VENLAFAXINE KERN PHARMA 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Venlafaxine Kern Pharma 50 mg film-coated tablets EFG

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

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

• Keep this leaflet, you may need to read it again.
• 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 Kern Pharma and what is it used for
2. What you need to know before you take Venlafaxine Kern Pharma
3. How to take Venlafaxine Kern Pharma
4. Possible side effects
5. Storing Venlafaxine Kern Pharma
6. Contents of the pack and other information

1. What is Venlafaxine Kern Pharma and what is it used for

Venlafaxine Kern Pharma 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 Kern Pharma is a treatment for adults with depression. Treating your depression adequately 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 Kern Pharma

Do not take Venlafaxine Kern Pharma

• If you are allergic to venlafaxine 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 Kern Pharma, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine Kern Pharma before you take any irreversible MAOI (see also the sections “Serotonin syndrome” and “Using Venlafaxine Kern Pharma with other medicines”).

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Venlafaxine Kern Pharma.

• If you are taking other medicines that, when taken with venlafaxine, may increase the risk of developing serotonin syndrome (see section “Using Venlafaxine Kern Pharma with 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 your blood (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency to bleed easily (a 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”).
• If your cholesterol levels increase.
• If you have a history of mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behaviour.

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

Do not drink alcohol while you are taking Venlafaxine Kern Pharma, as it may cause extreme drowsiness and unconsciousness. Taking it with certain medicines and/or with alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide 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.

Some medicines of the group that Venlafaxine Kern Pharma belongs to (called SSRIs/ SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Use in children and adolescents under 18 years of age

Venlafaxine Kern Pharma 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, your doctor may prescribe Venlafaxine Kern Pharma to patients under 18 when he/she decides that it is the best for the patient. If your doctor has prescribed Venlafaxine Kern Pharma to a patient under 18 and you want to discuss this, talk to your doctor. You should tell your doctor if any of the symptoms listed above develop or worsen when these patients under 18 are taking Venlafaxine Kern Pharma. Also, the long-term safety effects of venlafaxine regarding growth, maturation, and development in this age group have not been demonstrated.

Using Venlafaxine Kern Pharma with other medicines

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

Your doctor will decide whether you can take Venlafaxine Kern Pharma with other medicines.

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

• Irreversible monoamine oxidase inhibitors (MAOIs: see section “What you need to know before you take Venlafaxine Kern Pharma”)
• Serotonin syndrome: a potentially life-threatening condition (see section 4 “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 known as “Hypericum perforatum”, a herbal 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, rapid 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 Kern Pharma 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 Kern Pharma with food, drinks, and alcohol

Venlafaxine Kern Pharma should be taken with food (see section 3 “How to take Venlafaxine Kern Pharma”)

Do not drink alcohol while you are taking Venlafaxine Kern Pharma. Drinking alcohol while taking Venlafaxine Kern Pharma may cause drowsiness and/or unconsciousness, and may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breast-feeding, and fertility

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 Kern Pharma after discussing the potential benefits and risks with your doctor.

If you take Venlafaxine in the last 3 months of your pregnancy you may experience an increased risk of excessive bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife need to know that you are taking this medicine so that they can advise you.

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

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

Driving and using machines

While taking Venlafaxine Kern Pharma you may feel drowsy or dizzy.

Do not drive or use any tools or machines until you know how Venlafaxine Kern Pharma affects you.

3. How to take Venlafaxine Kern Pharma

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. If necessary, the dose can be increased up to a maximum of 375 mg per day for depression.

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

Venlafaxine Kern Pharma 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 Kern Pharma.

Do not stop taking Venlafaxine Kern Pharma without talking to your doctor (see the section “If you stop taking Venlafaxine Kern Pharma”).

If you take more Venlafaxine Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the national poison control centre, phone 91 562 04 20, indicating the medicine and the amount taken.

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

Symptoms of overdose may include rapid heart beat, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, dizziness or fits, and vomiting.

