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SUNVENIZ XL 150 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE

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Sunveniz XL 37.5 mg prolonged-release
tablets
Sunveniz XL 75 mg prolonged-release
tablets
Sunveniz XL 150 mg prolonged-release
tablets
venlafaxine
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 Sunveniz XL is and what it is used for
2.What you need to know before you take Sunveniz XL
3.How to take Sunveniz XL
4.Possible side effects
5.How to store Sunveniz XL
6.Contents of the pack and other information
1. What Sunveniz XL is and what it is used for
Sunveniz XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This
group of medicines is used to treat depression and other conditions
such as anxiety disorders. It is thought that people who are depressed
and/or anxious have lower levels of serotonin and noradrenaline in the
brain. It is not fully understood how antidepressants work, but they
may help by increasing the levels of serotonin and noradrenaline in the
brain.
Sunveniz XL is a medicine to treat adults with depression. Sunveniz is
also used to treat adults with the following anxiety disorders:
generalised anxiety disorder, social anxiety disorder (fear or avoidance
of social situations) and panic disorder (panic attacks). Treating
depression or anxiety disorders 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 more difficult to treat.

2.What you need to know before you take Sunveniz XL
Do not take Sunveniz XL
- if you are allergic to venlafaxine or any of the other ingredients of
this medicine (listed in section 6)
- if you are also taking or have taken any time within the last 14 days
any medicines known as irreversible monoamine oxidase inhibitors
(MAOIs), used to treat depression or Parkinson's disease. Taking an
irreversible MAOI together with other medicines, including Sunveniz
XL, can cause serious or even life-threatening side effects. Also,
you must wait at least 7 days after you stop taking Sunveniz XL
before you take any MAOI (see also “Other medicines and Sunveniz
XL” and the information in the section about “Serotonin Syndrome”).
Warnings and precautions
If any of the following apply to you, please tell your doctor or
pharmacist before taking Sunveniz XL
- if you use other medicines that taken together with Sunveniz XL
could increase the risk of developing serotonin syndrome (see the
section “ Other medicines and Sunveniz XL”)
- if you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye)
- if you have a history of high blood pressure
- if you have a history of heart problems
- if you have been told you have an abnormal heart rhythm
- if you have a history of fits (seizures)
- if you have a history of low sodium levels in your blood
(hyponatraemia)
- if you have a tendency to develop bruises or a tendency to bleed
easily (history of bleeding disorders), or if you are taking other
medicines that may increase the risk of bleeding e.g., warfarin
(used to prevent blood clots)
- if you have a history of, or if someone in your family has had, mania
or bipolar disorder (feeling over-excited or euphoric)
- if you have a history of aggressive behaviour.
Sunveniz XL may cause a sensation of restlessness or an inability to
sit or stand still during the first few weeks of treatment. You should tell
your doctor if this happens to you.

Tell your doctor immediately, or go to the casualty department at
your nearest hospital if you think serotonin syndrome is happening
to you.
You must tell your doctor if you are taking medicines that can affect
your heart rhythm.
Examples of the medicines include:
- Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide
(used to treat abnormal heart rhythm)
- Antipsychotics such as thioridazine (See also Serotonin syndrome
above)
- Antibiotics such as erythromycin or moxifloxacin (used to treat
bacterial infections)
- Antihistamines (used to treat allergy).
The following medicines may also interact with Sunveniz XL and
should be used with caution. It is especially important to mention to
your doctor or pharmacist if you are taking medicines containing:

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.

- ketoconazole (an antifungal medicine)
- haloperidol or risperidone (to treat psychiatric conditions)
- metoprolol (a beta blocker to treat high blood pressure and heart
problems).

Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This
may increase the risk of tooth decay (caries). Therefore, you should
take special care in your dental hygiene.

Sunveniz XL with food, drink and alcohol
Sunveniz XL should be taken with food (see section 3 “How to take
Sunveniz XL”).
You should avoid alcohol while you are taking Sunveniz XL.

Diabetes
Your blood glucose levels may be altered due to Sunveniz XL.
Therefore, the dosage of your diabetes medicines may need to be
adjusted.

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.

Children and adolescents
Sunveniz XL 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 this medicine for patients under 18
because he/she decides that this is in their best interests. If your
doctor has prescribed this medicine 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 Sunveniz XL. Also, the long-term
safety concerning growth, maturation and cognitive and behavioural
development of this medicine in this age group has not yet been
demonstrated.

Make sure your midwife and/or doctor knows you are on Sunveniz XL.
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.

Other medicines and Sunveniz XL
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 Sunveniz XL with
other medicines.

If you are taking this medicine during pregnancy, other symptoms your
baby might have when it is born is not feeding properly, in addition to
having trouble breathing. If your baby has these symptoms when it is
born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.

Do not start or stop taking any medicines, including those bought
without a prescription, natural and herbal remedies, before checking
with your doctor or pharmacist.

Breast-feeding
Sunveniz XL passes into breast milk. There is a risk of an effect on the
baby. Therefore, you should discuss the matter with your doctor, and
he/she will decide whether you should stop breast-feeding or stop the
therapy with this medicine.

Pregnancy
Tell your doctor if you become pregnant, or if you are trying to become
pregnant. You should use Sunveniz XL only after discussing the
potential benefits and the potential risks to your unborn child with your
doctor.

- Monoamine oxidase inhibitors which are used to treat depression or
Parkinson's disease must not be taken with Sunveniz XL. Tell your
doctor if you have taken these medicines within the last 14 days.
(MAOIs: see the section “What you need to know before you take
Sunveniz XL”).
- Serotonine syndrome:
A potentially life-threatening condition or Neuroleptic Malignant
Syndrome (NMS)-like reactions (see the section “Possible Side
Effects”), may occur with venlafaxine treatment, particularly when
taken with other medicines.

Driving and using machines
Do not drive or use any tools or machines until you know how this
medicine affects you.
Sunveniz XL contains lactose
This medicine contains 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.

Examples of these medicines include:
- triptans (used to treat migraine)
- other medicines used to treat depression, for instance SNRIs,
SSRIs, tricyclics, or medicines containing lithium
- medicines containing linezolid, an antibiotic (used to treat
infections)
- medicines containing moclobemide, a MAOI (used to treat
depression)
- medicines containing sibutramine (used for weight loss)
- medicines containing tramadol, fentanyl, tapentadol, pethidine, or
pentazocine (used to treat severe pain)
- medicines containing dextromethorphan (used to treat coughing)
- medicines containing methadone (used to treat opioid drug
addiction or severe pain)
- medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)
- products containing St. John's Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild
depression)
- products containing tryptophan (used for problems such as sleep
and depression)
- antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken
beliefs, unusual suspiciousness, unclear reasoning and becoming
withdrawn).

3.How to take Sunveniz XL
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per
day. The dose can be raised by your doctor gradually, and if needed,
even up to a maximum dose of 375 mg daily for depression. If you are
being treated for panic disorder, your doctor will start with a lower
dose (37.5 mg) and then increase the dose gradually. The maximum
dose for generalised anxiety disorder, social anxiety disorder and panic
disorder is 225 mg/day.
Method of administration
Take this medicine at approximately the same time each day, either in
the morning or in the evening. Tablets must be swallowed whole with
fluid and not crushed, chewed or dissolved.
Sunveniz XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your
dose of this medicine may need to be different.

Signs and symptoms of serotonin syndrome may include a
combination of the following:
Restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea, vomiting.

Do not stop taking this medicine without talking to your doctor (see the
section “If you stop taking Sunveniz XL”).
If you take more Sunveniz XL than you should
Call your doctor or pharmacist immediately if you take more of this
medicine than the amount prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heartbeat,
changes in level of alertness (ranging from sleepiness to coma),
blurred vision, seizures or fits, and vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may
include a combination of fever, fast heart beat, sweating, severe
muscle stiffness, confusion, increased muscle enzymes (determined
by a blood test).

Folding
248--2 --62 mm
375--3 --46.87 mm

248 mm

Name of Product:
Sunveniz XL 37,5 , 75 , 150 mg

AWS TYPE

[V009 & V010]

PIL

Country

Language

EUUK - UNITED KINGDOM

ENGLISH

Code

044BP1191D

Void artwork Code No: 044BP1191C

CD-PDD-

Actual Size

248 x 375 mm

Reason: New draft from Europe

REMARKS:

Barcode Area

41 x 16 mm

No. of Colors : 1

Specification / Type of paper

375 mm

Package leaflet: Information for the user

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 start taking 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.
- If you are a young adult. Information from clinical trials has shown
an increased risk of suicidal behaviour in adults (less than 25 years
old) 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.

Location
SPIL - Halol

Size: 248x375 mm
Patient Information
SUN EUROPE
EUUK - UNITED KINGDOM

Color codes:

Super Fine 41 GSM ITC Paper

Folding
248--2 --62 mm
375--3 --46.87 mm

BLACK

Prepared by

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Development Department [PDD]
SPIL - Vadodara
Checked by

Approved by

Approved by RA

Approval History Attached

FONTS SPECIFICATION
Patient info. Leaflet

Swiss 721 CN BT - 10 pt

Title and Tiltle Heading

Swiss 721 CN BT - 13 pt and 11 pt

Body Text

Swiss 721 CN BT - 8 pt

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Sunveniz XL-37_5-75-150mg-PIL-248x375mm-EUUK-REV2-18-07-17
18\07\2017 3:15:14 PM

