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DULOXETINE 40MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user

Duloxetine 20mg and 40mg
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 20mg
and 40mg Gastro-resistant Capsules, hard but
within the leaflet it will be referred to as Duloxetine
capsules.

Children and adolescents under the 18 years of age
Duloxetine capsules 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 capsules in
this age group have not yet been demonstrated.

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

The main ingredient of Duloxetine capsules,
duloxetine, is used in other medicines for other
conditions:
• diabetic neuropathic pain, depression, anxiety and
urinary incontinence.

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 a medicine to be taken by
mouth to treat Stress Urinary Incontinence (SUI) in
women.
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.
Duloxetine capsules is believed to work by increasing
the strength of the muscle that holds back urine when
you laugh, sneeze or perform physical activities.
The efficacy of Duloxetine capsules is reinforced when
combined with a training program called Pelvic Floor
Muscle Training (PFMT).
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.
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 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 depression or
anxiety disorder
Although Duloxetine capsules is not indicated for
the treatment of depression, its active ingredient
(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.
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.

Other medicines and Duloxetine capsules
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.

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) 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 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 sedative 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. You should take extra care if you drink alcohol
while taking 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.

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Duloxetine 20mg & 40mg capsule leaflet - Caduceus - UK

colours/plates:
1. Black

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AAAI6085

dimensions:

print proof no:

3

pharmacode:

origination date: 21.12.15
approved for print/date

min pt size:

145 x 400

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8

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originated by:

jh

revision date:

20.05.16

Technical Approval

revised by:

jh

date sent:

supplier:

Dupnitsa

technically app. date: 22.12.15

21.12.15

Non Printing Colours
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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.
The recommended dose is 40mg twice a day (in the
morning and late afternoon/evening). Your doctor
may decide to start your treatment with 20mg twice a
day for two weeks before increasing the dose to 40mg
twice a day.
To help you remember to take Duloxetine capsules,
you may find it easier to take it at the same times every
day.
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 2 weeks.
Some patients, who suddenly stop taking Duloxetine
capsules 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.
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.

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,
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), 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.
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.

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

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.

4. Possible side effects

Do not store above 25°C.

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 short time.

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.

Very common side effects (may affect more than 1
in 10 people)
• feeling sick (nausea), dry mouth, constipation
• fatigue.

6. Contents of the pack and other information

Common side effects (may affect up to 1 in 10
people)
• lack of appetite
• trouble sleeping, feeling agitated, less sex drive,
anxiety, difficulty sleeping
• headache, dizziness, feeling sluggish, feeling sleepy,
tremor, numbness, including numbness, pricking or
tingling of the skin
• blurred eyesight
• feeling of dizziness or “spinning” (vertigo)
• increased blood pressure, flushing
• 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 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.

What Duloxetine capsules contain
The active substance is duloxetine:
Each capsule contains 20mg or 40mg of duloxetine (as
hydrochloride).
The other ingredients are:
Capsule content: sugar spheres, hypromellose
phthalate, hypromellose, triethyl citrate, hydroxypropyl
cellulose, talc
Capsule shell 20mg: Brilliant Blue FCF(FD&C Blue 1)
(E133), titanium dioxide (E171), Hypromellose (E464),
edible printing ink
Capsule shell 40mg: titanium dioxide (E171), yellow iron
oxide (E172), Hypromellose (E464), 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: 20mg
and 40mg.
The 20mg capsules have an opaque blue body
imprinted with ‘DLX 20’ and an opaque blue cap,
imprinted with ‘DLX 20’.
The 40mg capsules have an opaque yellow body
imprinted with ‘DLX 40’ and an opaque yellow cap,
imprinted with ‘DLX 40’.
Duloxetine capsules is available in:
• 
HDPE containers with PP twist-off cap with
integrated silica gel desiccant in pack sizes of 28 and
56 capsules.
• 
Blister (AL/AL) in pack sizes of 28 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th floor, 94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa 2600
Bulgaria
This leaflet was last revised in
May 2016.

Continued top of next column

AAAI6085

Duloxetine 20mg & 40mg capsule leaflet - Caduceus - UK

colours/plates:
1. Black

item no:

AAAI6085

dimensions:

print proof no:

3

pharmacode:

origination date: 21.12.15
approved for print/date

min pt size:

145 x 400

2.
3.
4.

8

5.
6.

originated by:

jh

revision date:

20.05.16

Technical Approval

revised by:

jh

date sent:

supplier:

Dupnitsa

technically app. date: 22.12.15

21.12.15

Non Printing Colours
1.
2.
3.

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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