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BLISSEL 50 MICROGRAMS/G VAGINAL GEL

Active substance(s): ESTRIOL

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200 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Blissel 50 micrograms/g vaginal gel
Estriol
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.
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 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.
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.

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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
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.
2. What you need to know before you use Blissel
Do not use Blissel
if you are allergic (hypersensitive) to estriol or any of the other ingredients of
this medicine (listed in the section 6).
if you have, have had or it is suspected that you have a breast cancer or a
cancer of the womb
if you are pregnant or you think you may be pregnant
if you have unexpected vaginal bleeding
if you have abnormal growth of the lining of your womb (endometrial
hyperplasia)
if you have or have previously had blood clots in the veins of the legs (deep
venous thrombosis) or in the lungs (lung embolism)
if you have or have recently had heart problems such as angina or heart attack
if you have an acute liver disease or have previously had liver disease and
your liver function has not returned to normal
if you have porphyria (a rare metabolic disease)
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:
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.

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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
5

6

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.

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 clean water so it can be reused for the next
application.

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 (occur in less than 1 in 10 patients):
Itching, local irritation in or around the vagina
Uncommon side effects (occur in less than 1 in 100 patients):
Low abdominal pain, skin irritation, genital rash, headache, Candidiasis (vaginal
‘thrush’)
Other very rare side effects 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:
- Certain types of tumours such as endometrial cancer and breast cancer
- Blood clots in the veins
- Heart attack and stroke

300 mm

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 clean water so it can be reused for the next application.

- Gall bladder disease
- Skin problems such as rashes or red patches on the skin
- Dementia (brain disease)
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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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 leaflet was last revised in: 07 /2016

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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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