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DULOXETINE 40 MG GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Children and adolescents under 18 years of age
Duloxetine should 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. 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
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines,
including medicines obtained without a prescription.
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:

Duloxetine is a medicine to treat Stress Urinary
Incontinence (SUI) in women.

Monoamine oxidase inhibitors (MAOIs): You should
NOT take Duloxetine if you are taking or have recently
taken (within the last 14 days) an antidepressant
medicine called a monoamine oxidase inhibitor (MAOI).
Examples of MAOIs include moclobemide (an
antidepressant) and linezolid (an antibiotic). Taking a
MAOI together with 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.

Stress urinary incontinence is a medical condition in
which patients have accidental loss or leakage of urine
during physical exertion or activities such as laughing,
coughing, sneezing, lifting, or exercise.

Medicines that cause sleepiness: These include
medicines prescribed by your doctor including
benzodiazepines, strong painkillers, antipsychotics,
phenobarbital and sedative antihistamines.

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.

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DULOXETINE 20 mg AND 40 mg
GASTRO-RESISTANT
CAPSULES, HARD

Duloxetine is believed to work by increasing the
strength of the muscle that holds back urine when you
laugh, sneeze, or perform physical activities.

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

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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 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 substance 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.

Oral anticoagulants or antiplatelet medicines:
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
You should take extra care if you drink alcohol while
taking 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.

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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 depression or
anxiety disorder
Although Duloxetine is not indicated for the treatment
of depression, its active substance (duloxetine) is used
as an antidepressant medicine. 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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TAKE 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.
The recommended dose of Duloxetine is 40 mg twice a
day (in the morning and late afternoon/evening). Your
doctor may decide to start your treatment with 20 mg
twice a day for two weeks before increasing the dose to
40 mg twice a day.

Duloxetine is for oral use. You should swallow your
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
You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder, and it easier to take it at the same times every day.
ask them to read this leaflet. You might ask them to tell
Do NOT stop taking Duloxetine, or change your dose,
you if they think your depression or anxiety is getting
without talking to your doctor. Treating your disorder
worse, or if they are worried about changes in your
properly is important to help you get better. If it is not
behaviour.
treated, your condition may not go away and may
become more serious and difficult to treat.

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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),
The efficacy of Duloxetine is reinforced when combined
pethidine, St John’s Wort and MAOIs (such as
with a training program called Pelvic Floor Muscle
moclobemide and linezolid). These medicines increase
Training (PFMT).
the risk of side effects; if you get any unusual symptom
taking any of these medicines together with Duloxetine,
you should see your doctor.
WHAT YOU NEED TO KNOW BEFORE YOU

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.

• 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), sensitivity to sunlight
• muscle twitching
• difficulty or inability to pass urine, needing to pass
more urine than normal, having a decreased urine
flow
• abnormal periods, including heavy, painful, irregular
or prolonged periods, unusually light or missed
periods, abnormal production of breast milk
• falls (mostly in elderly people), abnormal gait.

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
Reporting of side effects
dose. Do NOT take more than the daily amount of
Duloxetine that has been prescribed for you in one day. 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
If you stop taking Duloxetine
Do NOT stop taking your capsules without the advice of directly via the Yellow Card Scheme at:
your doctor even if you feel better. If your doctor thinks www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
that you no longer need Duloxetine he or she will ask
this medicine.
you to reduce your dose over 2 weeks.
Some patients, who suddenly stop taking duloxetine
after more than 1 week of therapy, 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.

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 or bottle after EXP. The
expiry date refers to the last day of that month.

Do not store above 30°C.
Store in the original package in order to protect from
These symptoms are usually not serious and disappear moisture.
within a few days, but if you have symptoms that are
Do not throw away any medicines via wastewater or
troublesome you should ask your doctor for advice.
household waste. Ask your pharmacist how to throw
If you have further questions on the use of this
away medicines you no longer use. These measures
medicine, ask your doctor or pharmacist.
will help protect the environment.