Blank Area
do not print here

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4.Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you notice any of the following happen, do not take more Sunveniz
XL. Tell your doctor immediately, or go to the casualty department
at your nearest hospital:
Uncommon: may affect up to 1 in 100 people
- swelling of the face, mouth, tongue, throat, hands, or feet, and/or a
raised itchy rash (hives), trouble swallowing or breathing.
Frequency not known: frequency cannot be estimated from the
available data
- chest tightness, wheezing, trouble swallowing or breathing
- severe rash, itching, or hives (elevated patches of red or pale skin
that often itch)
- signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its more severe form, serotonin syndrome can resemble
Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of
NMS may include a combination of fever, fast heart beat, sweating,
severe muscle stiffness, confusion, increased muscle enzymes
(determined by a blood test).
- signs of infection, such as high temperature, chills, shivering,
headaches, sweating, flu-like symptoms. This may be the result of a
blood disorder which leads to an increased risk of infection.
- severe rash, which may lead to severe blistering and peeling of the
skin
- unexplained muscle pain, tenderness or weakness. This may be a
sign of rhabdomyolysis.
Other side effects that you should tell your doctor about include (The
frequency of these side effects are included in the list “Other side
effects that may occur” below):
- coughing, wheezing, shortness of breath and a high temperature
- black (tarry) stools or blood stools
- itchiness, yellow skin or eyes, or dark urine, which may be
symptoms of inflammation of the liver (hepatitis)
- heart problems, such as fast or irregular heart rate, increased blood
pressure
- eye problems, such as blurred vision, dilated pupils
- nerve problems, such as dizziness, pins and needles, movement
disorder (muscle spasms or stiffness), seizures or fits
- psychiatric problems, such as hyperactivity and feeling unusually
overexcited
- withdrawal effects (see the information under 'If you stop taking
Sunveniz XL ' in the section “How to take Sunveniz XL ”)
- prolonged bleeding – if you cut or injure yourself, it may take
slightly longer than usual for bleeding to stop.
The coating does not dissolve completely and is passed out in your
stools. Do not be concerned if you see small fragments in your stools
after taking this medicine. Even though you may see these fragments,
your dose of medicine has been absorbed.
Other side effects that may occur
Very common: may affect more than 1 in 10 people
- dizziness, headache
- nausea, dry mouth
- sweating (including night sweats).

Rare: may affect up to 1 in 1,000 people
- seizures or fits
- inability to control urination
- over activity, thoughts and decreased need for sleep (mania).
Frequency not known: frequency cannot be estimated from the
available data
- prolonged bleeding, which may be a sign of reduced number of
platelets in your blood, leading to an increased risk of bruising or
bleeding
- excessive water intake (known as SIADH)
- decrease in blood sodium levels
- suicidal ideation and suicidal behaviours, cases of suicidal ideation
and suicidal behaviours have been reported during venlafaxine
therapy or early after treatment discontinuation (see section 2
“What you need to know before you take Sunveniz XL”)
- disorientation and confusion often accompanied by hallucination
(delirium), aggression
- stiffness, spasms and involuntary movements of the muscles
- severe eye pain and decreased or blurred vision
- vertigo
- decrease in blood pressure, abnormal, rapid or irregular heart beat,
which could lead to fainting, unexpected bleeding, e.g. bleeding
gums, blood in the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels (broken veins)
- coughing, wheezing, shortness of breath and a high temperature,
which are symptoms of inflammation of the lungs associated with
an increase in white blood cells (pulmonary eosinophilia)
- severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
- itchiness, yellow skin or eyes, dark urine, or flu-like symptoms,
which are symptoms of inflammation of the liver (hepatitis), slight
changes in blood levels of liver enzymes
- itching, mild rash
- abnormal breast milk production.
Sunveniz XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat,
slight changes in blood levels or liver enzymes, sodium or cholesterol.
More rarely, Sunveniz XL may reduce the function or platelets in your
blood, leading to an increased risk of bruising or bleeding. Therefore,
your doctor may wish to do blood tests occasionally, particularly if you
have been taking Sunveniz XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

Folding
248--2 --62 mm
375--3 --46.87 mm

Coating
ethylcellulose aqueous dispersion,
mannitol,
povidone K30,
dibutyl sebacate,
triethyl citrate,
polysorbate 20,
opadry II 85F19250 clear, which consists of
talc,
macrogol 3350,
polysorbate 80,
polyvinyl alcohol.
Printing ink (opacode-s-1-17823 black ink)
shellac,
iron oxide black (E172),
propylene glycol.
What Sunveniz XL looks like and contents of the pack
Sunveniz XL 37.5 mg: This medicinal product is presented as a round,
pink and white coloured biconvex, 5.9 mm in diameter bilayer coated
prolonged-release tablet imprinted with “760” with black ink on one
side and plain on the other side.
Sunveniz XL 75 mg: This medicinal product is presented as a round,
pink and white coloured biconvex, 8.4 mm in diameter bilayer coated
prolonged-release tablet imprinted with “759” with black ink on one
side and plain on the other side.
Sunveniz XL 150 mg: This medicinal product is presented as an oval,
pink and white coloured biconvex, 16.35 mm x 7.85 mm bilayer
coated tablet imprinted with “758” with black ink on one side and plain
on the other side.
Blister: Pack sizes 14, 15, 20, 28, 30, 50 or 100 prolonged-release
tablets.
Tablet container: Pack sizes: 30 and 1000 (for dispensing only)
prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the
EEA under the following names:
Germany: 
Spain:   
The Netherlands: 
United Kingdom: 

Venlafaxin SUN 37,5 mg / 75 mg/ 150 mg,
Retardtabletten
Venlafaxina SUN 37,5 mg / 75 mg / 150 mg,
comprimido de liberación prolongada
Venlafaxine SUN 37,5 mg / 75 mg / 150 mg,
tablet met verlengde afgifte
Sunveniz XL 37.5 mg / 75 mg / 150 mg,
prolonged-release tablets

This leaflet was last revised in 02/2016.

5.How to store Sunveniz XL
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 after “EXP”. The expiry date refers to the last day of that month.
Blisters: Store in the original package in order to protect from moisture.
Tablet container: Keep the tablet container tightly closed in order to
protect from moisture.
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 protect the environment.

6.Contents of the pack and other information
What Sunveniz XL contains

Common: may affect up to 1 in 10 people
- appetite decreased
- confusion, feeling separated (or detached) from yourself, lack of
orgasm, decreased libido, nervousness, insomnia, abnormal dreams
- drowsiness, tremor, pins and needles, increased muscle tonus
- visual disturbance including blurred vision, diluted pupils, inability of
the eye to automatically change focus from distant to near objects
- ringing in the ears (tinnitus)
- palpitations
- increase in blood pressure, flushing
- yawning
- vomiting, constipation, diarrhoea
- increased frequency in urination, difficulties passing urine

Openable layer:
microcrystalline cellulose, silicified,
crospovidone Type A,
silica colloidal anhydrous,
sodium lauryl sulphate,
allura red aluminium lake (E129),
talc,
magnesium stearate.

375 mm

Your doctor will advise you on how you should gradually discontinue
Sunveniz XL. If you experience any of these or other symptoms that
are troublesome, ask your doctor for further advice.

Uncommon: may affect up to 1 in 100 people
- hallucinations, feeling separated (or detached) from reality,
agitation, abnormal orgasm (females), lack of feeling or emotion,
feeling over-excited, grinding of the teeth
- a sensation of restlessness or an inability to sit or stand still,
fainting, involuntary movements of the muscles, impaired
coordination and balance, altered taste sensation
- fast heartbeat, feeling dizzy (particularly when standing up too
quickly)
- shortness of breath
- vomiting blood, black tarry stools (faeces) or blood in stools, which
can be a sign of internal bleeding
- sensitivity to sunlight, bruising, rash, abnormal hair loss
- inability to pass urine
- weight gain, weight loss.

The active substance is venlafaxine.
Each prolonged-release tablet contains 37.5 mg, 75 mg or 150 mg
venlafaxine (as venlafaxine hydrochloride).
The other ingredients are:
Tablet core
Sustained release layer:
methyl hydroxypropyl cellulose,
povidone K30,
lactose monohydrate,
methacrylic acid-ethyl acrylate copolymer (1:1),
talc,
magnesium stearate.

248 mm

Suppliers LOGO / Id here

If you stop taking Sunveniz XL
Do not stop taking this medicine or reduce the dose without the advice
of your doctor even if you feel better. If your doctor thinks that you no
longer need Sunveniz XL, he/she may reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when
people stop using this medicine, especially when it is stopped
suddenly or the dose is reduced too quickly. Some patients may
experience symptoms such as tiredness, dizziness, light-headedness,
headache, sleeplessness, nightmares, dry mouth, loss of appetite,
nausea, diarrhoea, nervousness, agitation, confusion, ringing in the
ears, tingling or rarely electric shock sensations, weakness, sweating,
seizures, or flu-like symptoms.

- menstrual irregularities such as increased bleeding or increased
irregular bleeding, abnormal ejaculation/orgasm (males), erectile
dysfunction (impotence)
- weakness (asthenia), fatigue, chills
- increased cholesterol.

044BP1191D

If you forget to take Sunveniz XL
Do not take a double dose to make up a forgotten tablet. 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 more than the daily amount of Sunveniz XL that has been
prescribed for you in one day.

Size: 248x375 mm
Patient Information
SUN EUROPE
EUUK - UNITED KINGDOM

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Sunveniz XL-37_5-75-150mg-PIL-248x375mm-EUUK-REV2-18-07-17
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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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