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DULOXETINE 60MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE / DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user

Duloxetine 30mg and 60mg
Gastro-resistant Capsules, hard
Duloxetine (as hydrochloride)
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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
• The full name of this medicine is Duloxetine 30mg and
60mg Gastro-resistant Capsules, hard but within the
leaflet it will be referred to as Duloxetine capsules.
What is in this leaflet
1. What Duloxetine capsules are and what they are used
for
2. What you need to know before you take Duloxetine
capsules
3. How to take Duloxetine capsules
4. Possible side effects
5. How to store Duloxetine capsules
6. Contents of the pack and other information
1. What Duloxetine capsules are and what they are
used for
Duloxetine capsules contain the active substance
duloxetine. Duloxetine capsules increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine capsules 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 capsules 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
capsules 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
capsules
Do not take Duloxetine capsules 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 capsules’)
• 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 capsules’).
Talk to your doctor if you have high blood pressure or heart
disease. Your doctor will tell you if you should be taking
Duloxetine capsules.
Warnings and precautions
The following are reasons why Duloxetine capsules may
not be suitable for you. Talk to your doctor before you take
Duloxetine capsules if you:
• are taking other medicines to treat depression (see
‘Other medicines and Duloxetine capsules’)
• 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 capsules’).
Duloxetine capsules 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 the 18 years of age
Duloxetine capsules 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
Continued top of next column

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 capsules for patients under 18 because he/she
decides that this is in their best interests. If your doctor has
prescribed Duloxetine capsules 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 capsules. Also, the long-term safety
effects concerning growth, maturation and cognitive and
behavioural development of Duloxetine capsules in this
age group have not yet been demonstrated.
Other medicines and Duloxetine capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
The main ingredient of Duloxetine capsules, 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 capsules 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 capsules 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 capsules, 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 capsules. Also, you need to wait at least 5 days
after you stop taking Duloxetine capsules 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 capsules, 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 capsules with food, drink and alcohol
Duloxetine capsules may be taken with or without food.
Care should be taken if you drink alcohol while you are
being treated with Duloxetine capsules.
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 capsules. You should use Duloxetine capsules
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 capsules. 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 capsules 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 capsules while breastfeeding is not
recommended. You should ask your doctor or
pharmacist for advice.
Driving and using machines
Duloxetine capsules may make you feel sleepy or dizzy. Do
not drive or use any tools or machines until you know how
Duloxetine capsules affects you.
Duloxetine capsules contain sucrose
Duloxetine capsules contain sucrose. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Duloxetine capsules
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 capsules are 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 capsules is 60mg once a day,
but your doctor will prescribe the dose that is right for you.
Continued over page

Duloxetine 30mg & 60mg Capsules PIL - UK

colours/plates:
1. Black

item no:

AAAI1641

dimensions:

print proof no:

4

pharmacode:

origination date: 31.07.15
approved for print/date

min pt size:

145 x 400

2.
3.
4.

8pts

5.
6.

originated by:

jh

revision date:

14.12.16

Technical Approval

revised by:

sa

date sent: 31.07.15 + 09.12.16

supplier:

Dupnitsa

technically app. date: 12.12.16

Non Printing Colours
1.
2.
3.

