Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Orgametril, 5 mg, tablets
Lynestrenol
Please read 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, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Orgametril is and what it is used for
Important information before taking Orgametril
How to take Orgametril
Possible side effects
How to store Orgametril
Contents of the pack and other information

1. What Orgametril is and what it is used for

Orgametril contains lynestrenol, a synthetic progestagen similar to natural progesterone.
Progestagens, including Orgametril, are commonly used in menstrual cycle disorders.
Orgametril is indicated for use in adult female patients over 18 years of age.
Indications for Orgametril:

Frequent menstruation
Heavy menstrual bleeding and uterine hemorrhage
Selected cases of primary and secondary amenorrhea and oligomenorrhea
Endometriosis (endometrial tissue overgrowth)
Selected cases of endometrial carcinoma
Benign breast disorders
Suppression of menstruation, ovulation, painful ovulation, and dysmenorrhea
Delaying the onset of menstrual bleeding
Hormone replacement therapy in perimenopausal and postmenopausal women, as an adjunct to estrogen therapy to prevent endometrial hyperplasia.

2. Important information before using Orgametril

When not to use Orgametril:

if the patient is allergic to lynestrenol or any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant or suspects she may be pregnant;
if the patient has severe liver diseases such as cholestatic jaundice or hepatitis (or a history of liver disease if liver function parameters have not returned to normal), liver tumours, or Rotor, Dubin-Johnson syndromes;
if the patient has vaginal bleeding of unknown origin;
if the patient currently has or has had in the past rare conditions associated with sex hormone use, e.g. pruritus, cholestatic jaundice, herpes gestationis, porphyria, and otosclerosis. These may occur for the first time or worsen during pregnancy or while using hormonal medicines;
current venous thromboembolic disease. Thrombosis involves formation of clots blocking veins (e.g. in the legs (deep vein thrombosis) or in the lungs (e.g. pulmonary embolism)).

Warnings and precautions
Before starting Orgametril, discuss this with your doctor or pharmacist.
Patients with the following conditions should remain under close medical supervision.
Inform your doctor if you have:

blood clotting disorders (thrombosis)
heart or vascular disease
severe depressive mood
liver diseases, e.g. jaundice or liver tumours
abnormal vaginal bleeding
high levels of cholesterol or other lipids in the blood
melasma (skin pigmentation often occurring during pregnancy)
acne, seborrhoea, hirsutism (excessive hair growth on body or face)

Children and adolescents
The safety and efficacy of Orgametril in adolescents under 18 years of age have not been established. No data are available.

Orgametril and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
Other medicines may affect the effectiveness of Orgametril, and Orgametril may affect the effectiveness of other medicines. Always consult your doctor or pharmacist before taking any medicine.
Inform your doctor or pharmacist if you are taking or plan to take any of the following medicines:

Rifamycin or troleandomycin (medicines used for bacterial infections)
Hydantoin derivatives, barbiturates, carbamazepine (medicines used for epilepsy)
Aminoglutethimide (a medicine used in the treatment of Cushing's syndrome)
Cyclosporines (medicines used after organ transplantation)
Theophylline (medicines used for asthma, bronchitis, emphysema)
Beta-blocking agents (medicines used for hypertension)
Insulin (for diabetes treatment)

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use of Orgametril during pregnancy or if the patient suspects she may be pregnant is contraindicated.

Driving and operating machinery
Dizziness may occur in some patients. Do not drive or operate machinery if affected.

Orgametril contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before starting this medicine.

