Prospecto: information for the user

Venlapine Retard 150 mg prolonged-release hard capsulesEFG

venlafaxine

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the prospect:

Venlapine Retard contains the active ingredient venlafaxine.

Venlapine Retard is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The exact way in which antidepressants work is not fully understood, but they may help to increase the levels of serotonin and norepinephrine in the brain.

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

Do not take Venlapine Retard

• If you are allergic to venlafaxine or any of the other ingredients of this medication (listed in section 6).
• If you are also taking or have taken in the last 14 days, any medication known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlapine Retard may produce severe or potentially fatal side effects. Additionally, you should wait at least 7 days after stopping Venlapine Retard before taking any IMAO irreversible (see also the section "Taking Venlapine Retard with other medications" and the information in that section on "Serotonin syndrome").

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlapine Retard.

• If you are taking other medications that, taken with Venlapine Retard, may increase the risk of developing serotonin syndrome (see the section "Taking Venlapine Retard with other medications").
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been informed that your heart rhythm is altered.
• If you have a history of seizures (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop cardenials or a tendency to bleed easily (history of hemorrhagic disorders), or if you are using other medications that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see "Pregnancy and breastfeeding").
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

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

Do not drink alcohol while taking Venlapine Retard, as it may cause extreme fatigue and unconsciousness. The concomitant use with alcohol and/or certain medications may worsen your depression symptoms and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when starting to take antidepressants, as all these medications take time to become effective, usually two weeks but sometimes longer. These thoughts may also occur when reducing your dose or during the interruption of treatment with Venlapine Retard.

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 an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital directly.

You may find it helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlapine Retard. Therefore, you may need to adjust your diabetes medication.

Sexual problems

Medications like Venlapine Retard (SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have continued after stopping treatment.

Children and adolescents

Venlapine Retard should not be used normally in the treatment ofchildren and adolescents under 18 years of age. Additionally, you should know that in patients under 18 yearsthere is agreater risk of adverse effects such as suicide attempts,suicidal thoughtsand hostility (mainly aggression, confrontational behavior and irritability).Despite this, the doctor who prescribes this medication to you may prescribe it to patients under 18 years of age when they decide what is best for the patient. Ifyour doctorhas prescribed this medication to a patient under 18 years of age and you want to discuss this decision,please go backto your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years of age who are taking Venlapine Retard. In addition, the long-term safety in relation to growth, maturation and cognitive and behavioral development of this medication in this age group has not been demonstrated.

Other medications and Venlapine Retard

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Your doctor must decide if you can take Venlapine Retard with other medications.

Do not start or stop taking any medication, including those available over the counter, natural remedies, and herbal supplements, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, should not be taken with Venlapine Retard. Inform your doctor if you have taken these medications in the last 14 days. (IMAO: see section "What you need to know before taking Venlapine Retard").
• Serotonin syndrome:

Serotonin syndrome, a potentially fatal or life-threatening condition, may occur with the treatment of venlafaxine, particularly when taken with other medications.

Examples of these medications include:

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

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

In its most severe form, serotonin syndrome may resemble Serotonin Neuroleptic Malignant Syndrome (SNMS). The signs and symptoms of SNMS may include a combination of fever, tachycardia, sweating, severe muscle rigidity, confusion, 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.

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

Some examples of these medications include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used for treating abnormal heart rhythm).
• Antipsychotics such as thioridazine (see also serotonin syndrome above).
• Antibiotics such as erythromycin or moxifloxacin (used for treating bacterial infections)
• Antihistamines (used for treating allergies)

The following medications may also interact with Venlapine Retard and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

• Ketoconazole (an antifungal medication).
• Haloperidol or risperidone (for treating psychiatric conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking Venlapine Retard with food, drinks, and alcohol

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

Do not drink alcohol while taking Venlapine Retard. The concomitant use with alcohol may cause extreme fatigue and unconsciousness and may worsen your depression symptoms 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 before using this medication. You should only take Venlapine Retard after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking Venlapine Retard. When taken during pregnancy, similar medications (SSRIs) 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 appear within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are takingthis medicationduring pregnancy, other symptomsthat your babymay havewhen born is incorrect feeding,in addition to havingbreathing problems.If yourbaby hasthese symptomswhen bornand you areconcerned,contact your doctor and/or midwifewho can advise you.

If you take Venlapine Retard 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 should know that you are taking Venlapine Retard to be able to advise you.

Venlapine Retard passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor, and he will decide whether you should stop breastfeeding or stop taking this medication.

Driving and operating machinery

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

Venlapine Retard contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, so it is considered essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist if you have any doubts.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may 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.

Take Venlapine Retard 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.

Venlapine Retard should be taken with food.

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

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

If you take more Venlapine Retard than you should

Call your doctor or pharmacist immediately if you take more than the prescribed dose of Venlapine Retard. 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 with concomitant use of alcohol and/or certain medications (see “Other medications and Venlapine Retard”).

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

If you forget to take Venlapine Retard

If you have missed 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 Venlapine Retard prescribed to you in a day.

If you interrupt treatment with Venlapine Retard

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need Venlapine Retard, 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, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling, or in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Venlapine Retard. This may take several weeks or months. In some patients, it may be necessary to stop treatment very gradually over 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 any of the following effects occur, do not take more Venlapine Retard.Inform your doctor immediately, or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people)

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

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

• Pressure in the chest, wheezing, difficulty swallowing or breathing.

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

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

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

Unknown frequency (cannot be estimated from available data)

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

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

• Cough, wheezing, and difficulty breathing that may be accompanied by a fever.
• Stool (deposits) that are tar-like or blood in stool.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heart rate, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nerve problems, such as dizziness, numbness, movement disorder (muscle spasms and rigidity), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see "How to take Venlapine Retard, if you interrupt treatment with Venlapine Retard").
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for the bleeding to stop.

Other side effects that may occur

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

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

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

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

• Seizures.
• Cough, wheezing, and shortness of breath that may be accompanied by a fever.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• SIADH (excessive water intake).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heart rhythm, rapid or irregular heart rate, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

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

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

Unknown frequency (cannot be estimated from available data)

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

Venlapine Retard may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme levels, sodium, or cholesterol levels. Your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlapine Retard for a long time.

Reporting of side effects

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

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Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the Pharmacy Take-Back Point. If in doubt, please ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Venlapine Retard 150 mg hard capsules with prolonged release

The active ingredient is venlafaxine.

Each prolonged release capsule contains 150 mg of venlafaxine as venlafaxine hydrochloride.

The other components are:

Caplet content: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate

Coating: butylated basic methacrylate copolymer 12.5%,

Capsule: gelatin, titanium dioxide (E171), erythrosine (E 127), indigotin I (E 132),

Printing ink: shellac, iron oxide black (E172), propylene glycol (E1520).

Appearance of the product and content of the container

Venlapine Retard 150 mg hard capsules with prolonged release EFG: hard gelatin capsules of opaque red color (size 00) containing three coated round and biconvex tablets, printed VEN on the cap and 150 on the body.

Containers containing 28, 30, or 98 capsules.

Only some container sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

Pharmathen, S.A.

6, Dervenakion Str. – GR – 15351

(Pallini. Attikis) Greece

Or

Pharmathen International, S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Or

Neuraxpharm Pharmaceuticals, S.L.

Avda Barcelona

69 08970

Sant Joan Despi

Barcelona - Spain

Last review date of this leaflet: June 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.