PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Orgametril
5 mg, tablets
Lynestrenol
Please read this leaflet carefully before taking this 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. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 scanty menstruation
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 combination with estrogens during perimenopausal and postmenopausal periods 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 and 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, such as pruritus, cholestatic jaundice, herpes gestationis, porphyria, or otosclerosis. These may occur for the first time or worsen during pregnancy or while using hormonal medicines;
current venous thromboembolic disease. Thrombosis involves the 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 strict 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 cholesterol or other lipid levels in the blood
chloasma (skin pigmentation often occurring during pregnancy)
acne, seborrhoea, excessive body or facial hair.

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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
Taking other medicines may affect the effectiveness of Orgametril, and Orgametril may affect the effectiveness of other medicines. 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 to treat Cushing's syndrome)
Cyclosporines (medicines used after organ transplantation)
Theophylline (medicines used for asthma, bronchitis, emphysema)
Beta-adrenergic blocking agents (medicines used for hypertension)
Insulin (for diabetes treatment).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
The use of Orgametril during pregnancy or if you suspect you 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 you have previously been diagnosed with intolerance to certain sugars, consult your doctor before starting this medicine.

3. How to use Orgametril

This medicine should always be used as directed by the physician. If in doubt, consult your 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.
Selected 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 the 5th day of bleeding and continuing until day 25 of the cycle, and additionally administering 1 tablet of Orgametril daily from day 14 to day 25 of the cycle. This treatment should be continued for at least 1 more cycle.
Endometriosis:	1 to 2 tablets daily for at least 6 months.
Selected 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 of the cycle, administering 1 tablet daily. The treatment may be continued for many months (without interruption). If bleeding occurs despite administration of the drug, the dose of Orgametril should be increased to 2 to 3 tablets daily for 3 to 5 days.
Delaying the onset	Treatment should ideally begin 2 weeks
of menstrual bleeding:	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 this case, delaying menstruation by more than 1 week is not recommended. The later the treatment is started, the higher the risk of intermenstrual bleeding. Therefore, treatment should be initiated no later than 3 days before the expected onset of menstruation.
Adjunctive treatment to estrogen therapy in perimenopausal and postmenopausal period to prevent endometrial hyperplasia:	1 tablet daily for 12 to 15 days per month, e.g. during the first 2 calendar weeks of the month. Estrogens may be administered every day 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 another liquid.
If you feel that the effect of Orgametril is too strong or too weak, consult your doctor or pharmacist.

Taking 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 medication as soon as possible, unless the delay is longer than 24 hours. In that case, the missed dose should be skipped.

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

Lynestrenol affects the endometrial mucosa 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, shedding of the mucosal lining occurs, resulting in bleeding (similar to menstruation).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Depending on the dose and patient's sensitivity, the medicine Orgametril may cause adverse effects.
The following adverse effects 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 effects occur, inform your doctor or pharmacist, particularly if vaginal bleeding occurs.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181 C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects 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 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 stated month.
Medicines should 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 Orgametril contains

The active substance is lynestrenol. One tablet contains 5 mg of lynestrenol.
The other ingredients are: potato starch, all-rac-α-Tocopherol, 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 code TT above and "4" below the dividing line on the other side of the tablet.
The pack contains 30 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder 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:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa Street 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź
Marketing Authorization number in Belgium, country of export: BE011216
Parallel import authorization number: 429/22