Orgametril
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Orgametril
5 mg, tablets
Lynestrenol
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents
- 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 hemorrhage
- Selected cases of primary and secondary amenorrhea and hypomenorrhea
- Endometriosis (endometrial tissue overgrowth)
- Selected cases of endometrial carcinoma
- Benign breast disorders
- Suppression of menstrual bleeding, ovulation, painful ovulation, and dysmenorrhea
- Delaying the onset of menstrual bleeding
- Hormone replacement therapy adjunct to estrogen therapy in perimenopausal and postmenopausal women 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, Rotor or Dubin-Johnson syndromes;
- if the patient has vaginal bleeding of unknown origin;
- if the patient currently has or has had rare disorders associated with sex hormone use, such as pruritus, cholestatic jaundice, herpes gestationis, porphyria, and otosclerosis. These conditions may occur for the first time or worsen during pregnancy or while using hormonal medicines;
- 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 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
- melasma (skin pigmentation often occurring during pregnancy)
- acne, seborrheic skin, and 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 available 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 (medicines used for bacterial infections)
- Hydantoin derivatives, barbiturates, carbamazepine (medicines used for epilepsy)
- Aminoglutethimide (a medicine used in the treatment of Cushing's syndrome)
- Cyclosporines (medicines used after organ transplants)
- Theophylline (medicines used for asthma, bronchitis, emphysema)
- Beta-adrenergic blocking agents (medicines used for hypertension)
- Insulin (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.
The 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. Do not drive or operate machinery if affected.
Orgametril contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her 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 the doctor or pharmacist.
| Indications | Dosage |
| Frequent menstruation: | 1 tablet daily from day 14 to day 25 of the cycle. |
| Heavy menstrual bleeding and uterine haemorrhage: | 2 tablets daily for 10 days. Bleeding usually stops within a few days after 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 amenorrhoea and hypomenorrhoea: | 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 disorders: | 1 tablet daily from day 14 to day 25 of the cycle, for at least 3 to 4 months. |
| Suppression of menstrual bleeding, ovulation, painful ovulation, and dysmenorrhoea: | Treatment should begin on the first day of the cycle, but no later than day 5, administering 1 tablet daily. The treatment may be continued for several months (without interruption). If bleeding occurs despite treatment, the dose of Orgametril should be increased to 2 to 3 tablets daily for 3 to 5 days. |
| Delaying the onset of menstruation: | 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 onset of menstruation, the dose should be increased to 2 to 3 tablets daily. However, in such cases, delaying menstruation by more than 1 week is not recommended. The later the treatment is started, the higher the risk of intermenstrual bleeding. Therefore, treatment should be initiated no 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 Orgametril medication should be taken orally at the same time each day, with a small amount of water or another 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 have been 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 medication as soon as possible, unless the delay exceeds 24 hours. In that case, skip the missed dose.
Discontinuation of Orgametril
If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.
Linestrenol affects the endometrial lining 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 completing the intake of Orgametril, often within 3 days, shedding of the endometrial lining occurs, resulting in bleeding (similar to menstruation).
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Depending on the dose and individual patient sensitivity, the medicine Orgametril may cause adverse reactions. The following adverse reactions have been observed:
Very common (affecting 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
- Diarrhea
- Constipation
- Seborrhoea
- Intermenstrual bleeding occurring during the first 2 months of treatment.
Common (affecting less than 1 in 10 people):
- Hypersensitivity
- Fluid retention
- Changes in blood lipid and cholesterol levels
- Depressive mood
- Increased libido
- Headache
- Migraine
- Dizziness
- Excessive sweating
- Chloasma (brown patches on the face)
- Itching
- Acne
- Skin reactions
- Excessive hair growth on the body or face
- Breast tenderness
- Absence of menstruation
- Changes in liver function parameters.
Uncommon (affecting less than 1 in 100 people):
- Jaundice
- Hot flushes
If any of the above adverse reactions occur, inform your doctor or pharmacist, particularly if vaginal bleeding occurs.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.
5. How to store Orgametril
Store below 30°C. Do not freeze. Keep 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Package contents and other information
What Orgametril contains
- The active substance is linestrenol. One tablet contains 5 mg of linestrenol.
- The other ingredients are: α-Tocopherol (E 307), potato starch, glycerol (E 422), magnesium stearate (E 572), talc (E 553b), monohydrate lactose.
What Orgametril looks like and contents of the pack
White, round tablets with a score line, marked with "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.
Pack contains 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of marketing authorisation in the Netherlands, the country of export: RVG 00278
Parallel import authorisation number: 9/23