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DULOXETINE 60 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: information for the user

this age group have not yet been demonstrated.

Duloxetine 30 mg gastro-resistant
capsules, hard
Duloxetine 60 mg gastro-resistant
capsules, hard
duloxetine

Other medicines and Duloxetine Capsules
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

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 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
1. What Duloxetine Capsules are and
what they are used for
Duloxetine Capsules contains the active
substance duloxetine. Duloxetine increases
the levels of serotonin and noradrenaline in
the nervous system.
Duloxetine Capsules 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

The main ingredient of Duloxetine Capsules,
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 Capsules 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 Capsules 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 Capsules 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
Capsules 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.
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Duloxetine 40mg & 60mg gastro-resistant capsules, hard
- 28 capsules
Wockhardt UK

UK Supply
(w)135 x (h)560mm
9 pt.
Duloxetine Capsules_30mg-60mg_Leaflet_107616-1.ai
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- 3RD NOV. 2015
- 2ND DEC. 2015
- 22ND JAN. 2016
- 27TH JAN. 2016
- 3RD FEB. 2016
- 17TH MARCH 2016
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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.
If you suffer from any of the following at
any time during your treatment stop
taking the medicine and seek immediate
medical help:
• serious allergic reaction which causes
difficulty in breathing or dizziness with
swollen tongue or lips, allergic reactions.
• 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 behavior
• “Serotonin syndrome” (a rare reaction
which may cause feelings of great
happiness, drowsiness, clumsiness,
restlessness, feeling of being drunk, fever,
sweating or rigid muscles)
• 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)
• vomiting blood, or black tarry stools
(faeces)
• liver failure, yellowing of the skin or whites
of the eyes (jaundice)
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
• 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
Rare side effects (may affect up to 1 in
1000 people)
• decreased thyroid gland activity which can
cause tiredness or weight gain
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• dehydration
• mania (over activity, racing thoughts and
decreased need for sleep), hallucinations,
aggression and anger
• 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)
• 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 the national
reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517; Website: www.hpra.ie;
email: medsafety@hpra.ie
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 Capsules 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 laurilsulfate,
indigo carmine (E132).
Capsule shell (for 60 mg strength): gelatin,
titanium dioxide (E171), sodium laurilsulfate,
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 Capsules looks like and
contents of the pack
Duloxetine Capsules is a gastro-resistant
capsule, hard. Each capsule of Duloxetine
Capsules contains pellets of duloxetine
hydrochloride with a covering to protect
them from stomach acid.
Duloxetine Capsules 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 white coloured 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 white coloured pellets.
Duloxetine Capsules is available in:
30 mg: blister packs of 7, 28 and 56 capsules.
60 mg: blister packs of 28 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Other sources of information
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK only). Please be
ready to give the following information:
Duloxetine 30 mg
gastro-resistant capsules,
hard

PL 29831/0650

Duloxetine 60 mg
gastro-resistant capsules,
hard

PL 29831/0652

This is a service provided by the Royal
National Institute of Blind People.
For patients in the Republic of Ireland please
call +44 1978 661261.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
United Kingdom
Duloxetine 30 mg
gastro-resistant capsules,
hard

PL 29831/0650

Duloxetine 60 mg
gastro-resistant capsules,
hard

PL 29831/0652

Republic of Ireland
Duloxetine 30 mg
gastro-resistant capsules,
hard

PA1339/61/2

Duloxetine 60 mg
gastro-resistant capsules,
hard

PA1339/61/4

This leaflet was last revised in May 2016.
Detailed information on this medicine is
available on the website of MHRA, UK or
HPRA, Republic of Ireland.

107616/1

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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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