Package Insert: Information for the User

Venlabrain Retard 225 mg prolonged-release tablets

venlafaxine

Venlabrain Retard contains the active ingredient venlafaxine.

VenlabrainRetardis an antidepressant that belongs to a group of medications called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders.The exact mechanism of action of antidepressants is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

VenlabrainRetard is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), 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 more difficult to treat.

Do not takeVenlabrainRetard

-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 in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO) used to treat depression or Parkinson's disease. Taking an IMAO irreversible withVenlabrainRetard, may cause severe or potentially life-threatening side effects. Also, you should wait at least 7 days after stoppingVenlabrainRetard before taking any IMAO irreversible (see also the section “Taking Venlabrain Retard with other medicines” and the information in this section on Serotonin Syndrome).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlabrain Retard

VenlabrainRetard may cause a feeling of restlessness or difficulty sitting or being still during the first weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with this medicine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medicines 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 suicide. These thoughts may also increase when you start taking antidepressants, as all these medicines take time to work, 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 Venlabrain Retard.

It is more likely that you will have these thoughts in the following situations:

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

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

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

You may find it helpful to tell a close relative 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 getting worse, 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. You should take good care of your oral hygiene.

Diabetes

Your blood glucose levels may be affected byVenlabrainRetard, and you may need to adjust your diabetes medicines.

Sexual problems:

Medicines like Venlabrain Retard (also called SSRIs) may cause sexual symptoms (see section 4). In some cases, these symptoms may continue even after you have stopped treatment.

Children and adolescents

Venlabrain Retard should not normally be used to treat children and adolescents under 18 years old.Also, you should know that inpatients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, the doctor who prescribes this medicine may prescribe it to a patient under 18 years old if they decide it is best for the patient.If the doctor who prescribes this medicine has prescribed it to a patient under 18 years old and you want to discuss this decision, please go back 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 Venlabrain Retard. Also, the long-term effects of this medicine on growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Taking Venlabrain Retard with other medicines

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

Your doctor will decide if you can take Venlabrain Retard with other medicines.

Do not start or stop taking any medicine, including those available 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 Venlabrain Retard. Inform your doctor if you have taken these medicines in the last 14 days (IMAOs: see section “What you need to know before taking Venlabrain Retard”).
• Serotonin syndrome: a potentially life-threatening condition, or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

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, and vomiting.

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

If you think you are suffering from serotonin syndrome, inform your doctor immediately or go to the nearest hospital emergency department.

You should inform your doctor if you are taking medicines that may affect your heart rhythm.

Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, and dofetilide (used to treat abnormal heart rhythm).
• Antipsychotics such as thioridazine (see also Serotonin Syndrome above).
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections).

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

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

Taking Venlabrain Retard with food, drinks, and alcohol

VenlabrainRetard should be takenwith food (see section 4.3 “How to take Venlabrain Retard”).Do not drink alcohol during treatment with this medicine. 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

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.You should only useVenlabrainRetard after discussing with your doctor the possible benefits and risks for the unborn child.

Make sure your doctor and/or midwife know that you are takingVenlabrainRetard. When taken during pregnancy, similar medicines (called selective serotonin reuptake inhibitors: SSRIs) may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should contact your doctor and/or midwife immediately.

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

If you are taking this medicine during pregnancy, your baby may have problems breathing, as well as another symptom that may occur at birth, such as not feeding properly. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to advise you.

Venlabrain Retard passes into breast milk.There is a risk of an effect on the baby, so you should discuss this with your doctor, and theywill decide if you should stop breastfeeding or stop taking this medicine.

Driving and using machines

Do not drive or operate tools or machines until you know how Venlabrain Retard affects you.

Venlabrain Retard contains lactose

If your doctor has told you that you have a problem with certain sugars, consult with them before taking this medicine.

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

The normal 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, even more, up to a maximum dose 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 Venlabrain Retard approximately at the same time every day, either in the morning or at night.

The tablets should be swallowed whole with liquids and should not be crushed, chewed, or dissolved.

Venlabrain Retard 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 Venlabrain Retard without consulting your doctor (see section “If you interrupt treatment with Venlabrain Retard”).

If you take more Venlabrain Retard 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 put your life at risk, especially with the simultaneous taking of certain medications and/or alcohol (see Taking Venlabrain Retard with other medications).

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

If you forgot to take Venlabrain Retard

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 dose as usual.Do not take a double dose to compensate for the missed doses.Do not take more than the daily dose of Venlabrain Retard that you have been prescribed in a day.

