Modelle^® Mam (Tablets) Instructions for Use

Marketing Authorization Holder

Actavis Group PTC ehf. (Iceland)

Manufactured By

Laboratorios Leon Farma, S.A. (Spain)

ATC Code

G03AC09 (Desogestrel)

Active Substance

Desogestrel (Rec.INN registered by WHO)

Dosage Form

Modelle® Mam

Film-coated tablets, 75 mcg: 28, 84, or 168 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, smooth.

Excipients : lactose monohydrate, corn starch, povidone K30, D-alpha-tocopherol, colloidal hydrated silicon dioxide, colloidal anhydrous silicon dioxide, stearic acid.

Shell composition Aquarius BP 18033 cool vanilla (hypromellose 2910, polyethylene glycol, titanium dioxide).

28 pcs. – blisters (1) – cardboard packs^×.
28 pcs. – blisters (3) – cardboard packs^×.
28 pcs. – blisters (6) – cardboard packs^×.

^× protective stickers may be additionally applied.

Clinical-Pharmacological Group

Gestagen for oral contraception

Pharmacotherapeutic Group

Progestogen

Pharmacological Action

Synthetic progestin, chemically similar to levonorgestrel. It has progestogenic activity. It causes the transition of the endometrial epithelium from the proliferative phase to the secretory phase. It increases the viscosity of cervical mucus. It inhibits the secretion of LH by the pituitary gland and, thus, causes inhibition of ovulation. It has weak androgenic activity, which may not manifest.

Pharmacokinetics

After oral administration, Desogestrel is rapidly absorbed. The mean C_max in serum is reached after 1.8 h (T_max) after administration. The bioavailability of etonogestrel is about 70%.

Etonogestrel is 95.5-99% bound to plasma proteins, mainly to albumin and to a lesser extent to sex hormone-binding globulin (SHBG).

C_ss in plasma is established after 4-5 days.

Desogestrel is metabolized by hydroxylation and dehydrogenation into the active metabolite etonogestrel. Etonogestrel is metabolized by the formation of sulfate and glucuronide conjugates.

The mean T_1/2 of etonogestrel is about 30 h, both after single and multiple doses. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines (in a ratio of 1.5:1) as free steroids and conjugates.

Etonogestrel is excreted in breast milk.

Indications

Contraception.

ICD codes

Dosage Regimen

Take one 75 mcg tablet orally once daily at approximately the same time each day.

Begin taking the tablets on the first day of your menstrual cycle (first day of menstrual bleeding).

Continue taking one tablet daily without interruption. After finishing one blister pack, immediately start the next pack the following day.

If you are switching from a combined oral contraceptive, start Modelle^® Mam the day after taking the last active combined pill. No pill-free interval is required.

If you are switching from a progestogen-only method (mini-pill, implant, or IUD), start on the day of implant or IUD removal, or the day you would have taken your next mini-pill.

Take a missed tablet as soon as remembered, even if it means taking two tablets in one day. Continue taking the subsequent tablets at the usual time.

If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. Use a barrier method of contraception (e.g., condoms) for the next 7 days.

If vomiting or severe diarrhea (within 3-4 hours after tablet intake) occurs, take another tablet from a spare blister pack. Continue tablet-taking from the main pack as scheduled.

Irregular menstrual bleeding may occur, especially during the first few months of use. Continue taking your tablets regularly; do not stop taking them due to bleeding.

Adverse Reactions

Psychiatric disorders: frequent – mood changes, decreased libido, depressive disorder.

Nervous system disorders: frequent – headache.

Eye disorders infrequent – contact lens intolerance.

Gastrointestinal disorders: frequent – nausea; infrequent – vomiting.

Skin and subcutaneous tissue disorders: frequent – acne; infrequent – alopecia; rare – skin rash, urticaria, erythema nodosum.

Reproductive system disorders frequent – breast tenderness, irregular menstrual bleeding, amenorrhea; infrequent – dysmenorrhea, ovarian cyst, vaginitis; rare – breast discharge, ectopic pregnancy.

Other frequent – weight gain; infrequent – fatigue.

In women receiving (combined) oral contraceptives, various serious adverse effects have rarely been observed venous and arterial thrombosis and thromboembolism, hormone-dependent tumors (e.g., breast cancer) and chloasma.

Contraindications

Hypersensitivity to desogestrel; current or history of venous thromboembolism (including deep vein thrombosis of the lower extremities, pulmonary embolism); current or history of severe liver disease (until liver function tests return to normal); current or history of hepatic failure; established or suspected malignant hormone-dependent tumors (including breast cancer); vaginal bleeding of unknown etiology; established or suspected pregnancy; childhood and adolescence under 18 years of age.

With caution persistent arterial hypertension; prolonged immobilization associated with surgery, illness or injury, liver cancer, chloasma, especially in women with a history of chloasma during pregnancy, diabetes mellitus, porphyria, systemic lupus erythematosus, herpes (with a history of pregnancy).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use during breastfeeding is possible if indicated.

Use in Hepatic Impairment

Contraindicated for use in severe liver diseases, including history (until liver function tests return to normal), as well as in hepatic failure, including history.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Before using desogestrel, a thorough history should be taken and a gynecological examination should be performed to rule out pregnancy.

Despite regular use of desogestrel, irregular spotting may occur. If bleeding is frequent enough and irregular, it is necessary to consider prescribing another contraceptive method. If the above symptoms persist even after discontinuation of desogestrel, organic pathology should be ruled out.

The contraceptive effect of desogestrel is less effective in patients with high body weight.

Desogestrel can be used in combination with ethinylestradiol.

Drug Interactions

Drug interaction of desogestrel with drugs that induce microsomal enzymes is possible, leading to an increase in the clearance of sex hormones, for example, hydantoins (phenytoin), barbiturates (phenobarbital), primidone, carbamazepine, rifampicin; and probably also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and preparations containing St. John’s wort . Women using any of these drugs should use another method of contraception during the use of desogestrel.

When using activated charcoal, the absorption of desogestrel may decrease and, consequently, the contraceptive effectiveness may decrease.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.