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Utrogestan 100mg Capsules
UTROGESTAN® 100mg CAPSULES
1. What Utrogestan is and what it is used for
2. What you need to know before you take Utrogestan
3. How to take Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. Contents of the pack and other information
The name of your medicine is Utrogestan 100mg Capsules (called Utrogestan in this leaflet). Utrogestan contains a female hormone called progesterone and is to be used with another medicine called estrogen. The combination of Utrogestan and estrogen belongs to a group of medicines called hormone replacement therapy (HRT).
Utrogestan in combination with an estrogen is used to reduce the symptoms of the menopause (change of life).
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 HRT, 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 HRT.
Go for regular breast screening, as recommended by your doctor.
Do not take Utrogestan if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor or pharmacist before taking Utrogestan.
If any of the above conditions appear for the first time while taking Utrogestan, stop taking it at once and consult your doctor immediately.
Talk to your doctor or pharmacist before taking Utrogestan.
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 HRT. If so, you should see your doctor for more often check-ups:
If you notice any of the following when taking HRT:
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: 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 doctor for advice.
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking estrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer). The progestogen in Utrogestan protects you from this extra risk.
You will have a bleed once a month (so-called withdrawal bleed) while taking Utrogestan. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
See your doctor as soon as possible
Evidence suggests that taking combined estrogen-progestogen and possibly also estrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking estrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice any changes such as:
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example,in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:
For signs of a blood clot, see “Stop taking Utrogestan and see a doctor immediately”.
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking estrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e.an extra 5 cases).
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use estrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.
Utrogestan is not for use in children.
Utrogestan can affect the way some other medicines work. Also some medicines may interfere with the effect of Utrogestan. This might lead to irregular bleeding. This applies to the following medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
If you need a blood test, tell your doctor or the laboratory staff that you are taking HRT, because HRT can affect the results of some tests.
Do not take Utrogestan with food. See Section 3 ‘How to take Utrogestan’ for more information on when to take this medicine.
You may feel sleepy or dizzy while taking Utrogestan. If this happens, do not drive or use any tools or machines. Taking Utrogestan at bedtime can reduce these effects.
If you are allergic to peanut or soya, do not use this medicinal product.
Always take this medicine exactly as your doctor has told you. Always read the label. Check with your doctor or pharmacist if you are not sure.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26).
Alternatively, 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle.
If you are going to have surgery, tell the surgeon that you are taking HRT. You may need to stop taking HRT about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clot in a vein). Ask your doctor when you can start taking HRT again.
If you take more Utrogestan than you should, talk to your doctor or go to a hospital. Take the medicine pack with you.
The following effects may happen: feeling drowsy, dizzy, sleepy or tired
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:
For more information about these side effects, see Section 2.
The following side effects have been reported since Utrogestan came on the market and may happen with Utrogestan taken orally:
Frequency not known (frequency cannot be estimated from the available data):
During clinical trials, the following side effects have also been observed:
Frequency not known (frequency cannot be estimated from the available data):
The following side effects have been reported with other HRTs:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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This leaflet was last revised in February 2022
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