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DIALIDER FILM-COATED TABLETS

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DIALIDER FILM-COATED TABLETS
2mg Cyproterone acetate/35 micrograms Ethinylestradiol
Patient Information Leaflet (UK)

Please read all of this leaflet carefully before you start taking this medicine
 Keep this leaflet you may need to read it again.
 If you have further questions, please ask your doctor or your pharmacist.
 This medicine has been prescribed for you personally and you should not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
Contents
1.
2.
3.
4.
5.

What Dialider is and what it is used for
Before you take Dialider
How to take Dialider
Possible side effects
Storing Dialider

The name of your medicine is:
Dialider Film-coated tablets

What does Dialider contain?
The active substances are cyproterone acetate 2 mg and ethinylestradiol 35 micrograms.
The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K-30,
croscarmellose sodium and magnesium stearate in the tablet cores. Hypromellose, titanium
dioxide (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), iron oxide
yellow (E172), iron oxide red (E172), iron oxide black (E172), eurolake quinoline yellow (E104),
shellac, carnauba wax yellow, beeswax white and sucrose in the tablet coating.
Each pack of Dialider contains blister strips of 21 yellowish coloured, film-coated tablets (pills).
Marketing Authorisation Number: PL 35667/0001
Marketing Authorisation Holder: FARMALIDER S.A., C/ Aragoneses Nº 15, ES-28108 Alcobendas
(Madrid), Spain
Manufacturer:
Industrial Farmacéutica Cantabria, S.A., Carretera de Cazaño-Adarzo, s/n, 39011, Santander
Toll Manufacturing Services, S.L., C/ Aragoneses 2, 28108 Madrid, Spain
1. What Dialider is and what it is used for
Dialider is composed of the progestogen cyproterone acetate (an anti androgen) and the estrogen
ethinylestradiol. It therefore has a similar composition to that of a combined oral contraceptive.
Dialider is used to treat androgen-dependent diseases in women such as acne, especially
pronounced forms and those which are accompanied by seborrhoea or by inflammation or

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formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia and mild
forms of hirsutism.
Dialider is also indicated for oral contraception in women requiring treatment for these androgendependent diseases; it is not recommended in women solely for contraception.
It is recommended that treatment with Dialider is stopped 3 to 4 cycles after the condition(s) have
completely cleared and that Dialider is not continued solely to provide oral contraception. If the
conditions recur, further courses of Dialider may be given.
How Dialider works
In addition to female sex hormones (estrogens) your body also makes male sex hormones
(androgens). Your ovaries have to make androgens so that they can be changed into estrogens.
Androgens stimulate the growth of the skin, including the grease-glands and hairs that grow from
them. They also cause the grease-glands to make large amounts of “sebum”, the greasy substance
which gives you a greasy skin. If your body produces too much androgen or if your skin is
particularly sensitive to the effects of androgens, the grease-glands may produce too much sebum.
This can lead to blockage of the grease-glands which can then become infected and inflamed
causing acne spots. Androgens may also cause more growth of hair on the face and body.
In order to work, hormones need to become attached (like a key in a lock) to their own receptors in
the tissues where they are meant to work. The main ingredient in this medicine, cyproterone
acetate, attaches itself to androgen receptors in the skin and blocks them (like the wrong key
jammed in a lock) so that the androgens cannot affect the skin. This causes the body to produce
smaller amounts of androgens and also blocks the actions of those that are still produced so that
they cannot affect the skin.
Contraception
As with ordinary oral contraceptives, Dialider prevents the release of eggs (ova). It also makes the
mucus in the neck of the womb thick so that sperm cannot get through and makes the lining of the
womb unsuitable for an egg to grow on.
As it prevents pregnancy as well as any ordinary combined contraceptive pill (one of the most
effective methods of contraception), you should not use an additional hormonal contraceptive pill
as this will expose you to an excessive dose of hormones which is not necessary for effective
contraception. You do not need to use another contraceptive method to prevent pregnancy while
taking this medicine, except as described under “what to do if you forget to take a pill and are
relying on Dialider for contraceptive cover”, “stomach upsets” and “taking other medicines with
Dialider”.

