Medicinal Products

AMARANCE Ge

Generic drug of Trinordiol
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Brick coated tablet: Levonorgestrel, Ethinylestradiol, White coated tablet: Levonorgestrel, Ethinylestradiol, Yellow coated tablet: Levonorgestrel, Ethinylestradiol
laboratory: Pfizer Holding France

Coated tablet
Box of 3 Pads of 21
All forms

Indication

Oral hormonal contraception.

Dosage AMARANCE Ge Coated Tablet Box of 3 Pads of 21

Take regularly and without forgetting 1 tablet per day at the same time of the day, for 21 consecutive days with a stop of 7 days between each plate.

A withdrawal hemorrhage usually begins 2-3 days after the last tablet is taken and may continue after the beginning of the next pack.

The order of taking the tablets is as follows: 6 tablets bricks, then 5 white tablets, then 10 yellow tablets.

Beginning of mistreatment:

· Absence of hormonal contraception the previous month:

Take the first tablet on the first day of menstruation.

· Relay of another oral contraceptive estroprogestatif:

Take the first tablet the day after taking the last active tablet of the previous contraceptive or at the latest one day after the usual period of stopping the tablets.

· Relay of a progestative contraception (microdose pill, injectable, implant):

The relay microdosed contraception can be done at any time of the cycle and amarance must be started the day after the stop.

The relay of an implant is done the day of the withdrawal, and the relay of an injectable contraceptive is the day envisaged for the new injection. In all cases, it is recommended to use a complementary method of contraception during the first 7 days of treatment.

· After a first trimester pregnancy termination:

It is possible to start amarance immediately. It is not necessary to use a complementary method of contraception.

· After a second trimester delivery or pregnancy termination:

Since immediate postpartum is associated with an increased risk of thromboembolism, oral contraceptives should not be started less than 21 to 28 days after delivery or second trimester abortion. It is recommended to use a complementary method of mechanical contraception during the first 7 days of treatment. However, if sexual intercourse has already taken place, it should be ensured that there is no pregnancy before starting oral contraceptives or waiting for the first period.

· In case of breastfeeding: see section Pregnancy and breastfeeding .

Case of forgetfulness of one or more tablets.

Contraceptive security may be diminished in case of forgetfulness especially if this forgetfulness increases the time interval between the last tablet of the current wafer and the first tablet of the following wafer.

· If a tablet is missed within 12 hours of the usual time of taking, take the missed tablet immediately, and continue treatment normally by taking the next tablet at the usual time.

· If a tablet is missed more than 12 hours after the normal time, contraceptive security is no longer assured. Take the last missed tablet immediately, even if 2 tablets are to be taken on the same day, and continue oral contraceptive treatment until the end of the pack, using simultaneously another contraceptive method of the mechanical type (condoms, spermicides, .. .) for the next 7 days. If this 7-day period extends beyond the last tablet of the current tablet, the next pack should be started the day after the last tablet is taken. It is likely that no withdrawal haemorrhage will occur before the end of the second platelet. However, the patient may have spotting or bleeding.

If the patient does not have withdrawal bleeding at the end of the second platelet, the risk of pregnancy should be ruled out before continuing the treatment.

In case of gastrointestinal disorders:

The occurrence of intercurrent gastrointestinal disorders within 4 hours after taking, such as vomiting or severe diarrhea, may lead to a transient inefficiency of the method by reducing the absorption of hormones and impose the recommended course of action in case of forgetfulness less than 12 hours. An active tablet from another pack should be taken. If these episodes are repeated over several days, then it is necessary to combine another contraceptive method (condoms, spermicides, ...) until the recovery of the next pack.

Against indications

Hypersensitivity to the active substances or to any of the excipients

Arterial thromboembolic events (presence or antecedent)

Venous thromboembolic events (presence or antecedent) such as deep vein thrombosis or pulmonary embolism

· Inherited or acquired predisposition to venous or arterial thromboses (activated protein C resistance (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and anti-phospholipid antibodies)

· Cerebrovascular or coronary artery disease

· Uncontrolled hypertension

· Valvulopathy

· Thrombogenic rhythm disorders

· History of migraine with focal neurological signs

· Pancreatitis or history of pancreatitis associated with severe hypertriglyceridemia

· Complicated diabetes mic or macro angiopathy

· Known or suspected malignant tumor of the breast

· Carcinoma of the endometrium or any known or suspected estrogen-dependent tumor

· Adenoma or hepatic carcinoma, severe liver disease until hepatic function returns to normal

· Undiagnosed haemorrhages.

Adverse effects Amarance GE

The following side effects have been observed during treatment with oral estrogen / progestin contraceptives:

For serious side effects, such as venous and venous thromboembolic events, see Warnings and Precautions for Use section .

The most common (> 10%) adverse reactions reported by patients during Phase III clinical trials and post-marketing follow-up were headache including migraines, and bleeding / spotting.

Other side effects reported during the use of oral contraceptives:

Frequent

Rare

Rare

Very rare

Frequency unknown

( 1/100 and <1/10)

( ≥1 / 1000 and <1/100)

( ≥1 / 10000 and <1/1000)

( <1/10000)

Benign, malignant and unspecified tumors (incl cysts and polyps)

Hepatocellular carcinoma, benign liver tumors (eg focal nodular hyperplasia, hepatic adenoma).

Infections and infestations

Vaginitis including vaginal candidiasis

Immune system

Anaphylactic reactions with very rare cases of urticaria, angioedema, severe circulatory and respiratory disorders.

Exacerbation of systemic lupus erythematosus.

Metabolism and nutrition

Change in appetite (increase or decrease)

Glucose intolerance.

Exacerbation of a porphyria.

Psychiatric disorders

Mood change including depression, change in libido.

The nervous system

Nervousness, dizziness

Exacerbation of a chorea

Eye disorders

Irritation by contact lenses

Optic neuritis, retinal vascular thrombosis

Vascular disorders

Hypertension

Gastrointestinal disorders

Nausea, vomiting, abdominal pain

Abdominal cramps, bloating

pancreatitis

Ischemic colitis

Hepatobiliary disorders

Cholestatic jaundice

Biliary lithiasis, cholestasis

Skin and subcutaneous tissues

Acne

Rash, chloasma (melasma) with risk of persistence, hirsutism, alopecia

Erythema nodosum

Erythema multiforme

Renal and urinary disorders

Uremic hemolytic syndrome

Reproductive organs and breast

Breast pain and tension, secretion, dysmenorrhea, changes in vaginal secretions and menstruation

General disorders and administration site conditions

Fluid retention / edema Weight change (increase or decrease)

investigations

Modification of plasma lipids, including hypertriglyceridemia.

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