VENLAFAXINE Extended-Release VIATRIS 150 mg Hard Capsules

Introduction

Patient Information: Summary of Product Characteristics

Venlafaxine Retard Viatris75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Viatris 150 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Venlafaxine Retard Viatris and what is it used for
2. What you need to know before you take Venlafaxine Retard Viatris
3. How to take Venlafaxine Retard Viatris
4. Possible side effects
5. Storage of Venlafaxine Retard Viatris

1. Contents of the pack and further information

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

Venlafaxine Retard Viatris contains the active substance venlafaxine 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.

Venlafaxine is a treatment for adults with depression or to prevent the recurrence of depressive episodes. Venlafaxine 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). Properly treating depression and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve or may worsen and become more difficult to treat.

2. What you need to know before you take Venlafaxine Retard Viatris

Do not take Venlafaxine Retard Viatris:

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking, or have taken within the last 14 days, any medicinal products known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with venlafaxine can cause serious or potentially life-threatening side effects. You must also wait at least 7 days after stopping venlafaxine before taking any MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venlafaxine Retard Viatris”).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Venlafaxine Retard Viatris:

• If you are taking other medicines that, when taken with venlafaxine, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Retard Viatris”).
• If you have eye problems, such as certain types of glaucoma (increased eye pressure) or if your ophthalmologist has told you that you may have 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 you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia). Additionally, if you are an elderly person, are taking diuretics (water pills that can cause increased urine production), or are dehydrated (for example, due to severe diarrhea or illness).
• If you have a tendency to develop bruises or bleed easily (history of bleeding disorders), if you are taking other medicines 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 or if someone in your family has had mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior. You may feel aggressive, especially during the early stages of treatment with venlafaxine, if your dose is changed, or when you stop taking it.
• If you have diabetes (this medicine may affect your blood sugar levels).
• If you are taking any weight loss medicine.

During treatment

• This medicine may cause an increase in blood pressure or cholesterol levels. Your doctor should regularly check your blood pressure and cholesterol levels.
• If you feel restless or have difficulty sitting or standing still, which may occur during the early stages of treatment, talk to your doctor or pharmacist.
• If you are going to have a urine test to detect certain medicines, this medicine may affect the results. Tell your doctor or hospital staff that you are taking this medicine.
• The capsules of Venlafaxine Retard Viatris contain spheroids, the insoluble shell of which is eliminated and may be seen in the stool.

Do not drink alcohol during treatment with Venlafaxine Retard Viatris, as it may cause extreme fatigue and unconsciousness. Taking it 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 suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually around two weeks, but sometimes longer. These thoughts may also occur when you reduce the dose or during the discontinuation of treatment with venlafaxine.

This is more likely to happen:

• If you have had suicidal thoughts or self-harm before.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders who were 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 relative or close 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 worried about changes in your behavior.

Dry mouth

10% of patients treated with venlafaxine report dry mouth. This may increase the risk of dental caries. Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to venlafaxine, so it may be necessary to adjust the dose of your diabetes medicines.

Sexual dysfunction

Some medicines in the same group as Venlafaxine Retard Viatris (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and adolescents

Venlafaxine should not normally be used for 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 an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age when he/she decides that it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the above symptoms worsen or if you experience complications when patients under 18 years of age are taking venlafaxine. Studies in this age group with this medicine have not shown conclusively whether this medicine affects growth, maturity, and cognitive and behavioral development.

Other medicines and Venlafaxine Retard Viatris

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

Your doctor must decide whether you can take venlafaxine with other medicines.

• Do not take monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease, with venlafaxine. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOIs: see section “What you need to know before you take Venlafaxine Retard Viatris”).

