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Co-cyprindiol 2 mg / 0.035 mg coated tablets


One coated tablet contains:
Cyproterone acetate 2 mg
Ethinylestradiol 0.035 mg
For a full list of excipients, see section 6.1.


Coated tablet
Each tablet is round and beige.




Therapeutic indications
Co-cyprindiol is recommended for use in women only for the treatment of:
-a) severe acne, refractory to prolonged oral antibiotic therapy.
-b) moderately severe hirsutism.
Although Co-cyprindiol also acts as an oral contraceptive, it should only be used in
patients requiring hormone treatment for the above conditions (see section 4.4. For
duration of treatment, see section 4.2.)
The medicinal product is not recommended to be used for contraception only.


Posology and method of administration
Co-cyprindiol inhibits ovulation and thereby prevents conception. Patients
who are using Co-cyprindiol should not therefore use an additional hormonal
contraceptive, as this will expose the patient to an excessive dose of hormones
and is not necessary for effective contraception.
The first period of treatment is started on the first day of the menstrual cycle
then one tablet daily for 21 days. Each subsequent course is started after 7
tablet-free days following which menstruation should occur.
Withdrawal bleeding usually occurs by 2-4 days after the last tablet. If this
does not occur, it may be necessary to exclude pregnancy.
Starting tablets
No previous hormonal contraception (during the preceding month): Tablets
should be started on day 1 of the natural menstrual cycle (first day of
bleeding). Tablet-taking may also be started during bleeding days 2-5, but in
that case an additional non-hormonal contraceptive method is recommended
for the first seven days of the first cycle.
Switch from another combined oral contraceptive, patch or vaginal ring:
Tablets should preferably be started on the day following the intake of the last
active tablet of the previous combined oral contraceptive, but at the latest
following the usual tablet-free or placebo-tablet interval of the previous
combined oral contraceptive, or after removal of the patch or the vaginal ring.
Switch from progestagen -only contraceptives (minipills, injections, implants
or IUS): The switch from minipills can be made at all times (the switch from
implants or IUS on the day of its removal and from injections on the next
scheduled day of injection), but the user should be advised to use an additional
non-hormonal contraceptive method for the first seven days of tablet-taking.
After abortion during the first trimester: Tablet-taking can be started
immediately. In this case no other contraceptive method is needed.
After childbirth or abortion during the second trimester: Breast feeding
mothers: see section 4.6. The use of the tablets should be started 21 to 28 days
after childbirth or abortion during the second trimester. If tablet-taking is
started later than this, an additional non-hormonal contraceptive method
should be used for the first seven days of tablet-taking. However, if intercourse
has already occurred, pregnancy should be excluded or the woman should wait
for her first natural period before starting the next tablet.
Missing tablets: If the patient forgets a single tablet, it should be taken within
12 hours of the correct time to maintain contraceptive protection. With larger
errors, additional contraception (barrier method, such as a condom) is needed.
Handling of missed tablets may be managed by the following two basic rules:

Tablet-taking must never be discontinued for longer than 7 days.

Adequate suppression of the hypothalamic-pituitary-ovarian axis
requires 7 days of uninterrupted tablet-taking.
Accordingly, the following advice can be given for daily practice:
Week 1
The woman should take the last missed tablet as soon as she remembers, even
if this means taking two tablets at the same time. She then continues to take
the next tablets at her usual time. In addition, a barrier method such as a
condom should be used for the next 7 days. If the woman has had sexual
intercourse in the 7 days before missing the tablet, the possibility of a
pregnancy must be considered. The more tablets have been missed and the
closer they are to the regular tablet-free break, the higher the risk of
Week 2
The woman should take the last missed tablet as soon as she remembers, even
if this means taking two tablets at the same time. She then continues to take
the next tablets at her usual time. Provided that the woman has taken her
tablets correctly in the 7 days preceding the first missed tablet, there is no need
to use extra contraceptive precautions. If she has not taken the tablets correctly
or has missed more than one tablet, she should be advised to use extra
contraceptive precautions for the next 7 days.
Week 3
The risk of reduced contraceptive reliability is imminent because of the
forthcoming tablet-free break of 7 days. However, reduced contraceptive
protection can still be prevented by adjusting the dosage. By adhering to the
following advice, there is no need to use extra contraceptive precautions,
provided that all the tablets have been taken correctly in the 7 days preceding
the first missed tablet.
If this is not the case, the woman should follow the first of these two options
and use extra contraceptive precautions for the next 7 days as well.

