Prospect: information for the user

Vandral Retard 75 mg hard capsulesof prolonged release

Vandral Retard 150 mg hard capsulesof prolonged release

Vandral Retard 225 mg hard capsulesof prolonged release

venlafaxine

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the samesymptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Prospect content:

Vandral Retard contains the active ingredient venlafaxine.

Vandral Retard 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. The exact way in which antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Vandral Retard is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become harder to treat.

Do not take Vandral Retard

• If you are allergic to venlafaxine or any of the other ingredients in this medication (listed in section 6).
• 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 Vandral Retard may cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Vandral Retard before taking any IMAO (see also the section "Taking Vandral Retard with other medications" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Vandral Retard:

• If you are taking other medications that, when taken with Vandral Retard, may increase the risk of developing serotonin syndrome (see the section "Taking Vandral Retard with other medications").
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been informed that your heart rhythm is abnormal.
• 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 history of bleeding disorders (tendency to develop petechiae or tendency to bleed easily), or if you are taking other medications that may increase the risk of bleeding, such as warfarin (used to prevent blood clots), or if you are pregnant (see the section Pregnancy, breastfeeding, and fertility).
• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Vandral Retard may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with Vandral Retard, as it may cause extreme fatigue and loss of consciousness. Taking Vandral Retard with certain medications and/or alcohol may worsen 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 anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughtsmay increase when starting to take antidepressants, as all these medications take time to work, usually two weeks, although sometimes more. These thoughts may also occur when your dose is reduced or during the interruption of treatment with Vandral Retard.

This is more likely to happen:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. The information from clinical trials 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 (caries). Therefore, you should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Vandral Retard. Therefore, your doses of diabetes medications may need to be adjusted.

Sexual problems

Some medications in the group to which Vandral Retard belongs (called ISRN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Vandral Retard 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 behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, your doctor may prescribe this medication to patients under 18 years of age when they decide it is in the best interest of the patient. If your doctor has prescribed this medication 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 in these patients under 18 years of age who are taking Vandral Retard.

Furthermore, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Taking Vandral Retard with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Your doctor should decide if you can take Vandral Retard with other medications.

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's diseaseshould not be taken with Vandral Retard. Tell your doctor if you have taken any of these medications in the last 14 days. (IMAO: see the section "What you need to know before starting to take Vandral Retard").

• Serotonin syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see the section "Possible Side Effects") may occur with treatment with venlafaxine, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraines)
• Other medications to treat depression, such as ISRN, ISRS, tricyclic antidepressants, or medications containing lithium
• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing opioids (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain
• Medications containing dextromethorphan (used to treat cough)
• Medications containing methadone (used to treat opioid addiction or to treat severe pain)
• Medications containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's Wort (also known as Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw)

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.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood test).

Inform your doctor immediately or go to the nearest hospital emergency room if you think you are experiencing serotonin syndrome.

Inform your doctor if you are taking medications that may affect your heart rhythm.

Some examples of these medications include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or 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 medications may interact with Vandral Retard 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 treating psychiatric conditions).
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Vandral Retard with food, drinks, and alcohol

Vandral Retard should be taken with food (see section 3 "How to take Vandral Retard").

Do not drink alcohol during treatment with Vandral Retard. Taking Vandral Retard with alcohol may cause extreme fatigue and loss of consciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. You should only take Vandral Retard after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking Vandral Retard. When taken during pregnancy, similar medications (ISRS) may increase the risk of a severe condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

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

If you are taking this medication during the final stages of pregnancy, in addition to breathing problems, another symptom that your baby may have when born is feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

Vandral 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 this medication.

Driving and operating machinery

Do not drive or operate tools or machines until you know how this medication affects you.

Vandral Retard contains sodium

Vandral Retard 150 mg and 225 mg capsules contain less than 23 mg of sodium (1 mmol) per capsule; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication.In case of doubt, consult your doctor or pharmacist again.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. Your doctor may increase the dose gradually and if necessary, even more up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.

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

Vandral Retard should be taken with food.

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

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

If you take more Vandral Retard than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Overdose can put your life in danger, especially with the simultaneous taking of certain medications and/or alcohol (see Taking Vandral Retard with other medications).

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

If you forgot to take Vandral Retard

If you have not taken 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 a double dose to compensate for the missed doses. Do not take more than the daily dose of Vandral Retard that you have been prescribed in a day.

If you interrupt treatment withVandral Retard

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 Vandral Retard, they may ask you to reduce the dose gradually before interrupting treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, 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, convulsions or symptoms similar to the flu, vision problems and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually interrupt treatment with Vandral Retard. This may take several weeks or months. In some patients, the interruption may need to be done very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Rare (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and blistered skin, difficulty swallowing or breathing.

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

• Pressure in the chest, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

• Signs of infection, such as fever, chills, shivering, headache, sweating, or symptoms similar to the flu. This may be due to a blood disorder that can increase the risk of infection.
• Severe skin rash, which may lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

• Signs and symptoms of a condition called "stress cardiomyopathy," which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeat.

Other side effects that you should inform your doctor are (the frequency of these side effects are included in the list below "other side effects that may occur"):

• Cough, wheezing, and difficulty breathing that may be accompanied by a fever.
• Stool (deposits) that are tar-like or contain blood.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).

• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nerve problems, such as dizziness, numbness, movement disorder (muscle spasms and rigidity), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Vandral Retard, if you interrupt treatment with Vandral Retard”).
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you see white pellets or small granules in your stool after taking this medicine. Inside the Vandral Retard capsules, there are spheroids (small white pellets) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is released slowly. The "shell" of the spheroid does not dissolve and is eliminated in the stool. Therefore, although you see spheroids in the stool, the dose of the medicine has been absorbed.

Other side 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)

• Loss of appetite.
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, stool that is tar-like or contains blood, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, abnormal hair loss.
• Inability to control urination.
• Rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

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

• Convulsions or seizures.
• Cough, wheezing, and shortness of breath that may be accompanied by a fever.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• SIADH (excessive water intake).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid 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, yellow eyes or skin, dark urine, symptoms similar to the flu, which are symptoms of liver inflammation (hepatitis).

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of petechiae or bleeding.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of unexpected petechiae or vessel rupture (broken veins).

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. “What you need to know before taking Vandral Retard”).
• Aggression.
• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

Vandral Retard may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Vandral Retard 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 Vandral Retard for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not store at temperatures above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment..

Composition of Vandral Retard

The active ingredient is venlafaxine.

Vandral Retard 75 mg:

Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components are:

Capule content:microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capule coating:gelatin, iron oxide red and yellow (E172), titanium dioxide (E171).

Capule printing ink:shellac, iron oxide red (E172), ammonium hydroxide, simethicone, propylene glycol.

Vandral Retard 150 mg:

Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine base.

The other components are:

Capule content:microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capule coating:gelatin, iron oxide red and yellow (E172), titanium dioxide (E171).

Capule printing ink:shellac, sodium hydroxide (see section 2), povidone, titanium dioxide (E171), propylene glycol.

Vandral Retard 225 mg:

Each prolonged-release capsule contains 254.52 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine base.

The other components are:

Capule content:microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capule coating:gelatin, iron oxide black, red and yellow (E172), titanium dioxide (E171).

Capule printing ink:shellac, sodium hydroxide (see section 2), povidone, titanium dioxide (E171), propylene glycol.

Appearance of the product and contents of the package

Vandral Retard 75 mg is a hard (gelatin) prolonged-release capsule, opaque and orange-colored, 19.4 mm x 6.91 mm, with a 'W' and the dose '75' printed in red.

Vandral Retard 75 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 hard capsules and clinical packs of 500 (10x50) and 1,000 (10x100) hard capsules or in HDPE plastic bottles of 14, 20, 50, 100 hard capsules and clinical packs of 500 and 1,000 hard capsules.

Unit-dose blister packs of 14, 28, 84 and 100 hard capsules.

Vandral Retard 150 mg is a hard (gelatin) prolonged-release capsule, opaque and orange-colored, 23.5 mm x 7.65 mm, with a 'W' and the dose '150' printed in white.

Vandral Retard 150 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 hard capsules and clinical packs of 500 (10x50) and 1,000 (10x100) hard capsules or in HDPE plastic bottles of 14, 20, 50, 100 hard capsules and clinical packs of 500 and 1,000 hard capsules.

Unit-dose blister packs of 14, 28, 84 and 100 hard capsules.

Vandral Retard 225 mg is an opaque capsule with a light gray-colored coating and a dark orange-colored body, with 'W' and '225' printed in white.

Vandral Retard 225 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 and clinical packs of 500 (10x50) and 1,000 (10x100).

Unit-dose blister packs of 14, 28, 84 and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder, manufacturer and local representative

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

County Kildare

Ireland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names*:

*[Please note that not all products and concentrations listed may be marketed].

Last revision date of this leaflet: July 2023

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es