PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
Product Name
NORDETTE 150 µg/30 µg sugar-coated tablets
Active Ingredients
Levonorgestrel and ethinyl estradiol
Sugar Information
NORDETTE contains sugar.
| Tablet type | Sugar content |
|---|---|
| Active tablets | Lactose monohydrate 32,97 mg and sucrose 22,456 mg |
| Inactive tablets | Lactose monohydrate 38,006 mg and sucrose 25,686 mg |
Read Before Taking NORDETTE
Read all of this information carefully before you start taking NORDETTE.
Keep this information because you may need to read it again. If you have further questions, ask your doctor, pharmacist, nurse or other healthcare provider.
NORDETTE has been prescribed for you personally and should not be shared with other people. It may harm them, even if their symptoms are the same as yours.
What Is in This Article
- What NORDETTE is and what it is used for
- What you need to know before you take NORDETTE
- How to take NORDETTE
- Possible side effects
- How to store NORDETTE
- Contents of the pack and other information
1. What NORDETTE Is and What It Is Used For
NORDETTE belongs to a group of medicines called combined oral contraceptive pills, also known as the Pill.
NORDETTE is taken to prevent pregnancy. It may also be prescribed for the control of dysfunctional bleeding in the womb and for the symptomatic treatment of primary painful menstruation where contraception is also desired.
NORDETTE contains two types of female sex hormones:
| Hormone type | Ingredient |
|---|---|
| Estrogen | Ethinyl estradiol |
| Progestogen | Levonorgestrel |
These hormones help prevent pregnancy by:
| How NORDETTE works |
|---|
| Preventing an egg from being released from the ovaries |
| Making the mucus in the cervix thicker, making it more difficult for sperm to enter the womb |
| Preventing the lining of the womb from thickening enough for an egg to grow in it |
NORDETTE is a 28-day Pill. One tablet is taken each day for 28 days. The pack contains 21 active yellow tablets and 7 inactive red tablets.
NORDETTE must be taken as directed to prevent pregnancy.
2. What You Need to Know Before You Take NORDETTE
Do Not Take NORDETTE
Do not take NORDETTE if any of the following apply:
| Do not take NORDETTE if | Details |
|---|---|
| You are allergic to levonorgestrel or ethinyl estradiol | This includes allergy to any other ingredient in NORDETTE |
| You have depression that is not well controlled with treatment | Medical review is needed |
| You have had depression with previous use of hormonal contraceptives | Medical review is needed |
| You have or have ever had a blood clot | This includes clots in the legs, lungs or other organs |
| You have a blood clotting disorder | Examples include protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies |
| You need an operation or will be off your feet for a long time | This increases the risk of blood clots |
| You have ever had a heart attack or stroke | NORDETTE may not be suitable |
| You have or have had angina pectoris or transient ischaemic attack | These may be warning signs of serious cardiovascular disease |
| You have severe diabetes with blood vessel damage | This may increase the risk of blood clots |
| You have high blood pressure | This may increase cardiovascular risk |
| You have high cholesterol or triglycerides | This may increase cardiovascular risk |
| You have hyperhomocysteinaemia | This may contribute to arterial damage and blood clots |
| You have migraine with aura | This increases the risk of stroke |
| You have or have ever had breast cancer | NORDETTE should not be used |
| You have a family history of breast cancer | Medical review is needed |
| You have or have had severe liver disease | NORDETTE should not be used until liver function is normal |
| You have ever had liver tumours | NORDETTE should not be used |
| You are taking certain hepatitis C medicines | This includes medicines containing ritonavir, ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir |
| You have inherited BRCA 1 or BRCA 2 gene changes | Medical review is needed |
| You started menstrual periods before the age of 12 years | Medical review is needed |
| You have a history of non-cancerous breast disease | This includes atypical hyperplasia or lobular carcinoma in situ |
| You had radiation therapy to the chest or breast | Medical review is needed |
| You were exposed before birth to diethylstilbestrol | Medical review is needed |
| You are pregnant | NORDETTE should not be used |
| You are breastfeeding | NORDETTE should not be used |
General Notes
Before starting NORDETTE, it is important to understand the benefits and risks of treatment.
