Leaflet: information for the user

Venlafaxine Retard pensa pharma150 mg prolonged-release hard capsules

Read this 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, ask your doctor or pharmacist.

•This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

•If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Venlafaxine Retard Pensa Pharma and what it is used for

2. What you need to know before taking Venlafaxine Retard Pensa Pharma

3. How to take Venlafaxine Retard Pensa Pharma

4. Possible side effects

5. Storage of Venlafaxine Retard Pensa Pharma

6. Contents of the pack and additional information

Venlafaxina Retard Pensa Pharma contains the active ingredient venlafaxine.

Venlafaxina Retard Pensa Pharma 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 exact way in which antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline in the brain.

Venlafaxina Retard Pensa Pharma 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 harder to treat.

Do not take Venlafaxina Retard Pensa Pharma

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

•If you are also taking or have taken in the last 14 days, any medication known as an irreversible monoamine oxidase inhibitor (IMAO) used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxina Retard Pensa Pharma may produce severe or potentially fatal side effects. Additionally, you must wait at least 7 days after stopping Venlafaxina Retard Pensa Pharma before taking any IMAO (see also the section "Taking Venlafaxina Retard Pensa Pharma with other medications" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxina Retard Pensa Pharma:

• If you are taking other medications that, taken together with venlafaxine, may increase the risk of developing serotonin syndrome (see the section "Other medications and Venlafaxina Retard Pensa Pharma").
• If you have eye problems, such as certain types of glaucoma (increased eye pressure).
• 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 rhythm 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 history of bleeding disorders (tendency to develop ecchymoses or tendency to bleed easily), or if you are taking other medications that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you have a history of or if someone in your family has had mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine 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.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when starting to take antidepressants, as all these medications take time to work, usually two weeks, although sometimes more. These thoughts may also occur when your dose is reduced or during the interruption of treatment with Venlafaxina Pensa Pharma.

This is more likely to happen:

•If you have previously had thoughts of suicide or self-harm.

•If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders treated with antidepressants.

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

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

Dry mouth

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

Diabetes

Your blood glucose levels may be altered by venlafaxine. Therefore, your diabetes medication doses may need to be adjusted.

Sexual problems

Some medications in the group to which Venlafaxina Pensa Pharma belongs (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine should not be used normally 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 higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe this medication to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medication to a patient under 18 years old, and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old while they are taking venlafaxine.

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

Other medications and Venlafaxina Retard Pensa Pharma

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

Your doctor must decide if you can take venlafaxine with other medications.

Do not start or stop taking any medication, including those available over the counter, natural remedies, and herbal products, without checking with your doctor or pharmacist.

•Inhibitors of monoamine oxidase used to treat depression or Parkinson's diseaseshould not be taken with venlafaxine. Tell your doctor if you have taken any of these medications in the last 14 days. (IMAO: see section 2. "What you need to know before starting to take Venlafaxina Retard Pensa Pharma").

•Serotonin syndrome:

A potentially fatal state, or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section 4. "Possible Adverse Effects") may occur with treatment with venlafaxine, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraines)
• Other medications to treat depression, for example, SSRIs, SNRIs, tricyclic antidepressants, or medications containing lithium

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain
• Medications containing dextromethorphan (used to treat cough)
• Medications containing methadone (used to treat opioid addiction or to treat severe pain)
• Medications containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's Wort (also known asHypericum 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, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw)

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, and 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 stiffness, confusion, and increased muscle enzymes (determined by a blood test).

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

Inform your doctor if you are taking medications that may affect your heart rhythm.

Some examples of these medications 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 medications may interact with venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

•Ketoconazole (an antifungal medication).

•Haloperidol or risperidone (for treating psychiatric conditions).

•Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Venlafaxina Retard Pensa Pharma with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3. "How to take Venlafaxina Retard Pensa Pharma").

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme fatigue 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. You should only take Venlafaxina Retard Pensa Pharma after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking venlafaxine. When taken during pregnancy, similar medications (SSRIs) may increase the risk of a severe condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to 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 medication during pregnancy, in addition to breathing problems, another symptom your baby may have when born is feeding difficulties. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife for advice.

If you take Venlafaxina Retard Pensa Pharma in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine to be able to advise you.

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

Driving and operating machinery

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

Venlafaxina Retard Pensa Pharma contains yellow orange and sodium

It may cause allergic reactions because it contains yellow orange (E110).

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

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 venlafaxine approximately at the same time every day, either in the morning or at night. The capsules must be swallowed whole with liquid and should not be opened, crushed, chewed, or dissolved.

Venlafaxine 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 Pensa Pharma”).

If you take more Venlafaxina Retard Pensa Pharma than you should

Immediately contact your doctor or pharmacist if you take more medication than prescribed by your doctor.

Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (see Taking Venlafaxina Retard Pensa Pharma with other medications).

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

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 ingested.

If you forgot to take Venlafaxina Retard Pensa Pharma

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 compensate for the missed doses. Do not take more than the daily dose of venlafaxine that you have been prescribed in a day.

If you interrupt treatment with Venlafaxina Retard Pensa Pharma

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 venlafaxine, 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 suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with venlafaxine. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more. 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.

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

Do not worry if you notice small white grains or pellets in your stool after taking this medicine. Inside the Venlafaxina Retard Pensa Pharma capsules, there are spherical or small white pellets that contain the active ingredient venlafaxine. These pellets are released from the capsule in the stomach. As it circulates through the stomach and intestines, venlafaxine is released slowly. The "shell" of the pellet does not dissolve and is eliminated in the stool. Therefore, although you may see pellets in the stool, the dose of the medicine has been absorbed.

If any of the following effects occur, do not take more Venlafaxina Retard Pensa Pharma. Inform your doctor immediately, or go to the nearest hospital emergency room:

Rare (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and inflamed skin, 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, and vomiting. In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and 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 may increase the risk of infection.

?Severe rash, which may lead to severe blistering and skin peeling.

?Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

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

Other adverse effects that you should inform your doctor about (the frequency of these adverse effects are included in the lower list "other adverse effects that may occur"):

?Cough, wheezing, and difficulty breathing, which may be accompanied by a fever.

?Stool (deposits) or blood in stool.

?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: dizziness, numbness, movement disorder (muscle spasms and stiffness), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section“Stopping treatment with Venlafaxina Retard Pensa Pharma”).
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other adverse effects that may occur:

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

•Dizziness, headache, somnolence.

•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 or stay still, numbness, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• 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.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, grinding of teeth.
• Fainting, involuntary muscle movements, coordination and balance disturbances.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, stool (deposits) or blood in stool, 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 shortness of breath, which 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, 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 unexpected petechiae or vascular rupture (broken veins).

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. “What you need to know before starting to take Venlafaxina Retard Pensa Pharma”)
• Aggression
• Dizziness
• Heavy postpartum bleeding (hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Venlafaxina Retard Pensa Pharma 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 Pensa Pharma 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 Pensa Pharma 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 System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from humidity.

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

The active principle is venlafaxine.

Composition of Venlafaxina Retard Pensa Pharma 150 mg prolonged-release hard capsules EFG

Each prolonged-release capsule contains 169.8 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine base.

The other components (excipients) are:

Caplet content:

-Core:microcrystalline cellulose, povidone K-90 D, talc, anhydrous colloidal silica, magnesium stearate

-Coating: ethylcellulose and copovidone.

Caplet coating:gelatin, titanium dioxide (E171), yellow-orange S (E110), allura red AC (E129), and brilliant blue FCF (E133).

Caplet printing ink:shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), sodium hydroxide, povidone, and titanium dioxide (E171).

Product appearance and packaging content

Venlafaxina Retard Pensa Pharma 150 mg is presented in hard gelatin capsules, size 0, opaque dark orange in white print. The capsule contains 12 small coated tablets, white or off-white, round, biconvex, 12.5 mg each.

Venlafaxina Retard Pensa Pharma 150 mg is available in packs of 30 hard capsules.

Long-acting hard capsule.

Marketing authorization holder, manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid

Spain

Last review date of this leaflet:April2023

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