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FEMULEN

Active substance(s): ETYNODIOL DIACETATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Femulen.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms etynodiol diacetate.

3

PHARMACEUTICAL FORM
White tablet inscribed "SEARLE" on both sides.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Oral contraception.

4.2

Posology and method of administration
Starting on the first day of menstruation, one pill every day without a break in
medication for as long as contraception is required. Additional contraceptive
precautions (such as a condom) should be used for the first 7 days of the first
pack. Pills should be taken at the same time each day.
Missed pills: If a pill is missed within 3 hours of the correct dosage time then
the missed pill should be taken as soon as possible; this will ensure that
contraceptive protection is maintained. If a pill is taken 3 or more hours late it
is recommended that the woman takes the last missed pill as soon as possible
and then continues to take the rest of the pills in the normal manner. However,
to provide continued contraceptive protection it is recommended that an
alternative method of contraception, such as a condom, is used for the next 7
days.
Vomiting or diarrhoea: Gastrointestinal upsets, such as vomiting and
diarrhoea, may interfere with the absorption of the pill leading to a reduction
in contraceptive efficacy. Women should continue to take Femulen, but they
should also be advised to use another contraceptive method during the period
of gastrointestinal upset and for the next 7 days.

4.3

Contraindications
The contraindications for progestogen-only oral contraceptives are:
(i)

Known, suspected, or a past history of breast, genital or hormone
dependent cancer;
(ii) Acute or severe chronic liver diseases including past or present liver
tumours, Dubin-Johnson or Rotor syndrome;
(iii) Active liver disease;
(iv) History during pregnancy of idiopathic jaundice or severe pruritus;
(v)
Disorders of lipid metabolism;
(vi) Undiagnosed abnormal vaginal bleeding;
(vii) Known or suspected pregnancy;
(ix) Hypersensitivity to any ingredient in the product.
Combined oestrogen/progestogen preparations have been associated with an
increase in the risk of thromboembolic and thrombotic disease. Risk has been
reported to be related to both oestrogenic and progestogenic activity. In the
absence of long term epidemiological studies with progestogen-only oral
contraceptives, it is required that the existence, or history of thrombophlebitis,
thromboembolic disorders, cerebral vascular disease, myocardial infarction,
angina, coronary artery disease, or a haemoglobinopathy be described as a
contraindication to Femulen as it is to oestrogen containing oral
contraceptives.

4.4

Special warnings and precautions for use
Assessment of women prior to starting oral contraceptives (and at regular
intervals thereafter) should include a personal and family medical history of
each woman. Physical examination should be guided by this and by the
contraindications (section 4.3) and warnings (section 4.4) for this product. The
frequency and nature of these assessments should be based upon relevant
guidelines and should be adapted to the individual woman, but should include
measurement of blood pressure and, if judged appropriate by the clinician,
breast, abdominal and pelvic examination including cervical cytology.
Femulen should be discontinued if there is a gradual or sudden, partial or
complete loss of vision or any evidence of ocular changes, onset or
aggravation of migraine or development of headache of a new kind which is
recurrent, persistent or severe, suspicion of thrombosis or infarction,
significant rise in blood pressure or if jaundice occurs.
Malignant hepatic tumours have been reported on rare occasions in long-term
users of contraceptives. Benign hepatic tumours have also been associated
with oral contraceptive usage. A hepatic tumour should be considered in the
differential diagnosis when upper abdominal pain, enlarged liver or signs of
intra-abdominal haemorrhage occur.

Progestogen-only oral contraceptives may offer less protection against ectopic
pregnancy, than against intrauterine pregnancy.
Femulen should be discontinued at least 4 weeks before elective surgery or
during periods of prolonged immobilisation. It would be reasonable to resume
Femulen two weeks after surgery provided the woman is ambulant. However,
every woman should be considered individually with regard to the nature of
the operation, the extent of immobilisation, the presence of additional risk
factors and the chance of unwanted conception.
Caution should be exercised where there is the possibility of an interaction
between a pre-existing disorder and a known or suspected side effect. The use
of Femulen in women suffering from epilepsy, or with a history of migraine or
cardiac or renal dysfunction may result in exacerbation of these disorders
because of fluid retention. Caution should also be observed in women who
wear contact lenses, women with impaired carbohydrate tolerance, depression,
gallstones, a past history of liver disease, varicose veins, hypertension, asthma
or any disease that is prone to worsen during pregnancy (eg. multiple sclerosis,
porphyria, tetany and otosclerosis). Progestogen-only oral contraceptives may
offer less protection against ectopic pregnancy, than against intrauterine
pregnancy.
A meta-analysis from 54 epidemiological studies reported that there is a
slightly increased relative risk of having breast cancer diagnosed in women
who are currently using oral contraceptives (OC). The observed pattern of
increased risk may be due to an earlier diagnosis of breast cancer in OC users,
the biological effects of OCs or a combination of both. The additional breast
cancers diagnosed in current users of OCs or in women who have used OCs in
the last ten years are more likely to be localised to the breast than those in
women who never used OCs.
Breast cancer is rare among women under 40 years of age whether or not they
take OCs. Whilst the background risk increases with age, the excess number of
breast cancer diagnoses in current and recent progesterone-only pill (POP)
users is small in relation to the overall risk of breast cancer, possibly of similar
magnitude to that associated with combined OCs. However, for POPs, the
evidence is based on much smaller populations of users and so is less
conclusive than that for combined OCs.
The most important risk factor for breast cancer in POP users is the age
women discontinue the POP; the older the age at stopping, the more breast
cancers are diagnosed. Duration of use is less important and the excess risk
gradually disappears during the course of the 10 years after stopping POP use,
such that by 10 years there appears to be no excess.
The evidence suggests that compared with never-users, among 10,000 women
who use POPs for up to 5 years but stop by age 20, there would be much less
than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For
those stopping by age 30 after 5 years use of the POP, there would be an

estimated 2-3 extra cases (additional to the 44 cases of breast cancer per
10,000 women in this age group never exposed to oral contraceptives). For
those stopping by age 40 after 5 years use, there would be an estimated 10
extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of
breast cancer per 10,000 never-exposed women in this age group).
It is important to inform patients that users of all contraceptive pills appear to
have a small increase in the risk of being diagnosed with breast cancer,
compared with non-users of oral contraceptives, but this has to be weighed
against the known benefits.

4.5

Interaction with other medicinal products and other forms of interaction
Drug Interactions
The herbal remedy St. John’s wort (Hypericum perforatum) should not be
taken concomitantly with this medicine as this could potentially lead to a loss
of contraceptive effect.
Some drugs may modify the metabolism of Femulen reducing its
effectiveness; these include certain sedatives, antibiotics, anti-epileptic and
anti-arthritic drugs. During the time such agents are used concurrently, it is
advised that mechanical contraceptives also be used.

4.6

Fertility, Pregnancy and lactation
Pregnancy
Femulen is contraindicated in women with suspected pregnancy. Several
reports suggest an association between foetal exposure to female sex
hormones, including oral contraceptives, and congenital anomalies.
Lactation
There is no evidence that progestogen-only oral contraceptives diminish the
yield of breast milk. In a study of nursing mothers taking Femulen, the
median percentage of norethisterone, the principal metabolite of etynodiol
diacetate given to the mother which was ingested by the infant was 0.02%. No
adverse effect of the drug on the infants was noted.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Clinical investigations with Femulen indicate that side effects are infrequent
and tend to decrease with time. Known or suspected side effects of
progestogen-only oral contraceptives include gastrointestinal disorders such as
nausea and vomiting, skin disorders including chloasma, breast changes,
ocular changes, headache, migraine and depression, appetite and weight
changes, changes in libido, increase in size of uterine myofibromata, and
changes in carbohydrate, lipid or vitamin metabolism. Rarely dizziness,
hirsutism and colitis have been reported in users of progestogen-only oral
contraceptive.
The use of oral contraceptives has also been associated with a possible
increased incidence of gallbladder disease.
Tests of endocrine, hepatic and thyroid function, as well as coagulation tests
may be affected by Femulen.
Menstrual pattern: Women taking Femulen for the first time should be
informed that they may initially experience menstrual irregularity. This may
include amenorrhoea, prolonged bleeding and/or spotting but such irregularity
tends to decrease with time. If a woman misses two consecutive periods,
pregnancy should be ruled out before continuing the contraceptive regimen.

4.9

Overdose
Serious ill effects have not been reported following acute ingestion of large
doses of oral contraceptives by young children. Nausea and vomiting may
occur and vaginal withdrawal bleeding may present in pre-pubertal girls.
There is no specific antidote and treatment should be symptomatic. Gastric
lavage may be employed if the overdose is large and the patient is seen
sufficiently early (within four hours).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Femulen does not necessarily inhibit ovulation but it is believed to discourage
implantation of the fertilised ovum by altering the endometrium. Cervical
mucus viscosity is also changed which may render the passage of sperm less
likely.

5.2

Pharmacokinetic properties
Etynodiol diacetate is readily absorbed from the gastrointestinal tract and
rapidly metabolised, largely to norethisterone. Following administration of a
radiolabelled dose of etynodiol diacetate about 60% of the radioactivity is
stated to be excreted in urine and about 30% in faeces; half life in plasma was
about 25 hours.

5.3

Preclinical safety data
The toxicity of norethisterone is very low. Reports of teratogenic effects in
animals are uncommon. No carcinogenic effects have been found even in
long-term studies. In subacute and chronic studies only minimal differences
between treated and control animals are observed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Calcium phosphate dibasic anhydrous, maize starch, polyvinyl pyrrolidine,
sodium phosphate dibasic anhydrous, calcium acetate anhydrous, thixcin R
(hydrogenated castor oil).

6.2

Incompatibilities
None known.

6.3

Shelf life
The shelf life of Femulen is 5 years.

6.4

Special precautions for storage
Store in a dry place below 30°C

6.5

Nature and contents of container
Femulen tablets are stored in PVC/foil blister packs of 28 and 84 tablets.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ, UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00057/0975

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/11/2008

10

DATE OF REVISION OF THE TEXT
20/03/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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