Venlafaxine teva

Poland
Brand name Venlafaxine teva
Form capsules, extended release, hard
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100458820
Venlafaxine teva capsules, extended release, hard

Package leaflet: Information for the user

Venlafaxine Teva, 37.5 mg, extended-release capsules, hard
Venlafaxine Teva, 75 mg, extended-release capsules, hard
Venlafaxine Teva, 150 mg, extended-release capsules, hard
Venlafaxinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

  1. What Venlafaxine Teva is and what it is used for
  2. Important information before taking Venlafaxine Teva
  3. How to take Venlafaxine Teva
  4. Possible side effects
  5. How to store Venlafaxine Teva
  6. Contents of the pack and other information

1. What Venlafaxine Teva is and what it is used for

Venlafaxine Teva contains the active substance - venlafaxine.
Venlafaxine Teva is an antidepressant medicine belonging to a group of medicines called
serotonin-norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used in the treatment of depression and other conditions such as anxiety disorders. It is believed that people suffering from depression and (or) anxiety disorders have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of action of antidepressant medicines is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.
Venlafaxine Teva is used in the treatment of depression in adults. It is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). Proper treatment of depression and anxiety disorders is important for the patient's well-being. Without appropriate treatment, the patient's condition may not improve, may worsen, and may become significantly more difficult to treat.

2. Important information before using Venlafaxine Teva

When not to use Venlafaxine Teva

  • if the patient is allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
  • if the patient is currently taking or has taken within the last 14 days certain medicines belonging to the group of irreversible monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson's disease. Taking irreversible MAOIs together with Venlafaxine Teva may cause severe or even life-threatening adverse reactions.

The patient should wait at least 7 days after stopping Venlafaxine Teva before starting any medicine from the MAOI group
(see also section "Venlafaxine Teva with other medicines" and information in this section
regarding serotonin syndrome).
Warnings and precautions
Before starting treatment with Venlafaxine Teva, discuss the following with your doctor:

  • if the patient is taking other medicines which, when taken together with Venlafaxine Teva, may increase the risk of serotonin syndrome (see section "Venlafaxine Teva with other medicines")
  • if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eyeball)
  • if the patient has previously had high blood pressure
  • if the patient has previously had heart disease
  • if the patient has been diagnosed with heart rhythm disorders
  • if the patient has previously experienced seizures (epilepsy)
  • if the patient has previously had low sodium levels in the blood (hyponatraemia)
  • if the patient has a tendency to bruise or bleed (bleeding disorders in the past), if the patient is taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if the patient is pregnant (see "Pregnancy and breastfeeding")
  • if the patient or anyone in their family has previously had mania or bipolar affective disorders (feelings of excessive excitement or euphoria)
  • if the patient has previously exhibited aggressive behaviour.

Venlafaxine Teva may cause feelings of restlessness or inability to sit still during the first weeks of treatment. If such symptoms occur, inform the treating doctor.
Do not consume alcohol during treatment with Venlafaxine Teva, as this may cause extreme drowsiness and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working. Such thoughts may also occur when reducing the dose or stopping treatment with Venlafaxine Teva.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

  • the patient has previously had suicidal thoughts or a desire to self-harm
  • the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in young adults (individuals under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to the nearest hospital.
It may be helpful to inform family or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for help and request them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Dry mouth
Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.
Diabetes
Blood glucose levels may change during treatment with Venlafaxine Teva. Therefore, dosage adjustment of antidiabetic medicines may be necessary.
Sexual dysfunction
Medicines such as Venlafaxine Teva (SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Granules in stool
Do not be concerned if small white beads or granules are visible in the stool after taking this medicine. Inside the capsules of Venlafaxine Teva are spheroids (small white beads) containing the active substance (venlafaxine). These beads are released from the capsule into the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The spheroidal "shell" does not dissolve and is excreted in the stool. Therefore, even if spheroids are visible in the stool, the dose of medicine has been absorbed.
Children and adolescents
Venlafaxine Teva should generally not be used in children and adolescents under 18 years of age.
It should be emphasized that when taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviours, and manifestations of anger). Nevertheless, a doctor may prescribe Venlafaxine Teva to patients under 18 years of age if they determine it is in their best interest. If a doctor has prescribed Venlafaxine Teva to a patient under 18 years of age and any doubts arise, consult the treating doctor. Inform the doctor if any of the symptoms listed above occur or worsen in a patient under 18 years of age taking Venlafaxine Teva. There are also no available data on the long-term safety of using this medicine in this age group regarding growth, maturation, and cognitive and behavioural development.
Venlafaxine Teva with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The treating doctor will decide whether Venlafaxine Teva can be used together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting a doctor or pharmacist.