For generalised anxiety disorder:
The usual starting dose of Duloxetine capsules is 30mg
once a day after which most patients will receive 60mg
once a day, but your doctor will prescribe the dose that is
right for you. The dose may be adjusted up to 120mg a day
based on your response to Duloxetine capsules.
To help you remember to take Duloxetine capsules, 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 capsules. Do not stop taking Duloxetine
capsules, 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.
If you take more Duloxetine capsules than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Duloxetine capsules 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 capsules
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 capsules that has
been prescribed for you in one day.
If you stop taking Duloxetine capsules
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 capsules 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 capsules
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.
See your doctor immediately if you get any of the
following side effects:
Rare side effects (may affect up to 1 in 1000 people)
• if you have thoughts of harming or killing yourself at
any time, contact your doctor or go to a hospital straight
away (see section 2).
• mania (over activity, racing thoughts and decreased
need for sleep)
• serious allergic reaction which causes difficulty in
breathing or dizziness with swollen tongue or lips,
allergic reactions
• serious allergic reaction which causes swelling of the
face or throat (angioedema)
• serotonin syndrome; a rare reaction which may cause
feelings of great happiness, drowsiness, clumsiness,
restlessness, feeling of being drunk, fever, sweating or
rigid muscles
• Stevens Johnson syndrome (serious illness with
blistering of the skin, mouth, eyes and genitals)
• vomiting blood, or black tarry stools (faeces),
• liver failure, yellowing of the skin or whites of the eyes
(jaundice)
Other possible side effects:
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
• 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 capsules 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)
• hallucinations, aggression and anger
• fits
• increased pressure in the eye (glaucoma)
• inflammation of the mouth, passing bright red blood
in your stools, bad breath, inflammation of the large
intestine (leading to diarrhoea)
• 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 Website: 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 capsules
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 after “EXP”. The expiry date refers to the
last day of that month.
Do not store above 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 Duloxetine capsules contain
The active substance is duloxetine
Each capsule contains 30mg or 60mg of duloxetine (as
hydrochloride).
The other ingredients are:
Capsule content: sugar spheres, hypromellose phthalate,
hypromellose, triethyl citrate, hydroxypropyl cellulose, talc
Capsule shell 30mg: Hypromellose (E464), titanium dioxide
(E171), Brilliant Blue FCF(FD&C Blue 1) (E133), black iron
oxide (E172), edible printing ink
Capsule shell 60mg: Hypromellose (E464), titanium dioxide
(E171), black iron oxide (E172), edible printing ink
Edible Printing ink contains: shellac, propylene glycol, strong
ammonia solution, black iron oxide (E172), potassium
hydroxide.
What Duloxetine capsules look like and contents of the
pack
Duloxetine capsules is a hard gastro‑resistant capsule.
Each capsule of Duloxetine capsules contains pellets of
duloxetine hydrochloride with a covering to protect them
from stomach acid.
Duloxetine capsules is available in 2 strengths: 30mg and
60mg.
The 30mg capsules have an opaque grey body imprinted
with ‘DLX 30’ and an opaque blue cap, imprinted with ‘DLX
30’.
The 60mg capsules have an opaque grey body imprinted
with ‘DLX 60’ and an opaque white cap, imprinted with
‘DLX 60’.
Duloxetine capsules is available in:
• 
HDPE containers with PP twist-off cap with integrated
silica gel desiccant in pack sizes of 28 capsules.
• 
Blister (AL/AL) in pack sizes of 28.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa 2600
Bulgaria
This leaflet was last revised in
December 2016.

Actavis, Barnstaple, EX32 8NS, UK
AAAI1641

Continued top of next column

Duloxetine 30mg & 60mg Capsules PIL - UK

colours/plates:
1. Black

item no:

AAAI1641

dimensions:

print proof no:

4

pharmacode:

origination date: 31.07.15
approved for print/date

min pt size:

145 x 400

2.
3.
4.

8pts

5.
6.

originated by:

jh

revision date:

14.12.16

Technical Approval

revised by:

sa

date sent: 31.07.15 + 09.12.16

supplier:

Dupnitsa

technically app. date: 12.12.16

Non Printing Colours
1.
2.
3.

Package leaflet: Information for the user

Duloxetine 30mg and 60mg
Gastro-resistant Capsules, hard
Duloxetine (as hydrochloride)

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 side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Duloxetine 30mg and 60mg Gastro-resistant
Capsules, hard but within the leaflet it will be referred to as Duloxetine capsules.
What is in this leaflet
1. What Duloxetine capsules are and what they are used for
2. What you need to know before you take Duloxetine capsules
3. How to take Duloxetine capsules
4. Possible side effects
5. How to store Duloxetine capsules
6. Contents of the pack and other information

You should inform your doctor if any of the symptoms listed above develop or
worsen when patients under 18 are taking Duloxetine capsules. Also, the longterm safety effects concerning growth, maturation and cognitive and behavioural
development of Duloxetine capsules in this age group have not yet been
demonstrated.
Other medicines and Duloxetine capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
The main ingredient of Duloxetine capsules, 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.

1. What Duloxetine capsules are and what they are used for
Duloxetine capsules contain the active substance duloxetine. Duloxetine capsules
increases the levels of serotonin and noradrenaline in the nervous system.
Duloxetine capsules 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 capsules 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 capsules 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 capsules
Do not take Duloxetine capsules 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
capsules’)
• 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 capsules’).
Talk to your doctor if you have high blood pressure or heart disease. Your doctor
will tell you if you should be taking Duloxetine capsules.
Warnings and precautions
The following are reasons why Duloxetine capsules may not be suitable for you.
Talk to your doctor before you take Duloxetine capsules if you:
• are taking other medicines to treat depression (see ‘Other medicines
and Duloxetine capsules’)
• 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 capsules’).
Duloxetine capsules 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 capsules 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
capsules for patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Duloxetine capsules for a patient under 18
and you want to discuss this, please go back to your doctor.

