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ESTRADIOL GEL 0.06 % W/W

Active substance(s): 17-BETA-ESTRADIOL

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Pg 4

CUSTOMER:

Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

Oestrogel

ARTWORKER:

DT

DATE OF PROOF:

09/07/13

CODE:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 09/07/13

«PAdBì
Leaflet Flat Size = 296 x 420
April 2013

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

6464/0861G

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Undesirable effects observed with HRT products used in menopause are reported in the table below:
System

Common
Undesirable effects
(more than 1/100
person and less
than 1/10 person)

Uncommon
undesirable effects
(more than 1/1000
person and less than
1 /100 person)

Metabolism and
nutrition disorders

Headache,

Vascular
disorders
Gastrointestinal
disorders

Nausea,
Abdominal pain

Depression,
Mood swings

Change in libido

Vertigo
Migraine,

Aggravation of
epilepsy

Venous
thromboembolic
disease

Hypertension

Flatulence,
Vomiting

Hepato-biliary
disorders

Liver
function tests
abnormalities

Skin and
subcutaneous tissue
disorders

Reproductive system
and breast disorders

General disorders
and administration
site condition

Itch (pruritus)

Breast swelling/ pain,
Breast enlargement
Menstrual cramps
Heavy menstrual bleeding
Unexpected vaginal
bleeding
Vaginal discharge
Endometrial hyperplasia
Weight change
(increase or decrease)
Water retention with
peripheral oedema

Benign breast or uterine
neoplasm
Increased volume of
uterine
Vaginitis/vaginal
candidiosis

Weakness (asthenia)

What is in this leaflet:
1. What Oestrogel is and what it is used for
2. What you need to know before you use Oestrogel
3. How to use Oestrogel
4. Possible side effects
5. How to store Oestrogel
6. Contents of the pack and other information

1. What Oestrogel is and what it is used for

Appearance of milk
secretion (galactorrhea)

Oestrogel is used for:
Relieve of symptoms occuring after menopause
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause
symptoms such as hot face, neck and chest (“hot flushes”). Oestrogel alleviates these symptoms after
menopause. You will only be prescribed Oestrogel if your symptoms seriously hinder your daily life.

Anaphylactic reaction
(in women with past
history of allergic
reaction

5. How to store Oestrogel
Do not use after the expiry date printed on the carton or canister label.
Store below 25°C. Keep the gel in the original packaging.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop using the gel, we suggest you take it back to the pharmacist for safe disposal.
Only keep the gel if your doctor tells you to.
If the gel becomes brittle or discoloured on dispensing you should ask your doctor or pharmacist before using
it.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. Content of the pack and other information
Your medicine is called Oestrogel/Estradiol gel 0.06% w/w.
The gel contains 0.06% w/w of 17β- estradiol in a clear non-greasy, non-staining odourless hydro-alcoholic
gel.
Oestrogel/Estradiol gel 0.06% w/w also contains the following excipients:
Carbomer, triethanolamine, ethanol and purified water.
Oestrogel/Estradiol gel 0.06% w/w is available as a pump pack of 80 grams, which delivers 64 metered doses
each containing 1.25g Oestrogel/Estradiol gel 0.06% w/w (0.75mg 17β estradiol).
PL No: 6464/0861

This product is manufactured by Besins Manufacturing Belgium N.V., 1620 Drogenbos, Belgium and
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR.

Oestrogel is a registered trademark of Hoechst Marion Roussel Ltd.

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

The full name of your medicine is Oestrogel. Oestrogel is a Hormone Replacement Therapy (HRT). It contains
the female hormone oestrogen. Oestrogel is used in postmenopausal women with at least 6 months since their
last natural period.

If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet.

Leaflet revision and issue date (Ref.) 09.07.2013

(17β
β-estradiol)
Patient Information Leaflet

Skin decolouration
Acne

The following side effects have been reported with other HRTs:

gall bladder disease

various skin disorders:
- painful reddish skin nodules (erythema nodosum)
- rash with target-shaped reddening or sores (erythema multiforme)

POM

ESTRADIOL GEL 0.06% w/w

This product is known by the above names but will be referred to as Oestrogel in this leaflet.
Glucose intolerance

Psychiatric disorders
Nervous system
disorder

Rare undesirable
effects (more than
1/10000 person and
less than 1/1000 person)

OESTROGEL®/

Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available
options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you,
you can use Oestrogel to prevent osteoporosis after menopause.
How Oestrogel works
Oestrogel works by replacing the oestrogen in your body. This is so that you have a similar amount of
oestrogen as before your menopause.

2. What you need to know before you use Oestrogel
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding whether to start using it, or whether
to carry on using it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If
you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT your doctor will ask you about your own and your family’s medical history.
Your doctor may decide to perform a physical examination .This may include an examination of your breasts
and/or an internal examination, if necessary.
Once you have started on Oestrogel you should see your doctor for regular check-ups (at least once a year).
At these check-ups, discuss with your doctor the benefits and risks of continuing with Oestrogel.
Go for regular breast screening, as recommended by your doctor.
Do not use Oestrogel:
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor
before using Oestrogel.
Do not use Oestrogel:

If you have or have ever had breast cancer, or if you are suspected of having it,

If you have cancer which is sensitive to oestrogen, such as cancer of the womb lining
(endometrium), or if you are suspected of having it,

If you have any unexplained vaginal bleeding,

If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being
treated,

If you have or have ever had blood clots in a vein (thrombosis), such as in the legs (deep venous
thrombosis) or lungs (pulmonary embolism),

If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency),

If you have or recently have had a disease caused by blood clots in the arteries, such as a heart
attack, stroke or angina,

If you have or have ever had a liver disease and your liver function tests have not returned to
normal,

If you have a rare blood problem called “porphyria” which is passed down in families (inherited),

If you are allergic to estradiol or any other ingredients of this medicine (listed in section 6).
If any of the above conditions appear for the first time while using Oestrogel, stop using it at once and consult
your doctor immediately.
Warnings and precautions
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these
may return or become worse during treatment with Oestrogel. If so, you should see your doctor more often for
check-ups:

fibrosis inside your womb,

growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the
womb lining (endometrial hyperplasia),

increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”),

increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or
grandmother who has had breast cancer),

high blood pressure,

a liver disorder, such as a benign liver tumor,

diabetes,

gallstones,

migraine or severe headaches,

a disease of the immune system that affects many organs of the body (Systemic Lupus
Erythematosus, SLE).

epilepsy,

asthma,

a disease affecting the eardrum and hearing (otosclerosis),

a very high level of fat in your blood (triglycerides),

fluid retention due to cardiac or kidney problems.
UXt{ž

Pg 2 !

CUSTOMER:

Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

Oestrogel

ARTWORKER:

DT

DATE OF PROOF:

09/07/13

CODE:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 09/07/13

«PAdBì
Leaflet Flat Size = 296 x 420
April 2013

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

6464/0861G

Pg 2

Stop using Oestrogel and see a doctor immediately
If you notice any of the following when taking HRT:

any of the conditions mentioned in the ‘Do not use OESTROGEL’ section

yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease

a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).

migraine-like headaches which happen for the first time.

if you become pregnant

if you notice signs of a blood clot, such as:
° painful swelling and redness of the legs
° sudden chest pain
° difficulty in breathing
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Oestrogel is not a contraceptive. If it is less than 12 months since your last menstrual period or you are
under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your
doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)
Using oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the womb lining (endometrial cancer).
Using a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from
this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have
had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product
without a progestogen.

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Other medicines and Oestrogel
Some medicines may interfere with the effect of OESTROGEL. This might lead to irregular bleeding.
This applies to the following medicines:

Skin cleansers and detergents e.g. products containing benzalkonium chloride or sodium lauryl
sulphate.

Other skin products containing alcohol e.g. astringents or sunscreens.

Products to treat skin and scalp disorders e.g. products to cure warts, acne or dandruff.

Other skin medications which change how skin is made, e.g. anti-cancer products.

Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine).

Medicines for tuberculosis (such as rifampicin, rifabutin)

Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir).

Herbal products containing St John’s wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are using or have recently used any other medicines including
medicines obtained without a prescription, herbal medicines or other natural products.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are using Oestrogel, because this
medicine can affect the results of some tests.
Pregnancy and breast-feeding
Oestrogel is for use in postmenopausal women only. If you become pregnant, stop using Oestrogel and
contact your doctor.

3. How to use Oestrogel
Always use Oestrogel exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.

Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of using Oestrogel.
However, if the irregular bleeding:

carries on for more than the first 6 months

starts after you have been using Oestrogel for more than 6 months

carries on after you have stopped using Oestrogel
see your doctor as soon as possible.

Using this medicine

If you have never used any other HRT medicines or you are switching to Oestrogel from a
period-free HRT product, you can start using Oestrogel on any convenient day.

If you are currently using another type of HRT where you have a period, finish your current
medicine pack before you start using Oestrogel.

Do not ask anyone else to apply the gel. Only you should apply your medicine.

Do not use strong skin cleaners or detergents when washing the area where you will apply the gel.

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.

If the prescribed dose does not provide relief, tell your doctor. Do not use more than the prescribed
dose.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to
your doctor if you think this dose is too strong or not strong enough.

Breast cancer
Evidence suggests that using combined oestrogen-progestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping
treatment.
For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no
increase in breast cancer risk is shown.

Preparing your new Pump Pack
Before using your new Pump Pack for the first time, you need to prepare it for use as follows:

Remove the cap from the canister.

Remove the stopper from the spout.

Press the plunger down a few times until the gel comes out.

Do not use the first dose of gel from your Pump Pack. This dose should be discarded.