2. Before you take Dialider
Do not use Dialider
You must not take this medicine if you:
 are pregnant, or think you may be pregnant (see also the section “warnings”)
 have had any of the following conditions when you were pregnant:
 itching of your whole body (pruritus of pregnancy)
 the rash known as herpes gestationis
 worsening of inherited deafness (otosclerosis)
 yellowing of the skin (jaundice),

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have a family history where brothers, sisters or parents have had blood clots occurring in veins
at a relatively early age
have blood clots in your legs, lungs, eyes or anywhere else
have or have had a heart attack or stroke or if you have any medicinal condition which puts
you more at risk of developing these diseases (e.g. angina pectoris). See the section
“warnings”.
have any medical condition which puts you more at risk of developing blood clots. See
“warnings” for conditions which increase the risk of developing blood clots.
have abnormal red blood cells (sickle cell anaemia)
have disorders of blood fat (lipid) metabolism
have or suspect to have hormone-dependent tumours (e.g. mammary or endometrial cancer) or
have ever had either of these conditions
have any unexplained, abnormal bleeding from your vagina
have diabetes with blood vessel disease
have or have had severe liver disease
have or have had liver tumours
are allergic to any of the ingredients in Dialider
have migraine, which is accompanied by disturbance of sensation and perception
have severe high blood pressure
are smoking (see the section “warnings”).

Take special care with Dialider
Before you start taking Dialider, your doctor should take a medical history by asking you some
questions about yourself and also about other members of your family. Your doctor should also
ask you these questions on a regular basis, for example when you come back to see your doctor for
more pills. Your doctor will also take your blood pressure and may check your breasts, abdomen
and pelvic organs if this is considered necessary. You may also need to have a cervical smear test.
The doctor will also make sure you are not pregnant.
Reasons for stopping Dialider immediately
If you experience any of the following conditions take no further Dialider pills and consult your
doctor immediately. In the meantime use another method of contraception such as a condom.











Migraine for the first time, or if existing migraine occurs more often than before (this might be
a prodromal stage of a cerebral blood vessels disease)
unusually bad headaches or if you have headaches more often than before
sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch
dizziness, fainting or problems with movement
unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or
sudden shortness of breath, crushing pains or feelings of heaviness in your chest, coughing for
no apparent reason or if one side of your body suddenly becomes very weak or numb. These
may be symptoms of blood clot formation or symptoms of an inflammation of veins combined
with the formation of blood clots (thrombophlebitis)
your skin becomes yellow (jaundice), you develop hepatitis (inflammation of the liver) or your
whole body starts itching
an increase in the number of fits (epileptic seizures)
a large increase in your blood pressure
bilious complaints (cholestasis)

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severe depression
severe upper abdominal pains or unusual swelling of your abdomen
definite worsening of conditions which had got worse during a previous pregnancy or while
taking the oral hormonal contraceptive pill in the past
pregnancy
surgery or immobilisation. You must stop Dialider six weeks before a planned major operation
(e.g. stomach surgery), if you are having any surgery to the legs, or medical treatment for
varicose veins. Also if you are immobilised for a long time (e.g. you are in bed after an
accident or operation or you have a plaster cast on a broken leg). Your doctor will advise you
when to start taking Dialider again.

Tell your doctor as soon as you can if:
If anyone in your family has had any illness caused by blood clots, or a heart attack, or a stroke at
a young age, tell your doctor.
The following conditions need to be monitored carefully while you are taking Dialider. If any of
these conditions gets worse or you have them for the first time this may be a sign that you should
stop taking this medicine. If any of these conditions do get worse tell your doctor as soon as you
can.
 Diabetes (diabetes mellitus) or a tendency towards diabetes
 high blood pressure (hypertension)
 varicose veins
 the inherited form of deafness known as otosclerosis
 the disease of the nervous system called multiple sclerosis
 fitting (epilepsy)
 the inherited disease called porphyria
 calcium deficiency with cramps (tetany)
 disturbed liver function
 the movement disorder called Sydenham’s chorea
 kidney diseases
 you are overweight (obese)
 breast problems, past or present
 depression, past or present
 systemic lupus erythematosus – SLE (inflammation of connective tissue)
 uterine fibroids (benign tumours of the womb)
 an intolerance to contact lenses
 migraine
 gallstones
 diseases of the heart and blood vessels (cardiovascular disease)
 brown patches on the face and body (chloasma)
 asthma
 any disease that is prone to worsen during pregnancy
or if:
 you have had inflamed veins (phlebitis)
 anyone in your family has had breast cancer
 anyone in your family has had any illness caused by blood clots, or a heart attack or stroke at a
young age.
What else you need to know
Dialider does not protect against HIV infections (AIDS) and other sexually transmissible diseases.