  • Monoamine oxidase inhibitors used in the treatment of depression or Parkinson's disease must not be taken with Venlafaxine Teva. Inform the doctor if the patient has taken these medicines within the last 14 days. (MAOIs: see section "Important information before using Venlafaxine Teva").
  • Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or reactions resembling neuroleptic malignant syndrome (NMS) may occur (see section "Possible side effects"), especially when taken concomitantly with other medicines.

Examples of such medicines include:

  • triptans (used for migraine headaches)
  • other medicines used to treat depression, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium
  • medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
  • medicines containing the antibiotic linezolid (used to treat infections)
  • medicines containing moclobemide, an MAO inhibitor (used to treat depression)
  • medicines containing sibutramine (used for weight loss)
  • medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine or pentazocine) used to treat severe pain
  • medicines containing dextromethorphan (used to treat cough)
  • medicines containing methadone (used to treat opioid dependence or severe pain)
  • medicines containing methylene blue (used to treat high methemoglobin levels in the blood)
  • medicines containing St. John's wort (Hypericum perforatum, natural or herbal remedies used to treat mild depression)
  • medicines containing tryptophan (used for sleep problems and depression)
  • antipsychotic medicines (used to treat illnesses with symptoms such as hearing, seeing, and feeling things that are not there, false beliefs, unclear thinking, and withdrawal)

Subjective and objective symptoms of serotonin syndrome may include:
agitation, hallucinations, lack of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, lethargy, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms include: fever, rapid heartbeat, sweating, muscle stiffness, confusion, increased muscle enzyme levels (detected in blood tests).
If serotonin syndrome is suspected, immediately inform your doctor or go to the emergency department of the nearest hospital.
Inform your doctor if the patient is taking medicines that may affect heart rhythm. Examples of such medicines include:

  • antiarrhythmic medicines such as quinidine, amiodarone, sotalol or dofetilide (used to treat heart rhythm disorders)
  • antipsychotic medicines such as thioridazine (see also "Serotonin syndrome" above)
  • antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
  • antihistamine medicines (used to treat allergies).

The following medicines may also interact with Venlafaxine Teva and therefore should be used with caution. It is especially important to inform the doctor if the patient is taking medicines containing:

  • ketoconazole (an antifungal medicine)
  • haloperidol or risperidone (medicines used to treat psychiatric disorders)
  • metoprolol (a beta-blocker used to treat high blood pressure and heart disease).

Venlafaxine Teva with food, drink and alcohol
Venlafaxine Teva should be taken with food (see section 3 "How to use Venlafaxine Teva").
Do not consume alcohol during treatment with Venlafaxine Teva. Concurrent use with alcohol may cause extreme drowsiness and loss of consciousness and may worsen symptoms of depression and other medical conditions such as anxiety disorders.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Venlafaxine Teva should only be used after discussing the potential benefits and risks for the unborn child with a doctor.
Inform the doctor and (or) midwife about taking Venlafaxine Teva. Taking similar medicines (SSRIs) during pregnancy may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which manifests as rapid breathing and cyanosis. These symptoms usually appear within the first day after birth.
If such symptoms occur in the newborn, contact the midwife and (or) doctor immediately.
Taking Venlafaxine Teva towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Venlafaxine Teva, she should inform her doctor or midwife so they can provide appropriate advice.
If the patient takes this medicine during pregnancy, in addition to breathing difficulties, the newborn may experience other symptoms such as feeding problems. If the patient is concerned about such symptoms in the newborn, she should contact the doctor and (or) midwife, who will be able to provide appropriate advice.
Venlafaxine Teva passes into human milk. There is a risk that the medicine may affect the infant. Therefore, this issue should be discussed with the doctor, who will decide whether breastfeeding should be discontinued or treatment with this medicine stopped.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how the medicine affects them.
Venlafaxine Teva contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Venlafaxine Teva

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalised anxiety disorder, and social phobia is 75 mg once daily. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg once daily in the treatment of depression. For panic disorder, treatment should be initiated at a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalised anxiety disorder, social phobia, and panic disorder is 225 mg once daily.
Venlafaxine Teva is for oral use.
Venlafaxine Teva should be taken every day at approximately the same time, regardless of whether it is taken in the morning or evening. To ensure complete swallowing of the pellets (the small beads inside the capsules), the capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
Venlafaxine Teva should be taken with food.
If you have liver or kidney problems, inform your doctor, as your dose may need to be adjusted.
Do not stop taking this medicine without consulting your doctor (see section “Stopping treatment with Venlafaxine Teva”).

