Alventa

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Alventa

150 mg, prolonged-release hard capsules
Venlafaxine

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Alventa and what is it used for

Alventa contains the active substance venlafaxine.
Alventa 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 believed that in people with depression and/or anxiety, there is a lower concentration of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration of serotonin and norepinephrine in the brain.
Alventa is used to treat depression in adults. Alventa is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly. If the treatment is not started, the patient's condition may not improve, worsen, and become more difficult to treat.

2. Important information before taking Alventa

When not to take Alventa:

• 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 (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Alventa may cause severe or life-threatening side effects. Also, before starting to take any MAOI, the patient should wait at least 7 days after stopping Alventa (see also the section "Alventa and other medicines" and the information in this section about serotonin syndrome).

point "Alventa and other medicines" and the information in this section about serotonin syndrome).

Warnings and precautions

Before starting to take Alventa, the patient should discuss with their doctor or pharmacist:

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

Alventa may cause feelings of restlessness or inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, the patient should inform their doctor.
Suicidal thoughts and worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the start of treatment with antidepressants, as these medicines usually start to work after about 2 weeks, sometimes later. Such thoughts may also occur after reducing the dose or during withdrawal from Alventa.
These thoughts of suicide or self-harm are more likely to occur in:

• patients who have had thoughts of self-harm or suicide in the past;
• young adults. Clinical trial data show an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressants.

If the patient experiences thoughts of self-harm or suicide, they should immediately contact their doctor or go to the nearest hospital emergency department.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if they notice any worsening of depression or anxiety or any worrying changes in the patient's behavior.
Sexual dysfunction
Medicines like Alventa (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, it is essential to take good care of oral hygiene.
Diabetes
Alventa may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.
Children and adolescents
Alventa 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 manifestations of anger).
However, the doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial. If the doctor has prescribed this medicine to a patient under 18 years of age, in case of doubts, the patient should consult their doctor to discuss it. The patient should inform their doctor if any of the above symptoms or any other symptoms worsen in patients under 18 years of age taking Alventa. There is also no evidence of long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group.

Alventa and other medicines

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Alventa. The patient should tell their doctor if they have taken these medicines within the last 14 days (see the section "Important information before taking Alventa").
• Serotonin syndrome: During venlafaxine treatment, a life-threatening or neuroleptic malignant syndrome-like reaction may occur (see the section "Possible side effects"), especially when taken with medicines such as:
• triptans (substances used to treat migraine headaches);
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), norepinephrine and serotonin reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines;
• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity);
• medicines containing the antibiotic linezolid (used to treat infections);
• medicines containing the reversible MAOI, moclobemide (used to treat depression);
• medicines containing sibutramine (used for weight loss);
• medicines containing tramadol, fentanyl, buprenorphine, 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 methemoglobin levels in the blood);
• medicines containing St. John's Wort (Hypericum perforatum, herbal or natural remedies used to treat mild depression);
• medicines containing tryptophan (used for 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, abnormal perceptions and judgments, and withdrawal).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Its symptoms include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in a blood test).
If serotonin syndrome is suspected, the patient should immediately tell their doctor or go to the nearest hospital emergency department.
If the patient is taking medicines that may affect heart rhythm, they should inform their 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 Alventa, and the patient should use them with caution. It is especially important to inform the doctor if the patient is taking medicines containing:

• ketokonazole (an antifungal medicine),
• haloperidol or risperidone (medicines used to treat mental disorders),
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease).

Alventa with food, drink, and alcohol

Alventa should be taken with food (see section 3 "How to take Alventa").
The patient should avoid drinking alcohol while taking Alventa.

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.
Alventa should only be used after discussing the potential benefits and potential risks to the unborn child with the doctor.
Taking Alventa at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Alventa, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should inform their doctor and/or midwife about taking Alventa. Taking similar medicines during pregnancy (such as SSRIs) may increase the risk of severe complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and cyanosis. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
If the patient is taking this medicine during pregnancy, their child may experience difficulties with breathing or feeding after birth, in addition to other symptoms. 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.
Alventa passes into breast milk. There is a risk of an effect on the baby.
Therefore, the patient should discuss this with their doctor, and the doctor will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

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

Alventa contains sucrose

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Alventa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Alventa is available in doses of 37.5 mg, 75 mg, and 150 mg.
Usually, the recommended initial dose for the treatment of depression, generalized anxiety disorder, social phobia is 75 mg per day. This dose may be gradually increased by the doctor if necessary, up to a maximum dose of 375 mg per day in the case of depression. In the case of panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.
Alventa should be taken once a day, at approximately the same time, regardless of whether it is taken in the morning or evening. The capsules should be swallowed whole with a drink of water.
They should not be divided, crushed, chewed, or dissolved.
Alventa should be taken with food.
The patient should inform their doctor about liver or kidney problems, as it may be necessary to adjust the dose.
The patient should not stop taking this medicine without consulting their doctor (see the section "Stopping Alventa").

