Venlafaxine Aurovitas

Leaflet accompanying the packaging: patient information

Venlafaxine Apotex, 37.5 mg, prolonged-release, hard capsules
Venlafaxine Apotex, 75 mg, prolonged-release, hard capsules
Venlafaxine Apotex, 150 mg, prolonged-release, hard capsules
Venlafaxine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Venlafaxine Apotex and what is it used for
• 2. Important information before taking Venlafaxine Apotex
• 3. How to take Venlafaxine Apotex
• 4. Possible side effects
• 5. How to store Venlafaxine Apotex
• 6. Contents of the pack and other information

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

Venlafaxine Apotex is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). These medicines are used to treat depression and other conditions such as anxiety disorders. It is thought that in people with depression and/or anxiety, there is a lower level of serotonin and noradrenaline in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venlafaxine Apotex is used to treat depression in adults. Venlafaxine Apotex is also used to treat the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly. If the patient does not undergo treatment, their condition may not improve, may worsen, and will be much more difficult to treat.

2. Important information before taking Venlafaxine Apotex

When not to take Venlafaxine Apotex

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking, or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Venlafaxine Apotex can cause serious or even life-threatening side effects. Also, before starting to take any MAOI medicine, you should wait at least 7 days after stopping venlafaxine treatment (see also section "Serotonin syndrome" and "Venlafaxine Apotex with other medicines").

Venlafaxine Apotex may cause serious or even life-threatening side effects when taken with MAOIs.

Warnings and precautions

Medicines like Venlafaxine Apotex (so-called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
Before starting treatment with Venlafaxine Apotex, you should discuss the following with your doctor or pharmacist:

• if you are taking other medicines that, when taken with Venlafaxine Apotex, may increase the risk of developing serotonin syndrome (see section "Venlafaxine Apotex with other medicines").
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• if you have had high blood pressure in the past.
• if you have had heart problems in the past.
• if you have had irregular heart rhythms in the past.
• if you have had seizures (epilepsy) in the past.
• if you have had low sodium levels in your blood (hyponatremia) in the past.
• if you have a tendency to bruise or bleed easily (bleeding disorders in the past), or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• if you or anyone in your family has had mania (feeling excessively excited or elated) or bipolar disorder in the past.
• if you have had aggressive behavior in the past.

Venlafaxine Apotex may cause feelings of restlessness or an inability to sit or stand still during the first few weeks of treatment. If you experience such symptoms, you should inform your doctor.
If any of the above applies to you before starting treatment with Venlafaxine Apotex, you should consult your doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes think about harming themselves or committing suicide. Such thoughts or behavior may worsen at the beginning of treatment with antidepressants, as these medicines start to work usually after 2 weeks, sometimes later.
Suicidal thoughts or behavior are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; clinical trials have shown an increased risk of suicidal behavior in adults under 25 years with mental health conditions treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the nearest hospital emergency department.
It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask your relatives or friends to tell you if they notice that your depression or anxiety is getting worse or if you are behaving in a way that is unusual for you.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay special attention to oral hygiene.
Diabetes
Venlafaxine may affect blood sugar levels. Therefore, it may be necessary to adjust the dose of antidiabetic medicines.

Children and adolescents

Venlafaxine Apotex should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age who take medicines of this class are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Venlafaxine Apotex to patients under 18 years of age if they consider it beneficial. If your doctor has prescribed this medicine to a patient under 18 years of age, you should discuss any concerns with your doctor. You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Venlafaxine Apotex. The long-term safety of Venlafaxine Apotex in this age group, regarding effects on growth, puberty, and cognitive and behavioral development, has not been established.

Venlafaxine Apotex with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Your doctor will decide whether to prescribe Venlafaxine Apotex with other medicines.
Do not start or stop taking other medicines, including those available without a prescription, herbal, or dietary supplements, without consulting your doctor or pharmacist first.

• Irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with Venlafaxine Apotex.Tell your doctor if you have taken these medicines in the last 14 days (MAOIs; see section "Important information before taking Venlafaxine Apotex").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or a neuroleptic malignant syndrome-like reaction may occur, especially when taken with medicines such as:
• triptans (used to treat migraine headaches),
• medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines,
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity),
• medicines containing the antibiotic linezolid (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 addiction or severe pain),
• medicines containing methylene blue (used to treat high levels of methemoglobin in the blood),
• medicines containing St. John's Wort (Hypericum perforatum, herbal or dietary supplements used to treat mild depression),
• medicines containing tryptophan (used for sleep problems and depression),
• antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that are not there, delusions, unnatural suspicion, unclear thinking, and withdrawal).

Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Its symptoms include fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased muscle enzyme activity (detected in a blood test).

