Package Insert: Information for the User

Venlafaxine Extended-Release Tablets 150 mg, Hard CapsulesEFG

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may 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.

Venlafaxina Retard 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 Retard Kern Pharma is a treatment for adults with depression. Venlafaxina Retard Kern Pharma is also a treatment foradults 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 go away or may worsen and become more difficult to treat.

Do not take Venlafaxina Retard Kern Pharma

• If you are allergic to venlafaxine or any of the other components of this medication (listed in section 6).
• If you are also taking or have taken in the last 14 days, any medication known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with other medications, such as Venlafaxina Retard Kern Pharma, may produce severe or potentially fatal side effects. Additionally, you must wait at least 7 days after stopping Venlafaxina Retard Kern Pharma before taking any IMAO irreversible (see also the section “Use of other medications” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Be especially careful with Venlafaxina Retard Kern Pharma

• If you use other medications that, when taken at the same time as Venlafaxina Retard Kern Pharma, may increase the risk of developing serotonin syndrome (see the section “Use of other medications”).
• If you have eye problems, such as certain types of glaucoma (increased eye pressure).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of seizures (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop cardinals or a tendency to bleed easily (history of hemorrhagic disorders), or if you are using other medications that may increase the risk of bleeding, such as warfarin (used to prevent blood clots) or if you are pregnant (see “Pregnancy”1)
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Pregnancy

If you take Venlafaxina Retard Kern Pharma 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 hemorrhagic disorders. Your doctor or midwife must know that you are taking Venlafaxina Farmalider so that they can advise you.

Venlafaxina Retard Kern Pharma may cause restlessness or difficulty sitting or staying still. You should consult your doctor if this happens.

Some medications in the group to which Venlafaxina Retard Kern Pharma belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxina Retard Kern Pharma, as it may cause extreme fatigue 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This is more likely to happen:

• 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 disorders treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the emergency room 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 can also ask them to tell you if 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 tooth decay (caries). Therefore, you should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxina Farmalider. Therefore, your medication doses for diabetes may need to be adjusted.

Children and adolescents under 18 years of age

Venlafaxina Retard Kern Pharma should not be used normally in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Venlafaxina Retard Kern Pharma to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed Venlafaxina Retard Kern Pharma to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years of age who are taking Venlafaxina Retard Kern Pharma. Furthermore, the long-term effects of this medication on growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Use of Venlafaxina Retard Kern Pharma with other medications

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

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

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

• Inhibitors of monoamine oxidase used to treat depression or Parkinson's disease should not be taken with Venlafaxina Retard Kern Pharma. Tell your doctor if you have taken any of these medications in the last 14 days. (IMAO: see section “What you need to know before starting to take Venlafaxina Retard Kern Pharma”)

• Serotonin syndrome:

A potentially fatal state, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “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 treating depression, such as ISRN, ISRS, tricyclic antidepressants, or medications containing lithium
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemida, an irreversible IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing tramadol (a painkiller)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep 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)

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, coma, nausea, vomiting.

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

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

The following medications may also interact with Venlafaxina Retard 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 treating psychiatric disorders)
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxina Retard Kern Pharma with food and drinks and alcohol

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

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

Pregnancy, lactation, and fertility

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

Make sure your midwife and/or doctor know that you are taking Venlafaxina Retard Kern Pharma. When taken during pregnancy, similar medications (ISRS) may increase the risk of a severe condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medication during pregnancy, other symptoms that your baby may have when born are 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 Retard 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 taking this medication.

Driving and operating machinery

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

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

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Take Venlafaxina Retard Kern Pharma exactly as your doctor has told you to. Consult your doctor or pharmacist if you have any doubts.

The usual initial recommended 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, even more, up to a maximum of 375 mg per day for depression. The maximum dose for social anxiety disorder is 225 mg/day.

Take Venlafaxina Retard Kern Pharma approximately at the same time every day, either in the morning or at night. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxina 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 Venlafaxina Retard Kern Pharma.

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

If you take more Venlafaxina Retard Kern Pharma than you should

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

Overdose can put your life at risk, especially when taken with certain medications and/or alcohol (see Taking Venlafaxina Retard Kern Pharma with other medications).

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

If you forgot to take Venlafaxina Retard Kern Pharma

Do not take a double dose to make up for the 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 one dose as usual. Do not take more than the daily dose of Venlafaxina Retard Kern Pharma prescribed to you in a day.

If you interrupt treatment with Venlafaxina Retard 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 Retard 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 Retard Kern Pharma, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as fatigue, dizziness, lack of stability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop treatment with Venlafaxina 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 medication, ask your doctor or pharmacist.

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

If any of the following effects occur, do not take more Venlafaxina Retard 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, stabbing sensations, sudden redness of the skin, and/or a feeling of heat.
• Rash, itching, or urticaria (raised, red, or pale areas of 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, and vomiting.
• In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by blood tests).

Other side effects thatyou should inform your doctorare:

• Cough, wheezing, shortness of breath, and high temperature.
• Black stools 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 heart rate, or high blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: dizziness, numbness, movement disorders, seizures, or attacks.
• Psychiatric problems, such as hyperactivity and euphoria (an unusual feeling of overexcitement).
• Withdrawal effects (see section “how to take Venlafaxina Retard Kern Pharma”, If you interrupt treatment with Venlafaxina Retard Kern Pharma”).
• Prolonged bleeding - if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you see small white granules or beads in your stools after taking this medication. Inside the capsules of Venlafaxina Retard Kern Pharma, there are spheroids (small white beads) 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 released slowly. The “shell” of the spheroid does not dissolve and is excreted in the stool. Therefore, although you may see spheroids in the stool, the dose of the medication has been absorbed.

Complete list of side 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)

• Loss of appetite.
• Confusion; feeling detached (or disconnected) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Somnolence.
• Tremor; numbness; increased muscle tone.
• Visual disturbances, including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Palpitations.
• Increased blood pressure; hot flushes.
• Yawning.
• Vomiting; constipation; diarrhea.
• Increased frequency of urination; difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding; abnormal ejaculation (men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

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

• Seizures or attacks.
• Inability to control urination.
• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).

Unknown frequency

• Reduced platelet count in the blood, which increases the risk of bleeding or bruising; blood disorders, which may increase the risk of infection.
• Swelling of the face or tongue, shortness of breath, or difficulty breathing, often with skin rash (this may be a severe allergic reaction).
• Excessive water intake (SIADH).
• Decreased sodium levels in the blood.
• Suicidal thoughts and behavior; suicidal behavior has 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.
• High temperature with muscle rigidity, confusion, or agitation, and sweating, or if you experience involuntary muscle movements that you cannot control, may be symptoms of severe conditions known as neuroleptic malignant syndrome.
• Euphoric sensations, somnolence, rapid, sustained eye movements, clumsiness, restlessness, feeling drunk, sweating, or muscle rigidity, which are symptoms of serotonin syndrome; rigidity, spasms, and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Decreased blood pressure; abnormal heart rate, rapid, or irregular, which may lead to fainting; unexpected bleeding, such as bleeding gums, blood in stools or vomit, or unexpected bruising or broken blood vessels (veins).
• Cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with increased white blood cells (eosinophilic pneumonia).
• 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 levels.
• Rash that may lead to blisters and severe skin peeling; itching; mild rash.
• Unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).
• Abnormal milk production.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see“Pregnancy”1in section 2 for more information.

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rate; mild changes in liver enzyme levels, sodium, or cholesterol. Your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard Kern Pharma for a long time.

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

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

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.

Store below 30°C.

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 the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard Kern Pharma 150 mghard capsules with prolonged release

The active ingredient is venlafaxine. Each capsule contains 150 mg of the active ingredient venlafaxine (hydrochloride).

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

Appearance of the product and content of the container

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

The capsules are packaged inunit dose paperboard cartons and in Al/PVDC-PVC/PVDC blisters.

500 capsule clinical packs in Al/PVDC-PVC/PVDC blisters.

30 capsule packs in Al/PVDC-PVC/PVDC blisters.

30 capsule packs in unit dose paperboard cartons.

Unit dose paperboard cartons.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible 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

Last review date of this leaflet:April 2023

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