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DULOXETINE EIGNA 30 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Duloxetine Eigna 30 mg gastro-resistant capsules, hard
Duloxetine Eigna 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 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 Eigna 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 Eigna is and what it is used for

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

DO NOT take Duloxetine Eigna 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 Eigna )
− are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used
to treat some infections
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− are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Eigna )
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you
should be taking Duloxetine Eigna.

Warnings and precautions
The following are reasons why Duloxetine Eigna may not be suitable for you. Talk to your doctor before you
take Duloxetine Eigna if you:
- are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Eigna )
- 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 Eigna)
Duloxetine Eigna 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 Eigna 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 Eigna for patients under 18 because he/she
decides that this is in their best interests. If your doctor has prescribed Duloxetine Eigna 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 Eigna. Also, the
long-term safety effects concerning growth, maturation, and cognitive and behavioural development of
Duloxetine Eigna in this age group have not yet been demonstrated.
Other medicines and Duloxetine Eigna
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
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The main ingredient of Duloxetine Eigna, 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 Eigna 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 Eigna 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 Duloxetina pharma, 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 Eigna. Also, you need to wait at least 5 days after you stop
taking Duloxetine Eigna 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 symptom taking any of these medicines together with Duloxetine
Eigna, 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 Eigna with food, drink and alcohol
Duloxetine Eigna may be taken with or without food. Care should be taken if you drink alcohol while you
are being treated with Duloxetine Eigna.
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 Eigna. You should use Duloxetine Eigna 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 Eigna. 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 Eigna 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.

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• Tell your doctor if you are breast-feeding. The use of Duloxetine Eigna while breastfeeding is not
recommended. You should ask your doctor or pharmacist for advice.
Driving and using machines
Duloxetine Eigna may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you
know how Duloxetine Eigna affects you.
Duloxetine Eigna contains sucrose
Duloxetine Eigna contains sucrose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
3.

How to take Duloxetine Eigna

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 Eigna 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 Eigna 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 Eigna 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 Eigna.
To help you remember to take Duloxetine Eigna, 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 Eigna. Do not stop taking
Duloxetine Eigna, 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 Eigna than you should
Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Eigna 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 Eigna
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 Eigna that has been prescribed for you in one day.
If you stop taking Duloxetine Eigna
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 Eigna 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 Eigna 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.
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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
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periods, unusually light or missed periods, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
• weight gain
• Duloxetina pharma 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. 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 or 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 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 affects you can help provide more information on the safety of this medicine.
5.

How to store Duloxetine Eigna

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 carton.
Do not store above 30°C.
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 Eigna contains
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The active substance is duloxetine.
Each capsule of DULOXETINE EIGNA 30 mg contains 30mg of duloxetine (as hydrochloride).
Each capsule of DULOXETINE EIGNA 60mg contains 60mg of duloxetine (as hydrochloride).
The other ingredients are: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar
spheres, talc, titanium dioxide (E171), triethyl citrate. Capsule shell: gelatin, titanium dioxide (E171)
and purified water. DULOXETINE EIGNA 60mg also contains brilliant blue (E133) Printing ink:
shellac, black iron oxide (E172) and potassium hydroxide.

What Duloxetine Eigna looks like and contents of the pack
Duloxetine Eigna is a hard gastro-resistant capsule. Each capsule of Duloxetine Eigna contains pellets of
duloxetine hydrochloride with a covering to protect them from stomach acid.
Duloxetine Eigna is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules have white body, imprinted with ‘30 mg’ and a white cap.
The 60 mg capsules have white body, imprinted with ‘60 mg’ and an opaque blue cap
Duloxetine Eigna 30 mg is available in packs of 7, 28 and 98 capsules.
Duloxetine Eigna 60 mg is available in packs of 28 and 98 capsules.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
EIGNA PHARMA S.L.
C/Ernest Lluch 32
08302 Mataró
Spain
Manufacturer
Idiarma Desarrollo Farmacéutico S.L.
Polígono Mocholi, Calle CEIN 1
03331 Noain Navarra
Spain.
Date of last revision of the text: March 2016

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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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