NORDETTE is suitable for many healthy women, but it is not suitable for everyone. Tell your doctor if you have any illnesses or risk factors mentioned in this article.
Warnings and Precautions
Take Special Care With NORDETTE
Cigarette Smoking
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptives.
The risk increases with age and with heavy smoking, especially in women over 35 years of age.
Women taking NORDETTE are strongly advised to stop smoking.
Do not stop the oral contraceptive tablet without first using a satisfactory alternative method of contraception.
Before Starting NORDETTE
Your doctor may ask about your personal and family medical history, check your blood pressure and exclude pregnancy.
Other checks, such as breast examination, may be needed if they are necessary for you or if you have special concerns.
Tell Your Doctor If Any of the Following Apply
| Condition or situation |
|---|
| Symptoms of angioedema such as swollen face, tongue or throat, difficulty swallowing, hives or breathing difficulty |
| Treatment for depression |
| Depression with previous use of hormonal contraceptives |
| Substance abuse problem |
| Psychiatric disorder such as post-traumatic stress disorder or bipolar disorder |
| Family history of mental disorders |
| History of physical or sexual abuse |
| Severe kidney impairment |
| History of liver disease |
| Excessive alcohol use |
| Crohn’s disease |
| Ulcerative colitis |
| Systemic lupus erythematosus |
| Haemolytic uraemic syndrome |
| Sickle cell anaemia |
| Pancreatitis |
| High triglycerides |
| Need for surgery |
| Long-term immobility |
| Recent childbirth |
| Superficial thrombophlebitis |
| Varicose veins |
| Diabetes |
| Family history of heart or circulation problems |
| Family history of blood clotting problems |
| Porphyria |
| Obesity |
| Migraine |
| Any illness that worsened during pregnancy or previous use of NORDETTE |
| Dubin Johnson’s syndrome |
| Rotor syndrome |
| Irregular vaginal bleeding |
| Infrequent or abnormally light periods |
| Missing periods for three or more months after previously having normal periods |
| Changes in your period |
Medicines containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
Conditions That May Worsen During Pregnancy or Previous Pill Use
Tell your doctor if you notice any of the following:
| Condition |
|---|
| Yellowing of the skin |
| Persistent itching |
| Kidney or liver problems |
| Gallstones |
| Systemic lupus erythematosus |
| Blister-like rash during pregnancy |
| Inherited deafness |
| Sickle cell disease |
| Hereditary angioedema |
| Porphyria |
| Cancer of the cervix |
While You Are Taking NORDETTE
While taking NORDETTE, regular monitoring is important.
| What to do while taking NORDETTE |
|---|
| Attend regular check-ups with your doctor or healthcare provider |
| Continue regular cervical smear tests |
| Check your breasts and nipples every month for changes |
| Tell your doctor if you notice lumps, dimpling of the skin or other breast changes |
| Tell your doctor that you are taking NORDETTE before blood tests |
| Tell your doctor before surgery because NORDETTE may need to be stopped 4 to 6 weeks before the operation |
NORDETTE does not protect against sexually transmitted infections such as Chlamydia or HIV. Condoms are needed to help protect against these infections.
Blood Clots
Using a combined oral contraceptive such as NORDETTE increases the risk of developing a blood clot.
Blood clots can block blood vessels and cause serious problems.
| Where blood clots may form | Medical term |
|---|---|
| Veins | Venous thrombosis or venous thromboembolism |
| Arteries | Arterial thrombosis or arterial thromboembolism |
Recovery from blood clots is not always complete. Blood clots may cause serious lasting effects and may be fatal.
What Can Happen If a Blood Clot Forms?
| Blood clot location | Possible condition |
|---|---|
| Vein in the leg or foot | Deep vein thrombosis |
| Clot travelling from the leg to the lung | Pulmonary embolism |
| Vein in the eye | Retinal vein thrombosis |
| Artery | Heart attack or stroke |
When Is the Risk of Developing a Blood Clot Highest?
The risk is highest during the first year of taking NORDETTE for the first time.
