Product Details

Product Information for Lucette Tablets

WHAT YOU NEED TO KNOW BEFORE YOU USE LUCETTE
General notes
Before you start using Lucette you should read the information on blood clots in section 2. It is particularly important to read the
symptoms of a blood clot – see Section 2 “Blood clots”).
Before you can begin taking Lucette, your doctor will ask you some questions about your personal health history and that of your
close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry
out some other tests.
In this leaflet, several situations are described where you should stop using Lucette, or where the reliability of Lucette may be
decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions,
e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable
because Lucette alters the monthly changes of body temperature and cervical mucus.
Lucette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually
transmitted disease.
Do not use Lucette
You should not use Lucette if you have any of the conditions listed below. If you do have any of the conditions listed below, you
must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
• 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 section ‘Blood clots’).
• if you have ever had a heart attack or a 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
– very high blood pressure
– a very high level of fat in the blood (cholesterol or triglycerides)
– a condition known as hyperhomocysteinaemia.
• if you have (or have ever had) a type of migraine called ‘migraine with aura’;
• if you have (or have ever had) a liver disease and your liver function is still not normal;
• if your kidneys are not working well (renal failure);
• if you have (or have ever had) a tumour in the liver;
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs;
• if you have any unexplained bleeding from the vagina;
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6.). This
may cause itching, rash or swelling.
• If you are allergic to peanut or soya, do not use this medicinal product.
• Lucette contains lecithin which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
Do not use Lucette if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and
dasabuvir (see also in section Other medicines and Lucette).

Warnings and precautions

When should you contact your doctor?
Seek urgent medical attention
• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein
thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clots’ section below).
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.

Talk to your doctor or pharmacist before taking Lucette.
Tell your doctor if any of the following conditions apply to you.
In some situations you need to take special care while using Lucette or any other combination pill, and your doctor may need to
examine you regularly. If the condition develops, or gets worse while you are using Lucette, you should also tell your doctor:
• if a close relative who has ever had breast cancer.
• if you have a disease of the liver or the gallbladder.
• if you have diabetes.
• if you have depression or mood changes.
• if you have epilepsy (see“Other medicines and Lucette”).
• if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood
disease called porphyria, yellowing of the skin or eyes (jaundice), itching of the whole body (pruritus), skin rash with blisters
during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s chorea)).
• if you have ever had chloasma (a discolouration of the skin especially on the face or neck known as “pregnancy patches”). If
so, avoid direct sunlight or ultraviolet light.
• if you have hereditary angioedema, products containing oestrogens may cause or worsen the symptoms. You should see
your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or
difficulty swallowing or hives together with difficulty breathing.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system).
• if you have haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure of the kidneys).
• if you have sickle cell anaemia (an inherited disease of the red blood cells).
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• if you need an operation, or you are off your feet for a long time (see in section 2‘Blood clots’).
• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you
can start taking Lucette.
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis).
• if you have varicose veins

BLOOD CLOTS
Using a combined hormonal contraceptive such as Lucette increases your risk of developing a blood clot compared with not
using one. In rare cases a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Lucette is small.

See leaflet about blood clots

Psychiatric disorders
Some women using hormonal contraceptives including Lucette have reported depression or depressed mood. Depression can
be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact
your doctor for further medical advice as soon as possible.
Bleeding between periods
During the first few months that you are taking Lucette, you may have unexpected bleeding (bleeding outside the seven
pill-free days). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor as they
must find out if anything is wrong.

What to do if no bleeding occurs during the seven pill-free days
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other
medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Only start
the next strip if you are sure that you are not pregnant.
Other medicines and Lucette
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Lucette. They can tell you
if you need to take additional contraceptive precautions (for example condoms) and if so, for how long or whether the use of
another medicine you need must be changed.
Do not use Lucette if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and
dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Lucette can
be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Lucette”.
Some medicines can have an influence on the blood levels of Lucette and can make it less effective in preventing pregnancy, or
can cause unexpected bleeding. These include medicines used for the treatment of
• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
• tuberculosis (e.g. rifampicin);
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as
ritonavir, nevirapine, efavirenz)
• high blood pressure in the blood vessels in the lungs (bosentan);
• fungal infection (e.g. griseofulvin, ketoconazole)
• the symptomatic treatment of arthrosis (etoricoxib)
• the herbal remedy St. John’s wort (Hypericum perforatum). If you want to use herbal products containing St. John’s wort while
you are already using Lucette you should consult your doctor first.
Lucette may influence the effect of other medicines, e.g.
• ciclosporin (medicine used for the treatment of suppression of tissue rejection following transplant surgery)
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures) tizanidine (medicine used for the
treatment of muscle spasticity) theophyllin (a medicine for the treatment of asthma).
Ask your doctor or pharmacist for advice before taking any medicine.
Lucette with food and drink
Lucette may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal contraceptives can
affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Pregnancy
If you are pregnant, do not take Lucette. If you become pregnant while taking Lucette stop taking it immediately and contact your
doctor. If you want to become pregnant, you can stop taking Lucette at any time (see also “If you stop taking Lucette”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Lucette is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are
breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Lucette affects driving or the use of machines.
Lucette contains lactose and soya lecithin
Lucette contains 48.17 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Lucette also contains 0.070 mg soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.