Alventa

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Alventa, 150 mg, Prolonged-Release Hard Capsules

Venlafaxine

You Should Carefully Read the Contents of This Leaflet Before Using the Medication, as It Contains Important Information for the Patient.

• 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 Medication Has Been Prescribed Specifically for You. Do Not Give It to Others. The Medication Can Harm Another Person, Even If Their Symptoms Are the Same.
• If the Patient Experiences Any Adverse Reactions, Including Any Adverse Reactions Not Listed in This Leaflet, They Should Inform Their 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 Adverse Reactions
• 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 Medication Belonging to a Group of Medications Called Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs). These Medications 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 Antidepressant Medications 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 Properly. If the Treatment Is Not Initiated, the Patient's Condition May Not Improve, May Worsen, and Will Be Much 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 Medication (Listed in Section 6).
• If the Patient Is Taking or Has Taken in the Last 14 Days Any Medication from the Group of Irreversible Monoamine Oxidase Inhibitors (IMAOs) Used to Treat Depression or Parkinson's Disease. Taking Irreversible IMAOs at the Same Time as Alventa Can Cause Severe or Life-Threatening Adverse Reactions. Also, Before Starting to Take Any IMAO Medication, the Patient Should Wait at Least 7 Days After Stopping the Use of Alventa (See Also the Section "Alventa and Other Medications" and the Information in This Section Regarding Serotonin Syndrome).

Warnings and Precautions

Before Starting to Take Alventa, the Patient Should Discuss the Following with Their Doctor or Pharmacist:

• If the Patient Is Taking Other Medications That, When Taken with Alventa, May Increase the Risk of Serotonin Syndrome (See the Section "Alventa and Other Medications").
• If the Patient Has Eye Diseases, Such as Certain Types of Glaucoma (Increased Pressure in the Eye).
• 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 Medications That May Increase the Risk of Bleeding, Such as Warfarin (Used as an Anticoagulant).
• If the Patient Has Increased Cholesterol Levels.
• If the Patient or Any of Their Family Members Have Had Mania or Bipolar Disorder (Excessive Excitement or Euphoria) in the Past.
• If the Patient Has Had Aggressive Behavior in the Past.

Alventa May Cause a Feeling 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.
Do Not Consume Alcohol During Treatment with Alventa, as It May Cause Extreme Fatigue and Loss of Consciousness. Taking Alventa with Alcohol and/or Certain Medications May Increase the Severity of Symptoms 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 Antidepressant Medications, as These Medications Usually Start to Work Only After About 2 Weeks, Sometimes Later. Such Thoughts May Also Occur After Reducing the Dose or During Withdrawal of Alventa.
These Thoughts of Suicide or Self-Harm Are More Likely in:

• Patient Who Have Had Thoughts of Self-Harm or Suicide in the Past;
• Young Adult Patients. Clinical Trial Data Show an Increased Risk of Suicidal Behavior in People Under 25 with Mental Disorders Who Were Treated with Antidepressant Medications.

If the Patient Experiences Thoughts of Self-Harm or Suicide, They Should Immediately Contact Their Doctor or Go to the Hospital.
It May Be Helpful for the Patient to Inform Their Relatives or Friends About Their Depression or Anxiety Disorders and Ask Them to Read This Leaflet. The Patient May Ask to Be Informed If They Notice That the Depression or Anxiety Has Worsened or If There Are Concerning Changes in the Patient's Behavior.
Sexual Dysfunction
Medications Like Alventa (So-Called SSRIs or SNRIs) May Cause Symptoms of Sexual Dysfunction (See Section 4). In Some Cases, These Symptoms Persisted After Stopping the 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 Cause Changes in Blood Sugar Levels, and Therefore, There May Be a Need to Adjust the Dose of Antidiabetic Medications.
Children and Adolescents
Alventa Should Not Be Used in Children and Adolescents Under 18 Years of Age.
It Should Also Be Emphasized That Patients Under 18 Years of Age Who Take Medications from This Group Are at Increased Risk of Adverse Reactions, Such as Suicidal Attempts, Suicidal Thoughts, and Hostility (Especially Aggression, Defiant Behavior, and Expressions of Anger).
However, the Doctor May Prescribe This Medication to Patients Under 18 Years of Age If They Consider It Beneficial for Them. If the Doctor Prescribes This Medication to a Patient Under 18 Years of Age, in Case of Doubts, the Patient Should Consult Their Doctor Again to Discuss This. The Patient Should Inform Their Doctor If Any of the Above Symptoms or Other Symptoms Worsen in Patients Under 18 Years of Age Taking Alventa. So Far, There Is No Evidence of Long-Term Safety Regarding the Impact on Growth, Maturation, and Development of Cognitive and Behavioral Functions in This Age Group.

