NOVYNETTE Film-coated tablet Ref.[51230] Active ingredients: 17 alpha-Ethinylestradiol Desogestrel

Circulatory disorders

The use of NOVYNETTE and other combined oral contraceptives may be associated with an increased risk of venous and arterial thrombotic and thromboembolic diseases e.g. myocardial infarction, deep venous thrombosis, pulmonary embolism and stroke (ischaemic and haemorrhagic). Thrombosis has been reported to occur in other blood vessels, e.g. mesenteric, hepatic, renal or retinal veins and arteries.

The use of NOVYNETTE should be stopped immediately if symptoms indicating the development of thrombosis appear. Symptoms of venous or arterial thrombosis can include: unilateral leg pain and/or swelling, sudden severe chest pain, which may reach to the left arm, sudden shortness of breath, sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo, collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances.

The risk is higher with age, amongst smokers (especially in women over the age of 35) with other underlying risk factors of coronary disorders, e.g. hypertension, valvular heart disease, atrial fibrillation, hypercholesterolaemia, pathological obesity and diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn’s disease), sickle cell disease, prolonged immobilisation, major surgery, surgery to the legs or major trauma. In these cases it is advisable to discontinue the use of NOVYNETTE (4 weeks prior in the case of elective surgery) and not resume until two weeks after complete remobilisation.

Tumours

An increased risk of cervical cancer has been reported in long-term users of combined oral contraceptives.

The relative risk of breast cancer is slightly higher in women taking combined oral contraceptives. Benign hepatic adenomas and rarely malignant hepatic tumours are related to the use of contraceptive pills.

Other conditions

• Occurrence of retinal thrombosis during the use of contraceptive pills has rarely been reported. NOVYNETTE should be discontinued if inexplicable partial or complete loss of vision, appearance of exophthalmus or diplopia, papilloedema or retinal vascular injuries occurs.
• Increases in blood pressure may occur. Where hypertension is clinically significant, NOVYNETTE should be withdrawn and the hypertension should be treated. NOVYNETTE can be resumed once the blood pressure has been stabilised to normal values.
• Should acute or chronic disturbances of hepatic function occur, it may be necessary to discontinue NOVYNETTE until liver function markers return to normal values. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex hormones may require that NOVYNETTE be discontinued.
• Conditions e.g. jaundice and/or pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham’s chorea, herpes gestationis and otosclerosisrelated hearing loss may occur or deteriorate during the use of NOVYNETTE.
• Ulcerative colitis and Crohn’s disease have been associated with the use of combined oral contraceptives.
• Asthma may be worsened in women using combined oral contraceptives.
• In women with a history of chloasma gravidarum, chloasma may occur occasionally. Women with this tendency should avoid ultraviolet radiation and exposure to the sun.
• Occurrence or worsening of migraine or development of headache with a new pattern, which is recurrent, constant or serious, requires discontinuation of NOVYNETTE.
• NOVYNETTE should be stopped immediately in case of itching of the whole body or epileptic seizures.

Effects on carbohydrate and lipid metabolism

• Combined oral contraceptives may have an effect on peripheral insulin resistance and glucose tolerance. Although there is no evidence for dosage adjustments in diabetics, diabetic women should be closely monitored when taking combined oral contraceptives.
• Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using NOVYNETTE.

Bleeding disturbances

• Irregular bleeding (spotting or break-through bleeding) may occur during tablet taking, especially during the first three months.

If irregular uterine bleeding is persistent or it occurs after regular menstrual cycles have developed, treatment should be stopped and the cause of the bleeding ascertained.

Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmissible diseases. The efficacy of combined oral contraceptives may be reduced in the event of missed tablets, vomiting or concomitant medication which may interact with combined oral contraceptives.

Mood changes and depression are side effects reported with the use of hormonal contraceptives including NOVYNETTE. There is some evidence that hormonal contraceptive use may be associated with severe depression and a higher risk of suicidal thoughts/behavior (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide.

Prescribers should inform their patients to contact their doctor for advice if they experience mood changes and depression whilst on treatment with NOVYNETTE.

Contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take NOVYNETTE.

Interaction with other medicines

Reduced contraceptive protection and an increased incidence of breakthrough bleeding and bleeding disturbances have been related with the concomitant use of rifampicin.

It is advisable that non-hormonal methods of contraception (condoms and spermicides) in addition to the oral contraceptive be used (for duration of treatment and for 7 days afterwards) with the concurrent use of NOVYNETTE and barbiturates, phenylbutazone, phenytoin, griseofulvin, ampicillin and tetracyclines.

Interaction during metabolism

Interaction may occur with medicines inducing microsomal enzymes thus reducing ethinylestradiol concentrations (e.g. rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate). Interaction may also occur with medicines inhibiting microsomal enzymes (e.g. itraconazole, fluconazole), thus increasing ethinylestradiol concentrations.

The herbal preparation St. John’s Wort should not be taken concomitantly with NOVYNETTE as this can decrease the contraceptive effect of NOVYNETTE.

Effect on enterohepatic circulation

Some clinical reports indicate that enterohepatic circulation of oestrogen may be reduced by certain antibiotics, which may reduce ethinylestradiol concentrations (e.g. ampicillin, tetracycline).

Changes in laboratory tests

The use of NOVYNETTE may influence the results of certain laboratory tests e.g. the liver, thyroid, adrenal and renal functions, plasma levels of lipoproteins and carrier proteins, parameters of carbohydrate metabolism, coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

NOVYNETTE is contra-indicated during pregnancy. Oral contraceptives may reduce the production of breast milk and their use is not advised during breast-feeding.

NOVYNETTE can cause dizziness and visual disturbances, which may impair the ability to drive or operate machines.

Post marketing reported side effects

The following side effects have been reported with the post marketing use of hormonal contraceptives: Severe depression with a higher risk of suicidal thoughts/behavior and suicide.

Not applicable.