Venlafaxine prolonged-release Alter Genericos 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Retard Alter Generics 150 mg prolonged-release hard capsules EFG

Venlafaxine

Read the entire leaflet carefully before you start taking 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, because 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.

Leaflet contents

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

1. What Venlafaxine Retard Alter Genéricos is and what it is used for

Venlafaxine Retard Alter Genéricos contains the active substance venlafaxine.

Venlafaxine Retard Alter Genéricos 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 believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and norepinephrine in the brain. How antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine Retard Alter Genéricos is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). 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 Alter Generics

Do not take Venlafaxine Retard Alter Generics:

• If you are allergic to venlafaxine or to any of the other components of this medicine (listed in section 6).
• If you are currently 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 Alter Generics may cause serious, potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine Retard Alter Generics before starting any MAOI (see also section “Taking Venlafaxine Retard Alter Generics with other medicines” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Some medicines in the same class as Venlafaxine Retard Alter Generics (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

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

• If you are taking other medicines that, when taken together with Venlafaxine Retard Alter Generics, could increase the risk of developing serotonin syndrome (see section “Taking Venlafaxine Retard Alter Generics with other medicines”).
• 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 tend to develop bruises easily or have a tendency to bleed easily (history of bleeding disorders), or if you are pregnant (see “Pregnancy, breastfeeding and fertility”), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behavior.
• If you are taking medicines containing buprenorphine. Using these medicines together with venlafaxine may lead to serotonin syndrome, a potentially life-threatening condition (see “Taking Venlafaxine Retard Alter Generics with other medicines”).

Venlafaxine Retard Alter Generics 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.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts about harming yourself or suicide. This risk may increase when starting antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to happen:

• 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 behavior in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor 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 let you know if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Do not drink alcohol during treatment with Venlafaxine Retard Alter Generics, as it may cause extreme drowsiness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Dry mouth

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

Diabetes

Your blood glucose levels may be altered by Venlafaxine Retard Alter Generics. Therefore, the doses of your diabetes medications may need to be adjusted.

Children and adolescents

Venlafaxine Retard Alter Generics should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor 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 contact 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 Alter Generics.

In addition, long-term safety with regard to growth, maturation, and cognitive and behavioral development has not been established.

Taking Venlafaxine Retard Alter Generics with other medicines

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 Alter Generics with other medicines.

Do not start or stop taking any medicine, including over-the-counter medicines, herbal remedies, or plant-based products, without first 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 Alter Generics. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before starting to take Venlafaxine Retard Alter Generics”).
• Serotonin syndrome: Treatment with venlafaxine, particularly when taken with other medicines, may lead to a potentially life-threatening condition or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”).

Examples of such medicines include:

• triptans (used for migraine)
• other medicines to treat depression, e.g., 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, a reversible MAOI (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing tramadol, fentanyl, tapentadol, meperidine, 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 methemoglobin levels in blood)
• products containing St. John's wort (also called "Hypericum perforatum", a herbal or plant-based 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 are not there, false beliefs, unusual suspiciousness, unclear thinking, and tendency to withdraw).
• Medicines containing buprenorphine. These medicines may interact with venlafaxine and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, hyperactive reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

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 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 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 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 medicines may also interact with Venlafaxine Retard Alter Generics 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 (to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine Retard Alter Generics with food and drinks

Venlafaxine Retard Alter Generics should be taken with food (see section 3 “How to take Venlafaxine Retard Alter Generics”).

Do not drink alcohol during treatment with Venlafaxine Retard Alter Generics. Taking it together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy, breastfeeding and fertility

If you are pregnant, 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 Alter Generics after discussing with your doctor the possible benefits and possible risks to the unborn child.

Ensure that your midwife and/or doctor knows that you are taking Venlafaxine Retard Alter Generics. Medicines similar to this one (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after 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 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 so they can advise you appropriately.

Venlafaxine Retard Alter Generics passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

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

Important information about some of the components of Venlafaxine Retard Alter Generics 150 mg

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Venlafaxine Retard Alter Generics

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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, 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 Alter Generics 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 Alter Generics 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 Alter Generics”).

If you take more Venlafaxine Retard Alter Generics than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call 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 taken simultaneously with certain medicines and/or alcohol (see “Venlafaxine Retard Alter Generics with other medicines”).

Symptoms of 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 Alter Generics

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 the next 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 Alter Generics prescribed for you in one day.

If you stop taking Venlafaxine Retard Alter Generics

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Retard Alter Generics, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, especially when it is stopped suddenly or when the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, unsteadiness, 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, or flu-like symptoms.

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard Alter Generics. If you experience any of these or other bothersome symptoms, consult your doctor for 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 gets them.

If any of the following effects occur, stop taking Venlafaxine Retard Alter Generics and contact your doctor immediately 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, noisy breathing, 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 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 (detected by 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 severe blisters and peeling of the skin.
• Unexplained muscle pain, discomfort or weakness. This may be a sign of rhabdomyolysis.

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”):

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Tarry stools (faeces) or blood in faeces.
• 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-related problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Alter Generics, if you stop taking Venlafaxine Retard Alter Generics”).
• Prolonged bleeding—if you are cut or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice small granules or white beads in your faeces after taking Venlafaxine Retard Alter Generics. Inside the capsules of Venlafaxine Retard Alter Generics are spheroids or small white beads containing the active substance venlafaxine. These spheroids are released from the capsule in the gastrointestinal tract. As the spheroids move along the gastrointestinal tract, venlafaxine is slowly released. The “shell” of the spheroid remains undissolved and is excreted in the faeces. Therefore, even though you may see spheroids in your faeces, your dose of venlafaxine has been absorbed.

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, lack of orgasm, decreased libido, agitation, nervousness, 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, diarrhoea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (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, disturbance in coordination and balance.

• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.

• Vomiting blood, tarry stools (faeces) or blood in faeces, which may be a sign of internal bleeding.

• Sensitivity to sunlight, bruising, abnormal hair loss.

• Inability to control urine.

• 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 or fits.
• Cough, noisy breathing and shortness of breath that 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, 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, 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 reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from the available data)

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

Venlafaxine Retard Alter Generics 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 Alter Generics 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, particularly if you have been taking Venlafaxine Retard Alter Generics 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 Medicinal Products: 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 Alter Genéricos

Keep out of the sight and reach of children.

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

Do not store above 30°C.

Keep in a dry place.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Retard Alter Genéricos 150 mg prolonged-release hard capsules

The active substance is venlafaxine (hydrochloride). Each capsule contains 150 mg of venlafaxine.

The other components are: sugar spheres 20 (sucrose and maize starch), stearic acid, ethylcellulose and talc.

Capsule components: gelatin and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Venlafaxine Retard Alter Genéricos 150 mg is presented as prolonged-release hard capsules. The capsules are made of hard gelatin and contain white or almost white spheroids approximately 1 mm in diameter, with transparent cap and body.

Venlafaxine Retard Alter Genéricos 150 mg is available in packs containing 30 prolonged-release hard capsules.

Other presentations

Venlafaxine Retard Alter Genéricos 150 mg prolonged-release hard capsules EFG.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

NATRIX SCIENCES LTD.

Industrial State

Half Far

Malta

Or

FARMALIDER, S.A.

Aragoneses, 2

28108 – Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.