ALVENTA 75 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Alventa, 75 mg, prolonged-release, hard capsules
   2. Alventa, 150 mg, prolonged-release, hard capsules
   3. You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.
   4. Table of contents of the leaflet
2. What is Alventa and what is it used for
3. Important information before taking Alventa
   1. When not to take Alventa
   2. Warnings and precautions
   3. Alventa and other medicines
   4. Alventa with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Alventa contains sucrose
4. How to take Alventa
   1. Taking a higher dose of Alventa than recommended
   2. Missing a dose of Alventa
   3. Stopping Alventa treatment
5. Possible side effects
   1. Uncommon (may affect up to 1 in 100 people)
   2. Rare (may affect up to 1 in 1,000 people)
   3. Frequency not known (cannot be estimated from the available data)
   4. Other side effects
   5. Very common (may affect more than 1 in 10 people)
   6. Common (may affect up to 1 in 10 people)
   7. Uncommon (may affect up to 1 in 100 people)
   8. Rare (may affect up to 1 in 1,000 people)
   9. Very rare (may affect up to 1 in 10,000 people)
   10. Frequency not known (cannot be estimated from the available data)
   11. Reporting side effects
6. How to store Alventa
7. Contents of the pack and other information
   1. What Alventa contains
   2. What Alventa looks like and contents of the pack
   3. Packaging:
   4. Marketing authorization holder and manufacturer

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, 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 thought that in people with depression and/or anxiety, there is a decreased level of serotonin and norepinephrine in the brain. 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.
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 important that the treatment of depression and anxiety disorders is carried out properly. If 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 (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Alventa may cause serious or even life-threatening side effects. Also, before starting to take any MAOI, 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 this with your doctor or pharmacist:

• If you are taking other medicines that may increase the risk of developing serotonin syndrome when taken with Alventa (see section "Alventa and other medicines").
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have had high blood pressure in the past.
• If you have had heart problems in the past.
• If you have had irregular heart rhythms 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 easily (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 anyone in your family has had mania or bipolar disorder (feeling excessively energetic or elated).
• If you have had aggressive behavior in the past.

Alventa may cause feelings of anxiety 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 while taking Alventa, as this may cause extreme fatigue and loss of consciousness. Taking Alventa with alcohol and/or certain other medicines may increase the risk of worsening 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 thoughts or behavior may worsen when starting to take antidepressants, as these medicines start to work usually after about 2 weeks, sometimes later. Such thoughts may also occur when reducing the dose or when stopping Alventa.
These thoughts of suicide or self-harm are more likely to occur in:

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

If you experience thoughts of self-harm or suicide, 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 disorder and ask them to read this leaflet. You may ask them to tell you if they notice that your depression or anxiety has worsened or if you have any disturbing 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 have 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, rebelliousness, and anger).
However, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be beneficial. If your doctor has prescribed this medicine to a patient under 18 years of age, and you have any concerns, you should discuss this with your doctor again. You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Alventa. The long-term safety of Alventa in this age group, regarding effects on growth, maturation, and cognitive and behavioral development, has not been established yet.

Alventa and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Your doctor will decide whether you can take Alventa with other medicines.
Do not start or stop taking other medicines, including those that can be bought without a prescription, herbal or natural products, without consulting your doctor or pharmacist first.

• Irreversible monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, should not be taken with Alventa. Tell your doctor if you have taken these medicines in the last 14 days (see section "Important information before taking Alventa").
• Serotonin syndrome: During venlafaxine treatment, a potentially life-threatening condition or neuroleptic malignant syndrome-like reactions (see section "Possible side effects") may occur, especially when taken with medicines such as:
• triptans (used to treat migraine headaches);
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-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 MAOI, moclobemide (used to treat depression);
• medicines containing sibutramine (used for weight loss);
• medicines containing opioids (such as 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 levels of methemoglobin in the blood);
• medicines containing St. John's Wort (Hypericum perforatum, herbal or natural products 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 are not there, delusions, unnatural suspiciousness, abnormal perceptions, and judgments).

Symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heart rate, 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. Symptoms of neuroleptic malignant syndrome may include fever, rapid heart rate, sweating, muscle stiffness, confusion, increased levels of muscle enzymes in the blood (detected in blood tests).
If serotonin syndrome is suspected, you should immediately tell your doctor or go to the hospital.
If you are taking medicines that may affect your heart rhythm, you should inform your doctor. Examples of such medicines are:

• anti-arrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms),
• 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 conditions).

Alventa with food, drink, and alcohol

Alventa should be taken with food (see section 3 "How to take Alventa").
Do not drink alcohol while taking Alventa. Taking Alventa with alcohol may cause extreme fatigue and loss of consciousness, as well as worsening 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Alventa should only be used during pregnancy if your doctor considers it essential. Taking Alventa in late pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Alventa, you should inform your doctor or midwife so they can give you 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 a condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually appear in the first day after birth. If such symptoms occur in your newborn, you should contact your doctor and/or midwife immediately.
If you are taking this medicine during pregnancy, your baby may experience, in addition to breathing difficulties, other symptoms such as feeding problems after birth. If you are concerned about such symptoms in your newborn, you should contact your doctor and/or midwife, who will be able to give you 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 you should stop breastfeeding or stop Alventa treatment.

Driving and using machines

Do 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Typically, the recommended starting dose for depression, generalized anxiety disorder, and 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. 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.
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

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

Missing a dose of Alventa

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take only one dose at the usual time. Do not take a double dose of Alventa to make up for a missed dose. Do not take more than the prescribed daily dose of Alventa in a single day.

Stopping Alventa treatment

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

4. Possible side effects

Like all medicines, Alventa can cause side effects, although not everybody gets them.
If you experience 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 raised rash, often itchy),
• symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heart rate, 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. Symptoms of neuroleptic malignant syndrome may include fever, rapid heart rate, sweating, muscle stiffness, confusion, increased levels of muscle enzymes in the blood (detected in blood tests).
• symptoms of infection, 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 called "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 signs of liver inflammation,
• heart problems, such as rapid or irregular heartbeat, high blood pressure,
• eye problems, such as blurred vision, dilated pupils,
• nervous system problems, such as dizziness, tingling, coordination problems (muscle spasms or stiffness), seizures or convulsions,
• psychiatric problems, such as excessive restlessness and feeling unnatural excitement,
• withdrawal symptoms (see sections "How to take Alventa" and "Stopping Alventa treatment"),
• prolonged bleeding time - if you cut yourself, it may take slightly longer than usual for the bleeding to stop.

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 oneself), lack of orgasm, decreased libido, restlessness, nervousness, unusual dreams,
• tremors, feeling of anxiety or inability to sit or stand still, tingling, taste disturbances, increased muscle tone,
• vision problems, including blurred vision, dilated pupils, inability of the eye to accommodate (automatic change in focus from distant to near objects),
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, 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, fatigue, chills,
• weight gain, weight loss,
• increased cholesterol levels.

Uncommon (may affect up to 1 in 100 people)

• excessive restlessness and feeling unnatural excitement (mania),
• hallucinations, depersonalization (feeling of being detached from reality), orgasm disorders, apathy, feeling of unnatural excitement, teeth grinding,
• fainting, uncontrolled movements, coordination problems,
• dizziness (especially when standing up too quickly), low 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,
• 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 high fever,
• confusion and disorientation, often with hallucinations (delirium),
• syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• low sodium levels in the blood,
• severe eye pain and decreased vision or blurred vision,
• abnormal 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 may be signs of liver inflammation.

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

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

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

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

Alventa may also cause side effects that you 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, your doctor may recommend regular blood tests, especially during long-term treatment with Alventa.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your 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:
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

Keep this medicine out of the 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 storage precautions.

6. Contents of the pack and other information

What Alventa 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 sucrose spheres (sucrose and cornstarch), hydroxypropylcellulose (E463), povidone K-30 (E1201), ethylcellulose, dibutyl sebacate, and talc (E553B). The capsule shell ingredients 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 off-white pellets
Alventa, 75 mg: light pink capsules filled with white to off-white pellets
Alventa, 150 mg: orange-brown capsules filled with white to off-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

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