Venlafaxine prolonged-release ViatriS 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Venlafaxine Retard Viatris 75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Viatris 150 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

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

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. See section 4.

Leaflet contents

1. What Venlafaxine Retard Viatris is and what it is used for
2. What you need to know before taking Venlafaxine Retard Viatris
3. How to take Venlafaxine Retard Viatris
4. Possible side effects
5. How to store Venlafaxine Retard Viatris
6. Contents of the pack and other information

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

Venlafaxine Retard Viatris contains the active substance venlafaxine and is an antidepressant belonging 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 major 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 resolve or may worsen and become more difficult to treat.

2. What you need to know before taking 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 at any time within the last 14 days, a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may cause serious or even potentially life-threatening adverse effects. You must also wait at least 7 days after stopping venlafaxine before starting any MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venlafaxine Retard Viatris”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Venlafaxine Retard Viatris:

• If you are taking other medicines that, when combined 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 be at higher risk of developing glaucoma.
• If you have a history of high blood pressure or have recently had a heart attack.
• If you or a family member has a history of heart problems.
• If you have been diagnosed with an abnormal heart rhythm.
• If you have a history of seizures (epileptic fits).
• If you have a history of low sodium levels in the blood (hyponatremia). Also, if you are elderly, taking diuretics (water tablets, which may increase urine production), or are dehydrated (for example, due to severe diarrhoea or illness).
• If you tend to bruise easily or bleed excessively (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 or a family member has a history of mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behaviour. You may feel aggressive, especially during the initial stages of treatment with venlafaxine, when your dose is changed, or when you stop taking it.
• If you have diabetes (this medicine may affect blood sugar levels).
• If you are taking any medicine for weight loss.

During treatment

• This medicine may cause an increase in blood pressure or cholesterol levels. Your doctor should check your blood pressure and cholesterol levels regularly.
• If you feel restless or have difficulty sitting or staying still, which may occur during the early stages of treatment, speak to your doctor or pharmacist.
• If you are undergoing a urine test to detect certain drugs, this medicine may affect the results. Inform your doctor or hospital staff that you are taking this medicine.
• The capsules of Venlafaxine Retard Viatris contain pellets, the undissolved portion of which may be eliminated and observed in the faeces.

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

Suicidal thoughts and worsening of depression or anxiety disorder:

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines require time to work, usually about two weeks, but sometimes longer. These thoughts may also occur when the dose is reduced or during discontinuation of venlafaxine treatment.

This is more likely to happen:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with an antidepressant.

If you have any suicidal or self-harming thoughts at any time, contact your doctor or go to a hospital immediately.

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

Dry mouth

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

Sexual dysfunction

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

Children and adolescents

Venlafaxine is generally not recommended for use in children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be in the patient’s best interest. 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 symptoms listed above worsen or become complicated while a patient under 18 years of age is taking venlafaxine. Studies in this age group have not conclusively shown whether this medicine affects growth, maturation, or cognitive and behavioural development.

Other medicines and Venlafaxine Retard Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, or natural and 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, together with venlafaxine. Inform your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Retard Viatris”).

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

Examples of such medicines include:

• Triptans (used to treat migraines, e.g., sumatriptan, zolmitriptan).
• Other medicines for treating depression, e.g., SNRIs, 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, meperidine, 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 methylene blue (used to treat high levels of methemoglobin in blood).
• Products containing St. John’s wort (also called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression).
• Products containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not present, false beliefs, unusual suspicion, irrational interpretations, and social withdrawal).

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, mood changes, and increased muscle enzymes (detected by a blood test).

Contact your doctor immediately or go to the nearest hospital emergency department if you suspect you have serotonin syndrome or NMS.

You should inform your doctor if you are taking medicines that may affect heart rhythm.

Examples of such medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular 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 medicines may also interact with venlafaxine and should be used with caution. It is especially important to inform 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).

• Clarithromycin and telithromycin (antibiotics).

• Haloperidol or risperidone (to treat psychiatric conditions).

• Metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. You should only take venlafaxine after discussing with your doctor the potential benefits and risks to the fetus.

Ensure that your midwife and/or doctor knows that you are taking venlafaxine. Medicines similar to venlafaxine (SSRIs), when taken during pregnancy, 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 appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

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

If you are breastfeeding, seek advice from your doctor. Venlafaxine passes into breast milk. There is a risk it may affect the baby. Therefore, you should discuss the matter with your doctor, who will decide whether you should stop breastfeeding or stop treatment with venlafaxine.

Driving and using machines

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

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

3. How to take Venlafaxine Retard Viatris

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg once daily. Your doctor may gradually increase the dose, and if necessary, further increase it 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. Your doctor may recommend that you take this medicine for several months depending on your condition; regular check-ups during treatment are also likely.

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

This medicine should be taken with food.

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

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

Use in children and adolescents

Venlafaxine is generally not 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 medicine than prescribed. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

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

Symptoms of possible overdose may include fast or slow heartbeats or changes in the heart's electrical activity, which can be detected by tests, low blood pressure, dizziness, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, attacks or seizures, and vomiting.

If you forget to take Venlafaxine Retard Viatris

If you have missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the prescribed daily amount of the extended-release venlafaxine medication.

If you stop taking Venlafaxine Retard Viatris

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, particularly if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lightheadedness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, feelings of anxiety, nervousness, agitation, confusion, ringing in the ears, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, tremors, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. For some patients, discontinuation may occur gradually over several months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

4. Possible adverse effects

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

If you experience any of the following effects, stop taking venlafaxine and contact your doctor immediately or go to the nearest hospital emergency department:

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 rashes, itching, or hives (inflamed areas of pale or red skin that usually itch).
• Severe skin rash leading to serious blistering and 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 may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

• Signs of infection such as high temperature, chills, trembling, headache, sweating, and flu-like symptoms. This may be due to a blood disorder leading to an increased risk of infection.
• Unexplained muscle pain, tenderness, or 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, and 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 possible adverse effects" below):

• Cough, wheezing, and difficulty breathing, which may be accompanied by high temperature.
• Tar-like or bloody 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 sensations, movement disorders (muscle spasms or rigidity), seizures or fits.
• Psychiatric problems, such as hyperactivity and unusual feelings of overexcitement.
• Withdrawal effects (see the sections "Venlafaxine Retard Viatris" and "If you stop taking Venlafaxine Retard Viatris").
• Prolonged bleeding: if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Do not be concerned if you notice small white balls or granules in your stools after taking this medicine. Inside venlafaxine capsules are small spheres (white pellets) containing the active ingredient (venlafaxine). These spheres are released from the capsules into the stomach, and venlafaxine is slowly released as the spheres move through the stomach into the intestine. The "shell" of the spheres does not dissolve and is excreted in the stool. This means that, even though you may see the spheres in your bowel movements, the medicine dose has been absorbed.

Other possible adverse effects:

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

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

Common (may affect up to 1 in 10 people)

• Decreased appetite.

• Confusion, feeling detached (or separated) from oneself, inability to achieve orgasm, decreased libido, agitation, restlessness, abnormal dreams.

• Visual disturbances, including blurred vision; pupil dilation; inability to automatically adjust focus from distant to near objects.

• Ringing in the ears (tinnitus).

• Increased blood pressure, flushing.

• Yawning.

• Malaise (vomiting); diarrhea.

• Increased frequency of urination; inability to urinate, difficulty urinating.

• Menstrual irregularities such as increased bleeding or irregular bleeding; abnormal ejaculation/orgasm (in men); erectile dysfunction (impotence).

• Weakness (asthenia); fatigue; chills.

• Increased cholesterol in blood.

• Difficulty breathing.

• Mild rash, itching.

• Weight gain; weight loss.

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

• Rapid heartbeat (palpitations).

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).

• Hallucinations, feeling detached (or separated) from reality, abnormal orgasms, lack of sensations or emotions, feeling overstimulated, teeth grinding.

• Fainting, involuntary muscle movements, uncontrolled spasms, spasmodic or twisting movements, disturbances in coordination and balance.

• Feeling dizzy (especially when standing up quickly); decreased blood pressure.

• Vomiting blood, tarry stools or blood in the stool, which may indicate internal bleeding.

• Sensitivity to sunlight; bruising (ecchymosis); abnormal hair loss, hives.

• Low blood pressure.

• Slight changes in liver enzyme levels in blood, which may be observed through blood tests.

• Inability to control urination.

• Muscle rigidity, spasms, and involuntary muscle movements.

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

• Decreased sodium levels in blood, which may be observed through blood tests.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Cough, wheezing, and difficulty breathing, which may be accompanied by high temperature.
• Excessive water intake (known as inappropriate antidiuretic hormone secretion).
• Severe eye pain and blurred or reduced vision.
• Irregular, rapid, or abnormal heartbeat, which could lead to 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 production of breast milk.
• Prolonged bleeding, which may indicate a decrease in the number of platelets in blood, leading to an increased risk of bruising or bleeding.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or unexpected appearance of bruises or broken blood vessels (vein rupture).

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 discontinuation of treatment (see section 2, "What you need to know before taking Venlafaxine Retard Viatris").

• Aggressiveness.

• Vertigo.

• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

Occasionally, venlafaxine may cause side effects that may go unnoticed, such as high blood pressure, abnormal heartbeats, or slight changes in blood levels of liver enzymes, sodium, and cholesterol. Venlafaxine rarely reduces platelet function in blood, which could lead to an increased risk of bruising or bleeding. Therefore, your doctor may wish to perform blood tests occasionally, especially if you have been taking venlafaxine for a prolonged period.

Other adverse 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 adverse effects

If you experience any adverse 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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Viatris

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

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Retard Viatris:

The active substance 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), butyl methacrylate basic copolymer. The capsule shell contains: titanium dioxide (E-171), gelatin, iron oxide red (E-172) (for the 75 mg strength only), and erythrosine (E-127) and indigo carmine (E-132) (for the 150 mg strength only). Printing ink: shellac wax, black iron oxide (E-172).

Appearance of the product and contents of the pack

Prolonged-release hard capsules 75 mg:

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

Prolonged-release hard capsules 150 mg:

Opaque, deep red-colored, hard capsules marked with the text “VEN” on the 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, divided into 3 packs of 30 capsules each; multi-packs containing 100 capsules, divided into 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 certain 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
Hungary

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
Hungary

or

Viatris Sante
ZAC des Gaulnes, 360 Avenue Henri Schneider
69330 Meyzieu
France

or

Viatris Sante
1 Rue de Turin
69007 Lyon
France

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) 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 capsules for prolonged release 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 the most recent review of this leaflet: July 2023

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