Utrogestan 100mg capsules

Quantity	1 x 30 capsules, 2 x 30 capsules, 3 x 30 capsules

What is Utrogestan?

Utrogestan 100mg capsules contain the hormone progesterone and are used in combination with estrogen tablets as part of hormone replacement therapy (HRT). This combined HRT approach helps to alleviate menopausal symptoms such as hot flushes, mood swings, and vaginal dryness. It is also effective for women experiencing perimenopause.

Utrogestan is specifically designed for women who have an intact uterus or womb when used with estrogen-containing medications like Elleste Solo, Zumenon, or transdermal patches such as Evorel and Estradot. It is important to note that Utrogestan is not a contraceptive and does not prevent pregnancy.

The capsules are intended for oral use only. Alternatively, Utrogestan is available in a 200mg vaginal capsule form, which is inserted into the vagina for those who may benefit from this method of administration.

What is the active ingredient in Utrogestan?

Each capsule of Utrogestan contains the active ingredient: 100 mg progesterone.

What is Utrogestan used for?

Utrogestan, when taken alongside estrogen, is used to alleviate menopausal symptoms.

It is prescribed specifically for women who still have a uterus. Note that Utrogestan does not serve as a contraceptive.

Why Utrogestan is Taken with Estrogen

If your hormone replacement therapy (HRT) only includes estrogen, the lining of the womb can thicken, which might lead to complications.
Utrogestan helps to counteract this by prompting the shedding of the womb lining, thereby preventing such issues.
You may experience monthly bleeding similar to a period as a result of taking Utrogestan.

How does Utrogestan work?

As you approach menopause, the levels of the female hormones estrogen and progesterone in your body decrease.
Hormone replacement therapy (HRT) is designed to replenish these hormones, helping to alleviate menopausal symptoms.
Utrogestan provides progesterone, a crucial hormone that works in tandem with estrogen to balance hormone levels. This combination helps to manage symptoms such as hot flashes, mood changes, and vaginal dryness, while also preventing the excessive buildup of the uterine lining.
For women with an intact uterus, progesterone is particularly important because estrogen alone can cause the uterine lining to thicken excessively. This buildup can lead to complications such as abnormal bleeding or an increased risk of endometrial cancer.
By introducing progesterone through Utrogestan, the uterine lining is shed regularly, mimicking a natural menstrual cycle and reducing the risk of these issues. This helps maintain a healthier balance in the reproductive system and supports overall well-being during menopause.

How do you use Utrogestan?

How to Take Utrogestan

Follow Your Doctor's Instructions: Always take Utrogestan exactly as prescribed by your doctor and read the label carefully. If you have any doubts or questions, consult your doctor or pharmacist.
Dosage Guidance: Your doctor will prescribe the lowest effective dose for the shortest time necessary to manage your symptoms. If you believe the dose is too high or too low, discuss this with your doctor.
Standard Dosage: The usual dose is 200 mg taken at bedtime for twelve days in the latter half of each treatment cycle, starting on Day 15 and ending on Day 26. Alternatively, a dose of 100 mg can be taken at bedtime from Day 1 to Day 25 of the cycle.
Taking the Medicine:
- Swallow the capsule whole with a glass of water.
- Take it at bedtime.
- Avoid taking the capsule with food.
- Continue taking your estrogen HRT alongside Utrogestan as directed.
Dosage Details:
- For a 28-day cycle, take two capsules at bedtime from Day 15 to Day 26.
- You may experience withdrawal bleeding similar to a period shortly after completing the medication.
- Keep taking your estrogen HRT daily.
- If you have issues with withdrawal bleeding, consult your doctor, who might adjust your Utrogestan regimen to minimize bleeding.
If You Need Surgery:
- Inform your surgeon that you are taking HRT. You may need to stop taking HRT 4 to 6 weeks before the surgery to reduce the risk of blood clots. Ask your doctor when it is safe to resume taking HRT.
In Case of Overdose:
- If you take more Utrogestan than prescribed, contact your doctor or go to the nearest hospital immediately, bringing the medicine pack with you. Possible effects of an overdose include drowsiness, dizziness, sleepiness, or fatigue.
If You Miss a Dose:
- If you forget a dose, take it as soon as you remember unless it's close to the time for your next dose. In that case, skip the missed dose. Do not double up on doses.
Stopping Utrogestan:
- If you have any questions about how to use Utrogestan, consult your doctor or pharmacist for guidance.

Who should not use Utrogestan?

