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For Healthcare Professionals Only

EVRA® 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S):

norelgestromin and ethinyl estradiol

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S):

Female contraception. Safety/efficacy established in women aged 18-45 years.

DOSAGE & ADMINISTRATION:

Adults: Transdermal use. One patch for 7 days, for 3 weeks followed by 1 week patch free. No data in women >45 years of age. Contraceptive efficacy in women ≥ 90kg may be reduced

Children: Not recommended < 18 years of age
Renal impairment: Not studied but supervision required.
Hepatic impairment: Not studied – see contraindications.

CONTRAINDICATIONS:

Hypersensitivity. Presence or risk of venous or arterial thromboembolism (VTE/ATE), (refer to SmPC): Current VTE requiring anticoagulant therapy, history of deep vein thrombosis (DVT), or pulmonary embolism. Known hereditary or acquired risk of VTE or known thrombogenic mutations. Major surgery with prolonged immobilisation. History of myocardial infarction, angina pectoris. Presence of one serious risk factor for ATE: diabetes with vascular symptoms, severe hypertension, severe dyslipoproteinaemia. Cerebrovascular disease, current/history stroke, transient ischaemic attacks. Known hereditary or acquired predisposition for ATE. History of migraine with focal neurological symptoms. Known or suspected carcinoma breast, endometrium or other oestrogen-dependent neoplasia. Hepatic adenomas or carcinoma. Abnormal liver function related to acute or chronic hepatocellular disease. Undiagnosed abnormal genital bleeding. Drug combinations with paritaprevir/ritonavir, ombitasvir, and/or dasabuvir.

SPECIAL WARNINGS & PRECAUTIONS:

Exclude likelihood of pregnancy before starting treatment. Prior to initiation (and at regular intervals) assess personal and family medical history, measure blood pressure and perform physical examination. Discuss associated risk of VTE/ATE, known personal risk factors and symptoms of VTE and ATE. Increased risk of VTE in 6 week period of puerperium. Instruct to read leaflet carefully. Advise hormonal contraceptives do not protect against HIV infections or sexually transmitted disease. Discontinue: appearance of any contraindication; high blood pressure not responding to treatment; recurrence of cholestatic-related pruritus. Consider discontinuing: aggravation/new risk factors for VTE/ATE; acute/chronic liver function disturbances. As with all combined hormonal contraceptives: increased risk of cervical & breast cancer, worsening depression, epilepsy, Crohn’s disease, ulcerative colitis. Following may occur or deteriorate: jaundice and/or pruritus related to cholestasis, gallbladder disease including cholecystitis and cholelithiasis, porphyria, SLE, haemolytic uraemic syndrome, Sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, chloasma. Hepatic tumours reported rarely. Possible increased risk of pancreatitis with hypertriglyceridaemia (including family history). Observe diabetic women carefully. Irregular spotting or bleeding, especially in early treatment. Amenorrhoea/oligomenorrhoea after discontinuation.

SIDE EFFECTS:

Very common: headache, nausea, breast tenderness.
Common: (vulvo) vaginal fungal infection, vaginal candidiasis, mood, affect/anxiety disorders, migraine, dizziness, vomiting, diarrhoea, abdominal pain/distension, acne, rash, pruritus, skin reaction/irritation, muscle spasms, dysmenorrhoea, vaginal bleeding and menstrual disorders, uterine spasm, breast disorders, vaginal discharge, malaise, fatigue, application site reactions (erythema, irritation, pruritus, rash), weight increased.
Other side effects: hepatic neoplasm/adenoma, breast cancer, cervix carcinoma, uterine leiomyoma, fibroadenoma of breast, hypersensitivity, hypercholesterolaemia, hyperglycaemia/insulin resistance, cerebrovascular accident, cerebral haemorrhage, arterial thromboembolism, (acute) myocardial infarction, hypertension, hypertensive crisis, thrombosis (arterial/venous/pulmonary), venous thromboembolism, pulmonary embolism, hepatic lesion, jaundice cholestatic, cholestasis, angioedema, cervical dysplasia, lipid disorders.

Refer to SmPC for other side effects.

PREGNANCY:

Stop immediately.

LACTATION:

Not recommended.

INTERACTIONS:

Contraindicated: drug combinations containing paritaprevir/ritonavir, ombitasvir, and/or dasabuvir. Contraceptive failure: As with other combined contraceptives may occur with hepatic enzymes inducers; including, but not limited to: antiepileptics, certain antivirals (HIV medication ritonavir, nevirapine, efavirenz) and antifungals, antibiotics (rifampicin), sedatives (barbiturates), bosentan, modafinil and St John’s Wort. Combinations of HIV protease inhibitors and non nucleoside reverse transcriptase inhibitors, including HCV inhibitors, can increase/decrease plasma concentrations of oestrogen/progestins. Etoricoxib. Evra affects plasma concentrations of lamotrigine (reduces) and ciclosporin (increases). Some endocrine, liver function and blood component tests may be affected. For further information read Evra SmPC and SmPC for co-prescribed medication(s).

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
Transdermal Patch 9 patches EU 1/02/223/002 £19.51

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK.

Prescribing information last revised: September 2017

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.