VENLAFAXINE RETARD NORMON 225 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

VenlafaxineRetard Normon 225 mg prolonged-release hard capsules EFG

Venlafaxine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Venlafaxine Retard Normon and what is it used for
2. What you need to know before taking Venlafaxine Retard Normon
3. How to take Venlafaxine Retard Normon
4. Possible side effects
5. Storage of Venlafaxine Retard Normon
6. Package contents and additional information

1. What is Venlafaxine Retard Normon and what is it used for

Venlafaxine Retard Normon contains the active substance venlafaxine.

Venlafaxine Retard Normon 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. It is believed that people who are depressed and/or anxious have lower levels of serotonin and norepinephrine in the brain. The exact way antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine Retard Normon 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 improve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Retard Normon

Do not take Venlafaxine Retard Normon

• If you are allergic to venlafaxine or any of the other ingredients of this medication (listed in section 6).
• If you are also taking or have taken in the last 14 days a medication known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Venlafaxine Retard Normon can cause serious or potentially life-threatening side effects. Additionally, you must wait at least 7 days after stopping Venlafaxine Retard Normon before taking any MAOI (see also the section "Taking Venlafaxine Retard Normon with other medications" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacist beforestarting to take this medication:

• If you are using other medications that, when taken with this medication, may increase the risk of developing serotonin syndrome (see the section "Taking Venlafaxine Retard Normon with other medications").
• 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 informed that your heart rhythm is altered.
• If you have a history of seizures (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are using other medications 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 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.

Some medications in the same group as Venlafaxine Retard Normon (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxine Retard Normon, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications 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. This may increase when starting to take antidepressants, due to the fact that these medications take time to work, usually about two weeks but sometimes longer.

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 has shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric disorders who were treated with antidepressants.

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

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 package leaflet. You can also 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 this medication. Therefore, the doses of your diabetes medications may need to be adjusted.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. Despite this, your doctor may prescribe this medication to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed this medication to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking venlafaxine.

Additionally, long-term safety in relation to growth, maturity, and cognitive and behavioral development has not been demonstrated.

Taking Venlafaxine Retard Normon with other medications

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Your doctor must decide if you can take venlafaxine with other medications.

Do not start or stop taking any medication, including those sold without a prescription, natural remedies, and herbal products, 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 medications in the last 14 days. (MAOI: see section "What you need to know before taking Venlafaxine Retard Normon").

• Serotonin Syndrome:a potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section "Possible Side Effects") may occur with venlafaxine treatment, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraine).
• Other medications for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medications containing lithium.
• Medications containing the antibiotic linezolid (used to treat infections).
• Medications containing moclobemide, an MAOI (used to treat depression).
• Medications containing sibutramine (used for weight loss).
• Medications containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain).
• Medications containing dextromethorphan (used to treat cough).
• Medications containing methadone (used to treat opioid addiction or severe pain).
• Medications containing methylene blue (used to treat elevated methemoglobin levels in the blood).
• Products containing St. John's Wort (also known as "Hypericum perforatum", a natural 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, 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, 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).

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

Tell your doctor if you are taking medications that may alter your heart rhythm.

Some examples of these medications include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat altered 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 medications 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 medications containing:

• Ketoconazole (an antifungal medication).
• Haloperidol or risperidone (for treating psychiatric conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking Venlafaxine Retard Normon with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3 "How to take Venlafaxine Retard Normon").

Do not drink alcohol during treatment with Venlafaxine Retard Normon. 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 plan to become pregnant, consult your doctor or pharmacist before using this medication. You should only take venlafaxine after discussing the possible benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows you are taking venlafaxine. When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

If you are taking this medication during pregnancy, in addition to breathing problems, another symptom your baby may have at birth is feeding problems. 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 Normon in the final stage 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 Retard Normon 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 medication.

Driving and using machines

Do not drive or operate tools or machines until you know how this medication affects you.

This medication can cause allergic reactions because it contains carmoisine. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Venlafaxine Retard Normon

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

The 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 this medication approximately at the same time each day, either in the morning or 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 medication.

Do not stop taking this medication without consulting your doctor (see section "If you stop taking Venlafaxine Retard Normon").

If you take more Venlafaxine Retard Normon than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can put your life in danger, especially when taken simultaneously with certain medications and/or alcohol (see "Taking Venlafaxine Retard Normon with other medications").

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

If you forget to take Venlafaxine Retard Normon

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only 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 prescribed by your doctor in one day.

If you stop taking Venlafaxine Retard Normon

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need this medication, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that side effects occur when people stop using this medication, especially when stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as 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.

Your doctor will advise you on how to gradually stop taking this medication. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 this medicine anymore. Tell your doctor immediately, or go to the emergency department 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 that 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.

Other adverse effects that you should inform your doctor aboutare (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), seizures or attacks.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Normon, if you interrupt treatment with Venlafaxine Retard Normon”).
• 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 white balls or small granules in your stools after taking this medicine. Inside the capsules of this medicine, 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.
• 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 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.
• Slight changes in blood levels of liver enzymes.

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

• Seizures or attacks.
• 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.

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 that leads 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 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 Normon”).
• Aggression.
• Vertigo.
• 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 an abnormal heartbeat; slight 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, pharmacist or nurse, even if it is a possible adverse effect that is not listed in this prospectus. 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 Normon

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 and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away 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 way, you will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine Retard Normon

The active ingredient is venlafaxine.

Venlafaxine Retard Normon 225 mg:

Each prolonged-release capsule contains 254.52 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine base.

The other components are:

Capsule content:

Core:Microcrystalline cellulose, povidone, talc, anhydrous colloidal silica, magnesium stearate.

Coating:Ethyl cellulose, copovidone.

Capsule shell:

Gelatin, titanium dioxide (E171), carmoisine (E122).

Capsule printing ink:

Shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), carmine indigo (E132).

Appearance of the product and package contents

Venlafaxine Retard Normon 225 mg is a hard gelatin capsule, opaque pink, size “00”, with a wide and narrow circular band printed in blue ink, both on the body and on the cap of the capsule, and inside which are the mini-tablets.

Venlafaxine Retard Normon 225 mg is available in packs with aluminum-CFB, aluminum-PVC/Aclar white opaque or aluminum-PVC/PVdC white opaque blisters of 30 prolonged-release hard capsules.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the last revision of this prospectus: May 2023

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