ESOLUT 200 mg Pessary

Зміст інструкції

1. ESOLUT 200 mg vaginal suppositories
   1. What is ESOLUT and what is it used for
   2. What you need to know before using ESOLUT
   3. How to use ESOLUT
   4. Possible side effects
   5. How to store ESOLUT
   6. Contents of the pack and other information

ESOLUT 200 mg vaginal suppositories

Progesterone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ESOLUT is and what it is used for
• 2. What you need to know before using ESOLUT
• 3. How to use ESOLUT
• 4. Possible side effects
• 5. How to store ESOLUT
• 6. Contents of the pack and other information

1. What is ESOLUT and what is it used for

ESOLUT is a medicinal product for vaginal use containing progesterone, a sex hormone
naturally produced by the female body.
ESOLUT is used in women who need an integration of progesterone because their
body does not produce enough of it (luteal insufficiency). Progesterone acts on the wall
of the uterus, promoting the start and continuation of pregnancy.

2. What you need to know before using ESOLUT

Do not use ESOLUT if:

• you are allergic to the active ingredient (progesterone) or to any of the other ingredients of this medicine (listed in section 6);
• you have had an abortion;
• you have a severe impairment of liver function;
• you have or have had or suspect you have cancer of the breast or genital tract;
• you have or have had in the past blood clots (thrombi or emboli), for example in the lower limbs (thrombophlebitis) or in the lungs (pulmonary embolism);
• you have vaginal bleeding of unknown cause;
• you have bleeding in the brain (cerebral).

Warnings and precautions
Before prescribing ESOLUT, the doctor will perform a general and gynecological examination; furthermore
he/she will perform the PAP test and ask you questions about your personal and family medical history.
Consult your doctor before using ESOLUT if:

• there are cases of cancer in your family;
• you have repeatedly experienced a yellowish discoloration of the skin or persistent itching during a pregnancy;
• you have problems with the kidneys, liver or heart;
• you have isolated or widespread breast lumps (fibrocystic mastopathy);
• you suffer from epileptic seizures;
• you suffer from asthma;
• you have a decrease in hearing caused by a thickening of the inner ear tissues (otosclerosis);
• you have diabetes;
• you have a disease of the nervous system called multiple sclerosis;
• you have a connective tissue disease called systemic lupus erythematosus that causes joint pain, skin changes and disorders of various organs;
• you have hormonal problems;
• you experience episodes of great sadness (severe depression).

During therapy with ESOLUT, you will need to see your doctor for regular check-ups; your
doctor will determine when (at least once a year) and what tests to perform (e.g. breast exams and/or mammography). During these check-ups, the doctor may discuss with you the need
or not to continue using ESOLUT.
ESOLUT and the risk of cancer
In postmenopausal women who are undergoing or have undergone hormone replacement therapy
with progesterone, the risk of developing breast cancer increases. This increased risk
of cancer during hormone replacement therapy with progesterone may be due to both
early diagnosis in treated patients and a real effect of the therapy, or even to
the combination of both. The risk of developing breast cancer increases with the duration of
treatment and appears to return to the initial value after five years from discontinuation of therapy.
Breast cancer diagnosed in patients who use or have recently used hormone replacement therapy
with progesterone appears to be less invasive in nature than that of
untreated women.
ESOLUT is used for local treatment and contains a low dose of progesterone. However, if
you are concerned about the risk of developing cancer, discuss it with your doctor.

Pay particular attention with ESOLUT
If you experience any of the following conditions during treatment, inform your doctor immediatelybecause it may be necessary to stop therapy:

• blood clots in the lungs. This condition manifests with difficulty breathing, chest pain and cough;
• blood clots in the brain resulting in stroke. This condition manifests with severe headache or vomiting, dizziness, fainting or alterations in vision or speech, weakness or numbness of an arm or leg;
• blood clots in the limbs (peripheral vessels), especially in the legs. This condition manifests with swelling, redness and increased temperature of the affected part;
• changes in vision, such as double vision or decreased vision. Also inform your doctor if these symptoms appear some days after taking the last dose.

Other medicines and ESOLUT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is particularly important if you are taking bromocriptine, a medicine used for
example in galactorrhea (abnormal secretion of milk from the breast).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of ESOLUT in pregnancies at risk of abortion can only occur after careful
evaluation by the doctor.
If you are breastfeeding, it is not recommended to use this medicine.

Driving and using machines
ESOLUT does not impair the ability to drive vehicles or operate machinery.

3. How to use ESOLUT

Use this medicine following the instructions of your doctor exactly, who will establish the correct dose
and duration of treatment, based on your condition. If you have any doubts, consult your doctor or
pharmacist.
The recommended daily doseis 1 suppository (equivalent to 200 mg of progesterone), from the 14th to the 26th
day of the menstrual cycle or estrogen replacement therapy. The dose should be applied
deeply into the vagina, preferably in the evening before going to bed.
The durationof treatment will be established by your doctor: always follow their instructions.

INSTRUCTIONS FOR USING ESOLUT
Wash your hands thoroughly and take a suppository from the packaging.
Lie down with your knees bent and spread apart (as shown in the figure).
Gently insert the suppository into the vagina as deeply as possible.

If you use more ESOLUT than you should
No cases of overdose have been reported. If you use more ESOLUT than you should or in case of
accidental ingestion, contact your doctor or go to the nearest hospital.

If you forget to use ESOLUT
Do not use a double dose to make up for a missed dose.

If you stop using ESOLUT
Do not stop treatment without consulting your doctor. If you have any doubts about 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 everyone will experience them.
Contact your doctor immediately if you notice any changes in your menstrual flow,
drowsiness and dizziness. These side effects have occurred rarely.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak with your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can contribute to providing more information on the safety of this medicine.

5. How to store ESOLUT

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 packaging. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ESOLUT contains
The active ingredient is: progesterone.
Each suppository contains 200 mg of progesterone.
The other ingredients are: solid semi-synthetic glycerides.

Description of the appearance of ESOLUT and contents of the pack
ESOLUT suppositoriesis available in packs of 12 suppositories of 200 mg.

Marketing Authorisation Holder
Angelini Pharma S.p.A. - Viale Amelia, 70, 00181 Rome

Manufacturer
A.C.R.A.F. S.p A. - Via Vecchia del Pinocchio, 22, 60131 Ancona