Alventa and Other Medications

The Patient Should Tell Their Doctor or Pharmacist About All Medications They Are Currently Taking or Have Recently Taken, as Well as Any Medications They Plan to Take.
The Doctor Will Decide Whether to Use Alventa with Other Medications.
The Patient Should Not Start or Stop Taking Other Medications, Including Over-the-Counter Medications, Herbal or Natural Products, Without Consulting Their Doctor or Pharmacist First.

• 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 Medications in the Last 14 Days (IMAO: See the Section "Important Information Before Taking Alventa").
• Serotonin Syndrome: During Treatment with Venlafaxine, a Life-Threatening or Neuroleptic Malignant Syndrome-Like Reaction May Occur (See the Section "Possible Adverse Reactions"), Especially When Taken with Medications Such as:
• Triptans (Substances Used to Treat Migraines);
• Other Medications Used to Treat Depression, Such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or Medications Containing Lithium;
• Medications Containing Amphetamine Derivatives (Used to Treat Attention Deficit Hyperactivity Disorder (ADHD), Narcolepsy, and Obesity);
• Medications Containing the Antibiotic Linezolid (Used to Treat Infections);
• Medications Containing the Reversible IMAO Moclobemide (Used to Treat Depression);
• Medications Containing Sibutramine (Used for Weight Loss);
• Medications Containing Opioids (Such as Buprenorphine, Tramadol, Fentanyl, Tapentadol, Pethidine, or Pentazocine) Used to Treat Severe Pain;
• Medications Containing Dextromethorphan (Used to Treat Cough);
• Medications Containing Methadone (Used to Treat Opioid Dependence or Severe Pain);
• Medications Containing Methylene Blue (Used to Treat High Methemoglobin Levels in the Blood);
• Medications Containing St. John's Wort (Hypericum Perforatum, Herbal or Natural Products Used to Treat Mild Depression);
• Medications Containing Tryptophan (Used for Sleep Problems and Depression);
• Antipsychotic Medications (Used to Treat Conditions with Symptoms Such as Hearing, Seeing, or Feeling Things That Do Not Exist, Delusions, Unnatural Suspicion, Abnormal Perceptions and Judgments, Withdrawal).

The Subjective and Objective Symptoms of Serotonin Syndrome May Include a Combination of the Following Symptoms: Restlessness, Hallucinations, Loss of Coordination, Rapid Heart Rate, Elevated Body Temperature, Rapid Changes in Blood Pressure, 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 Heart Rate, Sweating, Muscle Stiffness, Disorientation, Elevated Enzyme Levels in the Muscles (Detected in Blood Tests).
If Serotonin Syndrome Is Suspected, the Patient Should Immediately Inform Their Doctor or Go to the Hospital.
If the Patient Is Taking Medications That May Affect Heart Rhythm, They Should Inform Their Doctor. Examples of Such Medications:

• Antiarrhythmic Medications, Such as Quinidine, Amiodarone, Sotalol, or Dofetilide (Used to Treat Heart Rhythm Disorders),
• Antipsychotic Medications, Such as Thioridazine (See Above - Serotonin Syndrome),
• Antibiotics, Such as Erythromycin or Moxifloxacin (Used to Treat Bacterial Infections),
• Antihistamine Medications (Used to Treat Allergies).

The Following Medications May Also Interact with Alventa, and Therefore, Should Be Used with Caution. It Is Especially Important to Inform the Doctor If the Patient Is Taking Medications Containing:

• Ketoconazole (an Antifungal Medication),
• Haloperidol or Risperidone (Medications 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 Consume Alcohol During Treatment with Alventa. Taking Alventa with Alcohol May Cause Extreme Fatigue and Loss of Consciousness, as Well as Increase the Severity of Symptoms of Depression and Other Conditions, Such as Anxiety Disorders.

Pregnancy, Breastfeeding, and Fertility

If the Patient Is Pregnant, Breastfeeding, or Thinks They May Be Pregnant, or Is Planning to Have a Child, They Should Consult Their Doctor or Pharmacist Before Taking This Medication.
Alventa Should Only Be Used After Discussing the Potential Benefits and Risks 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 They Can Provide Appropriate Advice.
The Patient Should Inform Their Doctor and/or Midwife About Taking Alventa. Taking Similar Medications 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 Appear in the First Day After Birth. If Such Symptoms Occur in the Newborn, the Patient Should Immediately Contact Their Doctor and/or Midwife.
If the Patient Is Taking This Medication During Pregnancy, Their Child May Experience Difficulty Breathing or Other Symptoms After Birth, Such as Feeding Problems. 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 in Nursing Mothers. There Is a Risk of an Effect on the Child. Therefore, the Patient Should Discuss This with Their Doctor, and the Doctor Will Decide Whether to Stop Breastfeeding or Discontinue This Medication.

