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DULOXETINE SANDOZ 30 MG GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Duloxetine 30 mg
gastro-resistant capsules
Duloxetine 60 mg
gastro-resistant capsules
Duloxetine

Read all of this leaflet carefully before you start
taking 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 of the 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 Duloxetine is and what it is used for
2. What you need to know before you take Duloxetine
3. How to take Duloxetine
4. Possible side effects
5. How to store Duloxetine
6. Contents of the pack and other information

1. What Duloxetine is and what it is used for
Duloxetine contains the active substance duloxetine.
Duloxetine increases the levels of serotonin and
noradrenaline in the nervous system.
Duloxetine is used in adults to treat:
• depression
• generalised anxiety disorder (chronic feeling of
anxiety or nervousness)
• diabetic neuropathic pain (often described as
burning, stabbing, stinging, shooting or aching or
like an electric shock. There may be loss of feeling
in the affected area, or sensations such as touch,
heat, cold or pressure may cause pain)
Duloxetine starts to work in most people with
depression or anxiety within two weeks of starting
treatment, but it may take 2-4 weeks before you feel
better. Tell your doctor if you do not start to feel better
after this time. Your doctor may continue to give you
Duloxetine when you are feeling better to prevent your
depression or anxiety from returning
In people with diabetic neuropathic pain it can take
some weeks before you feel better. Talk to your doctor
if you do not feel better after 2 months.

2. What you need to know before you take
Duloxetine
Do not take Duloxetine if you:
• are allergic to duloxetine or any of the other
ingredients of this medicine (listed in section 6)
• have liver disease
• have severe kidney disease
• are taking or have taken within the last 14 days,
another medicine known as a monoamine oxidase
inhibitor (MAOI) (see ‘Other medicines and
Duloxetine’)
• are taking fluvoxamine which is usually used to treat
depression, ciprofloxacin or enoxacin which are used
to treat some infections
• are taking other medicines containing duloxetine
(see ‘Other medicines and Duloxetine’)
Talk to your doctor if you have high blood pressure or
heart disease. Your doctor will tell you if you should be
taking Duloxetine.
Warnings and precautions
• The following are reasons why Duloxetine may not
be suitable for you. Talk to your doctor before you
take Duloxetine if you:
• are taking other medicines to treat depression (see
‘Other medicines and Duloxetine’)
• are taking St. John’s Wort, a herbal treatment
(Hypericum perforatum)
• have kidney disease
• have had seizures (fits)
• have had mania
• suffer from bipolar disorder
• have eye problems, such as certain kinds of
glaucoma (increased pressure in the eye)
• have a history of bleeding disorders (tendency to
develop bruises)
• are at risk of low sodium levels (for example if you
are taking diuretics, especially if you are elderly)
• are currently being treated with another medicine
which may cause liver damage
• are taking other medicines containing duloxetine
(see ‘Other medicines and Duloxetine’)
Duloxetine may cause a sensation of restlessness or an
inability to sit or stand still. You should tell your doctor
if this happens to you.
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you
can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to think like this if you:
• have previously had thoughts about killing or
harming yourself
• are a young adult. Information from clinical trials
has shown an increased risk of suicidal behaviour
in adults aged less than 25 years with psychiatric
conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder, and
ask them to read this leaflet. You might ask them to tell
you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your
behaviour.
Children and adolescents under 18 years of age
Duloxetine should normally not be used for children
and adolescents under 18 years. Also, you should
know that patients under 18 have an increased risk of
side-effects such as suicide attempt, suicidal thoughts
and hostility (predominantly aggression, oppositional
behaviour and anger) when they take this class of
medicines. Despite this, your doctor may prescribe
Duloxetine for patients under 18 because he/she
decides that this is in their best interests. If your doctor
has prescribed Duloxetine for a patient under 18 and

