50 micrograms / g vaginal 
gel estriol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Blissel is and what it is used for 
2. What you need to know before using Blissel 
3. How to use Blissel 
4. Possible side effects 
5. How to store Blissel 
6. Contents of the packaging and other information 

1. What Blissel is and what it is used for

Blissel contains estriol. It is a female sex hormone that is identical to a hormone that the body produces itself and is called estrogen.

Blissel is used to treat vaginal problems due to too little estrogen in the body. Lack of estrogen can make the vaginal wall thin and dry. Intercourse can be painful and you can get an infection in your vagina. These problems can be alleviated by using estrogen-containing medicines, such as Blissel. It may take several days or weeks before you notice an improvement.

Blissel is used to treat dry mucous membranes in the vagina in women who have passed menopause and who are deficient in estrogen.

Estriol found in Blissel may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Blissel

In addition to the benefits of hormone replacement therapy, there are also some risks that you need to consider when deciding whether to start or continue treatment.

Before starting hormone replacement therapy

Your doctor will ask you about your and your family’s medical history. Your doctor may want to examine your breasts or abdomen and may perform a gynecological examination. This will only be done if it is necessary for you or if you have something special that you are worried about.

  • Tell your doctor if you have any medical problems or diseases.

Regular checks

As soon as hormone replacement therapy has started, make regular visits to your doctor for check-ups. At these checkups, your doctor may want to discuss the benefits and risks of continuing hormone replacement therapy.

Do not use Blissel

  • If you have or have had breast cancer or if you suspect it may be
  • If you have cancer that is sensitive to estrogen, such as cancer of the womb lining ( endometrium ), or if you are suspected of having it.
  • If you have unexplained genital bleeding.
  • If you have untreated excessive growth of the uterine lining ( endometrial hyperplasia ).
  • If you have or have had a blood clot in a vein ( thrombosis ) such as in the legs (deep vein thrombosis ) or in the lungs ( pulmonary embolism ).
  • If you have a blood clotting disorder (such as a lack of protein C, protein S, or antithrombin).
  • If you have or have recently had a disease caused by blood clots in the arteries are as heart attack, stroke, or angina ( angina pectoris ).
  • If you have or have had liver disease and your liver function values ​​have not normalized;
  • If you have an unusual, inherited blood disorder called “porphyria”.
  • 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 occur for the first time when you use Blissel, stop taking Blissel immediately and consult a doctor immediately.

Warnings and cautions

This medicine is given with an applicator that is inserted into the vagina. It can cause discomfort and soreness in women who have severe vaginal atrophy (thin or inflamed mucous membranes of the vaginal walls).

Tell your doctor if you have or have had any of the following diseases/conditions, which in rare cases may return or worsen during treatment with Blissel:

  • heart disease or problems with blood circulation
  • too high cholesterol or too high levels of other fats in the blood
  • changes in the breasts
  • endometriosis (abnormal growth of uterine lining outside the uterus)
  • Nodule tissue in the uterus ( fibroids )
  • high blood pressure
  • diabetes
  • gallstones ar
  • migraine or severe headache
  • the systemic lupus erythematosus ( SLE ), a rare autoimmune disease
  • epilepsy (convulsions)
  • asthma
  • otosclerosis (hearing loss due to ossification in the middle ear)
  • kidney disease

Permission to contact a doctor immediately

  • jaundice (whites of the eyes and skin yellowing) or deterioration of liver function
  • a sudden increase in blood pressure et
  • if you have a migraine or severe headache for the first time
  • if you become pregnant
  • if something happens that is listed under the heading “Do not use Blissel”.

If any of the above occur, your doctor may need to stop treatment or give you another treatment. 

Treatment with estrogen preparations that contain high estrogen doses (such as tablets or patches ) increases the amount of estrogen in the blood and increases the risk of abnormally strong growth of the uterine lining ( endometrial hyperplasia ), certain types of cancer such as breast and uterine cancer and blood clots in the vein. Blissel is a vaginal gel for topical treatment and contains a very low dose of estriol. Therefore, the risk for you to develop these conditions is very small. If you still feel worried about the risks, discuss it with your doctor.

Other drugs and Blissel

Blissel contains a very low dose of estriol and the treatment is local. Therefore, Blissel is not expected to affect or be affected by concomitant use of other drugs. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, 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 taking this medicine.

You should not use Blissel if you are pregnant.

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

You should not use Blissel if you are breast-feeding.

