Venlabrain Retard 300 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlabrain Retard 300 mg prolonged-release tablets

venlafaxine

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Venlabrain Retard is and what it is 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. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline in the brain.

Venlabrain Retard is a treatment for depression in adults. It 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 Venlabrain Retard

Do not take Venlabrain Retard

• If you are allergic to venlafaxine or 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 any medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlabrain Retard may cause serious or even potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping Venlabrain Retard before starting any irreversible MAOI (see also section “Taking Venlabrain Retard with other medicines” and the information in this section on “Serotonin Syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting Venlabrain Retard

• If you are taking other medicines that, when combined with Venlabrain Retard, could increase the risk of developing serotonin syndrome (see section “Taking Venlabrain Retard with other medicines”).
• If you have swallowing difficulties or intestinal or stomach disorders that reduce your ability to swallow or evacuate 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 been told you have an irregular heartbeat.
• If you have a history of heart problems.
• 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 bruise easily or tendency to bleed easily), or if you are taking 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 a family member 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 an inability to sit or stay still during the first few weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with this medicine, as it may cause extreme drowsiness 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, as 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 Venlabrain Retard.

You are more likely to have these types of thoughts in the following situations:

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

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

Dry mouth

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

Diabetes

Your blood glucose levels may be affected by Venlabrain Retard, and doses of diabetes medications may need adjustment.

Sexual problems

Some medicines in the class to which Venlabrain Retard belongs (called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlabrain Retard should not normally be used in the treatment of 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 ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to a patient 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 must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlabrain Retard. Furthermore, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of this medicine have not yet been established.

Taking Venlabrain Retard with other medicines

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

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

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

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

Examples of such medicines include:

• Triptans (used to treat migraine).
• Other medicines to treat 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, meperidine, or pentazocine) (for treatment of severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used to treat opioid drug addiction or severe pain).
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood).
• Herbal products containing St. John’s wort (also known as Hypericum perforatum, a natural or herbal 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, or feeling things that are not there, false beliefs, unusual suspiciousness, confused thinking, and social withdrawal).

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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, tachycardia, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood test).

If you think you are experiencing serotonin syndrome, contact 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 such 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).
• 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 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 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 together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only use Venlabrain Retard after discussing with your doctor the potential benefits and possible risks to the unborn child.

Make sure your doctor and/or midwife know that you are taking Venlabrain Retard. When similar medicines (called serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your doctor and/or midwife immediately.

If you take Venlabrain Retard 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 know you are taking Venlabrain Retard so they can advise you.

If you take this medicine during pregnancy, your baby may have breathing difficulties and other symptoms at birth, such as poor feeding. 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 effects on the baby; therefore, you should discuss the case with your doctor, who will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

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

Venlabrain Retard contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Venlabrain Retard contains lactose

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

3. How to take Venlabrain Retard

Follow exactly the instructions for the use of this medicine given by your doctor or pharmacist. If in 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 once daily. Your doctor may gradually increase the dose and, if necessary, further up to a maximum dose of 375 mg daily for depression.

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

The tablets must be swallowed whole with liquid and must not be crushed, chewed, or dissolved.

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

If you take more VenlabrainRetard than you should

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

Overdose can be life-threatening, especially when taken simultaneously with certain medications and/or alcohol (see section "Taking Venlabrain Retard with other medicines").

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 Venlabrain Retard

If you have missed a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily amount of Venlabrain Retard prescribed for you in one day.

If you stop taking Venlabrain Retard

Do not stop taking your medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you no longer need Venlabrain Retard, they may instruct you to gradually reduce the dose before stopping the treatment completely. Adverse effects are known to occur when people discontinue this medicine, especially if it is stopped suddenly or the dose is reduced too quickly.

Some patients may experience symptoms such as suicidal thoughts, aggressiveness, tiredness, dizziness, loss of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, anxiety, confusion, tinnitus, tingling sensations or electric shock-like feelings, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlabrain Retard. This process may take several weeks or months. In some patients, discontinuation may need to be carried out very gradually over several 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 will experience them.

If you experience any of the following effects, stop taking Venlabrain Retard immediately and inform your doctor right away 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 itchy raised rash, 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 (raised red or pale areas of 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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, tachycardia, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected via 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.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage). See “Pregnancy and breastfeeding” 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, which may be accompanied by 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 disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems such as hyperactivity (unusual feeling of over-excitement).
• Effects due to discontinuation of treatment (see section “How to take Venlabrain Retard, If you stop taking Venlabrain Retard”).
• Prolonged bleeding: if you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be alarmed if you see a tablet in your faeces after taking this medicine. As the tablet passes through the entire gastrointestinal tract, venlafaxine is slowly released. The tablet structure does not dissolve and is excreted in the faeces. Therefore, even if you observe a tablet in your faeces, the dose of venlafaxine 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 detached from oneself and reality; decreased libido, absence of orgasm, agitation
• Nervousness, insomnia, abnormal dreams
• Tremor, restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability to automatically focus when shifting from distant to near objects.
• Ringing in the ears (tinnitus)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flushes
• Difficulty breathing, yawning
• Vomiting, diarrhoea
• Inability to urinate, difficulty urinating, increased frequency of urination
• Menstrual irregularities: 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, loss of sense of reality, abnormal orgasms; lack of feelings and emotions, feeling of over-excitement; teeth grinding
• Fainting, involuntary muscle movements, loss of coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, dark or bloody stools, which may be signs 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 bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and behaviours: cases of suicidal thoughts or behaviours have been reported during treatment with venlafaxine or immediately after treatment (see section 2: What you need to know before taking Venlabrain Retard).
• Aggression
• Vertigo

Venlabrain Retard sometimes causes 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, 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 carry out occasional blood tests, especially if you have been taking Venlabrain Retard for a long time.

Reporting of adverse effects:

If you experience any adverse effect, consult 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature.

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed over to the Sigre Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Venlabrain Retard

The active substance is venlafaxine.

Each prolonged-release tablet contains 300 mg of venlafaxine (as hydrochloride).

The other components (excipients) are:

Mannitol (E421), povidone, macrogol, microcrystalline cellulose (E 460(i)), colloidal anhydrous silica, magnesium stearate (E 470b), cellulose acetate, hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin.

Appearance of the product and contents of the pack

Prolonged-release tablets 300 mg: white/whitish, round tablets.

Venlabrain Retard is available in blister packs containing 10, 14, 20, 28, 30, 42, 50, 56, 60, 98, 100 and 500 tablets.

Only certain 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 Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Sweden: Venlafaxin Medical Valley 300 mg depottabletter
Denmark: Venlafaxin Medical Valley
Spain: Venlabrain Retard 300 mg prolonged-release tablets
Iceland: Venlafaxin Medical Valley 300 mg forðatöflur
Norway: Venlazid 300 mg

This leaflet was approved in: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS): http://www.aemps.gob.es/