Femodene is an oral contraceptive. Femodene tablets contain two hormones (gestodene and ethinyloestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.
Femodene prevents pregnancy in several ways:
- It inhibits the egg release by stopping it maturing.
- It changes the cervical mucus consistency making it difficult for the sperm to reach the egg.
- It changes the lining of the uterus making it less suitable for implantation.
Your doctor may have prescribed Femodene for another reason. Ask your doctor if you have any questions about why Femodene has been prescribed for you.
Dosage and Administration
Start with the first tablet from the green section marked with that day of the week, in accordance with one of the following:
No preceding hormonal contraceptive use (in the past month)
Tablet taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2 - 3 is allowed, but if this occurs a barrier contraceptive method is recommended in addition for the first 7 days of tablet taking.
Changing from another combined oral contraceptive (COC)
The woman should start with Femodene 28 preferably on the day after the last hormonal tablet of her previous COC, but at the latest on the day following the usual tablet-free or non-hormonal tablet interval of her previous COC.
Changing from a progestogen-only method (minipill, injection, implant) or progestogen-releasing intrauterine system (IUS)
The woman may switch any day from the minipill, from an implant or IUS on the day of its removal, or from an injectable when the next injection would be due. In all of these cases, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking.
Following first-trimester abortion
The woman may start immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion
The woman should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later than this, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before starting Femodene 28 or the woman has to wait for her first menstrual period.
Contra-Indications
Femodene 28 should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during their use, the product should be stopped immediately.
- Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
- presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
- diabetes mellitus with vascular involvement
- disturbed lipometabolism
- the presence of a severe or multiple risk factor(s) for venous or arterial thrombosis, including hereditary thrombophilia
- pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- presence or history of severe hepatic disease as long as liver function values have not returned to normal
- presence or history of liver tumours (benign or malignant)
- presence or history of migraine, particularly hemiplegic migraine
- known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced
- undiagnosed vaginal bleeding
- known or suspected pregnancy
- hypersensitivity to any of the components of Femodene 28
Side Effects
Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you thibk might be caused by Femodene 28.
Serious Side Effects
Serious reactions associated with the use of combined oral contraceptives such as Femodene 28, as well as the related symtoms are described in the leaflet included with your medication. Please read the "Before you use Femodene 28" section on the leaflet and consult your doctor where appropriate.
Other possible Side Effects
The following have been reported in users of combined oral contraceptives such as Femodene 28, although they may not be caused by the contraceptive Pill. Such undesirable effects that occur in the first few months that you are using Femodene 28 will probably lessen with time.\
- breast tenderness, pain, enlargement and secretion
- headache, migraine
- changes in sexual drive; depressive moods, mood changes
- contact lens intolerance
- nausea, vomiting and feeling sick
- changes in vaginal secretion
- various skin reactions
- fluid retention
- changes in body weight
- hypersensitivity reactions
Missed Tablets
If you have forgotten to take one or more of the large white non-hormonal tablets – there is no need to be concerned, simply take your next tablet, the next day as usual.
If you are less than 12 hours late in taking one of the small hormonal Femodene 28 tablets, you are still protected against pregnancy. Take the tablet as soon as you remember and take the next one at your usual time. This may mean that you are taking 2 tablets in one day.
If you are more than 12 hours late in taking one of your small hormonal Femodene 28 tablets you will not be protected. Take the last tablet as soon as you remember and take the next one at your normal time. This may mean taking 2 tablets in one day. You must take extra contraceptive precautions and you must follow the 7 day rule. Read the section on "Extra contraceptive precautions" and "The 7 day rule" that is on the leaflet included in your packet.
If you forgot tablets in the first week after taking the large non-hormonal tablets and had intercourse in the seven days before, consult your doctor as the possibility of pregnancy should be considered.
If you have forgotten to take your small hormonal Femodene 28 tablets for a few days, consult your doctor to be sure you are not pregnant, then discard the missed tablets and follow the 7 day rule.
Storage
Store Femodene 28 away from children.
Do not store Femodene 28 above 25°C (77°F).
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