Orgametril

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 you need to.
• 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 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 uterine mucosa 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 proliferation of the uterine mucosa.

2. Important information before taking Orgametril

When not to take 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 that she is pregnant;
• if the patient has severe liver disease such as cholestatic jaundice or hepatitis (or liver disease in the past, if liver function parameters have not returned to normal), liver tumors, Rotor and Dubin-Johnson syndromes;
• if the patient has vaginal bleeding of unknown origin;
• if the patient has currently or in the past rare diseases associated with the use of sex hormones, such as itching, cholestatic jaundice, pregnancy herpes, porphyria, and otosclerosis. They may occur for the first time or worsen during pregnancy or while taking hormonal medicines;
• current venous thromboembolic disease. Thromboembolism 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 vascular disease
• severe depressive moods
• liver disease, such as jaundice or liver tumors
• abnormal vaginal bleeding
• high cholesterol or other lipid levels 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 any 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 a 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)
• Beta-adrenergic receptor blockers (medicines used in hypertension)
• Insulin (diabetes treatment).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a 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

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 according to the doctor's recommendations. In case of doubts, you should consult a 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, you should consult a doctor or pharmacist.

Taking a higher dose of Orgametril than recommended

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

Missing a dose of Orgametril

You should not take a double dose to make up for a missed dose.
In case of missing 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 of the medicine.

Stopping treatment with Orgametril

In case of any further doubts about taking this medicine, you should consult a doctor or pharmacist.
Lynestrenol affects the uterine mucosa and can be used to treat menstrual cycle disorders. Cycles are normalized by taking Orgametril for several days a month. A few days after finishing the treatment, usually within 3 days, the uterine mucosa 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 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

In case of experiencing 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 this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 to gather more information on the safety of the medicine.

5. How to store Orgametril

Store at a temperature below 30°C. Protect from light and moisture.
The medicine should be stored in a place 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 packaging and other information

What Orgametril contains

• The active substance of Orgametril is lynestrenol. One tablet contains 5 mg of lynestrenol.
• The other ingredients are: potato starch, all-rac-α-tocopherol, glycerol, magnesium stearate, talc, lactose.

What Orgametril looks like and what the packaging contains

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 Belgium, the country of export:

Organon Belgium
Rue du Commerce 31
B-1000 Brussels

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB 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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Belgium, the country of export: BE011216
Parallel import authorization number: 429/22
Date of leaflet approval: 12.12.2022
[Information about the trademark]