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BLISSEL 50 MICROGRAMS/G VAGINAL GEL

Active substance(s): ESTRIOL / ESTRIOL / ESTRIOL

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200 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Blissel 50 micrograms/g vaginal gel
F020b-Rev02

Estriol

Prueba N.º
Version No.

7

Fecha
Date

29.03.2017

ITALFARMACO, S.A.
Código
P0544
Factory Code
Sustituye a
--Replace to
Producto / Product Name

PROSP. BLISSEL UK
Tamaño / Size

Diseño realizado a escala: 100%
Image prints @ 100%

200 x 300 mm
Plegado / Folded

Sin plegar / Not folded
N.º de Colores / No Colours

1/1
Colores / Colours

Negro / Black
Cód. Barras / Barcode

--Papel / Paper

Tipografía / Fonts
Helvetica
(condensed, italic y bold)
Tamaño / Type Size: 9 pt.
Interlínea / Leading: 9 pt.
Correcciones
Not Approved

Aprobado
Approved

Por favor, marque lo que corresponda
Please check the appropiate box

Fecha y Firma / Date and Signed

Anverso / Front
Reverso / Back

Blissel contains estriol, a female hormone that is identical to a hormone that your body
makes naturally called oestrogen.
Blissel is used: For vaginal problems caused by having too little ‘oestrogen’
Shortage of oestrogens may cause the vaginal wall to become thin and dry. So sexual
intercourse may become painful and you may get vaginal infections. These problems can
be relieved by using medicines like Blissel which contain oestrogen. It may take several
days or weeks before you notice an improvement.
Blissel is used for the treatment of vaginal dryness, which is due to lack of oestrogen
after menopause.
2. What you need to know before you use Blissel
As well as benefits, HRT (Harmone Replacement Therapy) has some risks that you need
to consider when you’re deciding whether to start taking it, or whether to carry on taking
it.
Before you start taking HRT
Your doctor should ask about you and your family’s medical history. Your doctor may
decide to examine your breasts or your stomach and may do an internal examination.
They will only do this if it is necessary for you or you have any special concerns.
Tell your doctor if you have any medical problems or illnesses.
Regular check-ups
Once you have started on HRT, see your doctor for regular check-ups. At these checkups, your doctor may discuss the benefits and risks of continuing to take HRT.
Do not use Blissel
If you have or have ever had breast cancer, or if you are suspected of having it;
If you have cancer which is sensitive to oestrogens, such as cancer of the womb
lining (endometrium), or if you are suspected of having it;
If you have any unexplained vaginal bleeding;
If you have excessive thickening of the womb lining (endometrial hyperplasia ) that
is not being treated;
If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs
(deep venous thrombosis) or the lungs (pulmonary embolism);
If you have a blood clotting disorder (such as protein C, protein S, or antithrombin
deficiency);
If you have or recently have had a disease caused by blood clots in the arteries, such
as a heart attack, stroke or angina;
If you have or have ever had a liver disease and your liver function tests have not
returned to normal;
If you have a rare blood problem called “porphyria” which is passed down in families
(inherited);
If you are allergic (hypersensitive) to Estriol or any of the other ingredients of Blissel
(listed in section 6 Further information);
If any of the above conditions appear for the first time while taking Blissel, stop taking it
at once and consult your doctor immediately.
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).
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:
any disease of the heart or circulation
too much cholesterol or other fatty substances in the blood
changes in your breast
endometriosis (abnormal growth of the inner lining of your womb outside the womb)
benign tissue lump in your womb (myoma)
high blood pressure
diabetes
gallstones
migraine or severe headache
a rare disease of the immune system called systemic lupus erythematosus (SLE)

epilepsy (fits)
asthma
otosclerosis (deafness caused by thickened ear tissue)
kidney disease
Reasons to contact your doctor immediately
you get jaundice (your eyes and skin go yellow) or problems with your liver function
a sudden increase in blood pressure
if you get migraine or severe headache, for the first time
you become pregnant
if anything under the heading “Do not use Blissel” occurs.
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.
3. 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.
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 (plunger and cannula).

1

Remove the tube cap, turn it upside down and use the sharp point to pierce the
seal on the neck of the tube. Do not use if seal is broken.

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. The
plunger will stop at the mark.

300 mm

Offset blanco / Offset white 56 g/m2

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Blissel is and what it is used for
2. What you need to know before you use Blissel
3. How to use Blissel
4. Possible side effects
5. How to store Blissel
6. Contents of the pack and other information
1. What Blissel is and what it is used for

200 mm

F020b-Rev02

4
5

Prueba N.º
Version No.

7

Fecha
Date

29.03.2017

Unscrew the cannula from the tube and replace the cap on the tube.

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.

ITALFARMACO, S.A.
Código
P0544
Factory Code
Sustituye a
--Replace to
Producto / Product Name

PROSP. BLISSEL UK
Tamaño / Size

6

After use,
Pack size of 10g – 1 Blister containing 10 disposable tubes (cannulas) and a
reusable plunger.
Pack size of 30g – 3 Blisters containing 30 disposable tubes (cannulas) and a
reusable plunger.
Pull the plunger out of the cannula, dispose of the cannula and rinse the plunger
well with warm and clean water so it can be reused for the next application.

