Skip to Content

UK Edition. Click here for US version.

DUCILTIA 30 MG HARD GASTRO-RESISTANT CAPSULES

Active substance(s): DULOXETINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Reason for Draft
New file
Revisions
Revisions
Text revisons

What DUCILTIA contains
- The active substance is duloxetine.
- Each 30 mg capsule contains 30 mg of duloxetine (as
hydrochloride).
- Each 60 mg capsule contains 60 mg of duloxetine (as
hydrochloride).
- The other ingredients are:
Capsule content: pregelatinised starch (maize),
microcrystalline cellulose, povidone K 30, talc,
magnesium stearate, sodium stearyl fumarate,
hypromellose acetate succinate, titanium dioxide (E171),
lactose monohydrate, hypromellose and macrogol 4000
Capsule shell: titanium dioxide (E171), gelatin, Brilliant
Blue FCF (E133), Allura Red (E 129). Quinoline yellow (E104)
(60 mg only), Sunset Yellow FCF (E110) (60 mg only).
Printing ink: shellac glaze, indigo carmine aluminum lake
(E132), titanium dioxide (E171), propylene glycol (E1520)
What DUCILTIA looks like and contents of the pack
DUCILTIA 30 mg gastro-resistant size 2 capsules are
presented as opaque dark blue cap-opaque white body
printed with “30”, containing 4 white to off white, round,
biconvex tablets, containing 30 mg of Duloxetine active
ingredient per capsule.
DUCILTIA 60 mg gastro-resistant size 0E capsules are
presented as opaque dark blue cap-opaque yellowish
green body printed with “60”, containing 8 white to off
white, round, biconvex tablets, containing 60 mg of
Duloxetine active ingredient per capsule.
DUCILTIA gastro-resistant capsules, hard are available in
(PVC/PE/PCTFE//Al blisters or PA/Al/PVC//Al) blisters in a
cardboard box.
Pack sizes:
DUCILTIA 30 mg: 7, 28 and 98 capsules
DUCILTIA 60 mg: 28, 56, 84, 98, 100 and 500 capsules
DUCILTIA gastro-resistant capsules are available in HDPE
bottles with child-resistant PP screw cap in a cardboard
box.
Pack size: 30 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmathen S.A.
6 Dervenakion str., 15351 Pallini, Attica, Greece
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5,
Rodopi 69300, Ellas
And
Pharmathen S.A.
Dervenakion 6, Pallini 15351, Attikis Greece
Distributed by:
Creo Pharma Ltd
Felsted Business Centre, Felsted, Essex CM6 3LY

Important
Please ensure that the texts and layout are to
your satisfaction as the studio cannot accept
liability for any errors overlooked.
All Bar Codes and Braille text must be verified
by the client/manufacturer/printer. The studio is
unable to do this and cannot accept liability for
any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

6. Contents of the pack and other information

CRE-DUC-PIL-176_04
13/09/2015

Myriad Pro 9/10 pt

This leaflet was last revised in 09/2015

Typefaces

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Duciltia 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 DUCILTIA 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 DUCILTIA 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 DUCILTIA.
To help you remember to take DUCILTIA 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 DUCILTIA. Do not stop taking DUCILTIA, 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 diffcult to treat.
If you take more DUCILTIA than you should
Call your doctor or pharmacist immediately if you take
more than the amount of DUCILTIA 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 DUCILTIA
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

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 blister / bottle / carton after EXP. The expiry
date refers to the last day of that month.
Store below 30°C.
HDPE bottles: after first opening, use within 30 days
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.

1

3. How to take DUCILTIA

5. How to store DUCILTIA

Date
18/08/2015
28/08/2015
28/08/2015
13/09/2015

Do not take DUCILTIA 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 DUCILTIA’)
- 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 DUCILTIA.
Warnings and precautions:
The following are reasons why DUCILTIA may not be
suitable for you. Talk to your doctor before you take
DUCILTIA if you:
- are taking other medicines to treat depression (see
‘Other medicines and DUCILTIA’)
- 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 DUCILTIA, 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.
DUCILTIA 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
DUCILTIA 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, a doctor may prescribe DUCILTIA for
patients under 18 because he/she decides that this is in
their best interests. If your doctor has prescribed
DUCILTIA for a patient under 18 and you want to discuss
this, please go back to your doctor. You should inform

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, diffculty or failure to experience orgasm
- anxiety
- 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
- 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
- diffculty sleeping, poor sleep quality
- 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
- diffculty concentrating
- changes in sense of taste
- diffculty controlling movement e.g. lack of
coordination or involuntary movements of the
muscles, restless legs syndrome
- 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
- diffculty 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
- diffculty or inability to pass urine
- diffculty 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, feeling hot
- abnormal gait
- thirst, shivering
- weight gain.
DUCILTIA 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.

No. of Draft
_01
_02
_03
_04

2. What you need to know before you take
DUCILTIA

4. Possible side effects

17/08/2015
Creo Pharma
UK
CRE-DUC-PIL-176

1. What DUCILTIA is and what it is used for
DUCILTIA contains the active substance duloxetine.
DUCILTIA increases the levels of serotonin and
noradrenaline in the nervous system.
DUCILTIA 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)
DUCILTIA 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 DUCILTIA
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.

your doctor if any of the symptoms listed above develop
or worsen when patients under 18 are taking DUCILTIA.
Also, the long-term safety effects concerning growth,
maturation, and cognitive and behavioural development
of DUCILTIA in this age group have not yet been
demonstrated.
Other medicines and DUCILTIA
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Your doctor should decide whether you can take
DUCILTIA 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 DUCILTIA 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 DUCILTIA, 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 DUCILTIA. Also, you need to wait at least 5 days
after you stop taking DUCILTIA 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 DUCILTIA,
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.
DUCILTIA with food, drink and alcohol
DUCILTIA may be taken with or without food. Care should
be taken if you drink alcohol while you are being treated
with DUCILTIA.
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
DUCILTIA. You should use DUCILTIA 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
DUCILTIA. 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 DUCILTIA 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
DUCILTIA while breast-feeding is not recommended. You
should ask your doctor or pharmacist for advice.
Driving and using machines
DUCILTIA may make you feel sleepy or dizzy. Do not drive
or use any tools or machines until you know how
DUCILTIA affects you.
DUCILTIA contains lactose, Allura Red (E 129) and
Sunset Yellow FCF (E110)
Lactose: If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
Allura Red (E 129) may cause allergic reactions.
Sunset Yellow FCF (E110) may cause allergic reactions
(only for DUCILTIA 60 mg).

Date
Client
Country
Job No.

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 DUCILTIA is and what it is used for
2. What you need to know before you take DUCILTIA
3. How to take DUCILTIA
4. Possible side effects
5. How to store DUCILTIA
6. Contents of the pack and other information

Rare side effects (may affect up to 1 in 1000 people)
- serious allergic reaction which causes diffculty 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 behavior
- 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, bad breath
- 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)
- 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 - Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Duciltia
12.5 mg
170 x 500 mm

Duloxetine

double dose to make up for a forgotten dose. Do not take
more than the daily amount of DUCILTIA that has been
prescribed for you in one day.
If you stop taking DUCILTIA
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 DUCILTIA he or she will ask you
to reduce your dose over at least 2 weeks before
stopping treatment altogether.
Some patients who stop taking DUCILTIA 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.

Product Title
Strength
PIL Format
Initial Code
No of Colours

Package leaflet: information for the user

DUCILTIA 30 mg hard gastro-resistant capsules
DUCILTIA 60 mg hard gastro-resistant capsules

Expand view ⇕

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.

Hide