Medical History and Regular Check-ups Considerations Before Starting HRT: When deciding to start or continue hormone replacement therapy (HRT), it's crucial to weigh the associated risks. This is especially important for women experiencing premature menopause due to ovarian failure or surgery, as the risks may differ. Consult with your doctor to understand these risks fully. Pre-Treatment Assessment: Before beginning or resuming HRT, your doctor will review your personal and family medical history. They may also perform a physical examination, which could include a breast examination or, if necessary, an internal examination. Ongoing Monitoring: Once you start HRT, you should have regular check-ups with your doctor, ideally at least once a year. These appointments are an opportunity to discuss the ongoing benefits and risks of continuing the therapy. It is also important to follow your doctor’s recommendations for regular breast screenings. Contraindications: Do not take Utrogestan if any of the following apply to you. If you’re unsure, consult your doctor or pharmacist:

Allergic to progesterone or any ingredients in Utrogestan.
History or suspicion of breast cancer.
Cancer sensitive to estrogens (e.g., endometrial cancer).
Unexplained vaginal bleeding.
History of blood clots in veins (e.g., deep vein thrombosis, pulmonary embolism).
Blood clotting disorders (e.g., protein C or S deficiency).
History of arterial blood clots (e.g., heart attack, stroke).
Liver disease with abnormal liver function tests.
Inherited blood disorder called porphyria.
Recent cerebral hemorrhage.
Breast-feeding.
Allergy to soya.

If any of these conditions develop while taking Utrogestan, stop the medication and contact your doctor immediately. Special Precautions with HRT: Inform your doctor if you have or have had any of the following conditions, as they may worsen with HRT. Regular monitoring may be needed:

Abnormal uterine growths (e.g., fibroids).
Endometriosis or history of endometrial hyperplasia.
Increased risk of blood clots.
Family history of estrogen-sensitive cancers (e.g., breast cancer).
High blood pressure.
Liver issues (e.g., benign liver tumors).
Diabetes.
Gallstones.
Migraine or severe headaches.
Systemic lupus erythematosus (SLE).
Epilepsy.
Asthma.
Otosclerosis (ear disease).
History of depression.
Light-sensitive skin (photosensitivity).

Immediate Medical Attention Required: Seek immediate medical attention if you experience any of the following symptoms while on HRT:

Symptoms listed in the ‘DO NOT take Utrogestan’ section.
Yellowing of skin or eyes (jaundice), which may indicate liver issues.
Significant increase in blood pressure (e.g., headache, dizziness).
New onset of migraine-like headaches.
Sudden or gradual vision loss, double vision, or eye swelling.
Symptoms of blood clots, such as leg swelling and redness, sudden chest pain, or difficulty breathing.

Contraception Note: Utrogestan is not a contraceptive. If it's been less than 12 months since your last period or if you are under 50, additional contraception may be necessary to prevent pregnancy. Consult your doctor for advice on this matter.

HRT and Cancer Risks

Endometrial Hyperplasia and Cancer: Estrogen-only HRT can increase the risk of excessive thickening of the womb lining (endometrial hyperplasia) and endometrial cancer. The progestogen in Utrogestan helps mitigate this risk by preventing abnormal growth of the womb lining. Unexpected Bleeding: While on Utrogestan, you will experience a monthly withdrawal bleed. If you encounter unexpected bleeding or spotting that:

Continues beyond the first six months,
Starts after six months of use,
Persists after stopping Utrogestan,

consult your doctor promptly. Breast Cancer: Evidence suggests that combined estrogen-progestogen HRT, and possibly estrogen-only HRT, may slightly increase the risk of breast cancer. This additional risk becomes evident within a few years and generally returns to normal within five years after discontinuing treatment. Risk Comparison: For women aged 50 to 79 who do not use HRT, the average risk of breast cancer is 9 to 17 cases per 1,000 over five years. For those using combined estrogen-progestogen HRT, this risk rises to 13 to 23 cases per 1,000 users, an additional 4 to 6 cases. Breast Self-Examination and Screening: Regularly check your breasts and report any changes such as skin dimpling, changes in the nipple, or visible or palpable lumps. Participate in mammography screening programs when offered and inform the healthcare professional performing the mammogram that you are on HRT, as this may affect mammogram results due to increased breast density. Ovarian Cancer: Ovarian cancer is less common than breast cancer but can be associated with both estrogen-only and combined estrogen-progestogen HRT. The risk is slightly higher with HRT use. For example, in women aged 50 to 54 who do not use HRT, the risk is about 2 cases per 2,000 over five years. For those on HRT for five years, the risk is about 3 cases per 2,000 users, an additional 1 case.

