Prospecto: information for the user

Venlafaxine Retard pensa pharma75 mg hard capsules of prolonged release EFG

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

•Keep this prospect, 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 other people, 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 prospect. See section 4.

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

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

3. How to take Venlafaxine Retard Pensa Pharma

4. Possible adverse effects

5. Storage of Venlafaxine Retard Pensa Pharma

6. Contents of the package 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 to increase the 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 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 Venlafaxina Retard Pensa Pharma may cause severe or potentially life-threatening side effects. Additionally, you should 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 medicines" 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 medicines that, taken with venlafaxine, may increase the risk of developing serotonin syndrome (see the section "Other medicines and Venlafaxina Retard Pensa Pharma").
• 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 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 medicines 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 restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue 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.

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 you start taking antidepressants, as all these medicines take time to work, usually two weeks or more, although sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with Venlafaxina Pensa Pharma.

It is more likely to happen:

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

•If you are a young adult. The 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 may also ask them to tell you if they think your depression or anxiety is getting worse, 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 affected by venlafaxine. Therefore, your doses of diabetes medicines may need to be adjusted.

Sexual problems

Some medicines 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 thoughts, suicidal behavior, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medicine 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 medicines 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 medicine.

Your doctor should decide if you can take venlafaxine with other medicines.

Do not start or stop taking any medicine, including those available over the counter, natural remedies, and herbal remedies, 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 medicines 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 life-threatening state, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section 4. "Possible side effects") may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

•Triptans (used for migraines)

•Other medicines to treat depression, for example, SSRIs, SNRIs, 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 IMAO (used to treat depression)

•Medicines containing sibutramine (used for weight loss)

•Medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain

•Medicines containing dextromethorphan (used to treat cough)

•Medicines containing methadone (used for the treatment of opioid addiction or for the treatment of severe pain)

•Medicines containing 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 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)

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

Inform your doctor immediately or go to the nearest hospital 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 interact with venlafaxine 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 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 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 if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. 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 medicines (SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. 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 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.

If you take Venlafaxina Retard Pensa Pharma in the final stages of pregnancy, there may be a higher 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 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 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.

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 increase the dose gradually 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 increase the dose gradually. 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

Contact your doctor or pharmacist immediately 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 Toxicology 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 reduce the dose gradually 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, numbness 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.

Uncommon (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). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, 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.

Frequency unknown (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 are (the frequency of these adverse effects are included in the lower list "other adverse effects that may occur"):

?Cough, wheezing, and difficulty breathing that 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 rigidity), 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 (males), 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, altered coordination and balance.
• 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 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, 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 rupture of blood vessels (veins).

Frequency unknown (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
• Excessive bleeding after childbirth (postpartum 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 moisture.

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. By doing so, you will help protect the environment.

The active principle is venlafaxine.

Composition of Venlafaxina Retard Pensa Pharma 75 mg prolonged-release hard capsules EFG

Each prolonged-release capsule contains 84.9 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components (excipients) are:

Capule content:

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

-Coating: ethylcellulose and copovidone.

Capule coating:gelatin, titanium dioxide (E171) and iron oxide red and black (E172).

Capule printing ink:shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), strong ammonia solution, and iron oxide red (E172).

Product appearance and packaging contents

Venlafaxina Retard Pensa Pharma 75 mg is presented in hard gelatin capsules, size 1, opaque orange in red print. The capsule contains 6 small coated white or off-white tablets, round, biconvex, 12.5 mg each.

Venlafaxina Retard Pensa Pharma 75 mg is available in packs of 30 hard capsules.

Prolonged-release 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:April 2023

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