The risk may also be higher if NORDETTE is restarted after a break of four weeks or more.
After the first year, the risk becomes smaller, but it remains higher than in women who are not using NORDETTE.
When NORDETTE is stopped, the risk of a blood clot returns to normal within a few weeks.
Factors That Increase the Risk of a Blood Clot
| Risk factor |
|---|
| Smoking |
| High blood pressure |
| Family history of heart attack or stroke at a young age |
| High blood cholesterol or triglycerides |
| Migraine, especially migraine with aura |
| Heart valve disorder |
| Atrial fibrillation |
| Diabetes |
| Obesity |
| Family history of blood clots at a young age |
| Surgery |
| Long-term immobility |
| Leg in a cast |
| Increasing age, especially above about 35 years |
| Recent childbirth |
| Air travel lasting more than four hours |
The risk increases further when more than one risk factor is present.
NORDETTE and Cancer
NORDETTE and Cancer of the Cervix
Oral contraceptives such as NORDETTE may increase the risk of cancer of the cervix.
All women should have regular smear tests.
NORDETTE and Breast Cancer
If you have breast cancer or have had breast cancer in the past, you should not take NORDETTE.
Oral contraceptives such as NORDETTE may increase the risk of breast cancer. Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This small increase gradually disappears during the 10 years after stopping the Pill.
While using NORDETTE, monthly breast self-examinations should be performed.
See a doctor as soon as possible if you notice:
| Breast warning signs |
|---|
| Dimpling of the skin |
| Changes in the nipple |
| Any lumps you can see or feel |
Your risk of breast cancer is higher if you have a close relative with breast cancer or if you are seriously overweight.
NORDETTE and Liver Disease
NORDETTE has been linked to liver diseases such as jaundice and non-cancerous liver tumours.
Oral contraceptives have also been linked with some forms of liver cancer in women who have taken them for a long time.
See a doctor as soon as possible if you develop severe stomach pain or yellowing of the skin or eyes.
Other Medicines and NORDETTE
Always tell your healthcare provider if you are taking any other medicines, including complementary or traditional medicines.
Some medicines may affect the blood levels of NORDETTE and may stop it from working properly.
| Medicine or medicine group | Examples |
|---|---|
| Medicines for epilepsy | Phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate |
| Medicines for HIV or hepatitis C | Ritonavir, nelfinavir, nevirapine, protease inhibitors and non-nucleoside reverse transcriptase inhibitors |
| Antifungal medicines | Griseofulvin, itraconazole, voriconazole, fluconazole |
| Antibiotics | Ampicillin, penicillin V, tetracycline, rifampicin, neomycin, chloramphenicol, sulphonamides, nitrofurantoin, erythromycin |
| Sedatives | Barbiturates such as phenobarbitone and primidone |
| Herbal medicines | St John’s Wort |
| Anti-inflammatory medicines | Etoricoxib |
If these medicines are needed, NORDETTE may not be suitable or extra contraception may be needed for a period of time.
Do not use NORDETTE if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir.
NORDETTE can also affect how well other medicines work.
| Medicine affected by NORDETTE | Use |
|---|---|
| Ciclosporin | Used to treat inflammatory diseases |
| Theophylline | Used to treat breathing problems such as asthma |
| Lamotrigine | Used to treat epilepsy |
Your doctor may need to adjust the dose of your other medicine.
NORDETTE may also interfere with some blood tests. Always tell your doctor that you are taking NORDETTE if blood tests are required.
NORDETTE With Food and Drink
There are no special instructions about food and drink while taking NORDETTE.
Pregnancy, Breastfeeding and Fertility
Do not take NORDETTE if you are pregnant or breastfeeding your baby.
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor, pharmacist or other healthcare provider before taking this medicine.
Driving and Using Machinery
NORDETTE is not expected to influence your ability to drive.
However, do not drive, use machinery or perform tasks requiring concentration until you are sure that NORDETTE does not affect your ability to do so safely.
NORDETTE Contains Lactose and Sucrose
NORDETTE contains lactose and sucrose.
If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking NORDETTE.
3. How to Take NORDETTE
Do not share medicines prescribed for you with any other person.
