Package Insert: Information for the User

Venlafaxine Extended-Release 75 mg Hard Capsules EFG

Read the entire package insert carefully before starting to take the medication

• Keep this package insert, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What is Venlafaxine Extended-Release and for what it is used

2. Before taking Venlafaxine Extended-Release

3. How to take Venlafaxine Extended-Release

4. Possible adverse effects

5. Storage of Venlafaxine Extended-Release

6. Additional Informationl

Venlafaxina Retard Vir is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or anxious have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxina Retard Vir is a treatment for adults with depression. Venlafaxina Retard Vir is also a treatment for adults with the following anxiety disorder: social anxiety disorder (fear or avoidance of social situations). 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 take Venlafaxina Retard Vir

• If you are allergic (hypersensitive) to venlafaxine or to any of the other components of Venlafaxina Retard Vir.
• If you are also taking or have taken in the last 14 days, any medication known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with other medications, such as Venlafaxina Retard Vir, may produce severe or potentially fatal side effects. Additionally, you must wait at least 7 days after stopping Venlafaxina Retard Vir before taking any IMAO irreversible (see also the sections “Serotonin syndrome” and “Use of other medications”).

Be especially careful with Venlafaxina Retard Vir

• If you are taking other medications that, when taken at the same time as Venlafaxina Retard Vir, may increase the risk of developing serotonin syndrome (see the section “Use of other medications”).
• If you have eye problems, such as certain types of glaucoma (increased eye pressure).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of seizures (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop bleeding or bruising easily (history of hemorrhagic disorders), if you are taking other medications that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy”).
• If your cholesterol levels are high.
• 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.

Venlafaxina Retard Vir may cause restlessness or difficulty sitting or staying still. You should consult your doctor if this happens.

If you can apply any of these situations, consult your doctor before taking Venlafaxina Retard Vir.

Do not drink alcohol during treatment with Venlafaxina Retard Vir, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications 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 committing suicide. This may be more likely to happen:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial information 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 committing suicide at any time, contact your doctor or go to the hospital directly.

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 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. Therefore, you should take care of your dental hygiene.

Use in children and adolescents under 18 years of age

Venlafaxina Retard Vir should not be used normally in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes Venlafaxina Retard Vir may prescribe it to patients under 18 years of age when they decide it is the best option for the patient. If the doctor who prescribes Venlafaxina Retard Vir has prescribed it to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years of age who are taking Venlafaxina Retard Vir. Additionally, the long-term effects of Venlafaxina Retard on safety and those related to growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Your doctor must decide if you can take Venlafaxina Retard Vir with other medications.

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

• Irreversible monoamine oxidase inhibitors (IMAO: see section “Before taking Venlafaxina Retard Vir”).
• Serotonin syndrome: Serotonin syndrome, a potentially fatal state (see section “Possible Adverse Effects”), may occur with treatment with venlafaxine, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraines)
• Medications to treat depression, such as ISRN, ISRS, tricyclic antidepressants, or medications containing lithium
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, a reversible IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing tramadol (a pain reliever)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal supplement used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression).

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, vomiting. Seek medical attention immediately if you think you are experiencing serotonin syndrome.

The following medications may also interact with Venlafaxina Retard Vir and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

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

Taking Venlafaxina Retard Vir with food and drinks

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

Do not drink alcohol during treatment with Venlafaxina Retard Vir. 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

Pregnancy

Inform your doctor if you become pregnant or are trying to become pregnant. You should only take Venlafaxina Retard Vir after discussing the possible benefits and risks for the unborn child with your doctor.

If you are taking Venlafaxina Retard Vir during pregnancy, tell your midwife and/or doctor as your baby may have some symptoms when born. These symptoms usually start within the first 24 hours after the baby is born. These include feeding problems and breathing problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

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

Breastfeeding

Venlafaxina Retard passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor and they will decide if you should stop breastfeeding or stop taking Venlafaxina Retard Vir.

Warnings and precautions

Some medications in the group to which venlafaxine belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Driving and operating machinery

During treatment with Venlafaxina Retard Vir, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Venlafaxina Retard Vir affects you.

Follow exactly the administration instructions for Venlafaxina Retard Vir as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual recommended initial dose for the treatment of depression and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, further increase it up to a maximum of 375 mg per day for depression. The maximum dose for social anxiety disorder is 225 mg/day.

Take Venlafaxina Retard Vir approximately at the same time every day, either in the morning or at night. The capsules must be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Retard Vir should be taken with food.

If you have liver or kidney problems, talk to your doctor as your dose of Venlaxina Retard Vir may need to be different.

Do not stop taking Venlafaxina Retard Vir without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Retard Vir”).

If you take more Venlafaxina Retard Vir than you should

Call your doctor or pharmacist immediately if you take more than the prescribed dose of Venlafaxina Retard Vir. You can also contact the Toxicology Information Service, phone 91562 04 20, indicating the medication and the amount taken.

Overdose can be life-threatening, especially when taken with certain medications and/or alcohol (see Taking Venlafaxina Retard Vir with other medications).

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

If you forgot to take Venlafaxina Retard Vir

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 one dose as usual. Do not take more than the daily dose of Venlafaxina Retard Vir prescribed to you in a day.

If you interrupt treatment with Venlafaxina Retard Vir

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need Venlafaxina Retard Vir, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using Venlafaxina Retard, especially when stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as fatigue, dizziness, lack of stability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard Vir. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

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

Like all medications, Venlafaxina Retard Vir may cause side effects, although not everyone will experience them.

