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DULOXETINE ZENTIVA 40 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user

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

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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.
The main ingredient of Duloxetine, duloxetine, is
used in other medicines for other conditions: diabetic
1. What Duloxetine is and what it is used for
neuropathic pain, depression, anxiety and urinary
incontinence.
Duloxetine contains the active substance duloxetine. Using more than one of these medicines at the same
Duloxetine increases the levels of serotonin and
time should be avoided. Check with your doctor if
noradrenaline in the nervous system.
you are already taking other medicines containing
Duloxetine is a medicine to be taken by mouth to
duloxetine.
treat Stress Urinary Incontinence (SUI) in women.
Your doctor should decide whether you can take
Stress urinary incontinence is a medical condition
Duloxetine with other medicines. Do not start or
in which patients have accidental loss or leakage of
stop taking any medicines, including those bought
urine during physical exertion or activities such as
without a prescription and herbal remedies, before
laughing, coughing, sneezing, lifting, or exercise.
checking with your doctor.
Duloxetine is believed to work by increasing the
You should also tell your doctor if you are taking any
strength of the muscle that holds back urine when
of the following:
you laugh, sneeze, or perform physical activities.
•• Monoamine oxidase inhibitors (MAOIs): You
should not take Duloxetine if you are taking or
The efficacy of Duloxetine is reinforced when
have recently taken (within the last 14 days) an
combined with a training program called Pelvic Floor
antidepressant medicine called a monoamine
Muscle Training (PFMT).
oxidase inhibitor (MAOI). Examples of MAOIs
2. What you need to know before you take
include moclobemide (an antidepressant) and
Duloxetine
linezolid (an antibiotic). Taking a MAOI together
with many prescription medicines, including
Do not take Duloxetine if you:
Duloxetine , can cause serious or even life•• are allergic to duloxetine or any of the other
threatening side effects. You must wait at least
ingredients of this medicine (listed in section 6);
14 days after you have stopped taking an MAOI
•• have liver disease;
before you can take Duloxetine. Also, you need
•• have severe kidney disease;
to wait at least 5 days after you stop taking
•• are taking or have taken within the last 14 days,
Duloxetine before you take a MAOI.
another medicine known as a monoamine oxidase


