Venlafaxine prolonged-release Kern Pharma 75 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Retard Kern Pharma 75 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet

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

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

Venlafaxine Retard 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 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 Retard Kern Pharma is a treatment for depression in adults. Venlafaxine Retard Kern Pharma is also a treatment for the following anxiety disorder in adults: social anxiety disorder (fear of, or avoidance of, social situations). Properly treating depressive and anxiety 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 Retard Kern Pharma

Do not take Venlafaxine Retard Kern Pharma

• If you are allergic to venlafaxine or to any of the other components of this medicine (listed in section 6).
• If you are currently taking or have taken 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 such as Venlafaxine Retard Kern Pharma may cause serious, and potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine Retard Kern Pharma before starting any irreversible MAOI (see also the section “Use with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Take special care with Venlafaxine Retard Kern Pharma

• If you are using other medicines that, when taken together with Venlafaxine Retard Kern Pharma, could increase the risk of developing serotonin syndrome (see section “Use 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 levels of sodium in the blood (hyponatremia).

1. If you have a tendency to develop bruises or tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”1).

• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behavior.

Pregnancy

If you take Venlafaxine Retard Kern Pharma in the later 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 Retard Kern Pharma so they can advise you appropriately.

Venlafaxine Retard Kern Pharma 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 Retard Kern Pharma belongs (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Do not drink alcohol during treatment with Venlafaxine Retard 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 have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This risk may increase when starting antidepressant treatment, as all of these medicines take time to become effective—usually about two weeks, but sometimes longer.

You are more likely to experience this if:

• You have previously had thoughts of suicide or of harming yourself.
• 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 disorders treated with antidepressants.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor immediately or go directly to a hospital.

It may be helpful to inform a close friend or family member that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they notice your depression or anxiety 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 tooth decay (caries). Therefore, you should pay careful attention to your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Venlafaxine Retard Kern Pharma. Therefore, the doses of your diabetes medications may need to be adjusted.

Children and adolescents under 18 years of age

Venlafaxine Retard Kern Pharma is not normally recommended for the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, the treating physician may prescribe Venlafaxine Retard Kern Pharma to patients under 18 years of age if they determine it is in the patient's best interest. If your physician has prescribed Venlafaxine Retard Kern Pharma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. 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 Retard Kern Pharma. Furthermore, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development, of this medication have not yet been established.

Use of Venlafaxine Retard Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

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

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Retard Kern Pharma. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before starting to take Venlafaxine Retard Kern Pharma”)

• Serotonin syndrome:

A potentially life-threatening condition, or reactions resembling Neuroleptic Malignant Syndrome (NMS) (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 used 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 known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)
• products containing tryptophan (used for conditions such as sleep problems and depression)
• antipsychotics (used to treat a disorder with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw)

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, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

Contact your doctor immediately or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

The following medicines may also interact with Venlafaxine Retard Kern Pharma and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (used to treat psychiatric conditions)
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine Retard Kern Pharma with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding and fertility

Inform your doctor if you become pregnant or are trying to become pregnant. You should only take Venlafaxine Retard Kern Pharma after discussing with your doctor the potential benefits and possible risks to the unborn child.

Ensure that your midwife and/or doctor knows you are taking Venlafaxine Retard Kern Pharma. Medicines of similar type (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns 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 baby, contact your midwife and/or doctor immediately.

If you take this medicine during pregnancy, other symptoms your baby may have at birth 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 Retard Kern Pharma passes into breast milk. There is a risk of effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

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

Important information about some of the components of Venlafaxine Retard Kern Pharma

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Venlafaxine Retard Kern Pharma

Always take Venlafaxine Retard Kern Pharma exactly as your doctor has instructed you. Consult your doctor or pharmacist if you have any doubts.

The usual recommended starting dose for the treatment of depression and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, and if necessary, further up to a maximum of 375 mg per day for depression. The maximum dose for social anxiety disorder is 225 mg/day.

Take Venlafaxine Retard Kern Pharma at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Kern Pharma should be taken with food.

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

Do not stop taking Venlafaxine Retard Kern Pharma without consulting your doctor (see section “If you stop taking Venlafaxine Retard Kern Pharma”).

If you take more Venlafaxine Retard Kern Pharma than you should

Contact your doctor or pharmacist immediately if you take more Venlafaxine Retard Kern Pharma 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 may be life-threatening, especially when taken simultaneously with certain medications and/or alcohol (see Taking Venlafaxine Retard 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, seizures or fits, and vomiting.

If you forget to take Venlafaxine Retard Kern Pharma

Do not take a double dose to make up for missed doses.

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

If you stop treatment with Venlafaxine Retard Kern Pharma

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you no longer need Venlafaxine Retard Kern Pharma, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when patients discontinue Venlafaxine Retard Kern Pharma, especially if the medication 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 sensations, or, in rare cases, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.

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

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

4. Possible adverse effects

Like all medicines, Venlafaxine Retard Kern Pharma can cause adverse effects, although not everyone experiences them.