Taking more Venlafaxine Teva than prescribed
If you take more Venlafaxine Teva than prescribed, contact your doctor or pharmacist immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section “Venlafaxine Teva and other medicines”).
Symptoms of overdose may include rapid heartbeat, disturbances in consciousness (ranging from drowsiness to coma), visual disturbances, seizures, and vomiting.

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

Stopping treatment with Venlafaxine Teva
Do not stop treatment or reduce the dose of this medicine without consulting your doctor, even if you feel better. If your doctor decides that treatment with Venlafaxine Teva can be discontinued, they will advise you on how to gradually reduce the dose before stopping completely. Patients discontinuing this medicine, especially those who stop abruptly or reduce the dose too quickly, may experience adverse effects.
Some patients may experience symptoms such as suicidal thoughts, aggressive behaviour, fatigue, dizziness, a feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, disorientation, tinnitus, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, visual disturbances, and elevated blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).
Your doctor will advise you on how to gradually discontinue Venlafaxine Teva. This process may take several weeks or months. In some patients, a very gradual discontinuation over several months or longer may be necessary. If any of the symptoms listed above, or other bothersome symptoms, occur, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue use of
Venlafaxine Teva and seek immediate medical attention by contacting your doctor or going to the emergency department of the nearest hospital:
Uncommon (may affect up to 1 in 100 people)

  • swelling of the face, lips, tongue, throat, hands or feet, and (or) raised, itchy rash (urticaria), difficulty swallowing or breathing.
    Rare (may affect up to 1 in 1000 people)
  • chest tightness, wheezing, difficulty swallowing or breathing
  • severe skin rash, itching or urticaria (red or pale raised swelling, often accompanied by itching)
  • symptoms of serotonin syndrome, such as: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, drowsiness, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
  • signs of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
  • severe skin rash, which may lead to formation of severe blisters and skin peeling
  • muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

  • Symptoms of a condition known as stress cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

You should inform your doctor if any other adverse reactions occur, such as (the frequency
of these adverse reactions is listed below under "Other adverse reactions"):

  • cough, wheezing and shortness of breath, possibly accompanied by high fever
  • black (tarry) stools or blood in stool
  • yellowing of the skin or eyes, or dark urine, which may be symptoms of hepatitis
  • heart problems, such as rapid or irregular heartbeat, elevated blood pressure
  • eye problems, such as blurred vision, dilated pupils
  • nervous system disorders, such as dizziness, tingling sensation, movement coordination problems (muscle spasms or stiffness), seizures or convulsions
  • psychiatric disorders, such as excessive restlessness and feelings of unnatural excitement
  • withdrawal symptoms (see sections "How to use Venlafaxine Teva" and "Discontinuing treatment with Venlafaxine Teva")
  • Prolonged bleeding time – in case of a cut, the wound may bleed slightly longer than usual.

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

  • dizziness, headache, drowsiness
  • insomnia
  • nausea, dry mouth, constipation
  • sweating (including night sweats)

Common (may affect up to 1 in 10 people)

  • decreased appetite
  • confusion, feeling detached (or separated) from oneself, anorgasmia, decreased libido, agitation, nervousness, unusual dreams
  • tremor, feeling of anxiety or inability to sit still or remain motionless, tingling, taste disturbances, increased muscle tension
  • visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects
  • ringing in the ears (tinnitus)
  • rapid heartbeat, palpitations
  • increased blood pressure, hot flushes
  • shortness of breath, yawning
  • vomiting, diarrhea
  • mild rash, itching
  • increased frequency of urination, urinary retention, difficulty urinating
  • menstrual disorders such as heavy bleeding or more frequent irregular bleeding; ejaculation and orgasm disorders (in men), erectile dysfunction (impotence)
  • weakness (asthenia), fatigue, chills
  • weight gain, weight loss
  • increased cholesterol levels

Uncommon (may affect up to 1 in 100 people)

  • excessive activity, racing thoughts and reduced need for sleep (mania)
  • hallucinations, feeling detached (or separated) from reality, orgasm disorders, lack of feelings or emotions, feeling overly stimulated, teeth grinding
  • fainting, involuntary muscle movements, coordination and balance disturbances
  • dizziness (especially upon standing too quickly), decreased blood pressure
  • blood in vomit, black (tarry) stools (faeces) or blood in stool, which may indicate internal bleeding
  • light sensitivity, bruising, excessive hair loss
  • uncontrolled urination
  • stiffness, spasms and uncontrolled muscle movements
  • minor changes in liver enzyme activity in blood

