Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
(Levonorgestrel/Ethinylestradiol)
“PACKAGE LEAFLET: INFORMATION FOR THE USER
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
(Levonorgestrel/Ethinylestradiol)
Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or Nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or Nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is and what it is used for
2. What you need to know before you take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
3. How to take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
4. Possible side effects
5. How to store Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
6. Contents of the pack and other information
1. WHAT FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/ ETHTNYLESTRADTOL 150/30 MICROGRAM COATED TABLETS IS AND WHAT IT IS USED FOR
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets are a combined oral contraceptive and belongs to a group of products often referred to as “the Pill”. Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets contains two hormones: oestrogen (Ethinylestradiol) and progestogen (Levonorgestrel). These hormones prevent you from getting pregnant, just as your natural hormones would prevent you from conceiving again when you are already pregnant.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS
General notes
Before you start using Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets 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 Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets, your doctor will ask you some questions about your personal health 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 Femicept Coated Tablets, or where the reliability of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets may be decreased. In such situations you should either not have intercourse 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 Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets alters the monthly changes of the cervical mucus.
Femicept Coated Tablets, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
You should not use Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets 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 are allergic to active substances or any of the other ingredients of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets (listed in section 6).
• 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 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 (had) a certain form of migraine (with so-called focal neurological symptoms).
• If you have (had) an inflammation of the pancreas (pancreatitis)
• If you have or have had in the past a liver disease and your liver function is still not normal.
• If you have or have had a tumour in the liver.
• If you have (had) or if you are suspected to having breast cancer or cancer of the genital organs.
• If you have any unexplained bleeding from the vagina.
• If you have absence of menstrual period and the cause is unknown
If any of these conditions appear for the first time while using Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, stop taking it at once and tell your doctor. In the meantime, use a non-hormonal contraceptive. See also ‘General Notes’ in section 2 above.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets.
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 recognize a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, you should also tell your doctor.
• If a close relative has or has had breast cancer
• If you have a disease of the liver or the gallbladder
• If you have diabetes
• If you have depression
If you have Crohn’s disease or ulcerative colitis (inflammatory bowel disease)
If you have HUS (haemolytic uraemic syndrome; a blood disease that causes kidney damage)
If you have epilepsy (see “Taking other medicines”)
If you have SLE (systemic lupus erythematosus; a disease of the immune system) If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for Example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)
If you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light.
If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of 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 breathing.
If a pre-existing high blood pressure condition worsens If a pre-existing high level of fat in blood worsens
if you have elevated levels of fat in the blood (14)) 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 Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets;
• 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 Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems.
3lood 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 having a harmful blood clot due to Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
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microgram Coated tablets is small. HOW TO RECOGNISE A BLOOD CL Seek urgent medical attention if you notict |
OT any of the following signs or symptoms. |
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Are you experiencing any of these signs? |
What are you possibly suffering frm? |
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• 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 |
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• 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 |
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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) |
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• 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 |
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• 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 |
Stroke |
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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. | |
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• swelling and slight blue discolouration of an extremity • severe pain in your stomach (acute abdomen) |
Blood clots blocking other blood vessels. |
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BLOOD CLOTS IN A VEIN | |
What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets your risk of a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is small.
- Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, such as Femicept 150/30 Coated Tablets, Levonorgestrel/
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Ethinylestradiol 150/30 microgram Coated tablets, about 5-7 will develop a blood clot in a year. - The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot in a vein” below). | |
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Risk of developing a blood clot in a year | |
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Women who are not using a combined hormonal pill and are not pregnant |
About 2 out of 10,000 women |
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Women using a combined hormonal contraceptive pill containing levonorgestrel |
About 5-7 out of 10,000 women |
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Women using Ethinylestradiol/ Levonorgestrel |
Not yet known |
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets is small but some conditions will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2)
• if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder
• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets ask your doctor when you can start using it again.
• as you get older (particularly above about 35 years)
• if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets need to be stopped.
