema.

Stop taking BIJUVA and see your doctor immediately:
If any of the following conditions occur during treatment with HRT:

• any of the situations listed in the “Do not take BIJUVA” 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, with difficulty breathing, which are indicative of angioedema;
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• a migraine-type headache that occurs for the first time;
• pregnancy;
• If you notice signs of a blood clot, such as:
• painful swelling and redness of the legs;
• sudden chest pain;
• difficulty breathing. For more information, see “Blood clots in a vein (thrombosis)”.
• very high levels of fats in the blood (triglycerides);
• fluid retention due to heart or kidney problems.

Note:BIJUVA 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 may need to use additional contraceptive measures to avoid pregnancy. Consult your doctor for advice.

HRT and cancer
Excessive thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial carcinoma).
The use of HRT (hormone replacement therapy) based on estrogen alone increases the risk of excessive thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial carcinoma).
The progestin present in BIJUVA protects against this additional risk.

Irregular bleeding
You may notice irregular bleeding or spotting during the first 3-6 months of using BIJUVA. However, if irregular bleeding:
or persists for more than the first 6 months of treatment
or occurs after more than 6 months of treatment with BIJUVA
or persists after stopping treatment with BIJUVA
see your doctor as soon as possible.

Breast cancer
Evidence shows that taking hormone replacement therapy (HRT) based on estrogen and progestin combined or based on estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk manifests 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 do not use HRT, breast cancer will be diagnosed on average in about 13-17 out of 1,000 over a 5-year period.
In women aged 50 who start using HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur in 1,000 users (i.e. 0-3 additional cases).
In women aged 50 who start using HRT based on estrogen and progestin combined for 5 years, there will be 13-21 cases in 1,000 women treated (i.e. 4 to 8 additional cases).
In women aged between 50 and 59 who do not use HRT, breast cancer will be diagnosed on average in 27 women out of 1,000 over a 10-year period.
In women aged 50 who start using HRT based on estrogen alone for 10 years, 34 cases will occur in 1,000 users (i.e. 7 additional cases).
In women aged 50 who start using HRT based on estrogen and progestin combined for 10 years, 48 cases will occur in 1,000 users (i.e. 21 additional cases).

• Check your breasts regularly. See your doctor if you notice any changes such as: o skin retraction; o changes in the appearance of the nipple; o any visible or palpable hardening.

In addition, we recommend that you participate in mammographic screening programs when you have the opportunity. For mammographic screening, it is important to inform the nurse/healthcare professional performing the X-ray that you are using hormone replacement therapy (HRT), as this therapy can increase breast density and therefore affect the image obtained with the mammogram. In case of greater breast density, mammography may not be able to detect all nodules.

Ovarian cancer
Ovarian cancer is much rarer than breast cancer. The use of estrogen-only or estrogen-progestin therapy 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 between 50 and 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 have been using HRT for 5 years, there will be about 3 cases in 2,000 women treated (i.e. about 1 additional case).

Effect of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of developing blood clots in the veinsis approximately 1.3 to 3 times higher in women who use HRT compared to non-users, especially during the first year of treatment.
Blood clots can be dangerous, and if one of them moves to the lungs, it can cause chest pain, shortness of breath, fainting or even death.
The likelihood of developing blood clots in the veins increases with age and with the presence of one of the conditions specified below. Therefore, tell your doctor if you fall into any of the following situations:

• are unable to walk for prolonged periods due to major surgery, injury or illness (see also section 3 if you are to undergo surgery);
• are severely overweight (BMI >30 kg/m²);
• suffer from blood clotting disorders requiring long-term treatment with anticoagulant drugs;
• one of your close relatives has suffered from blood clots in the legs, lungs or other organs;
• suffer from systemic lupus erythematosus (SLE);
• suffer from cancer.

Regarding the signs of the presence of thrombi, see “Stop taking BIJUVA and see your doctor immediately”.

