Prospect: information for the user

Venlafaxine Retard Qualigen 150 mg prolonged-release hard capsulesEFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, 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.

Content of the prospect:

Venlafaxina Retard Qualigen contains the active ingredient venlafaxine.

Venlafaxina Retard Qualigen 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. The exact way in which antidepressants work is not fully understood, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina Retard Qualigen 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 Venlafaxina Retard Qualigen

• If you are allergic to venlafaxine or any of the other components of Venlafaxina Retard Qualigen.
• 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 Venlafaxina Retard Qualigen may produce severe or potentially fatal adverse effects. Additionally, you must wait at least 7 days once you stop taking Venlafaxina Retard Qualigen before taking any IMAO irreversible (see also the section “Taking Venlafaxina Retard Qualigen with other medications” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxina Retard Qualigen:

• If you are using other medications that taken with Venlafaxina Retard Qualigen may increase the risk of developing serotonin syndrome (see the section “Other medications and Venlafaxina Retard Qualigen”)
• 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 cardenals or a tendency to bleed easily (history of bleeding 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.

Venlafaxina Retard Qualigen may cause a feeling of 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 Venlafaxina Retard Qualigen, 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 your 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 your dose decreases or during the interruption of treatment with venlafaxine.

It is more likely to happen:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. The information from clinical trials 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 dental deterioration (caries). Therefore, you should take care of your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlafaxina Retard Qualigen. Therefore, you may need to adjust the dose of your diabetes medication.

Sexual problems

Some medications in the group to which Venlafaxina Retard Qualigen belongs (called IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxina Retard Qualigen should not be used normally in the treatment ofchildren and adolescents under 18 years old. Additionally, you should know that in patients under 18 years oldthere is agreater risk of adverse effects such as attempts at suicide,suicidal thoughtsand hostility (predominantly aggression, confrontational behavior and irritability) when taking this type of medication. However, the doctor who prescribes this medication to you may prescribe it to patients under 18 years old when they decide what is best for the patient. If yourdoctorhas prescribed this medication to a patient under 18 years old 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 old who are taking Venlafaxina Retard Qualigen. Additionally, 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 Venlafaxina Retard Qualigen

Inform your doctor or pharmacist if you are using, have used recently or may need to use other medications.

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

Do not start or stop taking any medication, including those sold without a prescription, natural remedies and herbal remedies, before checking with your doctor or pharmacist.

• Inhibitors of monoamine oxidase used to treat depression or Parkinson's diseaseshould not be taken with Venlafaxina Retard Qualigen.Tell your doctor if you have taken any of these medications in the last 14 days. (IMAO: see section “What you need to know before taking Venlafaxina Retard Qualigen”)
• Serotonin syndrome:

A potentially fatal state, or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible Side Effects”), may occur with treatment with venlafaxine, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraines).
• Other medications to treat depression, for example, ISRN, ISRS, tricyclic antidepressants or medications containing lithium.Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an IMAO (used to treat depression).
• Medications containing sibutramine (used for weight loss).
• Medications containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, petidine or pentazocine) (used to treat severe pain).
• Medications containing dextromethorphan (used to treat cough).
• Medications containing methadone (used to treat opioid addiction or to treat severe pain).
• Medications containing methylene blue (used to treat high levels of methemoglobin in the blood).
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal remedy used to treat mild depression).
• Products containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing or feeling things that do not exist, false beliefs, unusual suspicion, unclear 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 malignant neuroleptic syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, 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 alter your heart rhythm.

Some examples of these medications include:

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

The following medications may also interact with Venlafaxina Retard Qualigen 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 (to treat psychiatric conditions).
• Metoprolol (a beta-blocker to treat high blood pressure and heart problems)

Taking Venlafaxina Retard Qualigen with food, drinks and alcohol

Venlafaxina Retard Qualigen should be taken with food (see section 3 “HOW TO TAKE VENLAFAXINA RETARD QUALIGEN”).

Do not drink alcohol while taking Venlafaxina Retard Qualigen. 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 or pharmacist before using this medication.

You should only take Venlafaxina Retard Qualigen after discussing with your doctor the possible benefits and risks for the unborn baby.

Make sure your midwife and/or doctor know that you are taking Venlafaxina Retard Qualigen. 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), making the baby 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 taking this medication during pregnancy, in addition to breathing problems, another symptom your baby may have when born is feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

If you take Venlafaxina Retard Qualigen in the final stages of pregnancy, there may be a greater 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 Venlafaxina Retard Qualigen to be able to advise you.

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

Driving and operating machines

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

Venlafaxina Retardcontains sodium

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

Follow exactly the administration instructions for Venlafaxina Retard Qualigen as indicated by your doctor.Consult your doctor or pharmacist if you have any doubts.

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, 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 Venlafaxina Retard Qualigen 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.

Venlafaxina Retard Qualigen should be taken with food.

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

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

If you take more Venlafaxina Retard Qualigen 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 with concomitant use of alcohol and/or certain medications (see “Other medications and Venlafaxina Retard Qualigen”).

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 forgot to take Venlafaxina Retard Qualigen

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 Venlafaxina Retard Qualigen prescribed to you in a day.

If you interrupt treatment with Venlafaxina Retard Qualigen

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 Venlafaxina Retard Qualigen, 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 flu-like symptoms, 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 Venlafaxina Retard Qualigen.This may take several weeks or months. In some patients, the interruption may need to be produced 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 Venlafaxina Retard Qualigen.Inform your doctor immediately, or go to the nearest hospital emergency room:

Rare (may affect up to 1 in 100 people)

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

Rare (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).
• Symptoms and signs 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). NMS symptoms and signs may include a combination of fever, rapid heart rate, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

• Symptoms 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 severe blistering and skin peeling.
• Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

• Symptoms and signs 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, breathing sounds, and difficulty breathing that may be accompanied by a fever.
• Stool (deposits) 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), seizures, or attacks.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see "Taking Venlafaxina Retard Qualigen, if you interrupt treatment with Venlafaxina Retard Qualigen").
• 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 focus on distant objects to near objects.
• Tinnitus (ringing in the ears).
• Rapid heart rate, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea
• Mild skin rash, itching.
• Increased 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, accelerated 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, coordination and balance disturbances
• Dizziness (especially when standing up too quickly); decreased blood pressure.
• Vomiting blood, stool (deposits) or blood in stool, 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, breathing sounds, and shortness of breath that may be accompanied by a fever.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• 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 Venlafaxina Retard Qualigen").
• Aggression
• Dizziness
• Abundant vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxina Retard Qualigen 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 Venlafaxina Retard Qualigen for a long time.

Reporting 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 Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not usethis 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 the containers and medicines you no longer need at thePharmacy Take-Backpoint. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard Qualigen 150 mghard 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:

Capule 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 contents of the packaging

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

Packagings containing 28, 30, or 98 capsules.

Only some packaging 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 Despí

Barcelona - Spain

Last review date of this leaflet:June 2024

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