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DULOXETINE 30 MG GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet:
Information for the patient

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 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
This medicine 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
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.
• have

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, including medicines obtained
without a prescription.
The main ingredient 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 breastfeeding 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 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
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 time 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.
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.





painful urination, frequent urination
problems getting an erection, changes in ejaculation
falls (mostly in elderly people), fatigue
weight loss

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.

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.

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

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, light-headedness 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 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
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

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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
Very rare side effects (may affect up to 1 in 10,000
people)
• inflammation of the blood vessels in the skin (cutaneous
vasculitis)

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 packaging after EXP. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from
moisture.
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 contains
• The active substance is duloxetine. Each hard gastroresistant capsule contains 30 mg or 60 mg duloxetine
(as duloxetine hydrochloride).
• The other ingredients are:
capsule contents: sugar spheres (sucrose, maize starch),
hypromellose 6 cP, sucrose, hypromellose phthalate, talc
and triethyl citrate
capsule shell: gelatin, titanium dioxide (E171), indigotine
(E132), yellow iron oxide (E172) – only in 60 mg
capsules, ink (shellac, black iron oxide (E172), propylene
glycol, concentrated ammonia solution, potassium
hydroxide)

See section 2 “Duloxetine contains sucrose“.
What Duloxetine looks like and contents of the pack
30 mg gastro-resistant capsules: White to almost white
pellets in a hard gelatine capsule size 3. The capsule
body is white and the cap dark blue. The capsule body is
imprinted with 30 in black.
60 mg gastro-resistant capsules: White to almost white
pellets in a hard gelatine capsule size 1. The capsule body
is yellowish green and the cap dark blue. The capsule body
is imprinted with 60 in black.
Duloxetine is available in packs containing 7, 10, 14, 28,
30, 56, 60, 90 and 100 hard gastro-resistant capsules in
blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Consilient Health Ltd., 5th floor, Beaux Lane House, Mercer
Street Lower, Dublin 2, Ireland
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472
Cuxhaven, Germany
This leaflet was last revised in September 2015

P0372

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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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