Venlafaxine Teva Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlafaxine Teva Italia 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

Venlafaxine
Generic Medicine
SOME IMPORTANT INFORMATION ABOUT Venlafaxine Teva Italia
Please read this leaflet before taking this medicine as it contains important information about
Venlafaxine Teva Italia

Venlafaxine Teva Italia is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia), and panic disorder (panic attacks). Venlafaxine Teva Italia is not indicated for use in children and adolescents – see section 2 "Use in children and adolescents".

If you are concerned about how you feel or about this medicine, it is important that you consult your doctor,
even if the matter worries or upsets you.
It may help to talk to a friend or relative about your depression or anxiety disorder, and to inform them that you
have been prescribed this medicine. You may find it helpful to show them this leaflet.

The effects of Venlafaxine Teva Italia may not be felt immediately. Some people taking antidepressants may feel worse before they start to feel better with the medicine. Your doctor may ask to see you a couple of weeks after you start treatment and then regularly until you begin to feel well again. Inform your doctor if you feel that the medicine is not helping you feel better.
Some people with depression may have thoughts of harming themselves or of suicide. If this happens to you, consult your doctor or go to hospital immediately – see section 2 "Suicidal thoughts and worsening of depression or anxiety disorder".
If you take more capsules than you should, it is important to contact your doctor immediately, even if you feel well, due to the risk of serious adverse effects.
Do not stop taking Venlafaxine Teva Italia or change the dose without consulting your doctor, even if you feel better. If you stop taking Venlafaxine Teva Italia abruptly, withdrawal symptoms may occur – see section 3 "If you stop taking Venlafaxine Teva Italia".
If you have heart problems such as rapid or irregular heartbeat, or high blood pressure, consult your doctor before taking Venlafaxine Teva Italia – see section 2 "Before taking Venlafaxine Teva Italia".
Taking certain other medicines together with Venlafaxine Teva Italia may cause problems. Inform your doctor if you are taking other medicines – see section 2 "Before taking Venlafaxine Teva Italia".
Contact your doctor immediately if you experience restlessness and an inability to remain still, if you feel euphoric or highly agitated, or if you experience sudden, uncontrollable muscle movements. See section 4 "Possible side effects" for further important information.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor – see section 2 "Pregnancy, breastfeeding and Venlafaxine Teva Italia". Further information on all these points is provided in the rest of this leaflet. Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Venlafaxine Teva Italia is and what it is used for
What you need to know before taking Venlafaxine Teva Italia
How to take Venlafaxine Teva Italia
Possible side effects
How to store Venlafaxine Teva Italia
Contents of the pack and other information

1. WHAT VENLAFAXINE TEVA ITALIA IS AND WHAT IT IS USED FOR

Venlafaxine Teva Italia is an antidepressant belonging 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 believed that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. The exact way antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venlafaxine Teva Italia is a treatment for depression in adults. Venlafaxine Teva Italia is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear of or tendency to avoid social situations), and panic disorder (panic attacks). Appropriate treatment of depression or anxiety disorders is important to help you feel better. If left untreated, your condition may not improve and may become more severe and more difficult to treat.

2. What you need to know before taking Venlafaxine Teva Italia

Do not take Venlafaxine Teva Italia

if you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
if you are currently taking or have taken 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 Venlafaxine Teva Italia, may cause serious or even life-threatening side effects. Additionally, you must wait at least 7 days after stopping treatment with Venlafaxine Teva Italia before taking any irreversible MAOI (also see sections “Serotonin syndrome” and “Other medicines and Venlafaxine Teva Italia”).

Warnings and precautions

Talk to your doctor before using Venlafaxine Teva Italia if:

you are using other medicines that, when taken together with Venlafaxine Teva Italia, may increase the risk of developing serotonin syndrome (see section “Taking Venlafaxine Teva Italia with other medicines”),
you have eye problems, such as certain types of glaucoma (increased pressure inside the eye),
you have a history of high blood pressure,
you have a history of heart problems,
you have been told you have an abnormal heart rhythm,
you have a history of seizures,
you have a history of low sodium levels in your blood (hyponatraemia),
you have a tendency to bruise easily or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding such as warfarin (used to prevent blood clots),
your cholesterol levels increase,
you have a history, or a family history, of mania or bipolar disorder (feelings of over-excitement or euphoria),
you have a history of aggressive behaviour.