4

POSSIBLE SIDE EFFECTS

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

Like all medicines, this medicine can cause side effects,
What Duloxetine contains
although not everybody gets them. These effects are
• The active substance is duloxetine.
normally mild to moderate and often disappear after a
• Each 20 mg gastro-resistant capsule, hard contains 20
short time.
mg of duloxetine (as hydrochloride).
• Each 40 mg gastro-resistant capsule, hard contains 40
Very common side effects (may affect more than 1 in 10
mg of duloxetine (as hydrochloride).
people)
The other ingredients are
• feeling sick (nausea), dry mouth, constipation
• Capsule contents: sugar spheres (sucrose, maize
• fatigue.
starch), povidone (K-30), sodium lauryl sulfate, talc,
hypromellose, sucrose, triethyl citrate, hypromellose
Common side effects (may affect up to 1 in 10 people)
acetate succinate and titanium dioxide (E171)
• lack of appetite

Capsule shells for 20 mg contain titanium dioxide
• trouble sleeping, feeling agitated, less sex drive,
(E171), red iron oxide (E172), indigo carmine (E132)
anxiety, difficulty sleeping
and gelatin
• headache, dizziness, feeling sluggish, feeling sleepy,

Capsule shells for 40 mg contain titanium dioxide
tremor, numbness, including numbness, pricking or
(E171), yellow iron oxide (E172), red iron oxide (E172),
tingling of the skin
indigo carmine (E132) and gelatin
• blurred eyesight
• Printing ink contains shellac, propylene glycol,
• feeling of dizziness or “spinning” (vertigo)
ammonium hydroxide 28 per cent, potassium
• increased blood pressure, flushing
hydroxide and black iron oxide (E172).
• diarrhoea, stomach pain, being sick (vomiting),
heartburn or indigestion
• increased sweating
• weakness, shivering.
Uncommon side effects (may affect up to 1 in 100
people)
• throat inflammation that causes a hoarse voice
• allergic reactions
• decreased thyroid gland activity which can cause
tiredness or weight gain
• dehydration
• grinding or clenching the teeth, feeling disorientated,
lack of motivation, difficulty or failure to experience
orgasm, unusual dreams
• feeling nervous, difficulty concentrating, changes in
sense of taste, poor sleep quality
• large pupils (the dark centre of the eye), problems
with eyesight, eyes feel dry
• tinnitus (hearing sound in the ear when there is no
external sound), ear pain
• feeling the heart pumping in the chest, fast and/or
irregular heart beat
• fainting
• increased yawning
• vomiting blood, or black tarry stools (faeces),
gastroenteritis, inflammation of the mouth, burping,
difficulty swallowing, breaking wind, bad breath
• inflammation of the liver that may cause abdominal
pain and yellowing of the skin or whites of the eyes
• (itchy) rash, night sweats, hives, cold sweats,
increased tendency to bruise
• muscle pain, muscle tightness, muscle spasm,
contraction of the jaw muscle
• difficulty to start urinating, painful urination, needing
to pass urine during the night, frequent urination,
abnormal urine odour
• abnormal vaginal bleeding, menopausal symptoms
• chest pain, feeling cold, thirst, feeling hot
• weight loss, 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.

What Duloxetine looks like and contents of the pack
Duloxetine is a gastro-resistant capsule, hard. Each
capsule of Duloxetine contains pellets of duloxetine
hydrochloride with a covering to protect them from
stomach acid.
Duloxetine is available in 2 strengths: 20 mg and 40 mg.
The 20 mg capsules are hard gelatin capsules with blue
opaque cap and blue opaque body, filled with off white
to yellow coated pellets. Imprinting on body: 20.
The 40 mg capsules are hard gelatin capsules with blue
opaque cap and gold opaque body, filled with off white
to yellow coated pellets. Imprinting on body: 40.
Duloxetine 20 mg is available in blister packs of 14, 28,
56, 84 and 98 capsules and bottles with child resistant
closure with or without silica gel desiccant canister
containing 100 capsules.
Duloxetine 40 mg is available in blister packs of 14, 28,
56, 84, 98, 140 and 196 (2x98) capsules and bottles with
child resistant closure with or without silica gel
desiccant canister containing 100 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 12/2014.
PL 00289/1921
PL 00289/1922

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
• 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, suicidal thoughts, 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, sudden
involuntary jerks or twitches of the muscles,
sensation of restlessness or an inability to sit or stand
still, difficulty controlling movement e.g. lack of
coordination or involuntary movements of the
muscles, restless legs syndrome
• increased pressure in the eye (glaucoma)
• dizziness, lightheadedness or fainting on standing up,
cold fingers and/or toes
• throat tightness, nose bleeds
• passing bright red blood in your stools
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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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