VENLAFAXINE RETARD AUROVITAS 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Aurovitas 75 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start 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 is Venlafaxine Retard Aurovitas and what is it used for
2. What you need to know before you take Venlafaxine Retard Aurovitas
3. How to take Venlafaxine Retard Aurovitas
4. Possible side effects
5. Storage of Venlafaxine Retard Aurovitas
6. Contents of the pack and other information

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

Venlafaxine Retard Aurovitas contains the active substance 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 thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, 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: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). Treating depression and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Venlafaxine Retard Aurovitas

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also 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 an irreversible MAOI with venlafaxine can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping venlafaxine before taking any irreversible MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venlafaxine Retard Aurovitas”).

Warnings and precautions

Consult your doctor or pharmacist before taking Venlafaxine Retard Aurovitas.

• If you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine 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 told you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency to bleed easily (history of bleeding disorders or if you are pregnant (see “Pregnancy and breast-feeding”)), or if you are using other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overexcited or irritable).
• If you have a history of aggressive behaviour.

Venlafaxine may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Do not drink alcohol while taking venlafaxine, as it may cause extreme drowsiness and unconsciousness. Taking it with certain medicines and/or with alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, because all these medicines take time to work, usually about 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, 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 behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should be careful with your dental hygiene.

Diabetes

Venlafaxine may affect your blood sugar levels. Therefore, the dose of your diabetes medicines may need to be adjusted.

Sexual problems

Some medicines of the same group as venlafaxine (called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years. In addition, you should know that in patients under 18 years, there is an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years when he decides that it is in the best interest of the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please contact your doctor. You should inform your doctor if any of the above symptoms occur or worsen when these patients under 18 years are taking venlafaxine. In addition, long-term safety data on growth, maturation, and cognitive and behavioural development in children and adolescents are not available.

Other medicines and Venlafaxine Retard Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor will decide whether you can take venlafaxine with other medicines.

Do not start or stop taking any medicines, including those bought without a prescription, natural remedies and herbal products, before 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 medicines in the last 14 days (MAOI: see section “What you need to know before you take Venlafaxine Retard Aurovitas”).
• Serotonin syndrome:

Treatment with venlafaxine, particularly when taken with other medicines, may cause a potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”).

Examples of these medicines include:

? Triptans (used for migraine).

? Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium.

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

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

? Medicines containing moclobemide, an MAOI (used to treat depression).

? Medicines containing sibutramine (used for weight loss).

? Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain).

? Medicines containing dextromethorphan (used to treat coughs).

? Medicines containing methadone (used for the treatment of opioid addiction or for the treatment of severe pain).

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

? Products containing St John’s Wort (also known as “Hypericum perforatum”, a herbal remedy used to treat mild depression).

? Products containing tryptophan (used for problems such as sleep and depression).

? Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a tendency to withdraw).

? Medicines containing buprenorphine. These medicines may interact with venlafaxine and you may experience symptoms such as involuntary muscle contractions, including the muscles that control eye movements, 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 heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

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

Tell your doctor immediately or go to the casualty department of the nearest hospital if you think you are experiencing serotonin syndrome.

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart beats).
• Antipsychotics such as thioridazine (see also serotonin syndrome above).
• Antibiotics such as erythromycin or moxifloxacine (used to treat bacterial infections).
• Antihistamines (used to treat allergies).

The following medicines 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 medicines containing:

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (for treating psychiatric diseases).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking Venlafaxine Retard Aurovitas with food, drinks, and alcohol

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only take venlafaxine after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking venlafaxine. When taken during pregnancy, medicines similar to venlafaxine (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you must contact your midwife and/or doctor immediately.

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

If you take venlafaxine in the last trimester of your pregnancy, you may experience an increased risk of heavy vaginal bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine so that they can advise you.

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

Driving and using machines

Do not drive or use tools or machines until you know how this medicine affects you.

Venlafaxine Retard Aurovitas contains sugar spheres, which contain sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Venlafaxine Retard Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit, which is essentially “sodium-free”.

3. How to Take Venlafaxine Retard Aurovitas

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

The recommended initial dose 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, 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 it may be necessary for your dose of this medication to be different.

Do not stop taking this medication without consulting your doctor (see section "If you stop treatment with Venlafaxine Retard Aurovitas").

If you take more Venlafaxine Retard Aurovitas than you should

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

Overdose can put your life in danger, especially with the simultaneous intake of certain medications and/or alcohol (see Other medications and Venlafaxine Retard Aurovitas).

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

If you forget to take Venlafaxine Retard Aurovitas

If you have not taken 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 single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily amount of venlafaxine that has been prescribed for you in one day.

If you stop treatment with Venlafaxine Retard Aurovitas

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes 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 too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, 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 very gradual over months or longer. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

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

4. Possible side effects

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

If any of the following effects occur, do not take venlafaxine. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

? Swelling of the face, mouth, tongue, throat, hands, or feet and/or swollen rash with itching, difficulty swallowing or breathing.

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

? Chest tightness, breathing sounds, difficulty swallowing or breathing.

? Severe skin rash, itching, or hives (elevated areas of red or pale 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 can resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

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

? Severe rash, which can lead to blistering and peeling of the skin.

? Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

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

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

Other adverse effects that you should inform your doctor aboutare (the frequency of these adverse effects is included in the list below "Other adverse effects that may occur"):

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

? Black stools (tarry) 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, tingling, movement disorder (muscle spasms and stiffness), seizures or attacks.

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

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

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

Do not worry if you notice small white balls or granules in your stools after taking this medication. Inside the Venlafaxine Retard Aurovitas capsules, there are spheroids (small white balls) 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 stools. Therefore, although you may see spheroids in the stools, the dose of the medication has been absorbed.

Other adverse effects that may occur

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

? Dizziness, headache, drowsiness.

? 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 stand still, tingling, altered taste, increased muscle tone.

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

? Ringing in the ears (tinnitus).

? Rapid heartbeat, palpitations.

? Increased blood pressure, hot flashes.

? Difficulty breathing, yawning.

? Vomiting, diarrhea.

? Mild skin rash, itching.

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

? Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence).

? Weakness (asthenia), fatigue, chills.

? Weight gain or loss.

? Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

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

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

? Fainting, involuntary muscle movements, altered coordination and balance.

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

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

? Sensitivity to sunlight, bruising, abnormal hair loss.

? Inability to control urination.

? Stiffness, spasms, and involuntary muscle movements.

? Mild changes in blood levels of liver enzymes.

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

? Seizures or attacks.

? Cough, breathing sounds, and shortness of breath that may be accompanied by a high temperature.

? 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, which can 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 that leads to an increased risk of bruising or bleeding.

? Abnormal milk production.

? Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

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

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

? Aggression.

? Vertigo.

? Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

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

Reporting of side effects

If you experience any 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 Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Venlafaxine Retard Aurovitas

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 EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine Retard Aurovitas

• The active ingredient is venlafaxine. Each prolonged-release hard capsule contains 75 mg of venlafaxine (as hydrochloride).
• The other ingredients are: sugar spheres (which contain sucrose), hypromellose, talc, and ethylcellulose.

Capsule components:

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

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

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

Appearance of the product and package contents

Hard gelatin capsule of size "1", with the body and cap of opaque peach color, with "E" printed on the cap and "74" on the body with edible black ink, filled with white or off-white spherical or oval granules.

Venlafaxine Retard Aurovitas prolonged-release hard capsules are available in PVC/PE/PVDC transparent-Aluminum blister packs.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:September 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).