Venlectine

Leaflet accompanying the packaging: patient information

Venlectine, 37.5 mg, prolonged-release hard capsules

Venlectine, 75 mg, prolonged-release hard capsules

Venlectine, 150 mg, prolonged-release hard capsules

Venlafaxine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Venlectine and what is it used for

Venlectine 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 who are depressed and/or anxious, the amount of serotonin and norepinephrine in the brain is low. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain. Venlectine is used to treat depression in adults. It is also used to treat the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear of social situations or avoidance of such situations), and panic disorder (panic attacks). For the patient to feel better, it is essential to follow the treatment correctly. If the treatment is not started, the patient's condition may not improve, and it may even worsen, making it more difficult to treat.

2. Important information before taking Venlectine

When not to take Venlectine

• 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 (IMAOs, see "Monoamine Oxidase Inhibitors") for the treatment of depression or Parkinson's disease. Taking IMAOs and Venlectine at the same time can cause serious or even life-threatening side effects. Similarly, before starting to take any MAOI, you should wait at least 7 days after stopping Venlectine (see also "Serotonin Syndrome" and "Venlectine and other medicines").

Taking Venlectine with IMAOs can cause severe or life-threatening side effects. Before starting to take any MAOI, you should wait at least 7 days after stopping Venlectine.

Warnings and precautions

Before starting treatment with Venlectine, you should discuss it with your doctor or pharmacist.

• If you are taking other medicines that, when taken with Venlectine, may increase the risk of developing serotonin syndrome or symptoms similar to neuroleptic malignant syndrome (see "Venlectine and 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 rhythm disorders in the past.
• If you have had seizures (epilepsy) in the past.
• If you have had low sodium levels in the blood (hyponatremia) in the past.
• If you have a tendency to bruise or bleed (bleeding disorders in the past) and if you are taking medicines that may increase the risk of bleeding, such as warfarin, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If your cholesterol levels are high.
• If you or anyone in your family has had mania or bipolar disorder (excessive excitement or euphoria) in the past.
• If you have had aggressive behavior in the past.
• If you have diabetes.

Venlectine may cause feelings of restlessness or an inability to sit or stand still. If you experience such symptoms, you should inform your doctor. Medicines like Venlectine (SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment. If any of the above applies to you, you should consult your doctor before starting treatment with Venlectine. You should not drink alcohol while taking Venlectine, as it may cause extreme fatigue and loss of consciousness. Taking Venlectine with alcohol and/or certain medicines may increase the severity of depression and other conditions, such as anxiety disorders.

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 antidepressant treatment, as these medicines usually start working after 2 weeks, sometimes later. The risk of suicidal thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult; clinical trial data suggest an increased risk of suicidal behavior in adults under 25 with mental disorders who were treated with antidepressants

If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the emergency room. It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask your relatives or friends to help you and ask them to inform you if they notice that your depression or anxiety has worsened or if you have concerning changes in behavior. Dry mouth Dry mouth is reported by 10% of patients treated with venlafaxine. It may increase the risk of tooth decay. Therefore, you should pay special attention to oral hygiene.

Children and adolescents

Venlectine 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 anger). However, your doctor may prescribe Venlectine to patients under 18 years of age if they consider it beneficial for them. If your doctor has prescribed Venlectine to a patient under 18 years of age, you should discuss any doubts 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 Venlectine. The long-term safety of Venlectine in this age group, regarding effects on growth, maturation, and cognitive and behavioral development, has not been established.

Venlectine and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor will decide whether to prescribe Venlectine with other medicines. You should not start or stop taking other medicines, including over-the-counter medicines, herbal medicines, or dietary supplements, without consulting your doctor or pharmacist first.

• Irreversible monoamine oxidase inhibitors (IMAOs: see "When not to take Venlectine").
• Serotonin syndrome:When taking venlafaxine, serotonin syndrome may occur, which is a potentially life-threatening condition. The risk of developing this syndrome is particularly high when venlafaxine is taken with other medicines, such as:
• triptans (used to treat migraine headaches)
• other medicines used to treat depression, such as serotonin and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, or lithium
• medicines containing moclobemide, a monoamine oxidase inhibitor (used to treat depression)
• medicines containing St. John's Wort (Hypericum perforatum, herbal medicines or dietary supplements used to treat mild depression)
• medicines containing the antibiotic linezolid (used to treat infections)
• 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 tryptophan (used to treat sleep problems 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)

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

• anti-arrhythmic 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 Venlectine, and you should use them 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)
• oral contraceptives, as there have been reports of unplanned pregnancies in women taking oral contraceptives with venlafaxine. The relationship between the concomitant use of these medicines and pregnancy is unknown, as the interaction between venlafaxine and hormonal contraceptives has not been studied.

