Venlafaxine Kern Pharma 37.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Venlafaxine Kern Pharma 37.5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Venlafaxine Kern Pharma is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline 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. How antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine Kern Pharma 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 go away or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Kern Pharma

Do not take Venlafaxine Kern Pharma

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are also 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 Kern Pharma, may cause serious or even potentially fatal adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine Kern Pharma before starting any irreversible MAOI (see also the sections “Serotonin syndrome” and “Use of Venlafaxine Kern Pharma with other medicines”).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Venlafaxine Kern Pharma.

• If you are using other medicines that, when taken concomitantly with Venlafaxine Kern Pharma, could increase the risk of developing serotonin syndrome (see section “Use of 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 the blood (hyponatremia).
• If you have a tendency to bruise easily or 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”).
• If your cholesterol levels increase.
• If you have a history of, or if anyone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine Kern Pharma may cause a feeling of restlessness or an inability to sit still or remain still. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with Venlafaxine Kern Pharma, 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 thought 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 behavior 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 think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

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 with your oral hygiene.

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

Use in children and adolescents under 18 years of age

Venlafaxine Kern Pharma 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 (predominantly aggression, oppositional behavior, and anger) when taking this group of medicines. Nevertheless, your doctor may prescribe Venlafaxine Kern Pharma to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Venlafaxine Kern Pharma 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 when these patients under 18 years of age are taking Venlafaxine Kern Pharma. In addition, the long-term effects on growth, maturation, and development in this age group have not been established.

Use of Venlafaxine Kern Pharma with other medicines

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

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

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

• Monoamine oxidase inhibitors (MAOIs): See section “What you need to know before taking Venlafaxine Kern Pharma”

• Serotonin syndrome: A potentially life-threatening condition (see section 4 “Possible side effects”) may occur with treatment with venlafaxine, particularly when taken with other medicines. Examples of these 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, diarrhea, nausea, vomiting, and coma. Seek immediate medical attention 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 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 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 during treatment with Venlafaxine Kern Pharma. 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, breastfeeding, and fertility

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 Kern Pharma after discussing the possible benefits and possible risks to the unborn child with your doctor.

If you take Venlafaxine during 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 this medicine so they can advise you.

If you are taking Venlafaxine Kern Pharma 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.

Venlafaxine Kern Pharma passes into breast milk. There is a risk of effects on the baby. Therefore, you and your doctor must discuss whether you should stop breastfeeding or stop treatment with Venlafaxine Kern Pharma.

Driving and using machines

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

Do not drive or operate tools or machinery until you know how this treatment affects you.

3. How to take Venlafaxine Kern Pharma

Follow exactly the administration instructions for this medicine given by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

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

Venlafaxine Kern Pharma should be taken with food.

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

Do not stop taking Venlafaxine Kern Pharma without consulting your doctor (see 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

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

If you forget to take Venlafaxine 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 the next single dose as usual. Do not take more than the daily amount of Venlafaxine Kern Pharma prescribed for you in one day.

If you stop taking Venlafaxine Kern Pharma

Do not stop or reduce your treatment without your doctor's advice, even if you feel better. If your doctor considers that you no longer need Venlafaxine Kern Pharma, he or she may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking Venlafaxine Kern Pharma, especially when 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 Kern Pharma. 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 product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Venlafaxine Kern Pharma may produce adverse effects, although not everyone experiences them.

Allergic reactions

If any of the following occur, stop taking Venlafaxine Kern Pharma and inform your doctor immediately or go to the nearest hospital emergency department:

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands or feet.
• Feeling nervous or anxious, dizziness, prickling sensations, sudden reddening of the skin and/or a sensation of warmth.
• Severe skin rash, itching, or severe hives (raised red or pale areas of 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 symptoms (see section 3 “How to take Venlafaxine Kern Pharma, If you stop taking Venlafaxine Kern Pharma”).

Complete list of adverse effects

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

Very common	Affects more than 1 in 10 patients
Common	Affects between 1 and 10 in 100 patients
Uncommon	Affects between 1 and 10 in 1,000 patients
Rare	Affects between 1 and 10 in 10,000 patients
Frequency not known	Frequency cannot be estimated from the available data

• Blood disorders

Uncommon: appearance of bruises, tarry stools (faeces), or blood in the stools, which may be signs of internal bleeding.

Frequency 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.

• Metabolism and nutritional disorders

Common: weight loss, increased cholesterol.

Uncommon: weight gain.

Frequency unknown: slight changes in blood levels of liver enzymes; reduction in blood sodium levels; 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 common: dry mouth, headache.

Common: abnormal dreams; decreased libido; dizziness; increased muscle tone; insomnia; nervousness; tingling; sedation; tremors; confusion; feeling detached from oneself and from 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.

Frequency unknown: high 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 feelings, 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); rigidity, spasms, and involuntary muscle movements; suicidal thoughts or thoughts of self-harm.

• Sensory disorders

Common: blurred vision.

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

Frequency unknown: severe eye pain and reduced or blurred vision.

• Cardiac or circulatory disorders

Common: increased blood pressure, hot flushes, palpitations.

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

Frequency unknown: reduction in blood pressure; abnormal, fast, or irregular heartbeat, which may lead to fainting.

• Respiratory disorders

Common: yawning.

Frequency 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 common: nausea.

Common: decreased appetite, constipation, vomiting.

Uncommon: teeth grinding, diarrhoea.

Frequency unknown: severe abdominal or back 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.

Frequency unknown: skin rash that may lead to severe blistering and peeling of the skin; itching; mild skin rash.

• Musculoskeletal disorders

Frequency unknown: unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).

• Urinary system disorders

Common: difficulty urinating; increased frequency of urination.

Uncommon: inability to urinate.

• Sexual and reproductive disorders

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

Uncommon: abnormal orgasm (in women).

Frequency unknown: heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see "Pregnancy" in section 2 for more information.

• General disorders

Common: weakness (asthenia), chills.

Uncommon: sensitivity to sunlight.

Frequency unknown: swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction).

Venlafaxine Kern Pharma sometimes causes unwanted 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 Kern Pharma 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 Kern Pharma for a long time.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, talk to your doctor or pharmacist, even if it is a reaction not mentioned in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Kern Pharma

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

No special storage conditions are required.

Store in a dry place.

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Venlafaxine Kern Pharma

The active substance is venlafaxine. Each tablet contains 37.5 mg of venlafaxine (as hydrochloride).

The other components are microcrystalline cellulose (E-460i), sodium carboxymethylstarch (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 contents of the pack

Venlafaxine Kern Pharma 37.5 mg is presented as tablets. The tablets are round and peach-coloured.

Venlafaxine Kern Pharma 37.5 mg is available in packs containing 60 tablets for oral administration.

Other presentations

Venlafaxine Kern Pharma 50 mg tablets EFG. Pack containing 30 tablets.

Venlafaxine Kern Pharma 75 mg tablets EFG. Pack containing 60 tablets.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent revision of this leaflet: April 2023

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