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DEPALTA30

Active substance(s): DULOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Depalta 30mg Gastro-resistant Capsules, hard
Depalta 60mg 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 Depalta Gastro-resistant Capsules are and what they are used for
2. What you need to know before you take Depalta Gastro-resistant Capsules
3. How to take Depalta Gastro-resistant Capsules
4. Possible side effects
5. How to store Depalta Gastro-resistant Capsules
6. Contents of the pack and other information

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1. What Depalta Gastro-resistant Capsules are and what they are used for
Depalta Gastro-resistant Capsules contain the active substance duloxetine. Duloxetine
increases the level of serotonin and noradrenaline in the nervous system.
Depalta is used to treat the following conditions in adults:
• depression
• 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)
• generalised anxiety disorder (chronic feeling of anxiety or nervousness)
Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule
Do not take Depalta Gastro-resistant Capsule 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
- have taken a monoamine oxidase inhibitor (MAOI) in the last 2 weeks
- are taking
• Other medicines containing duloxetine
• which is used to treat depression(eg. fluvoxamine),
• 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 Depalta Gastro-resistant Capsule.
Warnings and precautions
Talk to your doctor or pharmacist before taking Depalta Gastro-resistant Capsule. The
following are reasons why Depalta Gastro-resistant Capsule may not be suitable for
you. If you:
- are taking other medicines to treat depression
- have had mania
- have had seizures
- suffer from bipolar disorder
- have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
- have high blood pressure
- are already taking St. John's Wort (a herbal medicine for depression)
- have kidney disease
- have a history of bleeding disorders (such as gastrointestinal haemorrhage)
- are at risk of low sodium levels (for example if you are taking diuretics, especially if
you are elderly)
- are taking other medicines containing duloxetine
Depalta Gastro-resistant Capsule 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 suicidal thoughts or want to harm yourself, you must contact to your
doctor immediately. It can take few weeks before you illness improves so you may
still be at risk.
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
Depalta Gastro-resistant Capsule should normally not be used for children and
adolescents under 18 years as there is a risk of side-effects such as attempted suicide,

suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger).
However, your doctor may still prescribe for under 18 because he/she decides that this
is in their best interests.Discuss with your doctor If your are concerned. You should
inform your doctor if any of the symptoms listed above develop or worsen when taking
Depalta Gastro-resistant Capsule. Also, the long-term effects of Depalta Gastroresistant Capsule have not been demonstrated.
Other medicines and Depalta Gastro-resistant Capsule
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 Depalta Gastro-resistant Capsule ( duloxetine) is used in other
medicines for other 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 Depalta Gastro-resistant Capsule 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 use Depalta in
combination with MAOIs (such as moclobemide or linezolid) or within at least 2
weeks of discontinuing treatment with an MAOI. Also, you should wait at least 5
days after you stop taking Depalta before you take a MAOI. Taking MAOI together
with many prescription medicines including Depalta Gastro-resistant Capsule can
cause serious and even life threatening side effects.
- Fluvoxamine, since it is likely to result in higher concentrations of duloxetine.
- Medicines that increase the level of serotonin such as triptans, tramadol, tryptophan
SSRIs (such as paroxetineand fluoxetine) SNRIs (such as venlafaxine), tricyclic
antidepressants (such as clomipramine, amitryptaline) pethidine, St John's Wort.
These medicines increase the risk of side effects; if you get any unusual symptoms
taking any of these medicines together with Depalta Gastro-resistant Capsule, you
should see your doctor.
- medicines that cause sleepiness such as benzodiazepines, strong painkillers or
phenobarbital and anti histamines medicines which thin the blood or prevent the
blood from clotting (oral anticoagulants or antiplatelet agents. These medicines
might increase the risk of bleeding.
Depalta Gastro-resistant Capsule with food, drink and alcohol
You can take Depalta Gastro-resistant Capsules with or without food, Care should be
taken if you drink alcohol while you are being treated with Depalta Gastro-resistant
Capsule.
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. You
should use Depalta Gastro-resistant Capsule only after discussing the potential
benefits and any potential risks to your unborn child with your doctor.
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 Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule
while breastfeeding is not recommended. You should ask your doctor or pharmacist for
advice.
Driving and using machines
Depalta Gastro-resistant Capsule may make you feel sleepy or dizzy. Do not drive or
use any tools or machines until you know how Depalta Gastro-resistant Capsule
affects you.
Depalta Gastro-resistant Capsule contains sucrose
Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule
Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Depalta Gastro-resistant Capsule is for oral use. You should swallow your capsule
whole with a drink of water.
Dosage in Adults:
The recommended dose of Depalta Gastro-resistant Capsule is given below:

Condition
Depression

Dosage
The usual dose is 60 mg once a day, but your doctor will
prescribe the dose that is right for you.
Diabetic
The usual dose is 60 mg once a day, but your doctor
neuropathic pain will prescribe the dose that is right for you.
Generalised
The usual starting dose is 30 mg once a day after which
anxiety disorder 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 Depalta Gastro-resistant Capsule
Talk with your doctor about how long you should keep taking Depalta Gastro-resistant
Capsule. Do not stop taking Depalta Gastro-resistant Capsule, 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 Depalta Gastro-resistant Capsule than you should
Call your doctor or pharmacist immediately if you take more than the amount of

