Prospect: information for the user

Venlafaxine Retard Aurovitas 75mg prolonged-release hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Venlafaxine Retard Aurovitas and what it is used for

2.What you need to know before starting to take Venlafaxine Retard Aurovitas

3.How to take Venlafaxine Retard Aurovitas

4.Possible adverse effects

5.Storage of Venlafaxine Retard Aurovitas

6.Contents of the pack and additional information

Venlafaxina Retard Aurovitas contains the active ingredient venlafaxine. Venlafaxine is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. The exact way in which antidepressants work is not fully understood, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine is a treatment for adults with depression. This medicine is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become harder to treat.

Do not take Venlafaxina Retard Aurovitas

-If you are allergic to venlafaxine or any of the other ingredients of this medication (listed in section 6).

-If you are also taking or have taken in the last 14 days any medication known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with venlafaxine may produce severe or potentially fatal adverse effects. Additionally, you should wait at least 7 days after stopping venlafaxine before taking any IMAO irreversible (see also the sections “Serotonin syndrome” and “Other medications and Venlafaxina Retard Aurovitas”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxina Retard Aurovitas.

-If you are taking other medications that, taken together with venlafaxine, may increase the risk of developing serotonin syndrome (see the section “Other medications and Venlafaxina Retard Aurovitas”).

-If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

-If you have a history of high blood pressure.

-If you have a history of heart problems.

-If you have been informed that your heart rhythm is altered.

-If you have a history of seizures (convulsions).

-If you have a history of low sodium levels in the blood (hyponatremia).

-If you have a tendency to develop cardenalias or bleed easily (history of hemorrhagic disorders or if you are pregnant (see “Pregnancy and breastfeeding”)), or if you are taking other medications that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots).

-If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).

-If you have a history of aggressive behavior.

Venlafaxine may cause a feeling of restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when starting to take antidepressants because all these medications take time to become effective, usually two weeks, but sometimes it may take longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxine.

It is more likely to happen:

-If you have had previous thoughts of suicide or self-harm.

-If you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years old) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital directly.

You may find it helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take good care of your dental hygiene.

Diabetes

Venlafaxine may alter your blood glucose levels. Therefore, you may need to adjust the doses of your diabetes medications.

Sexual problems

Some medications in the group to which venlafaxine belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine should not be used normally in the treatment of children and adolescents under 18 years old. Additionally, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. Despite this, your doctor may prescribe this medication to patients under 18 years old when they decide it is the most convenient for the patient. If your doctor has prescribed this medication to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old who are taking venlafaxine. Furthermore, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medications and Venlafaxina Retard Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor should decide if you can take venlafaxine with other medications.

Do not start or stop taking any medication, including those sold over the counter, natural remedies, and herbal products, without checking with your doctor or pharmacist.

-Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with venlafaxine. Tell your doctor if you have taken any of these medications in the last 14 days (IMAO: see section “What you need to know before starting to take Venlafaxina Retard Aurovitas”).

-Serotonin syndrome:

With venlafaxine treatment, particularly when taken with other medications, may produce a potentially fatal state, or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible adverse effects”).

Examples of these medications include:

?Triptans (used for migraines).

?Other medications to treat depression, for example, IRSN, ISRS, tricyclic antidepressants, or medications containing lithium.

?Medications containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity).

?Medications containing the antibiotic linezolid (used to treat infections).

?Medications containing moclobemide, an IMAO (used to treat depression).

?Medications containing sibutramine (used for weight loss).

?Medications containing 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 addiction or to treat severe pain).

?Medications containing methylene blue (used to treat high levels of methemoglobin in the blood).

?Natural or herbal products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product used to treat mild depression).

?Natural or herbal products containing tryptophan (used for problems such as sleep and depression).

?Antipsychotics (used to treat a disorder with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

?Medications containing buprenorphine. These medications may interact with venlafaxine and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood test).

Inform your doctor immediately or go to the nearest hospital emergency room if you think you are experiencing serotonin syndrome.

Inform your doctor if you are taking medications that may alter your heart rhythm.

Examples of these medications include:

-Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders).

-Antipsychotics such as thioridazine (see also serotonin syndrome above).

-Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections).

-Antihistamines (used to treat allergies).

The following medications may also interact with venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

-Ketoconazole (an antifungal medication).

-Haloperidol or risperidone (used to treat psychiatric disorders).

-Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Venlafaxina Retard Aurovitas with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3 “How to take Venlafaxina Retard Aurovitas”).

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme fatigue and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should only take venlafaxine after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking venlafaxine. When taken during pregnancy, similar medications (ISRS) may increase the risk of a serious problem in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medication during pregnancy, in addition to breathing problems, another symptom that your baby may have when born is feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take venlafaxine in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of hemorrhagic disorders. Your doctor or midwife should know that you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor, and they will decide whether you should stop breastfeeding or stop taking this medication.

Driving and operating machinery

Do not drive or operate tools or machines until you know how this medication affects you.

Venlafaxina Retard Aurovitas contains sugar spheres, which contain sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Venlafaxina Retard Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, further increase it up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take venlafaxine approximately at the same time every day, either in the morning or at night. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, talk to your doctor as your dose of this medication may need to be different.

