Venlectine

Package leaflet: Information for the patient

Venlectine, 37.5 mg, prolonged-release capsules, hard
Venlectine, 75 mg, prolonged-release capsules, hard
Venlectine, 150 mg, prolonged-release capsules, hard
Venlafaxine
Please read carefully all the information in this leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Venlectine is and what it is used for

Venlectine is an antidepressant medicine belonging to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). Medicines in this group are used in the treatment of depression and other conditions such as anxiety disorders. It is believed that people suffering from depression and (or) anxiety have reduced levels of serotonin and norepinephrine in the brain.
The exact mechanism of action of antidepressant medicines is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.
Venlectine is used in the treatment of depression in adults. It is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear of, or avoidance of, social situations), and panic disorder (panic attacks). For the patient to feel better, it is important to follow the treatment correctly. If treatment is not initiated, the patient's condition may not improve, may worsen, and become more difficult to treat.

2. Important information before using Venlectine

When not to use 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 currently taking or has taken within the last 14 days any medicine from the group of irreversible monoamine oxidase inhibitors (MAOIs, Monoamine Oxidase Inhibitors), used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with other medicines, including Venlectine, may

cause severe or even life-threatening adverse reactions. Similarly,
before
starting treatment with any MAOI medicine, the patient should wait at
least 7 days after stopping Venlectine (see also section “Serotonin syndrome” and “Venlectine with other medicines”).

Warnings and precautions

Before starting treatment with Venlectine, discuss this with your doctor or pharmacist.

• If the patient is taking other medicines which, when taken together with Venlectine, may increase the risk of serotonin syndrome or symptoms resembling neuroleptic malignant syndrome (see section “Venlectine with other medicines”).
• If the patient has an eye disease, 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 or bleed (bleeding disorders in the past) and if taking medicines that may increase the risk of bleeding, e.g. warfarin, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”).
• If the patient has increased cholesterol levels.
• If the patient or anyone in their family has previously had mania or bipolar disorder (feelings of excessive excitement or euphoria).
• If the patient has previously exhibited aggressive behaviour.
• If the patient has diabetes.

Venlectine may cause restlessness or an inability to sit still or remain in one place. If such symptoms occur, inform your doctor.
Medicines such as Venlectine (so-called SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
If any of the above conditions apply to the patient, they should consult their doctor before starting treatment with Venlectine.
Do not consume alcohol while being treated with Venlectine, as this may cause extreme drowsiness and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders

Patients with depression and (or) anxiety disorders may sometimes think about self-harm or suicide. Such thoughts or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually start to work after about 2 weeks, sometimes later.

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

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

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately 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 the package leaflet. The patient may ask for help from family or friends and ask them to inform the patient if they notice worsening 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.

Children and adolescents

Venlectine 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 from this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe Venlectine to patients under 18 years of age if they consider it beneficial. If a doctor has prescribed Venlectine to a patient under 18 years of age, any doubts should be discussed again with the doctor. Inform the doctor if any of the above symptoms appear or worsen in patients under 18 years of age taking Venlectine. Long-term safety regarding the effects on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Venlectine with other medicines

Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as medicines the patient plans to take.
The treating doctor decides whether Venlectine can be used together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, herbal remedies, or plant-derived preparations, without first consulting a doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) (see “When not to use Venlectine”).
• Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur during treatment with venlafaxine. The risk of serotonin syndrome is particularly high when venlafaxine is taken with other medicines such as:
  • triptans (used for migraine headaches),
  • other medicines used to treat depression, e.g. serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs, Selective Serotonin Reuptake Inhibitors), tricyclic antidepressants, or medicines containing lithium,
  • medicines containing moclobemide, a monoamine oxidase inhibitor (used to treat depression),
  • medicines containing St. John's wort (Latin: Hypericum perforatum, plant-derived medicines or herbal preparations 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 methemoglobin levels in the blood),
• medicines containing tryptophan (used for sleep problems and depression),
• antipsychotic medicines (used to treat diseases with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear reasoning, social withdrawal).
  Symptoms indicating serotonin syndrome may include: agitation, 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. Its symptoms include: fever, rapid heart rate, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests). If serotonin syndrome is suspected, seek immediate medical attention 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:

• 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 Venlectine and therefore should be used with caution. It is particularly important to inform the doctor if 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),
• oral contraceptives, as there have been reports of unplanned pregnancies in women taking oral contraceptives concurrently with venlafaxine. The relationship between concurrent use of these medicines and pregnancy is unknown, as interactions between venlafaxine and hormonal contraceptives have not been studied.