Venlafaxine Teva Italia may cause a feeling of restlessness or inability to sit still.
If you experience these symptoms, you must inform your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from a depressive and/or anxiety disorder, you may sometimes have suicidal or self-harming thoughts.
These thoughts may increase when starting antidepressant treatment, as such medicines take some time to become effective, usually about 2 weeks, but sometimes longer.
You are more likely to experience such thoughts:

if you have previously had suicidal or self-harming thoughts,
if you are young. Clinical trial data have shown a higher risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If at any time you experience suicidal or self-harming thoughts, contact your doctor immediately or go to the nearest hospital.
It may help to tell a relative or close friend about your depressive or anxious condition and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.

Dry mouth
Dry mouth occurs in 10% of patients treated with venlafaxine. This may increase the risk of dental caries.
Therefore, you should pay particular attention to your oral hygiene.

Diabetes
Blood glucose levels may be altered due to Venlafaxine Teva Italia. Adjustment of the dosage of diabetes medications may be necessary.

Children and adolescents
Venlafaxine Teva Italia is generally not recommended for use in children and adolescents under 18 years of age. Furthermore, you should know that patients under 18 years of age have a higher risk of experiencing side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive behaviour, oppositional behaviour, and anger) when taking this class of medicines. Nevertheless, your doctor may prescribe Venlafaxine Teva Italia for patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Venlafaxine Teva Italia for a patient under 18 years of age and you wish to discuss this, speak to your doctor. You must inform the doctor if any of the listed symptoms appear or worsen when a patient under 18 years of age is taking Venlafaxine Teva Italia. In addition, the long-term effects on growth, maturation, and cognitive and behavioural development in this age group have not been established.

Other medicines and Venlafaxine Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Your doctor must decide whether you can take Venlafaxine Teva Italia with other medicines.
Do not start or stop taking any other medicines, including non-prescription medicines or herbal preparations, without first consulting your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Teva Italia. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “What you need to know before taking Venlafaxine Teva Italia”).
During treatment with venlafaxine, serotonin syndrome—a potentially life-threatening condition—or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur. This is especially likely when venlafaxine is taken with other medicines. Examples of such medicines include:
- Triptans (used for migraine)
- Medicines for depression, for example serotonin-norepinephrine reuptake inhibitors (SNRIs, SSRIs), tricyclic antidepressants, or medicines containing lithium
- Medicines containing linezolid, an antibiotic (used to treat infections)
- Medicines containing moclobemide, a reversible MAOI (used to treat depression)
- Medicines containing sibutramine (used for weight loss)
- Medicines containing tramadol (a painkiller), fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
- Medicines containing dextromethorphan (used to treat cough)
- Medicines containing methadone (used to treat opioid addiction or severe pain)
- Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
- Herbal preparations containing St. John’s wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression)
- Products containing tryptophan (used for sleep disorders and depression)
- Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or sensing things that are not present, false beliefs, unusual suspiciousness, unclear thinking, and reduced social interaction).

Signs and symptoms of serotonin syndrome may include a combination of: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In more severe forms, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood tests).

Contact your doctor immediately or go immediately to the nearest emergency room if you think you have serotonin syndrome.

Inform your doctor if you are taking medicines that may affect your heart rhythm.
Examples of such medicines include:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm abnormalities)
antipsychotics such as thioridazine (see also serotonin syndrome above)
antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
antihistamines (used to treat allergies)

The following medicines may also interact with Venlafaxine Teva Italia and should be used with caution. It is particularly important that you inform your doctor or pharmacist if you are taking medicines containing:

ketoconazole (an antifungal medicine)
haloperidol or risperidone (for the treatment of psychiatric disorders)
metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine Teva Italia with food and drink
You must take Venlafaxine Teva Italia with food (see section “How to take Venlafaxine Teva Italia”).
You must not drink alcohol while taking Venlafaxine Teva Italia.

Pregnancy and breastfeeding
Inform your doctor if you find out you are pregnant or if you are trying to become pregnant.
You should take Venlafaxine Teva Italia only after discussing with your doctor the potential benefits and possible risks to the unborn baby.
Make sure to inform your midwife and/or doctor that you are taking Venlafaxine Teva Italia.
If used during pregnancy, especially during the last 3 months, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and have a bluish skin colour. These symptoms usually appear within the first 24 hours after birth. If this condition affects your baby, contact your midwife and/or doctor immediately.
If you take this medicine during pregnancy, inform your doctor, as your baby may experience other symptoms after birth. These symptoms usually begin within 24 hours of birth and, in addition to breathing difficulties, may include poor feeding. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to assist you.

Venlafaxine Teva Italia is excreted in breast milk. There is a risk of effects on the infant. Therefore, you must discuss with your doctor, who will decide whether you should discontinue breastfeeding or stop treatment with Venlafaxine Teva Italia.

Driving and using machines
Do not drive and do not use tools or machinery until you know how Venlafaxine Teva Italia affects you.

Venlafaxine Teva Italia contains sucrose
This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Venlafaxine Teva Italia

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg daily. Your doctor may gradually increase the dose, and if necessary, 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 gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg daily.
Take Venlafaxine Teva Italia at approximately the same time each day, in the morning or evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
You must take Venlafaxine Teva Italia with food.
If you have liver or kidney problems, discuss this with your doctor, as dose adjustment of Venlafaxine Teva Italia may be necessary.
Do not stop treatment with Venlafaxine Teva Italia without consulting your doctor (see section “If you stop taking Venlafaxine Teva Italia”).

If you take more Venlafaxine Teva Italia than you should
Contact your doctor or pharmacist immediately if you take more Venlafaxine Teva Italia than prescribed by your doctor.
Symptoms of a possible overdose may include rapid heartbeat, changes in consciousness (ranging from drowsiness to coma), blurred vision, seizures, and vomiting.

If you forget to take Venlafaxine Teva Italia
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.
Do not take more than the prescribed daily amount of Venlafaxine Teva Italia in one day.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Venlafaxine Teva Italia
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Teva Italia, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects may occur when patients discontinue treatment with Venlafaxine Teva Italia, especially if Venlafaxine Teva Italia is stopped abruptly or if the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, lightheadedness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling or, rarely, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Teva Italia. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one may cause side effects, although not everyone experiences them.
If you experience any of the following effects, do not take any more Venlafaxine Teva Italia, contact your doctor immediately, or go to the nearest hospital emergency department.

Chest tightness, wheezing, difficulty swallowing or breathing.
Swelling of the face, throat, hands or feet.
Feeling nervous or anxious, dizziness, sensation of pulsation, sudden skin flushing and/or feeling of warmth.
Severe rash, itching, or hives (raised red or pale patches of skin that often itch).
Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting. In more severe cases, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood tests).

Other side effects that you must immediately report to your doctor are:

Cough, wheezing, shortness of breath and high temperature.
Black (tarry) stools or blood in the stool.
Yellowing of the skin or eyes, itching, or dark urine, which may be symptoms of liver inflammation (hepatitis).
Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
Eye problems, such as blurred vision, dilated pupils.
Nervous system problems, such as dizziness, tingling, movement disorders, seizures.
Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited).
Withdrawal syndrome (see section “How to take Venlafaxine Teva Italia, If you stop taking Venlafaxine Teva Italia”).
Prolonged bleeding – if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Do not be concerned if you notice small white balls or granules in your stool after taking this medicine.
Venlafaxine Teva Italia contains spheroids (small white balls) that contain the active substance (venlafaxine).
These spheroids are released from the capsule into the stomach. As they pass through the stomach and intestine,
venlafaxine is slowly released. The “shell” of the spheroids does not dissolve and is eliminated in the stool.
Therefore, even if you see spheroids in your stool, the dose of medicine has been absorbed.

Complete list of side effects

Very common (may affect more than 1 in 10 people)

Dizziness, headache;
Nausea, dry mouth;
Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

Decreased appetite
Confusion; feeling detached from oneself; absence of orgasm; decreased libido; nervousness; insomnia; abnormal dreams
Drowsiness; tremor; tingling; increased muscle tone
Visual disturbances including blurred vision; dilated pupils; inability of the eyes to automatically focus on near or distant objects
Ringing in the ears (tinnitus)
Palpitations
Increased blood pressure; hot flushes
Yawning
Vomiting; constipation; diarrhoea
Increased frequency of urination; difficulty passing urine
Menstrual irregularities such as increased bleeding or increased irregular bleeding; ejaculation/orgasm abnormalities (males); erectile dysfunction (impotence)
Weakness (asthenia); fatigue; chills
Increased cholesterol

Uncommon (may affect up to 1 in 100 people)

Hallucinations; feeling of separation (or detachment) from reality; agitation; orgasm abnormalities (females); lack of sensations or emotions; feeling of overexcitement; teeth grinding
Feeling restless or unable to sit still; fainting; involuntary muscle movements; altered coordination and balance; altered sense of taste
Fast heartbeat; dizziness (especially when standing up too quickly)
Shortness of breath
Vomiting blood, black tarry stools or blood in the stool, which may indicate internal bleeding
Generalised swelling of the skin, especially of the face, mouth, tongue, throat or hands and feet and/or raised skin rash (urticaria); sensitivity to sunlight; bruising; skin rash; abnormal hair loss
Inability to urinate
Weight gain or weight loss