Driving and Operating Machines

The Patient Should Not Drive or Operate Machines Until They Know How This Medication 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 Medication.

3. How to Take Alventa

This Medication Should Always Be Taken as Directed by the Doctor or Pharmacist. If the Patient Has Any Doubts, They Should Consult Their Doctor or Pharmacist.
Alventa Is Available in the Following Doses: 37.5 mg, 75 mg, 150 mg.
The Usual Recommended Initial Dose for the Treatment of Depression, Generalized Anxiety Disorder, and 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. For 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, Approximately at 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 Any Liver or Kidney Problems, as There May Be a Need to Adjust the Dose.
The Patient Should Not Stop Taking This Medication Without Consulting Their Doctor (See the Section "Stopping Alventa Treatment").

Taking a Higher Than Recommended Dose of Alventa

In Case of Taking a Higher Than Recommended Dose of This Medication, the Patient Should Immediately Contact Their Doctor.
Overdose Can Be Life-Threatening, Especially When Taken with Alcohol and/or Certain Medications (See the Section "Alventa and Other Medications").
Symptoms of Possible Overdose May Include Rapid Heart Rate, Disturbances of Consciousness (from Drowsiness to Coma), Vision Disturbances, Seizures or Convulsions, and Vomiting.

Missing a Dose of Alventa

If a Dose Is Missed, the Patient Should Take It as Soon as Possible. However, If the Time for the Next Dose Is Near, 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 Medication 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 Treatment

The Patient Should Not Stop the 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 the Treatment. In Patients Stopping Alventa, Especially If the Treatment Is Stopped Suddenly or the Dose Is Reduced Too Quickly, Adverse Reactions May Occur, Such as Suicidal Thoughts, Aggression, Fatigue, Dizziness, Headache, Insomnia, Nightmares, Dry Mouth, Loss of Appetite, Nausea, Diarrhea, Nervousness, Excitement, 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 Medication 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.
If the Patient Has Any Further Doubts About the Use of This Medication, They Should Consult Their Doctor or Pharmacist.

4. Possible Adverse Reactions

Like All Medications, Alventa Can Cause Adverse Reactions, Although Not Everybody Gets Them.
If Any of the Following Adverse Reactions Occur, the Patient Should Stop Taking Alventa and Immediately Contact Their Doctor or Go to the Hospital.

Uncommon (May Occur in Less Than 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 Occur in Less Than 1 in 1,000 People)

• Chest Tightness, Wheezing, Difficulty Breathing or Swallowing,
• 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 Heart Rate, Elevated Body Temperature, Rapid Changes in Blood Pressure, 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 Heart Rate, Sweating, Muscle Stiffness, Disorientation, Elevated Enzyme Levels in the Muscles (Detected in Blood Tests).
• 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 the Formation of Severe Blisters and Peeling of the Skin,
• Muscle Pain of Unknown Origin, 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 Any of the Following Adverse Reactions Occur, the Patient Should Consult Their Doctor.
(The Frequency of These Adverse Reactions Is Listed Below in the Section "Other Adverse Reactions"):

• Cough, Wheezing, and Shortness of Breath, Which May Be Accompanied by High Fever,
• Black (Tarry) 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,
• Eyesight Disturbances, Such as Blurred Vision, Dilated Pupils,
• Nervous System Disorders, Such as Dizziness, Tingling, Coordination Disturbances (Muscle Cramps or Stiffness), Seizures or Convulsions,
• Psychiatric Disorders, Such as Excessive Restlessness and Feeling of Unnatural Excitement,
• Withdrawal Symptoms (See the Sections "How to Take Alventa" and "Stopping Alventa Treatment"),
• Prolonged Bleeding Time - in Case of Injury, the Time to Stop the Bleeding May Be Slightly Longer Than Usual.

Other Adverse Reactions

Very Common (May Occur in More Than 1 in 10 People)

• Dizziness, Headache, Drowsiness,
• Insomnia,
• Nausea, Dry Mouth, Constipation,
• Sweating (Including Night Sweats).

