VENLAFAXINA 75 mg Hard Capsules, Prolonged Release

Зміст інструкції

1. Venlafaxina Mylan Generics 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules
   1. What you need to know before taking Venlafaxina Mylan Generics
   2. How to take Venlafaxina Mylan Generics
   3. Possible side effects
   4. How to store Venlafaxina Mylan Generics
   5. Package contents and other information

Venlafaxina Mylan Generics 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

(Venlafaxina)

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 their symptoms are the same as yours, as it could 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 Mylan Generics is and what it is used for

2. What you need to know before you take Venlafaxina Mylan Generics

3. How to take Venlafaxina Mylan Generics

4. Possible side effects

5. How to store Venlafaxina Mylan Generics

6. Contents of the pack and other information

1. What Venlafaxina Mylan Generics is and what it is used for

Venlafaxina Mylan Generics contains the active substance venlafaxine which is an antidepressant belonging to a
group of medicines called serotonin and noradrenaline 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 noradrenaline in the
brain. It is not fully understood how antidepressants work, however they may help by
raising the levels of serotonin and noradrenaline in the brain.
Venlafaxina Mylan Generics is a treatment for adults suffering from depression or to prevent relapses of major
depressive episodes. Venlafaxina Mylan Generics is also a treatment for adults with the following anxiety disorders:
generalised anxiety disorder, social anxiety disorder (fear of or tendency to avoid social situations) and panic disorder. Appropriate
treatment of depression or anxiety disorders is important to help you feel better. If left untreated, your condition may not
improve and may become more serious and more difficult to treat.

2. What you need to know before taking Venlafaxina Mylan Generics

Do not take Venlafaxina Mylan Generics

• if you are allergic (hypersensitive) 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 (IMAOs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with other medicines, including Venlafaxina Mylan Generics, can cause serious or even life-threatening side effects. You must also wait at least 7 days after stopping treatment with Venlafaxina Mylan Generics before taking any irreversible MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venlafaxina Mylan Generics”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxina Mylan Generics:

• if you are taking medicines that, when taken with Venlafaxina Mylan Generics, can increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxina Mylan Generics”).
• if you have eye problems, such as certain types of glaucoma (increased pressure inside the eye) or if your ophthalmologist has told you that you are at increased risk of developing glaucoma
• if you have a history of high blood pressure or have recently had a heart attack
• if you or a family member has a history of heart problems or irregular heartbeat
• if you have a history of seizures (fits)
• if you have a history of low sodium levels in the blood (hyponatraemia) or even if you are elderly, if you are taking diuretics (which can cause increased urine production) or if you are dehydrated (for example, due to severe diarrhoea or vomiting)
• 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 make your blood thinner and can increase the risk of bleeding.
• if you or someone in your family has a history of mania or bipolar disorder (feeling overexcited or euphoric)
• if you have a history of aggressive behaviour. You may feel aggressive especially during the initial stages of treatment with venlafaxine, if the dose is changed or when you stop taking it
• if you suffer from diabetes (this medicine can affect blood sugar levels)
• if you are taking any medicines for weight loss

During treatment

• This medicine can cause an increase in blood pressure or an increase in cholesterol levels. Your doctor may need to check your blood pressure or cholesterol levels regularly
• If you feel restless or unable to sit still or remain calm, which may occur during the initial stages of treatment, talk to your doctor or pharmacist
• If you need to have a urine test to check for certain medicines, this medicine can affect the results. Tell your doctor or hospital staff that you are taking this medicine
• Venlafaxina capsules contain spheroids, the insoluble portion of which is eliminated and may be observed in the stool.

Medicines like Venlafaxina Mylan Generics (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction
(see section 4.4). In some cases, these symptoms have continued after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety
If you are depressed and/or suffer from anxiety disorders, you sometimes may have thoughts of harming yourself or committing suicide.
These may increase when you first start taking antidepressants, as all medicines
like this take time to start working, usually about two weeks but sometimes longer.
You are more likely to have these thoughts:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. Information obtained from clinical studies has shown an increased risk of suicidal behaviour in young people (under 25 years of age) with psychiatric disorders who were treated with an antidepressant. If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to hospital immediately. It may help to tell a relative or close friend that you are depressed or suffering from an anxiety disorder, and

