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Utrogestan

Important Safety Information regarding Utrogestan 100mg Oral Capsules

Updated over 2 weeks ago

First of all, thank you for choosing Numan. If your prescription request for Utrogestan 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?

Utrogestan is an oral form of hormone replacement therapy (HRT) containing micronised progesterone. This is a 'body-identical' hormone, structurally identical to the progesterone produced by the body.

What is it used for?

Utrogestan is not a standalone form of HRT. It is prescribed specifically for women who have a uterus and are using a separate, oestrogen-only HRT product (such as a patch, gel, or spray). Its sole purpose is to protect the lining of the womb (endometrium) from the thickening effects of oestrogen, thereby preventing an increased risk of endometrial cancer.

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?

The protective effect of Utrogestan on the womb lining begins with the first dose, which must be taken by mouth at bedtime, on an empty stomach (at least two hours after eating). The capsules should be swallowed whole with a drink of water. Taking it at night is recommended because a common side effect is drowsiness, which can aid sleep. There are two main dosing schedules:

Sequential (or cyclical) regimen: For perimenopausal women. The usual dose is 200mg (two 100mg capsules) taken once daily at bedtime, for 12 days of your 28-day HRT cycle (typically from day 15 to day 26). This will cause a regular monthly withdrawal bleed.

Continuous regimen: For post-menopausal women (at least 6-12 months since the last period). The usual dose is 100mg (one capsule) taken once daily at bedtime, every day without a break. This regimen is designed to be "bleed-free" once your body gets used to it. Always take this medicine exactly as instructed, and check with your healthcare provider if you are not sure.

Special dosing requirements

The dosing regimen depends on whether you are perimenopausal or post-menopausal. 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: Utrogestan 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 healthcare provider for advice on this. The oral capsules are intended for use only in post-menopausal women. If you become pregnant while taking it, you must stop treatment immediately and contact your healthcare provider.

Breastfeeding: Utrogestan is not indicated during breastfeeding.

Other important safety information

Utrogestan contains soya lecithin and must not be taken by anyone with an allergy to peanuts or soya.

What are the associated risks with treatment?

Common side effects of treatment with Utrogestan include changes in your period (in the sequential regimen), headache, tiredness, dizziness, and abdominal pain or bloating. The drowsiness it can cause is often seen as a benefit for women who struggle with sleep, which is why it is taken at bedtime. The risks associated with systemic HRT (e.g., breast cancer, stroke) are primarily linked to the oestrogen component of your therapy, but taking a progestogen is a necessary part of combined HRT for safety. 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 will stop taking Utrogestan if you stop your oestrogen therapy or if you have a hysterectomy. You should stop taking Utrogestan 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 Utrogestan 100 mg Oral Capsules, in particular:

  • Leiomyoma (uterine fibroids) or endometriosis

  • Risk factors for thromboembolic disorders

  • Risk factors for estrogen 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

  • Fluid retention (e.g. cardiac, disease, renal disease)

  • Depression

  • Photosensitivity

Storage instructions

There are no special precautions for storage of Utrogestan 100mg Oral Capsules. 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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