Taking Venlectine with food, drink, and alcohol

Venlectine should be taken with food (see section 3 "How to take Venlectine"). You should not drink alcohol while taking Venlectine. Taking Venlectine with alcohol may cause extreme fatigue and loss of consciousness, and it may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Venlectine should only be used after discussing the potential benefits and risks with your doctor. You should ensure that your midwife and/or doctor know that you are taking Venlectine. The use of similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn, which causes the baby to breathe faster and turn blue. These symptoms usually appear in the first day of life. If you notice such symptoms in your baby, you should immediately contact your midwife and/or doctor. If you take this medicine during pregnancy, your baby may experience, in addition to breathing difficulties, 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. Taking Venlectine at the end of pregnancy may increase the risk of severe bleeding from the uterus, which occurs shortly after delivery, especially if you have a history of bleeding disorders. If you take Venlectine, you should inform your doctor or midwife so that they can provide you with appropriate advice. Venlafaxine passes into breast milk and may affect the breastfed baby. However, if you stop breastfeeding while taking venlafaxine, your baby may experience withdrawal symptoms. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or stop taking Venlectine.

Driving and using machines

You should not drive or operate machinery until you know how the medicine affects you.

Venlectine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule, which means it is essentially "sodium-free".

3. How to take Venlectine

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, you should consult your doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose up to a maximum of 375 mg per day for depression. For panic disorder, treatment should be started with a lower dose (37.5 mg) and gradually increased. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day. You should take Venlectine once a day, at approximately the same time, in the morning or evening. The capsules should be swallowed whole with a small amount of water. Do not open, crush, chew, or dissolve them. Venlectine should be taken with food (see section 2). You should inform your doctor about any liver or kidney problems, as a dose adjustment may be necessary. You should not stop taking Venlectine without consulting your doctor (see "Stopping Venlectine treatment").

Taking more Venlectine than prescribed

If you take more Venlectine than prescribed, you should immediately contact your doctor or pharmacist. Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Venlectine and other medicines"). Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), blurred vision, seizures, and vomiting.

Missing a dose of Venlectine

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take the next dose at the usual time. You should not take more than the prescribed daily dose of Venlectine within a 24-hour period.

Stopping Venlectine treatment

You should not stop taking Venlectine without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Venlectine, they will tell you how to gradually reduce the dose before stopping treatment completely. When stopping Venlectine treatment, especially if it is stopped abruptly or the dose is reduced too quickly, you may experience side effects. Some patients may experience symptoms such as fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, anxiety, agitation, confusion, ringing in the ears, tingling or (rarely) numbness, weakness, sweating, or flu-like symptoms. You should get information from your doctor on how to gradually stop taking Venlectine. If you experience any of the above symptoms or other symptoms that bother you, you should consult your doctor. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Venlectine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should stop taking Venlectine and contact your doctor or go to the emergency room immediately:

• chest pain, wheezing, difficulty swallowing or breathing
• swelling of the face, lips, tongue, throat, hands, or feet, and/or itchy rash (hives)
• severe rash, itching, hives (red or pale rash, often itchy)
• symptoms of serotonin syndrome with the most severe form resembling neuroleptic malignant syndrome (see section 2)
• high fever, chills, shivering, headache, sweating. These may be symptoms of a blood disorder, which can increase the risk of infection
• severe rash, which can lead to 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:

• cough, wheezing, shortness of breath, high fever
• black (tar-like) stools or blood in stools
• itching, yellowing of the skin or eyes, dark urine, which may be symptoms of liver inflammation
• heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure
• eye disorders, 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 euphoria
• withdrawal symptoms (see "How to take Venlectine" and "Stopping Venlectine treatment")
• prolonged bleeding time - in case of injury, the bleeding time may be slightly longer than usual

Full list of side effects

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

• dry mouth, nausea
• headache, dizziness
• excessive sweating (including night sweats)

