Patient Leaflet Updated 19-Jun-2018 | Orion Pharma (UK) Limited
Package Leaflet: Information for the user
Indivina 1 mg/2.5 mg tablets
Indivina 1 mg/5 mg tablets
Indivina 2 mg/5 mg tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Indivina is and what it is used for
2. What you need to know before you take Indivina
3. How to take Indivina
4. Possible side effects
5. How to store Indivina
6. Contents of the pack and other information
1. WHAT INDIVINA IS AND WHAT IT IS USED FOR
Indivina is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and progestogen. Indivina is used in menopausal women with at least three years since their last natural period.
Indivina is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Indivina alleviates these symptoms after menopause. You will only be prescribed Indivina if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Indivina to prevent osteoporosis after menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIVINA
Medical history and regular check-ups
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 Indivina 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 with Indivina.
Go for regular breast screening as recommended by your doctor.
Do not take Indivina:
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Indivina.
Do not take Indivina
If any of the above conditions appear for the first time while taking Indivina, stop using it at once and consult your doctor immediately.
Warnings and precautions
Talk to your doctor before starting the treatment if you have ever had any of the following problems, as these may return or become worse during treatment with Indivina. If so, you should see your doctor more often for check-ups:
Stop taking Indivina and see a doctor immediately, if you notice any of the following when taking HRT:
Note: Indivina 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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-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 Indivina protects you from this extra risk.
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Indivina. However, if the irregular bleeding:
see your doctor as soon as possible.
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-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 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. an extra 4 to 6 cases).
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 oestrogen-only or combined oestrogen-progestagen 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 2,000 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 2,000 users (i.e. about 1 extra case).
Effect of HRT on heart and circulation
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 Indivina 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 1,000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. an extra 5 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
The risk of getting a 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 1,000 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 1,000 users, over 5 years (i.e. an extra 3 cases).
Other medicines and Indivina
Some medicines may interfere with the effect of Indivina. 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 Indivina, because this medicine can affect the results of some tests.
Indivina with food and drink
Indivina can be swallowed with a glass of water at the same time each day.
Pregnancy and breast-feeding
Indivina is for use in postmenopausal women only. If you become pregnant, stop taking Indivina and contact your doctor.
Driving and using machines
Indivina has no influence on your ability to drive or use machines.
Indivina contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE INDIVINA
Always take this medicine exactly as your doctor has told you. 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.
Take one Indivina tablet every day, preferably at about the same time each day. Calendar days are printed on the blister sheet to help you follow your daily tablet intake. Swallow the tablet whole with a drink if necessary. You will normally start on the lowest dose of Indivina and this will be increased, if necessary. Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms. Talk to your doctor if your symptoms are not better after three months. If you feel that the effect of Indivina is too strong or too weak, do not change the dose or stop taking the tablets yourself, but ask your doctor for advice.
If you are not having periods and you have not previously taken HRT or you are changing from another continuous combined HRT product, treatment with Indivina may be started on any day.
If you switch from a cyclic HRT regimen, start Indivina treatment one week after taking the last tablet of the cyclic HRT. Talk to your doctor or pharmacist if you are unsure.
Whilst taking this medicine
When you first start taking Indivina you may get some bleeding at odd times for a few months (Please also refer to the section above on Endometrial cancer). However, if this is still happening after a few months or if you experience heavy bleeding tell your doctor.
If you take more Indivina than you should
If you or somebody else has taken too many Indivina tablets, talk to your doctor or pharmacist. An overdose of Indivina could make you feel sick, or make you get a headache or uterine bleeding.
If you forget to take Indivina
It is best to take the tablet at the same time each day. If you forget to take a tablet leave the forgotten tablet. You should then continue by taking the next tablet at your usual time. Missing a tablet or irregular use of Indivina tablets may cause breakthrough bleeding or spotting.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Indivina
If you want to stop taking Indivina, talk to your doctor first. He/she will explain the effects of stopping treatment and discuss other possibilities with you.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Indivina. You may need to stop using Indivina about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start using Indivina again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, particularly early on (in the first few months of treatment), for example irregular bleeding may occur. However, not everybody gets them. These often disappear with continued treatment.
There are a number of situations in which you may have to stop taking Indivina. Tell your doctor immediately if you develop any of the following conditions:
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 is a list of side effects that have been linked to the use of HRT:
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Frequency not known side effects (frequency cannot be estimated from the available data)
The following side effects have been reported with other HRTs:
Reporting of side effects
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 national reporting system, see below. By reporting side effects, you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. HOW TO STORE INDIVINA
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pack. Store below 25°C. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Indivina contains:
The active substances of Indivina tablets are estradiol valerate and medroxyprogesterone acetate. Three different strengths of tablets are available.
Indivina 1 mg/2.5 mg tablets contain 1 mg of estradiol valerate and 2.5 mg medroxyprogesterone acetate.
Indivina 1 mg/5 mg tablets contain 1 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.
Indivina 2 mg/5 mg tablets contain 2 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.
The other ingredients of all Indivina tablets are lactose monohydrate, maize starch, gelatin, and magnesium stearate.
What Indivina looks like and contents of the pack:
Indivina 1 mg/2.5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 2.5’on one side.
Indivina 1 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 5’on one side.
Indivina 2 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘2 + 5’on one side.
The tablets are packed in a PVC/PVDC-aluminium blister of 28 tablets. The pack sizes available are 1 x 28 tablets and 3 x 28 tablets for all three strengths. All pack sizes may not be available in your country.
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in 28 March 2018.
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