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Reduced efficacy
Dialider is an effective contraceptive if you take it regularly. Your contraceptive protection may
be reduced if you are missing a pill or you are vomiting or have very bad diarrhoea. The intake of
some medicines may stop Dialider working properly as a contraceptive.
Reduced cycle control
Bleeding and spotting between your periods can sometimes occur for the first few months but this
usually stops once your body has adjusted to Dialider. If it continues, becomes heavy or starts
again, contact your doctor.
Occasionally you may miss a period. This could mean that you are pregnant, but that is very
unlikely if you have taken your pills correctly. If you have not taken Dialider correctly or if you
have no bleeding in the 7 day break within two courses of Dialider tell your doctor as soon as
possible and do not start another course until your doctor tells you to.
When you stop taking this medicine it may take some time for your regular periods to return.
Sunbeds/Sun-ray lamps (ultraviolet)
Ultraviolet lamps are used by some women for acne as well as to tan the skin. Ultraviolet lamps
and prolonged sunbathing should be avoided if you are taking Dialider as their use increases the
chances of a patchy discolouration of the skin (chloasma) as also occurs with ordinary oral
contraceptives
Before you have any blood tests
Tell your doctor or laboratory staff that you are taking Dialider, because Dialider can affect the
results of some tests.
Using Dialider with food and drink
It is not expected that food or drink will affect the absorption of the hormones from Dialider.
Pregnancy
Do not use Dialider if you are pregnant (see also the section “Do not use Dialider”).
If you think you might be pregnant, stop taking Dialider and talk to your doctor immediately.
Until you have spoken to your doctor, use another method of contraception such as a condom or a
cap plus spermicide.
Breast-feeding
Do not use Dialider until you have completely stopped breast-feeding because it passes into breast
milk and could affect the baby.
Driving or using machines
You can drive and operate machinery while you are taking Dialider.
Important information about some of the ingredients of Dialider
Dialider contains lactose and sucrose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
Taking other medicines with Dialider
Some medicines may stop Dialider working properly as a contraceptive. If you are taking any
other medicines while you are relying on Dialider for contraception, be sure to tell your doctor (or
dentist). Your doctor (or dentist) can tell you whether you should use extra contraceptive
precautions and for how long.

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Medicines which can sometimes stop Dialider from working properly are antibiotics (such as
ampicillin and rifampicin or from the class of tetracyclines); griseofulvin (which is used to treat
fungal infections); phenylbutazone (which is used as an anti-inflammatory medicine to treat some
types of joint diseases); phenytoin, primidone, phenobarbitone and some other medicines used in
people with epilepsy, and carbamazepine (which can be used to treat epilepsy or other illnesses).
If you are relying on Dialider for contraception and you are taking any of these medicines you will
also need to use an extra contraceptive method (condoms or cap plus spermicide) while you are
taking the other medicine and for 7 days after you stop taking it. If your present course ends before
these 7 days, start the next course the next day without a break. If you run two courses together
you may not have a period until the end of the second course, but this is not harmful. If you do not
have a period after the second course, you must talk to your doctor before you start the next
course.
If your doctor prescribes oral antibiotics as well as this medicine for the treatment of your acne,
you must make it clear to your doctor if you want to rely on this medicine for contraception.
Medicines applied to the skin, including antibiotics, will not affect the contraceptive reliability of
Dialider.
If you are taking rifampicin, and you are relying on this medicine for contraception, you will need
to use another method of contraception as well as Dialider. You should do this while you are
taking the rifampicin and for 4 weeks after you stop.
Some medicines used to treat certain types of heart disease or vein thrombosis (blot clot in the
leg), high lipid blood level, high blood pressure (hypertension), depression, diabetics, can also be
affected by Dialider. If you are taking any other medicines to treat these conditions, tell your
doctor or pharmacist.
If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.
The herbal remedy, St John’s wort (Hypericum perforatum) should not be taken at the same time
as Dialider. If you already take a St John’s wort preparation, stop taking the St John’s wort and
mention it to your doctor at your next visit.
If you are in doubt, check with your doctor or pharmacist.
Warnings
Pregnancy
Androgens (male sex hormones) are necessary for the development of the sexual organs in males,
and the strong action of cyproterone acetate (contained in Dialider) against androgens has been
found to prevent the normal development of these organs during pregnancy in experimental
animals. The degree of risk in humans of such an effect (known as ‘feminisation’) is uncertain and
for this reason it is absolutely essential that you should not be pregnant while taking Dialider. If
you think you might be pregnant, stop taking Dialider and consult your doctor immediately. Use
another method of contraception such as a condom until you see your doctor.
The pill and thrombosis
As Dialider contains the progestogen (cyproterone acetate) and the estrogen (ethinylestradiol) and
is administered for 21 days of a monthly cycle, it has a similar composition to that of a combined
oral contraceptive pill (combination of two hormones). The use of any combined oral
contraceptive pill or Dialider carries an increased risk of developing various disorders of the
circulation of the blood including deep vein thrombosis (blood clot in the leg) and pulmonary

