ALVENTA 150 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Alventa, 75 mg, prolonged-release, hard capsules
   2. Alventa, 150 mg, prolonged-release, hard capsules
   3. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   4. Contents of the pack
2. What Alventa is and what it is used for
3. Before you take Alventa
   1. Do not take Alventa
   2. Warnings and precautions
   3. Alventa with 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. If you take more Alventa than you should
   2. If you forget to take Alventa
   3. If you stop taking Alventa
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. Very rare (may affect up to 1 in 10,000 people)
   4. Frequency not known (cannot be estimated from the available data)
   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 of 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

Package Leaflet: Information for the Patient

Alventa, 37.5 mg, prolonged-release, hard capsules

Alventa, 75 mg, prolonged-release, hard capsules

Alventa, 150 mg, prolonged-release, hard capsules

Venlafaxine

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Alventa is and what it is used for
• 2. Before you take 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 Alventa is and what it is 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 in the treatment of depression and other mood disorders.

It is thought that people who are depressed or anxious have lower levels of certain substances in the brain, including serotonin and norepinephrine. Antidepressant medicines like Alventa work by increasing the levels of these substances in the brain.

Alventa is used to treat depression in adults. Alventa is also used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder in adults.

2. Before you take Alventa

Do not 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), which are used to treat depression or Parkinson's disease.

Warnings and precautions

Before taking Alventa, tell your doctor:

• If you are taking any other medicines, including those that you have bought without a prescription.
• If you have any eye problems, such as certain types of glaucoma.
• If you have ever had high blood pressure.
• If you have ever had heart problems.
• If you have ever had irregular heartbeats.
• If you have ever had seizures (fits or convulsions).
• If you have ever had low sodium levels in your blood.
• If you have a history of bleeding disorders, or if you are taking other medicines that may increase the risk of bleeding.
• If you have ever had high cholesterol levels.
• If you or any member of your family has a history of mania or bipolar disorder.
• If you have a history of aggressive behavior.

Alventa may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. If you experience these symptoms, you should tell your doctor.

Do not drink alcohol while you are taking Alventa. Drinking alcohol while taking Alventa may cause drowsiness or increased risk of seizures.

Suicidal thoughts and worsening of depression or anxiety

Patients who are depressed or anxious may sometimes have thoughts of harming themselves or committing suicide. These thoughts may be more frequent when first taking antidepressants, since these medicines all take time to start working, usually about two weeks, but sometimes longer.

Thoughts of suicide or self-harm are more likely in:

• patients who have previously had thoughts of harming themselves or committing suicide;
• young adults. Data from clinical trials have shown an increased risk of suicidal behavior in young adults (less than 25 years old) with depression or other psychiatric conditions who were treated with an antidepressant.

If you experience any thoughts of suicide or self-harm, you should contact your doctor or go to the hospital immediately.

It may be helpful to tell a relative or close friend that you are depressed or anxious and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Sexual dysfunction

Medicines like Alventa (SSRIs and SNRIs) may cause sexual dysfunction (see section 4).

Dry mouth

Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay special attention to your dental hygiene.

Diabetes

Alventa may affect blood sugar levels. If you have diabetes, you may need to adjust the dose of your diabetes medicines.

Children and adolescents

Alventa should not be used in children and adolescents under the age of 18.

Also, patients under 18 are at increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger) when they take this class of medicines.

Despite this, your doctor may prescribe Alventa for patients under 18 if they decide that this is in their best interests. If your doctor has prescribed Alventa for a patient under 18 and you want to discuss this, please contact your doctor.

You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 taking Alventa.

Alventa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those that you have bought without a prescription.

• Irreversible MAOIs, which are used to treat depression or Parkinson's disease, should not be taken with Alventa.
• Serotonin syndrome: If you are taking venlafaxine, you may be at risk of a condition called serotonin syndrome, which can be life-threatening. This is more likely to happen when you first start treatment, or when you are taking other medicines that may increase the levels of serotonin in your body (see below).

Alventa with food, drink, and alcohol

Alventa should be taken with food (see section 3).

Do not drink alcohol while you are taking Alventa. Drinking alcohol while taking Alventa may cause drowsiness or increased risk of seizures.

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 clearly necessary.

Taking Alventa in the last month of pregnancy may increase the risk of heavy bleeding after delivery, especially if you have a history of bleeding disorders.

If you are taking Alventa and become pregnant, or if you are planning to become pregnant, you should inform your doctor or midwife.

