VENLAFAXINE KERN PHARMA 75 mg TABLETS

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 stopping Venlafaxine Kern Pharma before taking any irreversible MAOI (see also the sections “Serotonin syndrome” and “Using other medicines”).

Warnings and precautions

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

• If you are taking other medicines that, when taken with venlafaxine, could 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 (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) or if someone in your family has had mania or bipolar disorder.
• 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 consult your doctor if this happens to you.

Do not drink alcohol while you are taking Venlafaxine Kern Pharma, as this may increase the sedative effects of the medicine and may cause you to feel drowsy or less alert. Taking Venlafaxine Kern Pharma in combination with alcohol, as well as with certain other medicines, may increase the risk of side effects and may worsen your depression or other medical 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 can sometimes have thoughts of harming or killing yourself. These thoughts may be increased 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.

Some medicines of the same group as Venlafaxine Kern Pharma (so-called SSRI/SNRI) may cause symptoms of sexual dysfunction (see section 4). In some cases these symptoms have persisted after stopping treatment.

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 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 increased number of reports of hostility (predominantly aggression, oppositional behaviour and anger) when they took this group of medicines. Despite this, the doctor who prescribes the medicine to you may prescribe Venlafaxine Kern Pharma to patients under 18 when he/she decides that it is in the best interest of the patient. If your doctor has prescribed Venlafaxine Kern Pharma to a patient under 18 and you wish to discuss this, talk to your doctor. You should inform 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 in terms of growth, maturation and development have not been demonstrated in this age group.

Using Venlafaxine Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken 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 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 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 or affect your ability to stay alert, and may worsen your depression or other medical 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 during the last trimester of pregnancy, there is a risk that your baby may experience withdrawal symptoms or have other complications after birth. Your doctor or midwife need to know that you are taking this medicine to be able to 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 experiences these symptoms when it is born and you are concerned, 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 risks and benefits of breast-feeding with your doctor and they will help you to decide whether to stop breast-feeding or stop taking Venlafaxine Kern Pharma.

Driving and using machines

During treatment with 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

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

In case of doubt, consult your doctor or pharmacist again.

The usual recommended starting dose is 75 mg per day, divided into two or three doses.

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 intake, 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 to you in a 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 your treatment altogether. It is known that when people stop taking Venlafaxine Kern Pharma, they may experience side effects. These can include feeling dizzy or lightheaded, feeling tired, sleeping problems, headache, nausea, vomiting, and sweating. Your doctor will advise you on how to stop taking Venlafaxine Kern Pharma. If you experience any of these symptoms or other side effects that are troublesome for you, talk to your doctor.

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).

Severe Adverse Effects

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

• Cardiac 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

Infrequent: 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.

Infrequent: 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.

Infrequent: 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.

Infrequent: 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.

Infrequent: feeling dizzy (especially when standing 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 System Disorders

Very frequent: nausea.

Frequent: decreased appetite, constipation, vomiting.

Infrequent: teeth grinding, diarrhea.

Frequency not known: 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).

Infrequent: 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.

Infrequent: 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.

Infrequent: 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.

Infrequent: 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 adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. 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 this medicine 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 through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, 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

Venlafaxina Kern Pharma Composition

The active ingredient is venlafaxine. Each tablet contains 75 mg of venlafaxine (as hydrochloride).

The other components are microcrystalline cellulose (E-460i), sodium carboxymethylcellulose (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 75 mg is presented in the form of tablets. The tablets are round and peach-colored.

Venlafaxina Kern Pharma 75 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 50 mg tablets EFG. Package containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the Last Revision of this Prospectus: 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/