Background pattern

Venlafaxina retard viatris 75 mg capsulas duras de liberacion prolongada efg

About the medication

Introduction

Product Information for the Patient

Venlafaxine Retard Viatris75 mg Extended-Release Hard Capsules EFG

Venlafaxine Retard Viatris 150 mg Extended-Release Hard Capsules EFG

Read this entire product information carefully before starting to take this medication,because it contains important information for you.

  • Keep this product information, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

  • This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this product information. See section 4.
  1. What is Venlafaxine Retard Viatrisand for what it is used
  2. What you need to know before starting to take Venlafaxine Retard Viatris
  3. How to take Venlafaxine Retard Viatris
  4. Possible adverse effects
  5. Storage of Venlafaxine Retard Viatris

6. Contents of the pack and additional information

1. What is Venlafaxina Retard Viatris and what is it used for

Venlafaxina Retard Viatris contains the active ingredient venlafaxina and is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions, such as anxiety disorders.

Venlafaxina is a treatment for adults with depression or to prevent the recurrence of major depressive episodes.Venlafaxinais 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 depression and anxiety disorders properly is important to help you feel better. If not treated, your condition may not go away or may worsen and become more difficult to treat.

2. What you need to know before starting to take Venlafaxine Extended-Release Viatris

Do not take Venlafaxina Retard Viatris:

  • If you are allergic to venlafaxine or any of the other components of this medication (listed in section 6).
  • If you are also taking or have taken in the last 14 days any medication known as irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with venlafaxine may produce severe or potentially fatal adverse effects. You must also wait at least 7 days after stopping the use of venlafaxine before taking any IMAO (see also the sections “Serotonin syndrome” and “Other medications and Venlafaxina Retard Viatris”).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeVenlafaxina Retard Viatris:

  • If you are using other medications that, taken with venlafaxine, may increase the risk of developing serotonin syndrome (see the section “Other medications and Venlafaxina Retard Viatris”).
  • If you have eye problems, such as certain types of glaucoma (increased intraocular pressure) or if your ophthalmologist has told you that you may be at a higher risk of developing glaucoma.
  • If you have a history of high blood pressure or if you have recently had a heart attack.
  • If you, or someone in your family, have a history of heart problems.
  • If you have been told that you have an abnormal heart rhythm.
  • If you have a history of seizures (convulsions).
  • If you have a history of low sodium levels in the blood (hyponatremia). Additionally, if you are an elderly person, you are taking diuretics (tablets that can cause an increase in urine production) or are dehydrated (for example, due to severe diarrhea or disease).
  • If you have a tendency to develop bleeding or bruising easily (history of hemorrhagic disorders), if you are taking other medications that thin the blood and may increase the risk of bleeding, or if you are pregnant (see “Pregnancy and breastfeeding”).
  • If you have a history of mania or bipolar disorder (feeling overexcited or euphoric).
  • If you have a history of aggressive behavior. You may feel aggressive, especially during the initial stages of treatment with venlafaxine, if your dose is changed or when you stop taking it.
  • If you have diabetes (this medication may affect blood sugar levels).
  • If you are taking any weight loss medication.

During treatment

  • This medication may cause an increase in blood pressure or cholesterol levels. Your doctor must regularly check your blood pressure and cholesterol levels.
  • If you experience restlessness or difficulty sitting or staying still, which may occur during the initial stages of treatment, talk to your doctor or pharmacist.
  • If you are about to undergo a urine test to detect certain medications, this medication may affect the results. Inform your doctor or hospital staff that you are taking this medication.
  • The capsules ofVenlafaxina Retard Viatriscontain spheroids, whose insoluble part is eliminated and may be observed in the feces.

Do not drink alcohol during treatment with Venlafaxina Retard Viatris, 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 anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when starting to take antidepressants, as all these medications require time to work, usually around two weeks, but sometimes longer. These thoughts may also occur when reducing the dose or during the suspension of treatment with venlafaxina.

It is 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 a higher risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If you have thoughts of suicide or self-harm at any time,contact your doctor or go to the hospital immediately.

