VENLABRAIN RETARD 75 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Venlabrain Retard 75 mg prolonged-release tablets

venlafaxine

Contents of the pack:

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

1. What is Venlabrain Retard and what is it used for

Venlabrain Retard contains the active substance venlafaxine.

Venlabrain Retard 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 not fully understood how antidepressants work, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlabrain Retard 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 improve or may get worse and become more difficult to treat.

2. What you need to know before you start taking Venlabrain Retard

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 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 Venlabrain Retard can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Venlabrain Retard before taking any irreversible MAOI (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 pharmacist beforeyou start taking Venlabrain Retard

• If you are taking other medicines that, when taken with Venlabrain Retard, could increase the risk of developing Serotonin Syndrome (see the section "Taking Venlabrain Retard with other medicines").
• If you have problems with swallowing or have a condition that reduces your ability to swallow or pass food normally.
• 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 the blood (hyponatremia).
• If you have a history of bleeding disorders (tendency to develop bruises or tend to bleed easily), or if you are using other medicines that may increase the risk of bleeding (e.g., warfarin to prevent blood clots), or if you are pregnant (see "Pregnancy and breastfeeding").
• 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.

Venlabrain Retard 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 during treatment with this medicine, as it may cause extreme tiredness and unconsciousness. Taking it with certain medicines and/or alcohol may worsen 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 increase when you first start taking antidepressants, because all these medicines take time to work, usually around about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking Venlabrain Retard.

You are more likely to have these thoughts if:

• You have previously had thoughts of suicide or self-harm.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior 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 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 behavior.

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 oral hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlabrain Retard. The doses of your diabetes medicines may need to be adjusted.

Sexual problems

Medicines like Venlabrain Retard (also called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may continue after you stop taking the medicine.

Children and adolescents

Venlabrain Retard should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is an increased risk of side effects such as suicidal thoughts, suicidal attempts, and hostility (mainly aggression, confrontation, and irritability) when they take this type of medicine. However, your doctor may prescribe this medicine to a patient under 18 years when he decides that it is the best for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please go back to your doctor. You should tell your doctor if any of the above symptoms develop or get worse when these patients under 18 years are taking Venlabrain Retard. Also, the long-term effects of this medicine on safety, growth, maturity, cognitive, and behavioral development have not yet been demonstrated.

Taking Venlabrain Retard with other medicines

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

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

Do not start or stop taking any medicines, including those bought without a prescription, herbal or homeopathic remedies, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, must not be taken with Venlabrain Retard. Tell your doctor if you have taken these medicines in the last 14 days (MAOIs: see section "What you need to know before you take Venlabrain Retard").
• Serotonin Syndrome: a potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section "Possible side effects") may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used to treat migraine).
• Other medicines for treating depression, for example, SSRIs, SNRIs, tricyclic antidepressants, 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, a reversible MAOI (used to treat depression).
• Medicines containing sibutramine (used for weight loss).
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) (for the treatment of severe pain).
• Medicines containing dextromethorphan (used to treat coughs).
• Medicines containing methadone (used to treat addiction to opioid drugs or severe pain).
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood.
• Products containing St. John's Wort (also known as Hypericum perforatum, a herbal or homeopathic remedy used to treat mild depression).
• Products containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat disorders with symptoms such as hearing, seeing, feeling things that are not there, mistaken beliefs, unusual suspicions, confused reasoning, and withdrawal into oneself).

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, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, Serotonin Syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (analyzed through a blood test).

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

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

These include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol, and dofetilide (used to treat irregular heartbeat).
• 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 Venlabrain Retard and should be used with caution. It is especially important to tell 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 to treat high blood pressure and heart problems)

Taking Venlabrain Retard with food, drinks, and alcohol

Venlabrain Retard should be taken with 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 tiredness and unconsciousness, and 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only use Venlabrain Retard after discussing the potential benefits and risks to the unborn child with your doctor.