Diseño realizado a escala: 100%
Image prints @ 100%

200 x 300 mm
Plegado / Folded

Sin plegar / Not folded
N.º de Colores / No Colours

1/1
Colores / Colours

Negro / Black

Pack size of 10g – Bag containing 1 reusable tube (cannula) and a reusable
plunger.
Pack size of 30g – Bag containing 1 reusable tube (cannula) and a reusable
plunger.
Pull the plunger out of the cannula. Rinse both cannula and plunger well with
warm and clean water so it can be reused for the next application.

Cód. Barras / Barcode

--Papel / Paper

Tipografía / Fonts
Helvetica
(condensed, italic y bold)
Tamaño / Type Size: 9 pt.
Interlínea / Leading: 9 pt.
Correcciones
Not Approved

Aprobado
Approved

Por favor, marque lo que corresponda
Please check the appropiate box

Fecha y Firma / Date and Signed

Anverso / Front
Reverso / Back

If you use more Blissel than you should
If too much gel is applied at any time or someone has swallowed some gel accidentally,
there is no need to worry. However, you should consult a doctor for advice. You might
feel sick or be sick and some women may have some vaginal bleeding after a few days.
If you forget to use Blissel
Do not use a double dose to make up for a forgotten dose.
Apply the missed dose when you remember, unless you are more than 12 hours late. If
you are more than 12 hours late just skip the missed dose.
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, although not everybody gets
them.
Tell your doctor immediately if any of the conditions that are listed in the section “What
you need to know before you use Blissel” occur, such as vaginal bleeding. Your doctor
may need to stop treatment and give you an alternative.
At the beginning of treatment local irritation or itching may occur. In most patients these
side effects go away with continued use. Tell your doctor if vaginal bleeding occurs, or if
any of the following side effects become troublesome or continue.
Common side effects (may affect up to 1 in 10 people):
Itching, local irritation in or around the vagina
Uncommon side effects (may affect up to 1 in 100 people):
Low abdominal pain, skin irritation, genital rash, headache, Candidiasis (vaginal ‘thrush’)
Other very rare side effects (may affect up to 1 in 10,000 people): may occur when
higher dose oestrogen preparations that can raise blood levels of oestrogen (such as
tablets or stick on patches) are taken for a long time.
breast cancer;
abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or
cancer);
blood clots in the veins of the legs or lungs (venous thromboembolism);
heart disease;
stroke;
probable memory loss;
For more information about these side effects, see Section 2.
As Blissel is a vaginal gel for local treatment and contains a very low dose of estriol, your
risk of developing these side effects is very low.
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 (see
details below)
United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

CONSILIENT HEALTH

Ltd.

P0544

300 mm

Offset blanco / Offset white 56 g/m2

Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971 - Fax: +353 1 6762517
Website: www.hpra.ie - e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Blissel
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 carton and label. The
expiry date refers to the last day of that month.
Store below 25ºC.
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 Blissel contains
The active substance is estriol.
One applicator filled to the mark delivers a dose of 1 g vaginal gel that contains
50 micrograms estriol.
The other ingredients are: Glycerol (E422), sodium methyl parahydroxybenzoate
(E 219), sodium propyl parahydroxybenzoate (E 217), polycarbophil, carbopol, sodium
hydroxide, hydrochloric acid, purified water.
What Blissel looks like and content of the pack
This medicinal product is presented as a colourless, clear to slightly translucent vaginal
gel, pack size of 1 aluminium tube 10g or 30 g.
Pack size of 10g – Blister containing 10 disposable tubes (cannulas) and a reusable
plunger.
Cardboard box 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.
Cardboard box 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.
Cardboard box containing 30 g of Blissel and three blisters each containing 10
disposable tubes (cannulas) with a filling mark and a reusable plunger.
Pack size of 30g – Bag containing 1 reusable tube (cannula) and a reusable plunger.
Cardboard box containing 30g of Blissel and one bag containing 1 reusable tube
(cannula) with a filling mark and a reusable plunger.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid)- Spain
Distributor
United Kingdom
Consilient Health (UK) Ltd.
No. 1 Church Road,
Richmond Upon Thames,
Surrey,
TW9 2QE
Ireland
Consilient Health Limited
Block 2A
Richview Office Park,
Clonskeagh, Dublin 14,
Ireland
Manufacturer responsible for batch release
ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid)- Spain
This medicinal product is authorized in the Member States of the EEA under the
following names:
Es: Blissel 50 microgramos/g gel vaginal
Su: Blissel 50 mikrogram/g vaginal gel
Fr: Blissel 50 microgrammes/g gel vaginal
It: Blissel 50 microgrammi/g gel vaginale
Po: Blissel 50 microgramas/g gel vaginal
EL: Blissel 50 μικρογραμμάρια/g κολπική γέλη
Be: Blissel 50 microgrammes/g gel vaginal
Dk: Gelisse 50 mikrogram/g vaginalgel
Fi: Blissel 50 mikrog/g emätingeeli
IE: Blissel 50 micrograms/g vaginal gel
NL: Blissel 50 microgram/g gel voor vaginaal gebruik
No: Gelisse 50 mikrogram/g vaginalgel
UK: Blissel 50 micrograms/g vaginal gel
This leaflet was last revised in March 2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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