Do not worry if you see a small tablet in your stool after taking Venlafaxina Retard Vir. Inside the capsules of Venlafaxina Retard Vir, there is a small tablet that contains the active ingredient venlafaxine. This tablet is released from the capsule in the gastrointestinal tract. As it moves along the length of the gastrointestinal tract, venlafaxine is released slowly. The "shell" of the tablet remains undissolved and is eliminated in the stool. Therefore, although you may see a tablet in your stool, your dose of venlafaxine has been absorbed.

Allergic Reactions

If you experience any of the following effects, do not take more Venlafaxina Retard Vir. Inform your doctor immediately, or go to the nearest hospital emergency room:

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet.
• Feeling nervous or anxious, dizziness, stabbing sensations, sudden redness of the skin, and/or a feeling of heat.
• Rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).

Severe Side Effects

If you notice any of the following signs, you may need urgent medical attention:

• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: dizziness, numbness, movement disorders, convulsions, or seizures.
• Psychiatric problems, such as hyperactivity and euphoria.
• Withdrawal from treatment (see "How to Take Venlafaxina Retard Vir, If You Interrupt Treatment with Venlafaxina Retard Vir").

Complete List of Side Effects

The frequency (possibility of occurrence) of side effects is classified as follows:

• Blood Disorders

Uncommon:appearance of petechiae, black stools, or blood in the stool,

which may be a sign of internal bleeding.

Unknown:reduced platelet count in the blood, leading to an increased risk of petechiae or bleeding; blood disorders that may increase the risk of infection.

• Metabolic/Nutritional Disorders

Common:weight loss, increased cholesterol.

Uncommon:weight gain.

Unknown:slight changes in liver enzyme levels in the blood; decreased sodium levels in the blood; itching, yellow eyes or skin, dark urine, or flu-like symptoms, which

are symptoms of liver inflammation (hepatitis); confusion, excessive water intake (known as syndrome of inappropriate antidiuretic hormone secretion - SIADH); abnormal milk production.

• Nervous System Disorders:

Very Common:dry mouth, headache.

Common:abnormal dreams; decreased libido; dizziness; muscle tension; insomnia;

nervousness; numbness; sedation; tremors; confusion; feeling detached (or disconnected) from oneself and reality.

Uncommon:lack of emotions or feelings; hallucinations; involuntary muscle movements; agitation; balance and coordination disorders.

Rare:a feeling of restlessness or inability to sit or remain still; convulsions or seizures; overexcitement or euphoria.

Unknown:high temperature with rigid muscles, confusion, or agitation, and sweating, or if you experience involuntary, jerky muscle movements that you cannot control, these may be symptoms of severe conditions known as neuroleptic malignant syndrome; euforic feelings, drowsiness,

rapid, sustained eye movements, clumsiness, restlessness, feeling drunk, sweating, or rigid muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); rigidity, spasms, and involuntary muscle movements; thoughts of self-harm or suicide.

• Eye and Ear Disorders

Common:blurred vision.

Uncommon:altered taste perception, ringing in the ears (tinnitus).

Unknown:severe eye pain and reduced or blurred vision.

• Cardiac and Circulatory Disorders

Common:increased blood pressure, hot flashes, palpitations.

Uncommon:feeling dizzy (especially when standing up too quickly), fainting, rapid heartbeat.

Unknown:decreased blood pressure; abnormal heart rhythm, rapid, or irregular heartbeat, which may lead to fainting.

• Respiratory System Disorders

Common:yawns.

Unknown:coughing, difficulty breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (eosinophilic pneumonia).

• Digestive System Disorders

Very Common:nausea.

Common:decreased appetite, constipation, vomiting.

Uncommon:bruxism, diarrhea.

Unknown:severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas).

• Skin Disorders

Very Common:sweating (including night sweats).

Uncommon:skin rash, abnormal hair loss.

Unknown:skin rash that may lead to severe blisters and peeling of the skin; itching;

skin rash, mild.

• Musculoskeletal Disorders

Unknown:unexplained muscle pain, muscle weakness, or stiffness (rhabdomyolysis).

• Urinary System Disorders

Common:difficulty urinating; increased frequency of urination.

Uncommon:inability to urinate.

• Sexual and Reproductive Disorders

Common:abnormal ejaculation/orgasm (men), lack of orgasm, erectile dysfunction

(impotence); irregular menstrual periods, such as increased bleeding or irregular bleeding.

Uncommon:abnormal orgasm (women).

Unknown:excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

• General

Common:weakness (asthenia), chills.

Uncommon:sensitivity to sunlight.

Unknown:swelling of the face or tongue, shortness of breath, or difficulty breathing, often with skin eruptions (this may be a severe allergic reaction).

Venlafaxina Retard Vir may sometimes cause unwanted effects of which you may not be aware, such as increased blood pressure or abnormal heart rhythm; slight changes in liver enzyme levels, sodium, or cholesterol levels in the blood. Less frequently, Venlafaxina Retard Vir may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard for a long time.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Venlafaxine Extended-Release after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in a dry place.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Venlafaxina Retard Vir 75 mg prolonged-release hard capsules

The active ingredient is venlafaxine. Each capsule contains 75 mg of venlafaxine hydrochloride.

The other components are: hydroxypropyl methylcellulose, Eudragit RS 100, sodium lauryl sulfate, magnesium stearate, Eudragit E 12.5, titanium dioxide (E 171), iron oxide red (E 172), and gelatin.

Appearance of the product and contents of the package

Venlafaxina Retard Vir 75 mg is presented in the form of prolonged-release hard capsules. The capsules are hard gelatin capsules with a pale pink color, size 0, containing two rounded biconvex tablets.

Venlafaxina Retard Vir 75 mg is presented in packages containing 30 prolonged-release hard capsules.

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70.Industrial Estate URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing:

Pharmathen Farmaceutica Industry

6, Dervenakion Str

16351 - Greece

This leaflet has been reviewed in May 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.