PROGYNOVA TS 100

Active substance: ESTRADIOL

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(Estradiol)

Package Booklet: Information for the user

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80806035

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Read all of this booklet carefully before you
start taking this medicine.
• Keep this booklet. 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects get serious, or if
you notice any side effects not listed in this
booklet, please tell your doctor or
pharmacist.



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In this booklet
1. WHAT PROGYNOVA TS 100 IS AND WHAT
IT IS USED FOR
4
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE PROGYNOVA TS 100
6
Medical history and regular check-ups
6
Do not use Progynova TS 100
8
Warnings and precautions
10
HRT and Cancer
15
Effects of HRT on heart and circulation 21
Other conditions
26
Using other medicines
27
Laboratory tests
28
Pregnancy, breast-feeding and fertility 28


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Driving or using machines
3. HOW TO USE PROGYNOVA TS 100
Applying the patch
If you have been taking other HRT
preparations
If you apply more Progynova TS 100
than you should
If the patch falls off or if you forget
to apply Progynova TS 100
If you stop using Progynova TS 100
If you need to have surgery
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PROGYNOVA TS 100
6. FURTHER INFORMATION

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1. WHAT PROGYNOVA TS 100 IS AND
WHAT IT IS USED FOR
Progynova TS 100 is a Hormone Replacement
Therapy (HRT). It contains the female hormone,
oestrogen. Progynova TS 100 is used in
postmenopausal women with at least
12 months (1 year) since their last natural
period.
Progynova TS 100 is used for
Relief of symptoms occurring after
menopause
During the menopause, the amount of
oestrogen produced by a woman’s body drops.
This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Progynova TS
100 alleviates these symptoms after
menopause. You will only be prescribed


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Progynova TS 100 if your symptoms seriously
hinder your daily life.
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 Progynova TS 100
to prevent osteoporosis after menopause.



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2. WHAT YOU NEED TO KNOW BEFORE
YOU USE PROGYNOVA TS 100
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) taking
Progynova TS 100, 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


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examination of your breasts and/or an
internal examination, if necessary.
• Once you have started on Progynova TS
100, 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
Progynova TS 100.
• Your doctor may prescribe the hormone
progestogen in addition to Progynova TS
100 for about 12 days each month:
• if you still have your womb
or
• if you have a history of endometriosis.
 Go for regular breast screening, as
directed by your doctor.


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Do not use Progynova TS 100
If any of the following applies to you. If you
are not sure about any of the points below,
talk to your doctor before taking Progynova
TS 100
Do not use Progynova TS 100
• If you have or have ever had breast cancer,
or if you are suspected of having it
• If you have a cancer which is sensitive to
oestrogens (such as cancer of the womb
lining) 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
has not been treated


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• If you have or have had a blood clot in a
vein (thrombosis) such as in the legs (deep
vein thrombosis) or in 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 yet
returned to normal
• If you have a rare blood problem called
“porphyria" which is passed down in
families (inherited)


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• If you are allergic (hypersensitive) to
oestrogens or to any other ingredient in
Progynova TS 100
 If any of the above conditions appear for the
first time while using Progynova TS 100,
stop using it at once and consult your doctor
immediately.
Warnings and precautions
When to take special care with Progynova TS
100
Tell your doctor if you have ever had any of the
following problems, before you start treatment,
as these may return or become worse with
Progynova TS 100. If so, you should see your
doctor more often for check-ups:
• fibroids inside your womb

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• 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 an oestrogensensitive cancer (such as having a mother,
sister or grandmother who has had breast
cancer)
• high blood pressure
• a liver disorder, such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches

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• 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
• if you suffer from hereditary angioedema
Stop using Progynova TS 100 and see your
doctor immediately

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If you notice any of the following when using
HRT:
• any of the conditions mentioned in the ‘DO
NOT use Progynova TS 100’ section
• yellowing of the skin or the whites of your
eyes (jaundice). These may be signs of 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

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- difficulty in breathing
For more information, see ‘Blood clots in a vein
(thrombosis)’
Note: Progynova TS 100 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.

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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 lining of the womb (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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Compare
In women who still have a womb and who
are not taking 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.

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Unexpected bleeding
You will have a bleed once a month (so-called
withdrawal bleed) while using Progynova TS
100. But, if you have unexpected bleeding or
drops of blood (spotting) besides your monthly
bleeds, which:
• carries on for more than the first 6 months
• starts after you have been using Progynova
TS 100 more than 6 months
• carries on after you have stopped using
Progynova TS 100
see your doctor as soon as possible.

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Breast cancer
Evidence suggests that taking 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.

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Compare
Women aged 50 to 79 who are not taking
HRT, on average, 9 to 14 in 1000 will be
diagnosed with breast cancer over a 5-year
period.
For women aged 50 -79 who are taking
oestrogen-progestogen HRT over 5 years,
there will be 13 to 20 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

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Ovarian cancer
Ovarian cancer (cancer of the ovaries) 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 1000 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 1000 users (i.e. up to 1 extra
case).

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

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• you have had a 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 any other
organ
• you have systemic lupus erythematosus
• you have cancer
For signs of a blood clot, see “Stop taking
Progynova TS 100 and see a doctor
immediately”

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Compare
Looking at women in their 50s who are not
taking 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 are taking
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 taking
oestrogen-only HRT for over 5 years, there
will be 5 to 8 cases in 1000 users (i.e. 1 extra
case).

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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
taking any HRT.
For women who have had their womb removed
and are taking oestrogen-only therapy there is
no increased risk of developing heart disease.

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Stroke
The risk of having 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 1000 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 1000 users over
5 years (i.e. an extra 3 cases).

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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.
• If you have a tendency to develop blotchy
brown patches (chloasma) on the face you
should avoid exposure to the sun or
ultraviolet light whilst using Progynova TS
100.
• Women with hereditary angioedema who
take Progynova TS 100 may experience a
return or a worsening of their symptoms.
• Your doctor will monitor you carefully if you
have heart or kidney problems.

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Using other medicines
Some medicinces may interfere with the effect
of Progynova TS 100. This might lead to
irregular bleeding. This applies to the following
medicinces.
• 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)

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 Please tell your doctor or pharmacist if you
are taking or have recently taken 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 Progynova
TS 100, because this medicine can affect the
results of some tests.
Pregnancy, breast-feeding and fertility
Progynova TS 100 is for use in postmenopausal women only.
If you become pregnant, stop taking Progynova
TS 100 and contact your doctor.

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Driving or using machines
There is nothing to suggest that the use of
Progynova TS 100 affects driving or use of
machines.

3. HOW TO USE PROGYNOVA TS 100
Always apply Progynova TS 100 exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Your doctor will tell you how long you should
apply Progynova TS 100 for and whether you
should have a gap week (no patch for 7 days).
Do not start using Progynova TS 100 until at
least twelve months after your last natural
period.

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Applying the patch
Remove the protective liner from the patch.
Place the patch, sticky side down, on a clean,
dry area of the skin of your lower abdomen or
buttocks. Do not apply Progynova TS 100
patches to the breasts. Apply the patch to a
different site every time. Never apply the patch
to the same place twice in a row. Do not choose
an area that is oily, damaged or irritated. Avoid
the waistline since tight clothing may rub the
patch off. Apply the patch immediately after
opening the pouch and removing the protective
liner. Press the patch firmly in place with the
palm of the hand for about 10 seconds,
making sure there is good contact, especially
around the edges. Change the patch once a
week. If the patch is applied correctly, you can
bath or shower as usual. However, the patch

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might come off in very hot bath water or in the
sauna.
If you have been taking other HRT
preparations: carry on until you have finished
your current pack and have taken all the
treatment for that month. Start with the first
Progynova TS 100 patch the next day. Do not
leave a break between your old tablets and
Progynova TS 100.
If you have been using HRT treatment with a
gap week: start Progynova TS 100 immediately
after the gap days.
If this is your first HRT treatment: you can
start using Progynova TS 100 any day.
Continuous use: Apply 1 patch per week.
Remove this patch after 7 days and apply a
fresh patch to a different site on your body.

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Cyclical use (includes a gap week): Apply
1 patch per week for 3 weeks. Take a 7-day
break and then start again with the next patch.
You will have a bleed once a month (so-called
withdrawal bleed) while using Progynova TS
100.
If you apply more Progynova TS 100 than
you should
Only apply one patch at a time. If you apply
more by mistake you may feel sick, throw up or
have some menstruation-like bleeding. If this
happens remove the patches. No specific
treatment is necessary but you should consult
your doctor or pharmacist if you are concerned.

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If a patch falls off or if you forget to apply
Progynova TS 100
If a patch falls off before 7 days are up, it may
be reapplied. If necessary, you can apply a new
patch for the rest of the 7 days. If you forget to
replace the patch for several days you might
have breakthrough bleeding and spotting.
If you stop using Progynova TS 100
You may begin to feel the usual symptoms of
the menopause again, which may include hot
flushes, trouble sleeping, nervousness,
dizziness or vaginal dryness. Consult your
doctor or pharmacist if you are considering
stopping your Progynova TS 100 treatment.

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If you need to have surgery
If you are going to have surgery, tell the
surgeon that you are using Progynova TS 100.
You may need to stop using Progynova TS 100
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 Progynova TS 100 again.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Progynova TS 100 can cause
side effects, although not everybody gets them.
The following disease have been 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

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• probable loss of memory if HRT is started
over the age of 65
For more information about these side effects
see Section 2.
The following is a list of side effects that have
been linked to the use of Progynova TS 100:
Most frequent side effects:
• breakthrough bleeding at unexpected times
(see also section 2 "HRT and cancer")
• breast tenderness
• breast pains
These side effects occur during the first few
months of treatment with Progynova TS 100.
They are usually temporary and normally
disappear with continued treatment. If they do
not, contact your doctor.

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Common side effects (may affect between
1 and 10 in every 100 patients):
• depression, dizziness, nervousness, lack of
energy, increased sweating, hot flushes
• headache
• wind, nausea
• itching or rash at the site of application
• fluid retention, weight gain
• irregularities in your menstrual period,
changes in vaginal discharge
• generalized pain

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Uncommon side effects (may affect between
1 and 10 in every 1000 patients):
• increase in blood cholesterol
• anxiety, inability to sleep, apathy, mood
swings, poor concentration, extreme feelings
of euphoria, tremor, agitation, altered sex
drive
• pins and needles
• migraine
• visual disturbance, dry eye
• palpitations
• superficial inflammation of the veins
(phlebitis), high blood pressure
• breathlessness, runny or blocked nose
• increased appetite, constipation, indigestion,
diarrhoea, rectal disorder

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• unusual bleeding or bruising under the skin
(purpura)
• acne, hair loss, dry skin, nail problems,
small skin swellings, excessive hair growth
• joint pain, muscle cramps
• increased and frequent urge to pass urine,
urinary incontinence, bladder infections
(cystitis), discoloured urine, blood in the
urine
• benign growths in the lining of the womb,
thickening of the lining of the womb,
problems with the womb, swollen breasts,
tender breasts
• tiredness, irregular blood tests, high
temperature, lack of energy, feeling
generally unwell

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Additional side effects reported by
healthcare professionals:
• reduced oxygen flow to the brain or to a
section of the brain (see Section 2 ‘Stroke’)
• abdominal pain, bloating, yellowing of the
skin or eyes (jaundice)
• contact dermatitis
• fibroids
The following side effects have been
reported with other HRTs:
• gall bladder disease
• a variety of skin disorders:
- discoloration of the skin especially of the
face and neck known as “Pregnancy
patches” (chloasma)

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- painful reddish skin nodules (erythema
nodosum)
- rash with target-shaped reddening or
sores (erythema multiforme)
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet.

5. HOW TO STORE PROGYNOVA TS 100
Store your patches in the original packaging in
order to protect from moisture. Store below
30 °C.
Keep out of the reach and sight of children.
Do not use Progynova TS 100 after the expiry
date which is stated on the label after "EXP".
The expiry date refers to the last day of that
month.

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After use, the patch still contains the active
ingredient, which may have harmful effects on
the environment. Therefore, the used patch
should be discarded carefully. Fold any used or
unused patches in half, sticky side together,
and dispose of them in household rubbish. Do
not flush used patches down the toilet or any
liquid waste disposal systems. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Progynova TS 100 contains
Progynova TS 100 is a hormone patch. The
active substance is estradiol hemihydrate.
Each 25 cm2 patch contains 7.6 mg estradiol

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(from 7.8 mg estradiol hemihydrate), releasing
100 microgrammes of estradiol per 24 hours.
The other ingredients are isooctyl acrylate/
acrylamide/vinyl acetate copolymer, ethyl
oleate, isopropyl myristate and glycerol
monolaurate on a polyester release liner
protected with a polyethylene backing film.
What Progynova TS 100 looks like and
contents of the pack
Progynova TS 100 patches are oval translucent
patches. They are supplied in packs of 4 or
12 patches each.

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Marketing Authorisation Holder
Bayer PLC
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA.

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Manufacturer
Progynova TS 100 is made by: 3M Drug Delivery
Systems, Northridge, California, USA. Batch
release in the EU by Bayer Weimar GmbH and
Co. KG, 99427 Weimar, Germany.
Date of the last revision of this booklet:
September 2012.

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80806035

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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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