Venlafaxine aurovitas: detailed information

Package leaflet: Information for the patient

Venlafaxine Apotex, 37.5 mg, prolonged-release capsules, hard
Venlafaxine Apotex, 75 mg, prolonged-release capsules, hard
Venlafaxine Apotex, 150 mg, prolonged-release capsules, hard
Venlafaxinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

What Venlafaxine Apotex is and what it is used for
What you need to know before taking Venlafaxine Apotex
How to take Venlafaxine Apotex
Possible side effects
How to store Venlafaxine Apotex
Contents of the pack and other information

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

Venlafaxine Apotex is an antidepressant medicine that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are used to treat depression and other conditions such as anxiety disorders. It is believed that people experiencing depression and/or anxiety have lower levels of serotonin and noradrenaline in the brain. The exact 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 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 important that treatment for depression and anxiety disorders is properly managed. If the patient does not receive treatment, their condition may not improve, may worsen, and may become more difficult to treat.

2. Important information before using Venlafaxine Apotex

When not to use Venlafaxine Apotex

If the patient is allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
If the patient is currently taking or has taken within the last 14 days any medicine from the group of irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with Venlafaxine Apotex may cause severe or even life-threatening adverse reactions.
Also, before starting treatment with any MAOI medicine, the patient should wait at least 7 days after stopping venlafaxine (see also section "Serotonin syndrome" and "Venlafaxine Apotex with other medicines").

Warnings and precautions

Medicines such as Venlafaxine Apotex (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist despite discontinuation of treatment.

Before starting treatment with Venlafaxine Apotex, discuss the following with your doctor or pharmacist:

if the patient is taking other medicines which, when taken together with Venlafaxine Apotex, may increase the risk of serotonin syndrome (see section "Venlafaxine Apotex with other medicines").
if the patient suffers from eye disorders, such as certain types of glaucoma (increased pressure in the eyeball).
if the patient has previously had high blood pressure.
if the patient has previously had heart disease.
if the patient has previously had heart rhythm disorders.
if the patient has previously had seizures (epilepsy).
if the patient has previously had low sodium levels in the blood (hyponatraemia).
if the patient has a tendency to bruise easily or to bleeding (bleeding disorders in the past), or if the patient is taking other medicines that may increase the risk of bleeding, e.g., warfarin (used as an anticoagulant).
if the patient or anyone in their family has previously had mania (feelings of excessive excitement or euphoria) or bipolar disorder.
if the patient has previously exhibited aggressive behaviour.

Venlafaxine Apotex may cause feelings of restlessness or inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor.

If any of the above conditions apply to the patient before starting treatment with Venlafaxine Apotex, consult a doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

Patients suffering from depression and (or) anxiety disorders may sometimes think about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously had suicidal thoughts or self-harm tendencies;
the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who are treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical advice from a doctor or go to the nearest hospital emergency department.

It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from relatives or friends and request them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.

Dry mouth

Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.

Diabetes

Venlafaxine may alter blood glucose levels. Therefore, adjustment of the dose of antidiabetic medicines may be necessary.

Children and adolescents

Venlafaxine Apotex should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age who take medicines of this class are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviours, and manifestations of anger). Nevertheless, a doctor may prescribe Venlafaxine Apotex to patients under 18 years of age if they consider it beneficial. If a doctor has prescribed this medicine to a patient under 18 years of age, consult the doctor again to discuss any concerns. Inform the doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Venlafaxine Apotex. The long-term safety regarding the effect on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Venlafaxine Apotex with other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

The treating doctor will decide whether Venlafaxine Apotex can be taken with other medicines.

Do not start or stop taking any other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson's disease must not be taken together with Venlafaxine Apotex. Inform your doctor if you have taken any of these medicines within the last 14 days (MAOIs; see section "Important information before using Venlafaxine Apotex").
Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or reactions resembling neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when taken concomitantly with medicines such as:
- triptans (substances used for migraine headaches),
- medicines used to treat depression, e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium,
- 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 levels of methemoglobin in the blood),
- medicines containing St. John's wort (Hypericum perforatum, herbal or plant-based remedies used to treat mild depression),
- medicines containing tryptophan (used for sleep problems and depression),
- antipsychotics (used to treat disorders with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid fluctuations in blood pressure, hyperreflexia, diarrhoea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Its subjective and objective symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, disorientation, increased muscle enzyme levels (detected in blood tests).

If serotonin syndrome is suspected, inform your doctor immediately or go to the nearest hospital emergency department.