Make sure your doctor and/or midwife know you are taking Venlabrain Retard. When similar medicines (called selective serotonin reuptake inhibitors: SSRIs) are taken during pregnancy, there is a potential increased risk that the baby will develop a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually start during 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 last few months of your pregnancy, you may have 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 Venlabrain Retard so they can advise you.

If you are taking this medicine during pregnancy, your baby may have problems with breathing, as well as other symptoms when born, such as not feeding properly. 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.

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

Driving and using machines

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

Venlabrain Retard contains lactose

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

3. How to take Venlabrain Retard

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

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 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 at approximately the same time each day, either in the morning or in the evening.

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 you may need to take a different dose of this medicine.

Do not stop taking Venlabrain Retard without talking to your doctor (see section "If you stop taking 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see "Taking Venlabrain Retard with other medicines").

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

If you forget to take Venlabrain Retard

If you miss 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 a single dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily dose of Venlabrain Retard that has been prescribed for you in one day.

If you stop taking Venlabrain Retard

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks you no longer need Venlabrain Retard, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly.

Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, anxiety, confusion, ringing in the ears, tingling or sensations of electric shock, in rare cases, 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 taking Venlabrain Retard. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual over several months or more. If you experience any of these or other symptoms that are troublesome, consult your doctor for further advice.

If you have any other questions on 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 all people suffer from them.

If any of the following effects occur, do not take more Venlabrain Retard. Inform your doctor immediately or go to 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, wheezing, and 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, tachycardia, increased body temperature, sudden changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, tachycardia, sweating, severe muscle stiffness, confusion, increased muscle enzymes (analyzed through 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 the formation of severe blisters and skin peeling.
• 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" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

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

• Cough, wheezing, and difficulty breathing that may be accompanied by an increased temperature. Dark or bloody stools.
• Itching, yellowing of the 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.
• Nervous system problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Effect of treatment interruption (see section "How to take Venlabrain Retard, If you interrupt treatment with Venlabrain Retard").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than normal for the bleeding to stop.

Do not worry if you see a tablet in your stool after taking this medicine. As the tablet passes through the entire gastrointestinal tract, the venlafaxine is released slowly. The structure of the tablet does not dissolve and is eliminated in the stool. Therefore, even if you see a tablet in your stool, the venlafaxine dose 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 disconnected from oneself and reality; decreased libido, absence of orgasm, agitation
• Nervousness, insomnia, abnormal dreams
• Tremors, feeling of restlessness or inability to stay seated or still, tingling, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability to automatically focus on changing objects from far to near.
• Ringing in the ears (tinnitus)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flashes
• Difficulty breathing, yawning
• Vomiting, diarrhea
• Inability to urinate, difficulty urinating, increased urination frequency
• Menstrual irregularities: 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, loss of sense of reality, abnormal orgasms; lack of feelings and emotions, feeling of overexcitement; teeth grinding
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Bloody vomiting, dark or bloody stools, which may be a sign of internal bleeding
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urine.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes, sodium, or cholesterol.

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

• Seizures or convulsions
• Cough, breathing noise, 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, rapid, or irregular heartbeat, which can 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 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 bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding 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 available data)

• Suicidal thoughts and behaviors, 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 taking Venlabrain Retard)
• Aggression
• Dizziness

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlabrain Retard

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

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

This medicine does not require any special storage temperature.

Blisters: store in the original packaging to protect it from moisture.

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

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

6. Additional information

Composition of Venlabrain Retard

The active ingredient is venlafaxine.

Each prolonged-release tablet contains 75 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 packaging content

Prolonged-release tablets 75 mg: white or almost white, round, biconvex tablets with a diameter of 7.5 mm and a small mark on one side.

Venlabrain retard 75 mg is available in blisters of 10, 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, 105, 106, 110, and 500 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

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

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

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

Denmark: Venlafaxin Medical Valley

Spain: Venlabrain Retard 75/150/225 mg prolonged-release tablets

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

Norway: Venlazid 75/150/225 mg

Date of the last revision of this prospectus:July 2024

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