Driving and using machines

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

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

These may cause an allergic reaction (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 it is in this leaflet or as directed by your doctor or pharmacist. Contact your doctor or pharmacist if you are not sure. The recommended dose for the first 3 weeks of treatment is a dose with the applicator daily, (preferably in connection with bedtime). After 3 weeks of treatment, the symptoms should have been alleviated and the dose should be reduced. You may now only need one dose twice a week.

Use the applicator to insert the gel into the vagina (preferably before bedtime).

The following instructions explain how to use the gel.

In the picture below you can see the different parts of the tube and the applicator (including piston).

Blissel components

1. Remove the cap on the tube, turn the cap over and use its sharp tip to cut through the seal on the end of the tube. Do not use it if the seal is broken.

Bli 2

2. Remove an applicator and a plunger. Insert the white plunger as far as it will go into the applicator. Attach the applicator to the tube.

Bli 3

3. Press the tube so that the applicator fills with gel, to the filling mark. The piston stops at the marking.

Bli 4

4. Unscrew the piston from the tube and put the lid on the tube.

5

5. To apply gel one lies down, insert the end of the applicator deep into the vagina, and slowly push the plunger until it reaches the bottom.

6

6. After use:

Pack size 10 g – Blister containing 10 disposable applicators and 1 reusable flask

Pack size 30 g – 3 Blisters containing 30 disposable applicators and 1 reusable flask

Pull the flask out of the applicator, discard the applicator and rinse the flask well with warm and clean water so that it can be reused for the next application.





Pack size 10 g – Plastic pocket containing 1 reusable applicator and 1 reusable flask

Pack size 30 g – Plastic pocket containing 1 reusable applicator and 1 reusable flask

Pull the flask out of the applicator, rinse both the applicator and the flask well with warm and clean water so that it can be reused for the next application.

Number 9

.

If you forget to use Blissel

Do not take a double dose to make up for a forgotten dose.

Take the missed dose as soon as you remember, unless 12 hours have elapsed. If it is more than 12 hours since you forgot to take your dose, skip the missed dose.

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

4. Possible side effects

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

Talk to your doctor immediately if any of the conditions under “What you need to know before using Blissel” occur, e.g. vaginal bleeding. Your doctor may need to stop treatment or give you another treatment.

At the beginning of treatment, local irritation or itching may occur. In most patients, these side effects disappear with continued use. Talk to your doctor if any of the following side effects become bothersome or disappear.

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

Itching, local irritation in and around the vagina.

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

Pain in the lower abdomen, skin irritation, itching in the abdomen, headache, candidiasis (fungal infection of the vagina).

Other very rare side effects (may affect up to 1 in 10,000 people) can occur with estrogen preparations that contain high estrogen doses (such as tablets or patches ) that increase the amount of estrogen in the blood and are taken for a long time:

  • breast cancer
  • abnormal growth or cancer of the uterine lining ( 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 on side effects, see section 2.

Because Blissel is a vaginal gel for topical treatment and contains a very low dose of estriol, the risk of developing these side effects is very small.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects you can help increase the information about the safety of this medicine.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

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 expiration date is the last day of the specified month.

Do not store above 25 ° C.

The medicine 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is estriol. An applicator filled to the mark provides a dose of 1 g of a vaginal gel containing 50 micrograms of estriol.
  • The other ingredients are: Glycerol (E 422), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), polycarbophil, carbopol, sodium hydroxide, hydrochloric acid, purified water

What the medicine looks like and the contents of the pack

The drug is a colorless, almost transparent vaginal gel.

Package contents: 1 aluminum tube of 10 g or 30 g gel for vaginal application

  • Pack size 10 g – Blister containing 10 disposable applicators and 1 reusable flask. The medicine pack contains a tube containing 10 g Blissel and 1 blister, containing 10 dose-marked disposable applicators and a flask to be reused
  • Pack size 10 g – Plastic pocket containing 1 reusable applicator and 1 reusable flask. The medicine pack contains a tube containing 10 g Blissel and 1 plastic pocket, which contains 1 dose-marked reusable applicator and a flask to be reused
  • Pack size 30 g – Blister containing 30 disposable applicators and 1 reusable flask. The medicine pack contains a tube containing 30 g Blissel and 3 blisters, each blister containing 10 dose-marked disposable applicators and a flask to be reused
  • Pack size 30 g – Plastic pocket containing 1 reusable applicator and 1 reusable flask. The medicine pack contains a tube containing 30 g Blissel and 1 plastic pocket, which contains 1 dose-marked reusable applicator and a flask to be reused

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ITALFARMACO SA

San Rafael, 3 – 28108 Alcobendas

(Madrid), Spain

Agent:

CampusPharma AB

Karl Gustavsgatan 1A

411 25 Gothenburg

Muhammad Nadeem

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