3. How to use Orgametril

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

Indications	Dosage
Frequent menstruation:	1 tablet daily from day 14 to day 25 of the cycle.
Heavy menstrual bleeding and uterine hemorrhage:	2 tablets daily for 10 days. Bleeding usually stops within a few days after starting treatment. Treatment is repeated for the next 3 menstrual cycles, administering 1 tablet daily from day 14 to day 25 of each cycle. If symptoms do not resolve during or after treatment, additional diagnostic tests are necessary.
Select cases of primary and secondary amenorrhea and scanty menstruation:	Treatment should begin with administration of estrogens, e.g. 0.02 to 0.05 mg ethinylestradiol daily for 25 days. Concurrently, from day 14 to day 25 of the cycle, 1 tablet of Orgametril daily should be administered. Menstrual bleeding usually occurs within 3 days after completion of treatment. Treatment is repeated (second cycle), starting estrogen administration on day 5 of bleeding and continuing until day 25 of the cycle, along with 1 tablet of Orgametril daily from day 14 to day 25 of the cycle. This treatment should be continued for at least one more cycle.
Endometriosis:	1 to 2 tablets daily for at least 6 months.
Select cases of endometrial carcinoma:	6 to 10 tablets daily for a prolonged period.
Benign breast diseases:	1 tablet daily from day 14 to day 25 of the cycle, for at least 3 to 4 months.
Suppression of menstrual bleeding, ovulation, painful ovulation, dysmenorrhea:	Treatment should be started on the first day of the cycle, but no later than day 5, administering 1 tablet daily. The treatment may be continued for many months (without interruption). If bleeding occurs despite medication, the dose of Orgametril should be increased to 2 to 3 tablets daily for 3 to 5 days.
Delaying the onset of menstrual bleeding:	Treatment should ideally begin 2 weeks before the expected onset of
	menstruation, administering 1 tablet daily. If treatment is started less than 1 week before the expected onset of menstruation, the dose should be increased to 2 to 3 tablets daily. However, in such cases, delaying menstruation by more than 1 week is not recommended. The later the treatment is initiated, the higher the risk of intermenstrual bleeding. Therefore, treatment should not begin later than 3 days before the expected onset of menstruation.
Adjunctive therapy to estrogen replacement therapy in perimenopausal and postmenopausal women to prevent endometrial hyperplasia:	1 tablet daily for 12 to 15 days per month, e.g. during the first two calendar weeks of the month. Estrogens may be administered daily without interruption at the lowest effective dose.

WARNING: The first day of menstrual bleeding is the first day of the cycle.
Orgametril tablets should be taken orally at the same time each day, with a small amount of water or other liquid.
If you feel that the effect of Orgametril is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Orgametril
If more tablets than recommended have been swallowed, inform your doctor or pharmacist.
Nausea and vomiting may occur.
Missed dose of Orgametril
Do not take a double dose to make up for a missed dose.
If a dose has been missed, take the tablet as soon as possible, unless the delay is longer than 24 hours. In that case, the missed dose should be omitted.
Discontinuation of Orgametril
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrium and can be used in the treatment of menstrual cycle disorders. Cycles are regulated by administering Orgametril for several days each month. Several days after stopping Orgametril, often within 3 days, endometrial shedding occurs, resulting in bleeding (similar to menstruation).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Depending on the dose and patient's sensitivity, the medicine Orgametril may cause adverse reactions. The following adverse reactions have been observed:

Very common (affecting at least 1 in 10 people):

Increase in body weight
Increased blood glucose levels after meals (impaired glucose tolerance)
Nervousness
Decreased libido
Nausea
Vomiting
Abdominal pain
Diarrhea
Constipation
Seborrhoea
Intermenstrual bleeding occurring during the first 2 months of treatment

Common (affecting less than 1 in 10 people):

Hypersensitivity
Fluid retention
Changes in blood lipid and cholesterol levels
Depressive mood
Increased libido
Headache
Migraine
Dizziness
Excessive sweating
Chloasma (brown patches on the face)
Itching
Acne
Skin reactions
Excessive hair growth on the body or face
Breast tenderness
Absence of menstruation
Changes in liver function parameters

Uncommon (affecting less than 1 in 100 people):

Jaundice
Hot flushes

If any of the above adverse reactions occur, inform your doctor or pharmacist, especially if vaginal bleeding occurs.

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

5. How to store Orgametril

Store below 30°C. Protect from light and moisture.
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 pack and other information

What Orgametril contains

The active substance in this medicine is lynestrenol. Each tablet contains 5 mg of lynestrenol.
The other ingredients are: all-rac-α-Tocopherol, potato starch, glycerol, magnesium stearate, talc, lactose.

What Orgametril looks like and contents of the pack
White, round tablets with a score line, marked "Organon*" on one side and the tablet code "TT4" on the other side.
The pack contains 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Belgium, country of export:
Organon Belgium
Rue du Commerce 31
B-1000 Brussels, Belgium
Manufacturer:
N.V. Organon
Kloosterstraat 6, 5349 AB Oss
The Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Belgium, country of export: BE011216
Parallel import authorization number: 162/22