VENLAFAXINA 37,5 MG Prolonged-release hard capsule

Зміст інструкції

1. Venlafaxina Aurobindo 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules
   1. What is Venlafaxina Aurobindo and what is it used for
   2. What you need to know before taking Venlafaxina Aurobindo
   3. How to take Venlafaxina Aurobindo
   4. Possible side effects
   5. How to store Venlafaxina Aurobindo
   6. Package Contents and Other Information

Venlafaxina Aurobindo 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

Generic medicine

Read this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• 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 Venlafaxina Aurobindo is and what it is used for
• 2. What you need to know before you take Venlafaxina Aurobindo
• 3. How to take Venlafaxina Aurobindo
• 4. Possible side effects
• 5. How to store Venlafaxina Aurobindo
• 6. Contents of the pack and other information

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

Venlafaxina Aurobindo contains the active ingredient venlafaxine. Venlafaxina Aurobindo is an antidepressant
belonging to a group of medicines called selective serotonin and norepinephrine reuptake inhibitors (SNRI). 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 Aurobindo is a treatment for adults suffering from 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 serious and more difficult to treat.

2. What you need to know before taking Venlafaxina Aurobindo

Do not take Venlafaxina Aurobindo

• 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 (IMAO), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Venlafaxina Aurobindo may cause serious or even life-threatening side effects. You must also wait at least 7 days after stopping treatment with Venlafaxina Aurobindo before taking any MAOI (also see the section entitled “Other medicines and Venlafaxina Aurobindo” and the information contained in the section regarding “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Venlafaxina Aurobindo:

• If you are using other medicines that, when taken with Venlafaxina Aurobindo, may increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxina 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 you have an irregular heartbeat.
• If you have a history of seizures (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 using other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric) yourself or in your family.
• If you have a history of aggressive behaviour.

Venlafaxina Aurobindo may cause a feeling of restlessness or inability to sit still or remain calm
during the very first weeks of treatment. If this happens to you, you should tell your doctor.
Thoughts of suicide and worsening of depression or anxiety.
If you are depressed and/or anxious you may sometimes have thoughts of self-harm or suicide. These may
increase when you start taking antidepressants for the first time as all these medicines take time to work, about two weeks, but sometimes even longer.
You may be more likely to have these thoughts:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical studies has 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 thoughts of self-harm or suicide at any time, contact your doctor immediately or
go to the nearest hospital immediately.
You may find it helpful to tell a relative or close friend that you are depressed or anxious and
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 tooth decay. You should therefore pay particular attention to your oral hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlafaxina Aurobindo. Therefore the
dosage of your diabetes medicines may need to be adjusted.
Medicines such as Venlafaxina Aurobindo (so-called selective serotonin reuptake inhibitors
(SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see
section 4). In some cases, these symptoms have been observed to persist after stopping treatment.

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

Other medicines and Venlafaxina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The doctor will decide whether you can take Venlafaxina Aurobindo with other medicines.
Do not start or stop taking any other medicines, including those bought without a prescription
from a pharmacy, natural and herbal products, before asking your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken withVenlafaxina Aurobindo. 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 Aurobindo”).
• Serotonin syndrome: a potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS) can occur with treatment with venlafaxine, especially when taken with other medicines. Examples of these medicines include:
• Triptans (used for migraine).
• Other medicines for the treatment of 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, pethidine or pentazocine (used to treat severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used to treat opioid drug dependence 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 natural or herbal remedy used to treat mild depression).
• Products containing tryptophan (used for conditions such as sleep disorders and depression).
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or feeling things that do not exist, false beliefs, unusual suspicion, unclear reasoning and social withdrawal). Signs and symptoms of serotonin syndrome may include a combination of: restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, rapid fluctuations in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

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

If you think you have serotonin syndrome, tell your doctor immediately or go
immediately to the emergency room of the nearest hospital.
You need to 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 irregular heartbeat).
• 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 interfere with Venlafaxina Aurobindo 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).

Venlafaxina Aurobindo with food, drinks and alcohol
You should take Venlafaxina Aurobindo with food (see section 3 “How to take Venlafaxina
Aurobindo”).
You should avoid alcohol while taking Venlafaxina Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. You should only use
Venlafaxina Aurobindo after discussing with your doctor the potential benefits and potential risks to the
foetus.
If you are taking Venlafaxina Aurobindo, make sure that your midwife and/or doctor are informed. If taken
during pregnancy, medicines of this type (SSRIs) may increase the risk of a serious condition
in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby
breathe faster and makes the baby appear blue. Symptoms usually start within the first 24 hours after birth.
If this happens to your baby, contact your midwife and/or doctor immediately.
If you are taking this medicine during pregnancy, in addition to having difficulty breathing, another
symptom that your baby may present at birth is difficulty feeding properly. If
your baby shows these symptoms at birth and you are worried, contact your doctor and/or midwife who
will be able to assist you.
Venlafaxina Aurobindo passes into breast milk. There is a risk of an effect on the baby. Therefore, you
should discuss this with your doctor, who will decide whether to stop breastfeeding or the therapy with this
medicine.

Driving and using machines
Do not drive and do not use tools or machines until you understand how this medicine affects you.

Venlafaxina Aurobindo capsules contain sugar spheres 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 Venlafaxina Aurobindo

Take this medicine exactly as your doctor has instructed. 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 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 then gradually increase the dose.
The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg per
day.
Take Venlafaxina Aurobindo at approximately 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 should take Venlafaxina Aurobindo with food.
If you have liver or kidney problems, tell your doctor, as the dose of your medicine may be
different.
Do not stop treatment with this medicine without consulting your doctor (see section
“If you stop taking Venlafaxina Aurobindo”).

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

If you forget to take Venlafaxina Aurobindo
If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose,
skip the missed dose and take only one dose as usual. Do not take a double dose to
make up for a forgotten dose. Do not take more than the daily amount of Venlafaxina
Aurobindo prescribed to you in a single day.

If you stop taking Venlafaxina Aurobindo
Do not stop treatment or reduce the dose without your doctor's advice, even if you feel better. If the
doctor believes you no longer need Venlafaxina Aurobindo, they may ask you to reduce the dose
gradually before stopping treatment completely. It is known that undesirable effects occur when patients stop treatment with this medicine, especially when it 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, diarrhea, nervousness, agitation, confusion, ringing in the ears,
tingling or, rarely, electric shock sensations, weakness, sweating, convulsions or flu-like symptoms.
Your doctor will explain how to gradually stop treatment with Venlafaxina Aurobindo. If
you experience any of these or other symptoms that bother you, consult your doctor for further
advice.
If you have any further questions about 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 everyone gets them.
If you experience any of the following effects, do not take any more Venlafaxina Aurobindo. Seek
immediate medical attention, or go to the nearest hospital emergency room:
Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or a raised 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 rash, itching, or hives (raised, red or pale patches of skin that often itch).
• Signs and symptoms of serotonin syndrome which can include restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.
• In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS can include a combination of fever, fast heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
• Signs of infection, such as high temperature, chills, tremors, headache, sweating, flu-like symptoms. This may be due to a blood disorder that causes an increased risk of infection.
• Severe skin rash that can cause severe blistering and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

Other side effects that you must report to your doctorare (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 fever.
• 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 fast 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), convulsions or seizures.
• Psychiatric problems, such as hyperactivity and feeling unusually overexcited.
• Discontinuation syndrome (see section “How to take Venlafaxina Aurobindo - If you stop taking Venlafaxina Aurobindo”).
• Prolonged bleeding - if you cut or injure yourself, it may take longer for the blood to stop.

Do not be concerned if you notice small spheres or granules in your stools after taking this
medicine. Inside Venlafaxina Aurobindo there are spheroids (small white spheres) that
contain the active ingredient (venlafaxine). These spheroids are released from the capsule in your
stomach. As they travel through the stomach and intestine, the venlafaxine is released
slowly. The “capsule” of the spheroids does not dissolve and passes into the stool. Therefore, even if you observe
these spheroids in your stool, 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 separation) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, feeling of restlessness or inability to sit still or remain calm, tingling, altered sense of taste, 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).
• Fast heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Shortness of breath, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty passing urine.
• Menstrual irregularities such as increased bleeding or increased irregular 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, racing thoughts and decreased need for sleep (mania).
• Hallucinations, feeling of detachment (or separation) from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Feeling dizzy (especially when getting up too quickly), low blood pressure.
• Vomiting blood, dark stools or blood in the stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms and involuntary movements of the muscles.
• Mild changes in blood levels of liver enzymes.

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

• Convulsions.
• Cough, wheezing and shortness of breath, which may be accompanied by high fever.
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased blood levels of sodium.
• Severe eye pain and decreased or blurred vision.
• Abnormal heartbeat, fast or irregular, which can lead to fainting.
• 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 signs of liver inflammation (hepatitis).

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

• Prolonged bleeding, which may indicate a reduction in the number of platelets in the blood, leading to an increased risk of bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, such as bleeding from the gums, blood in the urine or vomit, or unexpected bruising or nosebleeds.

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

• Suicidal ideation and suicidal behaviour; cases of suicidal ideation and suicidal behaviour have been reported during therapy with venlafaxine or immediately after discontinuation of treatment (see section 2, What you need to know before you take Venlafaxina Aurobindo).
• Aggression.
• Vertigo.

Sometimes Venlafaxina Aurobindo causes side effects that you may not be aware of, such as increases
in blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes,
sodium or cholesterol. Less frequently, Venlafaxina Aurobindo may reduce the function of platelets in your
blood, leading to an increased risk of bruising and bleeding. Therefore, your doctor may want to do
blood tests occasionally, especially if you have been taking Venlafaxina Aurobindo for a long
time.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Venlafaxina 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
pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
Do not dispose of any medicine in 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 Venlafaxina Aurobindo Contains

• The active ingredient 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 ethyl cellulose.
The 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 Venlafaxina Aurobindo and Package Contents
Hard prolonged-release capsules.

Venlafaxina 37.5 mg hard prolonged-release capsules
Granules from white to almost white, from spherical to oval, contained in a hard gelatin capsule (size

• 3) with an opaque grey cap and an opaque peach body, with “E” printed on the cap and “73” on the body in edible black ink.

Venlafaxina 75 mg hard prolonged-release capsules
Granules from white to almost white, from spherical to oval, contained in a hard gelatin capsule (size

• 1) with an opaque peach cap and an opaque peach body, with “E” printed on the cap and “74” on the body in edible black ink.

Venlafaxina 150 mg hard prolonged-release capsules
Granules from white to almost white, from spherical to oval, contained in a hard gelatin capsule (size

• 0) with an opaque dark orange cap and an opaque dark orange body, with “E” printed on the cap and “89” on the body in edible black ink.

Venlafaxine capsules are available in
Transparent PVC/PE/PVDC - aluminum foil:
Venlafaxina 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:
Venlafaxina 37.5 mg/75 mg/150 mg: 30, 100 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)

Manufacturer
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 Member States of the European Economic Area with the following
names:
France Venlafaxine Arrow Génériques LP 37.5 mg/ 75 mg/150 mg prolonged-release capsule
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