Your doctor should decide whether you can take Duloxetine capsules 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
capsules 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
capsules, 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 capsules. Also, you need to wait at least 5 days after you stop taking
Duloxetine capsules 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 capsules, 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 capsules with food, drink and alcohol
Duloxetine capsules may be taken with or without food. Care should be taken if
you drink alcohol while you are being treated with Duloxetine capsules.
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 capsules. You should use Duloxetine capsules
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 capsules.
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 capsules 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 capsules while
breastfeeding is not recommended. You should ask your doctor or pharmacist
for advice.
Driving and using machines
Duloxetine capsules may make you feel sleepy or dizzy. Do not drive or use any
tools or machines until you know how Duloxetine capsules affects you.
Duloxetine capsules contain sucrose
Duloxetine capsules contain sucrose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
3. How to take Duloxetine capsules
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 capsules are 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 capsules is 60mg 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 capsules is 30mg once a day after which
most patients will receive 60mg once a day, but your doctor will prescribe the dose
that is right for you. The dose may be adjusted up to 120mg a day based on your
response to Duloxetine capsules.

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Duloxetine 30mg & 60mg 28 Tablets PIL - UK
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Date sent:
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Date received: 13.12.16

Dimensions:
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To help you remember to take Duloxetine capsules, 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
capsules. Do not stop taking Duloxetine capsules, 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.
If you take more Duloxetine capsules than you should
Call your doctor or pharmacist immediately if you take more than the amount of
Duloxetine capsules 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 capsules
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 capsules that has been prescribed for you in one
day.
If you stop taking Duloxetine capsules
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 capsules
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 capsules 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.

• 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 capsules 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)
• hallucinations, aggression and anger
• fits
• increased pressure in the eye (glaucoma)
• inflammation of the mouth, passing bright red blood in your stools, bad breath,
inflammation of the large intestine (leading to diarrhoea)
• 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 Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of
this medicine.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

5. How to store Duloxetine capsules

4. Possible side effects

Do not use this medicine after the expiry date which is stated on the carton after
“EXP”. The expiry date refers to the last day of that month.

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.
See your doctor immediately if you get any of the following side effects:
Rare side effects (may affect up to 1 in 1000 people)
• if you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away (see section 2).
• mania (over activity, racing thoughts and decreased need for sleep)
• serious allergic reaction which causes difficulty in breathing or dizziness with
swollen tongue or lips, allergic reactions
• serious allergic reaction which causes swelling of the face or throat
(angioedema)
• serotonin syndrome; a rare reaction which may cause feelings of great
happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever,
sweating or rigid muscles
• Stevens Johnson syndrome (serious illness with blistering of the skin, mouth,
eyes and genitals)
• 
vomiting blood, or black tarry stools (faeces),
• 
liver failure, yellowing of the skin or whites of the eyes (jaundice)
Other possible side effects:

Keep this medicine out of the sight and reach of children.

Do not store above 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 Duloxetine capsules contain
The active substance is duloxetine
Each capsule contains 30mg or 60mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: sugar spheres, hypromellose phthalate, hypromellose, triethyl
citrate, hydroxypropyl cellulose, talc
Capsule shell 30mg: Hypromellose (E464),titanium dioxide (E171), Brilliant Blue
FCF(FD&C Blue 1) (E133), black iron oxide (E172), edible printing ink
Capsule shell 60mg: Hypromellose (E464), titanium dioxide (E171), black iron oxide
(E172), edible printing ink
Edible Printing ink contains: shellac, propylene glycol, strong ammonia solution,
black iron oxide (E172), potassium hydroxide.

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
• 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

What Duloxetine capsules look like and contents of the pack
Duloxetine capsules is a hard gastro‑resistant capsule. Each capsule of Duloxetine
capsules contains pellets of duloxetine hydrochloride with a covering to protect
them from stomach acid.
Duloxetine capsules is available in 2 strengths: 30mg and 60mg.
The 30mg capsules have an opaque grey body imprinted with ‘DLX 30’ and an
opaque blue cap, imprinted with ‘DLX 30’.
The 60mg capsules have an opaque grey body imprinted with ‘DLX 60’ and an
opaque white cap, imprinted with ‘DLX 60’.
Duloxetine capsules is available in:
• HDPE containers with PP twist-off cap with integrated silica gel desiccant in
pack sizes of 28 capsules.
• Blister (AL/AL) in pack sizes of 28.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis, Barnstaple, EX39 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa 2600
Bulgaria
This leaflet was last revised in December 2016.

Actavis, Barnstaple, EX32 8NS, UK

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BBBA0337

Duloxetine 30mg & 60mg 28 Tablets PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0337

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
12.12.16
16.12.16
S.Anson

Date sent:
12.12.16
Date received: 13.12.16

Dimensions:
190 x 380
Min Body Text Size: 8pts
Supplier:
Actavis Bulgaria
Dupnitsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand view ⇕

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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