Nordette Tablets

NORDETTE belongs to a group of medicines called combined oral contraceptive pills (“the Pill”). You take it to prevent you from getting pregnant. Sometimes it is also prescribed for the control of cases of dysfunctional bleeding in the womb and in the symptomatic treatment of primary painful menstruation where contraception is also desired. This contraceptive contains two types of female sex hormones, estrogen and progestogen. These hormones stop you from getting pregnant by working in three ways: by preventing an egg being released from your ovaries; by making the fluid (mucous) in your cervix thicker, which makes it more difficult for sperm to enter the womb; and by preventing the lining of your womb thickening enough for an egg to grow in it. NORDETTE is a 28-day Pill - you take one each day for 28 days. There are 21 active yellow tablets and 7 inactive red tablets. NORDETTE needs to be taken as directed to prevent pregnancy.

Do not take NORDETTE:

• if you are hypersensitive (allergic) to levonorgestrel and/or ethinyl estradiol or any of the other ingredients of NORDETTE (listed in section 6).
• if you have depression and this is not well controlled with treatment.
• if you have had depression with previous use of hormonal contraceptives.
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs.
• if you know you have a disorder affecting your blood clotting, for instance protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies.
• if you need an operation or if you are off your feet for a long time (see Blood clots).
• if you have ever had a heart attack or stroke.
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms).
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
• severe diabetes with blood vessel damage,
• high blood pressure,
• a high level of fat in the blood (cholesterol or triglycerides),
• a condition known as hyperhomocysteinaemia (high homocysteine levels which can contribute to arterial damage and blood clots in your blood vessels).
• if you have (or have ever had) a type of migraine called ‘migraine with aura’.
• if you have or have ever had breast cancer.
• If you have a family history of breast cancer.
• if you have or have ever had a severe liver disease and you have been told by your doctor that your liver function test results are not yet back to normal.
• if you have ever had liver tumours.
• if you are also taking medicines containing ritonavir, ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and ofosbuvir/velpatasvir/voxilaprevir.
• if you are known to have inherited genetic changes called "BRCA 1 and/or BRCA 2 genes."
• if you started your menstrual periods (before the age of 12 years).
• if you have a history of non-cancerous breast diseases such as atypical hyperplasia or lobular carcinoma in situ.
• if you had any previous treatment using radiation therapy to the chest or breast.
• if you have been treated or exposed while in your mother's womb to a medicine called diethylstilbestrol (DES).
• if you are pregnant or breastfeeding your baby.

General notes

Before you start taking NORDETTE you should read the information on blood clots. It is particularly important to read the symptoms of a blood clot (see section 4). It’s important that you understand the benefits and risks of taking NORDETTE before you start taking it, or when deciding whether to carry on taking it. Although NORDETTE is suitable for most healthy women, it isn’t suitable for everyone. Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.

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

To prevent pregnancy, always take NORDETTE as described below. Check with your doctor or healthcare provider if you are not sure.

Take NORDETTE every day for 28 days. NORDETTE comes in strips of 28 tablets. There are 21 active yellow tablets, and 7 inactive red tablets.

• Take your tablet at the same time every day, no longer than 24 hours apart, preferably after the evening meal or at bedtime.
• Swallow each tablet whole, with water if necessary. Do not chew the tablet.
• If it is the first time you take NORDETTE, take one yellow tablet daily for 21 uninterrupted days, beginning on Day 1 of your menstrual cycle, i.e. the first day of bleeding.
• One red inactive tablet is taken daily for the next 7 continuous days.
• Withdrawal bleeding should usually occur 2 to 4 days after the last yellow tablet is taken.
• During this first cycle, an alternative method of contraception, such as a condom, should be used together with NORDETTE until 14 tablets have been taken. If the tablets are begun after day 5 of your menstrual cycle, or after giving birth, it must be considered that ovulation and conception may have occurred before the tablets were started.

Then start your next strip. The next and all the following courses will begin on the day after the last package was completed, even if withdrawal bleeding has not occurred or is still in progress. Each course of NORDETTE is therefore begun on the same day of the week and follows the same schedule (21 days of yellow tablets, 7 days of red inactive tablets) as the first course.