If any of the following effects occur, stop taking Venlafaxine Retard Kern Pharma immediately and contact your doctor 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 skin redness and/or a sensation of heat.
• Severe rash, itching or hives (raised areas of pale or reddened skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

Other adverse effects you should report to your doctor include:

• Cough, wheezing, shortness of breath and high fever.
• Tar-colored stools (feces) or blood in stools.
• Yellowing of the eyes or skin, itching, or dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision or dilated pupils.
• Nervous system problems, such as dizziness, tingling, movement disorders, seizures or fits.
• Psychiatric problems, such as hyperactivity and euphoria (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Kern Pharma. If you stop taking Venlafaxine Retard Kern Pharma”).
• Prolonged bleeding – if you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice small granules or white beads in your stools after taking this medicine. Inside the Venlafaxine Retard Kern Pharma capsules are spheroids (small white beads) containing the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The spheroid “shell” does not dissolve and is excreted in the feces. Therefore, even if you see spheroids in your stools, the dose of the medicine has been absorbed.

Complete list of adverse effects

Very common (may affect more than 1 in 10 people)

• Dizziness; headache.
• Nausea; dry mouth.
• Sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion; feeling detached (or separated) from oneself; absence of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Drowsiness.
• Tremor; tingling; increased muscle tone.
• Visual disturbances including blurred vision; dilated pupils; inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Palpitations.
• Increased blood pressure; hot flushes.
• Yawning.
• Vomiting; constipation; diarrhoea.
• Increased frequency of urination; difficulty urinating.
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasms (men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hallucinations; feeling detached from reality; agitation; abnormal orgasm (women); lack of feelings or emotions; feeling overexcited.
• Teeth grinding.
• A sensation of restlessness or inability to sit still or remain motionless; fainting; involuntary muscle movements; disturbance in coordination and balance; altered taste perception.
• Rapid heartbeat; feeling dizzy (especially when standing up too quickly).
• Vomiting blood, tarry stools (faeces), or blood in the stools, which may be a sign of internal bleeding.
• Generalized swelling of the skin, especially the face, mouth, tongue, throat area, hands and feet, and/or appearance of raised, itchy skin rash (urticaria).
• Sensitivity to sunlight; bruising; skin rash; abnormal hair loss.
• Inability to urinate.
• Weight gain or weight loss.

Rare (may affect up to 1 in 1,000 people)

• Seizures or fits.
• Inability to control urination.
• Hyperactivity, racing thoughts and reduced need for sleep (mania).

Frequency not known

• 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.
• Swelling of the face or tongue, shortness of breath or difficulty breathing, often accompanied by skin rash (this may be a serious allergic reaction).
• Excessive water intake (known as SIADH).
• Decreased levels of sodium in the blood.
• Suicidal thoughts and suicidal behaviour; cases of suicidal ideation and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before taking Venlafaxine Retard Kern Pharma”).
• Disorientation and confusion, often accompanied by hallucinations (delirium); aggression.
• 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; muscle rigidity, spasms and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Decreased blood pressure; abnormal, fast or irregular heartbeat, which may lead to fainting; unexpected bleeding, for example bleeding gums, blood in stools or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).
• 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).
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas).
• Itching, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis), mild changes in blood levels of liver enzymes.
• Skin rash that may lead to severe blistering and peeling of the skin; itching; mild skin rash.
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis).
• Abnormal production of breast milk.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy”1 in section 2 for more information.

Venlafaxine may sometimes cause adverse effects that you may not be aware of, such as increases in blood pressure or abnormal heart rate; mild changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, venlafaxine 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 Retard Kern Pharma for a long time.

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

5. Storage of Venlafaxine Retard Kern Pharma

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Retard Kern Pharma 75 mg prolonged-release hard capsules

The active substance is venlafaxine. Each capsule contains 75 mg of the active substance venlafaxine (hydrochloride).

The other components are: sugar spheres (sucrose and maize starch), stearic acid, ethylcellulose and talc. The components of the capsule shell are: gelatin and titanium dioxide (E-171).

Appearance of the product and contents of the container

Venlafaxine Retard Kern Pharma is presented as prolonged-release hard capsules. The capsules are hard gelatin capsules containing white or almost white spheroids approximately 1 mm in diameter, with an opaque white cap and body.

The capsules are packaged in unit-dose sachets made of coated paper composite and in Al/PVDC-PVC/PVDC blisters.

Clinical packs of 500 capsules in Al/PVDC-PVC/PVDC blisters.

Packs of 30 capsules in Al/PVDC-PVC/PVDC blisters.

Packs containing 30 capsules in unit-dose sachets made of coated paper composite.

Unit-dose sachet made of coated paper composite.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Manufacturers:

NATRIX SCIENCES LTD

Industrial State

Half Far – Malta

Farmalíder, S.A.

C/ Aragoneses 15,

28108 Alcobendas

Madrid, Spain

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

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