Package Insert: Information for the User

Venlafaxine Kern Pharma 75 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Venlafaxina Kern Pharma is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and noradrenaline in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina Kern Pharma is a treatment for adults with depression. 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.

Do not take Venlafaxina Kern Pharma

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Venlafaxina Kern Pharma.

Venlafaxina Kern Pharma may cause restlessness or an inability to sit or stand still. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with Venlafaxina Kern Pharma, as it may cause extreme drowsiness and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have thought about harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as these medications take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric conditions treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital directly.

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. They may ask if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Some medications in the group to which Venlafaxina Kern Pharma belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist 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 take care of your oral hygiene.

Use in children and adolescents under 18 years of age

Venlafaxina Kern Pharma should not be used in children and adolescents under 18 years of age. Additionally, you should know that patients under 18 years of age have an increased risk of adverse effects such as suicidal behavior, suicidal thoughts, and there has been an increase in reports of hostility (predominantly aggression, oppositional behavior, and anger) when they take this group of medications. Despite this, the doctor who prescribes Venlafaxina Kern Pharma may prescribe it to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed Venlafaxina Kern Pharma to a patient under 18 years of age and you want to discuss this decision, talk to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in patients under 18 years of age who are taking Venlafaxina Kern Pharma. Additionally, the long-term safety effects of venlafaxine on growth, maturation, and development in this age group have not been demonstrated.

Use of Venlafaxina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Your doctor should decide if you can take Venlafaxina Kern Pharma with other medications.

Do not start or stop taking any medication, including over-the-counter medications, natural remedies, and herbal supplements, without checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors (IMAO: See section “What you need to know before starting to take Venlafaxina Kern Pharma”)
• Serotonin syndrome: a potentially fatal state (see section 4 “Possible side effects”) may occur with treatment with venlafaxine, particularly when taken with other medications. Examples of these medications include:

• Triptans (used for migraines)
• Medications for depression, such as ISRN, ISRS, tricyclic antidepressants, or medications containing lithium
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an irreversible IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing tramadol (a pain reliever)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural or herbal remedy 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, hyperactive reflexes, diarrhea, nausea, vomiting, and coma. Seek medical attention immediately if you think you are experiencing serotonin syndrome.

The following medications may also interact with Venlafaxina Kern Pharma and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

• Ketoconazole (an antifungal medication).
• Haloperidol or risperidone (for psychiatric conditions).
• Metoprolol (a beta-blocker for high blood pressure and heart problems).

Taking Venlafaxina Kern Pharma with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxina Kern Pharma. Taking it with alcohol may cause extreme drowsiness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should only use Venlafaxina Kern Pharma after discussing the possible benefits and risks for the unborn child with your doctor.

If you take Venlafaxine in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medication to advise you.

If you are taking Venlafaxina Kern Pharma during pregnancy, tell your midwife and/or doctor as your baby may have some symptoms when born. These symptoms usually start within the first 24 hours after birth. These include feeding problems and breathing difficulties. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

Venlafaxina Kern Pharma passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor, and they will decide if you should stop breastfeeding or stop treatment with Venlafaxina Kern Pharma.

Driving and operating machinery

During treatment with Venlafaxina Kern Pharma, you may feel drowsy or dizzy.

Do not drive or operate tools or machinery until you know how Venlafaxina Kern Pharma affects you.

Follow exactly the administration instructions of this medication as indicated by your doctor.

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

The usual recommended initial dose is 75 mg per day in divided doses, two or three times a day.

Your doctor may gradually increase the dose and if necessary, even up to a maximum daily dose of 375 mg for depression.

Take Venlafaxina Kern Pharma approximately at the same time every day, in the morning and in the evening.

Venlafaxina Kern Pharma should be taken with food.

If you have liver or kidney problems, talk to your doctor as your dose of Venlafaxina Kern Pharma may need to be different.

Do not stop taking Venlafaxina Kern Pharma without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Kern Pharma”).

If you take more Venlafaxina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose may put your life at risk, especially with the simultaneous intake of certain medications and/or alcohol (see Taking Venlafaxina Kern Pharma with other medications).

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

If you forgot to take Venlafaxina Kern Pharma

If you have missed 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 one dose as usual. Do not take more than the daily dose of Venlafaxina Kern Pharma prescribed in a day.