Always take NORDETTE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
To prevent pregnancy, always take NORDETTE as directed.
Take NORDETTE Every Day for 28 Days
NORDETTE comes in strips of 28 tablets.
| Tablet type | Number of tablets |
|---|---|
| Active yellow tablets | 21 |
| Inactive red tablets | 7 |
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, which is the first day of bleeding.
One red inactive tablet is taken daily for the next 7 continuous days.
Withdrawal bleeding usually occurs 2 to 4 days after the last yellow tablet is taken.
During the first cycle, an alternative method of contraception, such as a condom, should be used together with NORDETTE until 14 tablets have been taken.
Then Start Your Next Strip
The next and all following courses begin on the day after the last package is completed, even if withdrawal bleeding has not occurred or is still in progress.
Each course of NORDETTE begins on the same day of the week and follows the same schedule: 21 days of yellow tablets, followed by 7 days of red inactive tablets.
Changing to NORDETTE From Another Contraceptive Pill
If 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, use an alternative method of contraception, such as a condom, until 14 uninterrupted tablets have been taken.
If spotting or breakthrough bleeding occurs, continue treatment. Such bleeding is usually not significant. If 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.
If You Are Taking a Progestogen-Only 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.
Starting NORDETTE After a Miscarriage or Abortion
If you have had a miscarriage or abortion during the first three months of pregnancy, your doctor may tell you to start taking NORDETTE straight away.
If you have had a miscarriage or abortion after the third month of pregnancy, ask your doctor for advice. Extra contraception, such as condoms, may be needed for a short time.
Contraception After Having a Baby
If you have just had a baby and are breastfeeding, your doctor may advise an alternative oral contraceptive 21 days after delivery, provided that you are fully mobile.
You do not have to wait for a period.
Another method of contraception, such as a condom, should be used until you start the oral contraceptive prescribed by your doctor and for the first 7 days of pill taking.
If You Are Sick or Have Diarrhoea
If vomiting or very bad diarrhoea occurs within 4 hours of taking NORDETTE, your body may not receive the usual dose of hormones from that tablet.
Take another tablet and continue with the pack.
Talk to your doctor if stomach upset continues or becomes worse. Another form of contraception may be recommended.
Missed a Period — Could You Be Pregnant?
Occasionally, withdrawal bleeding may be missed.
Pregnancy is unlikely if the tablets have been taken correctly. Start the next strip at the normal time.
If you think you may have been at risk of pregnancy, such as by missing pills or taking other medicines, or if you miss a second bleed, do a pregnancy test.
If you are pregnant, stop taking NORDETTE and see your doctor.
When You Want to Get Pregnant
If planning a baby, it is best to use another method of contraception after stopping NORDETTE until you have had a proper period.
Your doctor uses the date of your last natural period to calculate when the baby is due.
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, both should be taken as soon as you remember.
In either case, the next tablet should be taken at the usual time.
Each time one or two consecutive yellow tablets are missed, a mechanical method of contraception, such as a condom, should be used until 14 consecutive daily tablets have been taken, or until the package is finished if fewer than 14 yellow tablets remain.
If one or more red inert tablets are missed, you are still protected against pregnancy, provided that you begin the yellow tablets on the correct day.
If three consecutive yellow tablets are missed, stop NORDETTE and discard the rest of the package. Start a new package on the eighth day after the last tablet was taken.
Use a mechanical method of contraception, such as a condom, until 14 consecutive daily tablets have been taken.
If withdrawal bleeding does not occur and NORDETTE has been taken correctly, pregnancy is unlikely. Begin the next course on the usual day.
If bleeding does not occur at the end of the second cycle, do not take NORDETTE until pregnancy has been excluded by consulting your doctor and having a pregnancy test.
If one or more yellow tablets were missed, or tablets were started later than recommended, pregnancy should be considered at the time of the first missed period before NORDETTE is restarted.
4. Possible Side Effects
NORDETTE can have side effects.
