Venlafaxine Aurobindo: detailed information

Package leaflet: Information for the user

Venlafaxine Aurobindo 37.5 hard capsules prolonged release, 75 mg hard capsules prolonged release, 150 mg hard capsules prolonged release

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Venlafaxine Aurobindo contains the active substance venlafaxine. Venlafaxine Aurobindo is an antidepressant belonging to a group of medicines called serotonin and noradrenaline 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. The exact way in which antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and noradrenaline in the brain. Venlafaxine Aurobindo is a treatment for adults with depression. It 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 Venlafaxine Aurobindo

Do not take Venlafaxine Aurobindo

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 of the medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Aurobindo may result in serious, potentially life-threatening side effects. In addition, you must wait at least 7 days after stopping treatment with Venlafaxine Aurobindo before taking any MAOI (also see the section titled “Other medicines and Venlafaxine Aurobindo” and the information in the section on “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine Aurobindo:

If you are taking other medicines that, when taken together with Venlafaxine Aurobindo, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Aurobindo”).
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 abnormal heart rhythm.
If you have a history of seizures (epileptic fits).
If you have a history of low sodium levels 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 taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots).
If you or someone in your family has had a history of mania or bipolar disorder (feelings of over-excitement or euphoria).
If you have a history of aggressive behaviour.

Venlafaxine Aurobindo may cause a feeling of restlessness or an inability to sit or stand still during the first few weeks of treatment. If this happens to you, inform your doctor.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work—approximately two weeks, but sometimes longer.
You may be more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric conditions who were treated with an antidepressant.

If you have any thoughts of self-harm or suicide at any time, contact your doctor immediately or go straight to the nearest hospital.
You may find it helpful to tell a relative or close friend that you are depressed or suffering from anxiety, and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression or anxiety is getting worse, or if they are concerned about certain changes in your behaviour.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental caries. You should therefore pay particular attention to your oral hygiene.
Diabetes
Your blood glucose levels may be altered by Venlafaxine Aurobindo. Therefore, the dosage of your diabetes medication may need to be adjusted.
Medicines such as Venlafaxine Aurobindo (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Children and adolescents
Venlafaxine Aurobindo is generally not recommended for use in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. Nevertheless, your doctor may prescribe Venlafaxine Aurobindo for patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Venlafaxine Aurobindo for a patient under 18 years of age and you wish to discuss this, speak to your doctor. You must inform your doctor if any of the listed symptoms appear or worsen while a patient under 18 years of age is taking Venlafaxine Aurobindo. Furthermore, the long-term effects of this medicine on growth, maturation, and cognitive and behavioural development in this age group have not been established.
Other medicines and Venlafaxine Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will decide whether you can take Venlafaxine Aurobindo with other medicines.
Do not start or stop treatment with any other medicines, including those purchased without a prescription, herbal or natural remedies, before consulting your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Aurobindo. Inform your doctor if you have taken any of these medicines within the last 14 days (MAOIs: see section “What you need to know before taking Venlafaxine Aurobindo”).
Serotonin syndrome: a potentially life-threatening condition, or Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur during treatment with venlafaxine, especially when taken with other medicines. Examples of such medicines include:
Triptans (used for migraine).
Other medicines for depression, for example SNRIs, SSRIs, tricyclics, or medicines containing lithium.
Medicines containing linezolid, an antibiotic (used to treat infections).
Medicines containing moclobemide, an MAOI (used to treat depression).
Medicines containing sibutramine (used for weight loss).
Medicines containing tramadol, fentanyl, tapentadol, meperidine, 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 levels of methaemoglobin in the blood).
Herbal preparations containing St. John’s wort (also known as Hypericum perforatum, a natural or 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 feeling things that are not real, false beliefs, unusual suspiciousness, unclear thinking, and social withdrawal). 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 its most severe form, 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 test).
If you think you may have serotonin syndrome, inform your doctor immediately or go straight to the nearest hospital emergency department.
You must 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 abnormal heart rhythm).
Antipsychotics such as thioridazine (see also above, “Serotonin syndrome”).
Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections).
Antihistamines (used to treat allergies).

