Package Insert: Information for the User

Venlafaxine NORMON 50 mg Tablets EFG

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

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

Venlafaxina 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 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 NORMON is a treatment for adults with depression. Properly treating depressive disorders 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 NORMON

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you are also taking or have taken in the last 14 days any medication known as irreversible monoamine oxidase (IMAO) inhibitor used to treat depression or Parkinson's disease. Taking an IMAO irreversible with other medications, including Venlafaxina NORMON, may produce severe or potentially fatal side effects. You must also wait at least 7 days after stopping Venlafaxina NORMON before taking any IMAO irreversible (see also the sections “Serotonin syndrome” and “Use of other medications”).

Warnings and precautions

Consult your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

• If you use other medications that are taken concomitantly with Venlafaxina NORMON may increase the risk of developing serotonin syndrome (see section “Use of 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 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 cardenals or easily bleed (history of hemorrhagic disorders), or if you are using other medications that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy and breastfeeding”).
• If your cholesterol levels increase.
• 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.

Venlafaxina NORMON may cause a feeling of restlessness or an inability to sit or stand still. You must consult your doctor if this occurs.

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

If you can apply any of these states, consult your doctor before taking Venlafaxina NORMON.

Do not drink alcohol during treatment with Venlafaxina 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.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have thought about self-harm or suicide. These thoughts may increase when you start taking antidepressants, as these medications take time to act, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

• If you have previously had suicidal thoughts 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 conditions treated with antidepressants.

If you have thoughts of self-harm or 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. They may ask if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you must be careful with your oral hygiene.

Use in children and adolescents under 18 years of age

Venlafaxina NORMON should not be used for children and adolescents under 18 years of age. You should also know that patients under 18 years of age have an increased risk of adverse effects such as suicidal behavior, suicidal thoughts, and there has been an increase in reports of hostility (predominantly aggression, oppositional behavior, and anger) when they take this group of medications. Despite this, the doctor who prescribes Venlafaxina NORMON may prescribe it to patients under 18 years of age when they decide it is best for the patient. If your doctor has prescribed Venlafaxina NORMON to a patient under 18 years of age and you want to discuss this decision, talk to your doctor. You must inform your doctor if any of the symptoms listed above develop or worsen when these patients under 18 years of age are taking Venlafaxina NORMON. In addition, the long-term safety effects of venlafaxine on growth, maturation, and development in this age group have not been demonstrated.

Taking Venlafaxina NORMON with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. Your doctor must decide if you can take Venlafaxina NORMON with other medications.

Do not start or stop taking any medication, including those sold without a prescription, natural remedies, and herbal supplements, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase (IMAO) inhibitors: See section “Before taking Venlafaxina NORMON”
• Serotonin syndrome: Serotonin syndrome, a potentially fatal state (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)
• 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 moclobemida, a reversible IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing tramadol (a pain reliever)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal supplement used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)

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, nausea, vomiting, and coma. Seek medical attention immediately if you think you are experiencing serotonin syndrome.

The following medications may also interact with Venlafaxina NORMON 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 (to treat psychiatric conditions)
• Metoprolol (a beta-blocker to treat high blood pressure and heart problems)

Taking Venlafaxina NORMON with food, drinks, and alcohol

Venlafaxina NORMON should be taken with food (see section 3 “HOW TO TAKE VENLAFAXINA NORMON”)

Do not drink alcohol during treatment with Venlafaxina 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 and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. You should only use Venlafaxina NORMON after discussing the possible benefits and risks for the unborn child with your doctor.

If you are taking Venlafaxina NORMON during pregnancy, tell your midwife and/or doctor as your baby may have some symptoms when born. These symptoms usually start within the first 24 hours after birth. These include feeding problems and breathing problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

If you are taking Venlafaxina NORMON during pregnancy, tell your midwife and/or doctor. When taken during pregnancy, similar medications (called selective serotonin reuptake inhibitors: ISRS) may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this occurs in your case, you must contact a doctor and/or midwife immediately.

If you take Venlafaxina NORMON 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 hemorrhagic disorders. Your doctor or midwife must know that you are taking Venlafaxina NORMON to advise you.

Venlafaxina NORMON passes into breast milk. There is a risk of an effect on the baby. Therefore, you must discuss the case with your doctor, and he will decide if you should stop breastfeeding or stop taking Venlafaxina NORMON.

Driving and operating machinery

During treatment with Venlafaxina NORMON, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Venlafaxina NORMON affects you.

Venlafaxina NORMON contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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 recommended initial dose is 75 mg per day in divided doses, two or three times a day. Your doctor may gradually increase the dose and if necessary, even up to a maximum daily dose of 375 mg for depression.

Take Venlafaxina NORMON approximately at the same time every day, in the morning and in the evening.

Venlafaxina NORMON should be taken with food.

If you have liver or kidney problems, talk to your doctor as your dose of Venlafaxina NORMON may need to be different.

Do not stop taking Venlafaxina NORMON without consulting your doctor (see section “If you interrupt treatment with Venlafaxina NORMON”).

If you take more Venlafaxina NORMON than you should

Call your doctor or pharmacist immediately if you take more than the prescribed dose of Venlafaxina NORMON. You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can put your life at risk, especially with the simultaneous intake of certain medications and/or alcohol (see Taking Venlafaxina NORMON with other medications).

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

If you forgot to take Venlafaxina 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.

