Bijuva 1 mg/100 mg capsulas blandas

Label: Information for the Patient

Bijuva 1 mg/100 mg Soft CapsulesEstradiol/progesterone

Read the entire label carefully before starting to take this medication, because it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your pharmacist.

Keep this label, as you may need to refer to it again.

If you need advice or more information, consult your pharmacist.

If you experience adverse effects, consult your pharmacist, even if they are not listed in this label. See section 4. You should consult a doctor if it worsens or does not improve.

Bijuva is indicated as hormone replacement therapy (HRT).

It contains two types of female hormones, an estrogen and a progestogen. Bijuva is used in postmenopausal women who had their last natural menstrual period more than 1 year ago.

Relief of symptoms that appear after menopause

During menopause, the amount of estrogen produced by the woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest (“hot flashes”). Bijuva relieves these symptoms after menopause.

You will be prescribed Bijuva only if your symptoms seriously interfere with your daily life.

Medical History and Regular Reviews

The use of THS involves risks that must be taken into account when deciding whether to start or continue treatment.

The experience in treating women with premature menopause (due to ovarian insufficiency or surgical intervention) is limited. If you have premature menopause, the risks of using THS may be different. Consult your doctor.

Before starting (or resuming) THS, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast examination and/or an internal examination, if necessary.

Once started on Bijuva treatment, you must visit your doctor for regular reviews (at least once a year). In these check-ups, discuss with your doctor the benefits and risks of continuing with Bijuva.

Regular breast examinations will be required, as recommended by your doctor.

Do Not Take Bijuva

if you are affected by any of the following cases or are unsure about any of the following points, consult your doctor before taking Bijuva,consult your doctorbefore taking Bijuva,

Do Not Take Bijuva

• If you are allergic to estradiol hemihydrate or progesterone or to any of the other components of this medication (including those listed in section 6).
• If you have or have hadbreast canceror if you suspect that you may have it.
• If you have acancer sensitive to estrogens, such as endometrial cancer, or if you suspect that you may have it.
• If you haveabnormal vaginal bleeding.
• If you haveexcessive thickening of the uterine wall(endometrial hyperplasia), which is not being treated.
• If you have or have had the formation of ablood clot in a vein(thrombosis), e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have ablood clotting disorder(such as protein C deficiency, protein S deficiency, or antithrombin deficiency).
• If you have or have had recently a disease caused by blood clots in the arteries, such asheart attack, stroke, or angina pectoris.
• If you have or have had aliver diseaseand your liver function tests have not returned to normal.
• If you have a rare blood disorder called“porphyria”that is inherited.

If any of these diseases occur for the first time while taking Bijuva, discontinue treatment and consult your doctor immediately.

Be Cautious with Bijuva

Inform your doctor if you have ever had any of the following problems, before starting treatment, as they may recur or worsen during Bijuva treatment. If so, you must consult your doctor more frequently for check-ups:

• fibroids inside the uterus
• growth of the uterine wall outside the uterus (endometriosis) or history of excessive growth of the uterine wall (endometrial hyperplasia)
• increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
• increased risk of developing cancer sensitive to estrogens (e.g. having a mother, sister, or grandmother who has had breast cancer)
• high blood pressure
• liver disease, such as a benign liver tumor
• diabetes
• gallstones
• migraines or severe headaches
• a disease affecting many organs in the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and ear (otosclerosis)
• very high levels of fat 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 you notice any of the following disorders when taking THS:

• any of the disorders mentioned in the section “Do Not Take Bijuva”
• yellowing of the skin or white of the eyes (jaundice). This may be a sign of liver disease
• swelling of the face, tongue, or throat and difficulty swallowing or urticaria accompanied by difficulty breathing, which suggests angioedema
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine-type headaches that appear for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
• • swelling and pain in the legs;
  • sudden chest pain;
  • difficulty breathing;

for more information, see: “Blood clots in a vein (thrombosis)”

• very high levels of fat in the blood (triglycerides)
• fluid retention due to heart or kidney problems

Note:Bijuva is not a contraceptive. If you have passed less than 12 months since your last menstrual period or if you are under 50 years old, you may still need to use an additional contraceptive method to prevent pregnancy. Ask your doctor.

