Progesteron Adamed

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Progesteron Adamed, 100 mg, vaginal tablets

Progesteronum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 using Progesteron Adamed
• 3. How to use Progesteron Adamed
• 4. Possible side effects
• 5. How to store Progesteron Adamed
• 6. Contents of the packaging and other information

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

Progesteron Adamed is a medicine that contains 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, 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 the proper preparation of the endometrium for implantation of the embryo, for the maintenance of 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 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 using Progesteron Adamed

When not to use Progesteron Adamed:

• If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• If the patient has vaginal bleeding of unknown origin;
• If the patient has severe liver failure;
• If the patient has a liver tumor;
• If the patient has a breast or genital tumor or suspected tumor;
• If the patient has an active venous thrombosis (thromboembolism), such as deep vein thrombosis or pulmonary embolism, or if such thromboses have occurred in the past;
• If the patient is at risk of cerebral hemorrhage;
• 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 to take this medicine, you should discuss it with your doctor.
This medicine, when used as recommended, does not have a contraceptive effect.
Before starting hormone replacement therapy during menopause (and later at regular annual intervals), you should consult a doctor who will perform a breast examination and pelvic examination. You should tell your doctor if:

• you have a history of blood clots in the veins (venous thrombosis);
• you have uterine bleeding. You should stop taking this medicine if:
• you experience any vision disturbances (e.g., visual impairment, double vision, vascular changes in the retina);
• you have blood clots (thromboembolic disease);
• you have severe headaches. If you experience a lack of menstruation during treatment, you should ensure that you are not pregnant. During treatment, the endometrium may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If, during prolonged treatment, at the end of treatment, or after treatment, unexpected bleeding or spotting occurs and persists, you should contact your doctor. If you are being treated for depression and your mood changes or depressive symptoms worsen, you should contact your doctor as soon as possible. Your doctor will inform you about the need to report any changes in your breasts. This medicine should be used with particular 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 of age, smoking, and with risk factors for atherosclerosis.

Children and adolescents

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

Progesteron Adamed and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you 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 (anti-inflammatory medicine),
• spironolactone (diuretic),
• certain antifungal medicines (ketoconazole, griseofulvin). Similarly, Progesteron Adamed may affect the action of certain 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 you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Breastfeeding

• Women who are breastfeeding should not use this medicine.

Fertility

• This medicine may be taken by women who have difficulty becoming pregnant. This medicine does not have any harmful effect on fertility.
• Before starting to take this medicine, you should discuss it with your doctor.

Driving and using machines

Progesteron Adamed administered vaginally does not affect the ability to drive or use machines. If side effects such as drowsiness, concentration disorders, and dizziness occur, it is not recommended to drive or use machines (see section 4).

3. How to use Progesteron Adamed

This medicine should always be used as recommended by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Recommended dose
The dosage of progesterone should be determined individually each time, depending on the indications and efficacy of the action. For doses other than 100 mg, vaginal tablets of 200 mg are available.
Adults
In hormone replacement therapy, 200 mg per day is used for 12 days a month or 100-200 mg per day in continuous therapy.
In in vitro fertilization programs, 100 to 200 mg of progesterone is 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 of the medicine.

Instructions for use

Progesteron Adamed should be placed in the vagina using the enclosed applicator. The applicator enclosed 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. Unpack the applicator.
• 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 convenient position (standing, sitting, lying on your back with bent knees).
• 4. Insert the applicator into the vagina until the raised line felt with your finger is at the level of the labia majora.

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

• 6. Then, withdraw the applicator, rinse it thoroughly with warm running water, and dry it with a soft cloth.
• 7. The applicator should be kept for reuse.

Using a higher dose of Progesteron Adamed than recommended

If you have taken a higher dose of this medicine than recommended, you should contact your doctor or pharmacist immediately.
Symptoms of overdose that may occur include drowsiness, dizziness, and depression. These symptoms usually resolved on their own after the dose of the medicine was reduced. You should consult your doctor beforehand.

Missing a dose of Progesteron Adamed

A missed dose of the medicine should be taken as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping the use of Progesteron Adamed

Sudden discontinuation of progesterone may cause increased anxiety, mood changes, and seizures.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should stop using this medicine immediately if you experience any of the following side effects:

• stroke, blood clots, or cerebral hemorrhage,
• 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 (in 1 in 10 patients):

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

The following side effects are uncommon (in 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 candidiasis,
• breast disorders (e.g., breast pain, breast swelling, breast tenderness),
• itching in the genital area,
• peripheral edema (edema due to fluid accumulation).

The following side effects have been reported after the marketing of progesterone vaginal medicines.
Frequency not known(cannot be estimated from the available data):

• fatigue, vomiting,
• hypersensitivity reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Progesteron Adamed

Store at a temperature below 30°C.
Keep the 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Progesteron Adamed contains

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

What Progesteron Adamed looks like and what the packaging contains

The vaginal tablet is round, white or off-white, with the inscription "100" on one side and "22" on the other side.
The box contains 30, 60, or 90 vaginal tablets with 1 LDPE applicator marked: vaginal applicator 100.

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: