Alventa

Leaflet accompanying the packaging: patient information

Alventa, 37.5 mg, prolonged-release, hard capsules

Alventa, 75 mg, prolonged-release, hard capsules

Alventa, 150 mg, prolonged-release, hard capsules

Venlafaxine

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

• 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 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 pack 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). These medicines 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 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) used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Alventa may cause serious or life-threatening side effects. Also, before starting to take any IMAO medicine, you should wait at least 7 days after stopping Alventa (see also 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, you should discuss it with your doctor or pharmacist:

• If you are taking other medicines that may increase the risk of serotonin syndrome when taken with Alventa (see section "Alventa and other medicines").
• If you have eye diseases, such as certain types of glaucoma (increased pressure in the eyeball).
• If you have had high blood pressure in the past.
• If you have had heart disease in the past.
• If you have had heart 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) or if you are pregnant (see section "Pregnancy, breastfeeding, and fertility") or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If you have had high cholesterol levels.
• If you or a family member have had mania or bipolar disorder (excessive excitement or euphoria) in the past.
• If you have had aggressive behavior in the past.

Alventa may cause feelings of restlessness or inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, you should inform your doctor.
Do not drink alcohol during treatment with Alventa, as it may cause extreme fatigue and loss of consciousness. Taking Alventa 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 or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after about 2 weeks, sometimes later. Such thoughts may also occur after reducing the dose or during withdrawal of Alventa.
These suicidal thoughts or self-harm are more likely to occur in:

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

If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.
It may be helpful to inform your relatives or friends about your depression or anxiety disorders and ask them to read this leaflet. You can ask them to tell you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your 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, you should pay special attention to 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 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, 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, you should consult the doctor again to discuss it. You should inform the doctor if any of the above symptoms or any other symptoms worsen in patients under 18 years of age taking Alventa. So far, no long-term safety data are available regarding the effects on growth, maturation, and development of cognitive and behavioral functions in this age group.

Alventa and other medicines

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Alventa. You should tell your doctor if you have taken these medicines within the last 14 days (IMAO: see section "Important information before taking Alventa").
• Serotonin syndrome: During venlafaxine treatment, a life-threatening or neuroleptic malignant syndrome-like reaction may occur (see 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), serotonin and norepinephrine 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 IMAO, moclobemide (used to treat depression);
• medicines containing sibutramine (used for weight loss);
• medicines containing opioids (e.g., buprenorphine, 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 methemoglobin levels in the blood);
• medicines containing St. John's Wort (Hypericum perforatum, herbal or dietary supplements 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, impaired perception and judgment, 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, increased reflexes (hyperreflexia), diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. The symptoms of neuroleptic malignant syndrome may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in a blood test).
If serotonin syndrome is suspected, you should immediately tell your doctor or go to the hospital.
If you are taking medicines that may affect heart rhythm, you should inform your 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 should be used with caution. It is especially 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).

Alventa with food, drink, and alcohol

Alventa should be taken with food (see section 3 "How to take Alventa").
Do not drink alcohol during treatment with Alventa. Taking Alventa with alcohol may cause extreme fatigue and loss of consciousness, as well as 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 baby, you should consult your doctor or pharmacist before taking this medicine.
Alventa should only be used after discussing the potential benefits and risks with your doctor.
Taking Alventa in the last months of pregnancy may increase the risk of severe postpartum hemorrhage, especially if you have a history of bleeding disorders. If you are taking Alventa, you should inform your doctor or midwife so they can provide you with appropriate advice.
You should inform your 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, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually occur within the first day after birth. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife.
If you are taking this medicine during pregnancy, your baby may experience, in addition to breathing difficulties, other symptoms such as sucking problems after birth. If you are concerned about such symptoms in the newborn, you should contact your doctor and/or midwife, who will be able to provide you with appropriate advice.
Alventa passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and your doctor will decide whether to stop breastfeeding or stop this treatment.

Driving and using machines

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

Alventa contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Alventa

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
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 your 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.
You should inform your doctor about liver or kidney problems, as it may be necessary to adjust the dose.
Do not stop taking this medicine without consulting your doctor (see section "Stopping Alventa treatment").

Taking a higher dose of Alventa than recommended

In case of overdose, you should immediately contact your doctor.
Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see section "Alventa and other medicines").
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 a missed dose, you should take it as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose and take only one dose at the usual time. Do not take a double dose of the medicine to make up for the missed dose. Do not take a higher dose in one day than the daily dose of Alventa prescribed by your doctor.

Stopping Alventa treatment

You should not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Alventa, they will tell you how to gradually reduce the dose before completely stopping treatment. In patients stopping Alventa, especially when treatment is stopped abruptly or the dose is reduced too quickly, side effects may occur, such as suicidal thoughts, aggression, fatigue, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, 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.).
Your doctor will advise you on how to gradually stop taking 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 you experience any of the above symptoms or any other symptoms that are troublesome to 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, Alventa can cause side effects, although not everybody gets them.
In case of any of the following side effects, you should stop taking Alventa and contact your doctor immediately or go to the hospital:

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 (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, increased reflexes (hyperreflexia), diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. The symptoms of neuroleptic malignant syndrome may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in a blood test).
• infection symptoms, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• severe skin rash, which may lead to severe blistering 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 known as "stress cardiomyopathy", which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If you experience any of the following side effects, you should contact your doctor.
(The frequency of these side effects has been reported in the following section "Other side effects"):

• cough, wheezing, and shortness of breath, which may be accompanied by high fever,
• black (tar-like) stools or blood in stools,
• 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 problems (muscle spasms or stiffness), seizures or convulsions,
• psychiatric disorders, such as excessive restlessness and unnatural excitement,
• withdrawal symptoms (see sections "How to take Alventa" and "Stopping Alventa treatment"),
• prolonged bleeding time - in case of injury, the bleeding time 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), lack of orgasm, decreased libido, restlessness, nervousness, unusual dreams,
• tremors, feeling of restlessness or inability to sit or stand still, tingling, taste disturbances, increased muscle tone,
• vision disturbances, including blurred vision, dilated pupils, inability of the eye to accommodate (automatic change of focus from distant to near objects),
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, sudden flushing, especially of the face,
• shortness of breath, yawning,
• vomiting, diarrhea,
• mild skin rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding, ejaculation or orgasm disorders (men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased cholesterol levels.

Uncommon (may affect up to 1 in 100 people)

• excessive restlessness, racing thoughts, and reduced need for sleep (mania),
• hallucinations, depersonalization (feeling of being detached from reality), orgasm disorders, apathy, feeling of excessive restlessness, teeth grinding,
• fainting, uncontrolled movements, coordination and balance problems,
• dizziness (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, black (tar-like) stools or blood in stools, which may be signs of internal bleeding,
• increased sensitivity to light, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, muscle spasms, and involuntary movements,
• minor 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 high fever,
• disorientation and confusion, often with hallucinations (delirium),
• syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• decreased sodium levels in the blood,
• severe eye pain and vision loss or blurred vision,
• abnormal, rapid, or irregular heart rhythm, 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 a decreased platelet count, indicating an increased risk of bruising or bleeding,
• inappropriate milk secretion in women,
• unexpected bleeding, such as bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruises or 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 you may not be aware of, such as increased blood pressure or abnormal heart rhythm; minor 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, your doctor may recommend a blood test from time to time, especially during long-term treatment with Alventa.

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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Alventa

The medicine should be stored out of sight and reach of children.
Do 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. 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 pack and other information

What Alventa contains

• The active substance of Alventa is venlafaxine. Each prolonged-release, hard capsule contains 37.5 mg, 75 mg, or 150 mg of venlafaxine in the form of venlafaxine hydrochloride.
• The other ingredients are sucrose spheres (sucrose and cornstarch), hydroxypropylcellulose (E463), povidone K-30 (E1201), ethylcellulose, dibutyl sebacate, and talc (E553B). The ingredients of the capsule shell are: gelatin, iron oxide red (E172), titanium dioxide (E171), and iron oxide yellow (E172) - only in 75 mg and 150 mg capsules. See section 2 "Alventa contains sucrose".

What Alventa looks like and contents of the pack

Alventa, 37.5 mg: brown-pink and white (body: white, cap: brown-pink) capsules filled with white to almost white pellets
Alventa, 75 mg: light pink capsules filled with white to almost white pellets
Alventa, 150 mg: orange-brown capsules filled with white to almost white pellets

Packaging:

Alventa, 37.5 mg: 7, 28, or 112 prolonged-release, hard capsules in blisters, in a cardboard box
Alventa, 75 mg and Alventa, 150 mg: 28, 60, or 112 prolonged-release, hard capsules in blisters, in a cardboard box

Marketing authorization holder and manufacturer/importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Date of last revision of the leaflet:11.09.2024