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

• decreased appetite
• vomiting, diarrhea, constipation
• yawning
• confusion, feeling of detachment from oneself, nervousness, insomnia, drowsiness, unusual dreams
• weakness (asthenia), fatigue, chills
• tingling, tremors, increased muscle tone
• decreased libido, ejaculation disorders and/or orgasm disorders (men), anorgasmia, erectile dysfunction (impotence)
• menstrual disorders, such as heavy or irregular bleeding
• urination problems, increased frequency of urination
• impaired vision, including blurred vision, dilated pupils; inability of the eye to adapt, i.e., change focus from distant to near objects
• ringing in the ears (tinnitus)
• palpitations, increased blood pressure, flushing
• increased cholesterol levels

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

• hallucinations, feeling of detachment (or separation) from reality, agitation, apathy, mild mood elevation
• psychomotor restlessness, inability to sit or stand still
• involuntary muscle movements, coordination and balance disorders
• gastrointestinal bleeding (vomiting blood or black tarry stools or blood in stools)
• taste disorders
• teeth grinding
• shortness of breath
• dizziness when standing up quickly, which may be associated with low blood pressure, fainting
• bruises, rash, excessive hair loss
• swelling of the face, lips, tongue, throat, hands, or feet (angioedema), increased sensitivity to light
• urinary retention
• orgasm disorders (women)
• weight gain, weight loss

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

• seizures
• excessive excitement or euphoria and reduced need for sleep (mania)
• urinary incontinence

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

• swelling of the face or tongue, shortness of breath or difficulty breathing, often with itchy rash (anaphylactic reactions)
• dry cough, shortness of breath, and high fever, which are symptoms of pneumonia associated with an increased number of a type of white blood cell (eosinophilic pneumonia)
• excessive water retention (syndrome of inappropriate antidiuretic hormone secretion)
• thoughts of self-harm or suicide, aggression, altered consciousness, accompanied by visual, auditory, or tactile hallucinations (delirium)
• malignant neuroleptic syndrome, symptoms of serotonin syndrome (see section 2)
• dystonia, i.e., involuntary movements causing twisting and bending of different parts of the body, or dyskinesia, i.e., uncoordinated and involuntary movements of the limbs or the whole body (extrapyramidal disorders)
• severe eye pain and impaired vision or blurred vision (angle-closure glaucoma)
• dizziness with a feeling of spinning
• abnormal, rapid, or irregular heartbeat, low blood pressure, which may cause loss of consciousness (ventricular flutter, ventricular tachycardia), changes in the ECG in the form of QT interval prolongation
• low blood pressure, bleeding (including bleeding from mucous membranes)
• severe abdominal pain in the middle and upper parts, often radiating to the back or encircling, muscle pain, fever, vomiting (pancreatitis)
• severe rash, which can lead to blistering and peeling of the skin (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis), itching, hives
• unexplained muscle pain, tenderness, or weakness (rhabdomyolysis)
• itching, yellowing of the skin or eyes, dark urine, which may be symptoms of liver inflammation, mild changes in liver enzyme activity in the blood
• low sodium levels
• low platelet count, prolonged bleeding time, blood disorders [agranulocytosis, bone marrow depression-related anemia, decreased neutrophil count, decreased white blood cell count]
• severe bleeding from the uterus, which occurs shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• increased prolactin levels (symptoms: abnormal milk production in women)

Venlectine may also cause side effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in sodium, cholesterol, or liver enzyme levels in the blood. In rare cases, Venlectine may weaken the function of platelets, increasing the risk of bruising or bleeding. Therefore, your doctor may recommend regular blood tests, especially during long-term treatment with Venlectine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlectine

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicinal product. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Venlectine 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: hypromellose, Eudragit RS 100, sodium lauryl sulfate, magnesium stearate. Capsule shell: Eudragit E 100. Capsule shell ingredients: Venlectine, 37.5 mg, prolonged-release hard capsules: titanium dioxide (E 171), gelatin. Venlectine, 75 mg, prolonged-release hard capsules: titanium dioxide (E 171), iron oxide red, gelatin. Venlectine, 150 mg, prolonged-release hard capsules: titanium dioxide (E 171), erythrosine, indigo carmine, gelatin.

What Venlectine looks like and contents of the pack

PVC/PE/PVDC/Aluminum blisters in a cardboard box. 28 or 56 prolonged-release hard capsules (4 or 8 blisters of 7 capsules each).

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland, Tel.: +48 17 865 51 00

Manufacturer

Bausch Health Poland sp. z o.o., ul. Przemysłowa 2, 35-959 Rzeszów, Pharmathen S.A., Dervenakion 6, Pallini 15351, Attikis, Greece, Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece, Bausch Health Poland sp. z o.o., ul. Kosztowska 21, 41-409 Mysłowice

Date of last revision of the leaflet: