ORGAMETRIL 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Orgametril, 5 mg, tablets
   1. Read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Orgametril and what is it used for
4. Important information before taking Orgametril
   1. When not to take Orgametril:
   2. Warnings and precautions
   3. Children and adolescents
   4. Orgametril and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Orgametril contains lactose
5. How to take Orgametril
   1. Dosage
   2. Dosage
   3. Overdose of Orgametril
   4. Missed dose of Orgametril
   5. Stopping treatment with Orgametril
6. Possible side effects
   1. Reporting side effects
7. How to store Orgametril
8. Contents of the packaging and other information
   1. What Orgametril contains
   2. What Orgametril looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: 08/2022

Leaflet attached to the packaging: information for the user

Orgametril, 5 mg, tablets

Lynestrenol

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 inform 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 packaging 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 mucosa)
• 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:

• 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, discuss it with your doctor or pharmacist.
Patients with the following diseases should be under close medical supervision.
Inform your doctor about:

• blood coagulation 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.
Inform 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)
• Beta-adrenergic receptor blockers (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, 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 disappear during or after treatment, additional diagnostic tests are necessary.

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

Selected cases of primary and secondary absence and scanty 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 of completing the 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.
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 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.
Delaying the date 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 date 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.

Dosage

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 in the smallest 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 treatment with Orgametril

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrium, can be used to treat menstrual cycle disorders. Cycles are normalized by taking Orgametril for several days a month. A few days after completing the treatment, usually within 3 days, the endometrium 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 sensitivity of the patient, 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 lipid and cholesterol levels in the blood
• 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, 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 this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Orgametril

Store in a temperature below 30°C. 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 packaging and other information

What Orgametril contains

• The active substance of the medicine is lynestrenol.
• The other ingredients are: Di-alfa-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 pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

Date of last revision of the leaflet: 08/2022