Novelon 3 mg+0.03 mg

INDICATIONS

This combination tablet is indicated in oral contraception.

PHARMACOLOGY

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.

DOSAGE

When and how to take the tablets: The this tablet pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days don't take any tablet. A period should begin during these 7 days (the withdrawal bleed), unusually it will start on day 2-3 after the last this tablettablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week and also that you have your withdrawal bleed on about the same days each month. Starting your first pack of this tablet: When no hormonal contraceptive has been used in the past month. Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Sunday, take a tablet marked Sunday. Then follow thedaysin order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.When changing form another combined Pill: You can start taking this tablet the day after you have the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the first active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet free break of your present Pill (or the day after the last inactive tablet of your present Pill).When changing from progestogen-only Pill (Mini Pill): You can stop taking the mini pill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional-contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.When changing from an Injectable or Implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet you should discuss this first with your doctor.After a miscarriage or an abortion: Your doctor will advise you.If too many this tablet tablets are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablet tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet ask your doctor for advice.When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive.

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 & 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 & 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.

THERAPEUTIC CLASS

Oral Contraceptive preparations

STORAGE CONDITIONS

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