The woman should take the last missed tablet as soon as she
remembers, even if this means taking two tablets at the same time. She then
continues to take the next tablets at her usual time. The next pack is started as
soon as the current pack is finished, i.e. there is no tablet-free break. There will
probably be no withdrawal bleed until the end of the second pack, but the
woman may experience spotting or breakthrough bleeding on tablet-taking

It is also possible to stop taking tablets from the current pack. The
woman must then have a tablet-free break of 7 days, including the days she
missed tablets, and then continue with the next pack.
If the woman misses several tablets and has no withdrawal bleed during the
first normal tablet-free break, the possibility of a pregnancy must be
Vomiting or diarrhoea: If vomiting or diarrhoea occurs tablets should be taken
at regular time periods. In addition, a supplemental non-hormonal
contraceptive method should be used for the next 7 days.

The duration of treatment depends upon the severity of the disease and the
patient’s clinical status. Therapy usually lasts for several months. It is
recommended that intake of Co-cyprindiol be continued for at least 3-4 cycles
after symptoms have subsided, and that Co-cyprindiol is not continued solely
to provide oral contraception. Repeat courses may be given if the androgendependent condition(s) recur.




Pregnancy is an absolute contra-indication for treatment with Co-cyprindiol and must
be excluded before such treatment is begun (see section 4.6 and section 4.4).


Severe disturbances of liver function, jaundice or persistent itching during a previous
pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver

Personal or family history of confirmed, idiopathic venous thromboembolism (VTE)
(where a family history refers to VTE in a sibling or parent at a relatively early age.).

Current venous thrombotic or embolic processes.

Existing or previous arterial thrombotic or embolic processes.

The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
may also constitute a contraindication (see section 4.4.)

Sickle-cell anaemia.

Mammary or endometrial carcinoma, or a history of these conditions.

Severe diabetes mellitus with vascular changes.

Abnormal vaginal bleeding of unknown cause.

Disorders of lipid metabolism.

History of herpes gestationis.

Deterioration of otosclerosis during pregnancy.

Migraine with focal neurological symptoms.

Hypersensitivity to cyproterone acetate, ethinylestradiol or any of the excipients of
the medicinal product.

Special warnings and precautions for use
Prior to the initiation or reinstitution of treatment a complete medical history
(including family history) should be taken and pregnancy should be ruled out.
Blood pressure should be measured and a physical examination should be
performed guided by the contra-indications (section 4.3 Contra-indications)
and warnings (section 4.4 Special warnings and precautions for use). The
frequency and nature of examinations should be based on established practice

guidelines and be adapted to the individual woman. The woman should also be
instructed to carefully read the user leaflet and to adhere to the advice given.
Like many other steroids, Co-cyprindiol, when given in very high doses and
for the majority of the animal’s life span, has been found to cause an increase
in the incidence of tumours, including carcinoma, in the liver of rats. The
relevance of this finding to humans is unknown.
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 those contained in Cocyprindiol. If severe upper abdominal complaints, liver enlargement or signs
of intra-abdominal haemorrhage occur, a liver tumour should be included in
the differential diagnosis.
Pregnancy is an absolute contra-indication for treatment with Co-cyprindiol
and must be excluded before such treatment is begun (see section 4.6
‘Pregnancy and Lactation’ and section 4.3 ‘Contraindications’).
Co-cyprindiol is composed of the progestogen cyproterone acetate and the
oestrogen ethinylestradiol and is administered for 21 days of the monthly
cycle. It therefore has a similar composition to that of a combined oral
contraceptive (COC). The use of any COC or ‘Co-cyprindiol carries an
increased risk for venous thromboembolism (VTE), including deep venous
thrombosis and pulmonary embolism, compared with no use. The excess risk
of VTE is highest during the first year a woman ever uses a COC. This
increased risk is less than the risk of VTE associated with pregnancy, which is
estimated as 60 per 100,000 pregnancies.
Full recovery from such disorders does not always occur; VTE is fatal in 1-2%
of cases.
Epidemiological studies have shown that the incidence of VTE in users of oral
contraceptives with low oestrogen content (< 50µg ethinylestradiol) is up to 40
cases per 100,0000 women-years. This compares with 5-10 cases per 100,000
women-years for non-users.
Certain factors may increase the risk of venous thrombosis e.g. severe obesity
(body mass index >30 kg/m2), increasing age, a genetic predisposition to
clotting or a personal or family history of confirmed, idiopathic VTE (where
family history refers to VTE in a sibling or parent at a relatively early age, see
contraindications section 4.3). In addition, the risk of VTE may be
temporarily increased by prolonged immobilisation, major surgery, any
surgery to the legs, or major trauma (see “Reasons for stopping Co-cyprindiol
There is some epidemiological evidence that the incidence of VTE is higher in
users of Co-cyprindiol when compared to users of COCs with low oestrogen
content (<50µg).

