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DULOXETINE MILPHARM 20 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Duloxetine 20 mg
gastro-resistant
capsules, hard
Duloxetine 40 mg
gastro-resistant
capsules, hard

Duloxetine (as hydrochloride)
Read all of this leaflet carefully before you
start using 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 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 a medicine to be taken by mouth to
treat Stress Urinary Incontinence (SUI) in women.
Stress urinary incontinence is a medical condition
in which patients have accidental loss or leakage of
urine during physical exertion or activities such as
laughing, coughing, sneezing, lifting, or exercise.
Duloxetine is believed to work by increasing the
strength of the muscle that holds back urine when
you laugh, sneeze, or perform physical activities.
The efficacy of Duloxetine is reinforced when
combined with a training program called Pelvic
Floor Muscle Training (PFMT).
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 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
depression or anxiety disorder
Although Duloxetine is not indicated for the
treatment of depression, its active ingredient
(duloxetine) is used as an antidepressant medicine.
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 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. 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.
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) an
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 lifethreatening 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 sedative 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. You
should take extra care if you drink alcohol while
taking 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.
The recommended dose of Duloxetine is 40 mg
twice a day (in the morning and late afternoon/
evening). Your doctor may decide to start your
treatment with 20 mg twice a day for two weeks
before increasing the dose to 40 mg twice a day.
To help you remember to take Duloxetine, you may
find it easier to take it at the same times every day.
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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Package leaflet:
Information for the user

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
2 weeks.
Some patients, who suddenly stop taking
Duloxetine after more than 1 week of therapy, 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 or nurse.
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 short time.
Very common side effects (may affect more
than 1 in 10 people)
• feeling sick (nausea), dry mouth, constipation
• fatigue
Common side effects (may affect up to 1 in
10 people)
• lack of appetite
• trouble sleeping, feeling agitated, less sex
drive, anxiety, difficulty sleeping
• headache, dizziness, feeling sluggish, feeling
sleepy, tremor, numbness, including numbness,
pricking or tingling of the skin
• blurred eyesight
• feeling of dizziness or “spinning” (vertigo)
• increased blood pressure, flushing
• diarrhoea, stomach pain, being sick (vomiting),
heartburn or indigestion
• increased sweating
• weakness, shivering
Uncommon side effects (may affect up to 1 in
100 people )
• throat inflammation that causes a hoarse voice
• allergic reactions
• decreased thyroid gland activity which can
cause tiredness or weight gain
• dehydration
• grinding or clenching the teeth, feeling
disorientated, lack of motivation, difficulty or
failure to experience orgasm, unusual dreams
• feeling nervous, difficulty concentrating,
changes in sense of taste, poor sleep quality
• large pupils (the dark centre of the eye),
problems with eyesight, eyes feel dry
• tinnitus (hearing sound in the ear when there is
no external sound), ear pain
• feeling the heart pumping in the chest, fast and/
or irregular heart beat
• fainting
• increased yawning
• vomiting blood, or black tarry stools (faeces),
gastroenteritis, inflammation of the mouth,
burping, difficulty swallowing, breaking wind,
bad breath
• inflammation of the liver that may cause
abdominal pain and yellowing of the skin or
whites of the eyes
• (itchy) rash, night sweats, hives, cold sweats,
increased tendency to bruise
• muscle pain, muscle tightness, muscle spasm,
contraction of the jaw muscle
• difficulty to start urinating, painful urination,
needing to pass urine during the night, frequent
urination, abnormal urine odour
• abnormal vaginal bleeding, menopausal
symptoms
• chest pain, feeling cold, thirst, feeling hot
• weight loss, 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
• 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, suicidal thoughts, 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, sudden involuntary jerks or twitches of
the muscles, sensation of restlessness or an
inability to sit or stand still, difficulty controlling
movement e.g. lack of coordination or
involuntary movements of the muscles, restless
legs syndrome
increased pressure in the eye (glaucoma)
dizziness, lightheadedness or fainting on
standing up, cold fingers and/or toes
throat tightness, nose bleeds
passing bright red blood in your stools
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),
sensitivity to sunlight
muscle twitching
difficulty or inability to pass urine, needing
to pass more urine than normal, having a
decreased urine flow
abnormal periods, including heavy, painful,
irregular or prolonged periods, unusually light or
missed periods, abnormal production of breast
milk
falls (mostly in elderly people), abnormal gait

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 this medicine after the expiry date
which is stated on the label, carton and bottle after
EXP.The expiry date refers to the last day of that
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 20 mg of duloxetine (as
hydrochloride).
Each capsule contains 40 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: Iron oxide yellow (E172) (20 mg only),
titanium dioxide, FD & C Blue (20 mg only),
indigo carmine (40 mg only), gelatin, sodium
lauryl sulfate.
Body: Iron oxide yellow (E172), iron oxide red
(E172) (40 mg only), titanium dioxide, FD & C
Blue (20 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 20 mg gastro-resistant capsules, hard
Green opaque /green opaque, size “4” hard gelatin
capsules filled with white to off white pellets and
imprinted with “DLX” on green opaque cap and “20”
on green opaque body with black ink
Duloxetine 40 mg gastro- resistant capsules, hard
Blue opaque /orange opaque, size “2” hard gelatin
capsules filled with white to off white pellets and
imprinted with “DLX” on blue opaque cap and “40”
on orange 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: 14, 28, 56 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.

P15XXXXX

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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