Venlafaxine prolonged-release Vir 37.5 mg prolonged-release capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlafaxine Retard Vir 37.5 mg prolonged-release hard capsules

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Venlafaxine Retard Vir is and what it is used for
2. Before you take Venlafaxine Retard Vir
3. How to take Venlafaxine Retard Vir
4. Possible side effects
5. How to store Venlafaxine Retard Vir
6. Further information

1. What Venlafaxine Retard Vir is and what it is used for

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

Venlafaxine Retard Vir is a treatment for depression in adults. Venlafaxine Retard Vir is also a treatment for the following anxiety disorder in adults: social anxiety disorder (fear of, or avoidance of, social situations). 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. Before taking Venlafaxine Retard Vir

Do not take Venlafaxine Retard Vir

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

Take special care with Venlafaxine Retard Vir

• If you are using other medicines that, when taken together with Venlafaxine Retard Vir, could increase the risk of developing serotonin syndrome (see section “Use with other medicines”).
• 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 a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), if you are taking other medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy”).
• If your cholesterol levels increase.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine Retard Vir may cause a feeling of restlessness or difficulty sitting or standing still. You should consult your doctor if this occurs.

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

Do not drink alcohol during treatment with Venlafaxine Retard Vir, 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. This risk may increase when starting antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had thoughts of suicide or 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 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.

It may be helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

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 dental hygiene.

Use in children and adolescents under 18 years of age

Venlafaxine Retard Vir 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 Venlafaxine Retard Vir to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Venlafaxine Retard Vir to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlafaxine Retard Vir. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of Venlafaxine Retard have not yet been established.

Use with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Your doctor must decide whether you can take Venlafaxine Retard Vir with other medicines.

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

• Monoamine oxidase inhibitors (MAOIs) (see section “Before taking Venlafaxine Retard Vir”).
• Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition (see section “Possible Side Effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of such medicines include:

• triptans (used for migraine)
• medicines to treat depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• 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 tramadol (an analgesic)
• products containing St. John’s wort (also called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)
• products containing tryptophan (used for problems such as sleep and depression).

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 immediate medical attention if you think you are experiencing serotonin syndrome.

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

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

Taking Venlafaxine Retard Vir with food and drinks

Venlafaxine Retard Vir should be taken with food (see section 3 “HOW TO TAKE VENLAFAXINE RETARD VIR”).

Do not drink alcohol during treatment with Venlafaxine Retard Vir. 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

Pregnancy

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

If you are taking Venlafaxine Retard Vir during pregnancy, tell your midwife and/or doctor, as your baby may experience some symptoms after birth. These symptoms usually begin within the first 24 hours after birth. They include feeding difficulties and breathing problems. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

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

Breastfeeding

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

Warnings and precautions

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

Driving and use of machines

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

3. How to take Venlafaxine Retard Vir

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

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

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

Venlafaxine Retard Vir should be taken with food.

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

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

If you take more Venlafaxine Retard Vir than you should

Contact your doctor or pharmacist immediately if you take more Venlafaxine Retard Vir than prescribed. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

Overdose may be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Taking Venlafaxine Retard Vir 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 Venlafaxine 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 your usual single dose as scheduled. Do not take more than the daily amount of Venlafaxine Retard Vir that has been prescribed for you in one day.

If you stop treatment with Venlafaxine Retard Vir

Do not stop taking your medication or reduce the dose without consulting your doctor, even if you feel better.

If your doctor considers that you no longer need Venlafaxine Retard Vir, they may advise you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people discontinue Venlafaxine Retard, particularly if it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard Vir. 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Venlafaxine Retard Vir may cause adverse effects, although not everyone experiences them.

Do not be concerned if you notice a small tablet in your faeces after taking Venlafaxine Retard Vir. Inside the Venlafaxine Retard Vir capsules there is a small tablet containing the active substance venlafaxine. This tablet is released from the capsule in the gastrointestinal tract. As it moves along the gastrointestinal tract, venlafaxine is slowly released. The tablet's "shell" remains undissolved and is excreted in the faeces. Therefore, even though you may see a tablet in your faeces, your dose of venlafaxine has been absorbed.

