Oestrogel

OESTROGEL
PUMP-PACK
17 beta OESTRADIOL
Instructions for patients.
Not to be removed from the pack.

Your doctor should discuss OESTROGEL with you before you start to use it Please read this information careful before you start to use OESTROGEL This leaflet provides on a summary of the information available on your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

WHAT IS OESTROGEL?
OESTPOGEL is a clear non-greasy, non-staining, odourless transdermal gel containing the female hormone oestrogen (0.06% w/w 17 beta oestradiol).
Each OESTROGEL PUMP-PACK contains 80 g of gel. It delivers 64 metered doses containing 1.25 g OESTROGEL (0.75 mg 17 beta oestradiol).
Oestradiol is the main oestrogen (female sex hormone) produced by the human ovary. OESTROGEL also contains the following inactive ingredients: carbomer, triethanolamine, ethanol and purified water.
The product licence for OESTPOGEL PUMP-PACK is held by Hoechst Marion Roussel Ltd, Broadwater Park, Denham, Uxbridge, Middlesex, UB9 5HP OESTPOGEL PUMP-PACK is made for Hoechst Macon Roussel Ltd by Laboratoires Besins Iscovesco, 8 Rue Morel, 92120 Montrouge, France.

WHY HAS MY DOCTOR PRESCRIBED OESTROGEL?
OPSTROGEL when used as prescribed, restores the level of oestrogen in your body so that is similar to the level that existed before your menopause. This ‘hormone replacement therapy’ or HRT prevents or relieves the related symptoms you may have been experiencing.
OESTROGEL may also help to prevent brittle bone disease in women who are at risk of developing fractures.

WHAT IS THE MENOPAUSE?
The menopause, or ‘change of life’, occurs when your ovaries stop producing the female hormone oestrogen.
For most women this happens sometime over the age of 40, but can happen at any time if the ovaries are removed by surgery.
At the menopause periods become irregular both in timing and amount of bleeding, before they eventuality stop altogether. Other symptoms can include hot flushes, night sweat, mood swings, sleeping problems and vaginal dryness.

BEFORE TAKING YOUR MEDICINE:
Do not use OESROGEL if:

you have a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis”), or have had one of these in the past.
you have a blood clot that has travelled to your lung or another part of the body (an “embolus”), or have had one of these in the past.
you suffer from a serious liver kidney or heart disease, have high blood pressure or have a condition known as porphyria.
you have a cancer of the breast.
you have had treatment for a breast lump or any disease of the womb.
you have had some bleeding since your last period, or between periods if these are still regular.

CONSULT YOUR DOCTOR BEFORE USING OESTROGEL IF:

you have not had a complete physical and gynaecological examination.
you have not had a hysterectomy and your doctor has not prescribed other medicine to take while using OESTPOGEL.
you have breast pain or a strong family history of breast cancer.
you have high blood pressure or a history of high blood pressure.
you suffer how gallstones, migraine, diabetes, otosclerosis (hearing problems) or have a history of endometriosis (overgrowth of the lining of the womb).

USE WITH OTHER MEDICINES
It is important to tell your doctor about all the medicines you are faking including any you have bought without a prescription. Ask your doctor before using skin cleansers and other skin products during treatment with OESTEOGEL.

SPECIAL WARNINGS:

Do not exceed the prescribed dose. If the prescribed dose does not provide adequate relief of symptoms consuls your doctor.
Do not apply on or near the breasts or in the genital region.
Do not ask anyone else to apply the gel. Only you should apply OESTPOGEL and you should avoid close skin contact with your partner for one hour after application
Do not wash the skin or apply other skin care products until at least one hour after application
Do not use strong skin cleaners or detergents when washing the area of application.

Every woman is at risk of getting breast cancer whether or not she takes HRT. There is a small increase in the risk for women who have been using HRT for more than 5 years compared with women of the same age who have never used HRT. It is not known whether the difference is caused by HRT. It may be that women using HRT are examined more often so that breasts cancer is noticed earlier. The longer that HRT has been used, the more chance there is of having breast cancer diagnosed. This increased chance of breast cancer is similarly found in women whose menopause occurs late naturally without taking HPT
For women aged 50 who are not using HRT about 45 in every 1000 will have breast cancer diagnosed by the age of 70
For women who start using HRT at age 50, the extra number of breast cancer resulting from the use of HRT has been estimated as in the table below.

Length of time on HRT	Extra breast cancer found to age 70 per 1000 women
5 years	2%
10 years	6%
15 years	12%

If women stop taking HRT, the increased risk disappears by 5 years after stopping HRT and then the chances of finding breast cancer are the same as for women who have never used HRT. Breast cancer seems less likely to have spread when found in women who have used HRT than in women who have never used HRT.
If you are concerned about the risk of breast cancer discuss the risks compared to the benefits of HRT treatment wish your doctor.
All women have a small chance of having a blood clot in the veins of the leg, in the lung or other parts of the body whether m not they take HRT. For women who are not taking HRT, the chances of getting such a blood clot are about 1 in 10,000 women each year. While taking HRT such as OESTROGEL, the chances of getting a blood clot increase to 3 in 10,000 women each year.
You are more likely to have a blood clot whether or not you take HRT if:

you are very overweight.
you have had a blood clot in the veins or lungs before.
you have relatives who have suffered from these.
you are unable to move for long periods.
you have a serious injury or a major operation.

If any of these apply to you, you should talk to your doctor about whether you should take OESTROGEL.
If you know you will be having an operation that is likely to keep you off your feet for sometime, you should talk to your doctor as you may need to stop taking OESTROGEL about a month before the operation.
If you get a blood clot while you are taking OESTROGEL you should stop taking it immediately and contact your doctor.

Warning signs to look out for are:

coughing blood
unusual pain or swelling of your arms or legs
pains or feelings of heaviness in your chest
sudden shortness of breath
fainting

HOW SHOULD I USE OESTROOEL PUMP-PACK?
OESTROGEL should be used as directed by your doctor and is for topical use only.
If you are still having regular periods you should begin OESTROGEL medication within 5 days of she start of bleeding.
If your periods have stopped or are irregular you can start OESTROGEL medication as any time.
OESTROGEL may be applied once daily either in the morning or evening after washing, but preferably as about the same time each day.
If your doctor has prescribed 2 measures of gel, you will need so spread one measure over each arm and shoulder or each inner thigh. At this standard daily dose the OESTROGEL PUMP-PACK will last four weeks.
If 4 measures of gel have been prescribed you will need 2 measures on each arm and shoulder or each inner thigh. At this dose the OESTROGEL PUMP-PACK will last two weeks.
This leaflet, when fully opened out, covers an area of 375² cm. This is equal to the area of skin on each shoulder/arm or each inner thigh over which OESTROGEL should be spread.
To apply OESTROGEL remove the canister cap to reveal the plunger (figure 1). This plunger when depressed, dispenses the correct amount of gel.
On starting each new OESTROGEL PUMP-PACK you may need to press the plunger down a number of times before any gel is dispensed. This is normal and is needed to prime the pump with gel. When the first dose of gel is dispensed, this should be discarded, and she next dose used. This priming of the pump is only necessary when you begin a new canister of OESTROGEL PUMP-PACK. The next time you use it the first dose dispensed can be used.
Make sure that your hands and the skin of the area of application are clean dry and unbroken.
Hold the OESTROGEL PUMP-PACK in one hand and place the other hand under the spout, ready to collect the gel (figure 2).
Depress the plunger firmly, and one precise measure of OESTROGEL will be dispensed (figure 3).
Apply one or two measures of OESTROGEL to the skin of the arm/shoulder or inner thigh and spread over an area equivalent to this opened leaflet (figure 4)
Repeat the process for the other arm/shoulder or inner thigh.
Cover the spout using the attached stopper (figure 5) and don’t forget to replace the cap (figure 6).
Note: If on release of pressure the plunger does not return back to its original position, this means that the OESTROGEL PUMP-PACK it nearly empty and should no longer be used
Do not apply on or near the breasts, or in the genital region. Leave to dry for 5 minutes before covering with clothes

WHAT IF I MISS A DAYS TREATMENT?
If you forget to apply OESTROGEL at the usual time as instructed by your doctor you should apply it as soon as is possible.
If only one or two day’s treatment have been missed it is unlikely there will be any reduction in symptom relief.

WHAT IF I HAVE BEEN PRESCRIBED TABLETS AS WELL?
If you have not had a hysterectomy your doctor will have prescribed progestogen tablets to be taken while using OESTROGEL
You should take these tablets on the days instructed by your doctor It is best to take the tablet at the same time as you apply OESTROGEL
While you are using OESTROGEL and progestogen tablets you may have a period towards the end of the treatment bath the progestogen tablets. This is quite normal.
You may find it helpful to record each day of taking the tablet on the cut-out calendar printed here.
This will help remind you when your next course of progestogen tablets is due.

WHAT UNDESIRABLE EFFECTS MAY OESTROGEL CAUSE?
As with all medicines, it is possible that a small proportion of women using OESTROGEL may experience unwanted effects. Side-effects with OESTROGEL are similar to those found with other forms of HRT and may include:

headache, migraine or mood changes.
breast tenderness, secretion or enlargement.
nausea.
increased cervical mucus.
increase in size of uterine fibroids.
irritation or swelling at the site of application

If you think you are experiencing any unexplained effects, or if you have any concerns about your treatment you should consult your doctor.

HOW SHOULD I STORE MY OESTROGEL PUMP-PACK?
OESTROGEL PUMP-PACK should not be stored above 25°C
Do not use after the expiry date shown on both the carton and the OESTROGEL PUMP-PACK.
Keep your medicine in a safe place where children cannot reach it. Your medicine could harm them.
Remember this medicine is for you. Only a doctor can prescribe it for you.
Never give it to other people even if they have the same symptoms as you.
If you have any questions or are not sure about anything ask your doctor or pharmacists, who have access to additional information.

The information contained in this leafier applier only to:
OESTROGEL PUMP-PACK
OESTROGEL PUMP-PACK is distributed by:
Hoechst Marion Roussel.
Broadwater Park,
Denham,
Uxbridge,
Middlesex. UB9 5HP

Date of last Revision: May 1999
Hoechst Marion Roussel
Hoechst
The pharmaceutical company of Hoechst