you want to discuss this, please go back to your doctor.
You should inform your doctor if any of the symptoms
listed above develop or worsen when patients under
18 are taking Duloxetine. Also, the long-term safety
effects concerning growth, maturation, and cognitive
and behavioural development of Duloxetine in this age
group have not yet been demonstrated.
Other medicines and Duloxetine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The active substance of Duloxetine, duloxetine, is used
in other medicines for other conditions:
• diabetic neuropathic pain
• depression
• anxiety and
• urinary incontinence
Using more than one of these medicines at the same
time should be avoided. Check with your doctor if
you are already taking other medicines containing
duloxetine.
Your doctor should decide whether you can take
Duloxetine with other medicines. Do not start or
stop taking any medicines, including those bought
without a prescription and herbal remedies, before
checking with your doctor.
You should also tell your doctor if you are taking any of
the following:
Monoamine oxidase inhibitors (MAOIs):
You should not take Duloxetine if you are taking, or
have recently taken (within the last 14 days) another
antidepressant medicine called a monoamine
oxidase inhibitor (MAOI). Examples of MAOIs include
moclobemide (an antidepressant) and linezolid
(an antibiotic). Taking a MAOI together with many
prescription medicines, including Duloxetine, can
cause serious or even life-threatening side effects.
You must wait at least 14 days after you have stopped
taking an MAOI before you can take Duloxetine. Also,
you need to wait at least 5 days after you stop taking
Duloxetine before you take a MAOI.
Medicines that cause sleepiness:
These include medicines prescribed by your doctor
including benzodiazepines, strong painkillers,
antipsychotics, phenobarbital and antihistamines.
Medicines that increase the level of serotonin:
Triptans, tramadol, tryptophan, SSRIs (such as
paroxetine and fluoxetine), SNRIs (such as venlafaxine),
tricyclic antidepressants (such as clomipramine,
amitriptyline), pethidine, St John’s Wort and MAOIs
(such as moclobemide and linezolid). These medicines
increase the risk of side effects; if you get any unusual
symptom taking any of these medicines together with
Duloxetine, you should see your doctor.
Oral anticoagulants or antiplatelet agents:
Medicines which thin the blood or prevent the blood
from clotting. These medicines might increase the risk
of bleeding.
Duloxetine with food, drink and alcohol
Duloxetine may be taken with or without food. Care
should be taken if you drink alcohol while you are
being treated with Duloxetine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Tell your doctor if you become pregnant, or you are
trying to become pregnant, while you are taking
Duloxetine. You should use Duloxetine only after
discussing the potential benefits and any potential
risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you
are on Duloxetine. When taken during pregnancy,
similar drugs (SSRIs) may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby
breathe faster and appear bluish. These symptoms
usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact
your midwife and/or doctor immediately.
If you take Duloxetine near the end of your pregnancy,
your baby might have some symptoms when it is born.
These usually begin at birth or within a few days of
your baby being born. These symptoms may include
floppy muscles, trembling, jitteriness, not feeding
properly, trouble with breathing and fits. If your baby
has any of these symptoms when it is born, or you
are concerned about your baby’s health, contact your
doctor or midwife who will be able to advise you.
Tell your doctor if you are breast-feeding. The use of
Duloxetine while breast-feeding is not recommended.
You should ask your doctor or pharmacist for advice.
Driving and using machines
Duloxetine may make you feel sleepy or dizzy. Do not
drive or use any tools or machines until you know how
Duloxetine affects you.
Duloxetine contains lactose, Allura Red (E 129) and
Sunset Yellow FCF (E110)
Lactose: If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
Allura Red (E 129) may cause allergic reactions.
Sunset Yellow FCF (E110) may cause allergic reactions
(only for Duloxetine 60mg)