Taking Venlectine with food, drink and alcohol

Venlectine should be taken with food (see section 3 “How to take Venlectine”).
Do not consume alcohol while being treated with Venlectine. Concurrent use with alcohol may cause extreme drowsiness and loss of consciousness and may worsen symptoms of depression and other medical conditions such as anxiety disorders.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Venlectine may be used only after discussing with a doctor the potential benefits for the patient and the risks for the unborn child.
Ensure that the midwife and (or) doctor are aware that the patient is taking Venlectine.
Taking similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn, which causes the baby to breathe faster and the skin to turn blue. These symptoms usually appear in the newborn within the first day of life. If the patient notices such symptoms in the baby, she should contact the midwife and (or) doctor immediately.
If the patient takes this medicine during pregnancy, the newborn may experience other symptoms besides breathing difficulties, 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.
Taking Venlectine towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Venlectine, she should inform her doctor or midwife so they can provide appropriate advice.
Venlafaxine passes into human milk and may affect the breastfed infant, while the infant who has stopped breastfeeding from a mother taking venlafaxine may experience withdrawal symptoms. Therefore, these issues should be discussed with the doctor, who will decide whether to discontinue breastfeeding or stop taking Venlectine.

Driving and using machines

Do not drive or operate machinery until the patient knows how the medicine affects them.

Venlectine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium in one extended-release hard capsule, i.e. the medicine is considered “sodium-free”.

3. How to use Venlectine

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorders, and social
phobia is 75 mg per day. Your doctor may gradually increase the dose up to a maximum of
375 mg per day in the treatment of depression. For panic disorder, treatment should be initiated
at a lower dose (37.5 mg), which may then be gradually increased. The maximum dose in the treatment of
generalized anxiety disorders, social phobia, and panic disorder is 225 mg per day.
Venlectine should be taken every day at approximately the same time, in the morning or evening.
The capsules should be swallowed whole and taken with a small amount of water. Do not open, crush,
chew, or dissolve the capsules.
Venlectine 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 Venlectine without consulting your doctor (see section “Stopping
treatment with Venlectine”).
Taking more Venlectine than recommended
If you take more Venlectine than recommended, contact your doctor or pharmacist immediately.
Overdose may be life-threatening, especially when taken with alcohol and (or) certain medicines
(see section “Venlectine with other medicines”).
Symptoms of possible overdose may include rapid heartbeat, disturbances in consciousness (from drowsiness to coma),
blurred vision, seizures, and vomiting.
Missing a dose of Venlectine
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 the next dose at the usual time.
Do not take a double dose within the same day to make up for a missed dose. Do not exceed the daily dose of Venlectine prescribed by your doctor.
Stopping treatment with Venlectine
Do not stop or reduce the dose of Venlectine without consulting your doctor, even if you feel better. If your doctor decides that Venlectine can be discontinued, they will advise you on how to gradually reduce the dose before stopping treatment completely.
Patients discontinuing Venlectine, especially after abrupt cessation or too rapid dose reduction, may experience adverse effects. In some patients, symptoms such as fatigue, dizziness, feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling or (rarely) numbness, weakness, sweating, seizures, or flu-like symptoms may occur.
You should obtain information from your doctor on how to gradually discontinue Venlectine. If any of the symptoms listed above, or other symptoms that are bothersome, occur, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop taking the medicine Venlectine immediately
and contact your doctor or go straight to the nearest hospital emergency department:

• chest tightness, gasping, difficulty swallowing or breathing,
• swelling of the face, lips, tongue, throat, hands or feet and (or) itchy rash (urticaria),
• severe rash, itching, urticaria (red or pale raised areas, often accompanied by itching),
• symptoms of serotonin syndrome with the most severe form resembling neuroleptic malignant syndrome (see section 2),
• high fever, chills, tremor, headache, sweating, flu-like symptoms. These may be symptoms of a blood disorder, which may increase the risk of infection,
• severe rash, which may lead to blistering and peeling of the skin,
• unexplained muscle pain, tenderness or weakness. These may be symptoms of rhabdomyolysis.

If any of the following adverse effects occur, contact your doctor:

• cough, gasping, shortness of breath and 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 symptoms of liver inflammation,
• heart problems such as rapid or irregular heartbeat, high blood pressure,
• eye problems such as blurred vision, dilated pupils,
• nervous system disorders such as dizziness, tingling sensation, movement coordination problems (muscle spasms or stiffness), seizures or convulsions,
• psychiatric disorders such as excessive restlessness and euphoria,
• withdrawal symptoms (see section "How to take Venlectine" and "Stopping treatment with Venlectine"),
• prolonged bleeding time – in case of a cut, the time to stop bleeding may be slightly longer than usual.

