ORGAMETRIL

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Orgametril is and what it is used for
2. Important information before taking Orgametril
3. How to take Orgametril
4. Possible side effects
5. How to store Orgametril
6. 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 hypomenorrhea
• Endometriosis (endometrial hyperplasia)
• Selected cases of endometrial carcinoma
• Benign breast disorders
• Suppression of menstruation, ovulation, painful ovulation, and 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 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 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 blood lipid levels
• chloasma (skin pigmentation often occurring during pregnancy)
• acne, seborrhea, 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 transplants)
• Theophylline (medicines used for asthma, bronchitis, emphysema)
• Beta-adrenergic receptor blockers (medicines used for hypertension)
• Insulin (for treatment of diabetes).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your 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
Dizziness may occur in some patients. Do not drive or operate machinery if affected.

Orgametril contains lactose
If you have been previously 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. In case of 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. Menstrual bleeding usually stops within a few days after starting treatment.
The 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 menstrual bleeding: Treatment should begin with administration of 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 should be administered daily. Usually, bleeding appears within 3 days after completion of treatment. The treatment is repeated (second cycle), starting estrogen administration on day 5 of bleeding and continuing until day 25 of the cycle, and additionally, from day 14 to day 25 of the cycle, 1 tablet of Orgametril daily. This treatment should be continued for at least one 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 menstruation, ovulation inhibition, painful ovulation, dysmenorrhea: Treatment should begin 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, increase the dose of Orgametril 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 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 greater the risk of intermenstrual bleeding. Therefore, treatment should begin no later than 3 days before the expected onset of menstruation.

Adjunctive therapy to estrogen replacement therapy during perimenopausal and postmenopausal periods: 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 daily without interruption at the lowest effective dose, to prevent endometrial hyperplasia.

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 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 are taken, 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 is missed, take the medicine 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 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 completing the intake of Orgametril—often within 3 days—the endometrium sheds, resulting in bleeding (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 (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
• Diarrhea
• Constipation
• Seborrhoea
• Intermenstrual bleeding occurring during the first 2 months of treatment

Common (affects 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 (affects 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 adverse reactions not listed in this leaflet, 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 .
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Orgametril

Store below 30°C.
Keep blister packs 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 carton after "(EXP)". The expiry date refers to the last day of the month indicated.
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. Package contents and other information

What Orgametril contains

• The active substance is lynestrenol. One tablet contains 5 mg of lynestrenol.
• The other ingredients are: α-tocopherol, potato starch, glycerol (E 422), 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.
Pack contains 30 tablets.
For further information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
N.V. Organon
Kloosterstraat 6
Oss
The Netherlands
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 56/112/70-C
Parallel Import Authorisation number: 224/24