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DULOXETINE DR.REDDYS 60MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): 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 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
Romania
United
Kingdom

Duloxetin beta 30 mg / 60 mg
magensaftresistente Hartkapseln
Duloxetină Dr. Reddy's 30 mg /
60 mg capsule gastrorezistente
Duloxetine Dr. Reddy's 30 mg /
60 mg Gastro-Resistant Capsules,
Hard

This leaflet was last revised in 05/2015

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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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