Your Pump Pack is now ready to use.

Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast
cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5
years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

Regularly check your breasts. See your doctor if you notice any changes such as:

dimpling of the skin

changes in the nipple

any lumps you can see or feel

How much to use and when to use

Apply the gel once a day, either in the morning or evening.

Try to use the gel at about the same time each day.

Your doctor will prescribe the lowest dose for the shortest time to treat your symptoms.

The usual daily dose is 2 measures of gel. The Pump Pack will last four weeks.

If 4 measures of gel have been prescribed, the Pump Pack will last two weeks.

Spread the gel on a large area of skin on each shoulder, outer arm or each mid-inner thigh.

In women who still have a womb and who are not using HRT, on average, 5 in 1000 will be diagnosed with
endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60
women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on
the dose and for how long it is taken.

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women using HRT for
at least 5 to 10 years.
Women aged 50 to 69 who are not using HRT, on average about 2 women in 1000 will be diagnosed with
ovarian cancer over a 5-year period. For women who have been using HRT for 5 years, there will be between
2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially
during the first year of using it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or
even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.
Inform your doctor if any of these situations applies to you:

you are unable to walk for a long time because of major surgery, injury or illness (see also section
3, If you need to have surgery)

you are seriously overweight (BMI >30 kg/m2)

you have any blood clotting problem that needs long-term treatment with a medicine used to
prevent blood clots

if any of your close relatives has ever had a blood clot in the leg, lung or another organ

you have systemic lupus erythematosus (SLE)

you have cancer.
For signs of a blood clot, see “Stop using Oestrogel and see a doctor immediately”.
Compare
Looking at women in their 50s who are not using HRT, on average, over a 5-year period, 4 to 7 in 1000 would
be expected to get a blood clot in a vein.
For women in their 50s who have been using oestrogen-progestogen HRT for over 5 years, there will be 9 to
12 cases in 1000 users (i.e.an extra 5 cases).
For women in their 50s who have had their womb removed and have been using oestrogen-only HRT for over
5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop
heart disease than those not using any HRT.
For women who have had their womb removed and are using oestrogen-only therapy there is no increased
risk of developing a heart disease.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases
of stroke due to use of HRT will increase with age.
Compare
Looking at women in their 50s who are not using HRT, on average, 8 in 1000 would be expected to have a
stroke over a 5-year period. For women in their 50s who are using HRT, there will be 11 cases in 1000 users,
over 5 years (i.e. an extra 3 cases).

How to apply the gel
1. Make sure that your hands and the skin where you are going to apply the gel are clean, dry and unbroken.
2. Remove the canister cap to reveal the plunger.
3. Remove the stopper from the spout.
4. Hold the Oestrogel Pump Pack in one hand and place your other hand under the spout, ready to collect
the gel.
5. Push the plunger down firmly. This will dispense one measure of the gel.
6. Apply the gel to the skin of the outer arm and shoulder or the mid-inner thigh.
7. Do not apply on or near the breasts, or near the genital area.
8. Spread the gel over a large area of skin on each shoulder, outer arm or mid-inner thigh.
9. If your doctor has prescribed 2 measures of gel, spread 1 measure over each outer arm and shoulder, or
each mid-inner thigh. If 4 measures of gel have been prescribed, spread 2 measures over each outer arm
and shoulder or each mid-inner thigh. (See steps 4-8).
10. Cover the spout using the attached stopper.
11. Replace the cap.
12. Leave to dry for 5 minutes before covering with clothes.
How you know when your Pump Pack is empty

The Pump Pack is nearly empty when the plunger does not return back to its original position after
you have pushed it down.

When this happens, do not use the Pump Pack any longer. Start using a new Pump Pack.
If you use more Oestrogel than you should
The effects of overdosing are generally: breast tension, abdominal and pelvic swelling, nausea and vaginal
bleeding. These symptoms disappear when treatment is stopped or the dose is reduced. In case of the
accidental using of an excessive dose of the medicine tell your doctor immediately.
If you forget to use Oestrogel

If it is more than 12 hours until your next dose, apply the gel as soon as you remember and apply
the next dose at the normal time.

If it is less than 12 hours until your next dose, skip the missed dose and apply the next dose at the
normal time.

Do not use a double dose (two doses at the same time) to make up for a forgotten dose.
If you forget a dose you may have breakthrough bleeding or spotting.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are using Oestrogel. You may need to stop using
Oestrogel about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots
in a vein). Ask your doctor when you can start using Oestrogel again.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:

breast cancer,

abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer),

ovarian cancer,

blood clots in the veins of the legs or lungs (venous thromboembolism),

heart disease,

stroke,

probable memory loss if HRT is started over the age of 65.
HRT will not prevent memory loss.
For more information about these side effects, see Section 2.

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Other conditions
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start
using HRT after the age of 65. Speak to your doctor for advice.
Children
None
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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