Generic drug of the therapeutic class: Contraception and termination of pregnancy
active ingredients: White tablet: Levonorgestrel, Ethinylestradiol, Orange-pink tablet: Levonorgestrel, Ethinylestradiol
laboratory: Pfizer Holding France

Coated tablet
Box of 1 pack of 21 coated tablets (7 white + 14 orange)
All forms

Indication

Oral hormonal contraception.

Posology ADEPAL Coated Tablet Box of 1 Pack of 21 Coated Tablets (7 white + 14 orange)

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: 7 white tablets and 14 pink-orange tablets.

Beginning of treatment with ADEPAL, coated tablet:

· Absence of hormonal contraception the previous month:

Take the first tablet on the first day of menstruation.

· Relay of another estrogen / progestin hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or patch):

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. In the case of the vaginal ring or transdermal patch, take the first tablet on the day of withdrawal or at the latest on the day scheduled for the application of the new device or ring.

· Relay of progestative contraception (microdose pill, injectable, implant, intrauterine device [IUD] containing a progestin):

The relay of a microdosed contraception can be done at any time of the cycle and ADEPAL, coated tablet should be started the day after the stop.

The relay of an implant or IUD is done on the day of withdrawal, and the relay of an injectable contraceptive is made the day scheduled 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 ADEPAL, coated tablet 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. If treatment is started more than 28 days after a second trimester delivery or abortion, it is recommended that a complementary method of mechanical contraception be used for 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 .

What to do if you forget one or more tablets Contraceptive security can be reduced if you forget it, especially if you forget the time interval between the last tablet of the current tablet and the first tablet. the next plate.

· 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.

The following two basic rules apply if you forget to take tablets:

1. Taking tablets should never be interrupted for more than 7 days.

2. Uninterrupted tablet administration for 7 days is required to achieve correct inhibition of the hypothalamic-pituitary-ovarian axis.

The following tips will therefore be given in practice:

Week 1

The woman will take the last missed tablet as soon as she thinks about it, even if it means she has to take 2 tablets at the same time. She will then continue to take the following tablets at the usual time. She will also have to use a complementary mechanical contraception (example, a condom) for the next 7 days. In case of sexual intercourse during the preceding 7 days, the possibility of pregnancy should be considered. The risk of pregnancy is all the greater as the number of forgotten tablets is important or the date of forgetting is close to the beginning of the pack.

Week 2

The woman will take the last missed tablet as soon as she thinks about it, even if it means she has to take 2 tablets at the same time. She will then continue to take the tablets at the usual time. If the tablets have been taken correctly the 7 days before the forgotten tablet, it will not be necessary to take additional contraceptive measures. However, if multiple tablets have been missed, the woman will be advised to use another method of contraception for 7 days.

Week 3

The risk of decreased contraceptive effectiveness is greatest given the approach of the 7-day period without tablets. However, it is possible to prevent the reduction of contraceptive effectiveness by modulating the intake of tablets. Therefore, it will not be necessary to take additional contraceptive measures if one of the alternatives below is followed, provided that all tablets have been taken correctly during the 7 days prior to the missed pill. However, if this is not the case, the woman will be advised to follow the first of the two alternatives and simultaneously use another method of contraception for the next 7 days.

1. The woman will take the last missed tablet as soon as she thinks about it, even if it means she has to take 2 tablets at the same time. She will then continue to take the tablets at the usual time. She will begin the next pack immediately after taking the last tablet of the current pack, that is to say there will be no interruption between the pads. The onset of withdrawal haemorrhage before the end of the second platelet is unlikely but spottings (drops or blood spots) or bleeding are possible on the days of taking the tablets.

2. The woman may also be advised to stop taking tablets from the current pack. In this case, she should observe a tablet-free period of up to 7 days, including days when she has forgotten to take the tablets, and then continue with the next pack.

If the woman has forgotten tablets and has no withdrawal haemorrhage during the first normal period without a tablet, the possibility of pregnancy should be considered.

