SANDRENA 0.5MG GEL

Active substance: ESTRADIOL

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PACKAGE LEAFLET

Package leaflet: Information for the user
Sandrena 0.5 mg gel
Sandrena 1 mg gel
Estradiol
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.
What is in this leaflet
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

1. What Sandrena is and what it is used for
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.
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.
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).
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 checkups:
-

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 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 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.
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.
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.

Breast cancer
Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogenonly 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.
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 oestrogenprogestagen HRT over 5 years, there will be 13 to 23 cases in 1,000 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

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 nonusers, 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)
2

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

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.
For signs of a blood clot, see “Stop using Sandrena and see a doctor immediately”.
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).
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-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.
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.
2.
3.
4.
5.

Apply the gel once a day to the skin on your lower body or thighs.
Spread the gel over an area 1–2 times the size of your hand.
Allow the gel to dry for a few minutes.
Wash your hands after applying the gel. Avoid contact of the gel with your eyes. The gel may
irritate your eyes.
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.
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
France
Italy, the United Kingdom
Germany
Sweden

Ercostrol
Délidose
Sandrena
GynPolar Gel
Divigel

This leaflet was last revised in November 2013.

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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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