Venlafaxine prolonged-release 150 mg hard capsules EFG Pensapharma

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Retard Pensa Pharma 150 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Venlafaxine Retard Pensa Pharma is 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. How to store Venlafaxine Retard Pensa Pharma
6. Contents of the pack and other information

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

Venlafaxine Retard Pensa Pharma contains the active substance venlafaxine.

Venlafaxine Retard Pensa Pharma is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline in the brain.

Venlafaxine 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). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not resolve or may worsen and become more difficult to treat.

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

Do not take Venlafaxine Retard Pensa Pharma

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken within the last 14 days a medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlafaxine Retard Pensa Pharma may cause serious or even potentially life-threatening side effects. In addition, you must wait at least 7 days after stopping Venlafaxine Retard Pensa Pharma before starting any MAOI (see also section “Taking Venlafaxine Retard Pensa Pharma with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine Retard Pensa Pharma:

• If you are using other medicines that, when taken together 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 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 history of bleeding disorders (tendency to develop bruises 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 overly excited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should consult your doctor if this occurs.

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

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 yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work, usually about two weeks, although sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with 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. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants.

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

It may be helpful to inform 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 care of your dental hygiene.

Diabetes

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

Sexual problems

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

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms listed above develop or worsen when these patients under 18 years of age are taking venlafaxine.

In addition, the long-term safety regarding growth, maturation, and cognitive and behavioral development has not been established.

Other medicines and Venlafaxine Retard Pensa Pharma

Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.

Your doctor must decide whether you can take venlafaxine with other medicines.

Do not start or stop taking any medicine, including those sold without a prescription, herbal remedies, or plant-based products, without first checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with venlafaxine. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOIs: see section 2. “What you need to know before taking Venlafaxine Retard Pensa Pharma”).

• Serotonin syndrome:

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

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines to treat 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, meperidine, or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used for opioid addiction treatment or for treating severe pain)
• Medicines containing methylene blue (used to treat elevated methemoglobin levels in blood)
• Products containing St. John's wort (also called “Hypericum perforatum”, a natural or plant-based remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw)

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 may resemble Neuroleptic Malignant Syndrome (NMS). 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).

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

Inform your doctor if you are taking medicines that may affect your heart 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 allergy)

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 (to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme tiredness and unconsciousness, and may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxine Retard Pensa Pharma after discussing with your doctor the possible benefits and possible risks to the unborn child.

Make sure your midwife and/or doctor knows that you are taking venlafaxine. Medicines similar to venlafaxine (SSRIs) taken during pregnancy 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 begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take this medicine during pregnancy, in addition to breathing problems, another symptom your baby may have at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take Venlafaxine Retard Pensa Pharma in the late stages 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 you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or to stop treatment with this medicine.

Driving and using machines

Do not drive or operate tools or machinery until you know how this medicine affects you.

Venlafaxine Retard Pensa Pharma contains orange-yellow and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially “sodium-free”.

3. How to take Venlafaxine Retard Pensa Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg once daily. Your doctor may gradually increase the dose, and if necessary, further increase it 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 daily 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 must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be adjusted.

Do not stop taking this medicine without consulting 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 prescribed.

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

Symptoms of a possible overdose may include palpitations, changes in alertness (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 Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Venlafaxine Retard Pensa Pharma

If you have missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next scheduled dose as usual. Do not take a double dose to make up for a missed one. Do not take more than the prescribed daily amount of venlafaxine in one day.

If you stop taking Venlafaxine Retard Pensa Pharma

Do not stop taking this medicine or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may advise you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking this medicine, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

If you have any further questions about 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 everyone experiences them.

Do not be concerned if you notice small granules or white beads in your faeces after taking this medicine. Inside the Venlafaxine Retard Pensa Pharma capsules there are spheroids or small white beads containing the active substance venlafaxine. These spheroids are released from the capsule in the stomach. As it passes through the stomach and intestines, venlafaxine is slowly released. The spheroid "shell" does not dissolve and is excreted in the faeces. Therefore, even if you see spheroids in your faeces, the medicine dose has been absorbed.

If any of the following effects occur, stop taking Venlafaxine Retard Pensa Pharma immediately and contact your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or swollen itchy rash, difficulty swallowing or breathing.

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

? Chest tightness, noisy breathing, difficulty swallowing or breathing.

? Severe skin rash, itching, or hives (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, diarrhoea, coma, nausea, vomiting. In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected 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 may progress to the formation of severe blisters and peeling of the skin.

? 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," which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other adverse effects about which you should inform your doctor are (the frequency of these adverse effects are included in the list below, “Other adverse effects that may occur”):

? Cough, noisy breathing, and difficulty breathing, which may be accompanied by an increase in temperature.

? Tar-like stools or blood in the stools.

? Itching, yellowing of the 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 disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of being overexcited).
• Withdrawal effects (see section “If you stop taking Venlafaxine Retard Pensa Pharma”).
• Prolonged bleeding—if you are cut or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Other possible adverse effects:

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, inability to achieve orgasm, decreased libido, agitation, nervousness, abnormal dreams.
  • Tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
  • Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
  • Ringing in the ears (tinnitus).
  • Rapid heartbeat, palpitations.
  • Increased blood pressure, hot flushes.
  • 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 increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
  • Weakness (asthenia), fatigue, chills.
  • Weight gain or weight loss.
  • Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overstimulated, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces), or blood in the stools, which may be signs of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms, and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

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

• Seizures or fits.
• Cough, noisy breathing, and shortness of breath, which may be accompanied by 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, fast, 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, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs 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 blood platelets, leading to an increased risk of bruising or bleeding.

? Abnormal production of breast milk.

? 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 thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before taking Venlafaxine Retard Pensa Pharma”).
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Venlafaxine Retard Pensa Pharma may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; slight 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 wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Retard Pensa Pharma for a long time.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, please consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

The active substance 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:

Capsule contents:

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

• Coating: ethylcellulose and copovidone.

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

Printing ink of the capsule: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), sodium hydroxide, povidone and titanium dioxide (E171).

Appearance of the product and pack contents

Venlafaxina Retard Pensa Pharma 150 mg is presented as hard gelatin capsules, size 0, opaque orange-brown with white printing. The capsule contains 12 small white or almost white, round, biconvex film-coated tablets of 12.5 mg each.

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

Prolonged-release hard capsule.

Marketing Authorisation Holder, Manufacturer

Marketing Authorisation Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible:

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid

Spain

Date of the most recent revision of this leaflet: April 2023

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