Novelon 0.03 mg+3 mg Tablet

Novelon Tablet — Drospirenone + Ethinyl Estradiol

Indications

Novelon tablet is indicated in oral contraception.

Mechanism of Action

This is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. The contraceptive effect of this tablet is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in cervical secretion. When this tablet is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilized, the cervical mucus remains thick so as to constitute a barrier to sperm and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, estrogen/progestogen combinations have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter.Drospirenone has antimineralocorticoid activity, counteracting estrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone.

Contraindications

Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. If any of the conditions appear for the first time during their use, the product should be stopped immediately.

Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
Presence or history of prodromi of a thrombosis (e.g.transient ischaemic attack, angina pectoris)
Presence or history of migraine with focal neurological symptoms
Diabetes mellitus with vascular involvement
Disturbed lipometabolism
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
Presence or history of severe hepatic disease as long as liver function values have not returned to normal
Severe renal insufficiency or acute renal failure
Presence or history of liver tumours (benign or malignant)
Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced
Undiagnosed vaginal bleeding
Known or suspected pregnancy
Hypersensitivity to any of the components of this tablet.

Side Effects

Like other contraceptives some undesirable effects may have seen with this tablet, these include venous and arterial thromboembolic disorders. The following undesirable effects have been reported in users of COCs and whether this association is causal has not been confirmed: Nausea, abdominal pain, Vomiting, diarrhoea, Weight increased, Fluid retention, Headache, Migraine, Depressed mood, mood altered, Breast pain, breast tenderness, Libido decreased, Breast hypertrophy, Rash, urticaria. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

Pregnancy and Lactation

The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.The Pill and Pregnancy: This tablet must not be used by women who are pregnant or who think they may be pregnant.

Precautions and Warnings

The clinical and epidemiological evidence for estrogen/progestogen combinations like this tablet is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of this tablet. Also, increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely.

Cervical cancer
Hypertriglyceridemia
Blood pressure
Jaundice
Erythematosus
Haemolytic uraemic syndrome
Sydenham's chorea
Herpes gestationis
Otosclerosis-related hearing loss.
Hereditary angioedema
Acute or chronic disturbances of liver or kidney
Crohn's disease and ulcerative colitis
Chloasma

The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenyton, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampilicllin, tetracyclines, griseofulvin); for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell other doctor/dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.The Pill and Ability to Drive: There are no observed effects.

Storage

Store below 30°C. Store all drugs properly and keep them out of reach of children.

Medical Disclaimer: This information is provided for educational purposes only and is not intended as medical advice. Always consult a qualified healthcare professional before starting, changing, or stopping any medication.