Venlafaxine Normon 75 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlafaxine NORMON 75 mg tablets EFG

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

? Keep this leaflet, as you may need to read it again.

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

• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Venlafaxine NORMON is an antidepressant that belongs to a group of medicines known as serotonin and norepinephrine 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 suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. The exact way antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine NORMON is a treatment for depression in adults. Properly treating depressive 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 NORMON

Do not take Venlafaxine NORMON

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken at any time within the last 14 days any medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with other medicines, including Venlafaxine NORMON, may cause serious or even potentially fatal adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine NORMON before starting any irreversible MAOI (see also sections “Serotonin syndrome” and “Use of other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

• If you are using other medicines that, when taken concomitantly with Venlafaxine NORMON, could increase the risk of developing serotonin syndrome (see section “Use of 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 (hyponatraemia).
• If you tend to develop bruises easily or have a tendency to bleed easily (history of bleeding disorders), or if you are taking 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 over-excited or euphoric).
• 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 consult your doctor if this occurs.

Some medicines in the group to which Venlafaxine NORMON belongs (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 together 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 suffer from anxiety disorders, you may occasionally have thoughts about harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually about two weeks, but sometimes longer.

You may be more likely to have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric conditions treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to a 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 could ask them whether they notice your depression or anxiety getting worse, or if they are concerned 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 dental caries. Therefore, you should take care of your oral hygiene.

Use in children and adolescents under 18 years of age

Venlafaxine NORMON must not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and there have been increased reports of hostility (mainly aggression, oppositional behaviour and anger) when taking this group of medicines. Nevertheless, your doctor may prescribe Venlafaxine NORMON to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed Venlafaxine NORMON to a patient under 18 years of age and you wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlafaxine NORMON. In addition, the long-term effects on growth, maturation, and development have not been established in this age group.

Taking Venlafaxine NORMON with other medicines

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

Do not start or stop taking any medicine, including those sold without a prescription, natural remedies, or herbal products, without first 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 during treatment with venlafaxine, particularly when taken with other medicines. Examples of such medicines include:

• triptans (used for migraine)

• medicines to treat depression, for example, 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 (an analgesic)

• products containing St. John's wort (also called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)

• products containing tryptophan (used for problems such as sleep and depression)

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, diarrhoea, nausea, vomiting, and coma. Seek immediate medical attention 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 (to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme tiredness and unconsciousness, and may 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 become pregnant, consult your doctor or pharmacist before using this medicine. You should only use Venlafaxine NORMON after discussing the possible benefits and possible risks to the unborn child with your doctor.

If you are taking Venlafaxine NORMON during pregnancy, inform your midwife and/or doctor, as your baby may experience some symptoms after birth. These symptoms usually begin within the first 24 hours after birth. These include feeding difficulties and breathing 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 are taking Venlafaxine NORMON during pregnancy, inform your midwife and/or doctor. When similar medicines (called serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin 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 Venlafaxine NORMON in the late stages 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 be aware that you are taking Venlafaxine NORMON so they can advise you.

Venlafaxine NORMON passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with Venlafaxine NORMON.

Driving and using machines

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

Venlafaxine NORMON contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual recommended starting dose is 75 mg per day, divided into two or three doses taken morning and evening. Your doctor may gradually increase the dose and, if necessary, even 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 at night.

Venlafaxine NORMON should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of Venlafaxine NORMON may need to be adjusted.

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

Contact your doctor or pharmacist immediately if you take more Venlafaxine NORMON than prescribed. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

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

Symptoms of possible overdose may include palpitations, changes in alertness (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 almost time for your next dose, skip the missed dose and take only your next scheduled 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 your treatment or reduce your dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine NORMON, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when patients discontinue Venlafaxine NORMON, especially if treatment is stopped suddenly 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, tinnitus, tingling or electric shock-like sensations (rarely), weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine NORMON. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any further 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 everyone will experience them.

Allergic reactions

If any of the following occur, stop taking Venlafaxine NORMON. 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, prickling sensations, sudden skin redness and/or a sensation of warmth
• Severe skin rash, itching, or hives (raised areas of red or pale skin that often itch)

Serious adverse effects

If you notice any of the following signs, you may require 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 disorders, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria
• Withdrawal from treatment (see section “HOW TO TAKE VENLAFAXINE NORMON, If you stop taking Venlafaxine NORMON”)

Complete list of adverse effects

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

• Blood disorders

Uncommon: appearance of bruises, tarry stools (faeces), or blood in the stools, which may 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 may lead to an increased risk of infection; excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

• Metabolic and nutritional disorders

Frequent: weight loss, increased cholesterol

Uncommon: weight gain

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

• 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 separated) from oneself and reality

Uncommon: lack of feelings or emotions; hallucinations; involuntary muscle movements; agitation; disturbance in balance and coordination
Rare: a feeling of restlessness or inability to sit or stand still; seizures or fits; overexcitement or euphoria

Unknown: high body temperature with stiff muscles, confusion or agitation, and sweating, or if you experience jerky, uncontrolled muscle movements, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric sensations, drowsiness, sustained rapid eye movements, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); muscle rigidity, spasms, and involuntary muscle movements; suicidal thoughts or thoughts of self-harm.

• Sensory disorders

Frequent: blurred vision

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

Unknown: severe eye pain and reduced or blurred vision

• Cardiac or circulatory disorders

Frequent: increased blood pressure, hot flushes, palpitations

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

Unknown: decreased blood pressure; abnormal, fast, or irregular heartbeat, which may lead to fainting

• Respiratory system disorders

Frequent: yawning

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

• Gastrointestinal disorders

Very frequent: nausea

Frequent: decreased appetite, constipation, vomiting

Uncommon: teeth grinding, diarrhoea

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 may lead to severe blistering and peeling of the skin; 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 (in men), absence of orgasm, erectile dysfunction (impotence); menstrual irregularities, such as increased bleeding or increased irregular bleeding

Uncommon: abnormal orgasm (in 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 rashes (this may be a severe allergic reaction)

Venlafaxine NORMON may sometimes cause side effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine NORMON may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine NORMON for a long time.

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es).

5. Storage of Venlafaxine NORMON

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

Do not use Venlafaxine NORMON after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine NORMON

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

Appearance of the product and contents of the pack

Venlafaxine NORMON 75 mg is presented as tablets. The tablets are orange-colored, round, biconvex, scored, and printed. The tablet can be divided into equal halves.

Venlafaxine NORMON 75 mg is available in packs 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 most recent revision of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/