VENLAFAXINE RETARD KERN PHARMA 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information 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, 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.

Contents of the pack

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

1. What is Venlafaxine Retard Kern Pharma and what is it 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 thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. Antidepressants are not fully understood, but they can help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine Retard Kern Pharma is a treatment for adults with depression. Venlafaxine Retard Kern Pharma is also a treatment for adults with the following anxiety disorder: social anxiety disorder (fear or avoidance of social situations). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not disappear or may become worse and 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 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, such as Venlafaxine Retard Kern Pharma, can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine Retard Kern Pharma before taking any irreversible MAOI (see also section “Using other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Be especially careful with Venlafaxine Retard Kern Pharma

• If you are taking other medicines that, when taken at the same time as Venlafaxine Retard Kern Pharma, may increase the risk of developing serotonin syndrome (see section “Using 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).

1. If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are using 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 overexcited or euphoric).
• If you have a history of aggressive behavior.

Pregnancy

If you take Venlafaxine Retard Kern Pharma in the late stage of pregnancy, you may have a higher risk of heavy vaginal bleeding shortly after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Retard Kern Pharma so they can advise you.

Venlafaxine Retard Kern Pharma may cause a feeling of restlessness or difficulty sitting or standing still. You should consult your doctor if this happens to you.

Some medicines in the same group as Venlafaxine Retard Kern Pharma (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxine Retard Kern Pharma, as it may cause extreme fatigue and unconsciousness. Taking it 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 or killing yourself. This may increase when you first start taking antidepressants, because all these medicines take time to work, usually around 2 weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric conditions who were treated with antidepressants.

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

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 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 be careful with your dental hygiene.

Diabetes

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

Children and adolescents under 18 years of age

Venlafaxine Retard Kern Pharma should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Despite this, your doctor may prescribe Venlafaxine Retard Kern Pharma to patients under 18 years when they decide it is in the best interest of the patient. If your doctor has prescribed Venlafaxine Retard Kern Pharma to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You must inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years are taking Venlafaxine Retard Kern Pharma. Also, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of this medicine have not yet been demonstrated.

Using Venlafaxine Retard Kern Pharma with other medicines

Tell 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 if you can take Venlafaxine Retard Kern Pharma with other medicines.

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

• Monoamine oxidase inhibitors 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 in the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine Retard Kern Pharma”)

• Serotonin Syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “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, e.g., SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing medicines
• 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 (a pain reliever)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal remedy or supplement used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspicion, unclear reasoning, and a tendency to withdraw)

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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

Tell your doctor immediately or go to the emergency room 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 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 Retard Kern Pharma with food and 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 with alcohol may cause extreme fatigue and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

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

Make sure your midwife and/or doctor knows you are taking Venlafaxine Retard Kern Pharma. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you must contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, other symptoms your baby may have when born are feeding problems and breathing problems. If your baby has these symptoms when born 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 an effect on the baby. Therefore, you should discuss this with your doctor, and they will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

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

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Venlafaxine Retard Kern Pharma

Always take Venlafaxine Retard Kern Pharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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, 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 should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard 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 Retard Kern Pharma.

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

If you take more Venlafaxine Retard Kern Pharma than you should

Call your doctor or pharmacist immediately if you take more Venlafaxine Retard Kern Pharma than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see “Taking Venlafaxine Retard Kern Pharma with other medicines”).

The symptoms of a possible overdose may include palpitations, changes in the 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 forgotten doses.

If you miss 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 a single dose as usual. Do not take more than the daily dose of Venlafaxine Retard Kern Pharma that your doctor has prescribed for you in one day.

If you stop taking Venlafaxine Retard Kern Pharma

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need Venlafaxine Retard Kern Pharma, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects occur when people stop using Venlafaxine Retard Kern Pharma, especially when stopped suddenly or if 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, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop taking Venlafaxine Retard 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

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

• Chest compression, 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).
• Signs and symptoms of serotonin syndrome that may include agitation, 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 can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Other adverse effects that you should inform your doctor aboutare:

• Cough, wheezing, shortness of breath and high temperature.
• Tarry stools (deposits) or blood in stools.
• Yellow 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, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorder, seizures or attacks.
• Psychiatric problems, such as hyperactivity and euphoria (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxina Retard Kern Pharma, If you stop treatment with Venlafaxina Retard Kern Pharma").
• Prolonged bleeding - if you cut yourself or get injured, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice small granules or white balls in your stools after taking this medicine. Inside the Venlafaxina Retard Kern Pharma capsules, there are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and comes out in the stools. Therefore, even if you see spheroids in the 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 disconnected) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Drowsiness.
• Tremors; tingling; increased muscle tone.
• Visual disturbances including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Palpitations.
• Increased blood pressure; hot flashes.
• Yawning.
• Vomiting; constipation; diarrhea.
• 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 (or disconnected) from reality; agitation; abnormal orgasm (women); lack of feelings or emotions; feeling overexcited.
• Teeth grinding.
• A feeling of restlessness or inability to remain seated or still; fainting; involuntary muscle movements; altered coordination and balance; altered taste perception.
• Rapid heartbeat; feeling dizzy (especially when getting up too quickly).
• Vomiting blood, tarry stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Generalized swelling of the skin, especially the face, mouth, tongue, throat area, or hands and feet, and/or may appear as a raised rash with itching (hives).
• Sensitivity to sunlight; bruising; skin rash; abnormal hair loss.
• Inability to urinate.
• Weight gain or loss.

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

• Seizures or attacks.
• Inability to control urination.
• Hyperactivity, accelerated thoughts, and decreased 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 can lead to an increased risk of infection.
• Swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this can be a severe allergic reaction).
• Excessive water intake (known as SIADH)
• Decreased sodium levels in the blood
• Suicidal ideation and suicidal behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before taking Venlafaxina Retard Kern Pharma").
• Disorientation and confusion, often accompanied by hallucinations (delirium); aggression.
• A 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, rapid sustained eye movement, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; stiffness, spasms, and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Decreased blood pressure; abnormal heartbeat, rapid or irregular, which can 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, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (pulmonary eosinophilia).
• Severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis), mild changes in liver enzyme blood levels.
• Skin rash that can lead to severe blistering and peeling of the skin; itching; mild skin rash.
• Unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).
• Abnormal milk production.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxina sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in liver enzyme, sodium, or cholesterol blood levels. Less frequently, Venlafaxina 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 Retard 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.

5. Storage of Venlafaxina Retard Kern Pharma

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

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

Store below 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of 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

Composition of Venlafaxina Retard Kern Pharma 75 mgprolonged-release hard capsules

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

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

Appearance of the Product and Package Contents

Venlafaxina Retard Kern Pharma is presented in the form of prolonged-release hard capsules. The capsules are hard gelatin capsules that contain white or off-white spheroids approximately 1 mm in diameter, with a white opaque cap and body.

The capsules are packaged in single-dose paper envelopes and in Al/PVDC-PVC/PVDC blisters.

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

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

Packages containing 30 capsules in single-dose paper envelopes.

Single-dose paper envelope.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Manufacturer:

NATRIX SCIENCES LTD

Industrial State

Half Far – Malta

Farmalíder, S.A.

C/ Aragoneses 15,

28108 Alcobendas

Madrid, 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/