The user group of Co-cyprindiol as a treatment for severe acne or moderately
severe hirsutism is likely to include patients that may have an inherently
increased cardiovascular risk such as that associated with polycystic ovarian
Epidemiological studies have also associated the use of COCs with an
increased risk for arterial (myocardial infarction, transient ischaemic attack)
thromboembolism. Certain factors such as smoking, obesity, cardiovascular
disease, hypertension, diabetes and migraine may increase the risk of arterial
thromboembolism. The risk of arterial thrombosis associated with oral
contraceptives increases with age, and this risk is aggravated by cigarette
An increased risk of cervical cancer in long-term users of combined oral
contraceptives has been reported in some studies, but there continues to be
controversy about the extent to which this is attributable to the confounding
effects of sexual behaviour and other factors.
The possibility cannot be ruled out that certain chronic diseases may
occasionally deteriorate during the use of the medicinal product (see
‘Precautions’ ).
A meta-analysis from 54 epidemiological studies reported that there is a
slightly increased relative risk (RR= 1.24) of having breast cancer diagnosed
in women who are currently using combined oral contraceptives (COCs). The
excess risk gradually disappears during the course of the 10 years after
cessation of COC use. Because breast cancer is rare in women under 40 years
of age, the excess number of breast cancer diagnoses in current and recent
COC users is small in relation to the overall risk of breast cancer. The
observed pattern of increased risk may be due to an earlier diagnosis of breast
cancer in COC users, the biological effects of COCs or a combination of both.
The breast cancers diagnosed in ever-users tend to be less advanced clinically
than the cancers diagnosed in never-users.
Use with caution in women with a family history of breast cancer. Women on
this therapy, particularly with fibrocystic disease of the breast, or with a family
history of breast cancer (first degree relatives) should have regular breast
examinations, including mammography.
The medicinal product contains lactose monohydrate/sucrose.
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this
medicinal product.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicinal product.

Herbal preparations containing St John’s wort (Hypericum perforatum) should
not be used while taking Co-cyprindiol due to the risk of decreased plasma
concentrations and reduced clinical effects of Co-cyprindiol (see section 4.5).
Reasons for stopping Co-cyprindiol immediately:

Occurrence for the first time, or exacerbation, of migrainous headaches
or unusually frequent or unusually severe headaches.

Sudden disturbances of vision, or hearing or other perceptual disorders.

First signs of thrombophlebitis or thromboembolic symptoms (e.g.
unusual pains in or swelling of the leg(s), stabbing pains on breathing or
coughing for no apparent reason). Feeling of pain and tightness in the chest.

Six weeks before an elective major operation (e.g. abdominal,
orthopaedic), any surgery to the legs, medical treatment for varicose veins or
prolonged immobilisation, e.g. after accidents or surgery. Treatment should
not be restarted until 2 weeks after full ambulation.
In case of emergency surgery, thombotic prophylaxis is usually indicated e.g.
subcutaneous heparin.

Onset of jaundice, hepatitis, itching of the whole body.

Increase in epileptic seizures.

Significant rise in blood pressure.

Onset of severe depression.

Severe upper abdominal pain or liver enlargement.

