Progesterone adamed

Package leaflet: Information for the patient

Progesteron Adamed, 200 mg, vaginal tablets
Progesteronum
Please read all of this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Progesteron Adamed is and what it is 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 pack and other information

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

Progesteron Adamed is a medicine containing progesterone, a naturally occurring female sex hormone produced synthetically.
In the body, progesterone acts through specific receptors located, among others, in the uterus, mammary glands, central nervous system, and pituitary gland.
The most important effects of progesterone on reproductive organs include: enabling ovulation, transformation of the uterine mucosa (endometrium) allowing implantation of the fertilized egg, inhibition of excessive endometrial proliferation caused by estrogens, and cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogens also act on the mammary gland, stimulating growth of glands and ductal epithelium and enabling lactation.
Progesterone is a hormone essential for proper preparation of the endometrium for embryo implantation and for maintaining pregnancy throughout its duration: it suppresses spontaneous contractile activity of the pregnant uterus, inhibits the mother's immune response to fetal antigens, serves as a basic substance for the production of fetal hormones, and initiates labor.

Indications for use of Progesteron Adamed:

• In vitro fertilization (IVF).
• Hormone replacement therapy in postmenopausal women with an intact uterus, receiving estrogen therapy, to protect the uterine lining (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 cause;
• If the patient has severe liver failure;
• If the patient has a liver tumour;
• If the patient has or is suspected of having a tumour of the breast or genital organs;
• If the patient has active venous thrombosis (blood clots), e.g. in the limbs (deep vein thrombosis) or in the lungs (pulmonary embolism), or if such types of blood clots occurred in the past;
• If the patient is at risk of intracranial haemorrhage (bleeding into the brain);
• If the patient has a rare inherited blood disorder called porphyria;
• If miscarriage has occurred and there is suspicion that some tissue remains in the uterus, or if pregnancy is developing outside the uterus (ectopic pregnancy).

Warnings and precautions
Before starting treatment with Progesteron Adamed, discuss this with your doctor.
This medicine, when used as directed, does not have a contraceptive effect.
Before starting hormone replacement therapy for menopause (and subsequently at regular annual intervals), you should consult your doctor, who will perform an examination of the breasts and pelvic organs. Inform your doctor if:

• the patient has a history of venous thrombosis (blood clots in veins);
• the patient experiences uterine bleeding. This medicine should be discontinued if:
  • any visual disturbances occur (e.g. visual field defects, double vision, pathological changes in retinal blood vessels);
  • venous thromboembolism (venous thromboembolic disease or blood clots) occurs;
  • severe headaches develop.

If the patient does not have a menstrual period during treatment, pregnancy should be ruled out. During treatment, the endometrium (uterine lining) may undergo excessive growth (endometrial hyperplasia) or existing hyperplasia may worsen. If unexpected bleeding or spotting occurs during or after prolonged treatment, at the end of treatment, or after treatment has ended, and persists, contact your doctor. If a patient with depression experiences mood changes or worsening of depressive symptoms during treatment, she should contact her doctor as soon as possible. The doctor will inform the patient about the need to report any changes in the breasts. This medicine should be used with particular caution in patients:

• with mild to moderate liver dysfunction,
• with conditions whose symptoms may be exacerbated by fluid retention (e.g. epilepsy, migraine, asthma, heart or kidney dysfunction),
• with diabetes or diagnosed insulin resistance,
• aged over 35 years, who smoke, and who have 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
Inform your doctor about all medicines currently used, recently used, or planned for use.
Some medicines may affect the action of Progesteron Adamed:

• barbiturates used for sleep disorders or anxiety treatment,
• antiepileptic drugs (carbamazepine, phenytoin),
• certain antibiotics (ampicillins, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory medicine),
• spironolactone (a diuretic),
• certain antifungal medicines (ketoconazole, griseofulvin).

Likewise, Progesteron Adamed may affect the action of certain medicines used to treat diabetes. Herbal products containing St. John's wort (Hypericum perforatum) may reduce the effectiveness of Progesteron Adamed. Progesteron Adamed may enhance the effect of cyclosporine.

Pregnancy, breastfeeding and fertility

Pregnancy

• If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 has no harmful effect on fertility.
• Before starting to take this medicine, discuss this with your doctor.

Driving and using machines
Progesteron Adamed administered vaginally does not affect the ability to drive or operate machinery. However, if adverse effects such as drowsiness, difficulty concentrating, or dizziness occur, driving and operating machinery are not recommended (see section 4).

3. How to use Progesteron Adamed

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
Progesterone dosage should always be individually adjusted according to the indication and therapeutic response. For doses other than 200 mg, 100 mg vaginal tablets are available.

Adults
In in vitro fertilization programs, 100–200 mg of progesterone should be administered vaginally 2–3 times daily.
Treatment should continue until day 77 after embryo transfer.
Discontinuation of therapy should be done by gradually reducing the dose.

In hormone replacement therapy, the dose providing adequate endometrial protection is 200 mg daily for 12 days per cycle, or 100–200 mg daily in continuous combined therapy.

Instructions for use
Progesteron Adamed should be inserted into the vagina using the provided applicator. The applicator supplied with Progesteron Adamed is intended for personal use only and is designated for use by a single patient.

In pregnant women, due to a softened cervix, it is recommended to insert Progesteron Adamed with the index finger.

INSTRUCTIONS FOR USING THE APPLICATOR

1. Unpack the applicator.
2. Place one Progesteron Adamed tablet into the designated space at the end of the applicator. The tablet should fit snugly against the walls of the applicator and should not fall out.

3. The applicator may be inserted into the vagina in a comfortable position (standing, sitting, or lying on the back with knees bent).
4. Insert the applicator into the vagina until the convex mark, palpable under the finger, is level with the labia majora.

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

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

Overdose of Progesteron Adamed
If more than the recommended dose of this medicine has been taken, contact your doctor or pharmacist immediately. Symptoms of overdose may include drowsiness, dizziness, and depression. These symptoms usually resolve spontaneously upon dose reduction. Consult your doctor promptly.

Missed dose of Progesteron Adamed
If a dose is missed, take it 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 one.

Stopping Progesteron Adamed
Abrupt discontinuation of progesterone may cause increased anxiety, mood swings, and seizures.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop using this medicine immediately if the patient experiences any of the
following adverse reactions:

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

The following adverse reactions occur commonly (in 1 out of 10 patients):

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

The following adverse reactions occur uncommonly (in 1 out of 100 patients):

• dizziness,
• drowsiness,
• diarrhoea,
• constipation,
• urticaria (allergic rash),
• rash,
• vulvar and vaginal disorders (e.g. vaginal discomfort, burning, discharge, dryness and bleeding),
• vaginal fungal infection,
• breast disorders (e.g. breast pain, breast swelling, breast tenderness),
• itching in the genital area,
• peripheral oedema (swelling due to fluid accumulation).

The following adverse reactions have been observed after marketing of vaginal
preparations containing progesterone.
Frequency of occurrence is not known (cannot be estimated from available data):

• fatigue
• vomiting
• hypersensitivity reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Progesteron Adamed

Store below 30°C.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Progesteron Adamed contains

• The active substance is progesterone.
  Other components are: monohydrate lactose, maize gelatinized starch, sodium croscarmellose, hypromellose (6 mPa·s), monohydrate citric acid, magnesium stearate, colloidal anhydrous silica.

What Progesteron Adamed looks like and contents of the pack
White or off-white, round vaginal tablets.
The package contains 30, 60 or 90 vaginal tablets with 1 LDPE applicator
marked: vaginal applicator 200.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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