Impact on Heart and Circulation:

Blood Clots (Thrombosis): HRT increases the risk of blood clots in veins by approximately 1.3 to 3 times, particularly in the first year. Blood clots can be serious and may lead to conditions such as pulmonary embolism. Risk Comparison: For women in their 50s not using HRT, the risk of a blood clot is 4 to 7 per 1,000 over five years. For those using estrogen-progestogen HRT for more than five years, the risk increases to 9 to 12 per 1,000 users, an additional 5 cases. Heart Disease: There is no evidence that HRT prevents heart attacks. Women over 60 who use estrogen-progestogen HRT may have a slightly increased risk of heart disease. Stroke: The risk of stroke is about 1.5 times higher in HRT users compared to non-users, with the number of extra cases increasing with age. Risk Comparison: For women in their 50s not using HRT, the risk of stroke is 8 per 1,000 over five years. For those on HRT, the risk is 11 per 1,000 users, an additional 3 cases.

Other Considerations:

HRT does not prevent memory loss and may increase the risk of memory issues if started after age 65. Consult your doctor for advice on this matter. Children: Utrogestan is not intended for use in children. Laboratory Tests: If undergoing blood tests, inform the healthcare staff that you are on HRT, as it may affect certain test results. Food and Drink: Avoid taking Utrogestan with food. Refer to the section on dosage for proper administration timing. Pregnancy and Breast-Feeding: Do not use Utrogestan if you are pregnant or planning to become pregnant. It is for postmenopausal women only. If pregnancy occurs, discontinue Utrogestan and contact your doctor. Discuss use with your doctor if you are breastfeeding. Driving and Operating Machinery: Utrogestan may cause drowsiness or dizziness. Avoid driving or operating machinery if you experience these effects. Taking Utrogestan at bedtime can help minimize these effects. Allergy Information: Utrogestan contains soybean lecithin. Avoid using this product if you have an allergy to peanuts or soy.

What are the side effects with Utrogestan?

Like all medications, Utrogestan may cause side effects, though not everyone experiences them. Research indicates that women using hormone replacement therapy (HRT) may have a higher risk of certain conditions compared to those who do not use HRT. These include:

Breast cancer
Abnormal growth or cancer of the womb lining (endometrial hyperplasia or cancer)
Ovarian cancer
Blood clots in the veins of the legs or lungs (venous thromboembolism)
Heart disease
Stroke
Potential memory loss if HRT is started after age 65

For more details on these risks, please refer to Section 2. Reported Side Effects of Utrogestan Since its introduction, the following side effects have been reported with oral Utrogestan, though their frequency is not known:

Stomach pain
Nausea
Fatigue
Headache
Drowsiness
Dizziness
Vaginal bleeding
Intense itching (pruritus)

During clinical trials, additional side effects were observed, also with unknown frequency:

Abdominal bloating
Depression
Breast tenderness
Hot flashes
Vaginal discharge
Joint pain
Urinary issues

Other Potential Side Effects Noted with HRT From other hormone replacement therapies, the following side effects have been reported:

Gallbladder disease
Various skin disorders:
- Skin discoloration, particularly on the face or neck, known as "pregnancy patches" (chloasma)
- Painful reddish skin nodules (erythema nodosum)
- Rash with target-shaped redness or sores (erythema multiforme)
Breast pain (mastodynia)
Fluid retention (oedema)
Weight changes
Changes in sexual desire
Depression
Rashes
Urticaria (itchy, lumpy rash)
Patchy brown or dark brown skin discoloration (melasma)
Fever
Insomnia (difficulty sleeping)
Hair loss (alopecia)
Irregular menstruation
Absence of menstrual periods

Reporting Side Effects If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the website www.mhra.gov.uk/yellowcard or by searching for "MHRA Yellow Card" in the Google Play or Apple App Store. Reporting side effects helps enhance the understanding of the medicine's safety.

Does Utrogestan interact with other medicines?

Utrogestan may influence how other medications work, and some medications can also impact the effectiveness of Utrogestan, potentially leading to irregular bleeding. This interaction risk includes the following types of medicines:

Epilepsy medications: Phenobarbital, phenytoin, carbamazepine
Tuberculosis treatments: Rifampicin, rifabutin
HIV medications: Nevirapine, efavirenz, ritonavir, nelfinavir
Herbal remedies: St. John’s Wort (Hypericum perforatum)
Bromocriptine: Used for pituitary disorders or Parkinson’s Disease
Ciclosporin: Used to suppress the immune system
Antifungals: Ketoconazole, griseofulvin, terbinafine
Diuretics: Spironolactone
Antibiotics: Ampicillins, tetracyclines
Antisteroids: Medroxyprogesterone acetate, megestrol
Anticoagulants: Coumarins, phenindione
Diabetic medications
Emergency contraceptives: Ulipristal acetate
Diazepam
Tizanidine: Used for multiple sclerosis

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, including over-the-counter drugs, herbal supplements, or natural products.

Utrogestan FAQs

What is Utrogestan and what is it used for?

Utrogestan 100mg is a capsule containing progesterone, a hormone used in combination with estrogen as part of hormone replacement therapy (HRT). This treatment helps alleviate menopause symptoms such as hot flashes, mood swings, and vaginal dryness. It can also be used by women showing signs of perimenopause. Utrogestan is intended for women who still have a uterus and is not a contraceptive.

How does Utrogestan work?

As menopause approaches, the body's production of estrogen and progesterone declines. HRT, including Utrogestan, supplements these hormones to ease related symptoms. Estrogen alone can cause the lining of the womb to thicken, potentially increasing cancer risk. Utrogestan, when taken as directed, helps shed this lining monthly, reducing cancer risk.

Can Utrogestan be taken with food?

It is best to take Utrogestan on an empty stomach as food may increase drowsiness.

What are the benefits of Utrogestan for menopause?

Utrogestan contains a form of progesterone identical to the body’s natural hormone, which usually results in fewer side effects compared to older progestogens. It is associated with a lower risk of blood clots and heart disease compared to some older HRT forms.

How should I take Utrogestan 100mg?

Utrogestan 100mg capsules are for oral use and should be taken as directed by your doctor. Two common regimens are:

For women with recent periods: Take 2 capsules daily from day 15 to day 26 of a 28-day cycle to simulate a monthly bleed.
For women without recent periods: Take 1 capsule every evening continuously.

What are the ingredients in Utrogestan 100mg?

Each Utrogestan 100mg capsule contains 100 mg of progesterone. Other ingredients include sunflower oil, soya lecithin, gelatin, glycerol, titanium dioxide, and purified water.

What side effects might occur with Utrogestan?

Possible side effects include:

Stomach pain
Nausea
Constipation
Diarrhea
Dizziness
Drowsiness
Headaches
Intense itching
Breast pain
Vomiting
Irregular bleeding

Consult your doctor or pharmacist if you experience any side effects. For more details, refer to the Patient Information Leaflet.

What warnings should I be aware of?

Review all warnings and precautions in the Patient Information Leaflet. Consider risk factors related to HRT, such as certain health conditions and medications. Ensure annual health reviews with your GP to continue receiving Utrogestan on repeat prescription.

When should I stop taking Utrogestan and see a doctor?

Stop taking Utrogestan and consult your doctor immediately if you:

Suspect or develop genital tract, breast, or endometrial cancer
Experience unexplained vaginal bleeding or endometrial hyperplasia
Have a history of venous blood clots or clotting disorders
Have had a heart attack, stroke, or angina

Consult your doctor before starting Utrogestan if you have or develop:

Uterine fibroids
Endometriosis or endometrial hyperplasia
High blood pressure or high cholesterol
Liver, kidney, or heart disorders
Diabetes, SLE, epilepsy, or asthma
Gallstones
Migraine or severe headaches
Hypothyroidism
Hereditary angioedema

How does Utrogestan relate to cancer risks?

Research shows that using HRT, including Utrogestan, may slightly increase the risk of breast cancer. This risk increases with the duration of HRT use but returns to normal within 5 years after stopping. Regular breast self-exams and screenings are recommended.

What about blood clots?

Oral HRT, including Utrogestan, increases the risk of blood clots and stroke. If you experience symptoms of a blood clot or stroke, seek medical help immediately.

Is Utrogestan safe during pregnancy and breastfeeding?

Utrogestan should only be used by postmenopausal women and is not a contraceptive. If you become pregnant while using Utrogestan, stop taking it and contact your doctor. Utrogestan should not be used while breastfeeding.

Download patient leaflet

https://www.medicines.org.uk/emc/files/pil.352.pdf