Patient leaflet - Nodetrip (previously Xeristar)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Lilly S.A.
Avda. de la Industria N° 30,
28108 Alcobendas
Madrid
Spain
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for Article 107c(7) of Directive
2001/83/EC and any subsequent updates published on the Eur edicines web-portal.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
The MAH shall perform the require agreed RMP presented in Module 1. updates of the RMP.
acovigilance activities and interventions detailed in the he Marketing Authorisation and any agreed subsequent
- An updated RMP shoul At the request o Whenever th being recei
mitted:
European Medicines Agency;
anagement system is modified, especially as the result of new information t may lead to a significant change to the benefit risk profile or as the result
of an
t (pharmacovililance or risk minimisation) milestone being reached.
CARTONS FOR 30 MG HARD GASTRO-RESISTANT CAPSULES
-
1. NAME OF THE MEDICINAL PRODUCT
Nodetrip 30 mg hard gastro-resistant capsules. Duloxetine
Oral use.
Read the package leaflet before u
Contains sucrose
See leaflet for further information
3. LIST OF EXCIPIENTS
5. METHOD AND ROUTE
28 hard gastro-resistant capsules 7 hard gastro-resistant capsules
ISTRATION
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each capsule contains 30 mg of duloxetine (as hydrochloride)
-
4. PHARMACEUTICAL FORM AND CONTENTS
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIG
Keep out of the
7. O
D REACH OF CHILDREN
reach of children.
SPECIAL WARNING(S), IF NECESSARY
-
8. EXPIRY DATE
EXP
-
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture. Do not store above 30°C
-
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109 08038 Barcelona
Spain
Lot
Medicinal product subject to medical prescription.
12. MARKETING AUTHORISATION NUMBER( S)
14. GENERAL CLASSIFICATION FOR SUPPLY
16. INFORMATION IN BRAIL
EU/1/04/297/001 (28 hard gastro-resistant capsules)
EU/1/04/297/006 (7 hard gastro-resistant capsules)
Nodetrip 30 mg
2D barcode ca
13. BATCH NUMBER
IER – 2D BARCODE
unique identifier included.
15. INSTRUCTIONS ON USE
17. UNIQ UE ID
18. KUNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
30 mg hard gastro-resistant capsules
1. NAME OF THE MEDICINAL PRODUCT
Nodetrip 30 mg hard gastro-resistant capsules Duloxetine
CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES
Oral use.
Read the leaflet before use.
Contains sucrose
See leaflet for further information
3. LIST OF EXCIPIENTS
5. METHOD AND ROUTE
28 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules 56 hard gastro-resistant capsules
MINISTRATION
-
1. NAME OF THE MEDICINAL PRODUCT
Nodetrip 60 mg hard gastro-resistant capsules. Duloxetine
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each capsule contains 60 mg of duloxetine (as hydrochloride)
4. PHARMACEUTICAL FORM AND CONTENTS
6. SPECIA
OF THE
t and reach of children.
NG THAT THE MEDICINAL PRODUCT MUST BE STORED OUT T AND REACH OF CHILDREN
Keep out o
7.
THER SPECIAL WARNING(S), IF NECESSARY
-
8. EXPIRY DATE
EXP
-
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture. Do not store above 30°C
-
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109 08038 Barcelona
Spain
-
12. MARKETING AUTHORISATION NUMBER(S )
EU/1/04/297/002 (28 hard gastro-resistant capsules)
EU/1/04/297/003 (84 hard gastro-resistant capsules)
EU/1/04/297/004 (98 hard gastro-resistant capsules)
EU/1/04/297/005 (56 hard gastro-resistant capsules)
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical presc
15. INSTRUCTIONS ON US
Nodetrip 60 mg
17.
16. INFORMATIO
2
ILLE
IDENTIFIER – 2D BARCODE
e carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:
MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box)
| 1. name of the M | IEDICINAL PRODUCT |
| Nodetrip 60 mg hard gastr Duloxetine | o-resistant capsules. |
| 2. STATEMENT OF | |
| Each capsule contains 60 | ACTIVE SUBSTANCE(S) ^<5 mg of duloxetine (as hydrochloride) |
| 3. LIST OF EXCIPU | ENTS |
| Contains sucrose See leaflet for further info | O' rmation |
| 4. PHARMACEUTI | CAL FORM AND CONTENTS^ |
| 20 hard gastro-resistant ca | psules. Component of a multipack, can’t be sold separately. |
| 5. METHOD AND R | OUTE(S) OF ADMINISTRATION |
| Oral use. Read the leaflet before us | z |
| 6. SPECIAL WARN OF THE SIGHT A | NG THAT THE MEDICINAL PRODUCT MUST BE STORED OUT ND REACH OF CHILDREN |
| Keep out of the sight and | reach of children. |
| 7. OTHER SPECIAL | W WARNING(S), IF NECESSARY |
| 8. EXPIRY DATE | |
| EXP | |
| 9. SPECIAL STORA | GE CONDITIONS |
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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109 08038 Barcelona
Spain
-
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20)
EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20)
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
Nodetrip 60 mg
15. INSTRUCTIONS ON USE
16. INFORMATION IN B
MULTIPACK-OUTER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (with blue box)
-
1. NAME OF THE MEDICINAL PRODUCT
Nodetrip 60 mg hard gastro-resistant capsules. Duloxetine
INISTRATION
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each capsule contains 60 mg of duloxetine (as hydrochloride)
3. LIST OF EXCIPIENTS
Contains sucrose
See leaflet for further information
-
4. PHARMACEUTICAL FORM AND CONTENT
Multipack: 500 (25 packs of 20) hard gastro-resist
Multipack: 100 (5 packs of 20) hard gastro-resista
-
5. METHOD AND ROUTE(S) OF
Oral use.
