VENLAFAXINE RETARD NORMOGEN 37.5 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Venlafaxine Retard Normogen

Do not takeVenlafaxine Retard Normogen

• 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 medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking an irreversible MAOI with venlafaxine can cause serious or potentially life-threatening side effects. Additionally, you must wait at least 7 days after you stop taking venlafaxine before taking any MAOI (see also section “Other medicines and Venlafaxine Retard Normogen” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist beforeyou start taking Venlafaxine Retard Normogen:

• 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 Normogen”).
• 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 section 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 Retard Normogen, as it may cause extreme fatigue 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 anxiety disorders, 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 during the interruption of treatment with venlafaxine.

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 of age) 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 a hospital directly.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

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 (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 of age. Also, you should know that in patients under 18 years, there is an increased risk of side effects such as suicide 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 when they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years are taking venlafaxine.

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

Other medicines and Venlafaxine Retard Normogen

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.

• Monoamine oxidase inhibitors 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. (MAOI: see section “What you need to know before you take Venlafaxine Retard Normogen”).
• Serotonin Syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”) may occur with treatment with venlafaxine, 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 illnesses 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 can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

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

Tell your doctor if you are taking medicines that may 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 Normogen with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxine Retard Normogen. Taking it with alcohol may cause extreme fatigue 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 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 must contact your midwife and/or doctor immediately.

If you take venlafaxine in the last stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after giving birth, 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.

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.

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.

Venlafaxine Retard Normogen contains sodium

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

3. How to take Venlafaxine Retard Normogen

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual recommended initial dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take venlafaxine 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 consulting your doctor (see section “If you stop taking Venlafaxine Retard Normogen”).

If you take more Venlafaxine Retard Normogen than you should

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.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see “Other medicines and Venlafaxine Retard Normogen”).

The 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.

If you forget to take Venlafaxine Retard Normogen

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

If you stop taking Venlafaxine Retard Normogen

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 suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric 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 on 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 bother you, 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.

If any of the following effects occur, do not take more venlafaxine. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

Rare (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.

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

• Chest tightness, breathing sounds, 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 enzymes (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 the 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 report to your doctorare (the frequency of these adverse effects is included in the list below "other adverse effects that may occur"):

• Cough, breathing sounds, and difficulty breathing that may be accompanied by a high 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 "How to take Venlafaxine Retard Normogen, if you interrupt treatment with Venlafaxine Retard Normogen").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

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

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.
• Tremors, 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 getting 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 sounds, 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 the available data)

• Suicidal ideation and suicidal behavior, cases of suicidal ideation and behavior 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 Normogen").
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: 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 Normogen

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

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

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that 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 that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Venlafaxine Retard Normogen

The active ingredient is venlafaxine.

Each prolonged-release capsule contains 37.5 mg of venlafaxine in the form of hydrochloride.

The other components are:

Capsule content: microcrystalline cellulose, povidone, talc, anhydrous colloidal silica, magnesium stearate, ethylcellulose, copovidone.

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

Capsule printing ink: shellac, iron oxide (red) (E172), propylene glycol.

Appearance of the Product and Package Contents

Venlafaxine Retard Normogen 37.5 mg is a hard (gelatin) prolonged-release capsule, size '3', with an approximate length of 15.80 mm, opaque, and gray-light/peach in color, with thick and thin circular bands printed with red ink around the body and thin and thick circular bands printed with red ink on the head of the capsule, and inside which are the film-coated mini-tablets of white or off-white color, round, and biconvex.

Venlafaxine Retard Normogen is available in:

Blisters of 30 hard capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

You can request more information about your disease by contacting a patient organization. Consult your doctor.

Date of the Last Revision of this Leaflet: February 2024

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/