Progesteron Adamed

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Progesteron Adamed, 200 mg, vaginal tablets

Progesteronum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Progesteron Adamed and what is it used for
• 2. Important information before taking Progesteron Adamed
• 3. How to take Progesteron Adamed
• 4. Possible side effects
• 5. How to store Progesteron Adamed
• 6. Contents of the pack and other information

1. What is Progesteron Adamed and what is it used for

Progesteron Adamed is a medicine containing a synthetically obtained natural female sex hormone, progesterone.
In the body, progesterone acts through specific receptors located in the uterus, breast tissue, central nervous system, and pituitary gland.
The most important effects of progesterone on the reproductive organs are: enabling ovulation, transforming the endometrium to allow implantation of a fertilized egg, inhibiting excessive growth of the endometrium caused by estrogen, and cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogen also act on the breast tissue, stimulating the growth of glands and epithelium, and enabling lactation.
Progesterone is a hormone necessary for proper preparation of the endometrium for implantation of the embryo, for maintaining pregnancy throughout its duration: it suppresses the spontaneous contractile activity of the pregnant uterus, inhibits the mother's immune response to fetal antigens, is a basic substance for the production of fetal hormones, and initiates labor.
Indications for the use of Progesteron Adamed:

• In vitro fertilization.
• Hormone replacement therapy in postmenopausal women with an intact uterus, who are receiving hormone replacement therapy, to protect the endometrium.

2. Important information before taking Progesteron Adamed

When not to take Progesteron Adamed:

• If the patient is allergic to progesterone or any other component of this medicine (listed in section 6);
• If the patient has vaginal bleeding of unknown cause;
• If the patient has severe liver failure;
• If the patient has a liver tumor;
• If the patient has a breast tumor or a tumor of the genital organs, or if such a tumor is suspected;
• If the patient has an active venous thrombosis (thromboembolism), e.g., in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), or if such thromboses have occurred in the past;
• If the patient has a risk of internal bleeding into the brain;
• If the patient has a rare blood disease called porphyria, which is inherited from generation to generation (genetic disease);
• If there has been a miscarriage and it is suspected that some tissue still remains in the uterus, or if the pregnancy is developing outside the uterus.

Warnings and precautions

Before starting treatment with Progesteron Adamed, the patient should discuss it with their doctor.
This medicine, when used as directed, does not have a contraceptive effect.
Before starting hormone replacement therapy during menopause (and later at regular annual intervals), the patient should consult a doctor who will perform a breast examination and a pelvic examination. The patient should tell their doctor if:

• they have a history of blood clots in the veins (venous thrombosis);
• they have uterine bleeding. The patient should stop taking this medicine if:
• they experience any vision disturbances (e.g., impaired vision, double vision, pathological changes in the blood vessels of the retina);
• they have blood clots (thromboembolic disease);
• they have severe headaches. If the patient experiences a lack of menstruation during treatment, they should ensure they are not pregnant. During treatment, the endometrium may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If unexpected bleeding or spotting occurs and persists during prolonged treatment, at the end of treatment, or after treatment, the patient should consult their doctor. If the patient has depression and experiences mood changes or worsening of depressive symptoms, they should contact their doctor as soon as possible. The doctor will inform the patient about the need to report any changes in the breast area. This medicine should be used with special caution in patients:
• with mild to moderate liver function disorders,
• with diseases whose symptoms may worsen due to fluid retention (e.g., epilepsy, migraine, asthma, heart or kidney disorders),
• with diabetes or diagnosed insulin resistance,
• over 35 years old, smoking, and with risk factors for atherosclerosis.

Children and adolescents

There is insufficient data on the safety and efficacy of Progesteron Adamed in children and adolescents.

Progesteron Adamed and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Progesteron Adamed:

• barbiturates used for sleep disorders or anxiety treatment,
• medicines used for epilepsy (carbamazepine, phenytoin),
• certain antibiotics (ampicillins, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory medicine),
• spironolactone (a diuretic),
• certain antifungal medicines (ketoconazole, griseofulvin), Similarly, Progesteron Adamed may affect the action of some medicines used to treat diabetes. Herbal products containing St. John's Wort (Hypericum perforatum) may weaken the action of Progesteron Adamed. Progesteron Adamed may enhance the action of cyclosporine.

