Bijuve Capsules

Bijuve 1mg/100mg Capsules for Menopause

How do Bijuve capsules work?

Bijuve is a continuous combined hormone replacement therapy (HRT) that contains two female hormones, estradiol and progesterone, in a single daily capsule.

During the menopause, your body produces less oestrogen. This drop in hormone levels is what triggers many of the symptoms women find most disruptive, including hot flushes, night sweats, and mood changes. Bijuve delivers oral oestradiol to replace some of what your body has stopped producing, helping to ease these symptoms.

Estradiol

Estradiol is a form of oestrogen that is identical in structure to the hormones that naturally circulate in women’s bodies. It directly addresses the hormone deficiency that causes menopausal symptoms.

Progesterone

Progesterone is a progestogen that is included to protect the lining of the womb (the endometrium). Taking oestrogen on its own can cause excessive thickening of the womb lining over time, which increases the risk of endometrial cancer. The progesterone in Bijuve counteracts this, making it safe for women who still have their womb.

Because both hormones are chemically and biologically identical to those your body produces naturally, Bijuve is considered a body-identical HRT. It is prescribed at the lowest effective dose to manage your symptoms for as short a time as necessary.

What is Bijuve used for?

Bijuve is used to relieve symptoms of the menopause in postmenopausal women whose last natural menstrual period was at least 12 months ago.

It is prescribed when menopausal symptoms are significantly affecting your daily life. These symptoms are caused by falling oestrogen levels and can include:

• Hot flushes and night sweats
• Mood changes, low mood, or irritability
• Fatigue and poor sleep
• Vaginal dryness or discomfort
• Headaches and dizziness

Who are Bijuve capsules suitable for?

Bijuve is suitable for postmenopausal women who haven’t had a natural period for at least 12 months and whose menopausal symptoms are significantly affecting their daily life.

If you have experienced a premature menopause, the risks and benefits of using HRT may be different. Your doctor will be able to advise you on whether Bijuve is appropriate for your situation.

Do not take Bijuve if you:

• Have or have ever had breast cancer, or any cancer sensitive to oestrogens (such as cancer of the womb lining)
• Have unexplained vaginal bleeding
• Have or have ever had a blood clot in a vein (such as deep vein thrombosis or a pulmonary embolism)
• Have a blood-clotting disorder, such as protein C, protein S, or antithrombin deficiency
• Have or have recently had a heart attack, stroke, or angina
• Have liver disease where your liver function has not returned to normal
• Have a rare inherited blood condition called porphyria
• Are allergic to estradiol, progesterone, or any other ingredient in the capsule

Speak to your doctor before taking Bijuve if you:

• Have a history of fibroids, endometriosis, or excessive growth of the womb lining
• Have high blood pressure, diabetes, or gallstones
• Have migraines or severe headaches
• Have ever had a liver disorder
• Have epilepsy, asthma, or systemic lupus erythematosus (SLE)
• Have a family history of breast cancer or blood clots
• Are seriously overweight (BMI over 30)

Your doctor will review your personal and family medical history and will recommend regular check-ups at least once a year to discuss the benefits and risks of continuing treatment with Bijuve.

How to Take Bijuve Capsules

1. Take one capsule every day with a meal.
2. Swallow the capsule whole with a drink of water.
3. Take it at the same time each day to help keep hormone levels steady.

What should I do if I miss a dose of Bijuve?

If you remember within 12 hours of your usual time, take the missed capsule as soon as you remember. If more than 12 hours have passed, skip the missed dose and continue as normal the following day. Do not take a double dose to make up for a forgotten one. Missing a dose may increase the likelihood of spotting or breakthrough bleeding.

Can I take Bijuve capsules when I’m having surgery?

If you are due to have an operation, tell your surgeon that you are taking Bijuve. You may need to stop taking it 4 to 6 weeks before the procedure to reduce the risk of blood clots. Your doctor will advise you when it is safe to restart.

Bijuve Side Effects

Like all medicines, Bijuve can cause possible side effects, although not everyone experiences them.

