Package leaflet: Information for the patient

ESOLUT 200 mg vaginal ovules

Progesterone
Please read this leaflet carefully before using this medicine because 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 for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ESOLUT is and what it is used for
What you need to know before using ESOLUT
How to use ESOLUT
Possible side effects
How to store ESOLUT
Contents of the pack and other information

1. What ESOLUT is and what it is used for

ESOLUT is a vaginal medicine containing progesterone, a sex hormone naturally produced by the female body.
ESOLUT is used in women who require progesterone supplementation because their body does not produce enough of it (luteal phase deficiency). Progesterone acts on the uterine wall, supporting the establishment and maintenance of pregnancy.

2. What you need to know before using ESOLUT

Do not use ESOLUT if:

you are allergic to the active substance (progesterone) or to any of the other ingredients of this medicine (listed in section 6);
you have had a miscarriage;
you have severe liver dysfunction;
you have or have had, or suspect you may have, a breast or genital tract tumour;
you have or have had blood clots in blood vessels (thrombi or emboli), for example in the legs (thrombophlebitis) or lungs (pulmonary embolism);
you have vaginal bleeding of unknown cause;
you have or have had bleeding in the brain (cerebral haemorrhage).

Warnings and precautions
Before prescribing ESOLUT, your doctor will perform a general and gynaecological examination; in addition,
your doctor will perform a Pap test and ask you questions about your personal and family medical history.
Contact your doctor before using ESOLUT if:

there is a history of cancer in your family;
you have previously experienced repeated episodes of yellowing of the skin or persistent itching during pregnancy;
you have kidney, liver or heart problems;
you have isolated or widespread breast nodules (fibrocystic mastopathy);
you suffer from epileptic seizures;
you suffer from asthma;
you have hearing loss caused by thickening of internal ear tissues (otospongiosis);
you have diabetes;
you have a nervous system disorder called multiple sclerosis;
you have a connective tissue disease called systemic lupus erythematosus, which causes joint pain, skin changes and disturbances in various organs;
you have hormonal disorders;
you experience episodes of profound sadness (severe depression).

During treatment with ESOLUT, you must visit your doctor regularly for check-ups; your
doctor will determine when (at least once a year) and which tests to perform (e.g. breast examinations and/or mammography). During these check-ups, your doctor may discuss with you whether 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
during hormone replacement therapy with progesterone may be due to either earlier diagnosis in treated
patients, a real effect of the therapy, or a combination of both. The risk of developing breast cancer increases with the duration of
treatment and appears to return to baseline levels five years after stopping therapy.
Breast cancer diagnosed in patients who are currently using or have recently used hormone
replacement therapy with progesterone appears to be less invasive in nature compared to that in
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 this with your doctor.
Take special care with ESOLUT
If during treatment you experience any of the following conditions, inform your doctor immediately
because it may be necessary to discontinue treatment:

blood clots in the lungs. This condition manifests as difficulty breathing, chest pain and cough;
blood clots in the brain leading to stroke. This condition manifests as severe headache or vomiting, dizziness, fainting, or visual or speech disturbances, weakness or numbness in one arm or one leg;
blood clots in limbs (peripheral vessels), especially in the legs. This condition manifests as swelling, redness and increased temperature in the affected area;
visual disturbances, such as double vision or reduced vision. Inform your doctor even if these symptoms appear several days after taking the last dose.

Other medicines and ESOLUT
Inform 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 galactorrhoea (abnormal milk secretion from the breasts).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
The use of ESOLUT in pregnancies at risk of miscarriage may 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 exactly as instructed by your doctor, who will determine the appropriate dose
and duration of treatment based on your condition. If you have any doubts, consult your doctor or
pharmacist.
The recommended daily dose is 1 ovule (equivalent to 200 mg of progesterone), from day 14 to day 26
of the menstrual cycle or of estrogen replacement therapy. The dose should be administered
deeply into the vagina, preferably in the evening before going to bed.
The duration of treatment will be determined by your doctor: always follow his or her instructions.
INSTRUCTIONS FOR USING ESOLUT
Wash your hands thoroughly and take one ovule from the packaging.
Lie down in a position with knees raised and apart (as shown in the figure).
Gently insert the ovule into the vagina as deeply as possible.

Black line drawing showing a hand holding a syringe injecting a drug into the upper thigh of a bent leg

If you use more ESOLUT than you should
Overdose incidents have not been reported. If you use more ESOLUT than prescribed or if accidental
ingestion occurs, 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 the forgotten dose.
If you stop using ESOLUT
Do not stop treatment without consulting your doctor. If you have any doubts about using this
medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any changes in menstrual flow, drowsiness or dizziness. These side effects have occurred rarely.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide 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 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ESOLUT contains
The active substance is: progesterone.
Each suppository contains 200 mg of progesterone.
The other components are: solid semisynthetic glycerides.
Description of the appearance of ESOLUT and contents of the pack
ESOLUT suppositories is available in a carton pack containing 12 suppositories of 200 mg.
Marketing Authorization Holder
Angelini Pharma S.p.A. - Viale Amelia, 70, 00181 Rome, Italy
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22, 60131 Ancona, Italy