Serotonin syndrome: a potentially life-threatening or fatal disease, or reactions similar to neuroleptic malignant syndrome (NMS) (see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used to treat migraines, e.g., sumatriptan, zolmitriptan).
• Other medicines for treating depression, e.g., SSRIs, tricyclic antidepressants, or medicines containing lithium.
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity).
• Medicines containing linezolid, an antibiotic (used to treat infections).
• Medicines containing moclobemide, an MAOI (used to treat depression).
• Medicines containing sibutramine (used for weight loss).
• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used to treat opioid addiction or severe pain).
• Medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methemoglobin in the blood).
• Products containing St. John's Wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression).
• Products containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat diseases with symptoms such as hearing, seeing, or feeling things that are not there, 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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

Tell your doctor immediately or go to the emergency department of the nearest hospital if you think you are suffering from serotonin syndrome or NMS.

You must tell your doctor if you are taking medicines that may affect the heart rhythm.

Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat).
• Antipsychotics such as thioridazine (see also “Serotonin syndrome” above).
• Antibiotics such as erythromycin or moxifloxacine (used to treat bacterial infections).
• Antihistamines (used to treat allergies).

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

• Medicines that inhibit certain enzymes (CYP3A4) such as:

• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV).
• Ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medicines).
• Claritromycin and telithromycin (antibiotics).

• Haloperidol or risperidone (for treating psychiatric diseases).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking Venlafaxine Retard Viatris with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxine Retard Viatris. Taking it with alcohol may cause extreme fatigue and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take venlafaxine after discussing the potential benefits and risks to the fetus with your doctor.

Make sure your midwife and/or doctor knows you are taking venlafaxine. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you must immediately contact your midwife and/or doctor.

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

If you take venlafaxine in the final 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 know that you are taking venlafaxine so they can advise you.

If you are breastfeeding, ask your doctor for advice. Venlafaxine passes into breast milk. There is a risk of affecting the baby. Therefore, you should discuss this with your doctor, and he will decide whether you should stop breastfeeding or stop the treatment with venlafaxine.

Driving and using machines

Do not drive or operate tools or machines until you know how the treatment with venlafaxine affects you, as this medicine may affect your judgment, reasoning, or ability to drive or operate machines.

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

3. How to take Venlafaxine Retard Viatris

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

The recommended initial dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is usually 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. You may be advised to take this medication for several months depending on your condition; likewise, you will likely have regular check-ups during treatment.

Take venlafaxine approximately at the same time every day, either in the morning or at night. The 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 stop treatment with Venlafaxine Retard Viatris").

Use in children and adolescents

Venlafaxine is not normally recommended for use in children and adolescents (see section 2).

If you take more Venlafaxine 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

Symptoms of a possible overdose may include rapid or slow heartbeats or changes in heart electrical activity, which can be observed through tests, decreased blood pressure, dizziness, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or convulsions, and vomiting.

If you forget to take Venlafaxine 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 make up for missed doses. Do not take more than the daily amount of the slow-release venlafaxine medication that has been prescribed for you.

If you stop treatment with Venlafaxine Retard Viatris

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment altogether. It is known that adverse effects occur when people stop using this medication, especially when stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, drowsiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, feeling of anxiety, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, a sensation of electric discharge, weakness, sweating, convulsions, tremors, flu-like symptoms, and vision problems and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with venlafaxine. This process can take several weeks or months. For some patients, treatment may be stopped gradually 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

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

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (pale or red inflamed skin areas that usually itch).

• Severe skin rash with blistering, peeling of the skin.
• Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, or vomiting.

In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). Among the signs and symptoms of NMS are a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

• Signs of infection such as high temperature, chills, shivering, headaches, sweating, and flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• Pain, sensitivity, or unexplained muscle weakness. This may be a sign of rhabdomyolysis.

Frequency not known (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 heartbeats.

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

• Cough, wheezing, and difficulty breathing that may be accompanied by a high temperature.
• Black stools or blood in stools.
• Itching, yellowing of the skin or eyes, or dark urine, which may be due to symptoms of liver inflammation (hepatitis).
• Heart problems, such as irregular heartbeat or increased blood pressure.
• Eye problems, such as blurred vision or dilated pupils.
• Nerve problems, such as dizziness, tingling sensation, movement disorder (muscle spasms or muscle stiffness), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity and unusual overexcitement.
• Withdrawal effects (see the section "Venlafaxine Retard Viatris" and "If you stop treatment with Venlafaxine Retard Viatris").
• Prolonged bleeding: if you cut or injure yourself, bleeding may take a little longer to stop.

Do not worry if you notice small white balls or granules in your stool after taking this medication. Inside the venlafaxine capsules are spheroids (small white balls) that contain the active ingredient (venlafaxine). The spheroids come out of the capsules in the stomach, and venlafaxine is slowly released as the spheroids move through the stomach into the intestine. The "shell" of the spheroids does not dissolve and is deposited in the stool. This means that, despite seeing the spheroids in your stool, the dose of the medication will have 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)

• Decreased appetite.
• Confusion, feeling 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.
• Ringing in the ears (tinnitus).
• Increased blood pressure, flushing.
• Yawning.
• Nausea (vomiting); diarrhea.
• Increased frequency of urination; inability to urinate, difficulty urinating.
• Menstrual irregularities such as increased bleeding or irregular bleeding; abnormal ejaculation/orgasm (men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol in the blood.
• Difficulty breathing.
• Moderate rash, itching.
• Weight gain; weight loss.

• Feeling of restlessness or inability to sit or stay still, tingling sensation, altered taste, increased muscle tone.

• Rapid heartbeats (palpitations).

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).

• Hallucinations, feeling detached from reality, abnormal orgasms, lack of sensations or emotions, feeling of overexcitement, teeth grinding.
• Fainting, involuntary muscle movements, uncontrolled spasms, spasmodic or twisted movements, altered coordination and balance.
• Feeling of dizziness (especially when standing up quickly); decreased blood pressure.
• Vomiting blood, black stools, or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight; bruising (ecchymosis); abnormal hair loss, hives.
• Low blood pressure.
• Mild changes in liver enzyme levels in the blood, which can be observed through blood tests.
• Inability to control urination.
• Muscle stiffness, spasms, and involuntary muscle movements.

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

• Decreased sodium levels in the 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 antidiuretic hormone secretion).
• Severe eye pain and blurred or decreased vision.
• Irregular, rapid, or abnormal heartbeat, 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, indicating 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 the number of platelets in the blood, leading to an increased risk of bruising or bleeding.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected bruises or rupture of blood vessels (rupture of veins).

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 taking Venlafaxine Retard Viatris").

• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

Sometimes, venlafaxine causes unwanted effects that you may not be aware of, such as high blood pressure or abnormal heartbeats, or mild changes in blood levels of liver enzymes, sodium, and cholesterol. Venlafaxine rarely reduces the function of platelets in the blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform blood tests occasionally, especially if you have been taking venlafaxine for a long time.

Other side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Venlafaxine Retard Viatris

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine 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 ingredients are: hypromellose, ammonium methacrylate copolymer, sodium lauryl sulfate, magnesium stearate (E-572), butyl methacrylate basic 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 package contents

75 mg prolonged-release hard capsules:

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

150 mg prolonged-release hard capsules:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 from 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 under the following names:

Germany Venlafaxin dura 75 mg Hartkapseln, retardiert

Austria Venlafaxin Arcana retard - Kapseln

Belgium Venlafaxine Retard Mylan

Slovakia Venlafaxin Mylan

Spain: Venlafaxina Retard Viatris hard prolonged-release capsules EFG

France VENLAFAXINE Viatris gélule à libération prolongée

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

Ireland Venlofex

Italy Venlafaxina Mylan

Netherlands Venlafaxine Retard Mylan

Poland Faxigen XL

Portugal VENLAFAXINA MYLAN

United Kingdom Vexarin XL prolonged release capsules, hard

Czech Republic Venlafaxin Mylan

Sweden Venlafaxin Mylan

Date of last revision of this leaflet:July 2023

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