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DULOXETINE 30MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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DULOXETINE 30 mg AND 60 mg
GASTRO-RESISTANT
CAPSULES, HARD

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
PACKAGE LEAFLET: INFORMATION FOR THE USER
hostility (predominantly aggression, oppositional
Read all of this leaflet carefully before you start taking behaviour and anger) when they take this class of
medicines. Despite this, your doctor may prescribe
this medicine because it contains important
Duloxetine for patients under 18 because he/she
information for you.
decides that this is in their best interests. If your doctor
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or has prescribed Duloxetine for a patient under 18 and
you want to discuss this, please go back to your doctor.
pharmacist.
You should inform your doctor if any of the symptoms
• This medicine has been prescribed for you only. Do
listed above develop or worsen when patients under 18
not pass it on to others. It may harm them, even if
are taking Duloxetine. Also, the long-term safety effects
their signs of illness are the same as yours.
concerning growth, maturation, and cognitive and
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not behavioural development of duloxetine in this age
group have NOT yet been demonstrated.
listed in this leaflet. See Section 4.

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.

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
Duloxetine is used in adults to treat:
medicine called a monoamine oxidase inhibitor (MAOI).
• depression
Examples of MAOIs include moclobemide (an
• generalised anxiety disorder (chronic feeling of
antidepressant) and linezolid (an antibiotic). Taking a
anxiety or nervousness)
MAOI together with Duloxetine, can cause serious or
• diabetic neuropathic pain (often described as
even life-threatening side effects. You must wait at least
burning, stabbing, stinging, shooting or aching or like 14 days after you have stopped taking an MAOI before
an electric shock. There may be loss of feeling in the
you can take Duloxetine. Also, you need to wait at least
affected area, or sensations such as touch, heat, cold 5 days after you stop taking Duloxetine before you take
or pressure may cause pain).
a MAOI.
Medicines that cause sleepiness: These include
medicines prescribed by your doctor including
benzodiazepines, strong painkillers, antipsychotics,
phenobarbital and antihistamines.

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.

Oral anticoagulants or antiplatelet agents: Medicines
which thin the blood or prevent the blood from clotting.
These medicines might increase the risk of bleeding.

Medicines that increase the level of serotonin: Triptans,
tramadol, tryptophan, SSRIs (such as paroxetine and
fluoxetine), SNRIs (such as venlafaxine), tricyclic
In people with diabetic neuropathic pain it can take
antidepressants (such as clomipramine, amitriptyline),
some weeks before you feel better. Talk to your doctor if pethidine, St John’s Wort and MAOIs (such as
you do not feel better after 2 months.
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,
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
2 TAKE DULOXETINE
you should see your doctor.

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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.
The active ingredient of this medicine, 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.

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
medicines (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 cause a sensation of restlessness or an Duloxetine may make you feel sleepy or dizzy. Do NOT
inability to sit or stand still. You should tell your doctor drive or use any tools or machines until you know how
Duloxetine affects you.
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.

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Talk to your doctor if you have high blood pressure or
heart disease. Your doctor will tell you if you should be
taking Duloxetine.

Duloxetine with food, drink and alcohol
Care should be taken if you drink alcohol while you are
being treated with Duloxetine.

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 medicine.

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.
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
You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder, and day, but your doctor will prescribe the dose that is right
ask them to read this leaflet. You might ask them to tell for you. The dose may be adjusted up to 120 mg a day
based on your response to duloxetine.
you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your
Duloxetine is for oral use. You should swallow your
behaviour.
capsule whole with a drink of water.
Duloxetine may be taken with or without food.
To help you remember to take Duloxetine, you may find
it easier to take it at the same times every day.
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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.

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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

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.

