Blissel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Blissel 50 micrograms/g vaginal gel

estriol

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

• You should 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.

Contents of the pack and other information

• 1. What Blissel is and what it is used for
• 2. 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 belongs to a group of medicines called hormone replacement therapy (HRT) for vaginal use (local).
It is used to relieve symptoms of the menopause that occur in the vagina, such as dryness or irritation. In medical terms, this is called "vaginal atrophy". It is caused by a decrease in estrogen levels in the body and occurs naturally after menopause.
Blissel works by replacing estrogen, which is produced by the ovaries. The medicine is given vaginally, so the hormone is released where it is needed. This can help relieve discomfort in the vagina.

2. Before you use Blissel

Medical history and regular check-ups

The use of HRT carries risks that need to be considered when deciding whether to start or continue HRT.
Before starting (or restarting) HRT, your doctor should ask about your medical history and perform a physical examination. This may include a breast and/or gynecological examination if necessary.
If you start using Blissel, you should have regular check-ups with your doctor (at least once a year). During these check-ups, you should discuss the benefits and risks of continuing to use Blissel with your doctor.
Women should have regular breast screenings as recommended by their doctor.

When not to use Blissel

In case of any of the following conditions. If you are unsure about any of the following points, consult your doctor before using Blissel.

• If you currently have or have ever had breast cancer or if there is a suspicion of breast cancer;
• If you have an estrogen-sensitive tumor, such as endometrial cancer (cancer of the lining of the uterus), or if there is a suspicion of such a tumor;
• If you have vaginal bleeding of unknown cause;
• If you have untreated endometrial hyperplasia (thickening of the lining of the uterus);
• If you currently have or have ever had blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If you have blood clotting disorders (such as protein C, protein S, or antithrombin deficiency);
• If you currently have or have recently had a disease caused by the presence of blood clots in the arteries, such as a heart attack, stroke, or angina;
• If you have liver disease and liver function tests have not returned to normal;
• If you have a rare blood disorder called porphyria that is inherited in families;
• If you are allergic (hypersensitive) to estriol or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time while using Blissel, you should stop using it immediately and consult your doctor without delay.

Warnings and precautions

The medicine is given through the insertion of the applicator into the vagina. This may cause discomfort or pain in women with severe vaginal atrophy (thinning or inflammation of the vaginal walls).
Tell your doctor if you have or have had any of the following conditions (or diseases), which may rarely return or worsen during treatment with Blissel. In these cases, your doctor may decide to monitor you more closely:

• very high levels of triglycerides (a type of fat) in the blood,
• endometriosis (growth of uterine tissue outside the uterus) or endometrial hyperplasia (thickening of the uterine lining) in the past,
• uterine fibroids,
• high blood pressure,
• diabetes,
• gallstones,
• migraine or severe headache,
• a rare disease of the immune system called systemic lupus erythematosus (SLE),
• epilepsy,
• asthma,
• a disease that affects the eardrum and hearing (otosclerosis),
• fluid retention due to heart or kidney problems,
• increased risk of blood clots (see "Blood clots in the veins (thrombosis)"),
• increased risk of estrogen-dependent tumors (breast cancer in the mother, sister, or grandmother),
• liver disease, such as a benign liver tumor,
• inherited or acquired angioedema.

You should contact your doctor immediately in the following cases

• If you experience yellowing of the skin and eyes (jaundice) or liver problems;
• sudden increase in blood pressure;
• migraine or severe headache, occurring for the first time;
• pregnancy;
• If any of the conditions listed in the section "When not to use Blissel" occur.
• If you experience symptoms of blood clots, such as:
• painful swelling and redness of the legs,
• sudden chest pain,
• difficulty breathing.

See "Blood clots in the veins (thrombosis)" for more information.
If any of the above situations occur, it is possible that your doctor will need to stop treatment and prescribe another medicine.
Note: Blissel is not a contraceptive. If it has been less than 12 months since your last menstrual period or you are under 50 years old, you may need to use an additional method of contraception. Consult your doctor.

HRT and cancer

Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer

Long-term use of HRT tablets containing only estrogen may increase the risk of developing endometrial cancer.
It is not known if a similar risk exists with repeated or prolonged (longer than one year) use of Blissel. However, Blissel is absorbed into the bloodstream to a very small extent, and therefore, the addition of a progestogen is not necessary.
Bleeding or spotting is not usually a cause for concern, but you should consult your doctor. It may be a sign of endometrial hyperplasia.
The risks described below are associated with HRT medicines that circulate in the blood. Blissel, on the other hand, is intended for local use in the vagina and is absorbed into the bloodstream to a very small extent. The worsening or recurrence of the conditions mentioned below during treatment with Blissel is less likely, but if you have any concerns, you should consult your doctor.
Treatment with products containing higher doses of estrogen, which may increase estrogen levels in the blood (such as tablets or patches), increases the risk of abnormal growth of the uterine lining (endometrial hyperplasia), certain types of cancer, such as breast and endometrial cancer, and the occurrence of blood clots in the veins.

Breast cancer

Data indicate that the use of Blissel does not increase the risk of breast cancer in women who have never had it before. It is not known if Blissel can be safely used in women who have had breast cancer.

• You should have regular breast exams. You should contact your doctor if you notice any changes, such as:
• indentation of the skin,
• changes in the nipple,
• presence of lumps that are visible or palpable.

In addition, it is recommended to have regular mammography screenings as advised by your doctor.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. The use of HRT that only contains estrogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over a 5-year period.
In women who have taken HRT for 5 years, the number of cases will be about 3 out of 2,000 (i.e., 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in the veins (thrombosis)

The risk of blood clots in the veins is 1.3 to 3 times higher in women using HRT compared to those not using it, especially in the first year of use.
The formation of blood clots can have serious consequences, and if they move to the lungs, they can cause chest pain, shortness of breath, loss of consciousness, or even death.
The risk of blood clots in the veins is higher if you are older or if any of the following situations apply to you. You should inform your doctor if any of the following situations apply to you:

• if you are unable to walk for a long time due to a major operation, injury, or illness;
• if you have significant obesity (BMI > 30 kg/m2);
• if you have thromboembolic disorders that require long-term use of anticoagulant medications;
• if you or anyone in your close family has had blood clots in the legs or lungs in the past;
• if you have systemic lupus erythematosus;
• if you have been diagnosed with cancer.

Comparison
In women aged 50-59 who do not use HRT, the estimated number of cases of blood clots in the veins over a 5-year period is 4-7 per 1,000 women.
In women aged 50-59 who use estrogen-only HRT for more than 5 years, the number of cases will be 5-8 per 1,000 (i.e., 1 additional case).

Heart disease (heart attack)

Women using estrogen-only HRT do not have an increased risk of developing heart disease.

Stroke

The risk of stroke is about 1.5 times higher in women using HRT compared to those not using it.
The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-59 who do not use HRT, the estimated number of stroke cases over a 5-year period is about 8 per 1,000 women.
In women aged 50-59 who use HRT, the number of cases over a 5-year period will be 11 per 1,000 women (i.e., 3 additional cases).

Blissel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, herbal medicines, or other natural products.
Blissel contains a small dose of estriol and is intended for local use, so it is not expected to affect the action of other medicines you are taking or for other medicines to affect the action of Blissel. However, you should consider interactions with other medicines used locally in the vagina.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Blissel during pregnancy.
If you become pregnant while using Blissel, you should tell your doctor immediatelyand stop using Blissel.
Blissel should not be used during breastfeeding.

Driving and using machines

Blissel has no effect on the ability to drive or use machines.

Blissel contains methyl parahydroxybenzoate (sodium salt) (E 219) and propyl parahydroxybenzoate (sodium salt) (E 217)

The medicine may cause allergic reactions (possible late reactions).
Do not use this medicine if you are allergic to any of the ingredients.

3. How to use Blissel

This medicine should always be used as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose during the first 3 weeks of treatment is one dose given once daily, preferably before going to bed. After 3 weeks of treatment, discomfort should decrease, and the dose should be reduced. One dose given twice a week may be sufficient.
To administer the gel, use the applicator (it is recommended to use it before going to bed).
Your doctor should prescribe the lowest dose that will treat your symptoms for the shortest possible time. If you think that the dose of Blissel is too high or too low, you should consult your doctor.

The following instructions explain how to use the gel.

The image below shows the different parts of the tube and applicator (plunger and cannula).

• 1. Remove the cap from the tube, turn it upside down, and use the sharp end to pierce the protective membrane of the tube. Do not use if the membrane is damaged.

• 2. Remove the cannula and plunger. Insert the white plunger completely into the cannula. Screw the cannula onto the threaded end of the tube.

• 3. Squeeze the tube to fill the applicator with gel up to the fill mark. The plunger will stopat the fill mark.

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

• 5. To apply the gel, lie down, insert the tip of the applicator deeply into the vagina, and slowly press the plunger until it stops.

