SANDRENA 0.5MG GEL

Active substance: ESTRADIOL

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Package leaflet:
Information for the user

Estradiol

Sandrena is a Hormone Replacement Therapy
(HRT). It contains the female hormone
oestrogen.
Sandrena is used for:
Relief of symptoms occurring 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”). Sandrena
alleviates these symptoms after menopause.
You will only be prescribed Sandrena if your
symptoms seriously hinder your daily life.
You must talk to your doctor if you do not
feel better or if you feel worse.

2. What you need to know
before you use Sandrena
Medical history and regular check-ups
The use of HRT carries risks which need to
be considered when deciding whether to start
taking it, or whether to carry on taking 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 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 Sandrena 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 Sandrena.
Regularly check your breasts for any
changes (see ‘Breast cancer’ below). Go for
regular breast screening, as recommended by
your doctor.

• 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
Ovarian cancer
Ovarian cancer is rare.A slightly increased risk
of ovarian cancer has been reported in women
taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT,
on average about 2 women in 1,000 will be
diagnosed with ovarian cancer over a 5 year
period. For women who have been taking HRT
for 5 years, there will be between 2 and 3 cases
per 1,000 users (i.e. up to 1 extra case).
Effects 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
taking 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 or have had 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.

Do not use Sandrena:
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 Sandrena.

For signs of a blood clot, see “Stop using
Sandrena and see a doctor immediately”.

Do not use Sandrena:
- 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
oestrogens, 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 a blood clot
in a vein (thrombosis), such as in the legs
(deep venous thrombosis) or the 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 of
the other ingredients of this medicine
Sandrena (listed in section 6).

Heart disease (heart attack)
There is no evidence that HRT will prevent a
heart attack.

If any of the above conditions appear for the
first time while using Sandrena, stop using it
at once and consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before
using Sandrena. 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
Sandrena. If so, you should see your doctor
more often for check-ups:
- fibroids 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 oestrogensensitive 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 tumour
- 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
- hereditary angioedema.
Stop using Sandrena 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 Sandrena” 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: Sandrena 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)
Taking 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).
Taking a progestagen in addition to oestrogen
for at least 12 days of each 28 day cycle
protects you from this extra risk. So your
doctor will prescribe a progestagen 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 progestagen.

Compare
Looking at women in their 50s who are not
taking HRT, on average, over a 5 year period,
4 to 7 in 1,000 would be expected to get a
blood clot in a vein.
For women in their 50s who have been taking
oestrogen-progestagen HRT for over 5 years,
there will be 9 to 12 cases in 1,000 users (i.e.
an extra 5 cases).
For women in their 50s who have had their
womb removed and have been taking
oestrogen-only HRT for over 5 years, there
will be 5 to 8 cases in 1,000 users (i.e. 1 extra
case).

Women over the age of 60 years who use
oestrogen-progestagen HRT are slightly more
likely to develop heart disease than those not
taking any HRT.
For women who have had their womb
removed and are taking oestrogen-only
therapy there is no increased risk of developing
a heart disease.
Stroke
The risk of getting a 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
taking HRT, on average, 8 in 1,000 would be
expected to have a stroke over a 5 year period.
For women in their 50s who are taking HRT,
there will be 11 cases in 1,000 users, over 5 years
(i.e. an extra 3 cases).
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.
- Women with a tendency to discoloration of
the skin (chloasma) should minimise
exposure to the sun or ultraviolet radiation
whilst using Sandrena.
Other medicines and Sandrena
Some medicines may interfere with the effect
of Sandrena. This might lead to irregular
bleeding. This applies to the following
medicines:
- 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 remedies containing St. John’s
wort (Hypericum perforatum).
Tell your doctor or pharmacist if you are
taking, have recently taken or might take 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
Sandrena, because this medicine can affect the
results of some tests.
Pregnancy, breast-feeding and
fertility
Sandrena is for use in postmenopausal women
only. If you become pregnant, stop using
Sandrena and contact your doctor.
Driving and using machines
No studies on the effects of Sandrena on the
ability to drive and use machines have been
performed.
Sandrena contains propylene glycol
Sandrena contains propylene glycol, which may
cause skin irritation.

3. How to use Sandrena
Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
When to start using Sandrena
You can start using Sandrena straight away if:
- You have never used HRT before
- You are changing over from a period-free
HRT.
Wait for your period to end if:
- You are changing over from another type of
HRT where you have a period.
If you have not had your womb
removed, your doctor will normally
also prescribe another medicine
containing the hormone progestagen.
This is normally a tablet taken for 12 to 14 days
in each monthly cycle. After each course of
progestagen you will usually have a withdrawal
bleed, like a period.

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1. What Sandrena is and what
it is used for

Compare
Women aged 50 to 79 who are not taking HRT,
on average, 9 to 17 in 1,000 will be diagnosed
with breast cancer over a 5-year period. For
women aged 50 to 79 who are taking
oestrogen-progestagen HRT over 5 years,
there will be 13 to 23 cases in 1,000 users (i.e.
an extra 4 to 6 cases).

black

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

78

What is in this leaflet

Breast cancer
Evidence suggests that taking combined
oestrogen-progestagen 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.

140x720
140x180

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. See section 4.

Unexpected bleeding
If your doctor has prescribed you progestagen
tablets in addition to Sandrena, you will usually
have a bleed once a month (so-called
withdrawal bleed). But, if you have unexpected
bleeding or drops of blood (spotting) besides
your monthly bleeding, which:
• carries on for more than the first 6 months
• starts after you have been taking Sandrena
more than 6 months
• carries on after you have stopped using
Sandrena
see your doctor as soon as possible.

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Orion Oyj

Sandrena 0.5 mg gel
Sandrena 1 mg gel

In women who still have a womb and who are
not taking HRT, on average, 5 in 1,000 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 1,000 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.

How much to use
Sandrena comes in sachets of 0.5 mg estradiol
in 0.5 g of gel, or in sachets of 1 mg estradiol
in 1g of gel.
Each pack of Sandrena 0.5 mg gel contains
only 0.5 g sachets.
Each pack of Sandrena 1 mg gel contains
only 1 g sachets.
Use the amount of Sandrena gel that your
doctor has prescribed.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.
- The recommended dose is between 0.5 mg
and 1.5 mg of estradiol a day.
- Use the following number of 0.5 g or 1 g
sachets depending on the dose, and the pack
size prescribed by your doctor:
For a 0.5 mg daily dose: Use one 0.5 g sachet.
For a 1 mg daily dose: There are two options.
Use one 1 g sachet or use two 0.5 g sachets.
For a 1.5 mg daily dose: There are two options.
Use three 0.5 g sachets or use one 0.5 g sachet
with one 1 g sachet.
If you are also taking progestagen tablets, take
them as your doctor has told you. You will
normally have a withdrawal bleed after each
course of progestagen.
How to apply the gel
Sandrena should be rubbed gently on dry and
clean skin. It should not be swallowed.
Where to apply the gel
- Do not apply the gel to your breasts, face
or on irritated skin.
- Apply the gel to your lower body or thighs.
- Apply the gel to a different side of your body
each day.
Follow these instructions:
1. Apply the gel once a day to the skin on
your lower body or thighs.
2. Spread the gel over an area 1–2 times the
size of your hand.
3. Allow the gel to dry for a few minutes.
4.
Wash your hands after applying the gel.
Avoid contact of the gel with your eyes.The
gel may irritate your eyes.
5.
Do not wash the area where you have
applied the gel for at least one hour.
If you need to have surgery
If you are going to have surgery, tell the
surgeon that you are using Sandrena.You may
need to stop using Sandrena 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
Sandrena again.
If you use more Sandrena gel than
you should
If you use more gel than you should, talk to
your doctor or pharmacist.
You may feel bloated, anxious or irritable, or
your breasts may feel tender. Nausea, vomiting
and withdrawal bleeding may also occur in
some women.
Overdosage is unlikely with transdermal
application.Treatment is symptomatic.The gel
should be washed. The symptoms disappear
when the treatment is stopped or when the
dose is reduced.
If you swallow Sandrena
If you swallow Sandrena there is no need to
worry. However, you should talk to your
doctor.
If you forget to use Sandrena
- Apply the missed dose when you remember,
unless you are more than 12 hours late.
- If you are more than 12 hours late just skip
the missed dose.
- Missed doses may cause some bleeding
between your periods. This is called
breakthrough bleeding.
If you stop using Sandrena
Keep using this medicine as prescribed by your
doctor. Keep using Sandrena, even if you seem
to be better. If you stop too early or too
suddenly your problem may return.
If you have any further questions on the use
of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop using the gel and see your
doctor straight away, if you notice
any of the following serious side
effects:
- your blood pressure rises
- your skin or the whites of your eyes go
yellow (jaundice)
- you suddenly have migraine-type headaches
(see section 2)
- you have signs of a blood clot (see section 2)
- you get any of the problems listed in
section 2.
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.
For more information about these side effects,
see section 2.
During the first few months of treatment,
breakthrough bleeding, spotting and breast
tenderness or enlargement can occur. These
are usually temporary and normally disappear
after continued treatment.
Other side effects
Common (affects up to 1 in 10 people):
- itching of the skin, rash, pain, increased
sweating, swollen feet and lower legs
- breasts become tender or painful
- increase or decrease in your weight
- headache, dizziness
- tummy pains, feeling sick or being sick,
flatulence
- bleeding or spotting, menstrual disorder
- depression, nervousness, lethargy
- hot flushes.

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Uncommon (affects up to 1 in 100 people):
- changes to sex drive and mood, anxiety,
sleeplessness, apathy, emotional instability,
impaired concentration,euphoria, agitation
- migraine, delusion, trembling
- visual impairment, dry eye
- hypertension, superficial phlebitis, purpura
- shortness of breath, rhinitis
- benign breast or endometrial tumour
- increased appetite, high level of cholesterol
in the blood
- increased heart rate
- constipation, digestive disturbance, diarrhoea,
rectal disorder
- acne, alopecia, dry skin, nail disorder, skin
nodule, excessive growth of hair, urticaria (a
raised, itchy rash that appears on the skin),
painful reddish skin nodules (erythema
nodosum)
- joint disorders, muscle cramps
- increased urinary frequency/urgency, loss of
bladder control, urinary tract infection, urine
discoloration, haematuria
- tender or swollen breast, abnormal growth
of the lining of the womb, uterine disorder
- tiredness, abnormal laboratory test,
weakness, fever, flu syndrome, general feeling
of ill health
- allergic (hypersensitivity) reaction.
Rare (affects up to 1 in 1,000 people):
- venous thromboembolism
- alterations in liver function and biliary flow
- contact lense intolerance
- menstrual pain
- pre-menstrual like syndrome.
Adverse events reported post marketing with
frequency not known (cannot be estimated from
the available data):
- uterine fibroids
- hereditary angioedema
- cerebral circulatory disorder
- bloating
- liver disease causing yellowing of the skin
- contact rash, eczema
If you have any of these side effects tell your
doctor. The doctor may decide to stop your
treatment for a while.
Dementia
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.
The following side effects have been reported
with other HRTs:
- gall bladder disease
- probable dementia over the age of 65
- various skin disorders:
- discolouration of the skin especially of
the face or neck known as “pregnancy
patches” (chloasma)
- rash with target-shaped reddening or
sores (erythema multiforme)
- purpura due to loss of integrity or
function of the vessels (vascular
purpura)
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store Sandrena
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton and sachet after
“use by”.
Store the gel at room temperature (below
25°C).
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6. Contents of the pack and
other information
What Sandrena 0.5 mg gel and
Sandrena 1 mg gel contain
- The active substance is estradiol. There is
0.5 mg (milligrams) or 1.0 mg of estradiol in
each sachet.
- The other ingredients are Carbopol 974P,
trolamine, propylene glycol, alcohol and
purified water.
What Sandrena 0.5 mg gel and
Sandrena 1 mg gel look like and the
contents of the packs
Sandrena gel is a smooth alcohol-based gel.
Pack sizes:
Sandrena 0.5 mg gel comes in packs of 28 or
91 sachets.
Sandrena 1 mg gel comes in packs of 28 or
91 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Orion Corporation
PO Box 65
FIN-02101 Espoo
Finland
The manufacturer is:
Orion Corporation
PO Box 425
FIN-02101 Turku
Finland
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Denmark Ercostrol
France Délidose
Italy, the United Kingdom Sandrena
Germany GynPolar Gel
Sweden Divigel
This leaflet was last revised in
November 2013.

25.11.2013 11.46

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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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