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 syndrome or Dubin-Johnson syndrome?
  • Do you suffer from herpes developed during pregnancy (gestational herpes)?
  • 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
    • 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.

    1. Do not allow other people to use your medicines and do not use medicines meant for other people.
    2. 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.
    3. Return unused medicines to the pharmacy for disposal.
    4. Make sure that other people you live with or who look after you read this information.