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DULOXETINE MILPHARM 60 MG 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 (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

P15XXXXX

P15XXXXX

Duloxetine 30 & 60 mg

Duloxetine 30 & 60 mg

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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.

1. What Duloxetine is and what it is used for

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.

Duloxetine contains the active substance duloxetine. Duloxetine
increases the levels of serotonin and noradrenaline in the nervous
system.

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.

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
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

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.
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.
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.

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
• 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
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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

This medicinal product does not require any special storage
conditions.

4. Possible side effects

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.

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

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

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.

Duloxetine 30 mg gastro-resistant capsules, hard
Blue opaque /white opaque, size “3” hard gelatin capsule filled with
white to off white pellets and imprinted with “X” on blue opaque cap
and “02” on white opaque body with black ink

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

Duloxetine 60 mg gastro-resistant capsules, hard
Blue opaque /green opaque, size 'l' hard gelatin capsule filled with
white to off white pellets and imprinted with “X” on blue opaque cap
and “03” 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 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
P15XXXXX

This leaflet was last revised in 07/2015.

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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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