If the patient is taking medicines that may affect heart rhythm, inform the doctor. Examples of such medicines include:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders),
antipsychotics 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 therefore be used with caution. It is particularly important to inform the doctor if the patient is taking medicines containing:

ketoconazole (an antifungal medicine),
haloperidol or risperidone (medicines used to treat psychiatric 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, alcohol must not be consumed.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Venlafaxine Apotex should only be used after discussing the potential benefits and risks for the unborn child with a doctor.

Ensure that the midwife and/or doctor are aware that the patient is taking Venlafaxine Apotex. Similar medicines (from the group of serotonin reuptake inhibitors - SSRIs) taken by pregnant women may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and skin blueness in the baby. These symptoms usually appear within the first 24 hours after birth. If this occurs, contact the midwife and/or doctor immediately.

If the patient takes this medicine during pregnancy, in addition to breathing difficulties, the newborn may experience other symptoms such as poor feeding. If the patient is concerned about such symptoms in the newborn, contact the doctor and/or midwife, who will be able to provide appropriate advice.

Venlafaxine passes into breast milk. There is a risk of effects on the infant. Therefore, discuss this issue with the doctor, who will decide whether breastfeeding should be discontinued or treatment with this medicine should be stopped.

Driving and operating machinery

Do not drive or operate machinery until the effect of venlafaxine on the patient's body is known.

3. How to use Venlafaxine Apotex

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg per day in the treatment of depression. In the case of panic disorder, treatment should be initiated at a lower dose (37.5 mg), which may then be gradually increased. The maximum daily dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.

Venlafaxine Apotex should be taken every day at approximately the same time, regardless of whether it is taken in the morning or evening. The capsules must be swallowed whole with liquid. Do not divide, crush, chew, or dissolve the capsules.

Venlafaxine Apotex should be taken with food.

Inform your doctor if you have any liver or kidney problems, as your dose may need to be adjusted.

Do not stop treatment with this medicine without consulting your doctor (see section "Stopping treatment with Venlafaxine Apotex").

Taking more Venlafaxine Apotex than prescribed

If you take more Venlafaxine Apotex than prescribed, contact your doctor or pharmacist immediately.

Symptoms of possible overdose include rapid heartbeat, disturbances in consciousness (from drowsiness to coma), vision disturbances, seizures, or vomiting.

If you miss 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 your next dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Venlafaxine Apotex prescribed by your doctor within a 24-hour period.

Stopping treatment with Venlafaxine Apotex

Do not stop treatment or reduce the dose of this medicine without consulting your doctor, even if you feel better. If your doctor decides that treatment with Venlafaxine Apotex can be discontinued, they will advise you on how to gradually reduce the dose before stopping completely.

Patients discontinuing Venlafaxine Apotex, especially those who stop treatment suddenly or reduce the dose too quickly, may experience adverse effects such as fatigue, dizziness, feeling of emptiness in the head, 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.

Your doctor will advise you on how to gradually discontinue Venlafaxine Apotex. If any of the symptoms listed above, or other bothersome symptoms, occur, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the medicine
Venlafaxine Apotex and contact your doctor immediately or go to the nearest
hospital Emergency Department:

Uncommon (may occur in fewer than 1 in 100 patients)

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

Rare (may occur in fewer than 1 in 1,000 patients)

Chest tightness, wheezing, difficulty swallowing or breathing.
Severe skin rash, itching or urticaria (red or pale raised areas, often accompanied by itching).
Symptoms of serotonin syndrome, which may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
Signs of infection such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
Severe rash, which may lead to the formation of severe blisters and skin peeling.
Muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

If any of the following adverse reactions occur, contact your doctor
(The frequency of these adverse reactions is listed below under
"Other adverse reactions"):

Cough, wheezing and shortness of breath, possibly accompanied by high fever.
Black (tarry) stools or blood in the stool.
Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be signs of liver inflammation.
Heart problems such as rapid or irregular heartbeat, high blood pressure.
Vision disturbances such as blurred vision, dilated pupils.
Nervous system disorders such as dizziness, tingling sensation, movement coordination problems (muscle spasms or stiffness), seizures or convulsions.
Mental disturbances such as excessive activity and feelings of unnatural excitement.
Withdrawal symptoms (see sections "How to take Venlafaxine Apotex", "Stopping Venlafaxine Apotex").
Prolonged bleeding time – in case of a cut, the wound may bleed slightly longer than usual.

While taking the medicine, patients may notice small white granules or beads in the faeces.
Inside the Venlafaxine Apotex capsules are granules (small, white beads) which contain the active substance, venlafaxine. These granules are released into the gastrointestinal tract, travel through its entire length, and slowly release venlafaxine. The granule matrix does not dissolve and is excreted with the faeces. Therefore, even if granules are seen in the faeces, there is no cause for concern – the dose of venlafaxine has been absorbed.