Clear worsening of conditions known to deteriorate during use of
hormonal contraception or during pregnancy.

Pregnancy is a reason for stopping immediately because it has been
suggested by some investigations that oral contraceptives taken early in
pregnancy may slightly increase the risk of foetal malformations. Other
investigations have failed to support these findings. The possibility therefore
cannot be excluded, but it is certain that if a risk exists at all, it is small.
The following conditions require careful observation during medicinal
product- a deterioration or first appearance of any of these conditions may
indicate that use of Co-cyprindiol should be discontinued: a history of severe
depressive states, varicose veins, diabetes, hypertension, epilepsy, otosclerosis,
multiple sclerosis, porphyria, tetany, disturbed liver function, gall-stones,
cardiovascular diseases, renal diseases, chloasma, uterine fibroids, asthma,
intolerance to contact lenses, history of phlebitis, Sydenham’s chorea, family

history of clotting disorders, obesity, SLE (systemic lupus erythematosus) and
migraine or any disease that is prone to worsen during pregnancy. Some
women may experience amenorrhoea or oligomenorrhoea after discontinuation
of Co-cyprindiol, especially when these conditions existed prior to use.
Women should be informed of this possibility.
It should be borne in mind that the use of ultraviolet lamps for the treatment of
acne, or prolonged exposure to sunlight, increases the risk of the deterioration
of chloasma.


Interaction with other medicinal products and other forms of interaction
Some medicinal products taken concurrently accelerate the metabolism of the
hormones and may reduce the contraceptive reliability of the medicinal product and
include barbiturates, anti-epileptics such as primidone, phenobarbitone, phenytoin and
carbamazepine, phenylbutazone, rifampicin, ampicillin, griseofulvin, Oxcarbazepin,
Topiramat, Felbamat, Ritonavir and other antibiotics. Oral tetracyclines, if used in
conjunction with the medicinal product, may have such an effect, although it has not
been shown. When medicinal products of these classes are being taken, it is,
therefore, advisable to use additional methods of contraception (excluding oral
contraceptives and other hormonal methods) since an extremely high degree of
protection must be provided when the medicinal product is being taken. With
rifampicin additional contraceptive precautions should be continued for 4 weeks after
treatment stops. The requirement for oral antidiabetics or insulin can change. MAO
(Monoamine-oxidase) inhibitors inhibit the metabolism of oestrogen which may
cause oestrogen induced undesirable effects.
The herbal preparation 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. Break through bleeding and unintended pregnancies have been
reported. This is due to induction of medicinal product metabolising enzymes by St
John’s wort. The inducing effect may persist for at least two weeks after cessation of
treatment with St John’s wort.
For women taking rifampicin, additional contraceptive precautions should be
continued for 4 weeks after treatment stops, even if only a short course was


Pregnancy and lactation
Studies in animals have shown effects on embryonal/foetal development, the potential
risk for humans is unknown (see section 5.3).
Co-cyprindiol is contraindicated in pregnancy (see section 4.3).
Pregnancy should be excluded before treatment is begun.
If pregnancy occurs during use of Co-cyprindiol the therapy should be discontinued
Cyproterone Acetate and Ethinylestradiol are excreted in breast milk (0.2% and
0.02% respectively).
Co-cyprindiol is contraindicated during lactation (see section 4.3).


Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been


Undesirable effects
Undesirable effects which have been seen in connection with the use of combined
oral contraceptive pill have also been experienced when taking Co-cyprindiol.
Around 10-30% of women can expect some undesirable effects during the first few
cycles of treatment. These include tension in the breast, nausea, vomiting, headaches,
changed body weight or libido and depressive moods. These initial undesirable
effects are often mild and usually disappear within 2-4 months of treatment.
The use of combined oral contraceptives (COCs) is associated with an increased risk
for venous (deep venous thrombosis, pulmonary embolism) and arterial (myocardial
infarction, transient ischaemic attack) thromboembolism (For more information
concerning VTE and other possible severe adverse events see Section 4.4).
Reduction of menstrual flow may occur. This is not abnormal and it is to be expected
in some patients.
If withdrawal bleeding does not occur, pregnancy must be excluded by a pregnancy
test after a suitable interval before a new course of tablets is started.
Very light ‘spotting’ or heavier breakthrough bleeding may occur during tablettaking, especially in the first few cycles. It appears to be generally of no significance
except where it indicates errors of tablet-taking, or where the possibility of interaction
with other medicinal products exists. However, if irregular bleeding is persistent, an
organic cause should be considered.
Transient liver function changes may occur; occasionally there may also be an
increased risk of thromboembolic processes and raised blood-pressure in women who