Pregnancy, breastfeeding, and fertility Pregnancy

• If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Breastfeeding

• Breastfeeding women should not take this medicine.

Fertility

• This medicine may be taken by women who have difficulty getting pregnant. This medicine does not have a harmful effect on fertility.
• Before starting treatment with this medicine, the patient should discuss it with their doctor.

Driving and using machines

Progesteron Adamed administered vaginally does not affect the ability to drive or operate machines. If side effects such as drowsiness, concentration disorders, or dizziness occur, the patient should not drive or operate machines (see section 4).

3. How to take Progesteron Adamed

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
The dosage of progesterone should be determined individually each time, depending on the indications and efficacy of the treatment. For doses other than 200 mg, vaginal tablets of 100 mg are available.
Adults
In in vitro fertilization programs, 100-200 mg of progesterone are used 2-3 times a day vaginally.
Treatment is continued until the 77th day after embryo transfer.
Treatment should be discontinued by gradually reducing the administered dose.
In hormone replacement therapy, a dose of 200 mg daily for 12 days or 100-200 mg daily in continuous therapy is sufficient to provide adequate endometrial protection.

Instructions for use

Progesteron Adamed should be inserted into the vagina using the enclosed applicator. The applicator provided with Progesteron Adamed is for personal use and is intended for use by one patient only.
In pregnant women, due to the softened cervix, it is recommended to apply the medicine with the index finger.
INSTRUCTIONS FOR USING THE APPLICATOR

• 1. Remove the applicator from its packaging.
• 2. Place one Progesteron Adamed tablet in the designated place at the end of the applicator. The tablet should fit tightly against the applicator walls and not fall out.

• 3. The applicator can be inserted into the vagina in a comfortable position (standing, sitting, lying on the back with bent knees).
• 4. Insert the applicator into the vagina until the raised line felt with the finger is at the level of the labia majora.

• 5. Press the plunger of the applicator to release the tablet.

• 6. Then, remove the applicator, rinse it thoroughly with warm running water, and dry it with a soft cloth.
• 7. Keep the applicator for reuse.

Using a higher dose of Progesteron Adamed than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Symptoms of overdose that may occur include drowsiness, dizziness, and depression. These symptoms usually resolved spontaneously after reducing the dose of the medicine. The patient should consult their doctor beforehand.

Missing a dose of Progesteron Adamed

A missed dose of the medicine should be taken as soon as possible after remembering, unless it is close to the time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Progesteron Adamed

Sudden discontinuation of progesterone may cause increased anxiety, mood swings, and seizures.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking this medicine immediately if they experience any of the following side effects:

• stroke, blood clots, or internal bleeding into the brain,
• blood clots in the veins of the limbs or pelvis,
• sudden severe headaches,
• vision disturbances,
• jaundice (yellowing of the skin or whites of the eyes).

The following side effects are common (affecting 1 in 10 patients):

• headaches,
• bloating,
• abdominal pain,
• nausea,
• uterine cramps.

The following side effects are uncommon (affecting 1 in 100 patients):

• dizziness,
• drowsiness,
• diarrhea,
• constipation,
• hives (allergic rash),
• rash,
• disorders of the vulva and vagina (e.g., vaginal discomfort, burning, discharge, dryness, and bleeding),
• vaginal thrush,
• breast disorders (e.g., breast pain, breast swelling, breast tenderness),
• itching in the genital area,
• peripheral edema (swelling due to fluid accumulation).

The following side effects have been observed after the marketing of progesterone vaginal medicines.
The frequency of these side effects is unknown(cannot be determined from available data):

• fatigue
• vomiting
• hypersensitivity reactions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Progesteron Adamed

Store at a temperature below 30°C.
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 the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Progesteron Adamed contains

• The active substance of the medicine is progesterone. The other ingredients are: lactose monohydrate, maize starch, sodium carmellose, hypromellose (6 mPa·s), citric acid monohydrate, magnesium stearate, colloidal anhydrous silica.

What Progesteron Adamed looks like and contents of the pack

White or off-white round vaginal tablet.
The box contains 30, 60, or 90 vaginal tablets with 1 LDPE applicator marked: vaginal applicator 200.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel. +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: