Venlafaxine retard Aurovitas 150 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Retard Aurovitas 150 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Venlafaxine Retard Aurovitas is and what it is used for
2. What you need to know before taking Venlafaxine Retard Aurovitas
3. How to take Venlafaxine Retard Aurovitas
4. Possible side effects
5. How to store Venlafaxine Retard Aurovitas
6. Contents of the pack and other information

1. What Venlafaxine Retard Aurovitas is and what it is 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 believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. The way antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

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

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

Do not take Venlafaxine Retard Aurovitas

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken within the last 14 days a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may cause serious, potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before starting any irreversible MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venlafaxine Retard Aurovitas”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine Retard Aurovitas.

• If you are using other medicines that, when taken together 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 that your heart rhythm is abnormal.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to bruise easily or a tendency to bleed easily (history of bleeding disorders or if you are pregnant (see “Pregnancy and breastfeeding”)), or if you are taking 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 someone in your family has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behaviour.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stand 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 tiredness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Suicidal thoughts 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 yourself or committing suicide. These thoughts may increase when you first start taking antidepressants because all these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with venlafaxine.

This is more likely to happen if:

• You have previously had thoughts of suicide or self-harm.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric illnesses who were treated with antidepressants.

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

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 may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned 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 (cavities). Therefore, you should take care with your dental hygiene.

Diabetes

Venlafaxine may affect your blood glucose levels. Therefore, it may be necessary to adjust the doses of your diabetes medications.

Sexual problems

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

Children and adolescents

Venlafaxine should not normally be used to treat children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is the most appropriate for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine. In addition, the long-term safety with regard to growth, maturation, and cognitive and behavioural development has not been established.

Other medicines and Venlafaxine Retard Aurovitas

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

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

Do not start or stop taking any medicine, including those available without a prescription, herbal remedies, or plant-based products, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson’s disease must not be taken with venlafaxine. Tell your doctor if you have taken any of these medicines within the last 14 days (MAOI: see section “What you need to know before taking Venlafaxine Retard Aurovitas”).
• Serotonin syndrome:

Treatment with venlafaxine, particularly when taken with other medicines, may lead to 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 to treat 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 cough).

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

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

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

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

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

? Medicines containing buprenorphine. These medicines may interact with venlafaxine and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling 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.

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, diarrhoea, coma, nausea, vomiting.

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

Contact your doctor immediately or go to the nearest hospital emergency department 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:

• 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 medicines may also interact with venlafaxine and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat 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 during treatment with venlafaxine. Taking it together with alcohol may cause extreme tiredness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Ensure that your midwife and/or doctor know that you are taking venlafaxine. Medicines similar to venlafaxine (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after the baby’s birth. If this happens to your baby, 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 at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take venlafaxine in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether to discontinue breastfeeding or discontinue treatment with this medicine.

Driving and using machines

Do not drive or operate tools or machinery until you know how this medicine affects you.

Venlafaxine Retard Aurovitas contains sugar spheres containing sucrose

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

Venlafaxine Retard Aurovitas contains sodium

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

3. How to take Venlafaxine Retard Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual recommended starting 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 at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Retard Aurovitas”).

If you take more Venlafaxine Retard Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

Overdose can be life-threatening, especially when taken together with certain medicines and/or alcohol (see Other medicines and Venlafaxine Retard Aurovitas).

Symptoms of a possible overdose may include palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Retard Aurovitas

If you have missed 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. Do not take more than the daily amount of venlafaxine prescribed for you in one day.

If you stop taking Venlafaxine Retard Aurovitas

Do not stop taking this medicine or reduce the dose without your doctor's advice, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking this medicine, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If any of the following effects occur, stop taking venlafaxine immediately and contact your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

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

? Severe skin rash, itching, or hives (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, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected 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 may progress to the formation of severe blisters 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 available data)

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

Other adverse effects that you should report to your doctor (the frequency of these adverse effects is included in the list below, “Other possible adverse effects”):

? Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.

? Black (tarry) stools or blood in the stool.

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

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

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

? Nerve-related problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits.

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

? Withdrawal effects (see section “How to take Venlafaxine Retard Aurovitas” and “If you stop taking Venlafaxine Retard Aurovitas”).

? Prolonged bleeding—if you are cut or injured, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice white balls or small granules in your stools after taking this medicine. Inside the capsules of Venlafaxine Retard Aurovitas are spheroids (small white balls) containing the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is excreted in the stool. Therefore, even if you see spheroids in your stool, the dose of medicine 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, inability to reach orgasm, decreased libido, agitation, restlessness, abnormal dreams.

? Tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.

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

? Ringing in the ears (tinnitus).

? Rapid heartbeat, palpitations.

? Increased blood pressure, hot flushes.

? Difficulty breathing, yawning.

? Vomiting, diarrhea.

? Mild skin rash, itching.

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

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

? Weakness (asthenia), fatigue, chills.

? Weight gain or weight loss.

? Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

? Hyperactivity, racing thoughts, and reduced need for sleep (mania).

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

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

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

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

? Sensitivity to sunlight, bruising, abnormal hair loss.

? Inability to control urination.

? Muscle stiffness, spasms, and involuntary muscle movements.

? Slight changes in blood levels of liver enzymes.

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

? Seizures or fits.

? Cough, noisy breathing, and shortness of breath, which may be accompanied by high temperature.

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

? Excessive water intake (known as SIADH).

? Decreased levels of sodium in the blood.

? Severe eye pain and reduced or blurred vision.

? Abnormal, fast 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, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs 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 bruising or bleeding.

? Abnormal production of breast milk.

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

Frequency not known (cannot be estimated from available data)

? Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before taking Venlafaxine Retard Aurovitas”).

? Aggressiveness.

? Vertigo.

? Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight 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 wish to carry out occasional blood tests, especially if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Retard Aurovitas

• The active substance is venlafaxine. Each prolonged-release hard capsule contains 150 mg of venlafaxine (as hydrochloride).
• The other components are: sugar spheres (containing sucrose), hypromellose, talc and ethylcellulose.

Capsule components:

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, black iron oxide (E172).

Appearance of the product and contents of the pack

Hard gelatin capsule of size "0", with dark orange body and cap, printed with "E" on the cap and "89" on the body in edible black ink, filled with white or almost white spherical or oval granules.

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

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

Only some pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain:	Venlafaxine Retard Aurovitas 150 mg prolonged-release hard capsules EFG
Portugal:	Venlafaxine Aurovitas

Date of the most recent review of this leaflet: September 2023

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