are predisposed to this. In some cases there has been a reduced tolerance to contact
lens wear. If lens tolerance changes, an ophthalmologist should be consulted.
The radio-iodine uptake shows that thyroid function is unchanged. There is a rise in
serum protein-bound iodine, similar to that in pregnancy and during the
administration of oestrogens. This is due to the increased capacity of the plasma
proteins for binding thyroid hormones, rather than to any change in glandular
function. In women taking the medicinal product, the content of protein-bound iodine
in blood serum should, therefore, not be used for the evaluation of thyroid function.
The medicinal product may accelerate erythrocyte sedimentation in the absence of
any disease. This effect is due to change in the proportion of the plasma protein
fractions. Increases in plasma copper, iron and alkaline phosphatase have also been

System organ class

>1/100, <1/10

Blood and
lymphatic -system

Endocrine disorders

Nervous system

• Depressive
• Change in libido

>1/1,000, <1/100
• Elevation of
blood pressure

Breast tension

• Decreased epiphora
• There have been isolated
reports of poor tolerance of
contact lenses in association
with oral contraceptives.

Eye disorders


Skin and
subcutaneous tissue

• Hypersensitivity
• Oedema
• Skin rashes

system and breast

• Intermenstrual
• Dysmenorrhoea
• Breast tenderness
• Breast pain

>1/10000, <1/1000
• Venous
thromboembolism (deep
venous thrombosis, pulmonary
• Arterial
(myocardial infarction,
ischaemic attack).
• Blood sedimentation rate
• Increase of serum copper,
serum ferrum & alkaline
• Decreased glucose
• Elevated blood sugar
• Increased insulin need
• Pancreatitis


• Reduction of
menstrual flow

• Reversible elevation of
transaminase levels
• Hepatitis
• Intrahepatic cholestasis
• Gallstones
• Benign liver adenoma
• Focal nodular hyperplasia
• Disorder of the
metabolism of folic acid or
tryptophane can occur
• Cholelithiasis
• Cholestasis (including
cholestatic jaundice)
• Liver tumours (following
long-term use
• In predisposed women,
Co-cyprindiol may cause
chloasma, which may be
exacerbated by exposure to
• Pruritus
• Alopecia

• Increased tendency to
vaginal candidiasis, nonspecific discharge

• Galactorrhoea
• Breast
General disorders
and administration
site conditions


• Change in bodyweight
• Headache
• Migraine

Fluid retention

There have been no reports concerning overdose, but, on general principles from a
knowledge of the pharmacological actions of the constituents of the medicinal
product, it would seem unnecessary to treat. There are no specific antidotes and
treatment should be symptomatic.
Symptoms of overdose are nausea, vomiting and withdrawal bleeding.




Pharmacodynamic properties
Pharmacotherapeutic group: Antiandrogens and estrogens, Cyproterone and estrogen
ATC code: G03HB01
Cyproterone Acetate possesses anti-androgenic and progestational activity. It blocks
androgen-receptors; it also reduces androgen synthesis by a negative feedback effect
on the hypothalamo-pituitary-ovarian systems. Sex hormone-binding globulin
(SHBG) levels are increased by the oestrogen component of the medicinal product,
thus reducing the free, circulating plasma levels of androgens. Unlike some other
progestogens, cyproterone acetate has no tendency to reduce SHBG levels. The
oestrogen component also acts as an oral contraceptive, with a mode of action similar
to those for oestrogens in general.
The results from epidemiological investigations have shown that the use of high
dosed combined oral contraceptives (50µg ethinylestradiol) lowers the risk of
endometrial and ovarian cancer. However, it has yet to be established whether the
beneficial effects also apply to the lower dose oral contraceptives.