If you interrupt treatment with Venlafaxina 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 Venlafaxina NORMON, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using Venlafaxina NORMON, especially when stopping Venlafaxina NORMON suddenly or if the dose is reduced too 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, tinnitus, tingling or occasional sensations of electric discharge, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually interrupt treatment with Venlafaxina NORMON. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

If you have any other questions 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.

Allergic reactions

If any of the following occur, do not take more Venlafaxina NORMON. Inform your doctor immediately, or go to the nearest hospital emergency room:

• Chest tightness, wheezing, difficulty swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, sharp sensations, sudden redness of the skin, and/or a feeling of heat
• Severe skin rash, itching, or urticaria (raised areas of skin that are often itchy)

Severe side effects

If you notice any of the following signs, you may need urgent medical attention:

• Cardiac problems, such as rapid or irregular heartbeat, or increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nervous system problems: such as dizziness, numbness, movement disorder, convulsions, or seizures
• Psychiatric problems, such as hyperactivity and euphoria
• Withdrawal from treatment (see "How to take Venlafaxina NORMON" section for more information)

Complete list of side effects

The frequency (possibility of occurrence) of side effects is classified as follows:

• Blood disorders

Uncommon:Appearance of petechiae, black stools, or blood in stools, which may be a sign of internal bleeding.

Unknown:Reduced platelet count in the blood, leading to an increased risk of petechiae or bleeding; blood disorders that may increase the risk of infection; severe postpartum hemorrhage (bleeding after childbirth), see "Pregnancy and breastfeeding" section for more information.

• Metabolic/nutritional disorders

Common:Weight loss, increased cholesterol

Uncommon:Weight gain

Unknown:Mild changes in blood levels of liver enzymes; reduced sodium levels in blood; itching, yellow eyes or skin, dark urine, or flu-like symptoms, which are symptoms of liver inflammation (hepatitis); confusion, excessive water intake (known as SIADH); abnormal milk production.

• Nervous system disorders:

Very common:Dry mouth, headache

Common:Abnormal dreams; decreased libido; dizziness; muscle tension; insomnia; nervousness; numbness; sedation; tremors; confusion; feeling detached (or disconnected) from oneself and reality

Uncommon:Lack of emotions or feelings; hallucinations; involuntary muscle movements; agitation; balance and coordination disturbances

Rare:A feeling of restlessness or inability to sit or stand; convulsions or seizures; overexcitement or euphoria

Unknown:High temperature with rigid muscles, confusion, or agitation, and sweating, or if you experience involuntary, jerky muscle movements that you cannot control, these may be symptoms of a serious condition known as neuroleptic malignant syndrome; euphoric sensations, drowsiness, sustained rapid eye movements, clumsiness, restlessness, feeling drunk, sweating, or rigid muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); rigidity, spasms, and involuntary muscle movements; suicidal or self-harm thoughts.

• Sensory disorders

Common:Blurred vision

Uncommon:Altered taste perception, tinnitus (ringing in the ears)

Unknown:Severe eye pain and reduced or blurred vision

• Cardiac or circulatory disorders

Common:Increased blood pressure, hot flushes, palpitations

Uncommon:Dizziness (particularly when standing up too quickly), fainting, rapid heartbeat

Unknown:Reduced blood pressure; abnormal heart rhythm, rapid, or irregular heartbeat, which may lead to fainting

• Respiratory system disorders

Common:Yawning

Unknown:Coughing, difficulty breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with increased white blood cells (eosinophilic pneumonia)

• Digestive system disorders

Very common:Nausea

Common:Loss of appetite, constipation, vomiting

Uncommon:Teeth grinding, diarrhea

Unknown:Severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas)

• Skin disorders

Very common:Sweating (including night sweats)

Uncommon:Skin rash, abnormal hair loss

Unknown:Skin rash that may lead to severe blisters and skin peeling; itching; mild skin rash

• Musculoskeletal disorders

Unknown:Unexplained muscle pain, muscle weakness, or pain (rhabdomyolysis)

• Urinary system disorders

Common:Difficulty urinating; increased frequency of urination

Uncommon:Inability to urinate

• Sexual and reproductive disorders

Common:Abnormal ejaculation/ orgasm (men), lack of orgasm, erectile dysfunction (impotence); irregular menstrual periods, such as increased bleeding or irregular bleeding

Uncommon:Abnormal orgasm (women)

• General disorders

Common:Weakness (asthenia), chills

Uncommon:Sensitivity to sunlight

Unknown:Swelling of the face or tongue, shortness of breath, or difficulty breathing, often with skin rash (this may be a severe allergic reaction).

Venlafaxina NORMON may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxina NORMON 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 Venlafaxina NORMON for a long time.

Reporting 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 Pharmacovigilance of Medicines for Human Use. (Website: www.notificaRAM.es).

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

Do not use Venlafaxina NORMON after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Venlafaxina NORMON

• The active ingredient is venlafaxine. Each tablet contains 50 mg of venlafaxine (hydrochloride).
• The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium glycinate starch, magnesium stearate, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and content of the packaging

Venlafaxina NORMON 50 mg is presented in the form of tablets. The tablets are orange in color, round, biconvex, scored, and printed. The tablet can be divided into two equal halves.

Venlafaxina NORMON 50 mg is presented in packaging containing 30 tablets for oral administration.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON, S.A.

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

Date of the last review of this leaflet: May 2023

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