VENLAFAXINA 37,5 mg Extended-release hard capsule

Зміст інструкції

1. Venlafaxina Teva Italia 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules
   1. WHAT IS VENLAFAXINA TEVA ITALIA AND WHAT IT IS USED FOR
   2. What you need to know before taking Venlafaxina Teva Italia
   3. How to take Venlafaxina Teva Italia
   4. Possible side effects
   5. How to store Venlafaxina Teva Italia
   6. Package Contents and Other Information

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

Venlafaxina

Equivalent Medicinal Product
SOME IMPORTANT THINGS TO KNOW ABOUT Venlafaxina Teva Italia
Read this leaflet before taking this medicine because it contains important information about
Venlafaxina Teva Italia

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

If you are worried about how you feel or about this medicine, it is important to consult your doctor,
even if it concerns you or makes you anxious.
It may help to talk to a friend or relative about your depression or anxiety, and let them know that you have been prescribed this medicine. It may be helpful to show them this leaflet.

• The effects of Venlafaxina Teva Italia may not be noticeable immediately.Some people taking antidepressants may experience a worsening of their condition before they actually begin to feel better from the medication. Your doctor may ask to see you a couple of weeks after starting treatment and then regularly until you begin to feel well again. Tell your doctor if you feel that the medicine is not helping you feel better.
• Some people with depression may think about harming themselves or committing suicide. If this happens to you, consult your doctor or go to the hospital immediately - see section 2 "Suicidal thoughts and worsening of depression or anxiety".
• If you take more capsules than you should, it is important to seek immediate medical attention, even if you feel well, due to the risk of serious side effects.
• Do not stop taking Venlafaxina Teva Italia and do not change the dose without consulting your doctor, even if you feel better. If you suddenly stop taking Venlafaxina Teva Italia, withdrawal symptoms may occur - see section 3 "If you stop taking Venlafaxina Teva Italia".
• If you have heart problems such as a fast or irregular heartbeat, or high blood pressure, consult your doctor before taking Venlafaxina TevaItalia - see section 2 "Before taking Venlafaxina Teva Italia".
• Taking some other medicines with Venlafaxina Teva Italia can cause problems. Tell your doctor if you are taking any other medicines - see section 2 "Before taking Venlafaxina Teva Italia".
• Consult your doctor immediately if you feel restless and seem unable to stay still, if you feel euphoric or very excited, or if you experience involuntary muscle movements that you cannot control. See section 4 - "Possible side effects" for other important information.
• If you are pregnant or planning to become pregnant, or if you are breastfeeding, consult your doctor- see section 2 "Pregnancy, breastfeeding and Venlafaxina Teva Italia".

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 only for you. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Venlafaxina Teva Italia and what is it used for
• 2. What you need to know before you take Venlafaxina Teva Italia
• 3. How to take Venlafaxina Teva Italia
• 4. Possible side effects
• 5. How to store Venlafaxina Teva Italia
• 6. Contents of the pack and other information

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

Venlafaxina Teva Italia is an antidepressant belonging to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).
This group of medicines is used for the treatment of 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 norepinephrine in the brain. The way antidepressants work is not fully understood, however
they may help by raising the levels of serotonin and norepinephrine in the brain.
Venlafaxina Teva Italia is a treatment for adults suffering from depression. Venlafaxina 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 resolve and may become more severe and more difficult to treat.

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

Do not take Venlafaxina Teva Italia

• if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• if you are 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 Venlafaxina Teva Italia, can cause serious or even life-threatening side effects. You must also wait at least 7 days after stopping treatment with Venlafaxina Teva Italia before taking any irreversible MAOI (see also the sections “Serotonin syndrome” and “Other medicines and Venlafaxina Teva Italia”). Warnings and precautions
• Talk to your doctor before taking Venlafaxina Teva Italia if you are taking other medicines that, when taken together with Venlafaxina Teva Italia, may increase the risk of developing serotonin syndrome (see the section “Taking Venlafaxina Teva Italia with other medicines”),
• if you have eye problems, such as certain types of glaucoma (increased pressure inside the eye),
• if you have a history of high blood pressure,
• if you have a history of heart problems,
• if you have been told that you have an irregular heartbeat.
• if you have had seizures,
• if you have had low levels of sodium in your blood (hyponatraemia),
• if you have a tendency to bruise easily or a tendency to bleed easily (history of bleeding disorders), or if you are using other medicines that may increase the risk of bleeding such as warfarin (used to prevent blood clots),
• if your cholesterol levels are increasing,
• if you or someone in your family has suffered from mania or bipolar disorder (feeling of overexcitement or euphoria),
• if you have a history of aggressive behaviour.