Read the leaflet before use.
Keep ou
6. SPECIAL WA OF THE SI
7.
t and reach of children.
G THAT THE MEDICINAL PRODUCT MUST BE STORED OUT ND REACH OF CHILDREN
ER SPECIAL WARNING(S), IF NECESSARY
-
8. EXPIRY DATE
EXP
-
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture. Do not store above 30°C
-
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109 08038 Barcelona
Spain
-
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20)
EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20)
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
Nodetrip 60 mg
16. INFORMATION IN B
17. UNIQUE
IFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
1
NIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 mg hard gastro-resistant capsules
-
1. NAME OF THE MEDICINAL PRODUCT
Nodetrip 60 mg hard gastro-resistant capsules Duloxetine
Package leaflet: information for the user
Nodetrip 30 mg hard gastro-resistant capsules
Nodetrip 60 mg hard gastro-resistant capsules
Duloxetine (as hydrochloride)
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 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 pos side effects not listed in this leaflet. See section 4..
What is in this leaflet :
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1.
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2.
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3.
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4.
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5.
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6.
1.
What Nodetrip is and what it is used for
What you need to know before you take Nodetrip
How to take Nodetrip
Possible side effects
How to store Nodetrip
Contents of the pack and other information
What Nodetrip is and what it is used for
Nodetrip contains the active substance duloxetine. Nodetrip increases the levels of serotonin and noradrenaline in the nervous system.
Nodetrip is used in adults to treat:
- depression
- generalised anxiety disorder
- diabetic neuropathic pain (o
like an electric shock touch, heat, cold or p
(chronic feeling of anxiety or nervousness)
ten described as burning, stabbing, stinging, shooting or aching or may be loss of feeling in the affected area, or sensations such as
ure may cause pain)
Nodetrip starts to w treatment, but it better after prevent yo
ost people with depression or anxiety within two weeks of starting take 2–4 weeks before you feel better. Tell your doctor if you do not start to feel. Your doctor may continue to give you Nodetrip when you are feeling better to ession 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 Nodetrip
DO NOT take Nodetrip if you:
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– are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
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– have liver disease
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– have severe kidney disease
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– are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Nodetrip’)
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– are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
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– are taking other medicines containing duloxetine (see ‘Other medicines and Nodetrip’)
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking Nodetrip.
Warnings and precautions
The following are reasons why Nodetrip may not be suitable for you. Talk to your doctor before you take Nodetrip if you:
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– are taking other medicines to treat depression (see ‘Other medicines and Nodetrip’)
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– are taking St. John’s Wort, a herbal treatment (Hypericum perforatum )
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– have kidney disease
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– have had seizures (fits)
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– have had mania
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– suffer from bipolar disorder
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– have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
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– have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘)
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– are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly)
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– are currently being treated with another medicine which may cause liver damage
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– are taking other medicines containing duloxetine (see ‘Other medicines and Nodetrip’)
Nodetrip may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
Medicines like Nodetrip (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
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 increa
take time to work, usually about two weeks but sometimes longer.
n first starting antidepressants, since these medicines all
You may be more likely to thin
have previously had are a young adult. In behaviour in adults a an antidepressant
ke this if you:
s about killing or harming yourself
ation from clinical trials has shown an increased risk of suicidal
ed less than 25 years with psychiatric conditions who were treated with
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
Nodetrip 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 Nodetrip for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Nodetrip 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 Nodetrip. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Nodetrip in this age group have not yet been demonstrated.
Other medicines and Nodetrip
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 Nodetrip, 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 Nodetrip 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 Nodetrip if you are t recently taken (within the last 14 days) another antidepressant medicine called a mono
, or have ine oxidase inezolid (an
inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepress antibiotic). Taking a MAOI together with many prescription medicines, inclu serious or even life-threatening side effects. You must wait at least 14 da taking an MAOI before you can take Nodetrip. Also, you need to wait at taking Nodetrip before you take a MAOI.
odetrip, can cause you have stopped
5 days after you stop
Medicines that cause sleepiness: These include medicines p benzodiazepines, strong painkillers, antipsychotics, phenobar
d by your doctor including d 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 th any of these medicines together with N
ide effects; if you get any unusual symptom taking ou should see your doctor.