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WHAT IS IN THIS LEAFLET:

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
If you take more Duloxetine than you should
feeling or being sick, more serious symptoms are
Call your doctor or pharmacist immediately if you take
fainting, fits or falls), syndrome of inappropriate
more than the amount of Duloxetine prescribed by your
secretion of anti-diuretic hormone (SIADH)
doctor. Symptoms of overdose include sleepiness,
• suicidal behaviour, mania (over activity, racing
coma, serotonin syndrome (a rare reaction which may
thoughts and decreased need for sleep),
cause feelings of great happiness, drowsiness,
hallucinations, aggression and anger
clumsiness, restlessness, feeling of being drunk, fever,
sweating or rigid muscles), fits, vomiting and fast heart • “serotonin syndrome” (a rare reaction which may
cause feelings of great happiness, drowsiness,
rate.
clumsiness, restlessness, feeling of being drunk,
fever, sweating or rigid muscles), fits
If you forget to take Duloxetine
• increased pressure in the eye (glaucoma)
If you miss a dose, take it as soon as you remember.
• inflammation of the mouth, passing bright red blood
However, if it is time for your next dose, skip the
in your stools, bad breath
missed dose and take only a single dose as usual. Do
• liver failure, yellowing of the skin or whites of the
NOT take a double dose to make up for a forgotten
eyes (jaundice)
dose. Do NOT take more than the daily amount of
Duloxetine that has been prescribed for you in one day. • Stevens-Johnson syndrome (serious illness with
blistering of the skin, mouth, eyes and genitals),
If you stop taking Duloxetine
serious allergic reaction which causes swelling of the
Do NOT stop taking your capsules without the advice of
face or throat (angioedema)
your doctor even if you feel better. If your doctor thinks • contraction of the jaw muscle
that you no longer need Duloxetine he or she will ask
• abnormal urine odour
you to reduce your dose over at least 2 weeks before
• menopausal symptoms, abnormal production of
stopping treatment altogether.
breast milk in men or women.
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.

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

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.

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 carton/blister/bottle after EXP. The expiry
date refers to the last day of that month.

Do not store above 30°C.
Like all medicines, this medicine can cause side effects, Store in the original package in order to protect from
moisture.
although not everybody gets them. These effects are
normally mild to moderate and often disappear after a
Do not throw away any medicines via wastewater or
few weeks.
household waste. Ask your pharmacist how to throw
Very common side effects (may affect more than 1 in 10 away medicines you no longer use. These measures
will help protect the environment.
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.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Duloxetine contains
• The active substance is duloxetine.
• Each 30 mg capsule, hard contains 30 mg of
duloxetine (as hydrochloride).
• Each 60 mg capsule, hard contains 60 mg of
duloxetine (as hydrochloride).
• The other excipients are: Sugar spheres (sucrose,
maize starch), povidone (K-30), sodium lauryl sulfate,
talc, hypromellose, sucrose, triethyl citrate,
hypromellose acetate succinate, titanium dioxide
(E171), Indigotine (E132), gelatin, black iron oxide
(E172), strong ammonia solution (E527) and
propylene glycol (E1520).
• The 30 mg capsules also contain red iron oxide
(E172), shellac (E904) and potassium hydroxide
(E525). The 60 mg capsules also contain yellow iron
oxide (E172) and shellac glaze-45 (20% esterified).

What Duloxetine looks like and contents of the pack
Duloxetine is a gastro-resistant capsule, hard. Each
capsule of Duloxetine contains pellets of duloxetine
Children and adolescents under 18 years of age with
depression treated with this medicine had some weight hydrochloride with a covering to protect them from
stomach acid.
loss when they first start taking this medicine. Weight
increased to match other children and adolescents of
Duloxetine is available in 2 strengths: 30 mg and 60 mg.
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.

Duloxetine 30 mg are hard gelatin capsules with blue
opaque cap and white body, filled with off white to
yellow coated pellets, imprinted with “30” on body.
Duloxetine 60 mg are hard gelatin capsules with blue
opaque cap and light green body, filled with off white to
yellow coated pellets, imprinted with “60” on body.
Duloxetine 30 mg is available in PVC/ACLAR/PVC-Al or
PVC/ACLAR/PVdC/PVC-Al blisters of 7, 10, 14, 28, 30, 56,
98, 100 and 120 capsules or HDPE bottles with PP child
resistant closure with or without silica gel desiccant
canister containing 100 capsules.
Duloxetine 60 mg is available in PVC/ACLAR/PVC-Al or
PVC/ACLAR/PVdC/PVC-Al blisters of 10, 14, 28, 30, 56,
60, 84, 98, 100 and 120 capsules or HDPE bottles with
PP child resistant closure with or without silica gel
desiccant canister containing 100 and 200 capsules.
Not all pack sizes may be marketed
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren,
89143, Germany
This leaflet was last revised in 01/2015.
PL 00289/1924
PL 00289/1925

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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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