Orgametril

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Orgametril,5 mg, tablets
Lynestrenolum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 progestogen similar to natural progesterone.
Progestogens, 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 scarcity of menstrual bleeding
• endometriosis (proliferation of the uterine mucosa)
• selected cases of uterine mucosa cancer
• benign breast diseases
• inhibition of menstrual bleeding, ovulation, painful ovulation, painful menstruation
• delay of menstrual bleeding
• supplementary treatment to estrogen therapy during the perimenopausal and postmenopausal period to prevent proliferation of the uterine mucosa.

2. Important information before taking Orgametril

When not to take Orgametril:

• current venous thromboembolic disease. 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 to take Orgametril, you should discuss it with your doctor or pharmacist.
Patients with the following diseases should be under close medical supervision.
You should inform 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you 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, you should consult your doctor or pharmacist.
You should inform your doctor or pharmacist about taking or planning to take other medicines, such as:

• 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)
• Cyclosporins (medicines used after transplants)
• Theophylline (medicines used in asthma, bronchitis, pulmonary emphysema)
• Medicines blocking beta-adrenergic receptors (medicines used in hypertension)
• Insulin (treatment of diabetes).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should 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. You should not drive in such cases.

Orgametril contains lactose monohydrate

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

3. How to take Orgametril

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should 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 scarcity of menstrual bleeding:
Treatment should be started with the administration of estrogens, 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. The treatment is repeated (second cycle) starting the administration of estrogens 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.

• 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 uterine mucosa 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 be started 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.
Delay of menstrual bleeding:
Treatment should be started 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 onset of menstruation by more than 1 week. The later the treatment is started, the higher the risk of intermenstrual bleeding. Therefore, treatment should be started no later than 3 days before the expected date of menstruation.
Supplementary treatment to estrogen therapy during the perimenopausal and postmenopausal period to prevent proliferation of the uterine mucosa:
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, you should consult your doctor or pharmacist.

Overdose of Orgametril

In case of swallowing a larger number of tablets, you should inform your doctor or pharmacist.
Nausea and vomiting may occur.

Missed dose of Orgametril

You should not take a double dose to make up for a missed dose.
If you miss a dose, you should take the medicine as soon as possible, unless the interval is longer than 24 hours. In this case, you should skip the missed dose.

Stopping Orgametril treatment

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

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 in 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 in 1 in 100 people):

• Jaundice
• Leucorrhea.

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

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Orgametril

Do not store above 25°C. Store in the original packaging to protect from light and moisture.
The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. You should 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 of Orgametril 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 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 packaging contains 30 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

Organon Healthcare GmbH
Neuturmstraße 5
80331 Munich
Germany

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, country of export:12352

Parallel import authorization number: 213/24

Date of leaflet approval: 27.05.2024

[Information about the trademark]