Common (May Occur in Less Than 1 in 10 People)

• Decreased Appetite,
• Confusion, Depersonalization (Feeling of Estrangement from Oneself), Lack of Orgasm, Decreased Libido, Excitement, Nervousness, Unusual Dreams,
• Tremors, Feeling of Restlessness or Inability to Sit or Stand Still, Tingling, Taste Disturbances, Increased Muscle Tension,
• Vision Disturbances, Including Blurred Vision, Dilated Pupils, Inability of the Eye to Adapt (Automatic Change of Focus from Distant to Near Objects),
• Ringing in the Ears (Tinnitus),
• Rapid Heartbeat, Palpitations,
• Increased Blood Pressure, Sudden Redness of the Face,
• Shortness of Breath, Yawning,
• Vomiting, Diarrhea,
• Mild Rash, Itching,
• Increased Urination Frequency, Inability to Urinate, Difficulty Urinating,
• Menstrual Irregularities, Such as Heavy Bleeding or More Frequent Irregular Bleeding, Ejaculation/Orgasm Disorders (Men), Erectile Dysfunction (Impotence),
• Weakness (Asthenia), Fatigue, Chills,
• Weight Gain, Weight Loss,
• Increased Cholesterol Levels in the Blood.

Uncommon (May Occur in Less Than 1 in 100 People)

• Excessive Excitement and Reduced Need for Sleep (Mania),
• Hallucinations, Depersonalization (Feeling of Estrangement from Reality), Orgasm Disorders, Apathy, Feeling of Excessive Excitement, Teeth Grinding,
• Fainting, Uncontrolled Muscle Movements, Coordination and Balance Disturbances,
• Dizziness (Especially When Standing Up Too Quickly), Decreased Blood Pressure,
• Vomiting Blood, Black (Tarry) 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 Cramps, and Involuntary Muscle Movements,
• Slight Changes in Liver Enzyme Activity in the Blood.

Rare (May Occur in Less Than 1 in 1,000 People)

• Seizures,
• Cough, Wheezing, and Shortness of Breath, Which May Be Accompanied by High Fever,
• Disorientation and Confusion, Often with Accompanying Hallucinations (Delirium),
• Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH),
• Decreased Sodium Levels in the Blood,
• Severe Eye Pain and Vision Impairment or Blurred Vision,
• Abnormal, Rapid, or Irregular 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 Whites of the Eyes, Dark Urine, or Flu-Like Symptoms, Which Are Symptoms of Liver Inflammation.

Very Rare (May Occur in Less Than 1 in 10,000 People)

• Prolonged Bleeding, Which May Be a Sign of Decreased Platelet Count, Indicating an Increased Risk of Bruising or Bleeding,
• Inappropriate Milk Secretion in Women,
• Unexpected Bleeding, Such as Gum Bleeding, Blood in the Urine, or 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 Treatment with Venlafaxine, Suicidal Thoughts and Behaviors Have Been Reported (See Section 2 "Important Information Before Taking Alventa"),
• Aggressive Behavior,
• Dizziness,
• Severe Postpartum Hemorrhage, Occurring Shortly After Birth (Postpartum Hemorrhage), for More Information, See Section 2 "Pregnancy, Breastfeeding, and Fertility".

Alventa May Sometimes Cause Adverse Reactions That the Patient Is Not Aware Of, Such as Increased Blood Pressure or Abnormal Heart Function; Slight Changes in Sodium, Cholesterol, or Liver Enzyme Levels in the Blood. In Even Rarer Cases, Alventa May Affect Platelet Function, Leading to an Increased Risk of Bruising or Bleeding. Therefore, the Doctor May Recommend Blood Tests from Time to Time, Especially During Long-Term Treatment with Alventa.

Reporting Adverse Reactions

If Any Adverse Reactions Occur, Including Any Adverse Reactions Not Listed in This Leaflet, the Patient Should Inform Their Doctor or Pharmacist. Adverse Reactions Can Be Reported Directly to the Department of Medicinal Product Monitoring, 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 Adverse Reactions Will Help Gather More Information on the Safety of This Medication.

5. How to Store Alventa

The Medication Should Be Stored Out of Sight and Reach of Children.
Do Not Use This Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
There Are No Special Storage Instructions.
Medications Should Not Be Disposed of in Sewers or Household Waste. The Patient Should Ask Their Pharmacist How to Dispose of Medications They No Longer Need. 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.
• Other Ingredients Are: Sucrose, Spheres (Sucrose, Corn Starch), Hydroxypropyl Cellulose, 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 What the Packaging Contains

Orange-Brown Capsules Filled with White to Almost White Pellets.

Packaging:

30 or 60 Prolonged-Release Hard Capsules in PVC-PVDC/Aluminum Blisters, in a Cardboard Box.
For More Detailed Information, the Patient Should Contact the Marketing Authorization Holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Romanian Marketing Authorization Number:4317/2012/05
Parallel Import Authorization Number:54/19
This Medication Is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Date of Approval of the Leaflet: 06.02.2024

[Information About the Trademark]