Please read this leaflet carefully even if you have been using Levo-nor for some time – the information contained in it is continually being brought up to date.
The calendar pack (4-week pack) of Levo-nor holds 28 tablets each containing 0.03 mg levonorgestrel.
Levo-nor contains the oral synthetic progestogen derived from 19-nortestosterone; (levonorgestrel) which is considered to have the highest relative biologic progestin activity – in an extremely low dose. The continuous daily ingestion of 0.03 mg levonorgestrel brings about changes in the cervical mucus by which sperm migration and ascent are rendered difficult or blocked. Furthermore, changes in the endometrium throughout the cycle can be considered as having the effect of rendering the nidation difficult.
Ovulation is generally not inhibited but there is a decrease in corpus luteum function which contributes to the contraceptive action.
The reliability of progestogen-only contraceptives is slightly lower than that of conventional progestogen-estrogen combinations. However, Levo-nor offers a high degree of reliability.
Levo-nor is an alternative for users of non-hormonal contraceptive methods and for those who, for one reason or another, cannot take or are not willing to use progestogen-estrogen preparations.
Therapeutic Indication :
Hormonal contraception, notably in cases of intolerance to combined progestogen-estrogen preparations or when estrogens are contraindicated.
Before starting Levo-nor, a careful history and complete physical-with a special concern to the breasts-and gynecologic examination as well as blood pressure, urine malysis and cervical cytology-should be carried out and pregnancy must be excluded.
A gynecologic check examination should ideally be made every 6 months or at least yearly, while the individual is on medication.
Dosage and administration :
Start taking Levo-nor on the first day of the menstrual cycle. If you have been taking an oral contraceptive, start taking Levo-nor on the day after you took the last tablet of the previous contraceptive. On the start day take the first tablet from the appropriate blister of the calendar pack. For instance, if your period starts on a Monday, press
out the first tablet from a blister marked “Mon” and swallowof the day you take the tablet, but when you have selected a particular time you should keep to it every day, because the interval between taking two tablets should be as near m-Iiours as possible.
Make sure that you are never more than three hours behind these 24 hours because otherwise the protection may be reduced. From now on you must take a tablet every day in the direction indicated by the arrows on the pack until the pack is empty. Start a new pack without interruption on the very next day, again selecting the tablet
marked with the appropriate day of the week.
Please note :
During the first 14 days oftablet·taking you must employ, in addition, a non-hormonal method of contraception with the exception of the rhythm and temperature methods .. Irregular tablet-taking, vomiting or intestinal disorders with diarrhoea, very rare individual metabolic disturbances or prolonged simultaneous use of certain medical preparations (see “Please inform your doctor. can affect the contraceptive effect.
If you have been using another hormonal contraceptive or if you want to start taking the tablets very soon after a delivery or an abortion, you should first consult your doctor. If you are breast-feeding, your doctor should decide whether you can take Levo-nor.
The menstrual cycle under Levo-nor :
Most women find that menstruation under Levo-nor occurs at the usual intervals and that the bleeding of normal duration and intensity. However, you may be one of those women who find that Levo-nor alters the hitherto familiar intervals between periods, the interval between two periods becomes shorter or longer. Thus, there is an adjustment to a new pattern of menstrual cycles.
Intermenstrual bleeding of varying intensity may occur, particularly during the first few months of Levo-nor use. If no menstrual bleeding has occurred within 6 weeks after the last menstrual bleeding, pregnancy must be excluded-before tablertaktng iscontirnred.
If you forget to take your daily tablet :
If you miss the usual time for taking your tablet by more than three hours, or if you forget one or more tablets, you no longer have contraceptive protection. You must nevertheless continue to take the other tablets in the pack at the usual time, forgetting about the ones you have missed. But you will not be protected from pregnancy until you have 14 tablets consecutively and according to directions. During this period you must use, in addition, a non-hormonal method of contraceotion with the
Reliability in the case of vomiting or diarrhoea :
If you vomit shortly after taking the Levo-nor tablet you can maintain protection against conception by taking a second tablet within 3 hours of the first tablet provided you do not vomit again, For this second ingestion the last tablet in the pack should always be used, so as to avoid confusion on later days, In the case of repeated vomiting or prolonged diarrhoea, a non-hormonal contraceptive
method (with the exception of the rhythm and temprature) methods) should be used additionally as a precaution, This
method must be continued for a further 14 days after the symptoms have subsided,
Non-contraceptive benefits :
One of the most advantages of progestogen – only contracepnves over combined preparations is the lack of any adverse effects on breast feeding with no evidence of reduction in milk volume or quality and no effect on infant growth and development,
There is a strong evidence for a major degree of protection against endometrial cancer,
All progestogen methods probably exert some benefit on symptoms of dysmenorrhoea, premenstrual syndrome, mittelschmerz and mastalgia,
Diseases, for which a moderate or high degree of pirotecuon is likely but unconfirmed, include endometriosis, urterine myomas, benign breast diseases and ovarian cancer,
Side effects :
In rare cases, nausea, headaches, depressive moods, changes in body weight and libido can occur,
Pregnancy, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin- johnson syndrome, Rotor syndrome, previous or existing liver tumours, a history of herpes of pregnancy ,also contraindicated in case of inflammation of uterine tube, It has been concluded from epidemiological surveys that the use of oral ovulation inhibitors (combined preparations containing estrogen) is attended by an increased incidence of thromboembolic diseases, Although no such associations are suspected for Levo-nor, a progestogen-only preparation, it is recommended as a precaution that this preparation should not be used where there is a history of or existing thromboembolic processes (e.g, stroke, myocardial infarction), in the presence of severe diabetes with vascular changes or in sickle cell anaemia,
contraindicated in case of recent history to hepatitis and in case of severe disturbance in liver function and in case of inflammation uterine tube.
Please inform your doctor :
– if you suffer or have suffered from any of the conditions
mentloned under “Contraindications”, because in these cases Levo-nor must not be taken. If you are not sure whether you have or have had any of these conditions, ask your doctor to explain .
– if you suffer from diabetes, since this disease requires careful supervision. Women with a tendency to diabetes should also be supervised accordingly .
– if you are taking other medical preparations regularly for example, barbiturates, phenylbutazone, hydantoins, rifarnpicin, ampicillin), since they can impair the action of leve-nor. The requirement for oral antidiabetics or insulincan change.
Reasons for immediate discontinuation of Levo-nor :
Occurrence for the first time of migranous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (e. g. disturbances of vision or hearing), first signs of thrombophlebitis or thromboembolic symptoms (for example, unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and
tightness in the chest, pending operations (six weeks before-hand), immobilization (for instance, following accidents). In all these cases there may be an increased risk of thrombosis. Further reasons for discontinuation are; onset of jaundice, onset of hepatitis, itching of the whole body, significant rise in blood pressure, pregnancy.
Special notes :
If there is a history of extra-uterine pregnancy or one tube is missing, the use of Levo-nor should be decided on only after carefully weighing the benefits against the risks. If obscure lower abdominal complaints occur together with an irregular cycle pattern (above all amenorrhoea following persistent bleeding), an extra-uterine pregnancy must be considered.
According to the present state of knowledge, an association between the use of hormonal contraceptives and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out. the rela ive risk of arteriaIlfirom50ses e. g. stro e, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of hormonal contraceptives coincide.
In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to life threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Levo-nor. The doctor must therefore be informed of the occurrence of unusual upper abdominal complains which do not disappear spontaneously within a short time.
Calendar pack (4-week pack) containing 28 tablets.
– Store all drugs properly and keep them out of reach of children.
Store in a cool& dry place
Manufactured By :
Famy Care Ltd.
Packed by : CID
for: ACDIMA International