Very Common Side Effects

These may affect more than 1 in 10 people:

• Breast tenderness

Common Side Effects

These may affect up to 1 in 10 people:

• Headache or dizziness
• Mood changes
• Fatigue
• Nausea
• Abdominal or pelvic pain
• Back pain or pain in the arms and legs
• Vaginal discharge or vaginal bleeding
• Weight gain
• Acne or dry skin
• Breast pain
• Hair loss

Uncommon Side Effects

These may affect up to 1 in 100 people:

• High blood pressure
• Muscle pain
• Fluid retention
• Sleep disturbances or abnormal dreams
• Anxiety or low mood
• Vomiting or constipation
• Hot flushes
• Vaginal irritation or thrush
• Dry or itchy skin, or skin discolouration
• Blood clots
• Memory difficulties or severe headaches

Rare Side Effects

These may affect up to 1 in 1,000 people:

• Muscle weakness
• Benign growths in the womb

Serious Side Effects

The following conditions are reported more often in women using HRT compared to women not taking it. While the overall risk remains low, it is important to be aware of them:

• Breast cancer
• Cancer or thickening of the womb lining (endometrial hyperplasia or cancer)
• Ovarian cancer
• Blood clots in the legs or lungs
• Heart disease
• Stroke

For a complete list of uncommon side effects, please refer to the Bijuve Patient Information Leaflet.

Stop taking Bijuve and contact your doctor immediately if you experience sudden chest pain, difficulty breathing, severe leg pain or swelling, sudden weakness or numbness, yellowing of the skin or eyes, or signs of a severe allergic reaction such as swelling of the face or throat.

You can report any side effects to the MHRA Yellow Card Scheme.

Bijuve HRT Capsule Ingredients

Active ingredients: Estradiol 1mg (as estradiol hemihydrate) and Progesterone 100mg

Other ingredients: Medium chain mono/diglycerides, lauryl macrogolglycerides 32, gelatin, hydrolysed gelatin, glycerine (E422), allura red (E129), titanium dioxide (E171), propylene glycol (E1520), polyvinyl acetate phthalate, polyethylene glycol (E1521), and ammonium hydroxide (E527).

Please note that Bijuve contains allura red (E129), which may cause allergic reactions in some people.

Bijuve Information & Warnings

• Combined HRT slightly increases the risk of breast cancer. There is an increase in the risk with length of use, and it may persist for up to 10 years after stopping. Attend all recommended breast screening appointments and check your breasts regularly for any changes, such as lumps, dimpling of the skin, or changes to the nipple.
• Bijuve increases the risk of blood clots in the veins, particularly in the first year of use. The risk is higher if you are overweight, have limited mobility, or have a personal or family history of blood clots.
• Women over the age of 60 taking combined HRT have a slightly higher risk of developing heart disease. The risk of stroke is also higher in HRT users than in non-users, and these risks increase with age.
• Some medicines can impact the effect of Bijuve, or Bijuve can affect how other medicines work. This includes medicines for epilepsy, tuberculosis, HIV, and fungal infections, as well as St John’s Wort.
• If you are being treated for Hepatitis C virus, some combination drug regimens may affect liver function tests. Always tell your doctor or pharmacist about all medicines you are taking.
• Bijuve is not a contraceptive. If it has been less than 12 months since your last period, or you are under 50, you may still need to use contraception. Speak to your doctor for advice.
• You may experience irregular bleeding or spotting during the first 3 to 6 months of treatment. If bleeding continues beyond 6 months, starts after 6 months of use, or continues after you stop taking Bijuve, contact your doctor promptly.
• Taking oestrogen-only HRT can lead to excessive growth of the endometrium. The progesterone in Bijuve is included to prevent this. If you experience any unexpected bleeding, speak to your doctor.
• If you need to have a mammogram, tell the healthcare professional that you are taking HRT, as it can increase breast density and may affect the results.
• Do not stop taking Bijuve without speaking to your doctor first.
• Keep out of the sight and reach of children. Store in the original packaging to protect from light. Do not use after the expiry date shown on the carton.