Do not stop taking this medication without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Retard Aurovitas”).

If you take more Venlafaxina Retard Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (see Other medications and Venlafaxina Retard Aurovitas).

The symptoms of a possible overdose may include palpitations, changes in alertness (ranging from drowsiness to coma), blurred vision, seizures or attacks, and vomiting.

If you forgot to take Venlafaxina Retard Aurovitas

If you have missed a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to compensate for the missed doses. Do not take more than the daily dose of venlafaxine prescribed by your doctor in a day.

If you interrupt treatment with Venlafaxina Retard Aurovitas

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such assuicidal thoughts, aggression,fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, 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 treatment with venlafaxine.This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more time.If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

If any of the following side effects occur, do not take more venlafaxine.Inform your doctor immediately, or go to the nearest hospital emergency room:

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

?Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and inflamed skin, difficulty swallowing or breathing.

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

?Pressure in the chest, breathing sounds, difficulty swallowing or breathing.

?Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).

?Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and elevated muscle enzymes (determined by blood tests).

?Signs of infection, such as fever, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can increase the risk of infection.

?Severe rash, which may lead to the formation of severe blisters and skin peeling.

?Muscle pain, aches, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

•Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeat.

Other side effects thatyou should inform your doctorare (the frequency of these side effects is included in the list below "Other side effects that may occur"):

?Cough, breathing sounds, and difficulty breathing, which may be accompanied by a fever.

?Black stools (melena) or blood in stools.

?Itching, yellow eyes or skin, dark urine, which may be symptoms of liver inflammation (hepatitis).

?Heart problems, such as rapid or irregular heartbeat, increased blood pressure.

?Eye problems, such as blurred vision, dilated pupils.

?Nerve problems, such as dizziness, numbness, movement disorder (muscle spasms and rigidity), seizures, or attacks.

?Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).

?Withdrawal effects (see section "How to take Venlafaxine Retard Aurovitas, If you interrupt treatment with Venlafaxine Retard Aurovitas").

?Prolonged bleeding, if you cut or injure yourself, may take a little longer than usual to stop bleeding.

Do not worry if you see white pellets or small granules in your stools after taking this medication. Inside the capsules of Venlafaxine Retard Aurovitas, there are spheroids (small white pellets) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is eliminated in the stool. Therefore, although you see spheroids in the stool, the dose of the medication has been absorbed.

Other side effects that may occur

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

?Dizziness, headache, somnolence.

?Insomnia.

?Nausea, dry mouth, constipation.

?Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

?Decreased appetite.

?Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.

?Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone.

?Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.

?Tinnitus (ringing in the ears).

?Rapid heartbeat, palpitations.

?Increased blood pressure, hot flashes.

?Difficulty breathing, yawning.

?Vomiting, diarrhea.

?Mild skin rash, itching.

?Increased frequency of urination, inability to urinate, difficulty urinating.

?Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).

?Weakness (asthenia), fatigue, chills.

?Weight gain or loss.

?Increased cholesterol.

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

?Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).

?Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, grinding of teeth.

?Fainting, involuntary muscle movements, alteration of coordination and balance.

?Feeling dizzy (especially when standing up too quickly), decreased blood pressure.

?Vomiting blood, black stools (melena) or blood in stools, which may be a sign of internal bleeding.

?Sensitivity to sunlight, petechiae, abnormal hair loss.

?Inability to control urination.

?Rigidity, spasms, and involuntary muscle movements.

?Mild changes in liver enzyme levels.

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

?Seizures or attacks.

?Cough, breathing sounds, and lack of breath that may be accompanied by a fever.

?Disorientation and confusion, often accompanied by hallucinations (delirium).

?Excessive water intake (known as SIADH).

?Decreased sodium levels in the blood.

?Severe eye pain and reduced or blurred vision.

?Abnormal heartbeat, rapid or irregular heartbeat, which may lead to fainting.

?Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).

?Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

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

?Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of petechiae or bleeding.

?Abnormal milk production.

?Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or unexpected petechiae or vessel rupture (broken veins).

Frequency not known (cannot be estimated from available data)

?Suicidal ideation and behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. "What you need to know before starting to take Venlafaxine Retard Aurovitas").

?Aggression.

?Dizziness.

?Postpartum hemorrhage (excessive vaginal bleeding after childbirth), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, venlafaxine may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, especially if you have been taking venlafaxine for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard Aurovitas

-The active ingredient is venlafaxine. Each prolonged-release hard capsule contains 75 mg of venlafaxine (as hydrochloride).

-The other components are: sugar spheres (containing saccharose), hypromellose, talc, and ethylcellulose.

Components of the capsule:

Cap: gelatin, iron oxide red (E172), titanium dioxide (E171), and sodium lauryl sulfate.

Body: gelatin, iron oxide red (E172), titanium dioxide (E171), and sodium lauryl sulfate.

Printing ink: Shellac, iron oxide black (E172).

Appearance of the product and contents of the package

Prolonged-release hard gelatin capsule of size “1”, with the body and cap of peach opaque color, with “E” printed on the cap and “74” in the body with edible black ink, filled with white or off-white spherical or oval granules.

Venlafaxina Retard Aurovitas prolonged-release hard capsulesare available in PVC/PE/PVDC transparent-Aluminum blisters.

Package sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).