iMeds.se

Totelle Sekvens

Package leaflet: Information for the user


Totelle Sekvens coated tablets


Estradiol and estradiol/trimegestone


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 Totelle Sekvens is and what it is used for

2. What you need to know before you take Totelle Sekvens

3. How to take Totelle Sekvens

4. Possible side effects

How to store Totelle Sekvens

6. Contents of the pack and other information


What Totelle Sekvens is and what it is used for


Totelle Sekvensis a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Totelle Sekvensis used in postmenopausal women.


Totelle Sekvensis 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"). Totelle Sekvensalleviates these symptoms after menopause. You will only be prescribed Totelle Sekvensif 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 Totelle Sekvensto prevent osteoporosis after menopause.


What you need to know before you take Totelle Sekvens


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 Totelle Sekvensyou 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 Totelle Sekvens.


Go for regular breast screening, as recommended by your doctor.


Do not takeTotelle Sekvens

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 Totelle Sekvens,

Do not take Totelle Sekvens


If any of the above conditions appear for the first time while taking Totelle Sekvens, stop taking it at once and consult your doctor immediately.


Warnings and precautions


Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Totelle Sekvens. If so, you should see your doctor more often for check-ups:


Stop taking Totelle Sekvensand see a doctor immediately

If you notice any of the following when taking HRT:

For more information, see ‘Blood clots in a vein (thrombosis)’

if you experience symptoms of angioedema such as hives, generalised swelling of parts of the body, most particularly the face, tongue or throat; difficulty swallowing or breathing difficulties.


Note: Totelle Sekvens 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 Totelle Sekvensprotects you from this extra risk.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3 to 6 months of taking Totelle Sekvens. However, if the irregular bleeding:

see your doctor as soon as possible.


Breast cancer

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 14 in 1000 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 20 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:

dimpling of the skin

changes in the nipple

any lumps you can see or feel


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

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 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).


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:

you have cancer


For signs of a blood clot, see section “Stop taking Totelle Sekvensand 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 oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 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.


Stroke

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).


Other conditions

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.


If you suffer from a lack of parathyroid hormone (hypoparathyroidism) oestrogens can sometimes cause low levels of calcium in the blood.


Other medicines and Totelle Sekvens

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines


Some medicines may interfere with Totelle Sekvensreducing its effectiveness and result in a return of symptoms. This applies to the following medicines:

• Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)

• Medicines for tuberculosis (such as rifampicin)

• Medicines for HIV infection (such as ritonavir and nelfinavir)

• Herbal remedies containing St John’s Wort (Hypericum perforatum)

• Steroid medicines for inflammation such as dexamethasone

• Medicines for chronic hepatitis C (such as telaprevir)


Some medicines may increase oestrogen levels and may cause a higher risk of side effects. This applies to the following medicines:

• Medicines for infections such as erythromycin or ketoconazole

• Medicines for peptic ulcers such as cimetidine


The oestrogens in Totelle Sekvens may cause higher blood levels of some medicines such as:

• Medicines for treating depression or anxiety such as citalopram, imipramine and diazepam.


Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Totelle Sekvens, because this medicine can affect the results of some tests.


Pregnancy and breast-feeding

Totelle Sekvens is for use in postmenopausal women only. If you become pregnant, stop taking Totelle Sekvens and contact your doctor.


Driving and using machines

Taking Totelle Sekvens does not affect your ability to drive or use machinery.


Totelle Sekvenscontains lactose and sucrose

This medicine contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


3. How to take Totelle Sekvens


Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


You can start treatment with Totelle Sekvens on any day you choose. If you are transferring from a sequential HRT product (an HRT product that gives you a monthly bleed), treatment should begin the day after finishing the last pack unless instructed otherwise by your doctor.


Start your treatment by taking one estradiol tablet (white coated tablet) every day for 2 weeks (days 1 to 14), followed by one estradiol/trimegestone combined tablet (reddish-brown coated tablet) daily for another 2 weeks (days 15 to 28).

When you have finished each blister pack, start the next blister pack the next day.


Swallow your tablet whole, with water. You can take it during or between meals. It is best to take your tablet at the same time each day; this will help remind you to take your tablet.


If you take more Totelle Sekvens than you should

If you take too many tablets by accident consult your doctor or pharmacist.


You may feel some nausea, vomiting, breast tenderness, dizziness, drowsiness/tiredness or experience vaginal bleeding or spotting.


If you forget to take Totelle Sekvens

Do not worry if you forget to take your tablet - take it during the next 12 hours, otherwise discard it, and take the usual dose the next day. Then carry on with your usual tablet taking routine.


If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Totelle Sekvens. You may need to stop taking Totelle Sekvens 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 taking Totelle Sekvens again.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Very common side effects (may affect more than 1 in 10 people):

Breast pain


Common side effects (may affect up to 1 in 10people):


Uncommon side effects (may affect up to 1 in 100 people):


Rare side effects (may affect up to 1 in 1,000 people):


Very Rare side effects (may affect up to 1 in 10,000 people):


The following side effect has been reported with other HRTs:

Extensive bruising (vascular purpura).


Reporting of side effects

If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Totelle Sekvens


Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.


Do not use Totelle Sekvens after the expiry date which is stated on the outer carton and blister. The expiry date refers to the last day of the month.


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 Totelle Sekvens contains


The active substances are estradiol and estradiol/trimegestone;

Each white tablet contains 2.06 mg estradiol hemihydrate corresponding to 2.00 mg estradiol.

Each reddish-brown coated tablet contains 2.06 mg estradiol hemihydrate corresponding to 2.00 mg estradiol and 0.50 mg trimegestone.

The other ingredients are;

White coated tablet

Lactose monohydrate, Macrogol 8000, Magnesium stearate, Talc, Anhydrous calcium sulfate, Black iron oxide (E172), Carnauba wax, Glyceryl monooleate, Microcrystalline cellulose, Povidone, Pharmaceutical glaze (shellac), Macrogol 20 000, Propylene glycol, Stearic acid, Sucrose, Titanium dioxide (E171)


Reddish-brown coated tablet

Lactose monohydrate, Macrogol 8000, Magnesium stearate, Talc, Anhydrous calcium sulfate, Black iron oxide (E172), Carnauba wax, Glyceryl monooleate, Methyl parahydroxybenzoate (E218), Microcrystalline cellulose, Pharmaceutical glaze (shellac), Macrogol 20 000, Povidone, Propylene glycol, Propyl parahydroxybenzoate (E216), Red iron oxide (E172), Sodium benzoate (E211), Stearic acid, Sucrose, Titanium dioxide (E171)


What Totelle Sekvens looks like and contents of the pack


28 tablets in blister (PVC/PE/ACLAR/Aluminium)

Each blister contains 14 white round biconvex coated tablets printed with ‘2.0’ and 14 reddish-brown round biconvex coated tablets printed with ‘2/0.5’

The pack sizes are 1 x 28 tablets and 3 x 28 tablets. Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


<[To be completed nationally]>


{Name and address}

<{tel}>

<{fax}>

<{e-mail}>


This medicinal product is authorised in the Member States of the EEA under the following names:


Sweden : Totelle Sekvens coated tablets


This leaflet was last revised in 2016-06-10


<Detailed information on this medicine is available on the web site of: {name of MS/Agency}>

9