Comparison
Considering women around the age of 50 who do not use HRT, it can be assumed that an average of 4 to 7 cases of blood clot formation in the veins will be observed in 1,000 over a 5-year period.
In women around the age of 50 who use estroprogestinic HRT for 5 years, the number of cases with thrombosis rises to 9-12 per 1,000 (i.e. 5 more cases).

Heart disease (heart attack)
There is no evidence of protection from heart attack following HRT use.
Women over the age of 60 who use combined estroprogestinic HRT have a slightly higher probability of developing heart disease compared to women who do not use HRT.

Stroke
The risk of stroke is approximately 1.5 times higher in women who use HRT compared to non-users. The higher number of stroke cases due to HRT use increases with age.

Comparison
Considering women around the age of 50 who do not use HRT, it can be assumed that an average of 8 cases of stroke will be observed in 1,000 over a 5-year period. In women around the age of 50 who use HRT, the number of cases will rise to 11 per 1,000 over 5 years (i.e. 3 more cases compared to non-HRT users).

Other conditions
HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after the age of 65. Ask your doctor for advice.

Children
The use of BIJUVA is not indicated in children.

Other medicines and BIJUVA
BIJUVA may interfere with the way other medicines work. Some medicines may
interfere with the effect of BIJUVA. This can cause irregular bleeding. This condition
concerns the following medicines:

• medicines for epilepsy(such as phenobarbital, phenytoin and carbamazepine);
• medicines for tuberculosis(such as rifampicin, rifabutin);
• medicines for HIV infections(such as nevirapine, efavirenz, ritonavir and nelfinavir);
• herbal preparations containing St John's wort(Hypericum perforatum);
• bromocriptine used for problems with the pituitary gland or for Parkinson's disease;
• ketoconazole, griseofulvin (used for fungal infections);
• cyclosporine (used to suppress the immune system);
• lamotrigine (used to control epileptic seizures);
• medicines against the hepatitis C virus (HCV) (such as combination regimens with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir) may cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. BIJUVA contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using BIJUVA with this combination regimen against HCV. The doctor will give you the necessary instructions. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, herbal or other natural products.

Laboratory tests
If you are going to have a blood test, tell your doctor or laboratory personnel that you are
taking BIJUVA, as this medicine may alter the results of some tests.

Pregnancy and breastfeeding
BIJUVA is intended for use exclusively by postmenopausal women. If you become pregnant,
stop taking BIJUVA and contact your doctor.

BIJUVA contains the colorant Allura Red
Bijuva contains 0.042 mg of Allura Red (E129).
It may cause allergic reactions.

3. How to take BIJUVA

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist. Your doctor will prescribe the lowest effective dose
possible to treat your symptoms for the shortest necessary time. Consult your doctor if you think the dose is
too high or not sufficient for you.

Take one capsule daily in the evening with a meal.
Take this medicine every day without interruption of treatment.

If you take more BIJUVA than you should
If you have taken too many BIJUVA capsules, consult your doctor or go to hospital. Bring
the medicine packaging with you.
The following effects may occur: feeling of drowsiness, dizziness, sleepiness or fatigue.

If you forget to take BIJUVA
If you forget to take a dose, take it as soon as possible. However, if more than 12 hours have passed,
skip the forgotten dose.
Do not take a double dose to make up for a forgotten dose.
The probability of breakthrough bleeding or spotting may be increased.

If you stop taking BIJUVA
Do not stop treatment with BIJUVA without first consulting your doctor. If you have any
doubts about using this medicine, consult your doctor or pharmacist.

If you are going to have surgery
If you are going to have surgery, tell the surgeon that you are using BIJUVA. It
may be necessary to stop using BIJUVA approximately 4-6 weeks before the operation, to reduce
the risk of blood clot formation (see section 2, Blood clots in a vein).
Ask your doctor when you can resume using BIJUVA.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following conditions are observed more frequently in women using Hormone Replacement Therapy (HRT) compared to
women who do not use it:

• breast cancer;
• abnormal growth or tumor of the inner lining of the uterus (hyperplasia or endometrial cancer);
• ovarian cancer;
• formation of blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is started after the age of 65. For more information on these side effects, see paragraph 2.

