Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
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 the patient experiences any adverse effects, including any not listed in this leaflet, they should inform their 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 menstrual bleeding
Endometriosis (endometrial tissue overgrowth)
Selected cases of endometrial carcinoma
Benign breast diseases
Suppression of menstrual bleeding, ovulation, painful ovulation, and dysmenorrhea
Delaying the onset of menstruation
Additive 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, Dubin-Johnson syndromes;
if the patient has vaginal bleeding of unknown origin;
if the patient currently has or has had in the past rare disorders 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;
active 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 close medical supervision.
Inform your doctor if you have:

blood clotting disorders (thrombosis)
heart or vascular disease
severe depressive mood
liver disease, e.g. jaundice or liver tumors
abnormal vaginal bleeding
high cholesterol or other blood lipid levels
chloasma (skin pigmentation often occurring during pregnancy)
acne, seborrheic skin, and excessive body or facial hair growth.

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.
The use of 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 (used in bacterial infections)
Hydantoin derivatives, barbiturates, carbamazepine (used in epilepsy)
Aminoglutethimide (used in the treatment of Cushing's syndrome)
Cyclosporins (used after organ transplantation)
Theophylline (used in asthma, bronchitis, emphysema)
Beta-adrenergic receptor blockers (used in hypertension)
Insulin (for diabetes treatment).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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. In such cases, 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 exactly as directed by your 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 menometrorrhagia: 2 tablets daily for 10 days. Uterine 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, further diagnostic tests are necessary.

Selected cases of primary and secondary Treatment should be initiated with administration of
hypomenorrhea or oligomenorrhea: estrogens, e.g. 0.02 to 0.05 mg ethinylestradiol
daily for 25 days. Simultaneously, from day 14 to
day 25 of the cycle, 1 tablet of Orgametril daily is administered. Usually, bleeding appears 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, 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 one additional 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 disorders: 1 tablet daily from day 14 to day 25 of the cycle, for at least 3 to 4 months.
Suppression of menstrual bleeding, 1 tablet daily starting on the first day of the cycle,
anovulation, painful ovulation, painful but no later than day 5 of the cycle. The treatment
menstruation: may be continued for many months (without interruption). If bleeding occurs despite taking the medicine, increase the dose of Orgametril to 2 to 3 tablets daily for 3 to 5 days.
Delaying the onset of menstrual Treatment should ideally begin 2 weeks before the
bleeding: 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 started, the higher the risk of intermenstrual bleeding. Therefore, treatment should begin no later than 3 days before the expected onset of menstruation.
Add-on therapy to estrogen replacement 1 tablet daily for 12 to 15 days per month,
therapy in perimenopausal and postmenopausal e.g. during the first two calendar weeks of the month.
period to prevent endometrial hyperplasia: Estrogens may be administered daily without interruption at the lowest effective dose.

NOTE: The first day of menstrual bleeding is considered day one of the cycle.
Orgametril should be taken orally at the same time each day, with a small amount of water or other liquid.

If you feel the effect of Orgametril is too strong or too weak, consult your doctor or pharmacist.

Overdose of Orgametril
If more tablets than recommended are swallowed, inform your doctor or pharmacist immediately. 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 is missed, take the medicine as soon as possible, unless the delay exceeds 24 hours. In that case, skip the missed dose.

Stopping Orgametril
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Lynestrenol affects the endometrium and may be used in the treatment of menstrual cycle disorders. Cycles are normalized by administering Orgametril for several days each month. A few days after stopping Orgametril, often within 3 days, endometrial shedding occurs and bleeding appears (similar to menstruation).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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):

Increased 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 facial spots)
Itching
Acne
Skin reactions
Excessive hair growth on 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, particularly if vaginal bleeding occurs.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Orgametril

Do not store above 25°C. Keep in the original packaging to 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. Such measures 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, potato starch, glycerol, magnesium stearate, talc, lactose monohydrate.

What Orgametril looks like and contents of the pack
White, round tablets with a score line, marked with "Organon" on one side, and the code TT above and "4" below the dividing line on the other side of the tablet.
Pack contains 30 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Austria, country of export:
Organon Healthcare GmbH
Neuturmstraße 5
80331 Munich
Germany
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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Austria, country of export: 12352
Parallel Import Licence Number: 213/24