VENLAFAXINE NORMON 75 mg TABLETS

Introduction

Package Leaflet: Information for the User

Venlafaxine NORMON 75 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

?

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Venlafaxine NORMON and what is it used for
2. What you need to know before you take Venlafaxine NORMON
3. How to take Venlafaxine NORMON
4. Possible side effects
5. Storing Venlafaxine NORMON
6. Contents of the pack and other information

1. What is Venlafaxine NORMON and what is it used for

Venlafaxine NORMON is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. Antidepressants are not fully understood, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine NORMON is a treatment for adults with depression. Treating depressive disorders adequately 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 you take Venlafaxine NORMON

Do not take Venlafaxine NORMON

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking an irreversible MAOI with other medicines, including Venlafaxine NORMON, can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine NORMON before taking any irreversible MAOI (see also sections “Serotonin syndrome” and “Using other medicines”).

Warnings and precautions

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you use other medicines that, when taken with Venlafaxine NORMON, could increase the risk of developing serotonin syndrome (see section “Using other medicines”)
• 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 (fits).
• 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 medicines 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.

Venlafaxine NORMON may cause a feeling of restlessness or an inability to sit or stand still. You should consult your doctor if this happens to you.

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

If any of these conditions apply to you, consult your doctor before taking Venlafaxine NORMON.

Do not drink alcohol during treatment with Venlafaxine NORMON, as it may cause extreme tiredness and unconsciousness. Taking it with certain medicines and/or alcohol may worsen symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually around two weeks, but sometimes longer.

You may be more likely to think this way:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric conditions who were treated with antidepressants.

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

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

Dry mouth

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

Use in children and adolescents under 18 years of age

Venlafaxine NORMON should not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal thoughts, and there was an increase in reports of hostility (mainly aggression, oppositional behavior, and anger) when taking this group of medicines. Despite this, the doctor may prescribe Venlafaxine NORMON to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed Venlafaxine NORMON to a patient under 18 years of age and you wish to discuss this decision, tell 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 NORMON. Also, the long-term safety effects of venlafaxine regarding growth, maturation, and development in this age group have not been established.

Taking Venlafaxine NORMON with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor must decide whether you can take Venlafaxine NORMON with other medicines.

Do not start or stop taking any medicines, including those that can be bought without a prescription, natural remedies, and herbal products, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs: see section “Before taking Venlafaxine NORMON”)
• Serotonin syndrome: serotonin syndrome, a potentially life-threatening condition (see section “Possible side effects”), may occur with venlafaxine treatment, particularly when taken with other medicines. Examples of these medicines include:

• Triptans (used for migraine)
• Medicines for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain reliever)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product 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, overactive reflexes, diarrhea, nausea, vomiting, and coma. Get medical attention immediately if you think you are experiencing serotonin syndrome.

The following medicines may also interact with Venlafaxine NORMON and should be used with caution. It is especially important to tell your doctor or pharmacist if you are taking medicines containing:

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (for treating psychiatric conditions)
• metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxine NORMON with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxine NORMON. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only use Venlafaxine NORMON after discussing the potential benefits and risks to the unborn child with your doctor.

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

If you are taking Venlafaxine NORMON during pregnancy, tell your midwife and/or doctor. When similar medicines (called selective serotonin reuptake inhibitors: SSRIs) are taken during pregnancy, there may be an increased risk that the baby will suffer from a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe more quickly and appear blue. These symptoms usually start during the first 24 hours after birth. If this happens, you must contact a doctor and/or midwife immediately.

If you take Venlafaxine NORMON in the last trimester 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 NORMON so they can advise you.

Venlafaxine NORMON 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 Venlafaxine NORMON treatment.

Driving and using machines

During treatment with Venlafaxine NORMON, you may feel somnolent or dizzy. Do not drive or operate tools or machines until you know how the treatment with Venlafaxine NORMON affects you.

Venlafaxine NORMON contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Venlafaxine NORMON

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose is 75 mg per day, divided into two or three doses. Your doctor may gradually increase the dose, and if necessary, up to a maximum dose of 375 mg per day for depression.

