Venlafaxine Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

(Venlafaxine)
Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Venlafaxine Mylan Generics is and what it is used for
2. What you need to know before taking Venlafaxine Mylan Generics
3. How to take Venlafaxine Mylan Generics
4. Possible side effects
5. How to store Venlafaxine Mylan Generics
6. Contents of the pack and other information

1. What Venlafaxine Mylan Generics is and what it is used for
Venlafaxine 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 to treat 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. The exact way antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and noradrenaline in the brain.

Venlafaxine Mylan Generics is a treatment for adults with depression or to prevent recurrences of major depressive episodes. Venlafaxine Mylan Generics 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. Appropriate treatment of depression or anxiety disorders is important to help you feel better. If left untreated, your condition may not improve and could become worse and more difficult to treat.

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

Do not take Venlafaxine Mylan Generics

• if you are allergic (hypersensitive) to venlafaxine or to any of the excipients 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 other medicines, including Venlafaxine Mylan Generics, may result in serious or even life-threatening side effects. In addition, you must wait at least 7 days after stopping treatment with Venlafaxine Mylan Generics before starting any irreversible MAOI (also see sections “Serotonin syndrome” and “Other medicines and Venlafaxine Mylan Generics”).

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

• if you are taking medicines that, when taken with Venlafaxine Mylan Generics, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine 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 someone in your family has a history of heart problems or irregular heart rhythm
• if you have a history of seizures (epileptic fits)
• if you have a history of low sodium levels in the blood (hyponatraemia), or if you are elderly, if you are taking diuretics (which can increase urine production), or if you are dehydrated (e.g. 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 taking other medicines that thin the blood and may increase the risk of bleeding
• if you or someone in your family has a history of or has suffered from mania or bipolar disorder (feelings of over-excitement or euphoria)
• if you have a history of aggressive behaviour. You may feel aggressive, especially during the initial phases of treatment with venlafaxine, when the dose is changed, or when you stop taking it
• if you have diabetes (this medicine may affect blood sugar levels)
• if you are taking any weight-loss medicines

During treatment

• This medicine may cause an increase in blood pressure or an increase in cholesterol levels. Your doctor may need to monitor your blood pressure or cholesterol levels regularly
• If you feel restless or unable to sit still, which may occur during the initial phases of treatment, discuss this with your doctor or pharmacist
• If you are undergoing a urine test to detect certain drugs, this medicine may affect the results. Inform your doctor or hospital staff that you are taking this medicine
• Venlafaxine capsules contain spheroids, the insoluble portion of which is eliminated and may be observed in the faeces.

Medicines such as Venlafaxine Mylan Generics (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4.4). In some cases, these symptoms persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide.
These thoughts may increase when you first start taking antidepressants, as all medicines like this may take some time to become effective, usually about two weeks but sometimes longer.
You are more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data have 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 of suicide at any time, contact your doctor or go to the hospital immediately. It may help to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Dry mouth
One in ten patients taking venlafaxine reports dry mouth. This may increase the risk of dental caries. Therefore, you should pay particular attention to your oral hygiene.
Children and adolescents under 18 years
Venlafaxine Mylan Generics is normally not intended for use in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive behaviour, oppositional behaviour, and anger) when taking this class of medicines. Nevertheless, your doctor may prescribe Venlafaxine Mylan Generics for patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Venlafaxine Mylan Generics for a patient under 18 years of age and you wish to discuss this, talk 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 Mylan Generics. In addition, the long-term effects of Venlafaxine Mylan Generics on growth, maturation, and cognitive and behavioural development in this age group have not been established.

Other medicines and Venlafaxine Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, herbal remedies, or natural supplements.
Your doctor will decide whether you can take Venlafaxine Mylan Generics with other medicines.

• Do not take monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease together with venlafaxine. Inform your doctor if you have taken these medicines within the last 14 days. (For MAOIs, see section “What you need to know before taking Venlafaxine Mylan Generics”) Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition (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, e.g. sumatriptan, zolmitriptan)
• Medicines for treating 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)
• Preparations containing St. John’s wort (also known as 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 suspiciousness, unclear thinking, and withdrawing into oneself).

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. If you think you have serotonin syndrome, seek immediate medical help.
In its most severe forms, serotonin syndrome may resemble another potentially serious adverse effect called Neuroleptic Malignant Syndrome. Signs or symptoms of this syndrome may include a combination of the above symptoms with increased sweating, severe muscle rigidity, confusion, mood changes, and increases in muscle enzymes (detected by a blood test).
Inform your doctor immediately or go to the nearest hospital emergency department if you think you have serotonin syndrome or Neuroleptic Malignant Syndrome.
You must inform your doctor if you are taking medicines that may affect 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 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 Venlafaxine Mylan Generics and should be used with caution. It is particularly important that you inform your doctor or pharmacist if you are taking:

• 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 used to treat high blood pressure and heart problems)

Venlafaxine Mylan Generics and alcohol
Do not consume alcohol while taking Venlafaxine Mylan Generics.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. You should use Venlafaxine Mylan Generics only after discussing with your doctor the potential benefits and potential risks to the fetus.
Ensure that your midwife and/or doctor is aware that you are taking venlafaxine.
If taken during pregnancy, especially during the third trimester, medicines such as Venlafaxine Mylan Generics may 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 begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Venlafaxine Mylan Generics during pregnancy, other symptoms your baby may show at birth, in addition to rapid breathing, include irritability, tremors, floppy muscles (hypotonia), continuous crying, difficulty sleeping, and difficulty feeding properly. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will assist you.
If you are breastfeeding, consult your doctor. Venlafaxine Mylan Generics is excreted in 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 discontinue therapy with Venlafaxine Mylan Generics.
Driving and using machines
Do not drive and do not operate tools or machinery until you know how Venlafaxine Mylan Generics affects you, as this medicine may affect your judgment, thinking, and ability to drive or operate machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning it is essentially "sodium-free".

3. How to take Venlafaxine Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, you must
consult your doctor or pharmacist.
The recommended starting dose for the treatment of depression, social anxiety disorder, and generalized anxiety
disorder is 75 mg daily. Your doctor may gradually increase the dose, and if necessary, up to a maximum of 375 mg
daily 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 it. The maximum daily dose for generalized anxiety disorder, social anxiety disorder, and panic
attacks is 225 mg. Your doctor may recommend that you take this medicine for several months depending on your
condition and may monitor you regularly during treatment.
Take Venlafaxine Mylan Generics at approximately the same time each day, in the morning or evening. The capsules
must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
You should take Venlafaxine Mylan Generics with food.
If you have liver or kidney problems, discuss this with your doctor, as a dose adjustment of Venlafaxine Mylan
Generics may be necessary.
Use in children and adolescents
Venlafaxine Mylan Generics is generally not recommended for use in children and adolescents (see section 2).
Do not stop treatment with Venlafaxine Mylan Generics without consulting your doctor (see section “If you stop
taking Venlafaxine Mylan Generics”).
If you take more Venlafaxine Mylan Generics than you should
Contact your doctor or pharmacist immediately if you take more Venlafaxine Mylan Generics than prescribed.
Symptoms of a possible overdose may include rapid or slow heartbeat or changes in the heart's electrical activity that
can be observed in laboratory tests, low blood pressure, dizziness, altered level of consciousness (ranging from
drowsiness to coma), blurred vision, seizures or epileptic fits, and vomiting.
If you forget to take Venlafaxine Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose when
you remember, skip the missed dose and take only your next dose as usual. Do not take a double dose to make up for
the missed one.
If you stop taking Venlafaxine Mylan Generics
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor
considers that you no longer need Venlafaxine Mylan Generics, they may ask you to gradually reduce the dose before
stopping treatment completely. It is known that adverse effects may occur when patients stop taking Venlafaxine
Mylan Generics, especially if treatment 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 or vomiting, diarrhea, anxiety, nervousness, agitation, confusion, ringing in the ears, tingling, or
rarely electric shock-like sensations, weakness, sweating, seizures, tremor, or flu-like symptoms.
Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Mylan Generics.
If you experience any of these or other bothersome symptoms, consult 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 everyone gets them.
Contact your doctor immediately or go to the nearest hospital Emergency Department if you experience any of the
following side effects:
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, skin rash, itching or hives, drop in blood pressure causing fainting, chest tightness, wheezing, difficulty swallowing or breathing
• Skin redness with blistering and peeling. Severe bleeding and blistering of the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”
• Signs and symptoms of serotonin syndrome which may include: restlessness, hallucinations, lack of coordination, increased heart rate, elevated body temperature, rapid fluctuations in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome. Signs and symptoms of neuroleptic malignant syndrome include a combination of the symptoms listed above, along with increased sweating, mood changes, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).
• Reduction in red blood cells, white blood cells or platelets in the blood, which may 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 (pulmonary eosinophilia)
• Yellowing of the eyes and skin (hepatitis)
• Sudden onset of a measles-like rash, which may be associated with high fever and joint pain (Erythema multiforme). Other possible side effects you should discuss with your doctor include:

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, malaise, muscle pain, seizures, difficulty breathing, confusion, fatigue, loss of appetite, excessive water intake (all these symptoms are caused by inappropriate secretion of a specific hormone called antidiuretic hormone, SIADH)
• Vision changes due to increased pressure inside the eye (glaucoma). Other signs may include sudden eye pain, vision loss, seeing halos around lights, and dilated pupils
• Abnormal, rapid or irregular heartbeat, which may lead to fainting or changes in the heart's electrical activity, detectable on specific tests
• Seizures or epileptic fits.

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

• Swelling of the skin which may affect the face, throat, digestive tract and airways. (if you have difficulty swallowing or breathing, seek immediate medical help)
• Vomiting blood, black tarry stools or blood in the stools, which may be signs of internal bleeding
• Hyperactivity, wandering 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 the available data)

• Suicidal thoughts and suicidal behaviour. Cases of suicidal thoughts and suicidal behaviour have been reported during treatment with venlafaxine or shortly after 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
• Drowsiness
• Excessive sweating (including night sweats)
• Difficulty sleeping
• Constipation.

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

• Decreased appetite
• Confusion, feeling detached from oneself, absence of orgasm, decreased sexual desire, nervousness, abnormal dreams, restlessness
• Vision disturbances including blurred vision, dilated pupils, inability of the eyes to focus from distant to near objects
• Ringing in the ears (tinnitus)
• Hot flushes
• Yawning
• Vomiting, diarrhoea
• Increased frequency of urination, difficulty urinating
• Menstrual irregularities such as increased bleeding or increased abnormal bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence)
• Weakness (asthenia), fatigue, chills
• Increased blood cholesterol levels
• Altered sense of taste
• Shortness of breath
• Skin rash, itching
• Weight gain, weight loss
• Feeling restless or inability to sit still
• Increased heart rate, awareness of heartbeat (palpitations).

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

• Hallucinations, feeling detached from reality, agitation, abnormal orgasm, lack of emotions or sensations, hyperexcitability, teeth grinding
• Fainting, involuntary muscle movements, uncontrollable spasms, jerky movements or twisting, disturbances in coordination and balance
• Dizziness (especially when standing 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 may be detected by laboratory tests
• Involuntary and uncontrollable urination

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

• Decreased sodium levels in the blood, which may be detected by 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 may be detected by blood tests
• Involuntary movements, mainly of the face and tongue (tardive dyskinesia)
• Unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, or appearance of unexplained bruises or broken blood vessels

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

• Aggression
• Sensation of spinning (vertigo)

Additional side effects in children and adolescents
Although this medicine is not usually recommended for children and adolescents, hostility, self-harm, stomach pain, indigestion, heartburn and muscle pain have also been reported.
Reporting of side effects
If you experience any side effects, 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: 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 Venlafaxine Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/packaging after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must 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 Venlafaxine Mylan Generics contains
The active substance 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, butylated methacrylate copolymer.
The capsule shell contains: titanium dioxide E171, iron oxide red E172 (only in the 75 mg formulation), erythrosine E127 and indigo carmine E132 (only in the 150 mg formulation), printing ink, shellac, iron oxide black.

Description of the appearance of Venlafaxine Mylan Generics and contents of the pack
75 mg formulation
Opaque, carnation-coloured, hard capsules imprinted with “VEN” on the capsule cap and “75” on the body.
150 mg formulation
Opaque, scarlet-coloured, hard capsules imprinted with “VEN” on the capsule cap and “150” on the body.
Venlafaxine prolonged-release capsules are available in blister packs containing 7, 10, 14 (calendar pack for 75 mg), 20, 25, 28, 30, 30x1, 50, 56, 70, 90, 100, 500, 1000 capsules, and multi-packs containing 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, Italy

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, Mylan utca 1, H-2900 Komarom, Hungary
Pharmathen SA,
6, Dervenakion str.,
153 51 Pallini, Attiki,
Greece

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

This leaflet was last reviewed on