Oral anticoagulants or antiplatelet s : Medicines which thin the blood or prevent the blood from clotting. These medicines might increase the risk of bleeding.
Nodetrip with food, drink
Nodetrip may be tak being treated with N
Pregnancy an
d alcohol
or without food. Care should be taken if you drink alcohol while you are
your doc
feeding, think you may be pregnant or are planning to have a baby, ask harmacist for advice before taking this medicine.
our doctor if you become pregnant, or you are trying to become pregnant, while you are ing Nodetrip. You should use Nodetrip only after discussing the potential benefits and any otential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Nodetrip. 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 Nodetrip 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 Nodetrip near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
Available data from the use of Nodetrip during the first three months of pregnancy do not show an increased risk of overall birth defects in general in the child. If Nodetrip is taken during the second half of pregnancy, there may be an increased risk that the infant will be born early (6 additional premature infants for every 100 women who take Nodetrip in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.
Tell your doctor if you are breast-feeding. The use of Nodetrip while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.
Driving and using machines
Nodetrip may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Nodetrip affects you.
Nodetrip contains sucrose
an intolerance to some
Nodetrip contains sucrose. If you have been told by your doctor sugars, contact your doctor before taking this medicinal product.
Nodetrip contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take Nodetrip
Always take this medicine exactly or pharmacist if you are not sure.
doctor or pharmacist has told you. Check with your doctor
Nodetrip is for oral use.
ould swallow your capsule whole with a drink of water.
For depression and diabetic neuropathic pain:
The usual dose of Nodetrip is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
For gen The on
anxiety disorder:
rting dose of Nodetrip is 30 mg once a day after which most patients will receive 60 mg , 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 Nodetrip.
To help you remember to take Nodetrip, 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 Nodetrip. Do not stop taking Nodetrip, 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 Nodetrip than you should
Call your doctor or pharmacist immediately if you take more than the amount of Nodetrip 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 Nodetrip
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 Nodetrip that has been prescribed for you in one day.
If you stop taking Nodetrip
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 Nodetrip he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Some patients who stop taking Nodetrip suddenly have had symptoms such as:
- dizziness, tingling feelings like pins and needles or electric shock-like feelings (pa arly in
the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue piness,
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
octor 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 (m headache, feeling sleepy
- feeling sick (nausea), dry mo
an 1 in 10 people)
Common side effects (ma
up to 1 in 10 people)
lack of appetite trouble sleeping orgasm, un dizziness, f
g agitated, less sex drive, anxiety, difficulty or failure to experience s
sluggish, tremor, numbness, including numbness, pricking or tingling of the
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
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
throat tightness, nose bleeds
vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, inflammation of the liver that may cause abdominal pain and yellowin the eyes
night sweats, hives, cold sweats, sensitivity to sunlight, increased tend muscle tightness, muscle twitching
difficulty or inability to pass urine, difficulty to start urinating, needin
ulty swallowing e skin or whites of
to bruise
night, needing to pass more urine than normal, havin abnormal vaginal bleeding, abnormal periods, includ periods, unusually light or missed periods, pain in th
to pass urine during the urine flow
g heavy, painful, irregular or prolonged esticles or scrotum
- chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
- weight gain
- Nodetrip 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 of inappropriate secretion of anti-diuretic hormone (SIADH)
- suici ehaviour, mania (over activity, racing thoughts and decreased need for sleep), h ions, aggression and anger
tonin syndrome” (a rare reaction which may cause feelings of great happiness,
wsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
increased pressure in the eye (glaucoma)
coughing, wheezing and shortness of breath which may be accompanied by a high temperature 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
- excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
Very rare side effects (may affect up to 1 in 10,000 people)
- inflammation of the blood vessels in the skin (cutaneous vasculitis)
5. How to store Nodetrip
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.
Store in the original package to protect from moisture. Do not store above 30°C.
Or
Do not throw away any medicines via wastewater or household waste. Ask your
throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Nodetrip contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Capsule shell: gelatin, sodiu iron oxide (E172) (60 mg on Edible green ink: synthetic b
yl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow edible green ink (30 mg) or edible white ink (60 mg).
on oxide (E172), synthetic yellow iron oxide (E172), propylene
glycol, shellac.
Edible white ink: ti
dioxide (E171), propylene glycol, shellac, povidone.
What Nodetrip looks like and contents of the pack
Nodetrip is a hard gastro-resistant capsule. Each capsule of Nodetrip contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Nodetrip is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white and are printed with ‘30 mg’ and the code ‘9543’.
The 60 mg capsules are blue and green and are printed with ‘60 mg’ and the code ‘9542’.
Nodetrip 30 mg is available in packs of 7 and 28 capsules.
Nodetrip 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder : Esteve Pharmaceuticals, S.A. Passeig de la Zona Franca, 109, 08038
Barcelona, Spain.
Manufacturer : Lilly S.A., Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain.
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:.
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