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embolism (blood clots in the lungs), compared to no use of these products. The increased risk of
blood clots is highest during the first year a woman ever uses a combined oral contraceptive. This
increased risk is less than that associated with pregnancy which is estimated as 60 cases per
100,000 pregnancies.
Full recovery from such disorders does not always occur and blood clots are fatal in 1-2% of cases.
Studies have shown that the incidence of blood clots in users of oral contraceptives which have a
low estrogen content (<50 micrograms ethinylestradiol) is up to 40 cases per 100,000 women years
in comparison to 5-10 cases per 100,000 women years for non-users.
There is some statistical evidence that the incidence of blood clotting disorders is higher in users
of Dialider when compared to users of combination oral contraceptive pills having a low estrogen
content. One reason for this may be that the group using Dialider is likely to include patients that
may have an increased cardiovascular risk such as that associated with polycystic ovarian
syndrome.
The risk of venous thrombolism (blood clots) increases with:
 obesity
 increasing age
 if any members of your family (brothers, sisters or parents) have suffered from
thromboembolic disease (eg deep vein thrombosis, stroke or heart attack) at a young age. In
this case you should be referred to a specialist for advice before deciding about any hormonal
contraceptive use.
 a major operation, any surgery to the legs, a major accident or period of prolonged
immobilisation (eg you are in bed after an accident or operation or you have a plaster cast on a
broken leg)
The risk of arterial thromboembolic complications (e.g. heart attack and stroke) increases with:
 smoking (the risk further increases with heavier smoking and increasing age, especially in
women over 35 years of age)
 obesity
 valvular heart diseases
 fibrillation of the heart
 high blood pressure
 diabetes
 migraine
 increasing age
 if any members of your family (brothers, sisters or parents) have suffered from arterial
thrombosis at a young age. In this case you should be referred to a specialist for advice before
deciding about any hormonal contraceptive use.
Signs and symptoms of venous or arterial thrombosis can include:
 unusual pains in and/or swelling of your legs
 sudden severe pain in your chest (whether or not it radiates to the left arm)
 sudden shortness of breath
 sudden onset of coughing
 any unusual, severe, prolonged headache
 sudden partial or complete loss of vision
 double vision
 disturbance of speech
 vertigo

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physical breakdown with or without focal seizure
weakness or very marked loss of feeling suddenly affecting one side or one part o he body
motor disturbance
pain in the stomach.