Rare (may affect up to 1 in 1000 people)

  • convulsions
  • cough, wheezing and shortness of breath, possibly accompanied by high fever
  • excessive water intake (known as SIADH)
  • decreased sodium levels in blood
  • severe eye pain and visual disturbances or blurred vision
  • severe abdominal or back pain (which may indicate serious intestinal, liver or pancreatic disorders)
  • itching, yellow skin or eyes, dark urine or flu-like symptoms, which are signs of hepatitis
  • disorientation and confusion, often accompanied by hallucinations (delirium)
  • irregular, rapid or abnormal heartbeat, which may lead to fainting

Very rare (may affect up to 1 in 10,000 people)

  • prolonged bleeding, which may be a sign of reduced platelet count, indicating increased risk of bruising or bleeding
  • unusual milk production in women
  • unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, or appearance of unexpected bruises or broken blood vessels (broken veins)

Not known (frequency cannot be estimated from available data)

  • suicidal thoughts and behaviors: cases of suicidal thoughts and behaviors have been reported during treatment with venlafaxine or shortly after treatment discontinuation (see section 2. "Important information before taking Venlafaxine Teva")
  • aggressive behavior
  • vertigo of vestibular origin
  • severe vaginal bleeding shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine Teva may sometimes cause adverse reactions that the patient may not
be aware of, such as increased blood pressure or abnormal heart function; minor
changes in blood levels of sodium, cholesterol or liver enzymes. Rarely, Venlafaxine
Teva may impair platelet function, leading to increased risk of petechiae or bleeding.
Therefore, your doctor may recommend periodic blood tests, especially in the case of
long-term treatment with Venlafaxine Teva.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or nurse. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Venlafaxine Teva

Keep this medicine out of the sight and reach of children.
Do not use Venlafaxine Teva after the expiry date stated on the cardboard package and blister after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Venlafaxine Teva contains
The active substance is venlafaxine.
Venlafaxine Teva, 37.5 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to
37.5 mg of venlafaxine.
Venlafaxine Teva, 75 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to
75 mg of venlafaxine.
Venlafaxine Teva, 150 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to
150 mg of venlafaxine.
The other ingredients are:
Capsule contents: Sucrose, pellets (sucrose + corn starch), hypromellose, type 2910,
ethylcellulose, type B, talc.
Capsule shell:
Venlafaxine Teva, 37.5 mg:
Iron oxide black (E 172), titanium dioxide (E 171), gelatin, iron oxide red (E 172)
Venlafaxine Teva, 75 mg:
Iron oxide red (E 172), titanium dioxide (E 171), gelatin
Venlafaxine Teva, 150 mg:
Iron oxide yellow (E 172), titanium dioxide (E 171), gelatin, iron oxide red (E 172)
Ink: shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E172),
potassium hydroxide

What Venlafaxine Teva looks like and contents of the pack
Venlafaxine Teva 37.5 mg:
Hard gelatin capsules with an opaque grey cap and an opaque pink body, filled with white to beige microgranules. The capsules are printed in black ink with "VNL" on the cap and "37.5" on the body. Dimensions are approximately 16 mm x 6 mm.
Venlafaxine Teva 75 mg:
Hard gelatin capsules with an opaque pink cap and an opaque pink body, filled with white to beige microgranules. The capsules are printed in black ink with "VNL" on the cap and "75" on the body. Dimensions are approximately 20 mm x 7 mm.
Venlafaxine Teva 150 mg:
Hard gelatin capsules with an opaque brown cap and an opaque brown body, filled with white to beige microgranules. The capsules are printed in black ink with "VNL" on the cap and "150" on the body. Dimensions are approximately 24 mm x 8 mm.
Blister packs containing: 10, 14, 20, 28, 30, 50, 98 and 100 prolonged-release hard capsules, or unit dose blisters containing 100x1 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Poland

For further information about this medicinal product, contact the marketing authorisation holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Austria: Venlafaxin Actavis
Bulgaria: Лароксин XR
Croatia: Velafax XL
Denmark: Venlafaxin Teva
Laroxin XR
Finland: Venlafaxin ratiopharm
France: VENLAFAXINE TEVA LP
Netherlands: Venlafaxine retard Teva
Iceland: Venlafaxin Teva
Luxembourg: Venlafaxin-ratiopharm
Germany: Venlafaxin-ratiopharm
Norway: Venlafaxin Teva
Poland: Venlafaxine Teva
Portugal: Venlafaxina ratiopharm
Sweden: Venlafaxin Teva
Italy: Venlafaxina Teva