VENLAFAXINE RETARD QUALIGEN 150 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Qualigen 150 mg prolonged-release hard capsules EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Venlafaxine Retard Qualigen and what is it used for
2. What you need to know before you take Venlafaxine Retard Qualigen
3. How to take Venlafaxine Retard Qualigen
4. Possible side effects
5. Storing Venlafaxine Retard Qualigen
6. Pack contents and further information

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

Venlafaxine Retard Qualigen contains the active substance venlafaxine.

Venlafaxine Retard Qualigen 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. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine 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 depression and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Venlafaxine Retard Qualigen

• If you are allergic to venlafaxine or any of the other ingredients of Venlafaxine Retard Qualigen.
• If you are also taking or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Venlafaxine Retard Qualigen can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine Retard Qualigen before taking any irreversible MAOI (see also the section “Taking Venlafaxine Retard Qualigen with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxine Retard Qualigen:

• If you are using other medicines that, when taken with Venlafaxine Retard Qualigen, could increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxine 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 told you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are using other medicines 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.

Venlafaxine Retard Qualigen may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Do not drink alcohol while you are taking Venlafaxine Retard Qualigen, as it may cause extreme drowsiness and unconsciousness. Concomitant use with alcohol and/or certain medicines may worsen your symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, because all these medicines take time to work, usually around two weeks but sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital directly.

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

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental decay (caries). Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlafaxine Retard Qualigen. Consequently, it may be necessary to adjust the dose of your diabetes medication.

Sexual problems

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

Children and adolescents

Venlafaxine Retard Qualigen should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, the doctor who prescribes it to you may decide that it is the best treatment for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking Venlafaxine Retard Qualigen. Additionally, the long-term safety of this medicine in relation to growth, maturity, and cognitive and behavioral development in this age group has not been established.

Other medicines and Venlafaxine Retard Qualigen

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Your doctor must decide if you can take Venlafaxine Retard Qualigen with other medicines.

Do not start or stop taking any other medicines, including those that can be obtained without a prescription, herbal remedies, and supplements, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Venlafaxine Retard Qualigen.Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “What you need to know before taking Venlafaxine Retard Qualigen”)
• 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 these medicines include:

• Triptans (used for migraine).
• Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing medicines.
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity)
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, an MAOI (used to treat depression).
• Medicines containing sibutramine (used for weight loss).
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) (used to treat severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used for opioid addiction treatment or for severe pain).
• Medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methemoglobin in the blood).
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal remedy or supplement 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 do not exist, mistaken 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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

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

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

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

Taking Venlafaxine Retard Qualigen with food, drinks, and alcohol

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

Do not drink alcohol while you are taking Venlafaxine Retard Qualigen. Concomitant use with alcohol may cause extreme drowsiness and unconsciousness and may worsen your 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 using this medicine.

You should only take Venlafaxine Retard Qualigen after discussing the potential benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor know you are taking Venlafaxine Retard Qualigen. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in babies called persistent pulmonary hypertension in newborns (PPHN), making the baby breathe faster and have a bluish appearance. 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 medicine 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 Venlafaxine Retard Qualigen in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know you are taking Venlafaxine Retard Qualigen so they can advise you.

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

Driving and using machines

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

Venlafaxine Retard contains sodium

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

3. How to take Venlafaxine Retard Qualigen

Follow exactly the administration instructions of Venlafaxine Retard Qualigen given 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, 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 Venlafaxine Retard Qualigen at approximately the same time each day, either in the morning or evening. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Qualigen should be taken with food.

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

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Retard Qualigen”).

If you take more Venlafaxine Retard Qualigen than you should

Call your doctor or pharmacist immediately if you take more of this medicine than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Overdose can be life-threatening, especially with concomitant use of alcohol and/or certain medicines (see “Other medicines and Venlafaxine Retard Qualigen”).

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

If you forget to take Venlafaxine Retard Qualigen

If you miss 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 a single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily dose of Venlafaxine Retard Qualigen prescribed by your doctor in one day.

If you stop taking Venlafaxine Retard Qualigen

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need Venlafaxine Retard Qualigen, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that side effects occur when people stop using this medicine, especially when it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop taking Venlafaxine Retard Qualigen. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual over several months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If any of the following effects occur, do not take more Venlafaxina Retard Qualigen. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or swollen rash with itching, difficulty swallowing or breathing.

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

• Chest tightness, wheezing, difficulty swallowing or breathing.

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

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

• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which can lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort, 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" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

• Cough, breathing noise, and difficulty breathing that may be accompanied by an increased temperature.
• Tarry stools or blood in stools.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nerve problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), seizures, or attacks.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxina Retard Qualigen, if you interrupt treatment with Venlafaxina Retard Qualigen").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other adverse 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)

• Decreased appetite.
• Confusion, feeling unwell, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to remain seated or still, tingling, 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.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination frequency, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling detached 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 getting up too quickly); decreased blood pressure.
• Vomiting blood, tarry stools, or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes.

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

• Seizures.
• Cough, breathing noise, and shortness of breath that may be accompanied by a high temperature.
• 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, rapid, or irregular heartbeat, 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 bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from available data)

• Suicidal ideation and suicidal behavior, cases of suicidal ideation 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.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxina Retard Qualigen sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxina Retard Qualigen may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking Venlafaxina Retard Qualigen for a long time.

Reporting of adverse effects

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

5. Storage of Venlafaxina Retard Qualigen

Keep out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need in the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxina Retard Qualigen 150 mgprolonged-release hard capsules

The active ingredient is venlafaxine.

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

The other ingredients are:

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

Coating:methacrylic acid copolymer, type B, 12.5%,

Capsule:gelatin, titanium dioxide (E171), erythrosine (E 127), indigo carmine (E 132).

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

Appearance of the product and package contents

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

Packages containing 28, 30, or 98 capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Pharmathen, S.A.

6, Dervenakion Str. – GR – 15351

(Pallini. Attikis) Greece

O

Pharmathen International S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

O

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Date of the last revision of this leaflet:June 2024

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