Bijuva 1 mg/100 mg Soft Gel Capsules

BIJUVA is a hormone replacement therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. BIJUVA is used in postmenopausal women with at least 12 months (1 year) since their last natural period.

Relief of symptoms occurring after menopause

During the menopause, the amount of oestrogen produced by a woman’s body decreases. This can cause symptoms such as feeling hot in the face, neck and chest (“hot flushes”). BIJUVA alleviates these symptoms after menopause.

You will only be prescribed BIJUVA if your symptoms seriously hinder your daily life.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts, and/or an internal examination, if necessary.

Once you have started on BIJUVA, you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing to take BIJUVA.

Go for regular breast screening, as recommended by your doctor.

Do not take BIJUVA:

If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking BIJUVA.

• if you are hypersensitive (allergic) to estradiol hemihydrate, progesterone or any of the other ingredients of BIJUVA (see What BIJUVA contains).
• if you have or have ever had breast cancer, or if you are suspected of having it
• if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• if you have any unexplained vaginal bleeding
• if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• if you have or have ever had a liver disease and your liver function tests have not returned to normal
• if you have a rare blood disorder called porphyria which is passed down in families (inherited).

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

Warnings and precautions

Tell your doctor if you have or ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with BIJUVA. If so, you should see your doctor more often for check-ups:

• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots, see Blood clots in a vein (thrombosis)
• increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a high level of fat in your blood (triglycerides)
• fluid retention due to heart or kidney problems.

Stop taking BIJUVA and see a doctor immediately

If you notice any of the following when taking BIJUVA:

• any of the conditions mentioned in the ‘Do not take BIJUVA’ section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty in breathing.

For more information, see Blood clots in a vein (thrombosis) below.

Note: BIJUVA is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

Always take BIJUVA exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of BIJUVA is too strong or too weak, tell your doctor or pharmacist.

Take one capsule every day in the evening with food. Swallow the capsule with water.

The capsule should be taken every day without any break in the treatment.

If you take more BIJUVA than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining BIJUVA with you so the doctor will know what you have taken.

The following effects may happen feeling drowsy, dizzy, sleepy or tired.

If you forget to take BIJUVA

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

If you stop taking BIJUVA

Do not stop taking BIJUVA without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you need to have surgery

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

BIJUVA can have side effects. Not all side effects reported for BIJUVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIJUVA, please consult your health care provider for advice.

If any of the following happens, stop taking BIJUVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BIJUVA. You may need urgent medical attention or hospitalisation.

The following diseases are reported more often in women using HRT compared to women not using HRT:

• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65.

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

Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• tender breasts
• headache, dizziness
• back pain
• abdominal pain, feeling bloated
• breast pain, pain in the pelvic region
• weight gain
• acne
• hair loss
• feeling sick (nausea)
• severe contractions of the uterus, bleeding from the vagina or discharge from the vagina (white or yellowish discharge from the vagina)
• fatigue (feeling tired and weak)

Side effects occurring less frequently:

• pain in extremity (e.g. back pain, arms, legs, wrists, ankles)
• low iron content in blood
• high blood pressure
• excessive fluid in legs
• increased levels of cholesterol
• excessive eating from increase hunger or appetite (hyperphagia)
• muscle pain
• difficulty sleeping or abnormal dreams, difficulty to concentrate
• tumours in uterus or fallopian tube
• memory loss, severe headaches
• tingling or prickling sensation in the hands, arms, legs or feet
• loss of smell
• mood swings, feeling irritable or agitated
• vomiting (being sick)
• dry mouth
• constipation
• diarrhoea
• weight loss
• chills
• acute pancreatitis
• feeling depressed or anxious
• more interest in sex than usual
• hot flushes
• irritation or burning sensation of vagina
• vaginal infections such as thrush
• vaginal discharge or vaginal bleeding
• blood clots
• dry and itchy skin
• rash or small, widened blood vessels on the skin (telangiectasia)
• vertigo (feeling off balance or a spinning feeling)
• excessive hair growth
• impairment of your vision
• abdominal discomfort or tenderness
• flatulence
• gastroenteritis (stomach flu)
• indigestion
• oral discomfort
• taste disturbances
• skin abscesses (boils)
• ear infection
• abnormal liver tests
• breast disorders, benign growths in the breasts, nipple pain
• muscle weakness
• benign growths in the uterus smooth muscle
• cysts close to the fallopian tube
• abnormal biopsy
• dark coloured urine

The following side effects have been reported with other HRTs:

• gall bladder disease
• various skin disorders including discoloration of the skin especially of the face or neck known as “pregnancy patches” (chloasma), painful reddish skin nodules (erythema nodosum), rash with target-shaped reddening or sores (erythema multiforme).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of BIJUVA.

• Store at or below 25 °C.
• Keep the blister in the outer carton to protect from light.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).