If any of these conditions apply to you before you decide to take this medicine or while you are
taking it you must discuss them with your doctor.
The pill and cancer
The pill does give a substantial degree of protection against cancers of the ovary and the lining of
the womb. An increase in the risk of cervical cancer in long-term users of the pill has been
reported in some studies. It is uncertain whether this increased risk is caused by the pill as it could
be due to the effects of sexual behaviour and other factors.
Breast Cancer
Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare
under the age of 40 years but the risk increases as a woman gets older. Breast cancer has been
found slightly more often in women who take the pill than in women of the same age who do not
take the pill. If women stop taking the pill this reduces the risk so that 10 years after stopping the
pill, the risk of finding breast cancer is the same as for women who have never taken the pill.
Breast cancer seems less likely to have spread when found in women who take the pill than in
women who do not take the pill.
It is not certain whether the pill causes the increased risk of breast cancer. It may be that women
taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding
breast cancer is not affected by how long a woman takes the pill but by the age at which she stops.
This is because the risk of breast cancer strongly increases as a woman gets older.
Whilst there is the small extra risk of finding breast cancer in each age group, this small possible
additional risk in women who take the Pill has to be balanced against the fact that the Pill is a very
effective contraceptive and it may also help prevent cancer of the womb or ovary.
Liver tumours
On rare occasions, the use of the pill has led to liver diseases such as jaundice and benign liver
tumours, and very rarely, it has been associated with some forms of malignant liver tumours
(cancer) in long-term users. Liver tumours may lead to life-threatening intra-abdominal
haemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that
does not clear up quickly, tell your doctor. Also, if your skin becomes yellow (jaundice) you must
tell your doctor.
Certain conditions may sometimes get worse during use of the pill. The diseases are those listed
under ”Tell your doctor as soon as you can if”.

3. How to take Dialider
If you are relying on this medicine for contraception, it is important that you follow these
instructions carefully and read the section on contraception. The pack is designed to help you
remember to take your pills.
Always take Dialider exactly as your doctor tells you.

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Dialider is an effective oral contraceptive. The contraceptive action starts with the intake at the
first day of the menstrual cycle. You will not have to take extra contraceptive precautions during
the seven-day break from taking the pill, as long as you have taken your pills correctly.
While you are taking this medicine, you should not take any other oral contraceptive pill.
If you want to get pregnant, you should not take this medicinal product.
When to start
If you are new to Dialider or are starting it again after a break, take your first pill on the first day of
bleeding of your next period. For other users, follow the instructions for “Changing from another
type of oral contraceptive”, “Starting Dialider after having a baby” or “Starting Dialider
after a miscarriage or an abortion”.
Start with a pill marked with the correct day of the week. For example, if your period starts on a
Tuesday, start with a pill marked “Tue”
If you have amenorrhoea you can start Dialider on any day.
Taking your first course of Dialider:
After taking your first pill, take one pill each day. Follow the direction of the arrows on the foil,
until you have finished all 21 pills in the pack. By starting in this way you will have contraceptive
protection at once.
Your seven pill-free days:
After you have taken all 21 pills, you have 7 days when you take no pills. A few days after you
have taken the last pill from each course, you will have a period. Your periods will be regular,
probably lighter than before and almost always painless. The feelings that often make the last days
before a period unpleasant (called premenstrual syndrome) usually disappear. You are very
unlikely to become pregnant during the 7 day break from taking the pill, as long as you have taken
your pills correctly, and start the next course on time.
Subsequent courses:
Each subsequent course is started after 7 pill-free days have followed the preceding course. Each
new course will begin on the same day of the week as the one before, so it is easy to remember
when to start the new course. You should start taking your next course after the 7 pill-free days,
even if you are still bleeding.
Changing from another type of oral contraceptive
Changing from a 21-day combined oral contraceptive:
If you are taking a 21-day contraceptive pill, finish that pack and then start taking Dialider the next
day. You may also keep to your usual seven pill-free days and then start taking Dialider the next
day. Start with a pill marked with the correct day of the week and take one pill daily. You must
use an extra method of contraception such as condom or cap plus spermicide until you have taken
the first seven pills correctly. You may not have a period until the end of the first Dialider pack,
but this is not harmful. You may have some bleeding on pill-taking days, but do not worry.
Changing from a combined Every Day pill (28-day pill):
Dialider should be started after taking the last active pill from the Every Day pill pack or after
taking the last pill from the Every Day pack (this might include the inactive tablets). If you are not
sure which pills are the active ones, ask your doctor or pharmacist. The first Dialider pill is taken