Changing to NORDETTE from another contraceptive Pill

If you are changing from another oral contraceptive product to NORDETTE, start NORDETTE on the day you would usually start a new package of the other medicine. During the first NORDETTE cycle, an alternative method of contraception, such as a condom, should be used until 14 uninterrupted tablets have been taken. If temporary spotting or breakthrough bleeding occurs, continue the treatment since such bleeding is usually without significance. If the bleeding is persistent or prolonged, contact your doctor.

• If you are currently taking a 21-day Pill or a 28-day Pill: Start NORDETTE the next day after the end of the previous strip.
• Or, if you are taking a progestogen-only Pill (POP or ‘mini Pill’): Start NORDETTE on the first day of bleeding, even if you have already taken the progestogen-only Pill for that day. The remaining progestogen-only tablets should be discarded (see How to store NORDETTE).

Starting NORDETTE after a miscarriage or abortion

If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor may tell you to start taking NORDETTE straight away. Discuss this with your healthcare provider. If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time.

Contraception after having a baby

If you have just had a baby and you are breastfeeding, your doctor may advise you that you should start with an alternative oral contraceptive 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start the oral contraceptive your doctor has prescribed and for the first 7 days of pill taking.

If you are sick or have diarrhoea

If you are sick (vomit) or have very bad diarrhoea within 4 hours of taking NORDETTE, your body may not get its usual dose of hormones from that tablet. Take another tablet and continue with the pack. Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception.

Missed a period - could you be pregnant?

Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the pharmacy. If you are pregnant, stop taking NORDETTE and see your doctor.

When you want to get pregnant

If you are planning a baby, it’s best to use another method of contraception after stopping NORDETTE until you have had a proper period. Your doctor relies on the date of your last natural period to tell you when your baby is due. Your doctor will tell you how long your treatment with NORDETTE will last (see If you forget to take NORDETTE).

If you have the impression that the effect of NORDETTE is too strong or too weak, tell your doctor or pharmacist.

If you take more NORDETTE 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.

If you forget to take NORDETTE

Take a missed yellow tablet as soon as you remember. If two consecutive yellow tablets are missed, they should both be taken as soon as you remember. In either case, the next tablet should be taken at its usual time. Each time you miss one or two consecutive yellow tablets, a mechanical method of contraception, such as a condom, should be supplemented until 14 consecutive daily tablets have been taken or until the package is finished if less than 14 yellow tablets remain. If you miss one or more red inert tablets, you are still protected against pregnancy, provided you begin the yellow tablets on the proper day. If three consecutive yellow tablets are missed, NORDETTE should be discontinued, and the remainder of the package discarded. A new package should be started on the eighth day after the last tablet was taken. A mechanical method of contraception, such as a condom, should be used until 14 consecutive daily tablets have been taken. If withdrawal bleeding does not occur and NORDETTE has been taken according to directions, it is unlikely that you could be pregnant. Begin a second course of NORDETTE on the usual day. If bleeding does not occur at the end of this second cycle, you should not take NORDETTE until you are certain that you are not pregnant, by consulting your doctor and having a pregnancy test done. If you have missed one or more yellow tablets or started taking them on a day later than recommended, the probability of pregnancy should be considered at the time of the first missed period before NORDETTE is restarted.

NORDETTE can have side effects. Not all side effects reported for NORDETTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NORDETTE, please consult your healthcare provider for advice.

If any of the following happens, stop taking NORDETTE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are very serious side effects. If you have them, you may have had a serious reaction to NORDETTE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Are you experiencing any of these signs? What are you possibly suffering from?

• swelling of one leg or along a vein in the leg or foot especially when accompanied by:
• pain or tenderness in the leg which may be felt only when standing or walking
• increased warmth in the affected leg
• change in colour of the skin on the leg e.g. turning pale, red or blue

Deep vein thrombosis

• sudden unexplained breathlessness or rapid breathing
• sudden cough without an obvious cause, which may bring up blood
• sharp chest pain which may increase with deep breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• severe pain in your stomach

If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).