Venlafaxina Teva Italia may cause a feeling of restlessness or inability to sit still or remain calm.
If you experience these symptoms, you should tell your doctor.
.

Suicidal thoughts and worsening of your depression or anxiety disorder
If you have a depressive and/or anxiety disorder, you may sometimes have thoughts of self-harm or suicide.
These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually about 2 weeks, but sometimes longer.
You may be more likely to have these thoughts:

• if you have had suicidal thoughts or self-harmed before,
• if you are young. Data from clinical studies have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who were treated with an antidepressant.

If at any time you have suicidal thoughts or thoughts of self-harm, contact your doctor immediately or go to the nearest hospital.
It may help to tell a relative or close friend that you are feeling depressed or anxious, and if your depression or anxiety is getting worse or if you are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay.
Therefore, you should pay particular attention to your oral hygiene.
Diabetes
Blood glucose levels may be altered due to Venlafaxina Teva Italia. It may be necessary to adjust the dosage of your diabetes medicines.

Children and adolescents
Venlafaxina Teva Italia is normally not used for children and adolescents under the age of 18 years.
Also, you should know that patients under the age of 18 years have an increased risk of side effects, such as suicide attempts, suicidal thoughts and hostility (mainly aggressive behaviour, oppositional behaviour and anger) when taking this type of medicine. Despite this, your doctor may prescribe Venlafaxina Teva Italia for patients under 18 years of age, because they believe that this is in their best interest. If your doctor has prescribed Venlafaxina Teva Italia for a patient under 18 years of age, and you want to discuss this, talk to your doctor. You should inform your doctor if any of the symptoms listed appear or worsen when a patient under 18 years of age is taking Venlafaxina Teva Italia. Furthermore, the long-term effects of Venlafaxina Teva Italia on growth, maturation and cognitive and behavioural development in this age group have not been demonstrated.

Other medicines and Venlafaxina Teva Italia
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
Your doctor needs to decide whether you can take Venlafaxina Teva Italia with other medicines.
Do not start or stop taking any other medicines, including those available without a prescription, herbal remedies, before asking your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must notbe taken with Venlafaxina Teva Italia. Tell your doctor if you have taken these medicines in the last 14 days (MAOIs: see the section “What you need to know before taking Venlafaxina Teva Italia”)
• During treatment with venlafaxine, Serotonin Syndrome may occur: a potentially life-threatening condition or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see the section “Possible side effects”). This can happen especially when venlafaxine is taken with other medicines. Examples of these medicines include:
• Triptans (used for migraine)
• Medicines for the treatment of depression, for example serotonin and noradrenaline 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)
• St John's Wort preparations (also called Hypericum Perforatum, a herbal remedy used to treat mild depression)
• Products containing tryptophan (used for sleep disorders and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or perceiving things that are not there, having false beliefs, unusual suspicions, 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 fluctuations in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In more severe forms, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (confirmed by blood tests).

Immediately inform your doctor or go to the nearest emergency room if you think you have serotonin syndrome
Tell your doctor if you are taking medicines that can affect your heart rhythm.
Examples of these 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 interfere with Venlafaxina Teva Italia and must be used with caution. It is particularly important that you tell your doctor or pharmacist if you are using medicines that contain:

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

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

Pregnancy and breastfeeding
Tell your doctor if you discover that you are pregnant, or if you are trying to become pregnant.
You should only use Venlafaxina Teva Italia after discussing the potential benefits and risks with your doctor for the foetus.
Make sure you inform your midwife and/or doctor that you are taking Venlafaxina Teva Italia. If used during pregnancy, especially in the last 3 months of pregnancy, similar medicines (SSRIs) may increase the risk of developing a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which causes an increased breathing rate in the baby and a bluish discoloration of its skin. These symptoms usually appear within the first 24 hours after the baby is born. If this condition affects your baby, contact your midwife and/or doctor immediately.
If you are taking this medicine during pregnancy, inform your doctor, as your baby once born may have other symptoms. These symptoms generally begin within 24 hours of birth and include, in addition to breathing problems, failure to feed properly. If your baby presents these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will know how to assist you.
Venlafaxina Teva Italia is excreted in breast milk. There is a risk of an effect on the baby. Therefore, you should discuss with your doctor who will decide whether to stop breastfeeding or therapy with Venlafaxina Teva Italia.

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

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

3. How to take Venlafaxina Teva Italia

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.
The usual starting dose recommended for the treatment of depression, generalized anxiety
disorder and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose
and, if necessary, up to a maximum dose of 375 mg per day for depression. If you are being
treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and
subsequently increase the dose gradually. The maximum dose for generalized anxiety disorder, social
anxiety disorder and panic disorder is 225 mg per day.
Take Venlafaxina Teva Italia at about the same time each day, in the morning or evening. The capsules must
be swallowed whole with a liquid and must not be opened, broken, chewed or dissolved.
You must take Venlafaxina Teva Italia with food.
If you have liver or kidney problems, tell your doctor, as an adjustment of the dose of
Venlafaxina Teva Italia may be necessary.
Do not stop treatment with Venlafaxina Teva Italia without consulting your doctor (see the
paragraph “If you stop taking Venlafaxina Teva Italia”).

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

If you forget to take Venlafaxina Teva Italia
If you forget to take a dose, take it as soon as you remember. However, if you are due to take your
next dose when you remember the forgotten dose, skip the forgotten dose and take only one dose as you
usually do.
Do not take more than your usual daily dose of Venlafaxina Teva Italia in one day.
Do not take a double dose to make up for a forgotten dose

If you stop taking Venlafaxina Teva Italia
Do not stop treatment or reduce the dose without your doctor's advice, even if you feel better. If your
doctor believes that you no longer need Venlafaxina Teva Italia, they may ask you to reduce the dose
gradually before stopping treatment completely. It is known that unwanted effects occur when patients
stop taking Venlafaxina Teva Italia, especially when
Venlafaxina Teva Italia is stopped abruptly or when 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 sensations, weakness,
sweating, convulsions or flu-like symptoms.
Your doctor will tell you how to gradually stop treatment with Venlafaxina Teva Italia. If
you experience any of these or other symptoms that bother you, contact your doctor for further
advice.
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 experience any of the following effects, do not take any more Venlafaxina Teva Italia, contact your doctor immediately, or go to the nearest hospital emergency room.

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands or feet.
• Feeling of nervousness or anxiety, dizziness, feeling of pulsation, sudden redness of the skin and/or feeling of warmth.
• Severe rash, itching, or hives (red or pale raised patches on the skin that often itch).
• Signs and symptoms of serotonin syndrome, which can include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, over-reactive reflexes, diarrhea, coma, nausea, vomiting. In more severe forms, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS can include a combination of fever, rapid heartbeat

accelerated, sweating, severe muscle rigidity, confusion, increased muscle enzymes
(confirmed by blood tests).
Other side effects that you must immediately inform your doctorabout are:

• Cough, wheezing, shortness of breath and high temperature.
• Black (tarry) stools or blood in the stools.
• 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 of unusual excitement).
• Withdrawal syndrome (see the section “How to take Venlafaxina Teva Italia, If you stop taking Venlafaxina Teva Italia”).
• Prolonged bleeding - if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Do not worry if you notice small white balls or granules in your stools after taking this
medicine. Inside Venlafaxina Teva Italia there are spheroids (small white balls) that
contain the active ingredient (venlafaxine). These spheroids are released from the capsule into
the stomach. As they move through the stomach and intestines, the venlafaxine is slowly
released. The “shell” of the spheroids does not dissolve and is eliminated in the stool. Therefore, even if you notice
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 of detachment from oneself; lack 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; diarrhea
• Increased frequency of urination; difficulty emitting 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 of restlessness or inability to remain seated or still; fainting; involuntary muscle movements; impaired coordination and balance; altered sense of taste
• Fast heartbeat; feeling of dizziness (especially when getting up too quickly)
• Shortness of breath
• Vomiting blood, black tarry stools or presence of blood in the stools, which may be a sign of internal bleeding
• General swelling of the skin, especially of the face, mouth, tongue, throat or hands and feet and/or raised rash (urticaria); sensitivity to sunlight; bruising; skin rash; abnormal hair loss
• Inability to urinate
• Weight gain or loss