Rare (may affect up to 1 in 1,000 people)

Epileptic seizures or convulsions
Inability to control urination
Hyperactivity, wandering thoughts and reduced need for sleep (mania)

Not known: frequency cannot be estimated from the available data

Reduction in the number of platelets in the blood, which may increase the risk of bleeding or bruising; blood disorders that may increase the risk of infections
Swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (could be a severe allergic reaction)
Excessive water intake (known as SIADH)
Decreased sodium levels in the blood
Suicidal thoughts and behaviours; cases of suicidal thoughts and behaviours have been observed during treatment with venlafaxine or shortly after stopping treatment (see section 2, “What you should know before taking Venlafaxine Teva Italia”)
Disorientation and confusion often accompanied by hallucinations (delirium); aggressive behaviour
Elevated body temperature with muscle rigidity, confusion or agitation and sweating, or the appearance of uncontrolled, spasmodic movements, which may be symptoms of a serious condition known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, rapid prolonged eye movements, clumsiness, restlessness, feeling of drunkenness, sweating or muscle rigidity, which are symptoms of serotonin syndrome; muscle stiffness, spasms and involuntary muscle movements
Severe eye pain and reduced or blurred vision
Dizziness
Decreased blood pressure; abnormal, rapid or irregular heartbeat, which may lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, or unexpected bruising or broken blood vessels (vein rupture)
Cough, wheezing, shortness of breath and elevated body temperature, which may be symptoms of lung inflammation associated with increased white blood cells (pulmonary eosinophilia)
Severe abdominal or back pain (which may indicate a serious problem with the intestine, liver or pancreas)
Itching, yellowing of the skin or eyes, dark urine or flu-like symptoms, which are symptoms of liver inflammation (hepatitis); mild changes in liver enzyme levels in blood
Skin rash, possibly with severe blistering and peeling of the skin; itching; mild skin rash
Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Abnormal production of milk from the breasts

Venlafaxine Teva Italia may sometimes cause side effects that you may not notice, such as increases in blood pressure or abnormal heartbeat, mild changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, Venlafaxine Teva Italia may reduce platelet function in the blood, leading to an increased risk of bruising and bleeding. Therefore, your doctor may decide to have you undergo periodic blood tests, especially if you have been taking Venlafaxine Teva Italia for a long time.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlafaxine Teva Italia

Keep Venlafaxine Teva Italia out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the abbreviation EXP.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Venlafaxine Teva Italia contains

The active substance is venlafaxine.
Venlafaxine Teva Italia 37.5 mg prolonged-release hard capsules: Each prolonged-release hard capsule contains 37.5 mg of venlafaxine (equivalent to 42.43 mg of venlafaxine hydrochloride).
Venlafaxine Teva Italia 75 mg prolonged-release hard capsules: Each prolonged-release hard capsule contains 75 mg of venlafaxine (equivalent to 84.85 mg of venlafaxine hydrochloride).
Venlafaxine Teva Italia 150 mg prolonged-release hard capsules: Each prolonged-release hard capsule contains 150 mg of venlafaxine (equivalent to 169.70 mg of venlafaxine hydrochloride).

The excipients are:
Contents of the capsule: Sugar granules (sucrose, maize starch), hydroxypropylcellulose, povidone K30, ethylcellulose, dibutyl sebacate, talc.

The 37.5 mg prolonged-release hard capsules contain: gelatin, titanium dioxide (E171), red iron oxide (E172).
The 75 mg prolonged-release hard capsules contain: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
The 150 mg prolonged-release hard capsules contain: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Venlafaxine Teva Italia and package contents
Venlafaxine Teva Italia 37.5 mg prolonged-release hard capsules: Opaque capsules with a brownish-pink cap and a white body.
Venlafaxine Teva Italia 75 mg prolonged-release hard capsules: Opaque light pink capsules.
Venlafaxine Teva Italia 150 mg prolonged-release hard capsules: Opaque orange-brown capsules.

Pack sizes:
Blister packs containing 10, 14, 20, 28, 30, 50, 98, 100, or 100x1 prolonged-release hard capsules.
Bottles made of high-density polyethylene (HDPE) containing 50, 100, or 250 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Responsible manufacturer for batch release:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:

| Member State | Medicinal Product Name | |------------------|----------------------------| | Germany | Venla Teva | | Spain | Venlafaxina Retard Teva | | Finland | Esenerin | | Hungary | Falven | | Italy | Venlafaxina Teva Italia | | Portugal | Venlafaxina Teva | | United Kingdom | Rodomel XL |

This Patient Information Leaflet was last approved on: