Label: information for the user

Venlafaxine Retard Alter Generics 150 mg prolonged-release hard capsulesEFG

Venlafaxine

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

• Keep this label, 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 you must 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 not listed in this label. See section 4.

1. What isVenlafaxine RetardAlter Genericsand what it is used for

2. What you need to know before starting to takeVenlafaxine Retard Alter Generics

3. How to takeVenlafaxine Retard Alter Generics

4. Possible adverse effects

5. Storage ofVenlafaxine Retard Alter Generics

6. Contents of the pack and additional information

Venlafaxina RetardAlter Genéricoscontains the active ingredient venlafaxine.

Venlafaxina Retard Alter Genéricos is an antidepressant that belongs to a group of medications known as serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and noradrenaline in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina 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). 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 more difficult to treat.

Do not takeVENLAFAXINE RETARD ALTER GENERICOS:

- If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).

- If you are also taking or have taken in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxine Retard Alter Genéricos may cause severe or potentially fatal side effects. Also, you must wait at least 7 days after stopping Venlafaxine Retard Alter Genéricos before taking any IMAO (see also the section “Taking Venlafaxine Retard Alter Genéricos with other medicines” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Some medicines in the group to which Venlafaxine Retard Alter Genéricos belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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

• If you are taking other medicines that, taken with Venlafaxine Retard Alter Genéricos, may increase the risk of developing serotonin syndrome (see the section “Taking Venlafaxine Retard Alter Genéricos 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 informed that your heart rate 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 bleeding or bruising easily (history of haemorrhagic disorders), or if you are pregnant (see “Pregnancy, breastfeeding and fertility”), or if you are using 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 someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.
• If you are taking medicines that contain buprenorphine. The use of these medicines with venlafaxine may lead to serotonin syndrome, a potentially fatal state (see “Taking Venlafaxine Retard Alter Genéricos with other medicines”).

Venlafaxine Retard Alter Genéricos may cause restlessness or difficulty sitting or staying still during the first weeks of treatment.

You must consult your doctor if this happens.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. This may be more likely when you first start taking antidepressants, because they can take some weeks to work, but it may also be more likely when doses are changed or when you stop taking the antidepressants.

You are more likely to experience this:

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

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

You may find it helpful to tell a close relative or 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 behaviour.

Do not drink alcohol during treatment with Venlafaxine Retard Alter Genéricos, as it may cause extreme drowsiness and loss of consciousness. Taking it with certain medicines and/or alcohol may worsen the 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 must take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxine Retard Alter Genéricos. Therefore, your doses of diabetes medicines may need to be adjusted.

Children and adolescents

Venlafaxine Retard Alter Genéricos should not normally be used in the treatment of children and adolescents under 18 years of age. You should also know that in patients under 18 years of age, there is a higher risk of side effects such as suicidal thoughts, suicidal behaviour and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine for patients under 18 years of age if they decide it is the best option for the patient. If your doctor has prescribed this medicine for a patient under 18 years of age, and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above develop or worsen in patients under 18 years of age who are taking Venlafaxine Retard Alter Genéricos.

Furthermore, the long-term safety in relation to growth, maturation and development of cognitive and behavioural functions has not been demonstrated.

Taking Venlafaxine Retard Alter Genéricos with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medicine.

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

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Venlafaxine Retard Alter Genéricos. Tell your doctor if you have taken any of these medicines in the last 14 days. (IMAO: see section “What you need to know before taking Venlafaxine Retard Alter Genéricos”).
• Serotonin syndrome: With treatment with venlafaxine, particularly when taken with other medicines, may cause a potentially fatal or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible side effects”).

Examples of these medicines include:

• Triptans (used for migraines)
• Other medicines for treating depression, for example, ISRN, ISRS, 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 irreversible IMAO (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine or pentazocine (used to treat severe pain)
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used to treat opioid addiction or to treat severe pain)
• Medicines containing methylene blue (used to treat high levels of methaemoglobinemia 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 thinking and tendency to withdraw).
• Medicines containing buprenorphine. These medicines may interact withvenlafaxineand may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, high body temperature above 38°C. Contact your doctor if you experience these symptoms.

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, diarrhoea, 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 rigidity, confusion, increased muscle enzymes (determined by a blood test).

Inform 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 rate.

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 Genéricos and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

• 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 Alter Genéricos with food and drinks

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

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or 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 Genéricos after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor knows that you are taking Venlafaxine Retard Alter Genéricos. When taken during pregnancy, similar medicines (ISRS) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's 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 that 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.

Taking venlafaxine in the final stages of pregnancy may increase the risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife must know that you are taking venlafaxine so they can advise you.

Venlafaxine Retard Alter Genéricos passes into breast milk. There is a risk of an effect on the baby. Therefore, you must discuss the case with your doctor and they will decide if 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.

Important information about some of the components ofVenlafaxine Retard Alter Genéricos 150 mg

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, even more, 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 Alter Genéricos 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 Alter Genéricos 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 Alter Genéricos”).

If you take moreVenlafaxina Retard Alter Genéricosthan you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can put your life in danger, especially with the simultaneous use of certain medications and/or alcohol (see Venlafaxina Retard Alter Genéricos with other medications).

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

If you forgot to takeVenlafaxina Retard Alter Genéricos

If a dose has not been taken, 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 Alter Genéricos that you have been prescribed in a day.

If you interrupt the treatment withVenlafaxina Retard Alter Genéricos

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 Alter Genéricos, 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 fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling, or, in rare cases, electrical discharge sensations, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard Alter Genéricos. If you experience any of these or other symptoms that bother you, consult your doctor for 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 side effects occur, do not take more Venlafaxina Retard Alter Genéricos. Inform your doctor immediately, or go to the nearest hospital emergency department:Immediately tell your doctor or go to the nearest hospital emergency department if you experience any of the following:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or a raised, 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 urticaria (raised, red or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid 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). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

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

You must inform your doctor about the following side effects (the frequency of these side effects is included in the list below “other side effects that may occur”):Inform your doctor about the following side effects:

• Cough, wheezing, and difficulty breathing that may be accompanied by a fever.
• Black 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, numbness, movement disorders (muscle spasms and rigidity), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Venlafaxina Retard Alter Genéricos if you interrupt treatment with Venlafaxina Retard Alter Genéricos”).
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you see small white granules or beads in your stools after taking Venlafaxina Retard Alter Genéricos. Inside the capsules of Venlafaxina Retard Alter Genéricos, there are microspheres or small white beads that contain the active ingredient venlafaxine. These microspheres are released from the capsule in the gastrointestinal tract. Since the microspheres move along the length of the gastrointestinal tract, venlafaxine is released slowly. The “shell” of the microsphere remains undissolved and is eliminated in the stool. Therefore, although you may see microspheres in your stool, your dose of venlafaxine has been absorbed.

Other side effects that may occur

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

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

Common (may affect up to 1 in 10 people)

• Loss of appetite.
• Confusion, feeling strange, 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.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).

• Alucinaciones, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, grinding of teeth.
• Loss of consciousness, involuntary muscle movements, alteration of coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, black stools or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, abnormal hair loss.
• Inability to control urination.
• Rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

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

• Convulsions or seizures.
• Cough, wheezing, and difficulty breathing that may be accompanied by a fever.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• SIADH (excessive water intake).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, 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, symptoms similar to the flu, 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 unexpected petechiae or vascular rupture (broken veins).

Frequency not known (cannot be estimated with available data)

• Suicidal ideation and behavior, cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. “What you need to know before starting to take Venlafaxina Retard Alter Genéricos”).
• Aggression.
• Dizziness.
• Excessive postpartum bleeding (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in a dry place.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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

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

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

Components of the capsule: gelatin and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Venlafaxine Retard Alter Generics 150 mg is presented in the form of prolonged-release hard capsules. The capsules are hard gelatin that contain white or off-white spheres of approximately 1 mm in diameter, with transparent cap and body.

Venlafaxine Retard Alter Generics 150 mg is presented in packaging that contains 30 prolonged-release hard capsules.

Other presentations

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

NATRIX SCIENCES LTD.

Industrial State

Half Far

Malta

O

FARMALIDER, S.A.

Aragoneses, 2

28108– Alcobendas (Madrid)

Spain

Last review date of this leaflet: May 2023

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