Novynette ® Film-Coated Tablets

NOVYNETTE is a combined oral contraceptive containing specific hormones used to prevent pregnancy.

Before starting to take NOVYNETTE a complete medical and gynaecological examination should be performed so as to exclude diseases that may be risk factors to oral contraceptive use. During the use of this medication medical check-ups should be repeated regularly.

Do not take NOVYNETTE:

• If you are hypersensitive (allergic) to ethinylestradiol or desogestrel or any of the other ingredients of NOVYNETTE (see WHAT NOVYNETTE CONTAINS).
• If you are pregnant or suspecting pregnancy or breastfeeding your baby (see Pregnancy and breastfeeding).
• If you have thrombosis (formation of blood clots in the vessels leading to deep venous thrombosis, pulmonary embolism, heart attack or stroke), are at risk of thrombosis or have previously had thrombosis.
• If you have a severe liver disease or a liver tumour.
• If you have any malignant tumours of the breast or womb.
• If you have vaginal bleeding of unknown origin.
• If deterioration of otosclerosis (deafness) during pregnancy occurs or has occurred.
• If you have sickle-cell anaemia (abnormal red blood cells), severe disturbances of blood fat metabolism, severe high blood pressure, severe diabetes with complications.
• If jaundice or itching has occurred during pregnancy or while taking other contraceptive preparations or if herpes gestationis (rash during previous pregnancy) has occurred.
• You have depression, which is not well controlled with treatment.

Please inform your doctor immediately if you have any of these or other diseases. If you experience any of the above conditions while you are taking NOVYNETTE, stop taking it and consult your doctor immediately.

Take special care with NOVYNETTE:

• If you are at risk of a heart or blood vessel disease (cardiovascular disease) and thrombosis (risk factors include smoking, age above 35, thrombosis in the family, obesity, moderate disturbance of the fat metabolism, mild hypertension, heart beat disturbance).
• If you are a diabetic patient, you have depression, inherited deafness, multiple sclerosis (disorder of the central nervous system).
• If you are an epileptic, have a movement disorder, muscle stiffness (tetany), kidney diseases, porphyria, breast problems, inflammation of connective tissues (lupus), benign tumours of the womb and migraine.

Warnings and precautions

Tell your doctor before using NOVYNETTE:

• That you are on treatment for depression.
• That you have had depression with previous use of hormonal contraceptives.
• That you have a substance abuse problem.
• You have underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder.
• That you have a family history of mental disorders.
• That you have a history of physical or sexual abuse.

Hormonal contraceptives including NOVYNETTE, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/ behaviour (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. If you experience mood changes and depression contact your doctor for advice.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking NOVYNETTE. NOVYNETTE should not be used during pregnancy. Since the active ingredients of the pill may appear in breast milk and reduce the amount of breast milk, the use of NOVYNETTE is not recommended during breast-feeding.

Driving and using machinery:

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

Using other medicines with NOVYNETTE:

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Please consult your doctor, pharmacist or other healthcare professional for advice. The concomitant use of some other medicines such as anti-epileptic agents, tranquillizers, certain antibiotics, medicines to treat fungal and viral infections and tuberculosis, as well as products or herbal remedies containing St. John's Wort may decrease the effect of NOVYNETTE film-coated tablets. If you are taking rifampicin while you are taking NOVYNETTE, you will have to use an additional method of contraception as well, while you are taking rifampicin and for 4 weeks after you stop. During the use of NOVYNETTE it may be necessary to alter the dose of medicine required to treat diabetes.

In case of blood sampling you should tell your doctor that you are taking an oral contraceptive, because the preparation may affect the results of the laboratory tests. In case of missing your period, you can do a pregnancy test, the result of this is not affected by the pill. Although, a pregnancy is very unlikely if you have taken the pill as prescribed, if you have not had any stomach upset accompanied with vomiting and if you have not taken other medicines. However, before continuation of the treatment pregnancy should be excluded. NOVYNETTE, like other hormonal contraceptives, will not protect you against HIV infection (AIDS) and other sexually transmitted diseases.

