Orgametril

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language

Orgametril

5 mg, tablets

Lynestrenolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Orgametril and what is it 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 is Orgametril and what is it used for

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

• frequent menstruation
• heavy menstrual bleeding and uterine hemorrhage
• selected cases of primary and secondary absence and scanty menstrual bleeding
• endometriosis (proliferation of the uterine lining)
• selected cases of endometrial cancer
• benign breast diseases
• inhibition of menstrual bleeding, ovulation, painful ovulation, painful menstruation
• delaying the date of menstrual bleeding
• supplementary treatment to estrogen therapy during the perimenopausal and postmenopausal period to prevent endometrial hyperplasia.

2. Important information before taking Orgametril

When not to take Orgametril:

• if you currently have or have had deep vein thrombosis. Thrombosis is the formation of blood clots that block veins (e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)).

Warnings and precautions

Before starting Orgametril, discuss it with your doctor or pharmacist.
Patients with the following diseases should be under close medical supervision.
Tell your doctor about:

• blood clotting disorders (thrombosis)
• heart or blood vessel disease
• severe depressive moods
• liver disease, such as jaundice or liver tumors
• abnormal vaginal bleeding
• high cholesterol or other lipids in the blood
• chloasma (skin discoloration often occurring during pregnancy)
• acne, oily skin, and excessive hair growth on the body or face.

Children and adolescents

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

Orgametril and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription.
Taking other medicines may affect the effectiveness of Orgametril, and Orgametril may affect the effectiveness of other medicines. Before taking any medicine, consult your doctor or pharmacist.
Tell your doctor or pharmacist about taking or planning to take other medicines, such as:

• Rifamycin or troleandomycin (antibiotics)
• Hydantoin derivatives, barbiturates, carbamazepine (antiepileptics)
• Aminoglutethimide (a medicine used to treat Cushing's syndrome)
• Cyclosporins (medicines used after transplants)
• Theophylline (medicines used for asthma, bronchitis, pulmonary emphysema)
• Beta-adrenergic receptor blockers (medicines used for high blood pressure)
• Insulin (diabetes treatment).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Taking Orgametril during pregnancy or if you think you may be pregnant is contraindicated.

Driving and using machines

Some patients may experience dizziness. Do not drive in this case.

Orgametril contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Orgametril

Always take this medicine exactly as your doctor has told you.
If you are not sure, consult your doctor or pharmacist.

Dosage

Frequent menstruation:
1 tablet per day from the 14th to the 25th day of the cycle.
Heavy menstrual bleeding and uterine hemorrhage:
2 tablets per day for 10 days. Bleeding usually stops within a few days of starting treatment.
Treatment is repeated for the next 3 menstrual cycles, taking 1 tablet per day from the 14th to the 25th day of each cycle. If symptoms do not improve during or after treatment, additional diagnostic tests are necessary.

• If the symptoms do not improve during or after treatment, additional diagnostic tests are necessary.

Selected cases of primary and secondary absence and scanty menstrual bleeding:
Treatment should start with estrogen administration, e.g., 0.02 to 0.05 mg of ethinyl estradiol per day for 25 days. At the same time, from the 14th to the 25th day of the cycle, 1 tablet of Orgametril per day is administered.
Usually, within 3 days after the end of treatment, bleeding occurs. Treatment is repeated (second cycle) starting estrogen administration on the 5th day of bleeding and continuing until the 25th day of the cycle, and additionally, from the 14th to the 25th day of the cycle, 1 tablet of Orgametril per day is administered. This treatment should be continued for at least 1 cycle.
Endometriosis:
1 to 2 tablets per day for at least 6 months.
Selected cases of endometrial cancer:
6 to 10 tablets per day for a longer period.
Benign breast diseases:
1 tablet per day from the 14th to the 25th day of the cycle, for at least 3 to 4 months.
Inhibition of menstrual bleeding, ovulation, painful ovulation, painful menstruation:
Treatment should start on the first day of the cycle, but no later than the 5th day of the cycle, taking 1 tablet per day. The treatment can be continued for many months (without interruption). If, despite taking the medicine, bleeding occurs, the dose of Orgametril should be increased to 2 to 3 tablets per day for 3 to 5 days.
Delaying the date of menstrual bleeding:
Treatment should start preferably 2 weeks before the expected date of menstruation, taking 1 tablet per day. If treatment is started less than 1 week before the expected date of menstruation, the dose of Orgametril should be increased to 2 to 3 tablets per day. However, in this case, it is not recommended to delay the date of menstruation by more than 1 week. The later the treatment is started, the higher the risk of intermenstrual bleeding. Therefore, treatment should start no later than 3 days before the expected date of menstruation.

Dosage

in case of starting treatment less than 1 week before the expected date of menstruation, the dose of Orgametril should be increased to 2 to 3 tablets per day. However, in this case, it is not recommended to delay the date of menstruation by more than 1 week. The later the treatment is started, the higher the risk of intermenstrual bleeding. Therefore, treatment should start no later than 3 days before the expected date of menstruation.
Supplementary treatment to estrogen therapy during the perimenopausal and postmenopausal period to prevent endometrial hyperplasia:
1 tablet per day for 12 to 15 days a month, e.g., for the first 2 weeks of the calendar month.
Estrogens can be administered daily without interruption at the lowest effective dose.
NOTE:the first day of menstrual bleeding is the first day of the cycle.
Orgametril should be taken orally at the same time every 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.

Overdose of Orgametril

In case of swallowing a larger number of tablets, 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 the medicine as soon as possible, unless the interval is longer than 24 hours. In this case, skip the missed dose.

Stopping Orgametril treatment

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrium, and may be used to treat menstrual cycle disorders. The cycles are normalized by taking Orgametril for a few days a month. A few days after the end of Orgametril treatment, usually within 3 days, the endometrium is shed, and bleeding (similar to menstruation) occurs.

4. Possible side effects

Like all medicines, Orgametril can cause side effects, although not everybody gets them.
Depending on the dose and the patient's sensitivity, Orgametril may cause side effects. The following side effects have been observed:
Very common (occurring in at least 1 in 10 people):

• Weight gain
• Increased blood glucose levels after meals (decreased glucose tolerance)
• Nervousness
• Decreased libido
• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Constipation
• Oily skin
• Intermenstrual bleeding occurring in the first 2 months of treatment

Common (occurring less often than 1 in 10 people):

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

Uncommon (occurring less often than 1 in 100 people):

• Jaundice
• Leucorrhea

If you experience any of the above side effects, tell your doctor or pharmacist, especially if you experience vaginal bleeding.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 side effects will help gather more information on the safety of the medicine.

5. How to store Orgametril

Store below 30°C.
Store blisters 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 carton after "(EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will 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: 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 notch, with the inscription Organon on one side, the code TT above and "4" below the dividing line on the other side of the tablet.
The pack contains 30 tablets.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Manufacturer:

N.V. Organon
Kloosterstraat 6
Oss
Netherlands

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Czech Republic, the country of export: 56/112/70-C

Parallel import authorization number: 224/24

Date of leaflet approval: 04.06.2024

[Information about the trademark]