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DULOXETINE DISTRIQUIMICA 30 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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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
− 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 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.
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

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
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, 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. Alcohol
should be avoided while you are being treated with
Duloxetine.
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. 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.
Duloxetine contains sucrose
Duloxetine 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
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 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 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

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

You should also tell your doctor if you are taking any of the
following:

Colors

1. What Duloxetine is and what it is used for

Descripció
PROSP. DULOX30MG&60MG,
GLENMARK-UK BLI

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

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 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.

Proveïdor

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 of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

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.

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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 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

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. The expiry date refers to the last day of that
month.
30 mg:
Blister Alu/Alu: This medicine does not require any special
temperature storage conditions. Store in the original package
in order to protect from light.
Blister PVC/PVDC-Alu: Store below 30ºC. Keep the blister
in the outer carton in order to protect from light.
Bottle: This medicine does not require any special
temperature storage conditions. Keep the bottle tightly closed
in order to protect from light.
60 mg:
Blister Alu/Alu: This medicine does not require any special
storage conditions.
Blister PVC/PVDC-Alu: Store below 30ºC.
Bottle: This medicine does not require any special storage
conditions.
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 contains
- The active substance is duloxetine (as hydrochloride).
Each capsule contains 30 or 60 mg of duloxetine (as
hydrochloride).
- The other ingredients are:
Capsule content: Hypromellose, talc, titanium dioxide,
methacrylic acid-ethyl acrylate copolymer dispersion 30%
(sodium lauryl sulphate and polysorbate 80), triethyl
citrate, sugar spheres (maize starch and sucrose) and
sucrose (See end of section 2 for further information on
sucrose).
Capsule shell: gelatin, titanium dioxide (E171), FD& C
Blue 2/Indigo carmine (E132), printing ink (black iron
oxide (E-172), potassium hydroxide and shellac) and
yellow iron oxide (E172) (60 mg only).
What Duloxetine looks like and contents of the pack
Duloxetine is a gastro-resistant capsule, hard. Each capsule
of Duloxetine contains pellets of duloxetine hydrochloride
with a covering to protect them from stomach acid.
Duloxetine is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are printed (cap E/body 127), opaque
blue and opaque white, size 3, filled with off-white to
beige/salmon spherical pellets.
The 60 mg capsules are printed (cap E/body 129), opaque
blue and opaque green, size 1, filled with off-white to
beige/salmon spherical pellets.
Duloxetine 30 mg is available in:
- Alu/Alu blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84,
98 (2x49) and 504 (8x63) (hospital pack) capsules.
- PVC/PVDC-Alu blister packs of 7, 10, 14, 20, 28, 30, 50, 56,
60, 84, 98 and 504 (4x126) (hospital pack) capsules.
- Bottle pack of 500 (hospital pack) capsules.
Duloxetine 60 mg is available in:
- Alu/Alu blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60
(2x30), 84 (2x42), 98 (2x49) and 504 (8x63) (hospital pack)
capsules.
- PVC/PVDC-Alu blister packs of 7, 10, 14, 20, 28, 30, 50, 56,
60, 84, 98 and 504 (4x126) (hospital pack) capsules.
- Bottle pack of 500 (hospital pack) capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Distriquímica, S.A.,
Avda. Mare de Déu de Montserrat 221,
08041 Barcelona, Spain
Manufacturer: Laboratorios Dr. Esteve, S.A.,
C/ Sant Martí, s/n, Polígono Industrial, 08107 Martorelles,
Barcelona, Spain.
This leaflet was last revised in September 2016.
Detailed information on this medicine is available on the
website of Medicines and Healthcare Products Regulatory
Agency: http://www.mhra.gov.uk/
708294 - 03 - Ag

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5. How to store Duloxetine

Colors

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.

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 any side effects directly to the national
reporting
system
via
the
internet
at
www.mhra.gov.uk/yellowcard; or you can report via
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form available from
your local pharmacy. By reporting side effects you can help
provide more information on the safety of this medicine.

B/R - Lot

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, 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.

Very rare side effects (may affect up to 1 in 10,000 people)
• inflammation of the blood vessels in the skin (cutaneous
vasculitis)

Codi

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.

Descripció
PROSP. DULOX30MG&60MG,
GLENMARK-UK BLI

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.

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

Proveïdor

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, 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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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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