Other adverse reactions
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 fewer than 1 in 10 people)

Decreased appetite
Disorientation; feeling detached (or separated) from oneself; lack of orgasm; reduced sexual desire; agitation; nervousness; unusual dreams
Tremor; feeling of restlessness or inability to sit still or remain still; tingling; taste disturbances; increased muscle tension
Vision disturbances, including blurred vision; dilated pupils; inability of the eyes to accommodate (automatic adjustment of focus from distant to near objects)
Ringing in the ears (tinnitus)
Rapid heartbeat, palpitations
Increased blood pressure; sudden flushing
Shortness of breath, yawning
Vomiting; diarrhoea
Mild rash; itching
Increased frequency of urination; urinary retention; problems with urination
Irregular menstruation, i.e. heavy bleeding or more frequent irregular bleeding; ejaculation/orgasm disorders (men); erectile dysfunction (impotence)
Weakness (asthenia); fatigue; chills
Increased body weight; decreased body weight
Increased blood cholesterol levels

Uncommon (may affect fewer than 1 in 100 people)

Excessive arousal, racing thoughts and reduced need for sleep (mania)
Hallucinations; feeling detached (or separated) from reality; orgasm disturbances; apathy; feeling of excessive arousal; teeth grinding
Fainting; uncontrolled muscle movements; coordination and balance disturbances
Dizziness (especially when standing up too quickly); decreased blood pressure
Vomiting blood, black tarry stools (faeces) or blood in the stool, which may indicate internal bleeding
Light sensitivity; bruising; excessive hair loss
Urinary incontinence
Stiffness, spasms and uncontrolled muscle movements
Slight changes in liver enzyme activity in blood tests

Rare (may affect fewer than 1 in 1,000 people)

Convulsions or seizure
Cough, wheezing and shortness of breath, possibly accompanied by high fever
Disorientation and confusion, often with accompanying hallucinations (delirium)
Excessive fluid retention in the body
Low sodium levels in the blood
Severe eye pain and worsening or blurred vision
Irregular, 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 are signs of liver inflammation

Very rare (may affect fewer than 1 in 10,000 people)

Prolonged bleeding, which may be a sign of reduced platelet count, indicating increased risk of bruising or bleeding
Unusual milk secretion in women
Unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, appearance of unexpected bruises or broken blood vessels (ruptured veins)

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

Suicidal thoughts and behaviour; during treatment with venlafaxine or shortly after stopping treatment, cases of suicidal thoughts and behaviour have been reported (see section 2 "Important information before taking Venlafaxine Apotex")
Aggressive behaviour
Dizziness

Venlafaxine Apotex may sometimes cause adverse reactions that the patient may not be aware of, such as increased blood pressure, abnormal heart function, slight changes in liver enzyme activity, sodium or cholesterol levels in the blood. Even more rarely, Venlafaxine Apotex may impair platelet function, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may recommend periodic blood tests, especially during long-term treatment with Venlafaxine Apotex.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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: [email protected].
Adverse reactions can also be reported to the Marketing Authorisation Holder or its representative in Poland.
Reporting adverse reactions helps to gather more information on the safety of the 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: Expiry
(Exp). The expiry date refers to the last day of the stated month.
The batch number follows the abbreviation "Lot".
Store below 30 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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, hard capsule contains 37.5 mg, 75 mg or 150 mg of
venlafaxine as venlafaxine hydrochloride.
The other ingredients are:
37.5 mg, prolonged-release, hard capsule:
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate,
magnesium stearate
Coating: basic butyl methacrylate copolymer 12.5%
Capsule shell: gelatin, titanium dioxide (E 171).
75 mg, prolonged-release, hard capsule:
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate,
magnesium stearate
Coating: basic butyl methacrylate copolymer 12.5%
Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172).
150 mg, prolonged-release, hard capsule:
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate,
magnesium stearate
Coating: basic butyl methacrylate copolymer 12.5%
Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), indigo carmine I (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 imprint VEN on the cap and 37.5 on the body, containing one round, biconvex coated tablet.
Venlafaxine Apotex, 75 mg: beige, opaque, hard, gelatin capsules (size 0) containing two round, biconvex coated tablets, with the imprint 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 coated tablets, with the imprint VEN on the cap and 150 on the body of the capsule.

Packs contain:
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apotex Europe B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands

Manufacturer:
Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands
Pharmathen S.A.
6, Dervenakion Str.
15351 Pallini, Attikis
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5
69300 Rodopi
Greece