• 6. After use

Package size 10 g - 1 blister containing 10 single-use cannulas and a reusable plunger.
Package size 30 g - 3 blisters containing 30 single-use cannulas and a reusable plunger.
Remove the plunger from the cannula, discard the cannula, and wash the plunger thoroughly with warm, clean water so that it can be used again for the next administration.

Package size 10 g - a bag containing 1 reusable cannula and a reusable plunger.
Package size 30 g - a bag containing 1 reusable cannula and a reusable plunger.
Remove the plunger from the cannula. Wash both the cannula and plunger thoroughly with warm, clean water so that they can be used again for the next administration.

Using more Blissel than you should

If you accidentally use too much gel or swallow some, there is no need to worry. However, you should consult your doctor.
You may feel nauseous or vomit, and some women may experience vaginal bleeding a few days later.

Forgetting to use Blissel

Do not use a double dose to make up for a forgotten dose.
Use the forgotten dose as soon as you remember, if it is not more than 12 hours late. If more than 12 hours have passed, 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, Blissel can cause side effects, although not everybody gets them.
You should tell your doctor immediatelyif you experience any of the conditions listed in the section "Before you use Blissel", such as vaginal bleeding.
It is possible that your doctor will need to stop treatment and prescribe another medicine.
At the beginning of treatment, local irritation or itching may occur. In most patients, these side effects disappear as treatment continues. You should tell your doctor if you experience vaginal bleeding or if any of the following side effects become troublesome or persist.

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

Itching, local irritation in the vagina or around the vagina

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

Abdominal pain, skin irritation, rash on the genitals, headache, vaginal thrush (candidiasis)
The following conditions are reported more frequently in women using HRT medicines that circulate in the blood than in women not using HRT. This risk is lower with locally administered products like Blissel:

• blood clots in the veins (venous thromboembolism),
• ovarian cancer,
• stroke,
• possible loss of memory if HRT is started over the age of 65.

See section 2 for more information on these side effects.
The following side effects have been reported during HRT:

• gallstones,
• various skin disorders:
• skin discoloration, especially on the face or neck, known as chloasma (melasma),
• painful red lumps on the skin (erythema nodosum),
• rash with characteristic redness or pain (erythema multiforme).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
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 in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 fill mark delivers a dose of 1 g vaginal gel, which contains 50 micrograms of estriol.
The other ingredients are: glycerol (E 422), methyl parahydroxybenzoate (sodium salt) (E 219), propyl parahydroxybenzoate (sodium salt) (E 217), polycarbophil, carbomer, sodium hydroxide, hydrochloric acid, purified water.

What Blissel looks like and contents of the pack

This medicine is a colorless, transparent to slightly translucent vaginal gel.
Package size 10 g - a blister containing 10 single-use cannulas and a reusable plunger. A carton containing 10 g Blissel and one blister containing 10 single-use cannulas with fill mark and reusable plunger.
Package size 10 g - a bag containing 1 reusable cannula and a reusable plunger. A carton containing 10 g Blissel and one bag containing 1 reusable cannula with fill mark and reusable plunger.
Package size 30 g - 3 blisters containing 30 single-use cannulas and a reusable plunger. A carton containing 30 g Blissel and three blisters containing 30 single-use cannulas with fill mark and reusable plunger.
Package size 30 g - a bag containing 1 reusable cannula and a reusable plunger. A carton containing 30 g Blissel and one bag containing 1 reusable cannula with fill mark and reusable plunger.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid)- Spain
Tel: +34 916572323

Manufacturer

ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid)- Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT:
BLISSEL 50 Mikrogramm/g Vaginalgel
BE:
Blissel 50 Mikrogramm/g Vaginalgel
CY:
Blissel 50 μικρογραμμάρια/g κολπική γέλη
DK:
Gelisse 50 mikrogram/g vaginalgel
EL:
Blissel 50 μικρογραμμάρια/g κολπική γέλη
ES:
Blissel 50 microgramos/g gel vaginal
FI:
Blissel 50 mikrog/g emätingeeli
FR:
Blissel 50 microgrammes/g gel vaginal
IE:
Blissel 50 micrograms/g vaginal gel
NL:
Blissel 50 microgram/g gel voor vaginaal gebruik
NO:
Gelisse 50 mikrogram/g vaginalgel
PL:
BLISSEL
PT:
Blissel 50 microgramas/g gel vaginal
SE:
Blissel 50 mikrogram/g vaginal gel
UK (NI):
Blissel 50 micrograms/g vaginal gel

Date of last revision of the leaflet: