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DULOXETINE DR.REDDYS 60MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE / DULOXETINE HYDROCHLORIDE / DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Duloxetine 30 mg Gastro-Resistant Capsules, Hard
Duloxetine 60 mg Gastro-Resistant Capsules, Hard
Duloxetine
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 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

1. What Duloxetine is and what
it is used for
Duloxetine capsules contain 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 may cause pain).
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.
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
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.

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 substance 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.
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 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 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 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.

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

Care should be taken if you drink alcohol
while you are being treated with 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 breastfeeding is not
recommended. You should ask your
doctor or pharmacist for advice.

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 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
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 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.
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 it easier to take it at the same
time every day. 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.

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.

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
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 2
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
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
• 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 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, 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
• 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

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
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 blister/carton.
Do not store above 30°C. Store in the
original package to protect from moisture.
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 contain

The active substance is duloxetine.
Each 30 mg gastro-resistant capsule, hard
contains 30 mg of duloxetine (as
hydrochloride).
Each 60 mg gastro-resistant capsule, hard
contains 60 mg of duloxetine (as
hydrochloride).
The other ingredients are:
Capsule content: hypromellose,
hypromellose acetate succinate, sucrose,
sugar spheres (containing: sucrose, maize
starch), glycine talc, titanium dioxide
(E171), triethyl citrate.
Capsule shell: gelatin, sodium lauryl
sulphate, titanium dioxide (E171), indigo
carmine (E132), yellow iron oxide (E172)
(60 mg only)
Printing ink: propylene glycol, shellac,
yellow iron oxide (E172) (30 mg only),
titanium dioxide (E171) (60 mg only),
potassium hydroxide (60 mg only).

What Duloxetine capsules look like
and contents of the pack
Duloxetine is a gastro-resistant capsule,
hard. Each capsule of Duloxetine contains
pellets of duloxetine with a covering to
protect them from stomach acid.

Duloxetine 30 mg capsules are white to off
white spherical pellets filled in size ‘3’ hard
gelatin capsules with opaque blue coloured
cap and opaque white coloured body,
imprinted ‘RDY609’ on cap and ‘30mg’ on
body with golden yellow ink.
Duloxetine 60 mg capsules are white to off
white spherical pellets filled in size ‘1’ hard
gelatin capsules with opaque blue coloured
cap and opaque green coloured body,
imprinted ‘RDY610’ on cap and ‘60mg’ on
body with white ink.
Pack sizes of 28, 42, 56, 84 and 98
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6
Riverview Road, Beverley, East Yorkshire,
HU17 0LD, United Kingdom

This medicinal product is authorised in
the Member States of the EEA under the
following names:
Germany
Duloxetin beta 30 mg /
60 mg
magensaftresistente
Hartkapseln
Romania
Duloxetină Dr. Reddy's
30 mg / 60 mg capsule
gastrorezistente
United Kingdom
Duloxetine Dr. Reddy's
30 mg / 60 mg
Gastro-Resistant
Capsules, Hard
This leaflet was last revised in 08/2016

Expand Transcript

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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