Prescribing information For Healthcare Professionals Only

Cilest®

35 / 250 micrograms
film-coated tablets

PRESCRIBING INFORMATION

Active Ingredient(s):

0.035 mg ethinylestradiol and 0.25 mg norgestimate.

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

The CILEST® SmPCs are available at:

Please click the following product name to access the full SmPC
CILEST® 35 / 250 micrograms film-coated tablets

Indications(S):

Oral contraception

Dosage & Administration:

One tablet daily for 21 days followed by 7 tablet-free days. Reliability of contraception may be reduced in case of: missed tablets, vomiting/diarrhoea.
Children: not indicated before menarche.
Elderly: not indicated in post-menopausal women.

Contraindications:

Presence of multiple risk factors for venous thrombo-embolism (VTE) and arterial thromboembolism (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. Acute or chronic liver disease, including hepatitis (viral or non-viral) or severe cirrhosis, or history of these conditions until at least 3 months after LFTs have returned to normal; hepatic adenomas or carcinomas. Known or suspected breast carcinoma. Hypersensitivity to any ingredients. Combination of paritaprevir/ritonavir, ombitasvir, and/or dasabuvir due to potential ALT elevations. Discontinue immediately if any of these conditions occur for the first time during treatment.

Special warnings & Precautions:

Exclude likelihood of pregnancy before starting treatment. Prior to starting oral contraceptives (and at regular intervals) assess personal and family medical history, measure blood pressure and perform physical examination. Investigate undiagnosed vaginal bleeding. Discuss associated risk of VTE/ATE, known personal risk factors and symptoms of VTE and ATE. Discuss possible breast cancer risk. Increased risk of VTE in 6 week period of puerperium. Instruct to read leaflet carefully. Advise oral contraceptives do not protect against HIV infections or sexually transmitted disease.
Warning: if any conditions/risk factors are present discuss suitability.
Conditions requiring supervision Decision to prescribe in these conditions must be made with specialist clinical judgement as risks usually outweigh advantages; discontinue on appearance for the first time or if condition worsens: Patients with increased risk of VTE/ATEs. Presence of multiple risk factors for VTE/ATE. Adequately controlled hypertension. Obesity (BMI ≥ 35 kg/m2) History of cholestasis (related to combined oral contraceptives (COCs) use), current or medically treated gall bladder disease, porphyria, history of breast cancer (5 years disease-free). Investigate bleeding irregularities which persist beyond three-cycles after previously regular cycles.

Other conditions requiring consideration before prescribing, benefit generally outweighs risks: Known hyperlipidaemias, increased risk of pancreatitis when taking COCs with hypertriglyceridaemia (or history of). Diabetes without vascular involvement. Decreased glucose tolerance, monitor pre-diabetic women while taking COCs. Asymptomatic gall bladder disease or cholecystectomy, benign liver tumour, Crohn’s disease, ulcerative colitis, migraine without focal aura. Discontinue at onset or exacerbation of migraine or development of recurrent headache.
Conditions which may occur if previously developed or worsened during prior pregnancy or previous COC use: Elevated blood pressure, cholestasis, herpes gestationis, otosclerosis, SLE, severe headaches, haemolytic uraemic syndrome, Sydenham’s chorea. May depress serum folate levels. Tablets contain lactose, patients with galactose intolerance should not take Cilest®.

Side Effects:

Very common: headache, gastrointestinal (GI) disorder, vomiting, diarrhoea, nausea, dysmenorrhoea, metorrhagia, abnormal withdrawal bleeding.
Common: urinary tract infection, vaginal infection, hypersensitivity, fluid retention, mood altered, depression, nervousness, insomnia, migraine, dizziness GI/abdominal pain or distension, constipation, flatulence, acne, rash, muscle spasms, pain in extremity, back pain, amenorrhoea, genital discharge, breast pain, chest pain, oedema, asthenic conditions, weight increased.
Serious side effects: angioedema (possible hypersensitivity), ATE, VTE, breast cancer, cerebrovascular accidents, convulsion, DVT, hepatitis, hepatic tumours (benign and malignant), high blood pressure, myocardial infarction, new onset of migraine-type headache, pulmonary embolism, pancreatitis, retinal vascular thrombosis, venous thrombosis.
Refer to SmPC for other side effects.

Pregnancy:

Not indicated during pregnancy.

Lactation:

Advise not to use in breast-feeding mothers less than 6 weeks postpartum. May be excreted into breast-milk and decrease the quality and quantity of breast-milk.

Interactions:

Possible contraceptive failure with concomitant use of hepatic enzyme-inducing drugs including: anticonvulsants (carbamazepine, oxcarbazepine, fosphenytoin, phenytoin, topiramate, felbamate, primidone, eslicarbazepine acetate, rufinamide), barbiturates, rifampicin, rifabutin, HIV drugs (e.g. ritonavir, niverapine, nelfinavir, atazanavir, indinavir), Hepatitis C drugs (boceprevir, telaprevir), bosentan, griseofulvin, modafinil, metoclopramide, activated charcoal, St John’s Wort, colvesevelam, aprepitant and fosaprepitant. Other interactions: ciclosporin, prednisolone, selegiline, theophylline, tizanidine, etoricoxib and lamotrigine.
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
Blister pack 3 x 21 tablets PL 00242/0209 £7.16
Blister pack 6 x 21 tablets PL 00242/0209

£14.32

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

Prescribing information last revised: April 2017

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