Pharmacokinetic properties
Cyproterone Acetate

After oral administration of 2mg Cyproterone Acetate sugar-coated tablets, CPA is
completely absorbed. It is rapidly metabolised and slowly excreted in the faeces and
urine. Its terminal t½ after a single oral 50mg dose to healthy volunteers has been
reported to be between 38h (radioimmunoassay) and 39h (total radioactivity)
although a terminal half-life in healthy volunteers of up to 100 hours has also been
Cyproterone Acetate is metabolised first by hydrolysis to free cyproterone, then by 15
β-hydroxylation to 15-hydroxycyproterone. This metabolite has 10% of the
progestational activity of Cyproterone Acetate but has similar anti-androgenic
activity. Excretion is effected slowly via the kidneys and faeces.

Ethinylestradiol is rapidly and almost completely absorbed from the gastro-intestinal
tract, but is to a certain degree subject to a first-past metabolism in the intestine wall.
Bioavailability amounts to approximately 40%. Maximum plasma concentrations are
achieved 1-2 hours after oral application. Ethinylestradiol accumulates in the body
fat and endometrium. The reported (half-life t½) varies from 6 to 30 hours. In
comparison to other oestrogens it is only metabolised slowly in the liver. It is
conjugated with glucuronic acid and sulphate. Ethinylestradiol is subject to a clear
enterohepatic cycle. 60% of excretion is effected via the kidneys and 40% via faeces.


Preclinical safety data
In laboratory animals, most of the effects of cyproterone acetate following repeated
administration are related to the anti-androgenic and progestagenic actions of the
medicinal product. In rat and mouse studies, cyproterone acetate produced an
induction of liver enzymes and liver hypertrophy.
The potentially sensitising effect of ethinylestradiol and cyproterone acetate has not
been studied in animals.
Acknowledged first-line genotoxicity tests, carried out with cyproterone acetate,
usually showed negative results. Other tests, however, showed that cyproterone
acetate is able to produce DNA-adducts (and to increase the DNA-recovery activity)
in liver cells of rats and monkeys, as well as in freshly isolated humane hepatocytes.
This DNA-adduct formation was found in exposures expected to occur in the
recommended dosages for cyproterone acetate. An in vivo consequence of
cyproterone acetate treatment in the rat was the increased incidence of focal, possibly
preneoplastic liver impairments, in which cellular enzymes in female rats were
The clinical significance of these findings is uncertain at the moment. So far no
indications exist that the incidence of liver tumours in man is increased.
In long-term studies in mice and rats cyproterone acetate enhanced the incidences of
tumours of the pituitary, liver and/or mammary gland. Long-term treatment with
ethinyl estradiol can also enhance the incidences of certain neoplasms in laboratory
animals. The clinical relevance with respect to low-dose treatment with cyproterone
acetate and ethinyl estradiol is, however, questionable.
Animal studies have revealed that feminisation of male foetuses may occur if
cyproterone acetate is administered during the phase of embryogenesis at which

differentiation of the external genitalia occurs. Although the results of these tests are
not necessarily relevant to man, the possibility must be considered that administration
of Co-cyprindiol to women after the 45th day of pregnancy could cause feminisation
of male foetuses. It follows from this that pregnancy is an absolute contra-indication
for treatment with the Co-cyprindiol, and must be excluded before such treatment is
begun (for further information see Sections 4.3 and 4.4).




List of excipients
Tablet Core
Lactose monohydrate
Maize starch
Povidone K25
Magnesium stearate
Tablet Coating
Povidone 700 000
Macrogol 6000
Calcium carbonate
Glycerol 85%
Titanium dioxide (E171)
Iron oxide yellow (E172)
Montanglycol wax


Not applicable


Shelf life
3 years.


Special precautions for storage
Do not store above 25°C. Keep blister in the outer carton.


Nature and contents of container
Polyvinylchloride blisters sealed onto aluminium foil.
Pack sizes
21 and 63 (3x21) tablets. Calendar pack. Not all pack sizes may be marketed


Special precautions for disposal
No special requirements.


Generics (UK) Limited
Station Close, Potters Bar
United Kingdom


PL 04569/0486


05/07/2001 / 04/07/2006



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