If any of the above conditions change while you are using Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, for example a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is very small but can increase:
• with increasing age (beyond about 35 years)
• if you smoke. When using a combined hormonal contraceptive like Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke
• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides)
• if you get migraines, especially migraines with aura
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
• if you have diabetes.
If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, for example you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor.
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets and cancer
Breast cancer has been found slightly more often in women using combined pills, but it is not known whether this is caused by the combined pills. For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often. After stopping the combined pill, the increased risk gradually reduces.
It is important to check your breasts regularly and you should contact your doctor if you feel any lump.
You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2 “When to take special care with Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets”).
In rare cases, benign (noncancerous) liver tumours, and in even fewer cases malignant (cancerous) liver tumours have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.
Cervical cancer is caused by an infection with the human papilloma virus (HPV).
It has been reported to occur more often in women using the pill for a long time. It is unknown if this finding is due to the use of hormonal contraceptives or to other factors, such as difference in sexual behaviour.
Bleeding between periods
During the first few months that you are taking Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.
What you must do if no bleeding occurs in the gap week
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. Do not start the next strip until you are sure that you are not pregnant.
Other medicines and Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets. They can tell you if you need to take additional contraceptive precautions (barrier method) and, if so, for how long.
• Some medicines have an influence on the blood level of Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets 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. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (e.g. rifampicin);
-HTVand Elepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
- other infections (griseofulvin)- high blood pressure in the blood vessels in the lungs (bosentan).
• The herbal product St. John's wort may also stop Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets from working properly. If you want to use herbal products containing St. John’s wort while you are already using Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets you should consult your doctor first.
• Some medicines can increase the levels of the active substances of Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets in the blood. The effectiveness of the pill is maintained, but tell your doctor if you are using anti-fungal medicines
containing ketoconazole.
• Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets may also interfere with the working of other medicines - such as the anti-epileptic lamotrigine.
Effect on laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.
Pregnancy, breast feeding and fertility
Preenancv
If you become pregnant while taking Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets you must stop immediately and contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast feeding
Use of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets 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
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets does not have any known effect on your ability to drive or use machines.
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets contains lactose and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS
Always take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take one tablet of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet free days (otherwise called a stop or gap week) bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On file 8th day after the last Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets (that is, after the 7-day gap week), start file following strip, even if the bleeding has not stopped. This means that you should start the following strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.
If you use Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets in this manner, you are also protected against pregnancy during the 7 days that you are not taking a tablet.
Starting the first pack of Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets
• If you have not used a contraceptive with hormones in the previous month.
Begin with Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets on the first day of the cycle (that is the first day of your menstruation). If you start Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or combined contraceptive, vaginal ring or patch.
You can start Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets preferably on the day after the last active tablet (the last tablet containing the active substance) of your previous pill, but at the latest on file day after the tablet free days of your previous pill finish (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen only pill, injection, implant or a progestogen-releasing IUD).
You may switch any day from the progestogen-only pill (from an implant or the IUD on file day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage or an abortion.
Follow the advice of your doctor.
• After having a baby.
After having a baby, you can start Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets between 21 and 28 days later. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first seven days of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets use.
If, after having a baby, you have had intercourse before starting Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated Tablets (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed.
Let your doctor advice you in case you are not sure when to start.
• If you are breastfeeding and want to start Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets after having a baby.
Read the section on “Breast feeding”.
If you take more Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets than you should
There are no reports of serious harmful results of taking too many Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets.
If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.
If you have taken too many Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets
If you are less than 12 hours late in taking your pill, the protection from pregnancy is not reduced. Take the tablet as soon as you remember, and further pills again at file usual time.
If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk that the protection from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of the strip. Therefore, you should adhere to the following rules:
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had intercourse in the week before the oversight or you have forgotten to start a new strip after the tablet-free period, you must realize that there is a risk of pregnancy. In that case, contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time. The protection from pregnancy is not reduced, given that you have taken the tablets correctly in the previous 7 days, otherwise extra precaution should be used for the next 7 days.
• One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time. Instead of the tablet free period go straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may also have spotting or breakthrough bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on your fixed start day, make the tablet-free period less than 7 days.
