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DULOXETINE 60 MG GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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148 mm
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64 mm

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Duloxetine (as hydrochloride)

1985

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.

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, pharmacist or nurse.
- 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.

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.

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

Duloxetine, the main ingredient of this medicine,
is used in other medicines for other conditions:
! diabetic neuropathic pain, depression,
anxiety or urinary incontinence.
Using more than one of these medicines at the
same time should be avoided. Check with your
doctor or pharmacist if you are already taking
other medicines which contain duloxetine.

1 What Duloxetine is and what it is used
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.

for
Duloxetine 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 that may cause pain)

You should also tell your doctor or pharmacist 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 take Duloxetine. Also, you need to wait
at least five days, after you stop taking Duloxetine,
before taking an MAOI.

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.

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

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.

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 symptoms,
taking any of these medicines together with
Duloxetine, you should see your doctor.

2 What you need to know before you

take Duloxetine

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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
! are taking other medicines containing
duloxetine (see 'Other medicines and
Duloxetine')

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.

Talk to your doctor if you have high blood
pressure or heart disease. Your doctor will tell you
if you should be 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 if
you are trying to become pregnant, while you
are taking duloxetine. You should use
duloxetine only after discussing the potential
benefits and risks to your unborn child with
your doctor.
Make sure your midwife and/or doctor knows
you are taking duloxetine. When taken during
pregnancy, similar drugs, known as Selective
Serotonin Re-uptake Inhibitors (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 and they will be able to
advise you.
- Tell your doctor if you are breast-feeding. The
use of Duloxetine whilst breastfeeding is not
recommended. You should ask your doctor or
pharmacist for advice.

Warnings and precautions
The following are reasons why Duloxetine may
not be suitable for you. Talk to your doctor or
pharmacist 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 antidepressants

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
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.

If you have thoughts of harming or killing
yourself at any time, contact your doctor or go
to a hospital straight away.

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.

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.

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.

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

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 times every
day.

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Package leaflet: Information for the patient

Duloxetine 30 mg and 60 mg gastro-resistant
capsules hard

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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.

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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 the
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 two 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.
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.
Very common side effects (may affect more
than 1 in 10 people)
! headache, feeling sleepy
! feeling sick (nausea), dry mouth

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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, 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 started taking
this medicine. Weight increased to match other
children and adolescents of their age and sex after
six 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
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 the elderly, 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 antidiuretic hormone (SIADH)

!
!
!

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 system listed in the Yellow Card Scheme
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App store.
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 and blister. This
medicinal product does not require any special
temperature storage conditions.
Store in 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 that you no longer use.
These measures will help to protect the
environment.
6 Contents of the pack and other

information
What Duloxetine contains
The active substance is duloxetine. Each gastroresistant capsule hard contains 30 or 60 mg of
duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: Sugar spheres 20-25#,
hypromellose, mannitol, talc, macrogol, PEG 400,
methacrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30 %, triethyl citrate, sodium hydroxide
pellets
Capsule shell 30 mg:
Cap: Brilliant blue FCF aluminium lake (E133),
Allura red AC aluminium lake (E129), titanium
dioxide (E171), gelatin, water
Body: Titanium Dioxide (E171), gelatin, water
Capsule shell 60 mg:
Cap: Indigotine (E132), titanium dioxide (E171),
gelatin, water
Body: Indigotine (E132), iron oxide yellow (E172),
titanium dioxide (E171), gelatin, water
Printing ink contains: 30 mg: Shellac, propylene
glycol, yellow iron oxide (E172)
Printing ink contains: 60 mg: Shellac, propylene
glycol, potassium hydroxide and titanium dioxide
(E171)
What Duloxetine looks like and content of the
pack
Duloxetine is available in 2 strengths: 30 mg and
60 mg.
The 30 mg capsules are white to off white pellets
filled in size 3 hard gelatin capsule having opaque
blue coloured cap and opaque white coloured
body imprinted with HP 459 on cap and body with
gold ink.
Duloxetine 30 mg gastro-resistant capsules hard
are available in packs of 7, 28, 98, 100 capsules.
The 60 mg capsules are white to off white pellets
filled in size 1 hard gelatin capsule having opaque
blue coloured cap and opaque green coloured
body imprinted with HP 460 on cap and body with
white ink.
Duloxetine 60 mg gastro-resistant capsules hard
are available in packs of 28, 98, 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
220 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom
Manufacturer
Tillomed Laboratories Ltd
220 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom Duloxetine 30 mg gastroresistant capsules hard
Duloxetine 60 mg gastroresistant capsules hard
Germany
Duloxetina Tillomed 30 mg
magensaftresistente
Hartkapseln
Duloxetina Tillomed 60 mg
magensaftresistente
Hartkapseln
Italy
Duloxetina Tillomed
Spain
Duloxetine Tillomed 30 mg
cápsulas duras
gastrorresistentes EFG
Duloxetine Tillomed 60 mg
cápsulas duras
gastrorresistentes EFG
France
Duloxetine Tillomed 30 mg,
gélule gastro-résistante
Duloxetine Tillomed 60 mg,
gélule gastro-résistante
This leaflet was last revised in 10/2017
1985

Back

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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, 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)
contraction of the jaw muscle
abnormal urine odour
menopausal symptoms, abnormal production
of breast milk in men or women

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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.

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