Resource Medical UK Limited

Clinorette is used as hormone replacement therapy. Levels of the female hormones, estrogen and progesterone fall during and after the menopause and this fall causes symptoms such as hot flushes, sweats and vaginal dryness.
Clinorette contains estradiol to relieve these symptoms. Estradiol also stimulates the lining of the womb (the endometrium). Clinorette also contains norethisterone to stop the endometrium from becoming too thick, and to make sure it is shed during the regular vaginal bleeds, which go with this type of hormone replacement therapy (HRT).

Before you start taking HRT, your doctor should ask about your own and your family’s medical history. Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to:
Go for regular breast screening and cervical smear tests
Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.

Safety of HRT

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

Stroke

Recent research suggests that HRT slightly increase the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older
high blood pressure
smoking
drinking too much alcohol
an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor.

If you get:
unexplained migraine-type headaches, with or without disturbed vision
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

You are more likely to get a blood clot:

if you are seriously overweight
if you have had a blood clot before
if any of your close family have had blood clots
if you have had one or more miscarriages
if you have any blood clotting problem that needs treatment with a medicine such as warfarin
if you’re off your feet for a long time because of major surgery, injury or illness

If any of these things apply to you, talk to your doctor.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause.
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer
if you are seriously overweight

If you notice any changes in your breast, such as:

dimpling of the skin
changes in the nipple
any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk.

If you still have your womb, your doctor will usually prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.

CLINORETTE contains a progestogen.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:

carries on for more than the first few months
starts after you’ve been on HRT for a while
carries on even after you’ve stopped taking HRT

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

How to use Clinorette

What is the usual dose?

The usual dose of Clinorette is one tablet a day. Your doctor will aim to give you the lowest dose for the shortest duration to treat your symptoms.

When should I take the tablets?

The tablets are provided in a calendar pack. It is important that you take the correct tablet each day. You should take the tablets at a regular time each day, either in the morning or the evening. The next pack of Clinorette is usually taken without a break in therapy.

If you have not been taking another type of HRT:
If you are still having regular periods, you should take your first white tablet on the fifth day of bleeding. If you are not having regular periods you can start straight away.

If you are changing from another type of HRT:
If you are having periods, you should complete your current course of tablets for the month and then take your first Clinorette tablet the next day. If you are not having periods, then you may start Clinorette at any time or according to any instructions given to you by your doctor.

What should you do if you forget a tablet?

If you do forget to take a Clinorette tablet at the usual time of day, take it as soon as you remember. If a whole day has passed do not take two Clinorette tablets at the same time. Carry on taking one tablet a day until you have finished the 28 tablets in the pack and then carry on taking the tablets as usual. You might notice some bleeding or spotting if you miss a tablet.

Will I need to take other contraceptive precautions?

Clinorette is not a contraceptive and so additional contraceptive measures will be needed.
Clinorette should not be taken during pregnancy or during lactation.

If you have a blood test whilst you are taking Clinorette

Clinorette may affect the results of certain laboratory tests, so you should tell the person taking the sample that you are on Clinorette.

What might happen while you are using Clinorette (side effects)

Clinorette may cause weight gain or swelling because of fluid being retained. This may make epilepsy, migraine, asthma,kidney disease or heart disease worse. You should tell your doctor if you notice any change in your condition while you are taking Clinorette.

These side effects are also usually mild and disappear with continuing therapy.
If they are severe, or if you experience any other side effects
with Clinorette you should inform your doctor.

Reasons to stop taking Clinorette
You should stop taking Clinorette and tell your doctor immediately if you experience:

Jaundice (yellowing of the skin or eyes)
Unexplained migraine-type headaches, with or without disturbed vision.
Signs of heart disease e.g. pain in your chest that spreads to your arm or neck
Signs of a blood clot e.g. sudden chest pain, a painful swelling in your leg, or difficulty breathing.
Increased blood pressure (your doctor may advise you to stop treatment if your blood pressure rises)
You know or suspect you are pregnant

Storing your medicine

You will see that an expiry date is embossed on the pack. You should not use the product after this date.
Always store the Clinorette tablets below 25°C in a dry, dark place out of the reach of children.

Patient Information Leaflet

Clinorette PIL
“The abridged safety information and not a complete reflection of safety information, the complete PIL is available on request by contacting Resource medical [see contact us] “

Registered in: United Kingdom