For more information, see Section 1. Why am I using Norimin 28 Day? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Norimin 28 Day? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are using Norimin 28
Day.
Tell your doctor immediately if you become pregnant while taking Norimin 28 Day.
See your doctor if you have not taken your tablets correctly and have missed a period.
Have regular check ups from your doctor, including a Pap smear.
Perform regular breast self-examination
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Things you should not do
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Do not stop using this medicine or change the dosage, without checking with your doctor.
If you stop taking Norimin 28 Day or do not take a tablet every day without using
another form of contraception, you may become pregnant.
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Driving or using machines
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Make sure you know how Norimin 28 Day affects you before you drive or use machines.
Norimin 28 Day may cause dizziness in some people.
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Looking after your medicine
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Keep Norimin 28 Day in a cool, dry place where the temperature stays below 25°C.
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the blister pack, they may not keep well.
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For full list of side effects and further information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Do not use Norimin 28 Day if:
1. You are allergic to ethinylestradiol or norethisterone, or any other similar medicines (such as other oral contraceptives) or any of the ingredients listed at the end of this leaflet.
2. You have, or have had a blood clot in the:
3. You are at increased risk of a blood clot in the legs (DVT) or lungs (PE) due to any of the following:
4. You have, or have had, blood clots in the arteries (known as arterial thromboembolism (ATE)). Examples of these include:
5. You are at increased risk of ATE, including:
6. You have any of the following conditions:
7. You are pregnant or you think you are pregnant. Pregnancy must be excluded before you start taking Norimin 28 Day.
8. You are taking anti-viral hepatitis C virus (HCV) medicinal products such as those containing glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir with or without ribavirin.
Check with your doctor if you:
Pregnancy and breastfeeding
Blood clots
Stroke
Medical Check-ups
How much to take
When to take Norimin 28 Day
How to start taking Norimin 28 Day for the first time
How to switch to Norimin 28 Day from a different oral contraceptive
If switching from a 21 day oral contraceptive:
If you forget to use Norimin 28 Day
If you vomit or have diarrhoea after taking Norimin 28 Day
If you take too much Norimin 28 Day
(by calling 13 11 26), or
Things you should do
Missed periods
Medical Check Up
Breast cancer risk
Sexually transmitted disease (STD)
Things you should not do
Driving or using machines
Looking after your medicine
After stopping Norimin 28 Day
When to discard your medicine
Getting rid of any unwanted medicine
Side effects
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Side effects
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What to do
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Reproductive or breast problems:
changes in bleeding patterns, including break-through bleeding
spotting
painful periods
absence of periods, but if you have not taken Norimin 28 Day as directed you should
check whether you are pregnant
change in menstrual flow
change in cervical secretions
breast changes (tenderness, enlargement and secretion)
change in sexual drive
vaginal thrush (Candida), vaginal irritation, change in mucus from the vagina
pre-menstrual-like symptoms
suppression of milk production
Stomach problems such as:
gastric or stomach discomforts including abdominal pain, cramps, bloating, nausea,
vomiting and diarrhoea
change in appetite.
Difficulties thinking or working because:
headache, including migraines
nervousness, dizziness
mood change, including depression
fatigue or tiredness
contact lenses becoming uncomfortable to wear
Changes to your appearance such as:
change in weight
swelling of the hands, ankles or feet
dark discolouration of the skin
blotchy discolouration on the face or limbs (which may persist after the tablets have
been stopped)
hair growth or loss of scalp hair
increase in body hair
acne, rashes, itching
Aches and pains:
leg cramps
back ache
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Speak to your doctor if you have any of these side effects and they worry you.
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Serious side effects
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Serious side effects
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What to do
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Worsening of your existing conditions such as:
chorea (involuntary muscle spasm)
porphyria (a group of disorders than can cause skin or nerve problems)
systemic lupus erythematosus (Lupus)
varicose veins
gallbladder disease
kidney disease
hereditary angioedema (swelling of the face lips, mouth tongue or throat)
epileptic seizures
asthma attack.
Pain or discomfort:
fever
unexplained or persistent pains in the head, chest, arm or below the breastbone
severe pain, swelling or discolouration in either of your legs
discomfort radiating to the back, jaw, throat or stomach
abdominal pain
weakness or numbness in any part of your body
Digestive system problems:
bloody diarrhoea
feeling of indigestion or choking
rectal bleeding
loss of appetite or weight loss
Problems with your eyes or eyesight:
blurred or double vision
partial or complete loss of sight
eye protrusion, swelling of the eye or eye lesions
Migraines:
migraine headaches for the first time
more frequent or severe migraines if you already suffer from them
General feelings of unwellness, including:
feeling tired
shortness of breath
rapid or irregular heartbeat
dizziness or fainting, sometimes with loss of balance
sweating, nausea or vomiting
an unusual cough
Changes to your body:
confusion, trouble speaking or understanding
breast lumps
jaundice or a yellowing of the skin or eyes, often with fever, fatigue, loss of appetite,
dark coloured urine, nausea and vomiting. Taking oral contraceptives may be associated
with liver disease including liver cancer
rise in blood pressure. You may experience headache, blurred vision or palpitations.
Sometimes your blood pressure may rise without you experiencing any of these symptoms.
It is important to keep your routine doctor's appointments so that your blood pressure
can be checked.
swelling of the face, lips, tongue or other parts of the body, shortness of breath,
wheezing or trouble breathing.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention or hospitalisation.
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Reporting side effects
What Norimin 28 Day contains
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Active ingredient
(main ingredient)
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Each blue active tablet contains:
norethisterone 500 micrograms (mcg)
ethinylestradiol 35 micrograms (mcg)
The orange tablets do not contain active ingredients.
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Other ingredients
(inactive ingredients)
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The blue active tablets also contain:
magnesium stearate
povidone
maize starch
lactose monohydrate
indigo carmine CI 73015
The orange inactive tablets contain:
magnesium stearate
microcrystalline cellulose
lactose
lactose monohydrate
sunset yellow FCF (CI No. 15985)
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