In case of gastrointestinal disorders:

In severe gastrointestinal disorders (eg, vomiting or diarrhea), tablet absorption may not be complete; additional contraceptive measures must therefore be taken.

· If vomiting occurs within 3-4 hours of taking the tablet, a new tablet should be taken as a replacement as soon as possible. The new tablet should be taken, if possible, within 12 hours after the usual dose.

· If more than 12 hours have elapsed, the same guidelines as those given for tablet omissions should apply (see section 4.2) and how to take it in case of forgetting one or more tablets. ").

If the woman does not want to change the normal schedule of taking the tablets, she should take the extra tablet (s) from another pack.

Against indications

Combination oral contraceptives (COCs) should not be used under the following conditions. If any of the following conditions occur for the first time while taking a combination oral contraceptive, the use of oral contraceptives should cease immediately.

Venous thrombosis or history of venous thrombosis (deep vein thrombosis, pulmonary embolism);

Arterial thrombosis or history of arterial thrombosis (including myocardial infarction) or precursor signs of thrombosis (eg, angina and transient ischemic attack);

· Stroke or history of stroke;

· Inherited or acquired predisposition to venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibody, anticoagulant lupus);

· Presence of a severe risk factor or several risk factors for arterial thrombosis (see also section Warnings and precautions for use ):

o Valvulopathy, thrombogenic rhythm disorders,

o Diabetes complicated by a micro or macroangiopathy,

o severe hypertension,

o severe dyslipoproteinemia;

· Pancreatitis or a history of pancreatitis associated with severe hypertriglyceridemia;

· Severe liver disease or a history of severe liver disease, in the absence of normalized liver function tests;

· Active or benign hepatic (benign or malignant) tumors;

· Known or suspected hormone-dependent malignancy (eg, genital or breast tumors)

· Undiagnosed vaginal bleeding;

· History of migraines accompanied by focal neurological signs;

Hypersensitivity to the active substances or to any of the excipients of ADEPAL, coated tablet.

· ADEPAL, coated tablet is contraindicated in combination with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ).

Adepal side effects

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

For serious side effects, such as venous and arterial thromboembolic events, cervical cancer, breast cancer and malignant liver tumors, see Warnings and precautions for use .

Frequent
(≥1 / 100 and <1/10)

Rare
(≥1 / 1000 and <1/100)

Rare
(≥1 / 10000 and <1/1000)

Very rare
(<1/10000)

Not known frequency

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 disorders

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

Exacerbation of systemic lupus erythematosus.

Metabolism and nutrition disorders

Change in appetite (increase or decrease)

Glucose intolerance.

Exacerbation of a porphyria.

Psychiatric disorders

Mood change including depression, change in libido.

Nervous system disorders

Nervousness, dizziness

Exacerbation of a chorea

Eye disorders

Irritation by contact lenses

Optic neuritis, retinal vascular thrombosis

Vascular disorders

Hypertension

Aggravation of varicose veins

Gastrointestinal disorders

Nausea, vomiting, abdominal pain

Abdominal cramps, bloating

Ischemic colitis

Inflammatory bowel disease (Crohn's disease, ulcerative colitis)

Hepatobiliary disorders

Cholestatic jaundice

pancreatitis

Biliary lithiasis, cholestasis

Hepatocellular involvement (eg, hepatitis, abnormal liver function)

Skin and subcutaneous tissue disorders

Acne

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

Erythema nodosum

Erythema multiforme

Renal and urinary disorders

Uremic hemolytic syndrome

Reproductive system disorders and breast

Pain, tension, swelling and secretion of the breast, dysmenorrhea, modification of the rules, modification of an ectropion and vaginal secretions, amenorrhoea.

General disorders and administration site conditions

Fluid retention / edema
Weight change (increase or decrease)

investigations

Modification of plasma lipids, including hypertriglyceridemia, increase in blood pressure

Decreased serum folate level.

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