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the next day. Start with a pill marked with the correct day of the week and take one pill daily.
Return to your pharmacist any remaining inactive pills from your old Every Day pack. You must
use an extra method of contraception such as condom or cap plus spermicide until you have taken
the first seven pills correctly. You may not have a period until the end of your first course of
Dialider, but this is not harmful. You may have some bleeding on pill-taking days, but do not
worry.
Changing from a progestogen-only contraceptive:
Mini pill (progestogen-only pill)
You can stop taking the mini pill on any day and start taking Dialider the next day. Return to your
pharmacist any mini pills left in your old pack. Start with a pill marked with the correct day of the
week and take one pill daily. You must use an extra method of contraception such as condom or
cap plus spermicide until you have taken the first seven pills correctly.
Contraceptive injection or implant
If you have an injection of the hormone progestogen, you can start taking Dialider on the next day
that your injection is due, or on the day your implant is removed. Start with the pill marked with
the correct day of the week and take one pill daily. You must use an extra method of
contraception such as condom or cap plus spermicide until you have taken the first seven pills
correctly.
Starting Dialider after having a baby
If you have just had a baby, your doctor will advise you when to start taking Dialider and may
advise you to start taking Dialider about 21 to 28 days after delivery. You do not need to wait for
a period. .By starting this way, you will have contraceptive protection at once. Start with the pill
marked with the correct day of the week and take one pill daily.
If you start taking Dialider more than 28 days after you have had your baby, you must use an extra
method of contraception such as a condom or a cap plus spermicide until you have taken the first
seven pills correctly. Start with the pill marked with the correct day of the week and take one pill
daily.
If you have already had sex, you will have to wait until you have a period before you start taking
Dialider. This is to make sure that you aren’t pregnant again. You must use an extra method of
contraception such as a condom or a cap plus spermicide, until you start taking Dialider.
You must not breast feed if you take Dialider.
Starting Dialider after a miscarriage or abortion
If you have just had a miscarriage or an abortion during the first three months of your pregnancy
(also known as the first trimester), your doctor will advise you when to start taking Dialider and
may advise you to start using Dialider immediately. This means that you will have contraceptive
protection at once. Start with the pill marked with the correct day of the week and take one pill
daily.
If you have just had a miscarriage or an abortion during the middle (fourth to six) months of your
pregnancy (also known as the second trimester), your doctor may tell you to start taking Dialider
21 to 28 days after the event. By starting this way, you will have contraceptive protection at once.
Start with the pill marked with the correct day of the week and take one pill daily.
If you start taking Dialider more than 28 days after you have had a second trimester miscarriage or
abortion, you must use an extra method of contraception such as a condom or a cap plus

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spermicide until you have taken the first seven pills correctly. Start with the pill marked with the
correct day of the week and take one pill daily.
If you have already had sex, you will have to wait until you have a period before you start taking
Dialider. This is to make sure that you aren’t pregnant again. You must use an extra method of
contraception such as a condom or a cap plus spermicide, until you start taking Dialider.

While you are taking Dialider:
What to do if you forget to take a pill and are relying on Dialider for contraceptive cover
If one pill is 12 hours late or less
Don’t worry. Contraceptive protection should not be affected if you take the late pill at once, and
keep taking your next pills at the usual time.
If you are more than 12 hours late in taking a pill, or have missed more than one pill
Contraceptive protection may be lower, so you must use extra protection Take the most recent
missed pill as soon as you remember, and then keep taking your next pills at the usual times (do
not try and “catch up” more than one missed dose). Use an extra contraceptive method (condoms
or cap plus spermicide) for the next 7 days.
If your present course ends before the 7 days do, start the next course the next day, without a
break. This means taking a pill every day during your normal 7 pill-free days. You will not have
a period until you have finished the next course, but this is not harmful. You may see some
bleeding on pill-taking days, but do not worry. If no bleeding occurs in the 7 day break see your
doctor as soon as possible. Until you see your doctor do not have sex unless you use condoms or a
cap plus spermicide.
If you have missed more than seven pills ask your doctor when to start taking Dialider again.
Stomach Upsets
If you are sick (vomiting) and/or have diarrhoea within 3 to 4 hours of taking a pill, your
contraceptive protection could be affected. This is like missing a pill. If your symptoms stop
within 12 hours of taking a pill, just take an extra pill from a spare pack of Dialider and keep
taking your next pills at the usual time. In this case your contraceptive protection should not be
affected.
If the upset lasts longer than 12 hours, and you are relying on this medicine for contraception,
carry on taking it as usual, and also use another method of contraception (condoms or cap plus
spermicide), until 7 days after you have recovered from the stomach upset. If you finish your
course before these 7 days, start the next course the next day without a break. If you run two
courses together you may not have a period until the end of the second course, but this is not
harmful. If you do not have a period after the second course, you must talk to your doctor before
starting the next course. If your stomach upset continues for some time, consult your doctor who
may consider another form of contraception.
What to do if you miss a period
If you have no bleeding in the 7 day break, whether you have missed pills or not, tell your doctor
as soon as possible and do not start another course until your doctor tells you to. In the meantime,
do not have sex unless you use condoms or a cap plus spermicide.
What if you have bleeding between periods?

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A small number of women may have a little breakthrough bleeding or spotting while taking this
medicine, especially during the first few months. Normally, this bleeding is nothing to worry
about, and will stop in a day or two. Keep taking the pills as usual, and the problem should
disappear after the first few courses.
If the bleeding keeps on returning, is annoying or long-lasting, talk to your doctor. Also, if you
start to have breakthrough bleeding for the first time after being on this medicine for a long time,
you should see your doctor.
Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pills at the
same time every day.
What should you do if you lose a pill?
If you lose a pill, the easiest thing to do is to take the last pill of the course in place of the lost pill.
Then take the rest of the pills on their proper days. Your cycle will be one day shorter than
normal, but contraceptive protection is not affected. After your 7 pill-free days you will have a
new starting-day, one day earlier than before. Should you lose a pack of pills halfway through, ask
your doctor or pharmacist what to do.
What if you want to have a baby?
The bleeding you have after each course is not a true period. Your doctor relies on the date of
your last true period before you get pregnant to tell you when your baby will be born. So, if you
stop taking Dialider to have a baby, use another method of contraception until you have had a true
period. However, it will not be harmful if you become pregnant straight away.
How to take Dialider
You have to take the pill at the same time every day, for example, after breakfast. Swallow each
pill whole, and with some fluid. Do not chew the pill.
How long can you take Dialider?
Your doctor may advice you to take Dialider for several months and may advice you to continue
the treatment for at least 3 or 4 further courses after your skin is completely clear, or the amount of
body and facial hair growth has decreased.
If you don’t see a definite improvement in acne after about six months of taking this medicine your
doctor will decide if you should continue the treatment with Dialider. If you are taking this
medicine to treat excessive hair growth on your body or face, you should see a definite
improvement within twelve months. If you don’t see a definite improvement, your doctor will
decide if you should continue the treatment with Dialider.
Overdosage
Overdosage may cause nausea, vomiting and in females, withdrawal bleeding. You should consult
your doctor who will be able to advise you what action, if any, is necessary.
4. Possible side effects of Dialider
Sometimes unwanted effects occur with Dialider. These can be mild or serious.

13

Mild reactions
Sometimes mild unwanted effects can occur in the first few months after starting Dialider.









Bleeding and spotting between your periods can sometimes occur for the first few months but
this usually stops once your body has adjusted to Dialider. If it continues, becomes heavy or
starts again, contact your doctor.
Headaches,
Feeling sick (nausea), being sick (vomiting) and stomach upsets,
Sore breasts,
Depressive moods, loss of interest in sex,
Changes in weight,
Yellow brown patches on the skin (chloasma). This may happen even if you have been using
Dialider for a number of months. Chloasma may be reduced by avoiding too much sunlight.
Poor tolerance to contact lenses.

Serious reactions
More serious reactions have sometimes been associated with contraceptive pills that contain
estrogen and progestogen, for example thrombosis (the formation of a clot in blood vessels) or
liver disease. There is an increased risk of the formation of blood clots in veins for all women who
used Dialider. See the Warnings section for a more complete explanation of this.
Although, severe depression is not considered a direct side effect of Dialider, you should stop
Dialider as a precaution, if you develop severe depression.
If you think that you have a serious adverse reaction to Dialider, stop taking your pills and
consult your doctor as soon as possible.
Remember that when you stop Dialider you will need to use another contraception method if you
want to avoid pregnancy.
If you think you have an unwanted effect due to Dialider, even if it is not included in this leaflet,
tell your doctor or a pharmacist about it.
Effect on blood tests
The use of this medicine may affect the results of certain laboratory tests. Always tell your doctor
or the laboratory staff that you are using Dialider.
5. Storing Dialider
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date (EXP) shown on the outer pack.
This leaflet was last revised in February 2011

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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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