Complete list of adverse effects
Very common (may occur in more than 1 in 10 patients):

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

Common (may occur in no more than 1 in 10 patients):

• decreased appetite
• vomiting, diarrhoea, constipation
• yawning
• confusion, feeling detached from oneself, nervousness, insomnia, drowsiness, unusual dreams
• weakness (asthenia), fatigue, chills
• tingling, tremor, increased muscle tension
• decreased libido, ejaculation and (or) orgasm disorders (in men), absence of orgasm, erectile dysfunction (impotence)
• menstrual disorders such as heavy bleeding or more frequent irregular bleeding
• difficulty urinating, increased frequency of urination
• blurred vision, including blurred vision, dilated pupils; inability of the eye to accommodate (i.e. to change focus from distant to near objects)
• ringing in the ears (tinnitus)
• palpitations, increased blood pressure, sudden flushing
• increased blood cholesterol levels.

Uncommon (may occur in no more than 1 in 100 patients):

• hallucinations, feeling detached from reality, agitation, apathy, mild elevation of mood
• psychomotor restlessness, inability to sit still or remain still
• involuntary muscle movements, coordination and balance disorders
• gastrointestinal bleeding (vomiting blood or black tarry stools (faeces) or blood in the stool)
• taste disturbances
• teeth grinding
• shortness of breath
• rapid heartbeat, dizziness upon standing up too quickly related to decreased blood pressure, fainting
• bruising, rash, excessive hair loss
• swelling of the face, lips, tongue, throat, hands or feet (angioedema), light sensitivity
• urinary retention
• orgasm disorders (in women)
• weight gain, weight loss.

Rare (may occur in no more than 1 in 1000 patients):

• convulsions
• feeling of excessive excitement or euphoria and reduced need for sleep (mania)
• urinary incontinence.

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

• swelling of the face or tongue, shortness of breath or difficulty breathing, often with itchy skin rash (anaphylactic reactions)
• dry cough, shortness of breath and high body temperature, which are symptoms of lung inflammation associated with an increased number of one type of white blood cells (pulmonary eosinophilia)
• excessive water retention (syndrome of inappropriate antidiuretic hormone secretion)
• thoughts of self-harm or suicide, aggression, delirium accompanied by visual, auditory or tactile hallucinations (hallucinations)
• neuroleptic malignant syndrome, symptoms of serotonin syndrome (see section 2)
• dystonia, i.e. involuntary movements causing twisting and bending of various body parts, or dyskinesia, i.e. uncoordinated and involuntary movements of limbs or the whole body (extrapyramidal disorders)
• severe eye pain and vision loss or blurred vision (angle-closure glaucoma)
• dizziness with a spinning sensation
• abnormal, rapid or irregular heartbeat, low blood pressure, which may lead to loss of consciousness (ventricular fibrillation, ventricular tachycardia), ECG changes in the form of QT interval prolongation
• low blood pressure, bleeding (including from mucous membranes)
• severe abdominal pain in the upper middle part, 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, erythema multiforme, toxic epidermal necrolysis), itching, urticaria
• unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• itching, yellowing of the skin or eyes, dark urine or flu-like symptoms (liver inflammation), minor changes in liver enzyme activity in the blood
• decreased sodium concentration
• decreased platelet count, prolonged bleeding time, blood disorders [lack of white blood cells (agranulocytosis), anaemia due to impaired bone marrow function, decreased neutrophil count (one type of white blood cells), decreased count of all blood cells]
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effects on fertility" in section 2
• increased prolactin levels (symptoms: abnormal milk secretion in women).

Venlectine may sometimes cause adverse effects that the patient may not be aware of, such as increased blood pressure or abnormal heartbeat; minor changes in sodium, cholesterol or liver enzyme activity in the blood. In even rarer cases, Venlectine may impair platelet function, increasing the risk of petechiae or bleeding. Therefore, your doctor may recommend periodic blood tests, especially during long-term treatment with Venlectine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Venlectine

Keep this medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the carton following: EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• Other components are: hypromellose, Eudragit RS 100, sodium lauryl sulfate, magnesium stearate.
  Capsule shell composition:
  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/Aluminium blisters in a cardboard carton.
28 or 56 prolonged-release, hard capsules (4 or 8 blisters with 7 capsules each).

Marketing Authorisation 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
Poland
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
Poland