VENLAFAXINE Extended-Release 75 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Vir 75 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is Venlafaxine Retard Vir and what is it 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 thought that people who are depressed and/or have anxiety have lower levels of serotonin and noradrenaline in the brain. The way that antidepressants work is not fully understood but they may help to increase the levels of serotonin and noradrenaline in the brain.

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

Do not take Venlafaxine Retard Vir

• If you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of Venlafaxine Retard Vir.
• 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 other medicines, such as Venlafaxine Retard Vir, can cause serious side effects or even be life-threatening. Also, you must wait at least 7 days after stopping Venlafaxine Retard Vir before taking any irreversible MAOI (see also the sections “Serotonin syndrome” and “Using other medicines”).

Be careful when taking Venlafaxine Retard Vir

• If you are taking other medicines that, when taken with Venlafaxine Retard Vir, may increase the risk of developing serotonin syndrome (see the section “Using 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 (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency to bleed easily (history of bleeding disorders), if you are using 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 a family member has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behaviour.

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

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 tiredness and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of 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 may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour 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 a 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 behaviour.

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 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, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontation, and irritability) when they take this type of medicine. Nevertheless, your doctor may prescribe Venlafaxine Retard Vir to patients under 18 years when he/she decides that it is the best option for the patient. If your doctor has prescribed Venlafaxine Retard Vir to a patient under 18 years and you wish to discuss this, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years are taking Venlafaxine Retard Vir. Furthermore, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Venlafaxine Retard Vir have not been demonstrated yet.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

Do not start or stop taking any medicines, including those bought without a prescription, natural remedies, or herbal products, before 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 with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine).
• Medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing medicines.
• 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 (a painkiller).
• Products containing St. John’s Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product 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, overactive reflexes, diarrhoea, coma, nausea, vomiting. Get medical help immediately 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 mention to your doctor or pharmacist if you are taking medicines containing:

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

Taking Venlafaxine Retard Vir with food and drink

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 with alcohol may cause extreme tiredness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

Pregnancy

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

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

If you take Venlafaxine Retard Vir in the last trimester of your pregnancy, you may have an increased risk of heavy bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Retard Vir so that they can advise you.

Breastfeeding

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

Warnings and precautions

Some medicines of the same group as venlafaxine (called SSRIs/ SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Driving and using machines

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

3. How to take Venlafaxine Retard Vir

Take Venlafaxine Retard Vir exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual recommended starting dose for treating depression and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose 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 should be swallowed whole with fluids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Vir should be taken with food.

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

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

If you take more Venlafaxine Retard Vir than you should

Call your doctor or pharmacist immediately if you take more Venlafaxine Retard Vir than your doctor has prescribed. You can also contact the Poison Information Service, telephone 91562 04 20, stating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see “Taking Venlafaxine Retard Vir 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 Venlafaxine Retard Vir

If you miss a dose, take it as soon as you remember. However, if it is already the time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the prescribed daily dose of Venlafaxine Retard Vir in one day.

If you stop taking Venlafaxine Retard Vir

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 that you no longer need Venlafaxine Retard Vir, he/she may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects can occur when people stop using Venlafaxine Retard Vir, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you how to gradually stop taking Venlafaxine Retard Vir. If you experience any of these or other symptoms that are troublesome for you, consult your doctor for further advice.

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

4. Possible Adverse Effects

Like all medicines, Venlafaxina Retard Vir can cause adverse effects, although not all people suffer from them.

Do not worry if you notice a small tablet in your stool after taking Venlafaxina Retard Vir. Inside the Venlafaxina Retard Vir capsules, there is a small tablet that contains the active ingredient venlafaxina. This tablet is released from the capsule in the gastrointestinal tract. As it moves along the length of the gastrointestinal tract, venlafaxina is slowly released. 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 venlafaxina has been absorbed.

Allergic Reactions

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet.
• Feeling nervous or anxious, dizziness, tingling sensations, sudden reddening of the skin, and/or a feeling of heat.
• Severe skin rash, itching, or hives (elevated areas of red or pale skin that often itch).

Severe Adverse 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: such as dizziness, tingling, movement disorder, seizures, or attacks.
• Psychiatric problems, such as hyperactivity and euphoria.
• Treatment withdrawal (see section "HOW TO TAKE VENLAFAXINA RETARD VIR, If you interrupt treatment with Venlafaxina Retard Vir").

Complete List of Adverse Effects

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

• Blood Disorders

Uncommon: appearance of bruises, tarry stools (deposits) or blood in the stool, which may be a sign of internal bleeding.

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

• Metabolic/Nutritional Disorders

Frequent: weight loss, increased cholesterol.

Uncommon: weight gain.

Unknown: mild changes in blood levels of liver enzymes; 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 frequent: dry mouth, headache.

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

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

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

Unknown: high temperature with stiff muscles, confusion, or agitation, and sweating, or if you experience jerky muscle movements that you cannot control, may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, rapid sustained eye movement, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); stiffness, spasms, and involuntary muscle movements; thoughts of self-harm or 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 flashes, palpitations.

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

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

• Respiratory System Disorders

Frequent: yawning.

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

• Digestive Disorders

Very frequent: nausea.

Frequent: decreased appetite, constipation, vomiting.

Uncommon: teeth grinding, diarrhea.

Unknown: severe back or abdominal 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 that can lead to severe blistering and peeling of the skin; itching; mild skin rash.

• Muscle Disorders

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

• Urinary System Disorders

Frequent: difficulty urinating; increased frequency of urination.

Uncommon: inability to urinate.

• Sexual and Reproductive Disorders

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

Uncommon: abnormal orgasm (females).

Unknown frequency: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), 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).

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Venlafaxina Retard Vir

Keep out of the reach and sight of children.

Do not use Venlafaxina Retard Vir after the expiration date stated on the packaging, after CAD. The expiration date is 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. Deposit the packaging and any unused medicines at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional Information

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

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

The other ingredients 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 Packaging Contents

Venlafaxina Retard Vir 75 mg is presented in the form of prolonged-release hard capsules. The capsules are opaque hard gelatin capsules, size 0, which contain two round biconvex tablets.

Venlafaxina Retard Vir 75 mg is presented in packaging 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 leaflet was revised in May 2023

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