Allergic reactions

If any of the following effects occur, stop taking Venlafaxine Retard Vir and contact your doctor immediately or go to the nearest hospital emergency department:

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands or feet.
• Feeling nervous or anxious, dizziness, prickling sensations, sudden reddening of the skin and/or a sensation of warmth.
• Severe rash, itching or hives (raised, red or pale areas of skin that are often itchy).

Serious adverse effects

If you notice any of the following signs, you may require 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: such as dizziness, tingling, movement disorders, seizures or fits.
• Psychiatric problems, such as hyperactivity and euphoria.
• Withdrawal symptoms (see section "HOW TO TAKE VENLAFAXINE RETARD VIR, If you stop taking Venlafaxine Retard Vir").

Complete list of adverse effects

The frequency (likelihood of occurrence) of adverse effects is classified as follows:

Very common	Affects more than 1 in 10 patients
Common	Affects between 1 and 10 in 100 patients
Uncommon	Affects between 1 and 10 in 1,000 patients
Rare	Affects between 1 and 10 in 10,000 patients
Unknown	Frequency cannot be estimated from the available data

• Blood disorders

Uncommon: appearance of bruises, tarry stools (faeces), or blood in the stools, which may be signs of internal bleeding.

Unknown: reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which may lead to an increased risk of infection.

• Metabolism and nutritional disorders

Frequent: weight loss, increased cholesterol.

Uncommon: weight gain.

Unknown: slight changes in blood levels of liver enzymes; decreased blood sodium levels; itching, yellowing of the 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 production of breast milk.

• Nervous system disorders

Very frequent: dry mouth, headache.

Frequent: abnormal dreams; decreased libido; dizziness; increased muscle tone; insomnia; restlessness; tingling; sedation; tremors; confusion; feeling detached (or separated) from oneself and reality.

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

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

Unknown: high temperature with stiff muscles, confusion or agitation, and sweating; or if you experience jerky, uncontrolled muscle movements—these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, rapid sustained eye movements, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); rigidity, spasms, and involuntary muscle movements; thoughts of harming yourself or of suicide.

• Eye and ear disorders

Frequent: blurred vision.

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

Unknown: severe eye pain and reduced or blurred vision.

• Cardiac or circulatory disorders

Frequent: increased blood pressure, hot flushes, palpitations.

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

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

• Respiratory disorders

Frequent: yawning.

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

• Gastrointestinal disorders

Very frequent: nausea.

Frequent: decreased appetite, constipation, vomiting.

Uncommon: teeth grinding, diarrhoea.

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

• Skin disorders

Very frequent: sweating (including night sweats).

Uncommon: skin rash, abnormal hair loss.

Unknown: skin rash which may lead to severe blistering and peeling of the skin; itching; mild rash.

• Musculoskeletal disorders

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

• Urinary system disorders

Frequent: difficulty urinating; increased frequency of urination.

Uncommon: inability to urinate.

• Reproductive and sexual disorders

Frequent: abnormal ejaculation/orgasm (in men), lack of orgasm, erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding.

Uncommon: abnormal orgasm (in women).

Frequency not known: heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage)—see "Pregnancy" in section 2 for more information.

• General

Frequent: weakness (asthenia), chills.

Uncommon: sensitivity to sunlight.

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

Venlafaxine Retard Vir may sometimes cause side effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine Retard Vir may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Retard for a long time.

If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Venlafaxine Retard Vir

Keep out of the reach and sight of children.

Do not use Venlafaxine Retard Vir after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in a dry place.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of Venlafaxine Retard Vir 37.5 mg prolonged-release hard capsules

The active substance is venlafaxine. Each capsule contains 37.5 mg of venlafaxine hydrochloride.

The other components are: hypromellose, Eudragit RS 100, sodium lauryl sulfate, magnesium stearate, Eudragit E 12.5, titanium dioxide (E 171), and gelatin.

Appearance of the product and contents of the pack

Venlafaxine Retard Vir 37.5 mg is presented in the form of prolonged-release hard capsules. The capsules are opaque white, size 0, hard gelatin capsules containing a round biconvex tablet.

Venlafaxine Retard Vir 37.5 mg is available in packs containing 30 prolonged-release hard capsules.

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70.

Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Pharmathen Farmaceutica Industry 6, Dervenakion Str

16351 - Greece

This patient information leaflet was reviewed in May 2023

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.