Alventa passes into breast milk. There is a risk of an effect on the baby. Your doctor will discuss with you whether you should breastfeed or take Alventa.

Driving and using machines

Do not drive or use any tools or machines until you know how Alventa affects you.

Alventa contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Alventa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose is 75 mg per day, which can be increased by your doctor to a maximum of 375 mg per day for depression. For anxiety disorders, the maximum dose is 225 mg per day.

Take Alventa at the same time each day, with food.

Swallow the capsules whole with a glass of water. Do not divide, crush, chew, or dissolve them.

Tell your doctor if you have liver or kidney problems, as your dose may need to be adjusted.

Do not stop taking Alventa without talking to your doctor (see section 3, "If you stop taking Alventa").

If you take more Alventa than you should

If you have taken more Alventa than you should, contact your doctor or go to the hospital immediately.

Overdose can be fatal, especially when combined with alcohol or other medicines (see section 2, "Taking other medicines").

If you forget to take Alventa

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alventa

Do not stop taking Alventa without talking to your doctor. If your doctor decides that you can stop taking Alventa, your dose will be gradually reduced over a period of time.

When stopping Alventa, you may experience side effects such as dizziness, insomnia, headache, nausea, or vomiting. Your doctor will advise you on how to reduce these side effects.

4. Possible side effects

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

Stop taking Alventa and contact your doctor or go to the hospital immediately if you experience any of the following:

Uncommon (may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, or throat, and difficulty breathing or swallowing;

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

• chest pain, difficulty breathing, or rapid heartbeat;
• severe skin rash, itching, or hives;
• symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, high blood pressure, increased body temperature, and diarrhea;

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

• seizures;
• severe allergic reactions, including anaphylaxis;
• blood disorders, including low platelet count;

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

• suicidal thoughts or behaviors;
• aggressive behavior;
• dizziness;
• severe bleeding after delivery (postpartum hemorrhage);

Other side effects include:

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

• dizziness, headache, drowsiness;
• insomnia;
• nausea, dry mouth, constipation;
• sweating;

Common (may affect up to 1 in 10 people)

• decreased appetite;
• confusion, depersonalization, lack of orgasm, decreased libido, restlessness, nervousness, unusual dreams;
• tremors, feeling of anxiety or inability to sit still, paresthesia, taste disturbances, increased muscle tone;
• visual disturbances, including blurred vision, dilated pupils, inability to focus;
• ringing in the ears;
• rapid heartbeat, palpitations;
• increased blood pressure, flushing;
• shortness of breath, yawning;
• vomiting, diarrhea;
• mild rash, itching;
• increased frequency of urination, inability to urinate, difficulty urinating;

Uncommon (may affect up to 1 in 100 people)

• mania, excessive excitement, and decreased need for sleep;
• hallucinations, depersonalization, orgasmic dysfunction, apathy, excessive excitement, teeth grinding;
• fainting, involuntary movements, coordination disturbances;
• dizziness (especially when standing up), decreased blood pressure;
• vomiting blood, black tarry stools, or blood in stools, which may indicate internal bleeding;
• photosensitivity, bruising, excessive hair loss;
• urinary incontinence;
• stiffness, muscle spasms, and involuntary movements;
• mild changes in liver enzyme activity;

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

• seizures;
• cough, difficulty breathing, and 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 decreased vision or blurred vision;
• abnormal heart rhythms, which can cause fainting;
• severe abdominal or back pain, which may indicate serious problems with the intestines, liver, or pancreas;
• itching, yellowing of the skin or whites of the eyes, dark urine, or flu-like symptoms, which may indicate liver inflammation;

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

• prolonged bleeding, which may indicate a low platelet count;
• inappropriate milk production in women;
• unexpected bleeding, such as bleeding from the gums, blood in the urine or stool, or the appearance of unexpected bruises or broken blood vessels;

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

• suicidal thoughts and behaviors;
• aggressive behavior;
• dizziness;
• severe bleeding after delivery (postpartum hemorrhage);

Alventa may also cause side effects that you do not notice, such as increased blood pressure or changes in liver function or blood sugar control. In rare cases, Alventa may affect the function of platelets in the blood, leading to an increased risk of bleeding or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below.

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 which is stated on the packaging.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 corn starch), hydroxypropyl cellulose (E463), povidone K-30 (E1201), ethyl cellulose, dibutyl sebacate, and talc (E553B). The capsule shell contains gelatin, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172) - only in the 75 mg and 150 mg capsules.

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