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

• Seizures or convulsions
• Inability to control urine
• Hyperactivity, racing thoughts and decreased need for sleep (mania)

Not known: frequency cannot be estimated from the available data

• Reduction in the number of platelets in the blood, which can lead to an increased risk of bleeding or bruising; blood disorders that can lead to an increased risk of infection
• Swelling of the face or tongue, difficulty breathing or shortness of breath, often with skin rashes (may be a severe allergic reaction)
• Excessive water intake (known as SIADH)
• Decreased levels of sodium in the blood
• Suicidal thoughts and behaviors; cases of suicidal ideation and behavior have been observed during therapy with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before you take Venlafaxina Teva Italia”)
• Disorientation and confusion often accompanied by hallucinations (delirium); aggressive behavior
• High body temperature with muscle rigidity, confusion or agitation and sweating, or the appearance of uncontrollable spasmodic movements, may be symptoms of a serious condition known as neuroleptic malignant syndrome; euphoric sensations, drowsiness, prolonged rapid eye movements, clumsiness, restlessness, feeling of intoxication, sweating or muscle rigidity representing symptoms of serotonin syndrome; rigidity, spasms and involuntary movements of the muscles
• Severe eye pain and reduced or blurred vision
• Vertigo
• Decreased blood pressure; abnormal, rapid or irregular heartbeat, which can lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or vomit or unexpected bruising or broken blood vessels (ruptured veins)
• Cough, wheezing, shortness of breath and high temperature which may be symptoms of inflammation of the lungs associated with an increase in white blood cells (eosinophilic pneumonia)
• Severe abdominal or back pain (which may indicate a serious problem with the intestines, 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 the levels of liver enzymes in the blood
• Skin rash, with possible formation of severe blisters and peeling of the skin; itching; mild skin rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal production of milk from the breasts

Venlafaxina Teva Italia sometimes causes the appearance of 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. Less frequently Venlafaxina Teva Italia can reduce the functionality of
platelets in the blood, determining a higher risk of bruising and bleeding. Consequently, the doctor may
decide to subject you periodically to blood tests, particularly if you take Venlafaxina Teva Italia
for a long time.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 Venlafaxina Teva Italia

Keep Venlafaxina Teva Italia out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after the abbreviation EXP.
The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 Venlafaxina Teva Italia Contains

• The active ingredient is venlafaxine. Venlafaxina 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). Venlafaxina 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). Venlafaxina 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: Capsule contents: Sugar granules (sucrose, corn 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 Venlafaxina Teva Italia and Package Contents
Venlafaxina Teva Italia 37.5 mg prolonged-release hard capsules: opaque capsules with a pinkish-brown cap and a white body.
Venlafaxina Teva Italia 75 mg prolonged-release hard capsules: opaque light pink capsules.
Venlafaxina Teva Italia 150 mg prolonged-release hard capsules: opaque orange-brown capsules.
Pack sizes:
Packs of 10, 14, 20, 28, 30, 50, 98, 100, 100x1 prolonged-release hard capsules contained in blisters.
Packs of 50, 100 and 250 prolonged-release hard capsules contained in a high-density polyethylene (HDPE) bottle.
Not all pack sizes may be marketed.

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

Manufacturer Responsible for Batch Release:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
HU/H/0164/01/03
Member StateMedicinal Product Name
GermanyVenla Teva
SpainVenlafaxina Retard Teva
FinlandEsenerin
HungaryFalven
ItalyVenlafaxina Teva Italia
PortugalVenlafaxina Teva
United KingdomRodomel XL