3. How to take Duloxetine
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Duloxetine is for oral use. You should swallow your
capsule whole with a drink of water.
For depression and diabetic neuropathic pain:
The usual dose of Duloxetine is 60 mg once a day, but
your doctor will prescribe the dose that is right for you.
For generalised anxiety disorder:
The usual starting dose of Duloxetine is 30 mg once a
day after which most patients will receive 60 mg once a
day, but your doctor will prescribe the dose that is right
for you. The dose may be adjusted up to 120 mg a day
based on your response to Duloxetine.
To help you remember to take Duloxetine, you may
find it easier to take it at the same times every day.
Talk with your doctor about how long you should keep
taking Duloxetine. Do not stop taking Duloxetine, or
change your dose, without talking to your doctor.
Treating your disorder properly is important to help
you get better. If it is not treated, your condition may
not go away and may become more serious and
difficult to treat.
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If you take more Duloxetine than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Duloxetine prescribed by
your doctor. Symptoms of overdose include sleepiness,
coma, serotonin syndrome (a rare reaction which
may cause feelings of great happiness, drowsiness,
clumsiness, restlessness, feeling of being drunk, fever,
sweating or rigid muscles), fits, vomiting and fast heart
rate.
If you forget to take Duloxetine
If you miss a dose, take it as soon as you remember.
However, if it is time for your next dose, skip the missed
dose and take only a single dose as usual. Do not take
a double dose to make up for a forgotten dose. Do not
take more than the daily amount of Duloxetine that
has been prescribed for you in one day.
If you stop taking Duloxetine
Do not stop taking your capsules without the advice of
your doctor even if you feel better. If your doctor thinks
that you no longer need Duloxetine he or she will ask
you to reduce your dose over at least 2 weeks before
stopping treatment altogether.
Some patients who stop taking Duloxetine suddenly
have had symptoms such as:
• dizziness
• tingling feelings like pins and needles or electric
shock-like feelings (particularly in the head)
• sleep disturbances (vivid dreams, nightmares,
inability to sleep)
• fatigue, sleepiness
• feeling restless or agitated
• feeling anxious
• feeling sick (nausea) or being sick (vomiting)
• shaking (tremor)
• headaches
• muscle pain
• feeling irritable
• diarrhoea
• excessive sweating or
• vertigo
These symptoms are usually not serious and disappear
within a few days, but if you have symptoms that are
troublesome you should ask your doctor for advice.
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. These effects are
normally mild to moderate and often disappear after a
few weeks.
Very common side effects (may affect more than 1
in 10 people)
• headache, feeling sleepy
• feeling sick (nausea), dry mouth
Common side effects (may affect up to 1 in 10
people)
• lack of appetite
• trouble sleeping, feeling agitated, less sex drive,
anxiety, difficulty or failure to experience orgasm,
unusual dreams
• dizziness, feeling sluggish, tremor, numbness,
including numbness, pricking or tingling of the skin
• blurred eyesight
• tinnitus (hearing sound in the ear when there is no
external sound)
• feeling the heart pumping in the chest
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhoea, stomach pain,being sick
(vomiting),heartburn or indigestion, breaking wind
• increased sweating, (itchy) rash
• muscle pain, muscle spasm
• painful urination, frequent urination
• problems getting an erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• weight loss
Children and adolescents under 18 years of age with
depression treated with this medicine had some
weight loss when they first start taking this medicine.
Weight increased to match other children and
adolescents of their age and sex after 6 months of
treatment.
Uncommon side effects (may affect up to 1 in 100
people)
• throat inflammation that causes a hoarse voice
• suicidal thoughts, difficulty sleeping, grinding or
clenching the teeth, feeling disorientated, lack of
motivation
• sudden involuntary jerks or twitches of the muscles,
sensation of restlessness or an inability to sit or stand
still, feeling nervous, difficulty concentrating,
changes in sense of taste, difficulty controlling
movement e.g. lack of coordination or involuntary
movements of the muscles, restless legs syndrome,
poor sleep quality
• large pupils (the dark centre of the eye), problems
with eyesight
• feeling of dizziness or “spinning” (vertigo), ear pain
• fast and/or irregular heart beat
• fainting, dizziness, lightheadedness or fainting on
standing up, cold fingers and/or toes, throat
tightness, nose bleeds
• vomiting blood, or black tarry stools (faeces),
gastroenteritis, burping, difficulty swallowing
• inflammation of the liver that may cause abdominal
pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats, sensitivity to
sunlight, increased tendency to bruise
• muscle tightness, muscle twitching
• difficulty or inability to pass urine, difficulty to start
urinating, needing to pass urine during the night,
needing to pass more urine than normal, having a
decreased urine flow
• abnormal vaginal bleeding, abnormal periods,
including heavy, painful, irregular or prolonged
periods, unusually light or missed periods, pain in
the testicles or scrotum
• chest pain, feeling cold, thirst, shivering, feeling hot,
abnormal gait
• weight gain
Duloxetine may cause effects that you may not be
aware of, such as increases in liver enzymes or blood
levels of:
• potassium
• creatine phosphokinase
• sugar, or
• cholesterol.
Rare side effects (may affect up to 1 in 1000 people)
• serious allergic reaction which causes difficulty in
breathing or dizziness with swollen tongue or lips,
allergic reactions
• decreased thyroid gland activity which can cause
tiredness or weight gain
• dehydration, low levels of sodium in the blood
(mostly in elderly people; the symptoms may

