Micronelle 20 ED

if there is anything you do not understand in this leaflet,

if you are worried about taking your medicine, or

to obtain the most up-to-date information.

more regular periods, lighter periods

a decrease in anaemia (iron deficiency)

a decrease in period pain.

inhibiting ovulation (egg release)

changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg.

changing the lining of the uterus, making it less suitable for implantation.

the blood vessels of the legs (deep vein thrombosis)

the lungs (pulmonary embolism)

the heart (heart attack)

the brain (stroke)

other parts of the body.

any blood clotting disorders such as Protein C deficiency, Protein S deficiency, Leiden Factor V mutation, Antithrombin III deficiency or other inherited blood clotting conditions

a confirmed blood test showing:

increased levels of homocysteine

antiphospholipid antibodies (APLAs) e.g. anticardiolipin-antibodies and lupus anticoagulant. These may increase your risk for blood clots or pregnancy losses (miscarriage)

major surgery after which you have not been able to move around for a period of time

angina (chest pain)

mini-stroke (also known as TIA or transient ischaemic attack)

migraine, accompanied by visual symptoms, speech disability, or weakness or numbness in any part of your body

high risk of blood clots due to conditions such as diabetes mellitus with blood vessel damage, severe high blood pressure or severe high or low level of fats in your blood

pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood

severe liver disease and your liver function has not returned to normal

benign or malignant liver tumour

cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)

unexplained vaginal bleeding.

The expiry date (EXP) printed on the pack has passed.

The packaging is torn, shows signs of tampering or it does not look quite right.

you smoke

you are overweight

you or anyone in your immediate family has had blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, a stroke, breast cancer or high cholesterol.

any other medicines

any other substances, such as foods, preservatives or dyes.

diabetes

high blood pressure

heart valve disorders or certain heart rhythm disorders

inflammation of your veins (superficial phlebitis)

varicose veins

migraine

cancer

hyperhomocysteinaemia, a condition characterised by high levels of the amino acid homocysteine in the blood

high or low level of fats in your blood

have any hereditary or acquired conditions that may make it more likely for you to get blood clots

epilepsy

high cholesterol or triglycerides

liver disease

kidney disease

gall bladder disease

have jaundice (yellowing of the skin) and/or pruritus (itching of the skin) related to cholestasis (condition in which the flow of bile from the liver stops or slows)

Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)

systemic lupus erythematosus (SLE – a disease affecting the skin all over the body)

haemolytic uraemic syndrome (HUS – a disorder of blood coagulation causing failure of the kidneys)

sickle cell disease

a condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham's chorea)

chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid exposure to the sun or ultraviolet radiation

hereditary angioedema – you should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathing.

medicines used to treat tuberculosis, such as rifampicin and rifabutin

antibiotics (for e.g. penicillins, tetracyclines and macrolides such as erythromycin and clarithromycin)

medicines used to treat fungal infections, such as fluconazole and griseofulvin

medicines used to treat HIV, such as ritonavir and nevirapine

some medicines used to treat HCV, such as boceprevir, telaprevir, ombitasvir, paritaprevir, dasabuvir

medicines used to treat epilepsy, such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine

cyclosporin, an immunosuppressant medicine

etoricoxib, a medicine used to treat painful joint disease

melatonin, a hormone used as a sleep aid

midazolam, a medicine used as a sedative

theophylline, a medicine used to treat respiratory disease

tizanidine, a medicine used as a muscle relaxant

some medicine used for high blood pressure, chest pain and irregular heartbeats such as diltiazem and verapamil.

herbal medicines containing St John's wort.

grapefruit juice

Week 1 - Take the pink (active) tablet you missed as soon as you remember (even if this means taking 2 pink (active) tablets at the same time) and complete the pack as normal. You should also use an extra barrier method of contraception (e.g. condom) for 7 days. If you had sex in the previous 7 days you should speak to your doctor due to the possibility of pregnancy.

Week 2 - Take the pink (active) tablet you missed as soon as you remember (even if this means taking 2 pink (active) tablets at the same time) and complete the pack as normal. If you have also missed an additional pink (active) tablet in the previous 7 days, you should also use an extra barrier method of contraception (e.g. condom) for 7 days.

Week 3 - Take the pink (active) tablet you missed as soon as you remember (even if this means taking 2 pink (active) tablets at the same time) and continue taking the pink (active) tablets until they have all been taken. When the final pink (active) tablet has been taken, discard the 7 white placebo (inactive) tablets and start a new pack right away. If you have missed an additional pink (active) tablet in the previous 7 days, you should also use an extra barrier method of contraception (e.g. condom) for 7 days. You are unlikely to have a withdrawal bleed until the end of the pink (active) tablets of the second pack, but you may experience spotting or breakthrough bleeding on tablet-taking days.

you are about to be started on any new medicine

you are pregnant or are planning to become pregnant

you are breastfeeding or are planning to breast-feed

you are about to have any blood tests

you are going be immobilised, have surgery or an anaesthetic or are going into hospital (consult your doctor at least 4 weeks in advance).

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

one-sided swelling of the leg and/or foot or along a vein in the leg

pain or tenderness in the leg which may be felt only when standing or walking

increased warmth in the affected leg; red or discoloured skin on the leg

sudden onset of unexplained shortness of breath or rapid breathing

sudden coughing or coughing up of blood

sharp chest pain or sudden severe pain in the chest which may increase with deep breathing

severe light headedness or dizziness

rapid or irregular heartbeat

sudden pain, swelling and slight blue discoloration of an extremity

sudden numbness or weakness of the face, arm or leg, especially on one side of the body

sudden trouble walking, dizziness, loss of balance or coordination

sudden confusion, slurred speech or aphasia; sudden partial or complete loss of vision, double vision, painless blurring of vision which can progress to loss of vision

sudden, severe or prolonged headache with no known cause

loss of consciousness or fainting with or without seizure

pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest arm, or below the breastbone

discomfort radiating to the back, jaw, throat, arm, stomach

feeling of being full, having indigestion or choking

sweating, nausea, vomiting

extreme weakness and anxiety.

you have taken the pink (active) tablets at the right time

you have not been taking a medicine(s) that may interfere with this medicine

you have not vomited or had severe diarrhoea during this cycle.

Give this medicine to anyone else.

Take this medicine to treat any other condition unless your doctor tells you to.

Stop taking your medicine, or change the dosage, without first checking with your doctor. 
You may become pregnant if you are not using any other contraceptive and you stop taking this medicine, or you do not take a tablet every day.

nausea

stomach pain

changes in weight

headache, including migraines

mood changes, including depression

acne

breast tenderness or pain

abnormal growth of hair on the face and body.

hair loss

pain in the chest, arm or below the breastbone

pain or discomfort radiating to the back

breathlessness and/or difficulty breathing

swelling, pain or tenderness of one leg

sudden weakness, numbness or bad 'pins and needles' of the face, arm or leg, especially on one side of the body

sudden trouble walking, dizziness, loss of balance or coordination

severe, sudden stomach pains

a fainting attack or you collapse

unusual headaches or migraines that are worse than usual

sudden problems with your speech, understanding or eyesight.

jaundice (yellowing skin or yellowing eyes)

coughing up blood

breast lumps

unexplained vaginal bleeding.

cough, shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

lactose monohydrate

povidone

crospovidone

magnesium stearate

OPADRY II complete film coating system 85F34610 Pink (ARTG ID 108065).

lactose

povidone

magnesium stearate

OPADRY II complete film coating system 85F18422 White (ARTG ID 11376).