Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Orgametril
5 mg, tablets
Lynestrenol
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
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 others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 menstrual bleeding
Endometriosis (endometrial tissue overgrowth)
Selected cases of endometrial carcinoma
Benign breast diseases
Suppression of menstrual bleeding and ovulation, painful ovulation, dysmenorrhea
Delaying the onset of menstrual bleeding
Supplementary treatment to estrogen therapy 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 tumors, or Rotor and Dubin-Johnson syndromes;
if the patient has vaginal bleeding of unknown origin;
if the patient currently has or has a history of 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 medications;
current venous thromboembolic disease. Thrombosis involves the formation of blood 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 conditions listed below 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 tumors
abnormal vaginal bleeding
high cholesterol or other lipid levels in the blood
melasma (skin pigmentation often occurring during pregnancy)
acne, seborrheic skin, or 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 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
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 in bacterial infections)
Hydantoin derivatives, barbiturates, carbamazepine (medicines used in epilepsy)
Aminoglutethimide (a medicine used in the treatment of Cushing's syndrome)
Cyclosporines (medicines used after organ transplants)
Theophylline (medicines used in asthma, bronchitis, and emphysema)
Beta-adrenergic receptor blockers (medicines used in hypertension)
Insulin (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.
The use of Orgametril during pregnancy or if the patient suspects she may be pregnant is contraindicated.
Driving and operating machinery
Some patients may experience dizziness. If so, do not drive or operate machinery.
Orgametril contains monohydrate 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
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 persist during or after treatment, additional diagnostic evaluation is 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 should be administered daily. Usually, bleeding appears 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, 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 menstruation, ovulation, painful ovulation, and 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 menstruation:	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 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 periods 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 continuously every day 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.

Taking a higher than recommended dose of Orgametril
If you have taken more tablets than recommended, 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 you miss a dose, take it as soon as possible, unless the delay is longer than 24 hours. In that case, skip the missed dose.

Discontinuation of Orgametril
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrial lining of the uterine body and can be used in the treatment of menstrual cycle disorders. Cycles are normalized by administering Orgametril for several days each month. Several days after stopping Orgametril, often within 3 days, the endometrial lining sheds, resulting in bleeding (similar to menstruation).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 (affects 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
Diarrhoea
Constipation
Seborrhoea
Intermenstrual bleeding occurring during the first 2 months of treatment.

Common (affects less than 1 in 10 people):

Irritability
Fluid retention
Changes in blood lipid and cholesterol levels
Depressive mood
Increased libido
Headache
Migraine
Dizziness
Increased 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 (affects less than 1 in 100 people):

Jaundice
Vaginal discharge.

If any of the above adverse effects occur, inform your doctor or pharmacist, especially if vaginal bleeding occurs.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 181C
02-222 Warsaw
Tel.: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of additional information on the safety of the medicine.

5. How to store Orgametril

Do not store above 25°C. Keep in the original packaging to 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Orgametril contains

The active substance is lynestrenol. One tablet contains 5 mg of lynestrenol.
The other ingredients are: all-rac-α-Tocopherol (E 307), potato starch, glycerol (E 422), magnesium stearate, talc, lactose monohydrate.

What Orgametril looks like and contents of the pack
White, round tablets with a break-line. They are marked with "TT4" on one side and "Organon*"
on the other.
The pack contains 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
Organon Healthcare GmbH, Pestalozzistr. 31, 80469 Munich, Germany
Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Austria, the country of export: 12352
Parallel import licence number: 437/24