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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents 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 norepinephrine 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 concentration of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration of serotonin and norepinephrine in the brain.
Venlafaxine Apotex is used to treat depression in adults. Venlafaxine Apotex is also indicated for the treatment of 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, worsen, and become much more difficult to treat.

2. Important information before taking Venlafaxine Apotex

When not to take Venlafaxine Apotex

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

Venlafaxine Apotex may cause serious or life-threatening side effects when taken with certain other medicines, including IMAOs. Before starting to take any other medicine, the patient should tell their doctor or pharmacist if they have taken any IMAOs in the last 14 days.

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 treatment has stopped.
Beforestarting treatment with Venlafaxine Apotex, the patient should discuss the following with their doctor or pharmacist:

• if the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Venlafaxine Apotex (see "Venlafaxine Apotex with other medicines").
• if the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball).
• if the patient has a history of high blood pressure.
• if the patient has a history of heart disease.
• if the patient has a history of heart rhythm disorders.
• if the patient has a history of seizures (epilepsy).
• if the patient has a history of low sodium levels in the blood (hyponatremia).
• if the patient has a tendency to bruise or bleed easily (bleeding disorders in the past), or if they are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• if the patient or anyone in their family has a history of mania (feeling excessively excited or euphoric) or bipolar disorder.
• if the patient has a history of aggressive behavior.

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

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes think about self-harm or suicide. Such thoughts or behavior may worsen when starting to take antidepressants, as these medicines start to work usually after 2 weeks, sometimes later.
The risk of suicidal thoughts or behavior is higher if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trials have shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the emergency room immediately.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read the leaflet. The patient may ask their relatives or friends for help and ask them to monitor them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, it is essential to take good care of 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). Nevertheless, the doctor may prescribe Venlafaxine Apotex to patients under 18 years of age if they consider it beneficial. If the doctor has prescribed this medicine to a patient under 18 years of age, in case of any doubts, the patient or their guardian should consult the doctor to discuss this. The doctor should be informed if any of the above symptoms occur or worsen in patients under 18 years of age taking Venlafaxine Apotex. Long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group has not been established.

Venlafaxine Apotex with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor will decide whether to use Venlafaxine Apotex with other medicines.
The patient should not start or stop taking other medicines, including over-the-counter medicines, herbal or dietary supplements, without consulting their doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Venlafaxine Apotex.The patient should tell their doctor if they have taken these medicines in the last 14 days (IMAO; see "Important information before taking Venlafaxine Apotex").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or a malignant neuroleptic syndrome (see section "Possible side effects") may occur, especially when taken with medicines such as:
• triptans (substances used to treat migraine headaches),
• medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine 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 MAO inhibitor (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 dependence or severe pain),
• medicines containing methylene blue (used to treat high methemoglobin levels in the blood),
• medicines containing St. John's Wort (Hypericum perforatum, herbal or dietary supplements used to treat mild depression),
• medicines containing tryptophan (used to treat sleep disorders and depression),
• antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, and withdrawal).

Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heart rate, high body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble malignant neuroleptic 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, the patient should immediately tell their doctor or go to the emergency room.

If the patient is taking medicines that may affect heart rhythm, they should tell their doctor. Examples of such medicines include:

• antiarrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders)
• 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 the patient should use them with caution. It is especially important to inform the doctor if the patient is 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").
The patient should not drink alcohol during treatment with Venlafaxine Apotex.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking this medicine. Venlafaxine Apotex should only be used after discussing the potential benefits and risks to the unborn child with the doctor.
The patient should make sure that their midwife and/or doctor know that they are taking Venlafaxine Apotex. Similar medicines (from the SSRI group) taken by pregnant women may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue discoloration of the baby's skin. These symptoms usually occur in the first day of life. If this happens, the patient should contact their midwife and/or doctor immediately.
If the patient takes this medicine during pregnancy, after birth, the baby may experience symptoms other than breathing difficulties, such as poor feeding. If the patient is concerned about such symptoms in their newborn, they should contact their doctor and/or midwife, who will be able to provide appropriate advice.
Venlafaxine passes into breast milk. There is a risk of affecting the baby. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

The patient should not drive or operate machinery until they know how venlafaxine affects them.

