Resource Medical UK Limited

Bedol

See Also :

Clinorette |

Climedette |

Climanor

Bedol contains 17-β estradiol 2mg as white tablets.
Bedol is used as hormone replacement therapy (HRT). Levels of the female hormones, particularly estrogen, fall during and after the menopause and this fall causes symptoms such as hot flushes, sweats and vaginal dryness. Bedol contains estradiol to relieve these symptoms. It also stimulates the lining of the womb (the endometrium) unless this has already been removed. If your womb (uterus) is intact, another steroid, a progestogen, is usually prescribed with Bedol to stop the endometrium from becoming too thick.

You should not use Bedol if:

You are sensitive to any of the ingredients of Bedol.
You currently have, or, have previously had, or suspect you have breast cancer.
You know or suspect you have cancer which is dependent on estrogen e.g. endometrial cancer (cancer of the lining of the womb).
You have or have previously suffered from clots forming in the veins or traveling to other parts of the body such as the lungs.
You have porphyria.
You suffer from angina or have recently had a heart attack (myocardial infarction).
You know or suspect you are pregnant.
You are breast-feeding.

Talk to your doctor if you have any of the following, as Bedol may not be suitable for you:

Abnormal vaginal bleeding.
Liver diseases or a history of liver disease.

Be sure to:

Go for regular breast screening and cervical smear tests.

Do you have:

Epilepsy.
Migraine or severe headaches.
Asthma.
High blood pressure.
Fibroids or endometriosis.
Gall bladder disease.
Diabetes.

If you are suffering from any of these conditions or have suffered from these conditions in the past, please tell your doctor.

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.
If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

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.

If you get:
A pain in your chest that spreads to your arm or neck.
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Strokes

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.

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 to see if you should take HRT.

If you get:

Painful swelling in your leg.
Sudden chest pain.
Difficulty breathing.

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

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. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogen-only HRT (but estrogen plus progestogen HRT is beneficial for the endometrium).

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 may 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.

BEDOLis an estrogen-only product.

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.

Can Bedol be taken while taking other medicines?

You should tell your doctor if you are taking any other preparation, even medicines you can purchase from your pharmacist, without prescription including herbal preparations such as St Johns Wort, anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir).

BEDOL USE:

What is the usual dose?

The usual dose of Bedol is one tablet a day. However, your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms.

When should take the tablets?

You should take the tablets at a regular time each day, either in the morning or the evening. Bedol is usually taken continuously without a break in therapy. If you are still having regular periods, you should take your first tablet on the first day of bleeding. If you are not having regular periods or have had a hysterectomy, you can start straight away. If your doctor has given you instructions on taking Bedol these should be followed precisely.

If you are changing from another type of HRT, start-taking Bedol as soon as you have finished the last course or according to any instructions given to you by your doctor.

What should you do if you take too many tablets?

If you accidentally take too many Bedol tablets, stop taking the therapy and inform your doctor.
Severe reactions to Bedol after overdose are rare.

What should you do if you forget a tablet?

If you forget to take a Bedol tablet at the usual time of day take it as soon as you remember. If a whole day has passed do not take two Bedol tablets at the same time, but carry on taking one tablet a day. Missing a dose may increase the likelihood of breakthrough bleeding or spotting.

What vaginal bleeding should you expect if you are taking a progestogen as well as Bedol?

If you have been prescribed a progestogen to make sure that the lining of the womb is kept thin, you may experience regular or irregular bleeding, depending on whether the progestogen is taken at the same time as the Bedol tablets or on completion of the course of Bedol tablets. You should check the information supplied with the progestogen for any special warnings.

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

Bedol 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 Bedol.

You may experience the following unwanted effects:

In the reproductive and urinary system- vaginal thrush, bladder infection. If you are also taking a progestogen to ensure that the lining of the womb is kept thin, you may also notice changes in vaginal bleeding and symptoms similar to those felt just before a period.

In the breasts - tenderness, enlargement, secretion.
In the stomach - feeling sick, vomiting, stomach cramps, feeling bloated.
In the skin - changes in colour, which may persist when drug is discontinued.
In the eyes - difficulties with contact lenses.
In the nervous system - headaches, migraine, dizziness, chorea.
In other parts of the body - worsening of porphyria, accumulation of fluid, change in sex drive, leg cramps, gall bladder disease.

These side effects are also usually mild and disappear with continuing therapy. If you experience any other side effects with Bedol you should inform your doctor.

Other side effects that have been reported with estrogen treatment include blood clots, myocardial infarction and stroke, breast cancer and endometrial cancer.

Reasons to stop taking Bedol

You should stop taking Bedol 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.

Any condition listed in the section above ‘You should not use Bedol if:

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 Climanor tablets below 25°C in a dry, dark place out of the reach of children.

Patient Information Leaflet

Bedol PIL
"CLIMEDTTDE is not authorised for sale in the UK"

Registered United Kingdom