LINESSA

1 Dosing Considerations Patients should be instructed to read the package insert prior to starting LINESSA and any time they are unsure of administration. If they have additional questions, they should call their doctor or clinic. LINESSA tablets are prescribed as a 21-day or 28-day regimen.

LINESSA tablets must be taken at approximately the same time every day until the pack is empty. e. the first day of menstrual flow) or on the first Sunday after her period begins. If the period starts on Sunday, she should start that same day.

2 Recommended Dose and Dosage Adjustment LINESSA 21 (21-Day Regimen): One coloured tablet is to be taken as follows for 21 consecutive days (three weeks): light yellow for 7 days; orange for 7 days and red for 7 days. Tablets are then discontinued for one week.

The patient must not be off the pill for more than seven consecutive days. A new pack will be started on the eighth day. The patient will have a period during the seven days off the pill (the bleeding may be lighter and shorter than their usual period).

LINESSA 28 (28-Day Regimen):

Tablets are taken sequentially following the arrows marked on the dispenser. One light yellow tablet is taken daily for 7 days; followed by one orange tablet for 7 days then one red tablet daily for 7 days. On the fourth week the patient will take one “inactive” green pill daily for the next seven consecutive days.

A new pack will be started on the eighth day following completion of the green tablets. The patient will have a period during the seven days on the green pill. On this regimen the patient must not go a day without taking a pill. 4 Administration It is recommended that LINESSA be taken at the same time each day.

The patient should be counseled to associate the pill with some regular activity like eating a meal or going to bed. g. condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while they are getting used to taking them.

If spotting, light bleeding or feeling sick to their stomach occurs during the first three months the woman should be counseled to not stop taking the pill. The problem will usually go away. If it does not subside, the patient should consult with her doctor or clinic.

1 Adverse Reaction Overview An increased risk of the following serious adverse reactions has been associated with the use of combination hormonal contraceptives: ▪ arterial and venous thromboembolism ▪ benign and malignant hepatic tumours ▪ cerebral hemorrhage ▪ cerebral thrombosis ▪ congenital anomalies ▪ gallbladder disease ▪ hypertension ▪ mesenteric thrombosis LINESSA® 21 and LINESSA® 28 (desogestrel and ethinyl estradiol tablets) © 2025 Aspen Group of companies or its licensor.

All rights reserved. , retinal thrombosis) ▪ pulmonary embolism ▪ thrombophlebitis The following adverse reactions also have been reported in patients receiving combination hormonal contraceptives: nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or less of patients during the first cycle.

The following other reactions, as a general rule, are seen less frequently or only occasionally: ▪ abdominal pain ▪ amenorrhea during and after treatment ▪ angioedema (exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary or acquired angioedema) a ▪ auditory disturbances ▪ breakthrough bleeding ▪ breast changes: tenderness, enlargement, and secretion ▪ cataracts ▪ changes in appetite ▪ change in corneal curvature (steepening) ▪ changes in glucose tolerance or effect on peripheral insulin resistance ▪ changes in libido ▪ change in menstrual flow ▪ change in weight (increase or decrease) ▪ chloasma or melasma which may persist ▪ cholestatic jaundice ▪ chorea ▪ Crohn’s disease ▪ cystitis-like syndrome ▪ diarrhea ▪ dizziness ▪ dysmenorrhea ▪ edema ▪ endocervical hyperplasias ▪ erythema multiforme ▪ erythema nodosum ▪ gallstone formationa ▪ gastrointestinal symptoms (such as abdominal cramps and bloating) ▪ headache ▪ hemolytic uremic syndrome ▪ hemorrhagic eruption ▪ herpes gestationisa ▪ hirsutism ▪ hypersensitivity ▪ hypertension a LINESSA® 21 and LINESSA® 28 (desogestrel and ethinyl estradiol tablets) © 2025 Aspen Group of companies or its licensor.

3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): based on the data submitted and reviewed by Health Canada, LINESSA is not indicated for use in postmenopausal women. 2 CONTRAINDICATIONS Combined hormonal contraceptives (CHCs) should not be used in the presence of any of the conditions listed below.

Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. • LINESSA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. of the genital organs or of the breast); • undiagnosed abnormal vaginal bleeding; • Steroid-dependent jaundice, cholestatic jaundice, history of jaundice of pregnancy; • any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; • known or suspected pregnancy; LINESSA® 21 and LINESSA® 28 (desogestrel and ethinyl estradiol tablets) © 2025 Aspen Group of companies or its licensor.

All rights reserved. Page 5 of 72 Unclassified / Non classifié • current or history of migraine with focal aura; • history of actual pancreatitis if associated with severe hypertriglyceridemia. • Known predisposition for arterial or venous or thrombosis: • severe hypertension (persistent values of ≥160/100 mmHg) • hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden mutation and activated protein C (APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia (eg, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) • severe dyslipoproteinemia • smoking and over age 35 • diabetes mellitus with vascular involvement • major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) • prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS) • Major surgery with prolonged immobilisation • LINESSA is contraindicated for concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 9 DRUG INTERACTIONS).

Combined hormonal contraceptives (CHCs) should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. • LINESSA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. of the genital organs or of the breast); • undiagnosed abnormal vaginal bleeding; • Steroid-dependent jaundice, cholestatic jaundice, history of jaundice of pregnancy; • any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; • known or suspected pregnancy; LINESSA® 21 and LINESSA® 28 (desogestrel and ethinyl estradiol tablets) © 2025 Aspen Group of companies or its licensor.

All rights reserved. Page 5 of 72 Unclassified / Non classifié • current or history of migraine with focal aura; • history of actual pancreatitis if associated with severe hypertriglyceridemia. • Known predisposition for arterial or venous or thrombosis: • severe hypertension (persistent values of ≥160/100 mmHg) • hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden mutation and activated protein C (APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia (eg, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) • severe dyslipoproteinemia • smoking and over age 35 • diabetes mellitus with vascular involvement • major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) • prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS) • Major surgery with prolonged immobilisation • LINESSA is contraindicated for concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 9 DRUG INTERACTIONS).