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DULOXETINE 60 MG HARD GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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Pharma Code

20xxxxx

PACKAGE LEAFLET
Package leaflet: information for the user

Duloxetine 30 mg hard
gastro-resistant capsules
Duloxetine 60 mg hard
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 capsule is and what it is 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 capsule is and
what it is used for
Duloxetine capsule contains the active substance
duloxetine. Duloxetine capsule increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine capsule 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.
Warnings and precautions
The following are reasons why duloxetine 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. 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 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.
The main ingredient of Duloxetine capsule, 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, 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, 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 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 contains sucrose
Duloxetine capsule contains 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 capsule is for oral use. You should swallow
your capsule whole with a drink of water. Do not crush
or chew.
For depression and diabetic neuropathic pain:
The usual dose of Duloxetine capsule is 60 mg once a
day, but your doctor will prescribe the dose that is right
for you.
Pharma Code

Pharma Code

For generalised anxiety disorder:
The usual starting dose of Duloxetine capsule 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 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.
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 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
Pharma Code

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 behaviour, 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, inflammation of the large
intestine (leading to diarrhoea)
• 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
For UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
For Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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 and blister.
This medicine does not require any special storage
conditions.
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 capsule contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as
hydrochloride).
The other ingredients are:
Capsule content: sugar spheres (containing maize
starch and sucrose), hypromellose 2910 (E464),
crospovidone (type B), talc, sucrose, carboxy methyl
ethyl cellulose, povidone, titanium dioxide (E171),
Macrogol (E1521), Polysorbate 80 (E433) (See end of
section 2 for further information on sucrose).
Capsule shell (for 30 mg strength): gelatin, titanium
dioxide (E171), sodium laurilsulphate, indigo carmine
(E132).
Capsule shell (for 60 mg strength): gelatin, titanium
dioxide (E171), sodium laurilsulphate, indigo carmine
(E132), Iron oxide yellow (E172).
Edible gold ink (for 30 mg strength): shellac (E904),
propylene glycol, yellow iron oxide (E172).
Edible white ink (for 60 mg strength): shellac (E904),
propylene glycol, potassium hydroxide, titanium dioxide
(E171).
What Duloxetine capsule looks like and contents of
the pack
Duloxetine capsule is a gastro-resistant capsule, hard.
Each capsule of Duloxetine capsule contains pellets of
duloxetine hydrochloride with a covering to protect
them from stomach acid.
Duloxetine capsule is available in 30 mg and 60 mg
strengths.
The 30 mg capsules are opaque blue cap and opaque
white body size “3” (15.80 ± 0.40 mm), imprinted with
“H” on cap and “191” on body, filled with white to off
with colored pellets.
The 60 mg capsules are opaque blue cap and opaque
green body size “1” (19.30 ± 0.40 mm), imprinted with
“H” on cap and “192” on body, filled with white to off
with colored pellets.
Duloxetine capsule is available in:
30 mg: blister packs of 7, 10, 14, 28, 28x1, 30, 90, 98,
98x1 and 100 capsules.
60 mg: blister packs of 10, 14, 28, 28x1, 30, 90, 98,
98x1 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
Manufacturer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Hetero Malta Ltd.
KW20A Corradino Industrial Estate, Paola
PLA 3000, Malta
This leaflet was last revised in 09/2015.

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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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