Leaflet: information for the user

Venlafaxine Retard Normogen37.5 mg prolonged-release hard capsules EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isVenlafaxine Retard Normogenand what it is used for

2. What you need to know before you start takingVenlafaxine Retard Normogen

3. How to takeVenlafaxine Retard Normogen

4. Possible side effects

5. Storage ofVenlafaxine Retard Normogen

6. Contents of the pack and additional information

Venlafaxina Retard Normogencontains the active ingredient venlafaxine.

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

Venlafaxine 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 more difficult to treat.

Do not takeVenlafaxine Retard Normogen

• If you are allergic to venlafaxine or any of the other ingredients in 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 venlafaxine may cause serious or potentially life-threatening side effects. You should also wait at least 7 days after stopping venlafaxine before taking any IMAO (see also the section “Other medicines and Venlafaxine Retard Normogen” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxine Retard Normogen:

• If you are taking other medicines that may increase the risk of developing serotonin syndrome when taken withvenlafaxine(see the 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 that your heart rhythm is abnormal.
• 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 bruises or tendency to bleed easily), or if you are taking other medicines that may increase the risk of bleeding, for example, warfarin (used to prevent blood clots), or if you are pregnant (see the section Pregnancy, breastfeeding and fertility).
• If you have a history of 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 Retard Normogen, as it may cause extreme drowsiness 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, although 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 had previous thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric illnesses treated with antidepressants.

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

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

Dry mouth

Dry mouth has been reported in 10% of patients treated withvenlafaxine. This may increase the risk of tooth decay (caries). You should therefore take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by venlafaxine. Your diabetes medicines may therefore need to be adjusted.

Sexual problems

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

Children and adolescents

Venlafaxine should not normally be used to treat children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine for patients under 18 years old if they decide it is the best option for the patient. If your doctor has prescribed this medicine for 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 who 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 Venlafaxine Retard Normogen

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.

• Irreversible monoamine oxidase inhibitors 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 the section “What you need to know before starting to takeVenlafaxine Retard Normogen”).
• Serotonin syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see the section “Possible side effects”) may occur with venlafaxine treatment, 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 containingopioids (for example, buprenorphine,tramadol, fentanyl, tapentadol, pethidine or pentazocine), used to treat severe pain.
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used to treat opioid addiction or to treat 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, 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 stiffness, confusion, increased muscle enzymes (determined by a blood test).

Inform 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 allergies).

The following medicines may also 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 (used to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat 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 drowsiness 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 think you may be pregnant, consult your doctor or pharmacist before using this medicine. You should only take venlafaxine after discussing the possible benefits and risks for the unborn baby with your doctor.

Make sure your midwife and/or doctor knows that you are taking venlafaxine. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborn babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby 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 take venlafaxine in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine to be able to advise you.

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.

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

Driving and operating machines

Do not drive or operate machinery 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”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, 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 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 Normogen”).

If you take more Venlafaxina 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 medication and the amount ingested.

Overdose can put your life at risk, especially with the simultaneous use of certain medications and/or alcohol (see “Other medications and Venlafaxina Retard Normogen”).

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

If you forgot to take Venlafaxina Retard Normogen

If you have missed 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 prescribed to you in a day.

If you interrupt treatment with Venlafaxina Retard Normogen

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor believes you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue 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 doubts 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.

If any of the following effects occur, do not take more venlafaxine.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 blistered skin, difficulty swallowing or breathing.

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

• Pressure in the chest, 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 can increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

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

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

• Cough, wheezing, and difficulty breathing that may be accompanied by a fever.
• Stool (deposits) that are tar-like or contain blood.
• 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.
• Nervous system problems, such as dizziness, numbness, movement disorder (muscle spasms and rigidity), seizures, or attacks.
• 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 see white pellets or small granules in your stool after taking this medicine. Inside the capsules of Venlafaxine Retard Normogen, there are spheroids (small white pellets) 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 stool. Therefore, although you see spheroids in the stool, the dose of the medicine has been absorbed.

Other side 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 sit or stay still, numbness, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, grinding of teeth.
• Fainting, involuntary muscle movements, alteration of coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, stool that is tar-like or contains blood, 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)

Seizures or attacks.

• Cough, wheezing, and shortness of breath that may be accompanied by a fever.
• 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 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 the appearance of unexpected petechiae or blood vessel rupture (broken veins).

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. "What you need to know before taking Venlafaxine Retard Normogen").
• Aggression.
• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Venlafaxine 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, venlafaxine 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 venlafaxine for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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:www.notificaram.es. By reporting side 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 (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicationsshould not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat 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.

Composition ofVenlafaxine Extended-Release Normogen

The active ingredient is venlafaxine.

Each prolonged-release capsule contains 37.5 mg of venlafaxine as hydrochloride.

The other components are:

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

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

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

Appearance of the product and content of the packaging

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

Venlafaxine Extended-Release Normogen is available in:

Packages with blisters of 30 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

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.

Last review date of this leaflet: February 2024

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