Not all side effects reported for NORDETTE are included here. If general health worsens or any unwanted effects occur while taking NORDETTE, consult your healthcare provider.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious allergic reaction | Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing | Stop taking NORDETTE and seek urgent medical attention immediately |
| Very serious allergic reaction | Rash or itching | Stop taking NORDETTE and seek urgent medical attention immediately |
| Blood clot warning symptoms | Swelling of one leg or along a vein in the leg or foot, pain or tenderness in the leg, increased warmth in the affected leg, or skin colour change such as pale, red or blue skin | Seek urgent medical attention; possible deep vein thrombosis |
| Blood clot warning symptoms | Sudden unexplained breathlessness, rapid breathing, sudden cough that may bring up blood, sharp chest pain, severe light-headedness or dizziness, rapid or irregular heartbeat, or severe stomach pain | Seek urgent medical attention; possible pulmonary embolism |
| Blood clot warning symptoms | Immediate loss of vision or painless blurring of vision that can progress to loss of vision | Seek urgent medical attention; possible retinal vein thrombosis |
| Heart attack warning symptoms | Chest pain, discomfort, pressure, heaviness, squeezing or fullness in the chest, arm or below the breastbone; indigestion or choking feeling; pain radiating to the back, jaw, throat, arm or stomach; sweating, nausea, vomiting, dizziness, weakness, anxiety, shortness of breath or irregular heartbeat | Seek urgent medical attention |
| Stroke warning symptoms | Sudden weakness or numbness of face, arm or leg, sudden confusion, trouble speaking or understanding, sudden trouble seeing, walking difficulty, dizziness, loss of balance, severe headache, fainting or seizure | Seek urgent medical attention |
| Blood clots in other blood vessels | Swelling and slight blue discolouration of an extremity, or severe stomach pain | Seek urgent medical attention |
| Breast cancer warning signs | Dimpling of the skin, changes in the nipple, or lumps that can be seen or felt | Tell your doctor immediately |
| Cervical cancer warning signs | Vaginal discharge that smells or contains blood, unusual vaginal bleeding, pelvic pain, or painful sex | Tell your doctor immediately |
| Severe liver problems | Severe pain in the upper abdomen, yellow skin or eyes, light-coloured stools, dark urine, hepatitis, or whole-body itching | Tell your doctor immediately |
| Serious mental health effects | Suicidal thoughts, suicidal behaviour, or suicide | Seek urgent medical help immediately |
| Serious immune/inflammatory effects | Systemic lupus erythematosus | Tell your doctor immediately |
| Serious clotting effects | Hypertension, venous thromboembolism, arterial thromboembolism, myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis or pulmonary embolism | Seek urgent medical attention |
| Serious pancreatic effects | Inflammation of the pancreas, which may include upper stomach pain, stomach pain worse after eating, fever or rapid pulse | Tell your doctor immediately |
| Serious skin reaction | Erythema multiforme | Tell your doctor immediately |
| Serious bowel disease | Crohn’s disease, which can cause abdominal pain, severe diarrhoea, fatigue or weight loss | Tell your doctor |
| Serious metabolic disorder | Acute attack of porphyria | Tell your doctor immediately |
| Frequent side effects | Depressive moods, mood changes, mood swings, nervousness, headache, nausea, abdominal pain, breast pain, breast tenderness, acne, bleeding or spotting between periods, vaginal candidiasis, vaginitis | Tell your doctor if troublesome or persistent |
| Less frequent side effects | Hypersensitivity, worsening hereditary angioedema, fluid retention, high triglycerides, weight increase or decrease, appetite changes, decreased or increased interest in sex, PMS-like symptoms, migraine, dizziness | Tell your doctor |
| Less frequent eye effects | Changes in corneal curvature, contact lens intolerance, cataracts | Tell your doctor |
| Less frequent digestive effects | Vomiting, diarrhoea, abdominal cramps, bloating, gastrointestinal irritation | Tell your doctor |
| Less frequent liver/gallbladder effects | Liver function disturbances, gallbladder disease | Tell your doctor |
| Less frequent skin effects | Urticarial erythema nodosum, skin pigmentation | Tell your doctor |
| Less frequent breast/reproductive effects | Breast hypertrophy, vaginal discharge, breast secretion, change in cervical erosion or cervical secretion | Tell your doctor |
| Unknown frequency side effects | Hirsutism, loss of scalp hair, haemorrhagic eruption, cystitis-like syndrome, haemolytic uraemic syndrome, ulcerative colitis, reduced menstrual flow, post-pill amenorrhoea, worsening chorea, chloasma or melasma | Tell your doctor or pharmacist |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform your doctor or pharmacist |
Bleeding Between Periods Should Not Last Long
Some women may have unexpected bleeding or spotting while taking NORDETTE, especially during the first few months.
