VENLAFAXINE NORMON 50 mg TABLETS

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 have anxiety have lower levels of serotonin and noradrenaline in the brain. The way that antidepressants work is not fully understood but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine NORMON is used to treat adults with depression. Treating depression properly is important to help you feel better. If it is not treated, your condition may not improve or may get worse 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 even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine NORMON before you take 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 are using other medicines that, when taken with Venlafaxine NORMON, may 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 levels of sodium in the blood (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency 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 breast-feeding”).
• 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 elated).
• If you have a history of aggressive behaviour.

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

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

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

Do not drink alcohol while you are taking Venlafaxine NORMON, as it may increase the risk of side effects such as drowsiness. Taking it with certain medicines or alcohol may worsen your depression or 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 or killing yourself. These thoughts may be more frequent when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer.

You may be more likely to think this way if:

• You have previously had thoughts about killing or harming yourself.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

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 behaviour.

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 dental 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. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and there was an increase in reports of hostility (predominantly aggression, oppositional behaviour, and anger) when they took this group of medicines. Despite this, the doctor who prescribes you Venlafaxine NORMON may prescribe it to patients under 18 when they decide that it is the best for the patient. If your doctor has prescribed Venlafaxine NORMON to a patient under 18 and you wish to discuss this decision, talk to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 are taking Venlafaxine NORMON. Also, the long-term safety of venlafaxine regarding growth, maturation, and development in this age group has not been demonstrated.

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 will 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, herbal or natural remedies, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors (MAOIs: see section “Before you take 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, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• medicines containing the antibiotic linezolid (used for infections)
• medicines containing moclobemide, a reversible MAOI (used for treating depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing tramadol (a painkiller)
• products containing St. John’s Wort (also called Hypericum perforatum, a herbal or natural remedy used for 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, fast heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, nausea, vomiting, and coma. Get medical help 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 mention to your doctor or pharmacist if you are taking medicines that contain:

• 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 while you are taking Venlafaxine NORMON. Drinking alcohol while taking Venlafaxine NORMON may cause drowsiness and may worsen your depression or other conditions, such as anxiety disorders.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 with your doctor.

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

If you are taking Venlafaxine NORMON during pregnancy, tell your midwife or doctor. When similar medicines (called selective serotonin reuptake inhibitors, SSRIs) are taken during pregnancy, there is a potential increased risk that the baby will develop a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear bluish. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you should contact a doctor or midwife immediately.

If you take Venlafaxine NORMON in the last few months of your pregnancy, you may experience an increased risk of heavy bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine NORMON so that they can advise you.

Venlafaxine NORMON passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop Venlafaxine NORMON.

Driving and using machines

While taking Venlafaxine NORMON, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how 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, in divided doses, two or three times a day. Your doctor may gradually increase the dose to a maximum 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 talking to your doctor (see section “If you stop taking Venlafaxine NORMON”).

If you take more Venlafaxine NORMON than you should

Contact your doctor or pharmacist immediately if you take more Venlafaxine NORMON than you should. You can also contact the national Poison Information Centre, phone number 91 562 04 20, stating the medicine and the amount taken.

Overdose can be life-threatening, especially when taken with certain other medicines and/or alcohol (see “Taking Venlafaxine NORMON with other medicines”).

Symptoms of overdose may include fast heart beat, changes in 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 nearly time for your next dose, skip the missed dose and take only your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Venlafaxine NORMON

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks that you no longer need Venlafaxine NORMON, they may gradually reduce your dose before stopping your treatment completely. It is known that stopping Venlafaxine NORMON, especially suddenly or too quickly, may cause side effects such as dizziness, headache, nausea, vomiting, and diarrhoea. Some patients may experience symptoms such as fatigue, sleep disturbances, irritability, anxiety, or mood changes. Your doctor will advise you on how to gradually stop taking Venlafaxine NORMON. If you experience any of these or other symptoms that are troublesome for you, contact your doctor for further advice.

If you have any further questions on 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 can be a sign of internal bleeding.

Unknown: reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which can 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 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; alteration of balance and coordination

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 malignant neuroleptic syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being 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 getting 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 (males), lack of orgasm, erectile dysfunction (impotence); menstrual irregularities, such as increased bleeding or irregular bleeding

Uncommon: abnormal orgasm (females)

• 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 can 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 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 starch glycolate, magnesium stearate, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the Product and Package Contents

Venlafaxina NORMON 50 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 50 mg is presented in packages containing 30 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/