Contact your doctor if you notice the occurrence of any of the following side effects during the use of
BIJUVA:
Very common (affecting more than 1 in 10 people)

• painful breasts; Common (affecting less than 1 in 10 people)
• headache, dizziness
• mood changes;
• fatigue;
• back pain;
• abdominal pain, indigestion;
• pelvic pain;
• weight gain;
• acne, dry skin;
• breast pain;
• feeling unwell (vomiting);
• vaginal discharge (white or yellowish discharge from the vagina);
• vaginal bleeding or strong uterine contractions;
• hair loss;
• pain in the extremities (e.g., back, arms, legs, wrists, ankles). Uncommon (affecting less than 1 in 100 people)
• low iron levels in the blood;
• high blood pressure;
• excess fluid in the legs;
• increased cholesterol levels;
• increased appetite;
• problems with bowel movements;
• muscle pain;
• breast cancer;
• reduced sleep;
• tumors of the uterus or fallopian tube;
• memory loss, severe headache;
• tingling sensation;
• loss of smell;
• difficulty falling asleep or abnormal dreams;
• mood swings or feeling irritable;
• vomiting;
• dry mouth;
• constipation;
• diarrhea;
• weight loss, vertigo;
• chills;
• acute pancreatitis;
• anxiety, feeling depressed;
• increased interest in sex than usual;
• hot flashes;
• irritation or burning sensation in the vagina;
• vaginal infections such as thrush;
• blood clots;
• dry and itchy skin or skin discoloration;
• rash or appearance of red lines on the skin;
• vertigo;
• hirsutism;
• impaired vision;
• discomfort in the abdomen, abdominal tenderness;
• poor digestion (dyspepsia);
• excessive hunger (hyperphagia);
• oral discomfort;
• altered taste (dysgeusia);
• flatulence;
• hypersensitivity;
• gastroenteritis;
• boils,
• acute otitis media,
• abnormal liver function test;
• pain in the extremities;
• ovarian cysts
• attention disorder;
• paresthesia;
• alteration of smell (parosmia);
• agitation;
• breast diseases;
• fibrocystic mastopathy;
• nipple pain;
• benign breast tumor;
• endometrial hyperplasia;
• abnormal biopsy;
• postmenopausal bleeding;
• vulvovaginal itching and telangiectasia. Rare (affecting less than 1 in 1,000 people)
• muscle weakness;
• benign growths in the smooth muscle of the uterus;
• cysts near the fallopian tube. Very rare (affecting less than 1 in 10,000 people)
• itching, dark urine.

The following side effects have been reported with other HRT:

• problems with the gallbladder;
• various skin changes:
• skin discoloration, especially on the face or neck, a phenomenon known as “melasma” (cloasma);
• painful reddish nodules (erythema nodosum);
• skin rash with redness or target-shaped ulcers (erythema multiforme).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 contribute to providing more information on the safety of
this medicine.

5. How to store BIJUVA

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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 BIJUVA contains

• The active ingredients are estradiol (as estradiol hemihydrate) and progesterone.
• The other components are: medium-chain mono/diglycerides, lauroyl Macrogolglycerides 32, gelatin 200 Bloom, hydrolysed gelatin, glycerol (E422), Allura Red (E129), titanium dioxide (E171), propylene glycol (E1520), polyvinyl acetate phthalate, polyethylene glycol (E1521) and ammonium hydroxide (E527).

Description of the appearance of BIJUVA and contents of the pack
BIJUVA capsules are oval, opaque, light pink capsules on one side and dark pink on the other side
with “1C1” imprinted in white ink.
Blister pack containing 28 and 84 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer
Millmount Healthcare Ltd
Block-7
City North Business Campus
Stamullen, Co. Meath
K32 YD60
Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Poland, Spain: BIJUVA