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.
If you have any questions, consult your doctor or pharmacist.
6. Contents of the pack and additional information
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.
Do not take Venlafaxina Retard Viatris:
Warnings and precautions
Consult your doctor or pharmacist before starting to takeVenlafaxina Retard Viatris:
During treatment
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.
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:
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:
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:
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”.
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.
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):
Very rare (may affect up to 1 in 10,000 people):
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).
Frequency not known (cannot be estimated from available data):
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):
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:
Common (may affect up to 1 in 10 people):
Rare (may affect up to 1 in 100 people):
Very rare (may affect up to 1 in 10,000 people):
Very rare (may affect up to 1 in 10,000 people):
Frequency not known (cannot be estimated from available data):
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.
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.
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/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.