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DULOXETINE MILPHARM 60 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Duloxetine 30 mg
gastro-resistant
capsules, hard
Duloxetine 60 mg
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 any get any 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 contains the active substance
duloxetine. Duloxetine increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine is used 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 recently taken within the
last 14 days, another medicine known as a
monoamine oxidase inhibitor (MAOI) (see
also below in section: ‘Other medicines and
Duloxetine ’)
- are taking fluvoxamine which is usually used
to treat depression, ciprofloxacin or enoxacine
which are used to treat some infections
- are taking other medicines containing
duloxetine (see ‘Other medicines and
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Duloxetine
The following are reasons why Duloxetine may not
be suitable for you. Talk to your doctor before you
taking 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 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.

Black

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 any other medicines,
including medicines obtained without a prescription.
The main ingredient of Duloxetine, 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 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 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. 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, 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 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.
Pregnancy , breast-feeding and fertility
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.


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 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 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.
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.
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 one capsule
(60 mg duloxetine) 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.
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 user

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, fatigue, tingling feelings like pins
and needles or electric shock-like feelings
(particularly in the head) , sleep disturbances
(vivid dreams, nightmares, inability to sleep),
sleepiness, feeling restless or agitated, feeling
anxious, feeling sick (nausea) or being sick
(vomiting), (tremor )shakiness, 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, anxiety, feeling agitated ,less
sex drive, 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 decrease 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 and 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,
pharmacist or nurse.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 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.
This medicinal product does not require any special
storage conditions.
Do not use Duloxetine after the expiry date which
is stated on the label, carton and bottle after EXP.
The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines no longer required. 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 capsule contains 30 mg of duloxetine (as
hydrochloride)
Each capsule contains 60 mg of duloxetine (as
hydrochloride)
-

The other ingredients are
Capsule contents:
Sugar spheres, hypromellose, hydroxy
propyl cellulose, crospovidone (Type B), talc,
triethylcitrate, titanium dioxide, hypromellose
phthalate.
Capsule shell:
Cap: Titanium dioxide, FD & C blue, gelatin,
sodium lauryl sulfate.
Body: Iron oxide yellow (E172) (60 mg only),
titanium dioxide, FD & C Blue (60 mg only),
gelatin, sodium lauryl sulfate.
Printing ink: Shellac, propylene glycol, iron
oxide black (E172), potassium hydroxide.

What Duloxetine looks like and contents of the
pack
Gastro-resistant capsule, hard
Duloxetine 30 mg gastro-resistant capsules, hard
Blue opaque /white opaque, size “3” hard gelatin
capsules filled with white to off white pellets and
imprinted with “DLX” on blue opaque cap and “30”
on white opaque body with black ink
Duloxetine 60 mg gastro-resistant capsules, hard
Blue opaque /green opaque, size ‘l’ hard gelatin
capsules filled with white to off white pellets and
imprinted with “DLX” on blue opaque cap and “60”
on green opaque body with black ink
Duloxetine capsules are available in PVC/
Polyamide/ Aluminium foil/ PVC Aluminium
foil blister pack and HDPE bottle pack with
polypropylene closure containing silica gel as
desiccant.
Pack sizes:
Blister packs: 7, 14, 28, 30 and 98 capsules, hard
HDPE bottle pack: 30, 98, 250 and 1000 capsules,
hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 01/2016.

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Talk with your doctor about how
long you should keep taking
Duloxetine. Do not stop taking
Duloxetine 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.

+ 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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