THS and Cancer

Endometrial Hyperplasia and Endometrial Cancer

The use of THS with estrogens alone will increase the risk of developing endometrial hyperplasia and endometrial cancer.

The progesterone in Bijuva protects against this additional risk.

Irregular Bleeding

You may experience irregular bleeding or spotting during the first 3-6 months of taking Bijuva. However, if the irregular bleeding:

• continues for more than 6 months
• starts after taking Bijuva for more than 6 months
• continues after stopping Bijuva treatment

consult your doctor as soon as possible.

Breast Cancer

The available data show that the use of hormone replacement therapy (HRT) with estrogen-progestogen combinations or with estrogens alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. The additional risk becomes apparent within 3 years of use. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT has been used for more than 5 years.

Comparison

In women aged 50-54 who are not using HRT, a mean of 13-17 out of every 1,000 will be diagnosed with breast cancer in a 5-year period.

In women aged 50 who start HRT with estrogens alone for 5 years, there will be 16-17 cases per 1,000 users (i.e. 0-3 additional cases).

In women aged 50 who start HRT with estrogen-progestogen for 5 years, there will be 13-21 cases per 1,000 users (i.e. 4-8 additional cases).

In women aged 50-59 who are not using HRT, a mean of 27 cases of breast cancer will be diagnosed per 1,000 women in a 10-year period.

In women aged 50 who start HRT with estrogens alone for 10 years, there will be 34 cases per 1,000 users (i.e. 7 additional cases).

In women aged 50 who start HRT with estrogen-progestogen for 10 years, there will be 48 cases per 1,000 users (i.e. 21 additional cases).

• You must undergo regular breast examinations. Consult your doctor if you notice any changes such as:

• moles on the skin
• changes in the nipple
• any lump that you can see or feel

Additionally, it is recommended that you join the screening programs for mammograms when offered. For mammography screening, it is essential to inform the nurse/healthcare professional who will perform the radiography that you are a HRT user, as these medications can increase the density of the breasts, which can affect the mammography result. When the breast density increases, the mammography may not detect all lumps.

Endometrial Cancer

Endometrial cancer occurs less frequently than breast cancer. The use of HRT with estrogens alone or with the combination of estrogens-progestogens has been associated with a slightly higher risk of endometrial cancer.

The risk of endometrial cancer varies with age. For example, in women aged 50-54 who are not using HRT, there are approximately 2 cases of endometrial cancer per 2,000 women in a 5-year period. In women taking HRT for 5 years, there are approximately 3 cases per 2,000 patients (i.e. approximately 1 additional case).

Effects of HRT on the Heart and Circulation. Blood Clots in a Vein (Thrombosis)

The risk ofblood clots in veinsis approximately 1.3 to 3 times higher in HRT users compared to non-users, especially during the first year of use. Blood clots can be serious, and if one dislodges and travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.

You are more likely to have a blood clot in a vein with age and if any of the following cases affect you. Inform your doctor if any of these situations affect you:

• you cannot walk for a prolonged period due to major surgery, injury, or illness (see also section 3, If you need to undergo surgery)
• you have severe obesity (BMI > 30 kg/m²)
• you have a blood clotting disorder that requires long-term treatment with a medication used to prevent blood clots
• any of your close relatives have had a blood clot in the leg, lung, or other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer

For symptoms of a blood clot, see “Stop Taking Bijuva and See Your Doctor Immediately”.

Comparison

In women aged 50 who are not using HRT, a mean of 4-7 out of every 1,000 will have a blood clot in a vein in a 5-year period.

In women aged 50 who have been taking HRT with estrogen-progestogen, there will be 9-12 cases per 1,000 users (i.e. 5 additional cases) in a 5-year period.

