Venlafaxine Qualigen 75 mg prolonged-release hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlafaxine Qualigen 75 mg prolonged-release hard capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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 adverse effects not listed in this leaflet. See section 4.

Package leaflet:

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

1. What Venlafaxine Retard Qualigen is and what it is 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 noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline 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. Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

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

Do not take Venlafaxine Retard Qualigen

• If you are allergic to venlafaxine or to any of the other components of Venlafaxine Retard Qualigen.

If you are also taking or have taken within the last 14 days any medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlafaxine Retard Qualigen may cause serious, and even potentially life-threatening, adverse effects. Additionally, you must wait at least 7 days after stopping Venlafaxine Retard Qualigen before starting any irreversible MAOI (see also the section “Taking Venlafaxine Retard Qualigen with other medicines” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

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

• If you are taking other medicines which, when taken together with Venlafaxine Retard Qualigen, could increase the risk of developing serotonin syndrome (see 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 that your heart rhythm is abnormal.
• 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 a tendency to bleed easily (history of bleeding disorders), or if you are taking 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 a family member has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine Retard Qualigen may cause a feeling of restlessness or an inability to sit or stay still during the first weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol while being treated with Venlafaxine Retard Qualigen, as it may cause extreme drowsiness and unconsciousness. Concomitant use of 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 committing suicide. These thoughts may increase when starting treatment with antidepressants, as all of these medicines take time to become effective—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of venlafaxine treatment.

You are more likely to experience this:

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

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

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

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 pay careful attention to your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxina Retard Qualigen. Consequently, an adjustment of your diabetes medication dose may be necessary.

Sexual problems

Some medicines in the same class as Venlafaxina Retard Qualigen (known as SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine Retard Qualigen should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the treating physician may prescribe this medicine to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlafaxine Retard Qualigen. Furthermore, the long-term safety regarding growth, maturation, and cognitive and behavioral development of this medicine in this age group has not been established.

Other medicines and Venlafaxine Retard Qualigen

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Do not start or stop taking any medicine, including those sold without a prescription, herbal remedies, or plant-based medicines, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) 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 within 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 resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”), may occur during treatment with venlafaxine, particularly when taken together with other medicines.

Examples of such medicines include:

• Triptans (used for migraine).
• Other medicines to treat depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium.
• 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 treating severe pain).
• Medicines containing methylene blue (used to treat elevated levels of methemoglobin in the blood).
• Herbal products containing St. John’s wort (also called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression).
• Products containing tryptophan (used for conditions such as sleep disorders and depression).
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, unclear thinking, and a tendency to withdraw).

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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

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

Inform 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 moxifloxacin (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 inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (used to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat 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 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 lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Ensure that your midwife and/or doctor know that you are taking Venlafaxine Retard Qualigen. When taken during pregnancy, similar medicines (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 occur within the first 24 hours after birth. If this happens to your baby, 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 at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

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

Venlafaxine Retard Qualigen passes into breast milk. There is a risk of effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

Do not drive or operate tools or machinery 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; that is, essentially "sodium-free".

3. How to take Venlafaxine Retard Qualigen

Follow exactly the administration instructions for Venlafaxine Retard Qualigen provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual recommended starting 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 Venlafaxine Retard Qualigen at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Qualigen should be taken with food.

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

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

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

Symptoms of a possible overdose may include palpitations, changes in 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 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 a single dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily amount of Venlafaxine Retard Qualigen prescribed for you in one day.

If you stop treatment with Venlafaxine Retard Qualigen

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Retard Qualigen, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people discontinue this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, loss of balance, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard Qualigen. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

4. Possible adverse effects

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

If any of the following effects occur, stop taking Venlafaxine Retard Qualigen immediately and contact your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or swollen itchy rash, 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 (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 heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected 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 may progress to the formation of serious blisters and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

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

Other adverse effects you should report to your doctor (the frequency of these adverse effects is included in the list below, “Other adverse effects that may occur”) are:

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Black or tarry stools or blood in stools.
• Itching, yellowing of the 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 disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Qualigen, if you stop taking Venlafaxine Retard Qualigen”).
• Prolonged bleeding; if you cut yourself or sustain a wound, it may take 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 strange, inability to achieve orgasm, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased or irregular bleeding, abnormal ejaculation/orgasm (in men), reduced erectile function (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or weight loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Dizziness (especially when standing up too quickly); decreased blood pressure.
• Vomiting blood, black or tarry stools (bowel movements), or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms, and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

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

• Seizures.
• Cough, noisy breathing, and shortness of breath, which may be accompanied by high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased levels of sodium in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal, fast 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, yellowing of the 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 low number of platelets in the blood, leading to increased bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or appearance of bruises or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and suicidal behaviour: cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2, “What you need to know before taking Venlafaxine Retard Qualigen”).
• Aggression.
• Vertigo.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

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

Reporting of adverse effects

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

5. Storage of Venlafaxine Retard Qualigen

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the Punto Sigre at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Venlafaxine Retard Qualigen 75 mg prolonged-release hard capsules

The active substance is venlafaxine.

Each prolonged-release capsule contains 75 mg of venlafaxine as venlafaxine hydrochloride.

The other components are:

Capsule contents: hypromellose, methacrylic acid copolymer ammonium (type B), sodium lauryl sulfate (E487), magnesium stearate.

Coating: butylated methacrylate copolymer base 12.5%,

Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172),

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

Appearance of the product and contents of the pack

Venlafaxine Retard Qualigen 75 mg prolonged-release hard capsules: opaque beige-colored hard gelatin capsules (size 0) containing two round, biconvex film-coated tablets, printed with VEN on the cap and 75 on the body.

Packs containing 28, 30 or 98 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer Responsible

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

Date of the most recent review of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.