In case of suspected serotonin syndrome, you should immediately inform your doctor or go to the nearest hospital emergency department.

If you are taking medicines that may affect your heart rhythm, you should inform your doctor. Examples of such medicines are:

• anti-arrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms)
• antipsychotic medicines, such as thioridazine (see 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 Apotex and should be used with caution. It is particularly important to inform your doctor if you are taking medicines containing:

• ketokonazole (an antifungal medicine)
• haloperidol or risperidone (medicines used to treat mental disorders)
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease).

Taking Venlafaxine Apotex with food, drink, and alcohol

Venlafaxine Apotex should be taken with food (see section 3 "How to take Venlafaxine Apotex").
During treatment with Venlafaxine Apotex, you should not drink alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Venlafaxine Apotex should only be used after discussing the potential benefits and risks to the unborn child with your doctor.
Make sure your midwife and/or doctor know you are taking Venlafaxine Apotex. Similar medicines (SSRIs) taken during pregnancy by women have been associated with an increased risk of a serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish discoloration of the baby's skin. These symptoms usually occur in the first day of life.
If this happens, you should immediately contact your midwife and/or doctor.
If you are taking this medicine during pregnancy, after the baby is born, in addition to breathing difficulties, the baby may experience other symptoms such as poor feeding. If you are concerned about such symptoms in your newborn, you should contact your doctor and/or midwife, who will be able to provide appropriate advice.
Venlafaxine passes into breast milk. There is a risk to the baby. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

Do not drive or operate machinery until you know how venlafaxine affects you.

3. How to take Venlafaxine Apotex

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.
Usually, the recommended starting dose for depression, generalized anxiety disorder, and social phobia is 75 mg once daily. The dose may be gradually increased by your doctor if necessary, up to a maximum dose of 375 mg once daily for depression. If you are being treated for panic disorder, treatment should start with a lower dose (37.5 mg) and then gradually increase. The maximum dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg once daily.
Venlafaxine Apotex should be taken once daily, at approximately the same time, regardless of whether the medicine is taken in the morning or evening. The capsules should be swallowed whole with a drink of water. Do not divide, crush, chew, or dissolve them.
Venlafaxine Apotex should be taken with food.
You should inform your doctor if you have liver or kidney problems, as you may need a dose adjustment.
Do not stop taking this medicine without consulting your doctor (see section "Stopping treatment with Venlafaxine Apotex").

Taking a higher dose of Venlafaxine Apotex than recommended

If you have taken more Venlafaxine Apotex than you should, you should immediately contact your doctor or pharmacist.
Symptoms of possible overdose include rapid heart rate, changes in consciousness (from drowsiness to coma), changes in vision, seizures, or vomiting.

Missing a dose of Venlafaxine Apotex

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take only one dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the prescribed daily dose of Venlafaxine Apotex.

Stopping treatment with Venlafaxine Apotex

Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Venlafaxine Apotex, they will tell you how to gradually reduce the dose before stopping treatment completely. When stopping treatment with Venlafaxine Apotex, especially when stopping suddenly or reducing the dose too quickly, you may experience side effects such as feeling tired, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, confusion, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually stop taking Venlafaxine Apotex. If you experience any of the above symptoms or other symptoms that are troublesome for you, you should consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking Venlafaxine Apotex and immediately contact your doctor or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, throat, hands, or feet, and (or) a raised, itchy rash (hives), difficulty swallowing or breathing.

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

• Chest pain, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (a red or pale rash, often itchy).
• Symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome include fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased muscle enzyme activity (detected in a blood test).
• Symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• Severe rash that may lead to severe blistering and peeling of the skin.
• Muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

If you experience any of the following side effects, you should contact your doctor(The frequency of these side effects is not known):

• Cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• Black (tar-like) stools or blood in stools, which may indicate internal bleeding.
• Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation.
• Heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure.
• Vision disturbances, such as blurred vision, dilated pupils.
• Nervous system disorders, such as dizziness, tingling, coordination disturbances (muscle spasms or stiffness), seizures, or convulsions.
• Psychiatric disorders, such as excessive restlessness and unnatural excitement.
• Withdrawal symptoms (see sections "How to take Venlafaxine Apotex" and "Stopping treatment with Venlafaxine Apotex").
• Prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

During treatment with this medicine, you may notice small white granules or balls in your stool.

The prolonged-release capsules of Venlafaxine Apotex contain granules (small white balls) that release the active substance, venlafaxine, into the digestive tract, slowly releasing it as they pass through the digestive system.

The granule shell does not dissolve and is excreted in the stool. Therefore, if you notice granules in your stool, you should not be concerned, as the venlafaxine dose has been absorbed.

Other side effects

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)

• Decreased appetite
• Disorientation; feeling detached (or separated) from oneself; lack of orgasm; decreased libido; restlessness; nervousness; unusual dreams
• Tremors; feeling anxious or unable to sit or stand still; tingling; taste disturbances; increased muscle tone
• Vision disturbances, including blurred vision; dilated pupils; inability of the eyes to adapt (automatic change in focus from distant to near objects)
• Ringing in the ears (tinnitus)
• Rapid heartbeat, palpitations
• Increased blood pressure; flushing
• Shortness of breath, yawning
• Vomiting; diarrhea
• Mild rash; itching
• Increased frequency of urination; urinary retention; difficulty urinating
• Menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disturbances (men); erectile dysfunction (impotence)
• Weakness; fatigue; chills
• Weight gain; weight loss
• Increased cholesterol levels in the blood

Uncommon (may affect up to 1 in 100 people)

• Excessive excitement, racing thoughts, and reduced need for sleep (mania)
• Hallucinations; feeling detached (or separated) from reality; orgasm disturbances; apathy; feeling overly excited; teeth grinding
• Fainting; uncontrolled muscle movements; coordination and balance disturbances
• Dizziness (especially when standing up too quickly); decreased blood pressure
• Vomiting blood, black (tar-like) stools, or blood in stools, which may indicate internal bleeding
• Sensitivity to light; bruising; excessive hair loss
• Urinary incontinence
• Stiffness, muscle spasms, and uncontrolled muscle movements
• Mild changes in liver enzyme activity in the blood

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

• Seizures or convulsions
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever
• Disorientation and confusion, often with hallucinations (delirium)
• Excessive water retention in the body
• Decreased sodium levels in the blood
• Severe eye pain and decreased vision or blurred vision
• Abnormal, rapid, or irregular heartbeat, which may lead to fainting
• Severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas)
• Itching, yellowing of the skin or whites of the eyes, dark urine, or flu-like symptoms, which may be symptoms of liver inflammation

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

• Prolonged bleeding, which may be a sign of a low platelet count, increasing the risk of bruising or bleeding
• Unusual milk production in women
• Unexpected bleeding, such as bleeding from the gums, blood in the urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)

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

• Suicidal thoughts and behaviors; during treatment with venlafaxine or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Venlafaxine Apotex")
• Aggressive behavior
• Dizziness

Venlafaxine Apotex may also cause side effects that you are not aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme activity, sodium, or cholesterol levels in the blood. More rarely, Venlafaxine Apotex may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, your doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Apotex.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Venlafaxine Apotex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
The batch number is stated after the word "Lot".
Store in a temperature not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Venlafaxine Apotex contains

The active substance is venlafaxine.
Each prolonged-release capsule, hard, contains 37.5 mg, 75 mg, or 150 mg of venlafaxine as venlafaxine hydrochloride.
The other ingredients are:
37.5 mg, prolonged-release capsule, hard:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent
Capsule shell:gelatin, titanium dioxide (E 171)
75 mg, prolonged-release capsule, hard:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent
Capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172)
150 mg, prolonged-release capsule, hard:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent
Capsule shell:gelatin, titanium dioxide (E 171), erythrosine (E 127), indigo carmine (E 132)

What Venlafaxine Apotex looks like and contents of the pack

Venlafaxine Apotex, 37.5 mg: white, opaque, hard, gelatin capsules (size 0), with "VEN" printed on the cap and "37.5" on the body of the capsule, containing one round, biconvex, film-coated tablet.
Venlafaxine Apotex, 75 mg: light brown, opaque, hard, gelatin capsules (size 0) containing two round, biconvex, film-coated tablets with "VEN" printed on the cap and "75" on the body of the capsule.
Venlafaxine Apotex, 150 mg: light red, opaque, hard, gelatin capsules (size 00) containing three round, biconvex, film-coated tablets with "VEN" printed on the cap and "150" on the body of the capsule.

• Venlafaxine Apotex, 37.5 mg: 28 capsules
• Venlafaxine Apotex, 75 mg: 28 or 56 capsules
• Venlafaxine Apotex, 150 mg: 28 or 56 capsules

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Apotex Europe B.V.

Archimedesweg 2
2333 CN Leiden
Netherlands
Manufacturer:

Apotex Nederland B.V.

Archimedesweg 2
2333 CN Leiden
Netherlands

Pharmathen S.A.

6, Dervenakion Str.
15351 Pallini, Attikis
Greece

Pharmathen International S.A.

Sapes Industrial Park
Block 5
69300 Rodopi
Greece

Date of last revision of the leaflet: 03.2020