Prospecto: information for the patient

VenlafaxineRetard Normon 225 mg hard capsules with prolonged release EFG

Venlafaxine

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

- Keep this prospect, as you may have to read it again.

- If you have any doubts, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Venlafaxine Retard Normon

3. How to take Venlafaxine Retard Normon

4. Possible adverse effects

5. Storage of Venlafaxine Retard Normon

6. Contents of the pack and additional information

Venlafaxina Retard Normon contains the active ingredient venlafaxine.

Venlafaxina Retard Normon is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and noradrenaline in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina 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). 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 take Venlafaxina 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, any medication known as an irreversible monoamine oxidase inhibitor (IMAO) used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxina Retard Normon may cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Venlafaxina Retard Normon before taking any IMAO (see also the section "Taking Venlafaxina Retard Normon with other medications" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you are taking other medications that, when taken with this medication, may increase the risk of developing serotonin syndrome (see the section "Taking Venlafaxina 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 bleeding or bruising easily (history of bleeding disorders), or if you are taking other medications that may increase the risk of bleeding, such as 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 restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this occurs.

Some medications in the group to which Venlafaxina Retard Normon belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxina Retard Normon, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Possible 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. This may increase when starting to take antidepressants, as all these medications take time to become effective, usually within two weeks but sometimes longer.

You are more likely to experience this:

• If you have previously had 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 (under 25 years old) with psychiatric disorders treated with antidepressants.

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

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 worsening, 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 good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by this medication. Therefore, your diabetes medication doses may need to be adjusted.

Children and adolescents

Venlafaxine should not be used normally in the treatment of children and adolescents under 18 years old. Additionally, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe this medication to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medication to a patient under 18 years old, and you want to discuss this decision, please return 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, long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Taking Venlafaxina Retard Normon with other medications

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

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

Do not start or stop taking any medication, including those available over the counter, natural remedies, or herbal products, without checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with venlafaxine. Tell your doctor if you have taken any of these medications in the last 14 days. (IMAO: see section "What you need to know before starting to take Venlafaxina Retard Normon").

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

Examples of these medications include:

• Triptans (used for migraines).
• Other medications to treat depression, such as ISRN, ISRS, tricyclic antidepressants, or medications containing lithium.
• Medications containing the antibiotic linezolid (used to treat infections).
• Medications containing moclobemide, an IMAO (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 high levels of methemoglobin 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, 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 blood test).

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

Inform your doctor if you are taking medications that may affect your heart rhythm.

Examples of these medications 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 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 that contain:

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

Taking Venlafaxina Retard Normon with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxina Retard Normon. Taking it with alcohol may cause extreme fatigue and unconsciousness, 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 medication. You should only take venlafaxine after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking venlafaxine. When taken during pregnancy, similar medications (ISRS) 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, 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 when born is feeding difficulties. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

If you take Venlafaxina Retard Normon in the final stages of pregnancy, there may be a higher 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 Venlafaxina 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 the case with your doctor and they will decide if you should stop breastfeeding or stop taking this medication.

Driving and operating machinery

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

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

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 this medication approximately at the same time every day, either in the morning or at night. 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 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 Normon").

If you take more Venlafaxina Retard Normon 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 Taking Venlafaxina Retard Normon with other medications).

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

If you forgot to take Venlafaxina Retard Normon

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 that you have been prescribed in a day.

If you interrupt treatment with Venlafaxina Retard Normon

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need this medication, 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 fatigue, dizziness, lack of stability, headache, 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, convulsions, or symptoms similar to the flu.

Your doctor will advise you on how to gradually stop treatment with this medication. 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 any more of this medicine.Inform your doctor immediately, or go to the nearest hospital emergency department:

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.

Very 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).
• Serotonin syndrome signs and symptoms, 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 signs and symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

• Signs of infection, such as fever, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that may increase the risk of infection.
• Severe rash, which may lead to severe blistering and skin peeling.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

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.
• Black, tarry stools 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, 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 Normon, if you interrupt treatment with Venlafaxine Retard Normon”).
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for the bleeding to stop.

Do not worry if you see white specks or small granules in your stools after taking this medicine. Inside the capsules of this medicine, there are microspheres (small white specks) that contain the active ingredient (venlafaxine). These microspheres are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The “shell” of the microsphere does not dissolve and is eliminated in the stools. Therefore, although you see microspheres in the stools, 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)

• Loss of 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 detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Loss of consciousness, involuntary muscle movements, alteration of coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, black, tarry stools, or blood in stools, 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.

Very rare (may affect up to 1 in 10,000 people)

• Bleeding tendency, which may be due to a reduced number of platelets in the blood, leading to petechiae or hemorrhages.
• Abnormal milk production.
• Bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of petechiae or vessel rupture (broken veins).

Frequency not known (cannot be estimated with 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 Normon”).
• Aggression.
• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, 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 hemorrhage. 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, pharmacist, or nurse, 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 Vigilance of Medicines for Human Use: http://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 that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard Normon

The active ingredient is venlafaxine.

Venlafaxina 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:

Contents of the capsule:

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

Coating:Ethyl cellulose, copovidone.

Capsule coating:

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

Printing ink of the capsule:

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

Appearance of the product and contents of the packaging

Venlafaxina Retard Normon 225 mg is a hard gelatin capsule, opaque pink in color, size "00", with a wide and narrow blue printed bands, both on the body and the cap of the capsule, and inside which are the mini tablets.

Venlafaxina Retard Normon 225 mg is available in aluminum-CFB blister packs; aluminum-PVC/Aclar white opaque or aluminum-PVC/PVdC white opaque of 30 hard prolonged-release capsules.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet: May 2023

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