It may be helpful to tell a close family member or friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can 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

10% of patients treated with venlafaxine report dry mouth. This may increase the risk of developing dental caries. Therefore, you must take care of your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to venlafaxina, so you may need to adjust the dose of your diabetes medication.

Sexual dysfunction

Some medications in the group to whichVenlafaxina Retard Viatrisbelongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, venlafaxina should not be used to treat children and adolescents under 18 years old. Additionally, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe this medication to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medication to a patient under 18 years old and wants to discuss this decision, please see your doctor again. You must inform your doctor if any of the symptoms listed above worsen or if you experience complications when patients under 18 years old are taking venlafaxina. Studies conducted in this age group with this medication have not shown with certainty whether this medication affects growth, maturity, and cognitive and behavioral development.

Other medications and Venlafaxina Retard Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription or natural remedies and herbal products.

Your doctor must decide if you can takevenlafaxinawith other medications.

  • Do not take irreversible monoamine oxidase inhibitors (IMAO), used to treat depression or Parkinson's disease, with venlafaxina. Inform your doctor if you have taken any of these medications in the last 14 days. (IMAO: see section “What you need to know before starting to take Venlafaxina Retard Viatris”).

Serotonin syndrome: a potentially fatal disease or reactions similar to malignant neuroleptic syndrome (MNS) (see section “Possible side effects”), may occur with treatment with venlafaxina, particularly when taken with other medications.

Examples of these medications include:

  • Triptans (used to treat migraines, for example, sumatriptan, zolmitriptan).
  • Other medications to treat depression, for example, ISRN, ISRS, tricyclic antidepressants, or medications containing lithium.
  • Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
  • Medications containing linezolid, an antibiotic (used to treat infections).
  • Medications containing moclobemide, an IMAO (used to treat depression).
  • Medications containing sibutramine (used to lose weight).
  • Medications containing 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 severe pain).
  • Medications containing methylene blue (used to treat high levels of methemoglobin in the blood).
  • Natural remedies or herbal products containing St. John's Wort (also known asHypericum perforatum, used to treat mild depression).
  • Natural remedies or herbal products containing tryptophan (used to treat problems such as sleep and depression).
  • Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not present, false beliefs, unusual suspicions, irrational interpretations, and becoming withdrawn).

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, and vomiting.

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

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

You must inform your doctor if you are taking medications that may affect heart rhythm.

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 venlafaxina and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

  • Medications that inhibit certain enzymes (CYP3A4) such as:
  • Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medications used to treat HIV).
  • Ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medications).
  • Clarithromycin and telithromycin (antibiotics).
  • Haloperidolor risperidone (used to treat psychiatric disorders).
  • Metoprolol (a beta-blocker used to treat high blood pressure and cardiac problems).

Taking Venlafaxina Retard Viatris with food, drinks, and alcohol

Venlafaxina Retard Viatris should be taken with food (see section3 “How to take Venlafaxina Retard Viatris”).

Do not drink alcohol during treatment with Venlafaxina Retard Viatris. 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

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

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

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

If you take venlafaxina in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of hemorrhagic disorders. Your doctor or midwife must know that you are taking venlafaxina to be able to advise you.

If you are breastfeeding, ask your doctor for advice. Venlafaxina passes into breast milk. There is a risk that it may affect the baby. Therefore, you must discuss the case with your doctor, and they will decide whether you should stop breastfeeding or stop taking venlafaxina.

Driving and operating machinery

Do not drive or operate tools or machines until you know how venlafaxina affects you, as this medication may affect your judgment, reasoning, or ability to drive or operate machines.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

3. How to Take Venlafaxine Extended-Release Viatris

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

The usual recommended initial dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose 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 gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day. It is possible that your doctor will recommend taking this medication for several months depending on your condition; it is also likely that they will make regular reviews during treatment.

Take venlafaxine approximately at the same time every day, either in the morning or at night. Capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

This medication should be taken with food.

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

Do not stop taking venlafaxine without consulting your doctor (see section "If you interrupt treatment with Venlafaxina Retard Viatris").

Use in children and adolescents

Usually, the use of venlafaxine is not recommended in children and adolescents (see section 2).

If you take more Venlafaxina Retard Viatris than you should

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor.You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

A overdose can put your life at risk, especially when taken with certain medications and/or alcohol (see Taking Venlafaxina Retard Viatris with other medications).

The symptoms of a possible overdose may include rapid or slow heartbeats or changes in heart activity that can be seen through tests, decreased blood pressure, dizziness, changes in alertness (ranging from drowsiness to coma), blurred vision, seizures or convulsions, and vomiting.

If you forgot to take Venlafaxina Retard Viatris

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 slow-release venlafaxine that has been prescribed to you.

If you interrupt treatment with Venlafaxina Retard Viatris

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 venlafaxine, they may ask you to gradually reduce the dose before stopping 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, drowsiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, anxiety, nervousness, agitation, confusion, ringing in the ears, numbness, or, in rare cases, a feeling of electric shock, weakness, sweating, seizures, tremors, flu-like symptoms, 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 stop treatment with venlafaxine. This process may take several weeks or months. For some patients, treatment may be gradually stopped over several months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

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

4. Possible Adverse Effects

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

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

Rare (may affect up to 1 in 1,000 people):

  • Swelling of the face, mouth, tongue, throat, hands, or feet, or itching, rash, hives, difficulty swallowing or breathing.

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

  • Chest tightness, wheezing, difficulty swallowing or breathing.
  • Severe skin eruptions, itching, or hives (areas of pale or red skin that usually itch).
  • Severe skin rash that leads to severe blisters and skin peeling.
  • Signs and symptoms of serotonin syndrome that may include restlessness, hallucinations, loss of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, or vomiting.

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

  • Signs of infection such as high temperature, chills, tremors, headaches, sweating, and flu-like symptoms. This may be due to a hematological disorder that increases the risk of infection.
  • Muscle pain, sensitivity, or weakness that is unexplained. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data):

  • Signs and symptoms of a condition called “cardiomyopathy due to stress,” which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

  • Cough, wheezing, and difficulty breathing that may be accompanied by a high temperature.
  • Stool that is tar-like or contains blood.
  • Itching, yellowing of the skin or eyes, or dark urine that may be due to symptoms of liver inflammation (hepatitis).
  • Cardiac problems, such as an irregular heart rate or increased blood pressure.
  • Eye problems, such as blurred vision or dilated pupils.
  • Nervous system problems, such as dizziness, numbness, movement disorders (muscle spasms or muscle rigidity), convulsions, or seizures.
  • Psychiatric problems, such as hyperactivity and unusual feelings of overexcitement.
  • Withdrawal effects (see the section “Venlafaxine Retard Viatris” and “If you stop taking Venlafaxine Retard Viatris”).
  • Prolonged bleeding: if you cut or injure yourself, bleeding may take a little longer to stop.

Do not worry if you see small white pellets or granules in your stool after taking this medicine. Inside the venlafaxine capsules are small white pellets that contain the active ingredient (venlafaxine). The pellets come out of the capsules in the stomach, and the venlafaxine is slowly released as the pellets move through the stomach to the intestine. The “shell” of the pellets does not dissolve and is deposited in the stool. This means that, despite seeing the pellets in the stool, the dose of the medicine has been absorbed.

Other possible side effects:

Very common (may affect more than 1 in 10 people):

  • Dizziness; headache.
  • Nausea; dry mouth.
  • Drowsiness.
  • Excessive sweating (including night sweats).
  • Difficulty sleeping (insomnia).
  • Constipation.

Common (may affect up to 1 in 10 people):

  • Loss of appetite.
  • Confusion, feeling disconnected (or detached) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
  • Visual disturbances, including blurred vision; dilated pupils; inability to automatically change focus from distant to near objects.
  • Tinnitus (ringing in the ears).
  • Increased blood pressure, flushing.
  • Yawning.
  • Uncomfortable feeling (vomiting); diarrhea.
  • 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.
  • Increased blood cholesterol.
  • Difficulty breathing.
  • Moderate rash, itching.
  • Weight gain; weight loss.
  • Sensation of restlessness or inability to sit or remain still, numbness, altered sense of taste, increased muscle tone.
  • Irregular heartbeats (palpitations).

Rare (may affect up to 1 in 100 people):

  • Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
  • Hallucinations, feeling disconnected (or detached) from reality, abnormal orgasms, lack of sensations or emotions, feeling overexcited, teeth grinding.
  • Fainting, involuntary muscle movements, uncontrollable spasms, spasmodic or twisted movements, altered coordination and balance.
  • Sensation of dizziness (especially when standing up quickly); decreased blood pressure.
  • Vomiting with blood, tar-like stool, or blood in stool, which may be a sign of internal bleeding.
  • Sensitivity to sunlight; bruises (ecchymosis); abnormal hair loss, urticaria.
  • Low blood pressure.
  • Ligero cambio en los niveles de las enzimas hepáticas en sangre, que pueden observarse mediante análisis de sangre.
  • Incapacidad para controlar la orina.
  • Rigidez muscular, espasmos y movimientos musculares involuntarios.

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

  • Decreased sodium levels in blood, which can be observed through blood tests.
  • Disorientation and confusion, often accompanied by hallucinations (delirium).
  • Cough, wheezing, and difficulty breathing that may be accompanied by a high temperature.
  • Excessive water intake (known as inappropriate secretion of antidiuretic hormone).
  • Severe eye pain and blurred or decreased vision.
  • Irregular heartbeats, rapid, or abnormal, which could cause fainting.
  • Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
  • Itching, yellowing of the skin or eyes, or flu-like symptoms, which indicate liver inflammation (hepatitis).

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

  • Abnormal milk production.
  • Prolonged bleeding, which may be a sign of a decrease in platelet count in blood, which increases the risk of bruising or bleeding.
  • Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or unexpected bruising or rupture of blood vessels (hemorrhage).

Frequency not known (cannot be estimated from available data):

  • Suicidal thoughts and behaviors; suicidal thoughts and behaviors have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2, “What you need to know before starting to take Venlafaxine Retard Viatris”).
  • Aggression.
  • Dizziness.
  • Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.

In some cases, venlafaxine may cause unwanted effects that you may not know about, such as high blood pressure or abnormal heartbeats, or slight changes in blood levels of liver enzymes, sodium, and cholesterol. Venlafaxine rarely reduces platelet function in blood, which would increase the risk of bruising or bleeding. Therefore, your doctor may wish to perform occasional blood tests, especially if you have been taking venlafaxine for a prolonged period.

Other side effects in children and adolescents:

Although this medicine is not usually recommended for children and adolescents, cases of hostility, self-harm, stomach pain, indigestion, acid reflux, and muscle pain have also been reported.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

5. Conservation of Venlafaxina Retard Viatris

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

Do not use this medication after the expiration date that appears on the box after CAD or EXP.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Venlafaxina Retard Viatris:

The active ingredient is venlafaxine.

Each prolonged-release hard capsule contains venlafaxine hydrochloride, equivalent to 75 mg and 150 mg of venlafaxine (as hydrochloride).

The other components are: hypromellose, ammonio methacrylate copolymer, sodium lauryl sulfate, magnesium stearate (E-572), basic butyl methacrylate copolymer.The capsule contains:titanium dioxide (E-171), gelatin, red iron oxide (E-172) (only for the 75 mg dose) and erythrosine (E-127) and indigo carmine (E-132) (only for the 150 mg dose). Printing ink: Shellac wax, black iron oxide (E-172).

Appearance of the product and contents of the package

Prolonged-release hard capsules of 75 mg:

Opaque, beige-colored, hard capsules, marked with the text “VEN” on the capsule cap and “75” on the body.

Prolonged-release hard capsules of 150 mg:

Opaque, intense red-colored, hard capsules, marked with the text “VEN” on the capsule cap and “150” on the body.

Available in blisters of 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500, and 1000 capsules, perforated single-dose blisters of 30 capsules, multi-packs containing 90 capsules, included in 3 packs of 30 capsules each, multi-packs containing 100 capsules, included in 2 packs of 50 capsules each, and bottles containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, and 250 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories Ltd. T/A - Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini, Attiki

Greece

or

Pharma Pack Hungary Kft

Vasut utca 13. Kamaraerdo

2040 Budaörs

or

Mylan Hungary Kft

Mylan utca 1

H-2900 Komárom

Hungary

or

Europhartech

rue Henri Matisse

63370 Lempdes

France

or

Pharma Pack Hungary Kft

Vasut utca 13. Kamaraerdo

2040 Budaörs

or

Viatris Sante

ZAC des Gaulnes, 360 Avenue Henri Schneider

69330 Meyzieu

or

Viatris Sante

1 Rue de Turin

69007 Lyon

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names::

GermanyVenlafaxin dura 75 mg Hartkapseln, retardiert

AustriaVenlafaxin Arcana retard - Kapseln

BelgiumVenlafaxine Retard Mylan

SlovakiaVenlafaxin Mylan

Spain:Venlafaxina Retard Viatris hard prolonged-release capsules EFG

FranceVENLAFAXINE Viatris prolonged-release capsule

GreeceVenlafaxine/Mylan 75 mg/CAP Καψ?κιο παρατεταμ?νης αποδ?σμευσης, σκληρ?

IrelandVenlofex

ItalyVenlafaxina Mylan

NetherlandsVenlafaxine Retard Mylan

PolandFaxigen XL

PortugalVENLAFAXINA MYLAN

United KingdomVexarin XL prolonged release capsules, hard

Czech RepublicVenlafaxin Mylan

SwedenVenlafaxin Mylan

Last review date of this leaflet:July 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/

Country of registration
Active substance
Prescription required
Yes
Manufacturer
Composition
Laurilsulfato de sodio (18,96 mg mg), Alcohol etilico (etanol) (60,0 mg mg), Alcohol etilico (etanol) (12,0 mg mg)
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.

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Dr. Alina Tsurkan is a licensed family medicine doctor based in Portugal. She provides personalised primary care for both adults and children, helping patients manage a wide range of everyday health concerns with professionalism and attention to detail.

Dr. Tsurkan diagnoses and treats common conditions such as: • Respiratory infections (cold, flu, bronchitis, pneumonia) • Eye conditions: conjunctivitis (infectious and allergic) • ENT problems (sinusitis, ear infections, tonsillitis) • Digestive issues including gastritis, acid reflux, and IBS • Urinary tract infections and other frequent infections • Chronic conditions such as high blood pressure, diabetes, and thyroid disorders • Headaches and migraines

In addition to symptom-based care, Dr. Tsurkan focuses on prevention and early detection. She offers regular health check-ups, follow-up care, and medical prescriptions tailored to each patient’s needs.

With a comprehensive and caring approach, Dr. Tsurkan supports patients at every stage of life — from acute illnesses to long-term health management.

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5.09 reviews
Doctor

Andrei Popov

General Medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including: • Chronic pain lasting more than 3 months • Migraines and recurring headaches • Neck, back, lower back, and joint pain • Post-traumatic pain following injury or surgery • Nerve-related pain, fibromyalgia, and neuralgia In addition to pain management, Dr. Popov helps patients with: • Respiratory infections (colds, bronchitis, pneumonia) • High blood pressure and metabolic conditions such as diabetes • Preventive care and routine health check-ups

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

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5.01 review
Doctor

Yevgen Yakovenko

General Surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain, with a diverse clinical background in general and pediatric surgery, internal medicine, and pain management. With a strong focus on both practice and research, he provides comprehensive medical consultations for adults and children, covering both surgical and therapeutic needs.

Dr. Yakovenko offers expert care in the following areas: • Diagnosis and treatment of acute and chronic pain • Pre- and postoperative care, including risk assessment and follow-up • Surgical conditions such as hernias, gallbladder disease, and appendicitis • Pediatric surgery consultations, including congenital conditions and minor procedures • Trauma care: fractures, soft tissue injuries, and wound management • Oncological surgery consultation and post-treatment care • Cardiovascular and respiratory conditions (internal medicine) • Orthopedic concerns and post-trauma rehabilitation • Radiological interpretation for surgical planning

In addition to his clinical work, Dr. Yakovenko actively participates in medical research and international collaboration. He is a member of the German Surgeons Association (BDC), affiliated with the General Practitioners Association of Las Palmas, and works with the German Consulate in the Canary Islands. He regularly attends international medical conferences and has authored scientific publications.

With over a decade of multidisciplinary experience, Dr. Yakovenko delivers precise, evidence-based care tailored to each patient’s needs.

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