Dilena Tablets
What you should know about Dilena Tablets
Before you start to take this medicine please read this
leaflet carefully. If you have any questions or worries,
ask your doctor or pharmacist.
What is in your medicine?
The name of your medicine is Dilena.
Each strip contains eleven white tablets and ten blue
tablets. Both the white tablets and the blue tablets
contain 2 mg oestradiol valerate (an oestrogen). The
blue tablets also contain 10 mg medroxyprogesterone
acetate (a progestogen).
Other ingredients: Dilena tablets also contain the
following inactive ingredients: Lactose, corn starch,
gelatine, talc and magnesium stearate. The blue tablets
also contain polyvinylpyrrolidone K25 and indigo carmine
(E132).
Each strip contains eleven white tablets and ten blue
tablets.
Each carton contains either 1 or 3 foil strips of 21
tablets.
Dilena belongs to a group of medicines used in
Hormone Replacement Therapy (HRT).
Authorisation holder: The product licence for Dilena is
held by: Organon Laboratories Ltd, Science Park, Milton
Road, Cambridge, CB4 4FL.
Dilena is manufactured by: Orion Pharmaceutica, PO
Box 65 SF-02101, Espoo, Finland.
What this medicine is used for
Dilena is used to relieve the symptoms of the
menopause and prevent osteoporosis after the
menopause. It can also relieve these symptoms of the
menopause in women who have had their ovaries
removed.
How this medicine works
Dilena contains an oestrogen (oestradiol valerate) and a
progestogen (medroxyprogesterone acetate).
Oestrogens are mainly produced by the ovaries. They
are necessary for the normal sexual development of
women and to regulate the menstrual cycle during the
child bearing years. When women get older the ovaries
gradually produce less oestrogen. The period in which
this happens (usually around the age of 50) is called the
climacteric or menopause. If the ovaries are removed
surgically (oopherectomy) before the menopause, the
decrease in oestrogen production occurs very abruptly.
Shortage of oestrogen leads to complaints such as hot
flushes and night sweating. The vaginal wall may
become thin and dry, so sexual intercourse may be
painful. Vaginal infections can also occur. Some women
feel depressed and lose their sex drive. These
complaints can often be relieved by using medicines
containing oestrogen such as Dilena.
The blue tablets contain a progestogen to give you a
regular monthly bleed.
The shortage of oestrogen may cause thinning of
bones (osteoporosis). Other factors that contribute to
osteoporosis are early menopause, family history of
osteoporosis, recent corticosteroid therapy, a small body
frame, thinness and cigarette smoking. Over the years
the bones become brittle and break easily. Dilena can
also prevent osteoporosis.
When not to take Dilena
Dilena should not be taken by women who are pregnant.
 Do you have any disorders of the heart or the blood
circulation?
 Have you ever had a blood clot, or phlebitis?
 Do you suffer from liver or kidney disease?
 Are you suffering from cancer of the breast or
endometrium?
 Do you suffer from endometriosis?
 Do you suffer from a rare liver disorder such as Rotor
 Have you had jaundice or loss of hearing during
pregnancy?
 Do you suffer from vaginal bleeding?
 Do you suffer from diabetes?
If the answer is YES to any of these questions D0
NOT take the medicine, see your doctor.
Precautions and possible problems
While you are taking Dilena it is important to see your
doctor every 6-12 months for a check up. Normally you
will have a monthly period while taking Dilena. If you
notice any unusual vaginal bleeding tell your doctor at
once.
Interactions
Other medicines may influence the effects of Dilena or
vice versa. Tell your doctor if you are taking other
medicines.
Dilena may decrease the effect of the following
medicines:
 drugs used to treat high blood pressure
(antihypertensives)
 drugs used to treat diabetes (antidiabetics)
 drugs used to treat blood clots (oral anticoagulants)
 Similarly the following drugs may decrease the effect
of Dilena:
 Drugs sometimes used to treat sleeplessness or
epilepsy (barbiturates)
 Antibiotics such as ampicillin, rifampicin and
tetracyclines
 Drugs used to treat epilepsy (hydantoin)
Other ingredients in Dilena
Dilena contains lactose. If you are allergic to lactose or
any other ingredient in this medicine, ask you doctor
before taking it.
Using this medicine properly
If your periods are infrequent or have stopped you
can start taking your tablets straight away.
Take your tablets at about the same time each day.
Take one white tablet every day on days 1-11 then
take a blue tablet every day on days 12-21. Stop tablet
taking for the next 7 days. You should start bleeding
during this week. Some women may not bleed or only
bleed every few months.
After 7 tablet-free days start you r next pack of Dilena
tablets.
If you still have periods start taking the tablets on
the 5th day of your period.
At the top of the foil strip there are circles marked with
the days of the week. When you start taking the tablets
pierce the foil above the day of the week you started
(This is day 1). This may help you later on to check
whether you are taking the tablets on the right day.
Dilena tablets should be swallowed without chewing,
with some water.
What to do if someone accidentally takes too much
If this happens contact your nearest hospital casualty
department or tell your doctor immediately. Symptoms
include nausea, headache and vaginal bleeding.
What to do if you miss a tablet
If you forget to take a tablet, skip the missed tablet and
take the next tablet at the usual time.
After taking your medicine
This medicine sometimes causes side-effects in some
people such as:
- feeling sick, (nausea)
- swelling and increased tenderness of the breasts
- spotting (minor vaginal bleeding)
- no periods
- fluid retention in the tissues e.g. swollen feet and
- ankles
- weight gain
- tiredness
- mood changes
syndrome or Dubin-Johnson syndrome?
 Do you suffer from herpes developed during
pregnancy (gestational herpes)?
-
change in sex drive
headache
migraine
palpitations
bone pain
nervousness
continued
Tell your doctor if you suffer from any of these
side-effects or have any other unpleasant effect which is
serious or troublesome.
How to store this medicine
Keep the tablets in the original carton out of the reach of
r children. The carton should be stored in a cool dry
place (below 25°C). Do not take the tablets after the
"Use by" date.
This information was last updated in July 1995.
General things to remember about medicines
1. This medicine has been prescribed only for your
current medical problem. Do not use it for other
medical problems.
2. Do not allow other people to use your medicines and
do not use medicines meant for other people.
3. Tell any doctor treating you what medicines you are
taking. Always carry a medical information card
stating which medicines you are using. This can be
very important in case you are involved in an accident.
4. Return unused medicines to the pharmacy for
disposal.
5. Make sure that other people you live with or who look
after you read this information.