VENLAFAXINE Extended-Release 75 mg Hard Capsules

2. What you need to know before you take Venlafaxine Retard Alter Generics

Do not takeVenlafaxine Retard Alter Genericsif:

• You are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• 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 Alter Generics can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine Retard Alter Generics before taking 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 group as Venlafaxine Retard Alter Generics (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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

• If you are taking other medicines that, when taken 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 have a tendency to develop bruises or tend 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 overexcited or euphoric).
• If you have a history of aggressive behavior.
• If you are taking medicines containing buprenorphine. The use of these medicines 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 standing still during the first few weeks of treatment.

You should talk to your doctor if this happens.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, because these medicines all take time to work, usually about two weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had thoughts of killing or harming yourself.
• 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 conditions who were treated with antidepressants.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a 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 might 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.

Do not drink alcohol during treatment with Venlafaxine Retard Alter Generics, as it may cause extreme tiredness and unconsciousness. Taking it with certain medicines and/or with 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 should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Venlafaxine Retard Alter Generics. Therefore, the doses of your diabetes medicines 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 old. Additionally, you should know that in patients under 18 years old, 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 class of medicines. Nevertheless, your doctor may prescribe this medicine to patients under 18 years old when they decide what is best for the patient. If your doctor has prescribed this medicine to a patient under 18 years old 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 old are taking Venlafaxine Retard Alter Generics.

Additionally, long-term safety regarding growth, maturation, and cognitive and behavioral development has not been demonstrated.

Taking Venlafaxine Retard Alter Generics with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Your doctor will decide whether you can take Venlafaxine Retard Alter Generics with other medicines.

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

• 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 in the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine Retard Alter Generics”).
• Serotonin syndrome: With venlafaxine treatment, particularly when taken with other medicines, a potentially life-threatening or a condition similar to Neuroleptic Malignant Syndrome (NMS) may occur (see section “Possible side effects”).

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating depression, e.g., SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing medicines
• Medicines containing amphetamines (used for 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, 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 treatment)
• 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 natural remedy or herbal product 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, mistaken beliefs, unusual suspicion, unclear reasoning, and a tendency to withdraw)
• Medicines containing buprenorphine. These medicines may interact with venlafaxine, and you may experience symptoms such as involuntary muscle contractions, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, 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, 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 can 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 alter 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 mention to 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 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 with alcohol may cause extreme tiredness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Venlafaxine Retard Alter Generics after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor knows you are taking Venlafaxine Retard Alter Generics. When taken during pregnancy, similar medicines (SSRIs) 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 during the first 24 hours after the baby is born. 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 will be able to advise you.

If you take venlafaxine in the late stage 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 that you are taking venlafaxine so they can advise you.

Venlafaxine Retard Alter Generics 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.

Important information about some of the ingredients of Venlafaxine Retard Alter Generics 75 mg

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to Take Venlafaxine Alter Generics

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

The 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 Alter Generics 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.

Venlafaxine Retard Alter Generics should be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section "If you stop treatment with Venlafaxine Retard Alter Generics").

If you take moreVenlafaxine Retard Alter Genericsthan you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology 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 intake of certain medications and/or alcohol (see Venlafaxine Retard Alter Generics with other medications).

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

If you forget to takeVenlafaxine Retard Alter Generics

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily amount of Venlafaxine Retard Alter Generics that has been prescribed for you in one day.

If you stop treatment withVenlafaxine Retard Alter Generics

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Venlafaxine Retard Alter Generics, they may ask you to gradually reduce the dose before stopping treatment altogether. 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 too quickly. Some patients may experience symptoms such as 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 discharge, weakness, sweating, convulsions, or flu-like symptoms.

Your doctor will advise you on how to gradually stop treatment with Venlafaxine Retard Alter Generics. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

If any of the following effects occur, do not take more Venlafaxine Retard Alter Generics. Tell your doctor immediately, or go to the emergency room 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, breathing noise, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (elevated areas of red or pale 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 can resemble malignant neuroleptic syndrome (SNM). The signs and symptoms of SNM 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 blistering and peeling of the skin.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Other adverse effects that you should inform your doctor aboutare (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 a high temperature.
• Black stools (deposits) 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), convulsions or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxine Retard Alter Generics, if you stop treatment with Venlafaxine Retard Alter Generics").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

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.
• Tremors, a feeling of restlessness or inability to sit or stay still, tingling, altered taste, 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 frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, 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, 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 dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, black stools (deposits) 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 or convulsions.
• 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 heartbeat, rapid or irregular, which can 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 from the gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

Frequency Not Known (cannot be estimated from the available data)

• Suicidal ideation and suicidal behavior, cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before you start taking Venlafaxine Retard Alter Generics").
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Venlafaxine Retard Alter Generics 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, Venlafaxine Retard Alter Generics 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 Venlafaxine Retard Alter Generics 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 does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Venlafaxine Retard Alter Generics

Keep out of 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofVenlafaxine Retard Alter Generics75 mg prolonged-release hard capsules

The active ingredient is venlafaxine (hydrochloride). Each capsule contains 75 mg of venlafaxine.

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

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

Appearance of the Product and Package Contents

Venlafaxine Retard Alter Generics 75 mg is presented in the form of prolonged-release hard capsules. The capsules are hard gelatin capsules that contain white or off-white spherical pellets, approximately 1 mm in diameter, with a transparent cap and body.

Venlafaxine Retard Alter Generics 75 mg is presented in packages containing 30 prolonged-release hard capsules.

Other Presentations

Venlafaxine Retard Alter Generics 75 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 Last Revision of this Leaflet: May 2023

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