If you follow either of these two recommendations, you will remain protected against pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have bleeding in file first tablet-free period, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.
What must you do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substance in the pill are not fully absorbed into your body. The situation is similar to if you forget a tablet. After vomiting or diarrhoea, you must take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice given under ‘if you forget to take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets.
Delay of menstrual period: what must you know
Even if not recommended, delay of your menstrual period (withdrawal bleed) is possible by going straight on to a new strip of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets instead of the tablet-free period, to the end of the second strip. You may experience spotting (drops or flecks of blood) or breakthrough bleeding while using the second strip. After the usual tablet-free period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your menstrual period
Change of the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your menstrual period/ withdrawal bleed will begin in the tablet-free week. If you have to change this day, do this by making the tablet-free period shorter (but never longer!) For example, if your tablet-free period begins on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. If you make the tablet-free period very short (for example, 3 days or less) then it may be that you do not have any bleeding during this tablet-free period. You may then experience spotting (droplets or flecks of blood) or breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.
If you stop taking Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets
You can stop taking Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets whenever you want. If you do not want to become pregnant, ask you doctor for advice about other reliable methods of birth control.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe or persistent, or have any change to your health that you think may be due to Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, please talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present for all women using combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets”.
Very common (may affect more than 1 in 10 people):
• acne
• changes to menstrual periods (e.g. absence or irregularity)
Common (may affect up to 1 in 10 people):
• decreased interest in sex; depression/depressed mood; mood changes
• headache or migraine
• feeling sick (nausea)
• heavy menstrual periods; breast pain; pelvic pain
• weight gain
Uncommon (may affect up to 1 in 100 people):
• increased appetite; fluid retention (oedema)
• hot flush
• swollen abdomen
• increased sweating; hair loss; itching; dry skin; oily skin
• heaviness in limbs
• regular but scanty periods; larger breasts; breast lump; milk production while not pregnant; premenstrual syndrome; pain during intercourse; dryness in the vagina or vulva; spasm of the uterus
• irritability
• increased liver enzymes
Rare (may affect up to 1 in 1,000 people):
• harmful blood clots in a vein or artery, for example:
o in a leg or foot (i.e., DVT)
o in a lung (i.e., PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot.) decreased appetite
• increased interest in sex
• disturbance in attention
• dry eye; contact lens intolerance
• dry mouth
• golden brown pigment patches, mostly in the face; excessive hair growth
• vaginal smell; discomfort in the vagina or vulva
• hunger
• disease of the gallbladder
Allergic (hypersensitive) reactions have been reported in users of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, but the frequency cannot be estimated from the available data.
Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is described in section 3 ‘HOW TO TAKE FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS’.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the yellow card system at www.mhra. go.uk/yellowcard. By Reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister / carton after ‘ {EXP} ’. The expiry date refers to the last day of that month Store below 25° C
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets contains
- The active substances are Levonorgestrel (150 meg) and Ethinylestradiol (30 meg)
- The other ingredients are Lactose Monohydrate, Maize Starch, Povidone K-25, Sucrose, Talc, Calcium carbonate, Povidone K-90, Glycerin, Macrogol 6000, Titanium dioxide, Magnesium Stearate, Camauba Wax.
What Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets looks like and contents of the pack
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets are white, circular, biconvex and sugar coated.
Each box contains 1,3,6 and 13 blisters of 21 tablets each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Famy Care Europe Ltd.
One Wood Street London, EC2V 7WS United Kingdom
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is manufactured by:
Accord Healthcare Limited Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF, United Kingdom
Wessling Hungary Kft Foti ut 56., Budapest, 1047,
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
DE: Gloriamia 0,03 mg/0,15 mg tiberzogene Tabletten NO: Oralcon DK: Femicept
Ethinylestradiol/Levonorgestrel Mylan 0,03/0,15 mg Levonorgestrel/Ethinylestradiol 150/30 microgram Coated Tablets Oralcon 150mcg/30mcg Bevont tabletta
This leaflet was last revised in 03/2016.