Coronary Heart Disease (Heart Attack)

There is no evidence that HRT prevents heart attacks. Women over 60 years old using HRT with estrogen-progestogen are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of having a stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT use will increase with age.

Comparison

In women aged 50 who are not using HRT, a mean of 8 out of every 1,000 will have a stroke in a 5-year period. For women aged 50 who are taking HRT, there will be 11 cases per 1,000 users, in a 5-year period (i.e. 3 additional cases).

Other Diseases

HRT does not prevent memory loss. There is some evidence of greater memory loss in women who start using HRT after the age of 65. Consult your doctor.

Children

Bijuva should not be used in children.

Use of Bijuva with Other Medications

Bijuva may affect how other medications work. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may interfere with the effect of Bijuva, leading to irregular bleeding. These medications are as follows:

• medications forepilepsy(such as phenobarbital, phenytoin, and carbamazepine);
• medications fortuberculosis(such as rifampicin, rifabutin);
• medications forHIV infection(such as nevirapine, efavirenz, ritonavir, and nelfinavir);
• preparations based on plants containingSt. John's Wort(Hypericum perforatum);
• bromocriptine used for problems with the pituitary gland or Parkinson's disease;
• ketoconazole, griseofulvin (for the treatment of fungal infections);
• ciclosporin (used to suppress the immune system);

HRT may affect how other medications work:

• a medication for epilepsy (lamotrigine), as it may increase the frequency of seizures).
• medications for hepatitis C virus (HCV) (e.g. combination regimen for HCV or ombitasvir/paritaprevir/ritonavir with or without dasabuvir or glecaprevir/pibrentasvir) may cause elevated liver function test results (increased ALT levels) in women using HRT with ethinylestradiol. Bijuva contains estradiol instead of ethinylestradiol. It is unknown whether an increase in ALT levels can occur when Bijuva is used with this combination regimen for HCV. Your doctor will inform you about this.

Inform your doctor or pharmacist if you are using or have used recently any other medications, including those purchased without a prescription, herbal remedies, and other natural products.

Your doctor will advise you.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking Bijuva, as this medication may affect the results of some tests.

Pregnancy and Breastfeeding

Bijuva is indicated only for postmenopausal women. If you become pregnant while taking Bijuva, you must discontinue treatment and contact your doctor.

Excipients

Bijuva contains the red dye Allura. Bijuva contains 0.042 mg of red Allura (E129) per capsule. It may cause allergic reactions. It may cause asthma, especially in patients allergic to aspirin

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will prescribe the lowest dose to treat your symptom for the shortest time possible. Talk to your doctor if you think this dose is too strong or not strong enough,

Take one capsule a day with food.

Take this medication every day without any break in treatment.

If you take more Bijuva than you should

If you have taken more Bijuva than you should, you may feel drowsy, dizzy, drowsy, or tired.

If you have taken more Bijuva than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel: 91 562 04 20) indicating the medication and the amount used.

If you forget to take Bijuva

If you forget a dose, take it as soon as you remember. However, if more than 12 hours have passed, omit the missed dose.

Do not take a double dose to compensate for a missed dose.

The probability of unexpected bleeding or spotting may increase.

Ifyou interrupt treatment with Bijuva

Do not stop taking Bijuva without first talking to your doctor. If you have doubts about the use of this product, consult your doctor or pharmacist.

If you need surgery

If you are going to undergo surgery, inform the surgeon that you are taking Bijuva. You may need to stop taking Bijuva for 4 to 6 weeks before surgery to reduce the risk of blood clots (see also section 2 “Blood clots in a vein”). Ask your doctor when you can resume taking Bijuva.

Like all medicines, Bijuva can cause side effects, although not everyone will experience them.

The following conditions occur more frequently in women using THS compared to women not taking THS:

• breast cancer

• abnormal growth or cancer of the lining of the uterus (endometrial hyperplasia or cancer);

• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• coronary heart disease;
• stroke;
• probable memory loss if THS has been initiated after the age of 65;

For more information on these side effects, see section 2.