Do not share medicines prescribed for you with any other person. Always take NOVYNETTE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

One tablet should be taken daily, preferably always at the same time, starting on the first day of the monthly period for 21 days. This is followed by a tablet-free period of 7 days, during which a menstruation-like bleeding occurs. Intake of the next 21 tablets should be started on the 8th day, even if bleeding has not stopped. You should start the second pack of NOVYNETTE on the same day of the week as the first one. Your periods will be probably lighter but it is not harmful.

Taking NOVYNETTE for the first time

Wait for your period to begin, and take extra contraceptive precautions (use a condom or cervical cap plus spermicide). The first tablet should be taken on the first day of your period.

Changing from another oral contraceptive to NOVYNETTE

All pills in the old pack should be finished. The first NOVYNETTE tablet should be taken on the 1st day of your period occurring after the end of the previous oral contraceptive course. You can change from a mini pill to NOVYNETTE on any day but extra contraceptive precautions must be taken for the first 7 days of taking NOVYNETTE.

Use after a miscarriage or an abortion in the 1st trimester

After a miscarriage or an abortion you can start using NOVYNETTE immediately, according to the instructions of your doctor. In this case no additional contraceptive precautions are required.

Use after delivery or a miscarriage or an abortion in the 2nd trimester

Tablet intake can be started 21-28 days after a miscarriage or an abortion in the 2nd trimester or after childbirth if you are not breast-feeding. If you start taking the pill later, you should also use one of the barrier methods as additional contraceptive precaution for the first 7 days. If intercourse has already taken place, pregnancy should be excluded before tablet intake is started, or you should start using the pill when your first period appears.

If you have taken more NOVYNETTE than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. There are no serious ill-effects of overdosage. The symptoms which may occur are nausea, vomiting and, in young girls, a small vaginal bleeding.

If you forget to take a dose of NOVYNETTE:

If you forget to take the pill at the usual time, you should take it within 12 hours. Take the next pill at your normal time. Beyond 12 hours the reliability of the pill may be reduced. In this case do not take the missed pill(s), but continue tablet taking at the usual time. Additional contraceptive precautions are required for the next 7 days. If your present pack ends before the 7 days do, start the next pack the next day, without a break between packs. You will not have a period until you have finished the next pack. You may see some break-through bleeding on pill taking days. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.

If you have a stomach upset accompanied with vomiting within 3-4 hours after tablet intake, the absorption of NOVYNETTE may be decreased. Therefore, the precautions concerning forgotten tablets apply.

NOVYNETTE can have side effects. Not all side effects reported for NOVYNETTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

The most frequent side-effects which may occur during the first few months after starting with NOVYNETTE are intermenstrual bleeding (spotting or break-through bleeding). If any of the following occur, stop taking NOVYNETTE immediately and tell your doctor immediately since it may indicate a need for medical attention:

• If you notice possible signs of a thrombosis such as severe pain in the chest which may reach to the left arm, unusually severe pain in the legs, weakness or numbness in any part of your body, breathlessness, unusual cough, especially if you cough up blood, dizziness or fainting, visual disturbances, disturbed hearing or speech, sensory defect, migraine for the first time or if your migraine gets worse, unusual, recurrent or constant headache.
• If you develop jaundice (yellowing of the skin).
• If you can feel a lump in your breast.
• If you have sudden, severe abdominal pains.
• If you have unusual, heavy vaginal bleeding or if you miss your period twice in a row.
• In case of long-term bed-ridden state, or 4 weeks prior to a planned operation.
• If you suspect that you are pregnant.
• In case of increase in blood pressure.
• In case of a fit.

The above mentioned are all serious side-effects. You may need urgent medical attention. Other side-effects that occur with NOVYNETTE and other combined oral contraceptives are: Nausea, heartburn, flatulence, weight gain, loss of appetite, breast pain or tenderness, cysts, hot flushes, anxiety, depression, headache, migraine, intolerance to contact lenses, fluid retention, skin rash and itching. Mild diarrhoea, vomiting, break-through bleeding or spotting, vaginal fungal infections, high blood pressure, emotional disturbance, increased cough, nasal congestion, exacerbation of asthma, acne, muscle cramps or spasms, bladder infections, chest pain, fatigue. Side effects may include severe depression with a higher risk of suicidal thoughts/behaviour and suicide.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NOVYNETTE.

Store at or below 25 °C. Protect from light. Do not remove from the outer carton until required for use. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not use the tablets after the expiry date printed on the blisters and cartons. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).