If you forget to take Venlafaxine Kern Pharma

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 dose as usual. Do not take more than the daily dose of Venlafaxine Kern Pharma that has been prescribed for you in one day.

If you stop taking Venlafaxine Kern Pharma

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 Kern Pharma, he/she may gradually reduce your dose before stopping treatment altogether. It is known that discontinuation symptoms can occur when people stop using Venlafaxine Kern Pharma, especially when Venlafaxine Kern Pharma is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as dizziness, headache, nausea, vomiting, diarrhoea, nervousness, agitation, confusion, tingling, numbness or tremors, irritability, anxiety, insomnia, fatigue, excessive sweating, or flu-like symptoms. Your doctor will advise you on how to gradually stop taking Venlafaxine Kern Pharma. If you experience any of these or other symptoms that are troublesome for you, consult your doctor for further advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Venlafaxina Kern Pharma can cause adverse effects, although not all people suffer from them.

Allergic Reactions

If any of the following occur, do not take Venlafaxina Kern Pharma 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) that are severe.

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 3 "How to take Venlafaxina Kern Pharma", If you interrupt treatment with Venlafaxina Kern Pharma).

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.

Frequency not known: reduced platelet count in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which can lead to an increased risk of infection.

• Metabolic/Nutritional Disorders

Frequent: weight loss, increased cholesterol.

Uncommon: weight gain.

Frequency not known: slight changes in blood levels of liver enzymes; reduced 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; altered balance and coordination.

Rare: a feeling of restlessness or inability to sit or stand; seizures or attacks; overexcitement or euphoria.

Frequency not known: 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.

• Sensory Disorders

Frequent: blurred vision.

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

Frequency not known: severe eye pain and reduced or blurred vision.

• Cardiac/Circulatory Disorders

Frequent: increased blood pressure, hot flashes, palpitations.

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

Frequency not known: decreased blood pressure; abnormal, rapid, or irregular heartbeat, which can lead to fainting.

• Respiratory System Disorders

Frequent: yawning.

Frequency not known: coughing, 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 Disorders

Very frequent: nausea.

Frequent: decreased appetite, constipation, vomiting.

Uncommon: teeth grinding, diarrhea.

Frequency not known: severe back or abdominal pain (which can indicate a serious problem in the intestine, liver, or pancreas).

• Skin Disorders

Very frequent: sweating (including night sweats).

Uncommon: skin rash, abnormal hair loss.

Frequency not known: skin rash that can lead to severe blisters and skin peeling; itching; mild skin rash.

• Musculoskeletal Disorders

Frequency not known: 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).

Frequency not known: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

• General Disorders

Frequent: weakness (asthenia), chills.

Uncommon: sensitivity to sunlight.

Frequency not known: swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rash (this can be a severe allergic reaction).

Venlafaxina Kern Pharma 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 Kern Pharma 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 Kern Pharma for a long time.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlafaxina Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Store in a dry place.

Do not use Venlafaxina Kern Pharma after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, 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

Venlafaxina Kern Pharma Composition

The active ingredient is venlafaxine. Each tablet contains 50 mg of venlafaxine (as hydrochloride).

The other ingredients are: microcrystalline cellulose (E-460i), sodium carboxymethyl starch (Type A), magnesium stearate (E-470b), yellow iron oxide (E-172), red iron oxide (E-172), and titanium dioxide (E-171).

Product Appearance and Package Contents

Venlafaxina Kern Pharma 50 mg is presented in the form of tablets. The tablets are round and peach-colored.

Venlafaxina Kern Pharma 50 mg is presented in packages containing 60 tablets for oral administration.

Other Presentations

Venlafaxina Kern Pharma 37.5 mg tablets EFG. Package containing 60 tablets.

Venlafaxina Kern Pharma 75 mg tablets EFG. Package containing 60 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of Last Revision of this Leaflet: April 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/