If you interrupt treatment with Venlabrain Retard

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor believes that you no longer need Venlabrain Retard, 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 as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, anxiety, confusion, tinnitus, tingling or occasional sensations of electric discharge, 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 Venlabrain Retard. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more.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 medicationmay cause side effects, although not everyone will experience them.

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

Rare (may affect up to 1 in 100 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)

• Chest tightness, wheezing, and 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, sudden changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, and vomiting.

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

-Signs of infection, such as fever, chills, shivering, headache, sweating, or symptoms similar to the flu. 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.

-Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

• Signs and symptoms of a condition called "stress cardiomyopathy," which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.
• Excessive bleedingvaginalafter childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

Other side effects that you shouldinform your doctor(the frequency of these side effects are included in the list below "other side effects that may occur"):

• Cough, wheezing, and difficulty breathing that may be accompanied by an increased temperature.Dark or bloody deposits.
• Itching, yellow eyes and 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.
• Nervous system problems, such as dizziness, numbness, movement disorders (muscle spasms and rigidity), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity(unusual feeling of overexcitement).
• Discontinuation of treatment (see section "How to takeVenlabrainRetard, If you interrupt treatment withVenlabrainRetard").
• 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 see a tablet in your stool after taking this medication. As the tablet passes through the entire gastrointestinal tract, the venlafaxine is released slowly. The tablet structure does not dissolve and is eliminated through the stool. Therefore, although you may observe a tablet in the stool, the venlafaxine dose has been absorbed.

Other side 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)

• Loss of appetite
• Confusion; feeling disconnected from oneself and reality; decreased libido, absence of orgasm, agitation
• Nervousness, insomnia, abnormal dreams
• Tremor, 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 to automatically focus on distant objects.
• Tinnitus (ringing in the ears)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flashes
• Difficulty breathing, yawning
• Vomiting, diarrhea
• Inability to urinate, difficulty urinating, increased urination frequency
• Irregular menstrual periods: 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 100 people).

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, loss of sense of reality, abnormal orgasms; lack of feelings and emotions, feeling overexcited; teeth grinding
• Fainting, involuntary muscle movements, coordination and balance disturbances.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Bloody vomiting, dark or bloody stools that 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).

• Convulsions or seizures
• Cough, wheezing, 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 heartbeats, rapid or irregular heartbeats, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestines, liver, or pancreas).
• Itching, yellow eyes and skin, dark urine, symptoms similar to the flu, 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).

Unknown frequency (cannot be estimated from available data)

• Thoughts and behaviors of suicide, cases of suicidal thoughts or behaviors have been reported during treatment with venlafaxine or shortly after treatment (see section 2: What you need to know before starting to take Venlabrain Retard)
• Aggression
• Dizziness

VenlabrainRetardmay sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeats; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, VenlabrainRetardmay reduce blood platelet function, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may consider it appropriate to perform occasional blood tests, particularly if you have been taking VenlabrainRetardfor 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 Pharmacovigilance of Medicines for Human Use: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature..

Blister packs: store in the original packaging to protect from moisture.

Plastic bottle: keep the packaging perfectly closed to protect from moisture.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the pharmacy's Sigre Point.If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofVenlabrainRetard

The active ingredient is venlafaxine.

Each prolonged-release tablet contains 225 mg of venlafaxine (as hydrochloride).

The other components (excipients) are:

Core: mannitol (E421), povidone K-90, macrogol 400, microcrystalline cellulose(E 460(i)), anhydrous colloidal silica, magnesium stearate(E 470b).

Coating: cellulose acetate, macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin.

Appearance of the product and contents of the package

Prolonged-release tablets 225 mg: white to off-white colored, round, biconvex tablets with a diameter of 11mm and a small mark on one side.

Venlabrainretard is available in blisters of10, 14, 20, 28, 30, 42, 50, 56, 60, 100 and 500 tablets and in plastic bottles of 10, 14, 20, 28, 30, 50, 56, 60, 100 and 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain

Responsible manufacturer:

Laboratorios LICONSA, S.A.

Avda.Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

or

Winthrop Arzeinmittel GmbH

Brüningstraße 50

65926 Frankfurt am Main

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Sweden: Venlafaxin Medical Valley 75/150/225 mg prolonged-release tablets

Germany: Venlafaxin Winthroposmo 75/150/225 mg prolonged-release tablets

Denmark: Venlafaxin Medical Valley

Spain:VenlabrainRetard 75/150/225 mg prolonged-release tablets

Iceland: Venlafaxin Medical Valley 75/150/225 mgforðatöflur

Norway: Venlazid 75/150/225 mg

Last review date of this leaflet:July 2024

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