Novelon® tablet

What is this medicine?

Novelon® is a low dose combined oral contraceptive pill and is used as an effective means of birth control to prevent unwanted pregnancy. Novelon® contraceptive pills contain a combination of two hormones at low doses in a single pill. Each pack of Novelon® contains one month’s supply of pills of which there are 21 hormone-containing pills and 7 placebo (non-hormonal) pills, to allow each monthly cycle to end with a withdrawal bleed. When using Novelon® for contraception, you will probably find that your periods become more regular and you may also experience lighter, less painful menstruation and an improvement in pre-menstrual symptoms, like bloating, swelling or weight gain related to fluid retention; also an improvement in acne and reductions in greasiness of the skin and hair.

How does Novelon® work?

Novelon® contraceptive pills contain a combination of two hormones, ethinyloestradiol, a synthetic oestrogen, and desogestrel, a synthetic progestogen, which work together to protect against unwanted pregnancy. Preparation for pregnancy depends on a complex interaction between the female sex hormones produced by the ovaries; oestrogen, which stimulates ovulation, and progesterone which prepares the endometrium (lining of the uterus) for implantation of an embryo; as well as other regulating hormones, produced by the hypothalamus in the brain and the pituitary gland. Novelon® combined hormonal contraception works by disrupting the normal menstrual cycle, preventing egg maturation and suppressing ovulation, as well as preventing development of the endometrium, so that a fertilised egg would not be able to implant and grow. Another contraceptive action of Novelon® pill is that the cervical mucus, which normally changes consistency at ovulation to become thinner, remains thick, forming a physical barrier to sperm. Some synthetic progestogens have androgenic activity, but desogestrel in Novelon®, has very weak androgenic activity, which has a beneficial effect on androgen-related skin disorders such as acne and hirsutism (unwanted hair).

What should I tell my health care providers before I take this medicine?

You should not use Novelon® if you:

• are allergic to ethinyloestradiol or desogestrel or any of the ingredients in Novelon® contraceptive pills
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have high blood pressure, lipid disorders or migraine
• have had deep venous thrombosis, thromboembolic disorders, heart attack or stroke
• have diabetes with changes to the blood vessels
• abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are diabetic and taking Novelon® contraceptive pills your glucose tolerance may be affected and you may need to discuss using other antidiabetic drugs with your doctor
• are taking other medications that may interact with Novelon®, such as anticonvulsants like phenytoin and carbamazepin, barbiturates, anti-infectives like rifampicin, rifabutin, nevirapine, the antifungal griseofulvin, antibiotics like penicillin, preparations containing St John's Wort

How should I use this medicine?

You should take one Novelon® contraceptive pill each day with a glass of water at the same time each day. Each pack of Novelon® contraceptive pills contains 28 pills for a complete monthly cycle and should be taken continually to ensure effective contraception. The first 21 pills contain the contraceptive hormones and the last 7 pills are a placebo, which do not contain any hormones. While you are taking these placebo pills you will have a menstrual bleed. When you have finished one pack, start a new one the next day. If you have gastrointestinal problems like vomiting or diarrhoea within 3-4 hours of taking your hormonal pill, this is the same as missing a pill and you should take other contraceptive precautions for the next 7 days.

Taking Novelon® for contraception

Novelon® contraceptive pills contain a combination of two hormones, ethinyloestradiol, a synthetic oestrogen, and desogestrel, a synthetic progestogen, which work together to provide effective birth control by protecting against pregnancy. Novelon® contraceptive pills work by preventing egg maturation and suppressing ovulation, as well as preventing development and thickening of the endometrium (lining of the uterus) in preparation for implantation, so that a fertilised egg would not be able to implant and grow. You must take your Novelon® contraceptive pills continually to ensure effective contraception, with 21 days of hormonal pills followed by 7 days non-hormonal pills, during which time you will have a menstrual bleed, which may be light and less painful than usual.

What if I miss a dose?

If you miss a dose of Novelon® follow these guidelines to help you decide what to do:

Weeks 1 to 3 (large white hormonal pills)

• If you are less than 12 hours late in taking your pill, take it as soon as you remember and take the next one at your usual time. You are still protected against pregnancy.
• If you are more than 12 hours late in taking your pill, take the last tablet as soon as you remember and take the next one at your normal time, which may mean taking 2 tablets in one day. Contraceptive protection may be reduced and you are at risk of becoming pregnant, unless you take other contraceptive precautions for the next 7 days.

Week 4 (small white non-hormonal pills)

Take the next pill as usual and discard the missed pill. You are not at risk of becoming pregnant.

What may interact with this medicine?

Some medications interact with Novelon® contraceptive pills and prevent them working effectively, increasing your risk of becoming pregnant. If you are taking any of the following you may need to take other contraceptive precautions:

• anticonvulsants like phenytoin and carbamazepin
• barbiturates
• anti-infectives like rifampicin, rifabutin, nevirapine, griseofulvin
• antibiotics like penicillin
• preparations containing St John's Wort.

What side effects may I notice from this medicine?

The most frequently reported side effects when taking Novelon® contraceptive pills are: breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression. Less common side effects include: migraine, fluid retention, changes in body weight, changes in libido.

What should I watch for while using this medicine?

Avoid exposure to sunlight or tanning beds. Dapsone can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Where should I keep this medicine?

Keep your Novelon® contraceptive pills in their calendar pack until use. Store at room temperature below 25°C