include feeling dizzy, weak, confused, sleepy or very
tired, or feeling or being sick, more serious
symptoms are fainting, fits or falls), syndrome of
inappropriate secretion of anti-diuretic hormone
(SIADH)
• suicidal behavior, mania (over activity, racing
thoughts and decreased need for sleep),
hallucinations, aggression and anger
• “Serotonin syndrome” (a rare reaction which may
cause feelings of great happiness, drowsiness,
clumsiness, restlessness, feeling of being drunk,
fever, sweating or rigid muscles), fits
• increased pressure in the eye (glaucoma)
• inflammation of the mouth, passing bright red blood
in your stools, bad breath
• liver failure, yellowing of the skin or whites of the
eyes (jaundice)
• Stevens-Johnson syndrome (serious illness with
blistering of the skin, mouth, eyes and genitals),
serious allergic reaction which causes swelling of the
face or throat (angioedema)
• contraction of the jaw muscle
• abnormal urine odour
• menopausal symptoms, abnormal production of
breast milk in men or women
Very rare side effects (may affect up to 1 in
10,000 people)
• inflammation of the blood vessels in the skin
(cutaneous vasculitis)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme (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 Duloxetine
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 blister / bottle / carton after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
HDPE bottles: after first opening, use within 3 months
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 to protect the environment.

6. Contents of the pack and other information
What Duloxetine contains
• The active substance is duloxetine.
• Each capsule contains 30 mg of duloxetine (as
hydrochloride).
• Each capsule contains 60 mg of duloxetine (as
hydrochloride).
• The other ingredients are:
Capsule content: pregelatinised starch (maize),
microcrystaline cellulose, povidone K 30, talc,
magnesium stearate, sodium stearyl fumarate,
hypromellose Acetate Succinate, titanium dioxide
(E171), lactose monohydrate, hypromellose and
macrogol/4000.
Capsule shell: titanium dioxide (E171), Gelatin, Brilliant
Blue FCF (E133), Allura Red (E 129)
Quinoline yellow (E104) (60 mg only), Sunset Yellow
FCF (E110) (60 mg only).
Printing ink: shellac glaze, indigo carmine aluminum
lake (E132), titanium dioxide (E171), propylene glycol
(E1520)
What Duloxetine looks like and contents of the pack
Duloxetine 30 mg gastro-resistant size 2 capsules are
presented as Opaque dark blue cap-opaque white
body printed with “30”, containing 4 white to off
white, round, biconvex tablets, containing 30 mg of
Duloxetine active ingredient per capsule.
Duloxetine 60 mg gastro resistant size 0E capsules are
presented as Opaque dark blue cap-opaque yellowish
green body printed with “60”, containing 8 white to off
white, round, biconvex tablets, containing 60 mg of
Duloxetine active ingredient per capsule.
Duloxetine gastro-resistant capsules are available in
(PVC/PE/PCTFE //Al blisters or PA/Al/PVC//Al) blisters in
a cardboard box.
Pack sizes:
Duloxetine 30 mg: 7, 14, 28, 30 and 98 capsules
Duloxetine 60 mg: 14, 28, 30, 56, 84 and 98 capsules
Duloxetine gastro-resistant capsules are available in
HDPE bottles with child-resistant PP screw cap in a
cardboard box.
Pack size: 30, 120 and 200 capsules
The pack sizes of 120 and 200 capsules are limited for
hospital use and dose dispensing.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
Or
Pharmathen S.A.
Dervenakion 6,
Pallini 15351, Attikis,
Greece
Or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben,
Germany
This leaflet was last revised in 06/2016.

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Artwork Proof Box

Ref: V003: Addition of pack sizes of 14, 30, 120 and 200 and
Change to dimensions of the container + Day 30 responses
Proof no.
Date prepared:
Font size:
27/06/2016
9pt
002.1
Colours:
Black
Dimensions: 170 x 500 mm

Fonts:
Myriad Pro

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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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