Pulmonary embolism

Symptoms most commonly occur in one eye:

• immediate loss of vision or painless blurring of vision which can progress to loss of vision

Retinal vein thrombosis (blood clot in the eye)

• chest pain, discomfort, pressure, heaviness
• sensation of squeezing or fullness in the chest, arm or below the breastbone
• fullness, indigestion or choking feeling
• upper body discomfort radiating to the back, jaw, throat, arm and stomach
• sweating, nausea, vomiting or dizziness
• extreme weakness, anxiety, or shortness of breath, rapid or irregular heartbeats

Heart attack

• sudden weakness or numbness of the face, arm or leg, especially on one side of the body
• sudden confusion, trouble speaking or understanding
• sudden trouble seeing in one or both eyes
• sudden trouble walking, dizziness, loss of balance or coordination
• sudden, severe or prolonged headache with no known cause
• loss of consciousness or fainting with or without seizure

Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.

Stroke

• swelling and slight blue discolouration of an extremity, severe pain in your stomach (acute abdomen)

Blood clots blocking other blood vessels

Signs of breast cancer include:

• dimpling of the skin,
• changes in the nipple,
• any lumps you can see or feel.

Signs of cancer of the cervix include:

• vaginal discharge that smells and/or contains blood,
• unusual vaginal bleeding,
• pelvic pain, painful sex.

Signs of severe liver problems include:

• severe pain in your upper abdomen,
• yellow skin or eyes, light-coloured stools and dark urine (jaundice or obstructive jaundice,
• inflammation of the liver (hepatitis),
• your whole body starts itching.

suicidal thoughts/ behaviour and suicide,

inflammatory disease caused when the immune system attacks its own tissues (Systemic Lupus Erythematosus),

hypertension, venous thromboembolism (VTE), arterial thromboembolism (ATE). An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke (e.g. ischaemic stroke, haemorrhagic stroke), transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using combined oral contraceptives (COCs),

inflammation of the pancreas (may have symptoms of upper stomach pain, stomach pain that feels worse after eating, fever, rapid pulse),

erythema multiforme (skin reaction),

Crohn’s disease (can lead to abdominal pain, severe diarrhoea, fatigue, weight loss),

precipitation of acute attack of porphyria,

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• depressive moods,
• changed moods, mood swings, nervousness
• headache,
• nausea (feeling sick),
• abdominal pain (stomach ache),
• breast pain (sore or painful breasts),
• breast tenderness,
• acne,
• bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to NORDETTE. If it continues, becomes heavy or starts again, contact your doctor (see Bleeding between periods should not last long),
• vaginal candidiasis (fungal infection that causes irritation, discharge and intense itchiness of the vagina and the vulva),
• vaginitis (inflammation of the vagina).

Less frequent side effects:

• hypersensitivity,
• exacerbation of hereditary angioedema (recurrent episodes of severe swelling),
• fluid retention,
• hypertriglyceridaemia (elevated levels of fat),
• increase or decrease in weight,
• changes in appetite,
• decreased or increased interest in sex,
• premenstrual-like syndrome (PMS),
• migraine,
• dizziness,
• changes in corneal curvature (steepening),
• intolerance to contact lenses,
• cataracts,
• vomiting,
• diarrhoea,
• abdominal cramps,
• bloating,
• gastrointestinal irritation,
• liver function disturbances,
• gallbladder disease,
• urticarial erythema nodosum (type of skin inflammation),
• skin pigmentation,
• breast hypertrophy (overgrowth of breast tissue),
• vaginal discharge,
• breast secretion,
• change in cervical erosion or cervical secretion.

Side effects with an unknown frequency:

• hirsutism (abnormal growth of hair on a woman's face and body),
• loss of scalp hair,
• haemorrhagic eruption (bleeding),
• cystitis like syndrome (is a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain),
• haemolytic uremic syndrome (vessels in the kidney become damaged),
• ulcerative colitis (causes long-lasting inflammation and ulcers (sores) in your digestive tract),
• reduced menstrual flow,
• post pill amenorrhoea (missing of menstrual period),
• exacerbation of chorea (movement disorder),
• chloasma or melasma which may be persistent. Chloasma is yellow brown patches on the skin. This may happen even if you have been using NORDETTE for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking NORDETTE, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking NORDETTE as usual. The problem should disappear after the first few strips. You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:

• carries on for more than the first few months
• starts after you’ve been taking NORDETTE for a while
• carries on even after you’ve stopped taking NORDETTE.

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 Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 / +27 (0) 11 239 - 6200. By reporting side effects, you can help provide more information on the safety of NORDETTE.

Store all medicines out of reach of children.

Store at or below 25 °C. Protect from light. Keep the blisters in the carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).