This bleeding is usually not a concern and should stop after a day or two. Keep taking NORDETTE as usual. The problem should disappear after the first few strips.
Unexpected bleeding may also occur if the tablets are not taken regularly. Try to take the tablet at the same time every day.
Unexpected bleeding can also be caused by other medicines.
Make an appointment with your doctor if breakthrough bleeding or spotting:
| When to contact your doctor |
|---|
| Carries on for more than the first few months |
| Starts after you have been taking NORDETTE for a while |
| Continues after you have stopped taking NORDETTE |
Reporting of Side Effects
If side effects occur, talk to your doctor, pharmacist or nurse.
Reporting side effects helps provide more information on the safety of NORDETTE.
5. How to Store 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, including toilets.
6. Contents of the Pack and Other Information
What NORDETTE Contains
The active substances in each yellow active sugar-coated tablet are:
| Active substance | Quantity |
|---|---|
| Levonorgestrel | 150 µg |
| Ethinyl estradiol | 30 µg |
Other Ingredients
Active Tablets
The active tablets contain:
| Other ingredients |
|---|
| Calcium carbonate |
| Iron oxide yellow |
| Lactose monohydrate |
| Magnesium stearate |
| Maize starch |
| Methyl parahydroxybenzoate |
| Polyethylene glycol |
| Povidone |
| Povidone 25 |
| Povidone 90F |
| Propyl parahydroxybenzoate |
| Purified talc |
| Sucrose refined white H1 |
| Titanium dioxide |
| Waradur XE |
Preservatives in Active Tablets
| Preservative | Strength |
|---|---|
| Methyl parahydroxybenzoate | 0,001 % m/m |
| Propyl parahydroxybenzoate | 0,00076 % m/m |
Inactive Tablets
Each red inactive sugar-coated tablet contains:
| Other ingredients |
|---|
| Calcium carbonate |
| FD&C Red No. 3 aluminium lake |
| FD&C Yellow No. 6 / sunset yellow FCF |
| Magnesium stearate |
| Microcrystalline cellulose PH 102 |
| Polyethylene glycol |
| Ponceau 4R aluminium lake |
| Povidone |
| Quinoline yellow aluminium lake |
| Purified talc |
| Povidone 90F |
| Sodium benzoate |
| Sucrose refined white H1 |
| Tablettose 80 |
| Waradur XE |
Preservative in Inactive Tablets
| Preservative | Strength |
|---|---|
| Sodium benzoate | 0,0018 % m/m |
What NORDETTE Looks Like and Contents of the Pack
| Tablet type | Description |
|---|---|
| Active tablets | Yellow, lustrous, round, biconvex sugar-coated tablets |
| Inactive tablets | Red, biconvex sugar-coated tablets |
Each pack contains 28 tablets, consisting of 21 yellow active tablets and 7 red inert tablets.
The tablets are packed in clear polyvinyl chloride blister strips sealed with aluminium foil backing. One blister strip is packed into a pre-printed cardboard carton together with a leaflet.
Not all packs and pack sizes are necessarily marketed.
Holder of Certificate of Registration
PHARMACARE LIMITED
Healthcare Park
Woodlands Drive
Woodmead 2191
Hotline: 0800 122 912 / +27 (0) 11 239-6200
This Leaflet Was Last Revised In
03 June 2023
Registration Number
F/18.8/229
Additional Registration Information
| Country | Registration information |
|---|---|
| Botswana | B9319920 S2 |
| Namibia | NS2 90/18.8/001077 |
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist, nurse or other healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
