VENLAFAXINE RETARD PENSA PHARMA 75 mg PROLONGED-RELEASE HARD CAPSULES

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

Do not take Venlafaxine 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 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 Pensa Pharma can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine Retard Pensa Pharma before taking any MAOI (see also section “Taking Venlafaxine Retard Pensa Pharma with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist beforestarting treatment with Venlafaxine Retard Pensa Pharma:

• If you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine 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 you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatremia).
• If you have a history of bleeding disorders (tendency to develop bruises or tendency to bleed easily), or if you are using 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 a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

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

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually around two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking Venlafaxine 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 conditions who were treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to 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.

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. Therefore, the doses of your diabetes medicines may need to be adjusted.

Sexual problems

Some medicines in the same group as Venlafaxine Pensa Pharma (called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years old. Also, you should know that in patients under 18 years old, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when they take this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years old when they decide that it is the best 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 above symptoms develop or worsen when these patients under 18 years old are taking venlafaxine.

Additionally, long-term safety data on growth, maturation, and cognitive and behavioral development in children and adolescents are not available.

Other medicines and Venlafaxine Retard Pensa Pharma

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 with other medicines.

Do not start or stop taking any medicines, including those that can be bought without a prescription, herbal remedies, and supplements, 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. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section 2. “What you need to know before you take Venlafaxine Retard Pensa Pharma”).

• Serotonin syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section 4. “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
  • Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity)

• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, an MAOI (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 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 herbal remedy or supplement 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 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, 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 may 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 affect your heart rhythm.

Some examples of these medicines include:

? Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat)

? 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 and should be used with caution. It is especially important to tell 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 Pensa Pharma with food, drinks, and alcohol

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

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen 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 Pensa Pharma after discussing the potential benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows you are taking venlafaxine. When similar medicines (SSRIs) are taken during pregnancy, they 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 can advise you.

If you take Venlafaxine Retard Pensa Pharma in the last trimester 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 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 use tools or machines until you know how this medicine affects you.

3. How to take Venlafaxine Retard Pensa Pharma

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, 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 at approximately the same time each day, either in the morning or in the evening. The capsules should 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 you may need a different dose of this medicine.

Do not stop taking this medicine without talking to your doctor (see section “If you stop taking Venlafaxine Retard Pensa Pharma”).

If you take more Venlafaxine Retard Pensa Pharma than you should

Contact your doctor or pharmacist immediately if you take more of the medicine than your doctor prescribed.

Overdose can be life-threatening, especially when taken with certain medicines and/or alcohol (see “Taking Venlafaxine Retard Pensa Pharma with other medicines”).

Symptoms of a possible overdose may include palpitations, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, 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 medicine and the amount taken.

If you forget to take Venlafaxine Retard Pensa Pharma

If you miss 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 a single dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily dose of venlafaxine prescribed by your doctor in one day.

If you stop taking Venlafaxine Retard Pensa Pharma

Do not stop taking your treatment or reduce the dose without your doctor's advice, 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 side effects occur when people stop using this medicine, especially when it is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, unsteadiness, 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 shock, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you how to gradually stop taking venlafaxine. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual over several months or more. If you experience any of these or other symptoms that are troublesome, consult your doctor for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

If any of the following effects occur, do not take more Venlafaxine Retard Pensa Pharma. Inform 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 reddened 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 neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS 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 the formation of severe blisters and skin peeling.

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

Frequency not known (cannot be estimated from available data)

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

Other adverse effects that you should inform your doctor about are (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 an increased temperature.

? Tarry 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 "If you stop treatment with Venlafaxine 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, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Decreased appetite.
  • Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
  • Tremor, a feeling of restlessness or inability to remain seated or still, tingling, 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.
  • Ringing in the ears (tinnitus).
  • Rapid heartbeat, palpitations.
  • Increased blood pressure, hot flashes.
  • Difficulty breathing, yawning.
  • Vomiting, diarrhea.
  • Mild skin rash, itching.
  • Increased urination frequency, inability to urinate, difficulty urinating.
  • Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), 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 standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry 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, 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, 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 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 taking Venlafaxine Retard Pensa Pharma")
• Aggression
• Dizziness
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Venlafaxine Retard Pensa Pharma sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine Retard Pensa Pharma 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 Pensa Pharma for a long time.

Reporting 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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Pensa Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

The active ingredient is venlafaxine.

Composition of Venlafaxine 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 ingredients (excipients) are:

Capsule content:

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

-Coating: ethylcellulose and copovidone.

Capsule shell:gelatin, titanium dioxide (E171), and red and black iron oxides (E172).

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

Product Appearance and Package Contents

Venlafaxine Retard Pensa Pharma 75 mg is presented in hard gelatin capsules, size 1, opaque peach-colored with red printing. The capsule contains 6 small white or off-white film-coated tablets, round, biconvex, 12.5 mg each.

Venlafaxine Retard Pensa Pharma 75 mg is available in packages 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

Manufacturer:

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid

Spain

Date of Last Revision of This Leaflet:April 2023

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