Femodene Ed 0,03 mg/0,075 mg Tablets

FEMODENE ED is a combined oral contraceptive pill and is used to prevent pregnancy. Each of the 21 smaller white coated tablets contains a small amount of the female hormones ethinylestradiol and gestodene.

General notes
Before you can begin taking FEMODENE ED, 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 FEMODENE ED, or where the reliability of FEMODENE ED 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 FEMODENE ED alters the monthly changes of body temperature and cervical mucus. FEMODENE ED, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take FEMODENE ED if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use FEMODENE ED. Your doctor may advise you to use a different type of pill or an entirely different (including non-hormonal) method of birth control.

• if you are hypersensitive (allergic) to ethinylestradiol, gestodene or any of the other ingredients in FEMODENE ED. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body
• if you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• if you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack)
• if you have a high risk of venous or arterial blood clots (see ‘FEMODENE ED and blood clots’. Consult your doctor who will decide whether you may use FEMODENE ED)
• if you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness or numbness in any part of your body)
• if you have diabetes mellitus with damaged blood vessels.
• if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin (jaundice) or itching over the whole body) and your liver is still not working normally
• if you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
• if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• if you have (or have ever had) a benign or malignant tumour of the liver
• if you have any unexplained bleeding from the vagina
• if you are pregnant or think you might be pregnant

If any of these conditions appear for the first time while using FEMODENE ED, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures. See also ‘General notes’.

Do not share medicines prescribed for you with any other person. The FEMODENE ED pack contains 28 tablets. Take your tablet at about the same time each day, with some liquid if necessary. Follow the direction of the arrows until all 28 tablets have been taken. Usually a period will start on day 2 - 3 after the last hormone-containing smaller white FEMODENE ED tablet (i.e. while you are taking the last 7 hormone-free larger white tablets). Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days every month.

When can you start with the first pack?
If you have not used a contraceptive with hormones during the previous month, wait for your next period to occur. Start with FEMODENE ED on the first day of the cycle (= 1st day of bleeding) from the silver section of the pack and select the right tablet for that day of the week (e.g. “MO” for Monday). During the first cycle, you must use extra protective measures (for example, a condom) for the first 14 days of FEMODENE ED use.

Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch.
You can start taking FEMODENE ED the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains hormone-free tablets you can start FEMODENE ED on the day after taking the last tablet containing hormones (if you are not sure which this is, ask your doctor or pharmacist). In case you have used a vaginal ring or transdermal patch, start using FEMODENE ED on the day of removal of the last ring or patch of a cycle pack. If you follow these instructions, it is not necessary to use an additional contraceptive method.

Changing from a progestogen-only method (progestogen-only pill, injection, implant or a progestogen-releasing ‘IUS’, intrauterine system).
You may switch from the progestogen-only pill any day (from an implant or the IUS on the 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) during the first 14 days of FEMODENE ED use.

After a miscarriage.
Follow the advice of your doctor, but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking.

After having a baby
If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking FEMODENE ED. Sometimes it is possible to start sooner. Your doctor will advise you but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking. If, after having a baby, you have had sex before starting FEMODENE ED, be sure that you are not pregnant or wait until the next menstrual period. If you want to start FEMODENE ED after having a baby and are breastfeeding, discuss this first with your doctor.

If you take more FEMODENE ED than you should
There are no reports of serious harmful effects of taking too many FEMODENE ED tablets. If you take several hormone-containing tablets at once, you may feel sick or vomit or may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take FEMODENE ED
Depending on the day of the cycle on which one tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom. In case of doubt, contact your doctor.

FEMODENE ED can have side effects. Not all side effects reported for FEMODENE ED are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FEMODENE ED, please consult your health care provider for advice. Tell your doctor if you notice any of the following:

Frequent side effects:
• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness

Less frequent side effects:
• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex
• breast enlargement
• rash
• urticaria (hives)
• contact lens intolerance
• allergic reactions (hypersensitivity)
• weight loss
• increased interest in sex
• vaginal discharge
• breast discharge
• erythema nodosum or multiforme (skin disorders)
• venous and arterial thromboembolic events*

* Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. The term venous and arterial thromboembolic events covers the following: any blockage or clot in a deep peripheral vein, clots which travel through the venous blood system (e.g. to the lung known as pulmonary embolism or as pulmonary infarction), heart attack caused by blood clots, stroke caused by blockage of the blood supply to or in the brain.

Description of selected adverse reactions
Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed below (see also sections ‘Do not take FEMODENE ED’ and ‘Warnings and precautions’):

Tumours:
• The frequency of diagnosis of breast cancer is very slightly increased among users of oral contraceptives. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. It is not known whether there is a direct link to users of combined oral contraceptives.
• liver tumours (benign and malignant)

Other conditions:
• women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives)
• high blood pressure
• occurrence or worsening of conditions for which a link to combined oral contraceptives is not definite: jaundice and/or itching related to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uremic syndrome (a blood clotting disease); a neurological condition called Sydenham’s chorea; herpes gestationis (a type of skin condition that occurs during pregnancy); otosclerosis-related hearing loss
• In women with hereditary angioedema (characterised by sudden swelling of e.g. the eyes, mouth, throat etc.) external estrogens may induce or worsen symptoms of angioedema
• disturbed liver function
• changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn’s disease, ulcerative colitis
• chloasma

Interactions:
Unexpected bleeding and/or contraceptive failure may result from interactions of other medicines with oral contraceptives (e.g. the herbal remedy St. John’s wort, or medicines for epilepsy, tuberculosis, HIV infections and other infections).

Reporting of side effects:
If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za.Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FEMODENE ED.

Keep out of the reach and sight of children. Store at or below 30 °C. Protect from light. Store in the blister in the outer carton.