Medicines that cause sleepiness: These
inhibitor (MAOI) (see “Other medicines and
include medicines prescribed by your doctor
Duloxetine”);
including benzodiazepines, strong painkillers,
•• are taking fluvoxamine which is usually used to
antipsychotics, phenobarbital and sedative
treat depression, ciprofloxacin or enoxacin which
antihistamines.
are used to treat some infections.
Talk to your doctor if you have high blood pressure or •• Medicines that increase the level of
serotonin: Triptans, tramadol, tryptophan,
heart disease. Your doctor will tell you if you should
SSRIs (such as paroxetine and fluoxetine), SNRIs
be taking Duloxetine
(such as venlafaxine), tricyclic antidepressants
Warnings and precautions
(such as clomipramine, amitriptyline), pethidine,
The following are reasons why Duloxetine may not be
St. John’s Wort and MAOIs (such as moclobemide
suitable for you. Talk to your doctor before you take
and linezolid). These medicines increase the risk
Duloxetine if you:
of side effects; if you get any unusual symptom
•• are taking medicines to treat depression (see
taking any of these medicines together with
“Other medicines and Duloxetine ”);
Duloxetine, you should see your doctor.
•• are taking St. John’s Wort, a herbal treatment
•• Oral anticoagulants or antiplatelet agents:
(Hypericum perforatum);
Medicines which thin the blood or prevent the
•• have kidney disease;
blood from clotting. These medicines might
•• have had seizures (fits);
increase the risk of bleeding.
•• have had mania;
Duloxetine with food, drink and alcohol
•• suffer from bipolar disorder;
Duloxetine may be taken with or without food. You
•• have eye problems, such as certain kinds of
should take extra care if you drink alcohol while
glaucoma (increased pressure in the eye);
•• have a history of bleeding disorders (tendency to taking Duloxetine.
Pregnancy and breast-feeding
develop bruises);
•• are at risk of low sodium levels (for example if you If you are pregnant or breast-feeding, think you may
are taking diuretics, especially if you are elderly); be pregnant or are planning to have a baby, ask your
•• are currently being treated with another medicine doctor or pharmacist for advice before taking this
medicine.
which may cause liver damage;
•• are taking other medicines containing duloxetine Tell your doctor if you become pregnant, or you are
(see “Other medicines and Duloxetine”).
trying to become pregnant, while you are taking
Duloxetine may cause a sensation of restlessness or
Duloxetine. You should use Duloxetine only after
an inability to sit or stand still. You should tell your
discussing the potential benefits and any potential
doctor if this happens to you.
risks to your unborn child with your doctor.
Thoughts of suicide and worsening of
Make sure your midwife and/or doctor knows you are
depression or anxiety disorder
on Duloxetine. When taken during pregnancy, similar
Although Duloxetine 20 or 40 mg is not indicated
drugs (SSRIs) may increase the risk of a serious condition
for the treatment of depression, its active ingredient
in babies, called persistent pulmonary hypertension of
(duloxetine) is used as an antidepressant medicine. If
the new-born (PPHN), making the baby breathe faster
you are depressed and/or have anxiety disorders you
and appear bluish. These symptoms usually begin during
can sometimes have thoughts of harming or killing
the first 24 hours after the baby is born. If this happens
yourself. These may be increased when first starting
to your baby you should contact your midwife and/or
antidepressants, since these medicines all take time to doctor immediately.
work, usually about two weeks but sometimes longer.
If you take Duloxetine near the end of your
You may be more likely to think like this if you:
pregnancy, your baby might have some symptoms
•• have previously had thoughts about killing or
when it is born. These usually begin at birth or within
harming yourself;
a few days of your baby being born. These symptoms
•• are a young adult. Information from clinical
may include floppy muscles, trembling, jitteriness,
trials has shown an increased risk of suicidal
not feeding properly, trouble with breathing and fits.
behaviour in adults aged less than 25 years
If your baby has any of these symptoms when it is
with psychiatric conditions who were treated
born, or you are concerned about your baby’s health,
with an antidepressant.
contact your doctor or midwife who will be able to
If you have thoughts of harming or killing
advise you.
yourself at any time, contact your doctor or go
Tell your doctor if you are breast-feeding. The use of
to a hospital straight away.
Duloxetine while breastfeeding is not recommended.
You may find it helpful to tell a relative or close friend You should ask your doctor or pharmacist for advice.
that you are depressed or have an anxiety disorder,
and ask them to read this leaflet. You might ask them Driving and using machines
Duloxetine may make you feel sleepy or dizzy. Do not
to tell you if they think your depression or anxiety is
drive or use any tools or machines until you know
getting worse, or if they are worried about changes
how Duloxetine affects you.
in your behaviour.
Duloxetine contains sucrose
Children and adolescents
If you have been told by your doctor that you have
Duloxetine should not be used for children and
an intolerance to some sugars, contact your doctor
adolescents under 18 years. Also, you should know
that patients under 18 have an increased risk of side- before taking this medicinal product.
effects such as suicide attempt, suicidal thoughts and 3. How to take Duloxetine
hostility (predominantly aggression, oppositional
Always take this medicine exactly as your doctor has
behaviour and anger) when they take this class
told you. Check with your doctor or pharmacist if you
of medicines. Also, the long-term safety effects
are not sure.
concerning growth, maturation, and cognitive and

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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

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.
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 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 further questions on the use of this
medicine, ask your doctor or pharmacist.
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 heartbeat;
•• 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.

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 label and carton after “EXP”.
The expiry date refers to the last day of that month.
Store below 25 °C. Store in the original package in
order 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 protect the environment.
6. Contents of the pack and other information
What Duloxetine contains
The active substance is duloxetine. Each capsule
contains 20 or 40 mg of duloxetine.
The other ingredients are:
Capsule content: sucrose, maize starch, hypromellose
2910/5, hypromellose 2910/6, talc, hypromellose
acetate succinate, triethyl citrate.
Capsule shell:
Duloxetine 20 mg:
Capsule cap and body: Indigo carmine FD&C Blue 2
(E132), titanium dioxide (E171), gelatin
Duloxetine 40 mg:
Capsule cap: Indigo carmine FD&C Blue 2 (E132),
titanium dioxide (E171), gelatin
Capsule body: red iron oxide (E172), yellow iron oxide
(E172), titanium dioxide (E171), gelatin
What Duloxetine looks like and contents of
the pack
Duloxetine is a gastro-resistant hard capsule. Each
capsule of Duloxetine contains pellets of duloxetine
hydrochloride with a covering to protect them from
stomach acid.
Duloxetine 20 mg capsules are hard opaque gelatin
capsules of length approx. 14.3 mm with light-blue
opaque body and light-blue opaque cap which contain
off-white to light-brown-yellow spherical pellets.
Duloxetine 40 mg capsules are hard opaque gelatin
capsules of length approx. 18 mm with orange opaque
body and light-blue opaque cap which contain offwhite to light-brown-yellow spherical pellets.
Duloxetine is available in packs of 14, 28, 56 and 98
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS
Manufacturer
S.C.Zentiva S.A.
B-dul. Theodor Pallady nr.50, sector3 Bucuresti
032266
Romania
This leaflet was last revised in October 2015.

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4. Possible side effects

Rare side effects (may affect up to 1 in 1,000
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, light-headedness or fainting on
standing up, cold fingers and/or toes;
•• Throat tightness, nose bleeds;
•• Passing bright red blood in your stools,
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), 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 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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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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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