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DUTOR 60 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Dutor 30 mg Gastro-resistant Capsules, Hard
Dutor 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 Dutor is and what it is used for
2. What you need to know before you take Dutor
3. How to take Dutor
4. Possible side effects
5. How to store Dutor
6. Contents of the pack and other information
1. What Dutor is and what it is used for
Dutor contains the active substance duloxetine. Dutor increases the levels of serotonin and noradrenaline in the
nervous system.
Dutor 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)
Dutor 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 Dutor 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 Dutor
Do not take Dutor 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 Dutor’).

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 Dutor.
Warnings and precautions
The following are reasons why Dutor may not be suitable for you. Talk to your doctor before you take Dutor if you:

are taking other medicines to treat depression (see ‘Other medicines and Dutor’).

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.
The active substance of Dutor, 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.
Dutor 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
Dutor 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 Dutor for patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Dutor 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 Dutor. Also, the long-term safety effects concerning growth, maturation, and
cognitive and behavioural development of Dutor in this age group have not yet been demonstrated.
Other medicines and Dutor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription.
Your doctor should decide whether you can take Dutor 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 Dutor 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 Dutor, 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 Dutor. Also, you need to wait at least 5 days after you stop taking Dutor before you take a MAOI.
Medicines that cause sleepiness:
These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics,
phenobarbital and antihistamines.

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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 Dutor, 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.
Dutor with food, drink and alcohol
Care should be taken if you drink alcohol while you are being treated with Dutor.
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 Dutor.
You should use Dutor 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 Dutor. When taken during pregnancy, similar
medicines (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 Dutor 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.


If you take more Dutor than you should
Call your doctor or pharmacist immediately if you take more than the amount of Dutor 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 Dutor
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 Dutor that has been prescribed for you in one day.
If you stop taking Dutor
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 Dutor he or she will ask you to reduce your dose over at least 2 weeks before stopping
treatment altogether.
Some patients who stop taking Dutor 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.
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, change 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

Dutor 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 1,000 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 affects 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.
5. How to store Dutor
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 and blister/bottle pack. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Shelf life after first opening of the HDPE bottle:
28’s container: 30 days
98’s and 100’s container: 100 days
Do not throw away any medicines via wastewater. 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 Dutor contains
The active substance is duloxetine.
Dutor 30 mg:
Each gastro-resistant capsule, hard contains 30 mg of duloxetine (as hydrochloride).
Dutor 60 mg:
Each gastro-resistant capsule, hard contains 60 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: Hypromellose 2910, hypromellose acetate succinate, sucrose, sugar spheres (consisting of
sucrose, maize starch, (liquid) glucose, purified water), talc, titanium dioxide (E 171), triethyl citrate, macrogol
400
Dutor 30 mg:
Capsule shell: gelatine, sodium lauryl sulphate, titanium dioxide (E 171), indigo carmine (E 132)
Black Printing ink: Shellac, black iron oxide (E 172), potassium hydroxide
White Printing ink: Shellac, titanium dioxide (E171), potassium hydroxide
Dutor 60 mg:
Capsule shell: gelatine, sodium lauryl sulphate, titanium dioxide (E 171), indigo carmine (E 132) iron oxide yellow
(E 172)
Printing ink: Shellac, sodium hydroxide, povidone K16, titanium dioxide (E 171)
What Dutor looks like and contents of the pack
Dutor is a gastro-resistant capsule, hard. Each capsule of Dutor contains pellets of duloxetine hydrochloride with
a covering to protect them from stomach acid.

Tell your doctor if you are breast-feeding. The use of Dutor while breastfeeding is not recommended. You
should ask your doctor or pharmacist for advice.

30 mg: Size ‘3’ hard gelatin capsule having blue cap and milky white body, imprinted with ’30 mg’ on the body
with black ink and ’30 mg’ on the cap with white ink, containing off white to reddish brown coloured pellets.

Driving and using machines
Dutor may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Dutor
affects you.

60 mg: Size ‘1’ hard gelatin capsule having opaque blue cap and yellow body, imprinted with ’60 mg’ on the body
and ‘1111’ on the cap with white ink, containing off white to reddish brown coloured pellets.

Dutor contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Dutor
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
For depression and diabetic neuropathic pain:
The usual dose of Dutor 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 Dutor 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 Dutor.
Dutor is for oral use. You should swallow your capsule whole with a drink of water.
Dutor may be taken with or without food.

Pack sizes:
Dutor 30 mg is available in blister packs of 7, 28, 56, 98 capsules.
Dutor 60 mg is available in blister packs of 7, 28, 56, 84, 98, 140 and 196 (2 x 98) capsules.
Dutor 30 mg/60 mg is available in HDPE bottles with PP screw cap of 28, 98 and 100 capsules
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
Torrent Pharma (UK) Ltd
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex
RH11 7XA
United Kingdom
This leaflet was last approved in 10/2016

To help you remember to take Dutor, 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 Dutor. Do not stop taking Dutor, 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.

8062362-7803

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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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