If you interrupt treatment with Venlafaxina Kern Pharma

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need Venlafaxina Kern Pharma, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using Venlafaxina Kern Pharma, especially when stopping Venlafaxina Kern Pharma suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, lack of stability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling or electric shock sensations in some cases, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually interrupt treatment with Venlafaxina Kern Pharma. 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 product, consult your doctor or pharmacist.

Like all medicines, Venlafaxina Kern Pharma can cause side effects, although not everyone will experience them.

Allergic reactions

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet.
• Feeling nervous or anxious, dizziness, prickling sensations, sudden redness of the skin, and/or a feeling of heat.
• Severe skin rash, itching, or urticaria (raised areas of skin that are often itchy and red).

Severe side effects

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

• Cardiac problems, such as rapid or irregular heartbeat, or increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, numbness, movement disorders, convulsions, or seizures.
• Psychiatric problems, such as hyperactivity and euphoria.
• Withdrawal from treatment (see section 3 “How to take Venlafaxina Kern Pharma,if you interrupt treatment with Venlafaxina Kern Pharma”).

Complete list of side effects

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

• Blood disorders

Uncommon:appearance of petechiae, black stools, or blood in stools, which may be a sign of internal bleeding.

Unknown frequency:reduced platelet count in the blood, leading to an increased risk of petechiae or bleeding; blood disorders that may increase the risk of infection.

• Metabolic/nutritional disorders

Common:weight loss, increased cholesterol.

Uncommon:weight gain.

Unknown frequency: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 common:dry mouth, headache.

Common:abnormal dreams; decreased libido; dizziness; muscle tension; insomnia; nervousness; numbness; sedation; tremors; confusion; feeling detached (or disconnected) from oneself and reality.

Uncommon:lack of emotions or feelings; hallucinations; involuntary muscle movements; agitation; balance and coordination disorders.

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

Unknown frequency:high fever with rigid muscles, confusion, or agitation, and sweating, or if you experience involuntary, jerky muscle movements that you cannot control, these may be symptoms of severe conditions known as neuroleptic malignant syndrome; euforic feelings, somnolence, sustained rapid eye movements, clumsiness, restlessness, feeling drunk, sweating, or rigid muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); rigidity, spasms, and involuntary muscle movements; suicidal or self-harm thoughts.

• Sensory disorders

Common:blurred vision.

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

Unknown frequency:severe eye pain and reduced or blurred vision.

• Cardiac/circulatory disorders

Common:increased blood pressure, hot flushes, palpitations.

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

Unknown frequency:reduced blood pressure; abnormal heartbeat, rapid, or irregular, which may lead to fainting.

• Respiratory system disorders

Common:yawns.

Unknown frequency:cough, difficult breathing, shortness of breath, and high fever, which are symptoms of lung inflammation associated with increased white blood cells (eosinophilic pneumonia).

• Digestive system disorders

Very common:nausea.

Common:decreased appetite, constipation, vomiting.

Uncommon:bruxism, diarrhea.

Unknown frequency:severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas).

• Skin disorders

Very common:sweating (including night sweats).

Uncommon:skin rash, abnormal hair loss.

Unknown frequency:skin rash that may lead to severe blisters and skin peeling; itching; mild skin rash.

• Musculoskeletal disorders

Unknown frequency:unexplained muscle pain, muscle weakness, or pain (rhabdomyolysis).

• Urinary system disorders

Common:difficulty urinating; increased frequency of urination.

Uncommon:inability to urinate.

• Sexual/reproductive disorders

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

Uncommon:abnormal orgasm (women).

Unknown frequency:excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy” in section 2 for more information.

• General disorders

Common:weakness (asthenia), chills.

Uncommon:sensitivity to sunlight.

Unknown frequency:swelling of the face or tongue, shortness of breath, or difficulty breathing, often with skin rash (this may be a severe allergic reaction).

Venlafaxina Kern Pharma may sometimes cause 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 platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Kern Pharma for a long time.

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

Reporting side effects

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

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

No special storage conditions are required.

Store in a dry place.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Venlafaxina Kern Pharma

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

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

Appearance of the product and content of the packaging

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 packaging containing 60 tablets for oral administration.

Other presentations

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

Venlafaxina Kern Pharma 50 mg tablets EFG. Packaging containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: April 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/