Generic drug of Trinordiol
Therapeutic class: Contraception and termination of pregnancy
active ingredients: 6 pink tablets: Levonorgestrel, Ethinylestradiol, 5 white tablets: Levonorgestrel, Ethinylestradiol, 10 yellow tablets: Levonorgestrel, Ethinylestradiol
laboratory: Pierre Fabre Medicament
Box of 1 Plate of 21
Dosage DAILY Ge Coated Tablet Box of 1 Plate of 21
Take regularly and without forgetting 1 tablet a day at the same time of the day, for 21 consecutive days, with a stop of 7 days between each plate.
- Start of oral contraception:
1st tablet to take the 1st day of the rules.
The order of taking the tablets is as follows: 6 pink tablets, 5 white tablets, 10 yellow tablets.
- Relay of another estrogen / progestin contraceptive:
1st tablet: after a stop of 7 days if the previous plate contained 21 tablets (6 days if it contained 22 and without interval if it contained 28). If there is no withdrawal haemorrhage for 6 to 7 days after stopping the previous pill, make sure there is no pregnancy before starting treatment.
- Cases of forgetfulness of one or more tablets:
Forgetting a tablet puts you at risk for pregnancy.
. If missed within 12 hours of the usual time of taking, immediately take the missed tablet and continue treatment normally by taking the next tablet at the usual time.
. If forgetfulness is observed more than 12 hours after the normal time of taking, contraceptive security is no longer assured. Immediately take the last missed tablet and continue oral contraceptive treatment until the end of the pack, using simultaneously a contraceptive method of mechanical type (condoms, spermicides ...) until the resumption of the next pack, including during the rules.
- Thromboembolic accidents or arterial thromboembolic history (in particular myocardial infarction, stroke).
- Thromboembolic accidents or venous thromboembolic episodes (phlebitis, pulmonary embolism) with or without triggering factor.
- Cardiovascular disorders: arterial hypertension, coronary heart diseases, valvulopathies, thrombogenic rhythm disorders.
- Ocular pathology of vascular origin.
- Diabetes complicated by micro or macroangiopathy.
- Malignant tumors of the breast and uterus.
- Severe or recent liver disorders.
- Pituitary tumors.
- Undiagnosed haemorrhages.
- Ritonavir, nelfinavir, efavirenz, nevirapine, lopinavir, bosentan, St. John's Wort (oral) (enzyme inducer) (see interactions).
Due to the presence of lactose, this drug is contraindicated in case of galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
Due to the presence of sucrose, this drug is contraindicated in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
NOT RECOMMENDED :
- Metabolic disorders: uncomplicated diabetes, hyperlipidemia (hypertriglyceridemia, hypercholesterolemia).
- Obesity (body mass index: weight / height²> = 30 kg / m²).
- Benign breast tumors and uterine dystrophies (hyperplasia, fibroma).
- Hyperprolactinemia with or without galactorrhea.
- Renal failure.
- Recurrent cholestasis or pruritus recurring during an earlier pregnancy.
- Herpes gestationis.
- Association with enzyme inducers [anticonvulsants (phenobarbital, phenytoin, primidone, carbamazepine), rifabutin, rifampicin, griseofulvin); the modafinil; topiramate (see interactions).
- Breast-feeding: In case of breast-feeding, the use of this drug is not recommended due to the passage of estrogen-progestogen in breast milk. If the woman wishes to breastfeed, another means of contraception should be offered.
- Pregnancy: this medicine is not indicated during pregnancy. In clinical studies, unlike diethylstilbestrol, the results of numerous epidemiological studies have made it possible to rule out until now a malformative risk of estrogen alone or in combination, at the beginning of pregnancy. Moreover, the risks relating to the sexual differentiation of the fetus (especially female), risks described with old progestins very androgenomimetic, do not need to be extrapolated to recent progestins such as that presented in this specialty, much less, if at all, androgenomimetic. Consequently, the discovery of a pregnancy under estroprogestations does not justify the interruption.
Daily Side Effects
- relatively rare side effects but having to stop the treatment:
. Arterial thromboembolic accidents (especially myocardial infarction, stroke).
. Venous thromboembolic accidents (phlebitis, pulmonary embolism).
. Hypertension, coronary heart disease.
. Hyperlipidemia (hypertriglyceridemia and / or hypercholesterolemia), diabetes.
. Severe mastodynia, benign mastopathy.
. Pituitary adenoma with prolactin (possibly revealed by galactorrhea).
. Major and unusual headaches, migraines, vertigo, change in vision.
. Exacerbation of a comitiality.
. Hepatic adenoma, cholestatic jaundices.
- More frequent undesirable effects, do not usually prevent the continuation of the treatment but which could envisage a change of the type of estroprogestatif:
. Nausea, common headache, weight gain, irritability, heavy legs.
. Mammary tension, intermenstrual bleeding, oligomenorrhea, amenorrhea, change in libido.
. Eye irritation by contact lenses.
Acne, seborrhea, hypertrichosis.
- Effects upon discontinuation of treatment:
Amenorrhea with anovulation (more likely to occur in women with a history of irregular cycles) may be observed upon discontinuation of treatment. They usually give way spontaneously. In case of prolongation, before any new prescription, the search for a possible pituitary pathology is necessary.