Taking a higher dose of Alventa than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact their doctor.
Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures or convulsions, and vomiting.

Missing a dose of Alventa

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

Stopping Alventa

The patient should not stop treatment or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop Alventa, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients stopping Alventa, especially if treatment is stopped abruptly or the dose is reduced too quickly, side effects may occur, such as suicidal thoughts, aggression, feeling tired, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise the patient on how to gradually stop Alventa. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over several months or longer. If any of the above symptoms or other symptoms that are troublesome to the patient occur, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Alventa can cause side effects, although not everybody gets them.
In case of experiencing any of the following side effects, the patient should stop taking Alventa and contact their doctor immediately or go to the nearest hospital emergency department.

Uncommon (may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, throat, hands, or feet, and (or) a raised, itchy rash (hives), difficulty swallowing or breathing.

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

• chest pain, wheezing, difficulty swallowing or breathing,
• severe skin rash, itching, or hives (a red or pale rash, often itchy),
• symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in a blood test).
• symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be the result of a blood disorder that increases the risk of infection.
• severe rash, which may lead to severe blisters and peeling of the skin,
• muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

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

• symptoms of a condition called "stress cardiomyopathy", which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If the patient experiences any of the following side effects, they should contact their doctor.
(The frequency of these side effects has been reported in the section "Other side effects" below):

• cough, wheezing, and shortness of breath, which may be accompanied by a high temperature,
• black (tar-like) stools or blood in the stool,
• itching, yellowing of the skin or eyes, or 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 feeling unnatural excitement,
• withdrawal symptoms (see the sections "How to take Alventa" and "Stopping Alventa"),
• prolonged bleeding time - in case of injury, the time to stop bleeding may be slightly longer than usual.

Other side effects

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

• dizziness, headache, drowsiness,
• insomnia,
• nausea, dry mouth, constipation,
• sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• decreased appetite,
• confusion, depersonalization (feeling of being detached from reality), anorgasmia, apathy, feeling of excessive excitement, teeth grinding,
• tremor, feeling of restlessness or inability to sit or stand still, tingling, taste disorders, increased muscle tone,
• vision disorders, including blurred vision, dilated pupils,
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, sudden flushing, especially of the face,
• shortness of breath, yawning,
• vomiting, diarrhea,
• mild rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding, ejaculation disorders/orgasm disorders (men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased cholesterol levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• excessive excitement, racing thoughts, and decreased need for sleep (mania),
• hallucinations, depersonalization (feeling of being detached from reality), anorgasmia, apathy, feeling of excessive excitement, teeth grinding,
• fainting, uncontrolled movements, coordination disorders,
• dizziness (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, black (tar-like) stools or blood in the stool, which may be signs of internal bleeding,
• increased sensitivity to light, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, muscle spasms, and involuntary movements,
• slight changes in liver enzyme activity in the blood.

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

• seizures,
• cough, wheezing, and shortness of breath, which may be accompanied by a high temperature,
• disorientation and confusion, often with hallucinations (delirium),
• syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• decreased sodium levels in the blood,
• severe eye pain and decreased vision or blurred vision,
• abnormal or rapid heartbeat, which may cause fainting,
• severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas),
• itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which are symptoms of liver inflammation.

Very rare (may affect up to 1 in 10,000 people)

• prolonged bleeding, which may be a sign of decreased platelet count, increasing the risk of bruising or bleeding,
• inappropriate milk production in women,
• unexpected bleeding, such as bleeding from the gums, blood in the urine or vomit, or unexpected bruising or bleeding from broken blood vessels (broken veins).

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

• suicidal thoughts and behaviors, during venlafaxine treatment or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Alventa"),
• aggressive behavior,
• dizziness,
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), for more information, see section 2 "Pregnancy, breastfeeding, and fertility".

Alventa may sometimes cause side effects that the patient may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in sodium, cholesterol, or liver enzyme levels in the blood. In rare cases, Alventa may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, the doctor may recommend a blood test from time to time, especially during long-term treatment with Alventa.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Alventa

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Alventa contains

• The active substance of Alventa is venlafaxine. Each prolonged-release hard capsule contains 150 mg of venlafaxine in the form of venlafaxine hydrochloride.
• The other ingredients are sucrose, pellets (sucrose and cornstarch), hydroxypropylcellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc. The ingredients of the capsule shell are: gelatin, iron oxide red (E 172), titanium dioxide (E 171), iron oxide yellow (E 172). See section 2 "Alventa contains sucrose".

What Alventa looks like and contents of the pack

Orange-brown capsules filled with white to almost white pellets.
Packaging:
10, 14, 20, 28, 30, 50, 60, 98, or 100 prolonged-release hard capsules in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export:
4317/2012/01
4317/2012/02
4317/2012/03
4317/2012/04
4317/2012/05
4317/2012/06
4317/2012/07
4317/2012/08

Parallel import authorization number: 278/18

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 19.09.2023

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