Take Venlafaxine NORMON at approximately the same time each day, in the morning and evening.

Venlafaxine NORMON should be taken with food.

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

Do not stop taking Venlafaxine NORMON without consulting your doctor (see section “If you stop taking Venlafaxine NORMON”).

If you take more Venlafaxine NORMON than you should

Call your doctor or pharmacist immediately if you take more Venlafaxine NORMON than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

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

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

If you forget to take Venlafaxine NORMON

If you miss a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Venlafaxine NORMON

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need Venlafaxine NORMON, they may ask you to reduce the dose slowly before stopping treatment completely. It is known that side effects occur when people stop using Venlafaxine NORMON, especially when Venlafaxine NORMON is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop taking Venlafaxine 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Allergic Reactions

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

• Chest tightness, wheezing, difficulty swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, tingling sensations, sudden reddening of the skin, and/or a feeling of heat
• Severe skin rash, itching, or hives (elevated areas of red or pale skin that often itch)

Severe Adverse Effects

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

• 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, tingling, movement disorder, seizures, or attacks
• Psychiatric problems, such as hyperactivity and euphoria
• Treatment withdrawal (see section "HOW TO TAKE VENLAFAXINA NORMON,If you interrupt treatment with Venlafaxina NORMON")

Complete List of Adverse Effects

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

• Blood Disorders

Uncommon: appearance of bruises, tarry stools (deposits), or blood in the stool, which may be a sign of internal bleeding.

Unknown: reduced platelet count in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which may lead to an increased risk of infection; heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and Breastfeeding" in section 2 for more information.

• Metabolic/Nutritional Disorders

Frequent: weight loss, increased cholesterol

Uncommon: weight gain

Unknown: slight changes in blood levels of liver enzymes; reduction of sodium levels in the 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 frequent: dry mouth, headache

Frequent: abnormal dreams; decreased libido; dizziness; increased muscle tone; insomnia; nervousness; tingling; sedation; tremors; confusion; feeling detached (or disconnected) from oneself and reality

Uncommon: lack of feelings or emotions; hallucinations; involuntary muscle movement; agitation; balance and coordination disorders Rare: a feeling of restlessness or inability to sit or stand; seizures or attacks; overexcitement or euphoria

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

• Disorders of the Senses

Frequent: blurred vision

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

Unknown: severe eye pain and reduced or blurred vision

• Cardiovascular/Circulatory Disorders

Frequent: increased blood pressure, hot flashes, palpitations

Uncommon: feeling dizzy (especially when standing up too quickly), fainting, rapid heartbeat

Unknown: decreased blood pressure; abnormal, rapid, or irregular heartbeat, which can lead to fainting

• Respiratory System Disorders

Frequent: yawning

Unknown: cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (pulmonary eosinophilia)

• Digestive System Disorders

Very frequent: nausea

Frequent: decreased 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 frequent: sweating (including night sweats)

Uncommon: skin rash, abnormal hair loss

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

• Musculoskeletal Disorders

Unknown: unexplained muscle pain, discomfort, or weakness (rhabdomyolysis)

• Urinary System Disorders

Frequent: difficulty urinating; increased frequency of urination

Uncommon: inability to urinate

• Sexual and Reproductive Disorders

Frequent: abnormal ejaculation/orgasm (men), lack of orgasm, erectile dysfunction (impotence); menstrual irregularities, such as increased bleeding or irregular bleeding

Uncommon: abnormal orgasm (women)

• General Disorders

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. (Website: www.notificaRAM.es).

5. Storage of Venlafaxina NORMON

Keep this medicine out of sight and reach of children.

Do not use Venlafaxina NORMON after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Venlafaxina NORMON

• The active ingredient is venlafaxine. Each tablet contains 75 mg of venlafaxine (hydrochloride).
• The other ingredients (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the Product and Package Contents

Venlafaxina NORMON 75 mg is presented in the form of tablets. The tablets are orange, round, biconvex, scored, and serigraphed. The tablet can be divided into two equal halves.

Venlafaxina NORMON 75 mg is presented in packages containing 60 tablets for oral administration.

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/