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Bijuve

Important Safety Information regarding BIJUVE 1mg/100mg Capsules Capsules

Updated over 2 weeks ago

First of all, thank you for choosing Numan. If your prescription request for BIJUVE 1mg/100mg Capsules has been accepted, or if you considering whether this treatment may be suitable for you, we'd like to help you learn how to use it to its best effect, and give you some important information before you start taking it. You can also refer to this page throughout your treatment.

What is it?

BIJUVE is a continuous combined oral (systemic) form of hormone replacement therapy (HRT), and contains the body-identical hormones estradiol (1mg) and micronised progesterone (100mg) in a single soft capsule.

What is it used for?

BIJUVE is licensed in the UK for continuous combined HRT to treat oestrogen deficiency symptoms in postmenopausal women with an intact uterus who are at least 12 months past their last period.

How long does it take to work?

Many women notice an improvement in their symptoms within a few weeks of starting treatment. However, it can sometimes take up to three months for your body to adjust and for you to feel the full benefits.

How do I use it?

Take one capsule orally every evening with food. The treatment is continuous, so you take one capsule every day without any interruption between packs.

Missed dose: If you forget to take a capsule and it has been less than 12 hours since your usual time, take it as soon as you remember. If it has been more than 12 hours, you should discard the missed capsule and take the next one at your usual time. Do not take two capsules to make up for a missed dose. Always take this medicine exactly as instructed, and check with your healthcare provider if you are not sure. Please be aware that the likelihood of breakthrough bleeding or spotting may be increased with missed doses, however.

Special dosing requirements

This is a standard fixed-dose combination. The goal of HRT is always to use the lowest effective dose for the shortest duration necessary to manage your symptoms.

There are no special dosage requirements for elderly patients, though experience in treating women over 65 years is limited. This medicine is not for use in children.

Information on fertility, pregnancy and lactation

Pregnancy: BIJUVE is not a contraceptive and is intended for use only in post-menopausal women. 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 healthcare provider for advice on this. If you become pregnant while taking it, you must stop treatment immediately and contact your healthcare provider.

Breastfeeding: BIJUVE is not indicated during breastfeeding.

Other important safety information

Some women tolerate body-identical progesterone better than synthetic progestogens, experiencing fewer side effects like mood swings or bloating. Bijuve offers the convenience of a single daily capsule containing both body-identical oestrogen and progesterone, which may be an alternative for women who experience side effects from other combined HRT products or who prefer not to take separate oestrogen and progesterone (Utrogestan) preparations.

What are the associated risks with treatment?

The most commonly reported side effects in clinical trials with Bijuve were breast tenderness, headache, nausea, pelvic pain, and vaginal bleeding. As an oral (systemic) HRT, BIJUVE is associated with a small increased risk of blood clots (venous thromboembolism), stroke, and breast cancer. The risk of ovarian cancer may also be slightly increased. These risks are generally small and depend on factors like your age, medical history, and how long you take HRT for. For a full list of side effects, please see the Patient Information Leaflet provided with your medication and also linked at the bottom of this page.

What monitoring or follow-up is needed to continue taking treatment safely?

Your clinician will review your treatment after three months to check how you’re responding. After that, you should have a check-up at least once a year. These reviews will assess whether HRT is still right for you, make sure your symptoms are under control, ask about any side effects and vaginal bleeding, request a check of your weight and your blood pressure, and decide if you need further tests such as a bone density scan. You should also examine your breasts regularly, and make sure to attend all routine screening appointments such as mammograms and cervical screening, if applicable to you. If you have a premature menopause, the risks of using HRT may be different, which you should discuss with your clinician.

When to stop treatment

You should stop taking BIJUVE immediately and consult your doctor if you experience any of the following: signs of a blood clot (e.g. painful swelling in the leg), a swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema, jaundice (yellowing of the skin or eyes), a significant increase in your blood pressure, the new onset of a migraine-type headache, or if you become pregnant. When you and your clinician decide it is time to stop HRT, the dose is often reduced gradually to help prevent your menopausal symptoms from returning suddenly.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, you should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with BIJUVE 1mg/100mg Capsules, in particular:

  • Leiomyoma (uterine fibroids) or endometriosis

  • Risk factors for thromboembolic disorders

  • Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer

  • Hypertension

  • Liver disorders (e.g. liver adenoma)

  • Diabetes mellitus with or without vascular involvement

  • Cholelithiasis

  • Migraine or (severe) headache

  • Systemic lupus erythematosus

  • A history of endometrial hyperplasia

  • Epilepsy

  • Asthma

  • Otosclerosis

Storage instructions

Store at room temperature, at or below 25°C, within the original box. Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.

Further information:

If you have questions about your medication, wish to discuss alternative treatment plans, or need reassurance, our clinicians are available to provide expert advice and support. Just email us at [email protected].

Lastly, please read the Patient Information Leaflet linked below and included with your treatment for a full list of side effects, contraindications, and precautions.

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