Inform your doctor if you notice any of the following side effects during the use of Bijuva:

Very common (affects more than 1 in 10 people)

• breast tenderness

Common (affects less than 1 in 10 people)

• headache, dizziness
• changes in mood
• fatigue
• back pain
• abdominal pain, indigestion
• pelvic pain
• weight gain
• acne, dry skin
• breast pain
• unpleasant feeling (nausea)
• vaginal discharge (white or yellowish vaginal discharge)
• vaginal bleeding or severe uterine contractions
• hair loss
• pain in the limbs (e.g. back pain, arms, legs, wrists, ankles)

Uncommon (affects 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 urination
• muscle pain
• breast cancer
• sleep disorders
• uterine or Fallopian tube tumors
• memory loss, severe headaches
• tingling sensation
• loss of smell
• difficulty sleeping or abnormal dreams
• mood changes or irritability
• vomiting
• dry mouth
• constipation
• diarrhea
• weight loss, dizziness
• chills
• acute pancreatitis
• anxiety, feeling depressed
• increased libido
• hot flashes
• vaginal irritation or burning sensation

• vaginal infections such as candidiasis

• blood clots

• dry skin, itching skin or skin discoloration
• skin rash or appearance of red lines on the skin

• dizziness
• hirsutism
• visual disturbances
• abdominal discomfort, abdominal sensitivity
• indigestion
• increased appetite
• oral discomfort
• disturbances in taste
• flatulence
• hypersensitivity
• gastroenteritis
• carbuncle
• acute otitis media
• abnormal liver function tests
• pain in the limbs
• uterine or Fallopian tube polyps
• decreased attention capacity,
• paresthesia
• parosmia,
• agitation
• breast changes
• fibrocystic disease
• pain in the nipple
• benign breast neoplasia
• endometrial hyperplasia
• abnormal biopsy
• postmenopausal bleeding
• vulvovaginal pruritus and telangiectasia

Rare (affects less than 1 in 1,000 people)

• muscle weakness
• benign growths in the smooth muscle of the uterus (fibroids)
• polyps near the Fallopian tube

Very rare (affects less than 1 in 10,000 people)

• itching, dark urine

The following side effects have been reported with other THS:

• gallbladder disease
• various skin disorders:

- skin discoloration, especially on the face or neck, known as "pregnancy mask" (melasma);

- painful red nodules on the skin (erythema nodosum);

- skin rash with red spots or blisters (erythema multiforme).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children.

This medication does not require special temperature storage conditions. Keep the blister pack in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

The active principles are estradiol (such as estradiol hemihydrate) and progesterone.

The other components are: medium-chain mono/diglycerides, lauroyl macrogolglycerides 32, gelatin 200 Bloom, hydrolyzed gelatin, glycerin (E422), Allura Red (E129), titanium dioxide (E171), propylene glycol (E1520), polyvinyl acetate phthalate, polyethylene glycol (E1521), and ammonium hydroxide (E527).

Appearance of the product and contents of the package

Bijuva capsules are oval, opaque, light pink on one side and dark pink on the other side with the imprint “1C1” in white ink.

They are supplied in blisters containing 28 or 84 capsules.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Pfizer Italia S.R.L.,

Marino Del Tronto

63100 Ascoli Piceno (AP)

Italy

Millmount Healthcare Ltd

Block-7

City North Business Campus

Stamullen, Co.Meath

K32 YD60

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

This medication is authorized in the EEA member states with the following name:

Netherlands: Bijuva 1 mg/100mg zachte capsules

Belgium: Bijuva 1 mg/100mg zachte capsules

Luxembourg, Italy, France, Poland: Bijuva

Germany: Bijuva 1mg/100mg Weichkapseln

Spain: Bijuva 1 mg/100 mg cápsulas blandas

Last review date of this leaflet: January 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)