Skip to Content

DEPALTA30

Active substance(s): DULOXETINE HYDROCHLORIDE / DULOXETINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

350 mm

Package leaflet: Information for the user
Duloxetine 30mg gastro-resistant capsules, hard
Duloxetine 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 Duloxetine Gastro-resistant Capsules are and what they are used for
2. What you need to know before you take Duloxetine Gastro-resistant
Capsules
3. How to take Duloxetine Gastro-resistant Capsules
4. Possible side effects
5. How to store Duloxetine Gastro-resistant Capsules
6. Contents of the pack and other information
1. What Duloxetine Gastro-resistant Capsules are and what they are
used for
Duloxetine Gastro-resistant Capsules contain the active substance
duloxetine. Duloxetine increases the level of serotonin and noradrenaline in
the nervous system.
Duloxetine 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)
Duloxetine 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 Duloxetine
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 Duloxetine Gastro-resistant
Capsule
Do not take Duloxetine 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
o Other medicines containing duloxetine
o which is used to treat depression(eg. fluvoxamine),
o 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 Duloxetine Gastro-resistant
Capsule
Warnings and precautions
Talk to your doctor or pharmacist before taking Duloxetine Gastro-resistant
Capsule. The following are reasons why Duloxetine 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
Duloxetine 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
startingantidepressants, 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
Duloxetine 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 Duloxetine Gastro-resistant Capsule. Also, the long-term effects of
Duloxetine Gastro-resistant Capsule have not been demonstrated.
Other medicines and Duloxetine 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 Duloxetine 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 Duloxetine 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
duloxetine 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
Duloxetine before you take a MAOI. Taking MAOI together with
many prescription medicines including Duloxetine 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 Duloxetine
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.
Duloxetine Gastro-resistant Capsule with food, drink and alcohol
You can take Duloxetine Gastro-resistant Capsules with or without food,
Care should be taken if you drink alcohol while you are being treated with
Duloxetine 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 Duloxetine 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 Duloxetine 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 Duloxetine Gastroresistant Capsule while breastfeeding is not recommended. You should ask
your doctor or pharmacist for advice.
Driving and using machines
Duloxetine Gastro-resistant Capsule may make you feel sleepy or dizzy. Do
not drive or use any tools or machines until you know how Duloxetine
Gastro-resistant Capsule affects you.
Duloxetine Gastro-resistant Capsule contains sucrose
Duloxetine 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 Duloxetine 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.
Duloxetine 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 Duloxetine 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 will
neuropathic pain prescribe the dose that is right for you.
Generalized
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 Gastro-resistant Capsules, Duloxetine

200 mm
Font : times new roman

Size : 9

∙ 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 Duloxetine 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 25°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 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 Duloxetine Gastro-resistant Capsule looks like and contents of the
pack
Duloxetine 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.
Duloxetine 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”.
Duloxetine 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.
For Medical Information queries please call : 08443358270
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 2016

200 mm
Font : times new roman

Size : 9

ACE0295L/01

350 mm

Talk with your doctor about how long you should keep taking Duloxetine
Gastro-resistant Capsule. Do not stop taking Duloxetine 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 Duloxetine Gastro-resistant Capsule than you should
Call your doctor or pharmacist immediately if you take more than the amount
of Duloxetine 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 Duloxetine 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 Duloxetine Gastro-resistant Capsule that has been
prescribed for you in one day.
If you stop taking Duloxetine Gastro-resistant Capsule
DO NOT stop taking Duloxetine Gastro-resistant Capsule without
consulting your doctor first. When stopping taking Duloxetine Gastroresistant 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 Duloxetine 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 Duloxetine 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
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. lack of coordination or 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

Expand Transcript

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