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Blissel

Document: Blissel vaginal gel ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Blissel 50 micrograms/g vaginal gel

Estriol


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.



What is in this leaflet


What Blissel is and what it is used for

What you need to know before you use Blissel

How to use Blissel

Possible side effects

How to store Blissel

Contents of the pack and other information


What Blissel is and what it is used for


Blissel contains estriol, a female hormone that is identical to a hormone that your body makes naturally called oestrogen. Estriol helps to keep the cells lining the vagina (mucosa) elastic and more resistant to mechanical influence and makes you less likely to develop an infection.

Blissel is used for the treatment of vaginal dryness, which is due to lack of oestrogen after menopause.


What you need to know before you use Blissel


Do not use Blissel


Warnings and precautions

The medicine is given by inserting an applicator into the vagina. This may cause discomfort or soreness in women who have severe vaginal atrophy (thinning or inflammation of the vaginal walls).


Medical check-ups

Before treatment with Blissel, your doctor should ask you about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

Once you have started to use Blissel, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the need to continue using Blissel.


Please tell your doctor if you have or have had any of the following disease/conditions, that in rare cases can return or become worse during treatment with Blissel:



Reasons to contact your doctor immediately

If any of the above occurs, your doctor may need to stop treatment and give you an alternative.


Treatment with higher dose oestrogen preparations that can raise your blood levels of oestrogen (such as tablets or stick on patches) increases the risk for abnormal growth of the lining of your womb (endometrial hyperplasia), certain types of cancer such as breast and endometrial cancer and blood clots in the veins. Blissel is a vaginal gel for local treatment and contains a very low dose of estriol, therefore your risk of developing these conditions is very low. Nevertheless, if you are concerned about these risks, you should discuss it with your doctor.


Other medicines and Blissel

Blissel contains a low dose of estriol and is for local treatment, therefore it is not expected to affect or be affected by taking other medicines.


Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.


Pregnancy,breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Blissel if you are pregnant.

If you do become pregnant during treatment, tell your doctor immediately and do not use Blissel.

You should not use Blissel during breast-feeding.


Driving and using machines

Blissel has no effect on your ability to drive and use machines.


Blissel contains

Sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217). They may

cause allergic reactions (possibly delayed).

Do not use this medicine if you are allergic to any of the ingredients.


How to use Blissel


Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for the first 3 weeks of treatment is one applicator-dose per day, preferably before going to bed. After 3 weeks of use, your discomfort should have decreased and the dose should be lowered. You may only need one dose twice a week.


How to apply the gel


Pack size of 10g – Blister containing 10 disposable tubes (cannulas) and a reusable plunger.

Inside the cardboard box you will find a tube containing 10g of Blissel and one blister containing 10 disposable tubes (cannulas) with a filling mark and a reusable plunger.


Pack size of 10g – Bag containing 1 reusable tube (cannula) and a reusable plunger.

Inside the cardboard box you will find a tube containing 10g of Blissel and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.


Pack size of 30g – 3 Blisters each-containing 10 disposable tubes (cannulas) and a reusable plunger.

Inside the cardboard box you will find a tube containing 30 gof Blissel and three blisters eachcontaining 10disposable tubes (cannulas) with a filling mark and a reusable plunger.


Pack size of 30g – Bag containing 1 reusable tube (cannula) and a reusable plunger.

Inside the cardboard box you will find a tube containing 30g of Blissel and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.


Use the applicator to insert the gel in the vagina (it is recommended before going to bed).



The following instructions explain how the gel should be used.


In the picture below you can see different elements of the tube and the applicator.




1. Remove the tube cap, turn it upside down and use the sharp point to pierce the seal on the neck of the tube.




2. Take out a cannula and the plunger. Insert the white plunger all the way into the cannula. Screw the cannula on the neck of tube.



3.Squeeze the tube to fill the applicator with the gel up to the filling mark


4.Unscrew the cannulafrom the tubeand replace the cap on the tube.


5. To apply the gel, lie down, insert the end of the applicator deep into the vagina and slowly push the plunger all the way down.