3. How to take Venlafaxine Apotex

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, the recommended initial dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. This dose may be gradually increased by the doctor if necessary, up to a maximum dose of 375 mg per day in the case of depression. If the patient has panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.
Venlafaxine Apotex should be taken once a day, 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. They should not be divided, crushed, chewed, or dissolved.
Venlafaxine Apotex should be taken with food.
The patient should inform their doctor about any liver or kidney problems, as a dose adjustment may be necessary.
The patient should not stop taking this medicine without consulting their doctor (see "Stopping Venlafaxine Apotex").

Taking a higher dose of Venlafaxine Apotex than recommended

In case of taking a higher dose of Venlafaxine Apotex than recommended, the patient should immediately contact their 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

In case of missing a dose, the patient should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and take only one dose at the usual time. The patient should not take a double dose to make up for the missed dose. The patient should not take a higher dose in one day than the daily dose of Venlafaxine Apotex prescribed by their doctor.

Stopping Venlafaxine Apotex

The patient should not stop taking this medicine or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop taking Venlafaxine Apotex, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients who stop taking Venlafaxine Apotex, especially when stopping treatment abruptly or reducing the dose too quickly, side effects may occur, such as feeling tired, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms.
The doctor will advise the patient on how to gradually stop taking Venlafaxine Apotex. If the patient experiences any of the above symptoms or other symptoms that are bothersome, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Venlafaxine Apotex can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Venlafaxine Apotex and contact their doctor or go to the emergency room immediately:

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 tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (red or pale rash, often itchy).
• Symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heart rate, high body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Symptoms of malignant neuroleptic 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 the result of a blood disorder that increases the risk of infection.
• Severe rash, which may lead to severe blisters and skin peeling.
• Muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

In case of experiencing any of the following side effects, the patient should contact their doctor(the frequency of these side effects is listed below in the "Other side effects" section):

• Cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• Black (tar-like) stools or blood in stools, which may be a sign of 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 disorders (muscle spasms or stiffness), seizures, or convulsions.
• Psychiatric disorders, such as excessive restlessness and feeling unnatural excitement.
• Withdrawal symptoms (see sections "How to take Venlafaxine Apotex" and "Stopping Venlafaxine Apotex").
• Prolonged bleeding time - in case of a cut, the wound may bleed slightly longer than usual.

The patient may notice small white granules or balls in their stool.

Inside the capsules of Venlafaxine Apotex, there are granules (small, white balls) that contain the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract, passing through its entire length, slowly releasing venlafaxine.

The skeleton of the granule does not dissolve and is excreted in the stool. Therefore, if the patient notices granules in their stool, they should not be concerned, as the dose of venlafaxine 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; agitation; nervousness; unusual dreams
• Tremors; feeling restless 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 accommodate (automatic change of 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 urination frequency; urinary retention; urination problems
• Menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disorders (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 decreased need for sleep (mania)
• Hallucinations; feeling detached (or separated) from reality; orgasm disorders; apathy; feeling excessively excited; teeth grinding
• Fainting; uncontrolled muscle movements; coordination and balance disorders
• Dizziness (especially when standing up too quickly); decreased blood pressure
• Vomiting blood, black (tar-like) stools, or blood in stools, which may be a sign of 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 vision disturbances or blurred vision
• Abnormal, rapid, or irregular heartbeat, which may lead to fainting
• Severe abdominal or back pain (which may indicate serious intestinal, liver, or pancreatic problems)
• 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 decreased platelet count, increasing the risk of bruising or bleeding
• Unusual milk production in women
• Unexpected bleeding, such as bleeding from the gums, blood in 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 sometimes cause side effects that the patient is 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. Even more rarely, Venlafaxine Apotex may affect platelet function, leading to an increased risk of bruising or bleeding. In this regard, the doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Apotex.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after: Expiry date (EXP). The expiry date refers to the last day of the month.
The batch number is stated after the abbreviation "Lot".
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What Venlafaxine Apotex contains

The active substance of the medicine is venlafaxine.
Each prolonged-release, hard capsule contains 37.5 mg, 75 mg, or 150 mg of venlafaxine in the form of venlafaxine hydrochloride.
The other ingredients of the medicine are:

37.5 mg, prolonged-release, hard capsule:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:butyl methacrylate copolymer (12.5%)
Capsule shell:gelatin, titanium dioxide (E 171)
75 mg, prolonged-release, hard capsule:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:butyl methacrylate copolymer (12.5%)
Capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172)
150 mg, prolonged-release, hard capsule:
Capsule contents:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate
Capsule shell:butyl methacrylate copolymer (12.5%)
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 the inscription VEN 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 the inscription VEN 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 the inscription VEN on the cap and 150 on the body of the capsule.

• The pack contains:

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