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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)
• feeling sick (nausea), dry mouth
• headache, feeling sleepy
Common side effects (may affect up to 1 in 10 people)
• decrease sense of appetite
• anxiety, trouble sleeping, feeling agitated, less sex drive, difficulty or failure to
experience orgasm, unusual dreams
• feeling sluggish, dizziness, tremor, numbness, pricking or tingling of the skin
• eyesight blurred
• hearing sound in the ear when there is no external sound(tinnitus)
• feeling the heart pumping in the chest,
• increased in blood pressure, flushing
• increased yawning
• increased sweating, (itchy) rash
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or
indigestion, breaking wind
• pain in muscle or muscle spasm
• frequent urination, pain during urination,
• problems with erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• loss in body weight
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. However,
their 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)
• inflammation in the throat that causes a hoarse voice
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or
whites of the eyes
• weight gain
• suicidal thoughts, difficulty in 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 . l a c k o f c o o r d i n a t i o n o r
involuntary movements of the muscles, restless leg syndrome, poor sleep quality
• problems with eyesight , large pupils
• feeling of dizziness or “spinning” (vertigo), pain in ear
• fast and/or irregular heart beat
• fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or
toes
• abnormal vaginal bleeding, abnormal periods(including heavy, painful, irregular or
prolonged periods, unusually light or missed periods) pain in the testicles or scrotum
• throat tightness, nose bleeds
• vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty
swallowing
• night sweats, cold sweats, hives, sensitivity to sunlight, increased tendency to bruise
• difficulty or inability to pass urine, difficulty in starting to pass urine, needing to pass
urine during the night, needing to pass more urine than normal, having a decreased
urine flow
• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait 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 such as difficulty in breathing or dizziness with swollen
tongue or lips
• decreased thyroid gland activity which can cause tiredness or weight gain
• increased pressure in the eye (glaucoma)
• abnormal urine odour
• dehydration, feeling dizzy, weak, confused, sleepy or very tired, or feeling sick,
more serious symptoms are fainting, fits or falls
• 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
• inflammation of the mouth, passing bright red blood in your stools, bad breath,
inflammation of the large intestine (leading to diarrhoea)
• yellowing of the skin or whites of the eyes (jaundice), liver failure
• 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
• menopausal symptoms, abnormal production of breast milk in men or women
• contraction of jaw muscle
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 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 Depalta Gastro-resistant Capsule
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 as EXP or
EXP date.
Store in the original package to protect from moisture. Store below 250C.
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 Depalta Gastro-resistant Capsule contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: Sugar sphere, hypromellose, purified talc, sucrose, hypromellose
phthalate, triethyl citrate (See end of section 2 for further information on sucrose).
Capsule shell:
30mg: Gelatin, titanium dioxide (E171), edible grey and black ink
60mg: Gelatin, titanium dioxide (E171), FD & C Blue 2 (E132), edible grey and black
ink
Edible grey ink: titanium dioxide (E171), black iron oxide (E172), propylene glycol,
shellac.
Edible black ink: black iron oxide (E172), propylene glycol, shellac.
What Depalta Gastro-resistant Capsule looks like and contents of the pack
Depalta Gastro-resistant Capsule is a hard gastro-resistant capsule. Each capsule
contains pellets of duloxetine hydrochloride with a covering to protect them from
stomach acid.
Depalta Gastro-resistant Capsule is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are white and clear and are printed with “ ”and "085".
The 60 mg capsules are blue and clear and are printed with “ ”and "086”.
Depalta Gastro-resistant Capsule 30 mg and 60mg is available in packs of 7, 14, 28, 56,
84, 98, 100 and 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Wave Pharma Limited.,
4th floor, Cavendish House,
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW, United Kingdom.
If you would like this leaflet in a different format or register a complaint, please contact
the Marketing Authorisation holder listed above.
This leaflet was last revised in November 2017.
ACE0499L/01

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Depalta Gastro-resistant Capsule prescribed by your doctor. Symptoms of
overdose include sleepiness, coma, feelings of great happiness, drowsiness,
fever, sweating, rigid muscles, vomiting' and fast heart rate.
If you forget to take Depalta Gastro-resistant Capsule
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 Depalta Gastro-resistant Capsule that has been prescribed for you in one
day.
If you stop taking Depalta Gastro-resistant Capsule
DO NOT stop taking Depalta Gastro-resistant Capsule without consulting your doctor
first. When stopping taking Depalta Gastro-resistant Capsule, your doctor will help
you to gradually take less of the medicine. This might be done by slowly reducing the
amount of medicine you take each day, week by week.
As you take less Depalta Gastro-resistant Capsule you may notice some side-effects
such as:
• Tingling feelings like Pins and needles or electric shock-like feelings (particularly
in the head), inability to sleep, feeling restless or agitated, feeling anxious, dizziness,
feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle
pain, diarrhoea, excessive sweating.
Most people find that any effects are mild and may go away in few days. If you notice
any effects when you are reducing Depalta Gastro-resistant Capsule, your doctor may
decide that you should come off it more slowly. If you notice any severe side-effects,
talk to your doctor. Your doctor may ask you to start taking a slightly higher dose again
and then reduce it more slowly.
If you have any further questions on the use of this medicine, ask your
doctor/pharmacist.

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Product Name : DEPALTA 30-60 mg Gastro-resistant Capsules, hard Duloxetine
( Wave Pharma Limited, )

Literature (Front & Back Side)

01
200 x 300 mm (L x H)

ACE0499L/01
Substrate : Maplitho Paper
Specification : 60 GSM
Pharmacode : 1243
Any Other Requirement :
Change History : New Product

Date : 01/12/2017

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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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