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

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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 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 the patient currently has venous thromboembolic disease. Thromboembolism is the formation of blood clots that block veins (e.g., in the legs (deep vein thrombosis) or lungs (pulmonary embolism)).

Warnings and precautions

Before starting Orgametril, discuss it with your doctor or pharmacist.
Patient 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:

• Rifampicin or troleandomycin (medicines used in bacterial infections)
• Hydantoin derivatives, barbiturates, carbamazepine (medicines used in epilepsy)
• Aminoglutethimide (a medicine used to treat Cushing's syndrome)
• Cyclosporins (medicines used after transplants)
• Theophylline (medicines used in asthma, bronchitis, pulmonary emphysema)
• Medicines that block beta-adrenergic receptors (medicines used in 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 monohydrate

If you have been diagnosed with an intolerance to some sugars, contact 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, ask your doctor or pharmacist.

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.

Taking a higher dose of Orgametril than recommended

If you have taken more tablets than recommended, inform your doctor or pharmacist.
Nausea and vomiting may occur.

Missing a 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 more than 24 hours. In this case, skip the missed dose.

Stopping Orgametril

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrium, and it may be used to treat menstrual cycle disorders. Cycles are normalized by taking Orgametril for several days a month. A few days after stopping Orgametril, 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 any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Orgametril

Store below 30°C. Store the blister 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 month.
Medicines should 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. 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 what the pack contains

White, round tablets with a notch, with the inscription Organon and a star on one side, and 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, contact 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 56/112/70-C

Parallel import authorization number: 186/20

Date of leaflet approval: 18.06.2025

[Information about the trademark]