Orgametril
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Orgametril
5 mg, tablets
Lynestrenol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Orgametril is and what it is used for
- What you need to know before taking Orgametril
- How to take Orgametril
- Possible side effects
- How to store Orgametril
- Contents of the pack and other information
1. What Orgametril is and what it is used for
Orgametril contains lynestrenol, a synthetic progestagen similar to natural progesterone.
Progestagens, including Orgametril, are commonly used in menstrual cycle disorders.
Orgametril is indicated for use in adult female patients over 18 years of age.
Indications for Orgametril:
- Frequent menstruation
- Heavy menstrual bleeding and uterine haemorrhage
- Selected cases of primary and secondary amenorrhoea and scanty menstruation
- Endometriosis (endometrial hyperplasia)
- Selected cases of endometrial carcinoma
- Benign breast disorders
- Suppression of menstrual bleeding, ovulation, painful ovulation, and dysmenorrhoea
- Delaying the onset of menstrual bleeding
- Supplementary treatment to estrogen therapy during perimenopausal and postmenopausal periods to prevent endometrial hyperplasia.
2. Important information before using Orgametril
When not to use 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 she may be pregnant;
- if the patient has severe liver diseases such as cholestatic jaundice or hepatitis (or a history of liver disease if liver function parameters have not returned to normal), liver tumors, or Rotor and Dubin-Johnson syndromes;
- if the patient has vaginal bleeding of unknown origin;
- if the patient currently has or has had in the past rare conditions associated with sex hormone use, e.g., pruritus, cholestatic jaundice, herpes gestationis, porphyria, and otosclerosis. These may occur for the first time or worsen during pregnancy or while using hormonal medications;
- current venous thromboembolic disease. Thrombosis involves the formation of clots blocking veins (e.g., in the legs (deep vein thrombosis) or in the lungs (e.g., pulmonary embolism)).
Warnings and precautions
Before starting to use Orgametril, discuss this with your doctor or pharmacist.
Patients with the conditions listed below should remain under close medical supervision.
Inform your doctor if you have:
- blood clotting disorders (thrombosis);
- heart or vascular disease;
- severe depressive mood;
- liver diseases, e.g., jaundice or liver tumors;
- abnormal vaginal bleeding;
- high levels of cholesterol or other lipids in the blood;
- chloasma (skin pigmentation often occurring during pregnancy);
- acne, seborrheic skin, excessive body or facial hair.
Children and adolescents
The safety and efficacy of Orgametril in adolescents under 18 years of age have not been established. No data are available.
Orgametril and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
Taking other medicines may affect the effectiveness of Orgametril, and Orgametril may affect the effectiveness of other medicines. Consult your doctor or pharmacist before taking any medicine.
Inform your doctor or pharmacist if you are taking or plan to take any of the following medicines:
- Rifamycin or troleandomycin (used to treat bacterial infections);
- Hydantoin derivatives, barbiturates, carbamazepine (used in epilepsy);
- Aminoglutethimide (used in the treatment of Cushing's syndrome);
- Cyclosporines (used after organ transplantation);
- Theophylline (used in asthma, bronchitis, and emphysema);
- Beta-adrenergic receptor blockers (used in hypertension);
- Insulin (used in diabetes treatment).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use of Orgametril during pregnancy or if the patient suspects she may be pregnant is contraindicated.
Driving and operating machinery
Some patients may experience dizziness. If so, do not drive or operate machinery.
Orgametril contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before starting this medicine.
3. How to use Orgametril
This medicine should always be used as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
| Indications | Dosage |
| Frequent menstruation: | 1 tablet daily from day 14 to day 25 of the cycle. |
| Heavy menstrual bleeding and uterine hemorrhage: | 2 tablets daily for 10 days. Bleeding usually stops within a few days of starting treatment. Treatment is repeated for the next 3 menstrual cycles, using 1 tablet daily from day 14 to day 25 of each cycle. If symptoms persist during or after treatment, additional diagnostic tests are necessary. |
| Selected cases of primary and secondary amenorrhea and oligomenorrhea: | Treatment should begin with administration of estrogens, e.g. 0.02 to 0.05 mg ethinylestradiol daily for 25 days. Concurrently, from
|
| Endometriosis: | 1 to 2 tablets daily for at least 6 months. |
| Selected cases of endometrial carcinoma: | 6 to 10 tablets daily for a prolonged period. |
| Benign breast disease: | 1 tablet daily from day 14 to day 25 of the cycle, for at least 3 to 4 months. |
| Suppression of menstruation, ovulation inhibition, painful ovulation, dysmenorrhea: | Treatment should be started on the first day of the cycle, but no later than day 5, administering 1 tablet daily. The treatment may be continued for many months (without interruption). If bleeding occurs despite medication, the dose of Orgametril should be increased to 2 to 3 tablets daily for 3 to 5 days. |
| Postponement of menstrual period: | Treatment should ideally begin 2 weeks before the expected onset of menstruation, administering 1 tablet daily. If treatment is started less than 1 week before the expected menstruation, the dose should be increased to 2 to 3 tablets daily. However, in such cases, postponement of menstruation by more than 1 week is not recommended. The later the treatment is initiated, the higher the risk of intermenstrual bleeding. Therefore, treatment should not begin later than 3 days before the expected onset of menstruation. |
| Adjunctive treatment to estrogen therapy in perimenopausal and postmenopausal periods to prevent endometrial hyperplasia: | 1 tablet daily for 12 to 15 days per month, e.g. during the first 2 calendar weeks of the month. Estrogens may be administered daily without interruption at the lowest effective dose. |
WARNING: The first day of menstrual bleeding is the first day of the cycle.
The medicine Orgametril should be taken orally at the same time each 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.
Use of a higher than recommended dose of Orgametril
If more tablets are swallowed than recommended, 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 a dose has been missed, take the medicine as soon as possible, unless the delay is longer than 24 hours. In that case, the missed dose should be omitted.
Discontinuation of Orgametril
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
Lynestrenol affects the endometrium and can be used in the treatment of menstrual cycle disorders. Cycles are normalized by administering Orgametril for several days each month. Several days after stopping Orgametril, often within 3 days, endometrial shedding occurs and bleeding appears (similar to menstruation).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Depending on the dose and the patient's sensitivity, the medicine Orgametril may cause adverse effects. The following adverse effects have been observed:
Very common (affects at least 1 in 10 people):
- Increase in body weight
- Increased blood glucose levels after meals (impaired glucose tolerance)
- Nervousness
- Decreased libido
- Nausea
- Vomiting
- Abdominal pain
- Diarrhoea
- Constipation
- Seborrhoea
- Intermenstrual bleeding occurring during the first 2 months of treatment.
Common (affects less than 1 in 10 people):
- Hypersensitivity
- Fluid retention
- Changes in blood lipid and cholesterol levels
- Depressive moods
- Increased libido
- Headache
- Migraine
- Dizziness
- Excessive sweating
- Chloasma (brown patches on the face)
- Itching
- Acne
- Skin reactions
- Excessive hair growth on body or face
- Breast tenderness
- Absence of menstruation
- Changes in liver function parameters.
Uncommon (affects less than 1 in 100 people):
- Jaundice
- Hot flushes.
If any of the above adverse effects occur, inform your doctor or pharmacist, particularly if vaginal bleeding occurs.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse effects helps to provide more information on the safety of the medicine.
5. How to store Orgametril
Store below 30°C. Keep the blister 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 score line, marked "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, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, 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. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Czech Republic, country of export: 56/112/70-C
Parallel import licence number: 186/20