The following medicines may also interact with Venlafaxine Aurobindo 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 (used to treat psychiatric disorders).
Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Venlafaxine Aurobindo with food, drinks and alcohol
You should take Venlafaxine Aurobindo with food (see section 3 “How to take Venlafaxine Aurobindo”).
You should avoid alcohol while taking Venlafaxine Aurobindo.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You should use Venlafaxine Aurobindo only after discussing with your doctor the potential benefits and possible risks to the unborn baby.
If you are taking Venlafaxine Aurobindo, make sure your midwife and/or doctor are aware. Medicines of this type (SSRIs), when taken during pregnancy, 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 appear blue. Symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you are taking this medicine during pregnancy, in addition to breathing difficulties, another symptom your baby may have at birth is difficulty feeding properly. 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 Aurobindo passes into breast milk. There is a risk of effects on the infant. Therefore, you should discuss this with your doctor, who will decide whether you should discontinue breastfeeding or stop treatment with this medicine.
Driving and using machines
Do not drive and do not operate tools or machinery until you know how this medicine affects you.
Venlafaxine Aurobindo capsules contain spheres of sugar containing 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 Venlafaxine Aurobindo

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 Aurobindo at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
You must take Venlafaxine Aurobindo with food.
If you have liver or kidney problems, discuss this with your doctor, as your dose may need to be adjusted.
Do not stop treatment with this medicine without consulting your doctor (see the section “If you stop taking Venlafaxine Aurobindo”).

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

If you forget to take Venlafaxine Aurobindo
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 your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Do not take more Venlafaxine Aurobindo in one day than the prescribed daily amount.

If you stop taking Venlafaxine Aurobindo
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you no longer need Venlafaxine Aurobindo, they may instruct you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects may occur when patients discontinue treatment with this medicine, especially if it 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, ringing in the ears, tingling sensations, or rarely electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually stop treatment with Venlafaxine Aurobindo. If you experience any of these or other bothersome symptoms, contact your doctor for further advice.

If you have any further questions about the use of this medicine, consult 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 Venlafaxine Aurobindo. Contact your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

Swelling of the face, mouth, tongue, throat, hands or feet and/or appearance of a rash with itching (urticaria), difficulty swallowing or breathing.

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

Chest tightness, wheezing, difficulty swallowing or breathing.
Severe skin rash, itching, or hives (raised patches of pale or red skin that often itch).
Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.
In its most severe form, 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).
Signs of infection, such as high temperature, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder causing an increased risk of infection.
Severe skin rash that may cause extensive blistering and peeling of the skin.
Unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Other side effects that you must report to your doctor are (the frequencies of these side effects are included in the list “Other side effects that may occur”):

Cough, wheezing, and shortness of breath, which may be accompanied by high temperature.
Dark stools or blood in the stools.
Itching, yellowing of the skin or eyes, 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 (muscle spasms or stiffness), seizures or epileptic fits.
Psychiatric problems, such as hyperactivity and feeling unusually overexcited.
Withdrawal syndrome (see section “How to take Venlafaxine Aurobindo – If you stop taking Venlafaxine Aurobindo”).
Prolonged bleeding – if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Do not be alarmed if you notice small white spheres or granules in your stools after taking this medicine. Venlafaxine Aurobindo contains spheroids (small white spheres) that contain the active substance (venlafaxine). These spheroids are released from the capsule in your stomach. As they travel through the stomach and intestine, venlafaxine is slowly released. The “capsule” of the spheroids does not dissolve and passes into the stools. Therefore, even if you see these spheroids in your stools, 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, drowsiness.
Insomnia.
Nausea, dry mouth, constipation.
Sweating (including night sweats).

Common (may affect up to 1 in 10 people)

Reduced appetite.
Confusion, feeling of detachment (or disconnection) from oneself, inability to reach orgasm, decreased libido, agitation, nervousness, abnormal dreams.
Tremor, feeling restless or inability to sit still or remain motionless, tingling, altered taste sensation, increased muscle tone.
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, inability to urinate, difficulty in passing urine.
Menstrual irregularities such as increased bleeding or irregular increased bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
Weakness (asthenia), fatigue, chills.
Weight gain, weight loss.
Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

Hyperactivity, accelerated thinking and reduced need for sleep (mania).
Hallucinations, feeling of detachment from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
Fainting, involuntary muscle movements, impaired coordination and balance.
Dizziness (especially when standing up too quickly), low blood pressure.
Vomiting blood, dark stools or blood in the stools, which may indicate internal bleeding.
Sensitivity to sunlight, bruising, abnormal hair loss.
Inability to control urine.
Muscle stiffness, spasms and involuntary muscle movements.
Slight changes in blood levels of liver enzymes.

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

Seizures.
Cough, wheezing and shortness of breath, which may be accompanied by high temperature.
Disorientation and confusion often accompanied by hallucinations (delirium).
Excessive water intake (known as SIADH).
Decreased blood sodium levels.
Severe eye pain and reduced or blurred vision.
Abnormal, rapid or irregular heartbeat, which may lead to fainting.
Severe abdominal or back pain (which may indicate a serious problem with the intestine, liver or pancreas).
Itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation (hepatitis).

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

Prolonged bleeding, which may indicate a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding.
Abnormal production of milk in the breast.
Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or appearance of unexpected bruises or broken veins.

Frequency not known (cannot be estimated from the available data)

Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and suicidal behaviour have been reported during venlafaxine therapy or immediately after discontinuation of treatment (see section 2, What you need to know before taking Venlafaxine Aurobindo).
Aggressiveness.
Vertigo.

Sometimes Venlafaxine Aurobindo causes side effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, Venlafaxine Aurobindo may reduce the function of platelets in your blood, leading to an increased risk of bruising and bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Aurobindo 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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlafaxine Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the label of the bottle and on the
carton after EXP. The expiry date refers to the last day of that 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 Aurobindo contains

The active substance is venlafaxine.

Each prolonged-release capsule contains 37.5 mg of venlafaxine (as hydrochloride).
Each prolonged-release capsule contains 75 mg of venlafaxine (as hydrochloride).
Each prolonged-release capsule contains 150 mg of venlafaxine (as hydrochloride).

The other components of the capsules are:
Sugar spheres (containing sucrose), hypromellose, talc and ethylcellulose.

Capsule shell contains:
Cap: Gelatin, red iron oxide (E172) (only for 75 mg and 150 mg), black iron oxide (E172) (only for 37.5 mg), titanium dioxide (E171) and sodium lauryl sulfate.
Body: Gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate.
Printing ink: Shellac and black iron oxide (E172).

Description of the appearance of Venlafaxine Aurobindo and pack sizes

Prolonged-release hard capsules.

Venlafaxine 37.5 mg prolonged-release hard capsules
White to almost white, spherical to oval granules contained in a hard gelatin capsule (size 3) with an opaque grey cap and an opaque peach body, printed with “E” on the cap and “73” on the body in edible black ink.

Venlafaxine 75 mg prolonged-release hard capsules
White to almost white, spherical to oval granules contained in a hard gelatin capsule (size 1) with an opaque peach cap and an opaque peach body, printed with “E” on the cap and “74” on the body in edible black ink.

Venlafaxine 150 mg prolonged-release hard capsules
White to almost white, spherical to oval granules contained in a hard gelatin capsule (size 0) with an opaque dark orange cap and an opaque dark orange body, printed with “E” on the cap and “89” on the body in edible black ink.

Venlafaxine capsules are available in:

PVC/PE/PVDC transparent-aluminium foil blisters:
Venlafaxine 37.5 mg/75 mg/150 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 capsules.

HDPE bottle with polypropylene closure:
Venlafaxine 37.5 mg/75 mg/150 mg: 30, 100 and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA), Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Arrow Génériques
26 avenue Tony Garnier, 69007 Lyon, France

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:

France: Venlafaxine Arrow Génériques LP 37.5 mg/75 mg/150 mg gélule à libération prolongée
Germany: Venlafaxin Aurobindo 37.5 mg/75 mg/150 mg Hartkapseln, retardiert
Ireland: Vedixal XL 75 mg/150 mg prolonged-release capsules, hard
Italy: Venlafaxina Aurobindo
Malta: Venzip XL 37.5 mg/75 mg/150 mg prolonged-release capsules, hard
Netherlands: Venlafaxine Aurobindo 37.5 mg/75 mg/150 mg, capsules met verlengde afgifte, hard
Poland: Venlafaxine Aurovitas
Portugal: Venlafaxina Aurobindo
Romania: Venlafaxina Aurobindo 37.5 mg/75 mg/150 mg capsule cu eliberare prelungită
Spain: Venlafaxina Aurobindo 37.5 mg/75 mg/150 mg mg cápsulas duras de liberación prolongada EFG
United Kingdom: Venzip XL 75 mg/150 mg prolonged-release capsules, hard

This Patient Information Leaflet was last approved on