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

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

• Keep this leaflet, so you can read it again if you need to.
• 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 those not listed in this leaflet, they should tell their 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). Medicines in this group are used to treat depression and other conditions such as anxiety disorders. It is thought that in people with depression and/or anxiety, the levels of serotonin and norepinephrine in the brain are lower. 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 indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (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 may even worsen, making it more difficult to treat.

2. Important information before taking Venlectine

When not to take Venlectine

• 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, see "Monoamine Oxidase Inhibitors") used to treat depression or Parkinson's disease. Taking irreversible IMAOs at the same time as other medicines, including Venlectine, can cause serious or life-threatening side effects. Similarly, before starting to take any IMAO, the patient should wait at least 7 days after stopping Venlectine (see also "Serotonin Syndrome" and "Venlectine and other medicines").

Taking Venlectine with IMAOs can cause serious or life-threatening side effects. Before starting to take any IMAO, the patient should wait at least 7 days after stopping Venlectine.

Warnings and precautions

Before starting to take Venlectine, the patient should discuss it with their doctor or pharmacist.

• If the patient is taking other medicines that, when taken with Venlectine, may increase the risk of serotonin syndrome or symptoms similar to neuroleptic malignant syndrome (see "Venlectine and other medicines").
• If the patient has eye disease, 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 (bleeding disorders in the past) and is taking medicines that may increase the risk of bleeding, such as warfarin, or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility").
• If the patient has high cholesterol levels.
• If the patient or any of their family members have a history of mania or bipolar disorder (feeling excessively excited or euphoric).
• If the patient has a history of aggressive behavior.
• If the patient has diabetes.

Venlectine may cause feelings of restlessness or an inability to sit or stand still. If such symptoms occur, the patient should inform their 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 the patient, they should consult their doctor before starting Venlectine. The patient should not drink alcohol during treatment with 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 to take antidepressants, as these medicines usually start to work after 2 weeks, sometimes later. The risk of suicidal thoughts is higher if the patient has had suicidal thoughts or self-harm in the past, or if the patient is a young adult; clinical trial data suggest an increased risk of suicidal behavior in adults under 25 with mental disorders who are being treated with antidepressants.

• if the patient has had suicidal thoughts or self-harm in the past
• if the patient is a young adult

If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the hospital immediately. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read the leaflet. The patient may ask family members or friends for help and ask them to inform the doctor 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. It may increase the risk of tooth decay. Therefore, special attention should be paid 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 in this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, the doctor may prescribe Venlectine to patients under 18 years of age if they consider it beneficial for them. If the doctor prescribes Venlectine to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor to discuss it. The doctor should be informed 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

The patient should inform 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 Venlectine with other medicines. Without consulting a doctor or pharmacist, the patient should not start or stop taking other medicines, including those available without a prescription, herbal medicines, or dietary supplements.

• 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 serotonin syndrome is particularly high when venlafaxine is used with other medicines, such as:
• triptans (used to treat migraine headaches)
• other medicines used to treat depression, such as SNRIs, SSRIs (Selective Serotonin Reuptake Inhibitors), 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 dependence or severe pain)
• medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• 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)

If the patient is taking medicines that may affect heart rhythm, they should tell their 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 therefore, should be used with caution. It is particularly 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)
• 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"). The patient should not drink alcohol during treatment with Venlectine. Taking Venlectine with alcohol may cause extreme fatigue and loss of consciousness, and may increase the severity of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Venlectine should only be used after discussing the potential benefits and risks with the doctor. The patient should ensure that their midwife and/or doctor know that they are taking Venlectine. The use of similar medicines (SSRIs) 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 the patient notices such symptoms in their baby, they should contact their midwife and/or doctor immediately. If the patient takes this medicine during pregnancy, after birth, their baby may experience difficulties with feeding, in addition to breathing difficulties. 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. Taking Venlectine in the last months of pregnancy may increase the risk of severe bleeding from the uterus, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Venlectine, they should inform their doctor or midwife so that they can provide appropriate advice. Venlafaxine passes into breast milk and may affect the breastfed baby. However, in babies who have stopped breastfeeding from mothers taking venlafaxine, withdrawal symptoms may occur. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop taking Venlectine.

Driving and using machines

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

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

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, and social phobia is 75 mg per day. The 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 then gradually increased. The maximum dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day. Venlectine should be taken 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. They should not be opened, crushed, chewed, or dissolved. Venlectine 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 Venlectine without consulting their doctor (see "Stopping Venlectine").

Taking more Venlectine than prescribed

If the patient has taken more Venlectine than prescribed, they should contact their doctor or pharmacist immediately. 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 fast heartbeat, changes in consciousness (from drowsiness to coma), blurred vision, seizures, and vomiting.

Missing a dose of Venlectine

If the patient misses a dose, they should take it as soon as possible. However, if it is close to the time for the next dose, they should skip the missed dose and take the next dose at the usual time. The patient should not take more than the prescribed daily dose of Venlectine within a 24-hour period.

Stopping Venlectine

The patient should not stop taking Venlectine without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop taking Venlectine, they will tell the patient how to gradually reduce the dose before stopping treatment completely. In patients who stop taking Venlectine, especially after sudden discontinuation or too rapid dose reduction, side effects may occur. Some patients may experience symptoms such as fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or (rarely) seizures or flu-like symptoms. The patient should get information from their doctor on how to gradually stop taking Venlectine. If any of the above symptoms occur or are troublesome, the patient should consult their doctor. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should stop taking Venlectine and contact their doctor or go to the hospital 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, which may be itchy)
• symptoms of serotonin syndrome with the most severe form resembling neuroleptic malignant syndrome (see section 2)
• high fever, chills, shivering, headache, sweating, flu-like symptoms. These may be symptoms of a blood disorder, which can increase the risk of infection
• severe rash, which may lead to blistering and peeling of the skin
• muscle pain, tenderness, or weakness, which may be symptoms of rhabdomyolysis

If the patient experiences any of the following side effects, they should contact their 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 fast 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")
• 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)
• abnormal menstrual bleeding, such as heavy or irregular bleeding
• urination disorders, such as frequent urination
• visual disturbances, such as blurred vision, dilated pupils; inability of the eye to accommodate, 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 disorders, and balance disorders
• gastrointestinal bleeding (vomiting blood or black tarry stools or blood in stools)
• taste disorders
• teeth grinding
• shortness of breath
• fast heartbeat, dizziness when standing up quickly, which may be related to 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
• feelings of excessive excitement or euphoria and reduced need for sleep (mania)
• urinary incontinence

Frequency not known (frequency 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, which may be accompanied by visual, auditory, or tactile hallucinations (delirium)
• neuroleptic malignant syndrome, serotonin syndrome symptoms (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 decreased vision or blurred vision (angle-closure glaucoma)
• dizziness with a feeling of spinning
• abnormal, fast, or irregular heartbeat, low blood pressure, which may cause loss of consciousness (ventricular arrhythmias, including 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 upper and middle parts, often radiating to the back or encircling, muscle pain, fever, vomiting (pancreatitis)
• severe rash, which may lead to blistering and peeling of the skin (Stevens-Johnson syndrome, 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 [lack of white blood cells (agranulocytosis), anemia associated with bone marrow dysfunction, decreased neutrophil count, decreased count of all blood cells]
• 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 the patient 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, the doctor may recommend regular blood tests, especially during long-term treatment with Venlectine.

Reporting side effects

If the patient experiences any side effects, including those not listed in the 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, 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, more information can be collected on the safety of the 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. The patient should 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. The patient should ask their 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 ingredients: Eudragit E 100. Capsule 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: [insert date]