What are Ovestin Tablets?

The name of your medicine is Ovestin Tablets.

Each Ovestin Tablet contains 1 milligram (mg) of the active ingredient oestriol.

They also contain magnesium stearate, amylopectin, potato starch and lactose (milk-sugar).

Ovestin Tablets are white, round tablets, marked with ORGANON* on one side and with the code DG7 on the other side.

Each carton contains 30 tablets.

Ovestin Tablets is one of a group of medicines called Hormone Replacement Therapy (HRT).

The Product Licence is held by:

Organon Laboratories Ltd., Science Park, Cambridge CB4 4FL

Ovestin Tablets are made by

NV Organon, Oss, The Netherlands.

What are Ovestin Tablets used for?

Ovestin Tablets are used to treat vaginal complaints that are caused by having too little oestrogen.

Before you take the tablets

  • Do you think you may be pregnant?
  • Are you breast-feeding?
  • Have you had a thrombosis (a blood clot)?
  • Have you had tumours of the breast or other sex organs?
  • Have you had unexplained vaginal bleeding?
  • Do you have porphyria (a metabolic disorder)?
  • Do you have very high blood pressure?
  • Have you had liver disease?

If the answer to any of these questions is

YES:

  • Did you tell your doctor at the last visit or an earlier visit ?
  • If you did NOT then you should do so as soon as possible and before taking these tablets.

Even so, your doctor may still want you to

take it.

What do I need to know before taking my medicine?

If you have a vaginal infection, your doctor

may also prescribe a medicine to treat the infection.

While you are taking Ovestin Tablets, regular medical checks by a doctor are recommended. Sometimes a tissue examination (cervical smear) will be necessary.

Taking oestrogens for a very long time may increase the chance of tumours of the lining of the womb very slightly.

Extra supervision by your doctor may be necessary in some cases.

Tell your doctor if you have ever had:

  • a coagulation disorder such as thrombosis (a blood clot);
  • any disease of the heart or circulation - high blood pressure; - migraine headaches: - epilepsy:
  • liver disease such as jaundice: - kidney disease:
  • endometriosis (a disorder of the womb lining):
  • lumps in the breast - diabetes:
  • too much cholesterol or other fatty substances in the blood
  • skin rash (herpes gestationis) or severe itching during pregnancy or while taking steroids.

What other medicines are you taking?

Other medicines may affect how Ovestin Tablets works or it may affect how they work. Tell your doctor if you are taking (or intend to take) any other medicines.

What about allergies to the tablets?

The tablets contain lactose. The amount of lactose is so small that problems are unlikely, even in people with allergy to lactose.

continued

How do I take Ovestin Tablets?

It is important to take this medicine only as directed by your doctor or pharmacist

Take the whole daily dose at the same time each day.

How much.

The usual dose is:

0.5 mg - 3 mg a day ( 1/2 - 3 tablets) for up to one month.

Then the dose is reduced to 0.5 mg - 1 mg a day (1/2- 1 tablet)

How to take the tablets.

Swallow the tablets with some water or other drink. Do not chew the tablets.

What to do if Ovestin Tablets are swallowed accidentally.

If someone has swallowed some tablets by accident there is no need to worry. However, you should consult a doctor.

The person may feel sick or be sick.

Women may have some vaginal bleeding after a few days.

What if I miss a dose?

Skip the missed dose and take the next dose at the usual time.

What about side-effects?

Ovestin Tablets sometimes cause side effects in some people.

  • These usually settle down during treatment as the body adjusts to the medicine.
  • If you have any of these side effects, tell your doctor. He may decide to stop your treatment for a while.

Some people may feel sick or be sick. Sometimes the breasts become swollen, tender or painful.

Women who still have regular periods, and are taking high doses, may have a longer monthly bleed than usual. Tell your doctor if vaginal bleeding occurs.

You may notice an increased vaginal discharge.

Very occasionally headaches occur.

Tell your doctor about any problems that you think might be caused by the tablets

How should you store this medicine?

Do not use this medicine after the "use by" date on the pack.

Keep the tablets between 2-30°C (room temperature) out of the light

Keep the tablets in the original box where children cannot see or reach them

This information was written in September 1 995

MORE ABOUT OVESTIN TABLETS

Ovestin Tablets contains oestriol, one of the natural female sex hormones (oestrogens or estrogens).

Oestrogens are produced in the ovaries They cause sexual development in women and control the menstrual cycle during the childbearing years.

When women get older the ovaries gradually produce less oestrogen This happens at the menopause (usually around the age of 50).

If the ovaries are removed surgically (ovariectomy} before the menopause, oestrogen production stops very suddenly.

Shortage of oestrogens may lead to complaints such as vaginal infections and recurrent cystitis.

These complaints can be relieved by taking medicines containing oestrogen. However it may take several days or weeks before you notice an improvement.

Unlike most oestrogens, oestriol has little effect on the inner lining of the womb. So Ovestin Tablets usually do not cause vaginal bleeding.

THINGS TO REMEMBER ABOUT MEDICINES

  1. This medicine has been prescribed for your current medical problems. Do not take it for other medical problems.
  2. Do not allow other people to take your medicines and do not take 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 taking. This can also 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 may live with or who look after you read this information.