anxiety is getting worse or are worried about changes in your behaviour.
Dry mouth
One in ten patients taking venlafaxine reports dry mouth. This may increase the risk of
tooth decay. You should therefore pay particular attention to your oral hygiene.
Children and adolescents under 18 years of age
Venlafaxina Mylan Generics is normally not used for children and adolescents under 18
years of age. Also, you should know that patients under 18 years of age 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 Mylan Generics to patients under 18 years of age, because they believe that this is in their best
interest. If your doctor has prescribed Venlafaxina Mylan Generics 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 listed symptoms
occur or worsen when a patient under 18 years of age is taking Venlafaxina Mylan Generics. Also, the long-term effects on safety of Venlafaxina Mylan Generics on growth, maturation and
cognitive and behavioural development in this age group have not been demonstrated.

Other medicines and Venlafaxina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription, herbal remedies or nutritional supplements.
The doctor will decide if you can use Venlafaxina Mylan Generics with other medicines.

• Do not take monoamine oxidase inhibitors (MAOIs) that are used to treat depression or Parkinson's disease, together with venlafaxine. Tell your doctor if you have taken these medicines in the last 14 days. (MAOIs see section “What you need to know before taking Venlafaxina Mylan Generics”) Serotonin syndrome: serotonin syndrome, a potentially life-threatening condition (see section “Possible side effects”) can occur with treatment with venlafaxine, especially when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine, e.g. sumatriptan, zolmitriptan)
• Medicines for the treatment of depression, for example SNRIs, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (used to treat 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 mental health conditions with symptoms such as hearing, seeing or perceiving things that do not exist, false beliefs, unusual suspicion, unclear reasoning and withdrawing into yourself).

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. If you think you have serotonin syndrome, seek
immediate medical attention.
In its most severe forms, serotonin syndrome can resemble another potential serious side
effect called Neuroleptic Malignant Syndrome. The signs or symptoms of this syndrome may include
a combination of the above symptoms with increased sweating, severe muscle rigidity, confusion,
mood changes, increases in muscle enzymes (determined by a blood test).
Tell your doctor immediately or go to the nearest hospital emergency room if you think you have Serotonin
Syndrome or Neuroleptic Malignant Syndrome.
You should 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 abnormal heart rhythm)
• 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).

Also, the medicines listed below can interfere with Venlafaxina Mylan Generics and must be used
with caution. It is particularly important that you tell your doctor or pharmacist if you are using:

• Medicines that inhibit certain enzymes (CYP3A4) such as:
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV):
• ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medicines)
• clarithromycin and telithromycin (antibiotics)
• Haloperidol or risperidone (for the treatment of psychiatric disorders)
• Metoprolol (a beta-blocker for the treatment of high blood pressure and heart problems)

Venlafaxina Mylan Generics with alcohol
Do not drink alcohol while taking Venlafaxina Mylan Generics.

Pregnancy and breastfeeding
Tell your doctor if you are pregnant, if you think you may be pregnant or if you are planning to become pregnant. You should use
Venlafaxina Mylan Generics only after discussing with your doctor the potential benefits and potential risks to the
foetus.
Make sure your midwife and/or doctor knows that you are taking venlafaxine.
If taken during pregnancy, especially in the last trimester of pregnancy, medicines like Venlafaxina
Mylan Generics can increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe faster and appear bluish. These symptoms usually start within the first 24 hours of birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you are taking Venlafaxina Mylan during pregnancy, other symptoms that your baby may show at
birth in addition to faster breathing, are irritability, tremor, flaccid muscles (hypotonia), continuous crying,
difficulty sleeping and 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.
If you are breastfeeding, ask your doctor for advice. Venlafaxina Mylan Generics is excreted in 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
therapy with Venlafaxina Mylan Generics.

Driving and using machines
Do not drive and do not use tools or machines until you understand what effects Venlafaxina Mylan Generics has on you,
because this medicine can affect your ability to judge, think and drive or use
machines.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning that it is practically “sodium-free”.

3. How to take Venlafaxina Mylan Generics

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended starting dose for the treatment of depression, social anxiety disorder and generalized 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 attacks, your doctor may 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 attacks is 225 mg per day. Your doctor may recommend that you take this medicine for several months depending on your condition and may check you regularly during treatment.
Take Venlafaxina Mylan Generics 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 Mylan Generics with food.
If you have liver or kidney problems, tell your doctor, as an adjustment to the dose of Venlafaxina Mylan Generics may be necessary.

Use in children and adolescents
Venlafaxina Mylan Generics is normally not recommended for use in children and adolescents (see section 2).
Do not stop treatment with Venlafaxina Mylan Generics without consulting your doctor (see section “If you stop taking Venlafaxina Mylan Generics”).

If you take more Venlafaxina Mylan Generics than you should
Contact your doctor or pharmacist immediately if you take more of Venlafaxina Mylan Generics than you have been prescribed by your doctor.
Symptoms of a possible overdose may include fast or slow heartbeat or changes in heart electrical activity that can be observed in laboratory tests, low blood pressure, dizziness, changes in consciousness (ranging from drowsiness to coma), blurred vision, convulsions or seizures and vomiting.

If you forget to take Venlafaxina Mylan Generics
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 missed 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.

If you stop taking Venlafaxina Mylan Generics
Do not stop treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need Venlafaxina Mylan Generics, 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 Mylan Generics, especially when Venlafaxina Mylan Generics 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 or vomiting, diarrhea, anxiety, nervousness, agitation, confusion, ringing in the ears, tingling or rarely sensations of electric shock, weakness, sweating, convulsions, tremor or flu-like symptoms.
Your doctor will tell you how to gradually stop treatment with Venlafaxina Mylan Generics.
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 everyone gets them.

Immediately inform your doctor or go to the nearest hospital emergency room if any of the following side effects occur:
Rare (may affect up to 1 in 1,000 people):

• Allergic reaction causing sudden swelling of the face, lips, tongue, throat, hands, feet or other parts of the body, rash, itching or hives, decreased blood pressure causing fainting, chest tightness, wheezing, difficulty swallowing or breathing
• Redness of the skin with blister formation and peeling. Severe bleeding and blistering may also occur on the lips, eyes, mouth, nose and genitals. This could be a “Stevens-Johnson syndrome” or a “toxic epidermal necrolysis”
• Signs and symptoms of serotonin syndrome which may include: restlessness, hallucinations, loss of coordination, increased heart rate, increased body temperature, rapid fluctuations in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome. Signs and symptoms of neuroleptic malignant syndrome include a combination of the symptoms reported above, with increased sweating, changes in mood, severe muscle rigidity, confusion, increased enzymes in the muscles (determined by a blood test).
• Decreased red blood cells, white blood cells or platelets in the blood, which can lead to more frequent infections (such as sore throat or mouth ulcers), fever, weakness, easy bruising, bleeding or prolonged bleeding.
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis).
• Cough, wheezing, shortness of breath and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (eosinophilic pneumonia)
• Yellowing of the eyes and skin (hepatitis)
• Sudden onset of a measles-like rash that may be associated with high fever and joint pain (Multiforme Erythema). Other possible side effects that you should tell your doctor aboutinclude.

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

• Pain in the upper abdomen and back, feeling unwell, malaise, which may be caused by inflammation of the pancreas (pancreatitis)
• Decreased sodium levels in the blood, feeling unwell, muscle pain, seizures, difficulty breathing, confusion, fatigue, loss of appetite, excessive water consumption (all of these symptoms are caused by inappropriate secretion of a specific hormone called antidiuretic hormone, SIADH)
• Changes in vision caused by increased pressure inside the eye (glaucoma). Other signs may include sudden eye pain, vision loss, halos around lights, and dilated pupils
• Abnormal, fast or irregular heartbeat, which can lead to fainting or changes in the heart's electrical activity, which can be observed on specific tests
• Convulsions or seizures.

Uncommon (may affect up to 1 in 100 people):

• Swelling of the skin that may affect the face, throat, digestive tract and airways. (if you have difficulty swallowing or breathing, seek immediatemedical attention)
• Vomiting blood, black tarry stools or blood in the stool, which may be signs of internal bleeding
• Hyperactivity, racing thoughts and reduced need for sleep (mania)

Common (may affect up to 1 in 10 people):

• Inability to urinate
• Tremor, tingling, increased muscle tone
• Increased blood pressure.

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and suicidal behavior, cases of suicidal ideation and suicidal behavior have been reported during treatment with venlafaxine or immediately after its discontinuation (see section 2 “What you need to know before taking Venlafaxine Mylan Generics”).

Other possible side effects

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

• Dizziness, headache
• Nausea, dry mouth
• Sleepiness
• Excessive sweating (including night sweats)
• Difficulty sleeping
• Constipation.

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Confusion, feeling detached from oneself, lack of orgasm, decreased sexual desire, nervousness, abnormal dreams, agitation
• Visual disturbances including blurred vision, dilated pupils, inability of the eyes to focus from distant to near objects
• Tinnitus (ringing in the ears)
• Hot flashes
• Yawning
• Vomiting, diarrhea
• Increased frequency of urination, difficulty urinating
• Menstrual irregularities such as increased bleeding or abnormal bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence)
• Weakness (asthenia), fatigue, chills
• Increased cholesterol in the blood
• Altered sense of taste
• Shortness of breath
• Rash, itching
• Weight gain, weight loss
• Feeling restless or inability to sit or stay still
• Increased heartbeat, perception of heartbeat (palpitations).

Uncommon (may affect up to 1 in 100 people)

• Hallucinations, feeling detached from reality, agitation, abnormal orgasm, lack of sensations or emotions, hyperexcitation, teeth grinding
• Fainting, involuntary muscle movements, uncontrollable spasms, jerky or contorted movements, impaired coordination and balance
• Dizziness (especially when getting up too quickly) due to low blood pressure
• Sensitivity to sunlight, bruising (ecchymosis), abnormal hair loss, hives
• Low blood pressure
• Changes in blood levels of liver enzymes, which can be observed with laboratory tests
• Involuntary and uncontrolled urination

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

• Decreased levels of sodium in the blood that can be observed in blood tests
• Disorientation and confusion, often accompanied by hallucinations (delirium).

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

• Abnormal or increased production of a hormone called prolactin, which can be observed with blood tests
• Involuntary movements, mainly of the face and tongue (Tardive dyskinesia)
• Unexpected bleeding, e.g. bleeding gums, blood in the urine or vomit or the appearance of unexplained bruises or rupture of blood vessels

Frequency not known (cannot be estimated from available data)

• Aggression
• Feeling of spinning.

Additional side effects in children and adolescents
Although this medicine is not usually recommended in children and adolescents, hostility,
self-harm, stomach pain, indigestion, heartburn and muscle pain have also been reported.

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: https://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 Mylan Generics

Keep this medicine out of the sight and reach of children .
Do not use the medicine after the expiry date which is stated on the label/packaging after “EXP”. The expiry
date refers to the last day of the month.
This medicine does not require any particular precautions for storage.
Medicines should not be disposed of 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 VenlafaxinaMylan Genericscontains
The active ingredient is venlafaxine.
Each prolonged-release hard capsule contains venlafaxine hydrochloride equivalent to 75 mg or 150 mg of venlafaxine
(as hydrochloride).
The excipients are: hypromellose, ammonium methacrylate copolymer, sodium lauryl sulfate, magnesium stearate, basic
butyl methacrylate copolymer
The capsule shell contains: titanium dioxide E171, red iron oxide E172 (only for the 75 mg formulation),
erythrosine E127 and indigo carmine E132 (only for the 150 mg formulation), printing ink, shellac,
black iron oxide.

Description of the appearance of Venlafaxina Mylan Generics and package contents
75 mg formulation
Hard, opaque, flesh-colored capsules, with “VEN” imprinted on the capsule cap and 75 on the body.
150 mg formulation
Hard, opaque, scarlet capsules, with “VEN” imprinted on the capsule cap and 150 on the body.
Venlafaxina prolonged-release capsules are available in blister packs of 7, 10, 14 (calendar pack for 75 mg), 20, 25, 28, 30, 30x1, 50, 56, 70, 90, 100, 500, 1000 and multi-pack of 90 (3 packs of 30) or 100 (2 packs of 50) capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturers responsible for batch release:
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Pharmathen International S.A.
Sapes Industrial Park, Block 5, 69300 Rodopi,
Greece
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Pharmathen SA,
6, Dervenakion str.,
153 51 Pallini, Attiki,
Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised on