Leaflet: information for the user

Venlafaxine prolonged-release Krka150 mg hard capsules EFG

hydrochloride of venlafaxine

Read 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Venlafaxina retard Krka contains the active ingredient venlafaxine.

Venlafaxina retard Krka 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 anxious have lower levels of serotonin and noradrenaline in the brain. The exact way in which antidepressants work is not fully understood, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina retard Krka is a treatment for adults with depression. Venlafaxina retard Krka is also a treatment for adults with the following anxiety disorders:generalized anxiety disorder,social anxiety disorder (fear or avoidance of social situations)andpanic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not disappear or may worsen and become more difficult to treat.

Do not take Venlafaxina retard Krka

• 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 in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxina retard Krka may cause severe or potentially life-threatening side effects. Also, you should wait at least 7 days after stopping Venlafaxina retard Krka before taking any IMAO irreversible (see also the section titled “Other medicines and Venlafaxina retard Krka” and the information in that section about the “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxina retard Krka:

• If you are taking other medicines that, taken with Venlafaxina retard Krka, may increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxina retard Krka”)
• 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 been informed that your heart rhythm is altered
• 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 bleeding or bruising easily (history of haemorrhagic disorders), if you are pregnant (see Pregnancy, breastfeeding and fertility) or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots)
• If your cholesterol levels are high
• 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

Venlafaxina retard Krka may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxina, as it may cause extreme drowsiness and loss of consciousness. Taking it with certain medicines 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. These thoughts may increase when you start taking antidepressants, as all these medicines take time to work, usually two weeks but sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with Venlafaxina retard Krka.

It 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 behaviour 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 hospital directly.

You may find it helpful to tell a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may 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 behaviour.

Sexual dysfunction

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

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxina. This may increase the risk of tooth decay. Therefore, you should take good care of your dental hygiene.

Diabetes

The levels of glucose in the blood may be altered due to Venlafaxina retard Krka. Therefore, you may need to adjust the dosages of your diabetes medicines.

Children and adolescents

Venlafaxina retard Krka should not be used normally in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is a greater risk of side effects such as suicidal thoughts, ideas of suicide and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, the doctor who prescribes it may prescribe it to patients under 18 years when they decide what is best for the patient. If the doctor who prescribes it has prescribed it to a patient under 18 years and wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in patients under 18 years taking Venlafaxina retard Krka. Also, the long-term effects, safety, growth, maturity and development, cognitive and behavioural development of this medicine have not yet been demonstrated.

Other medicines and Venlafaxina retard Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Your doctor should decide if you can take Venlafaxina retard Krka with other medicines.

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Venlafaxina retard Krka. Inform your doctor if you have taken these medicines in the last 14 days (IMAO: see section “What you need to know before starting to take Venlafaxina retard Krka”).
• Serotonin syndrome: a potentially life-threatening or reactions compatible with malignant neuroleptic syndrome (MNS) may occur with the treatment of venlafaxina, particularly when taken with other medicines. Examples of these medicines include:

• Triptans (used for migraines)
• Other medicines for treating depression, e.g. ISRN, ISRS, tricyclic antidepressants or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemida, an irreversible IMAO (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used for opioid addiction treatment or for severe pain treatment)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal remedy 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, false beliefs, unusual suspicion, lack of clarity in reasoning and withdrawal syndrome).

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, diarrhoea, coma, nausea, vomiting.

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

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

Inform your doctor if you are taking medicines that may alter your heart rhythm.

Some examples of these medicines include:

The following medicines may interact with Venlafaxina retard Krka 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 Venlafaxina retard Krka with food, drinks and alcohol

Venlafaxina retard Krka should be taken with food (see section 3 “How to take Venlafaxina retard Krka”).

Do not drink alcohol during treatment with venlafaxina. Taking it with alcohol may cause extreme drowsiness and loss of consciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding and fertility

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

You should only take Venlafaxina retard Krka after discussing the possible benefits and risks for the unborn child with your doctor.

If you take Venlafaxina retard Krka in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxina retard Krka to be able to advise you.

Make sure your midwife and/or doctor knows that you are taking Venlafaxina retard Krka. When taken during pregnancy, similar medicines (ISRSs) may increase the risk of severe conditions in the baby called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear blue. These symptoms usually start in the first 24 hours of the baby's life. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing problems, other symptoms that your baby may have when born are feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

Venlafaxina retard Krka 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 whether you should stop breastfeeding or stop taking this medicine.

Driving and operating machines

Do not drive or operate tools or machines until you know how Venlafaxina retard Krka affects you.

Venlafaxina retard Krka contains saccharose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may increase the dose gradually, and if necessary, even up to a maximum dose of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take Venlafaxina retard Krka 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 Krka should be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section “If you interrupt treatment with Venlafaxina retard Krka”).

If you take more Venlafaxina retard Krka than you should

Call your doctor or pharmacist immediately if you take more than the prescribed amount of this medication. You can also contact the toxicology information service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (Other medications and Venlafaxina retard Krka).

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 Krka

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 a double dose to compensate for the missed doses.Do not take more than the daily amount of Venlafaxina retard Krka prescribed to you in a day.

If you interrupt treatment with Venlafaxina retard Krka

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 Krka, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Venlafaxina retard Krka. This may take several weeks or months. In some patients, the interruption may need to be very gradual over months or more. 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, this medicine can cause side effects, although not everyone will experience them.

If any of the following effects occur, do not take more Venlafaxine retard Krka.Inform your doctor immediately, or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and inflamed skin, difficulty swallowing or breathing.

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

• Pressure in the chest, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, lack 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).

The signs and symptoms of NMS may include a combination of fever, rapid heart rate, sweating, acute muscle rigidity, confusion, and increased muscle enzymes (determined by blood tests).

• Signs of infection, such as fever, chills, shivering, headache, sweating, or symptoms similar to the flu. This may be due to a blood disorder that can increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Frequency unknown (cannot be estimated from available data)

• Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other side effects that you should inform your doctorare (the frequency of these side effects are included in the list below "Other side effects that may occur"):

• Cough, wheezing, and difficulty breathing that may be accompanied by a high temperature.
• Black stools (tarry stools) or blood in the stools
• Itching, yellow eyes or skin, dark urine, which may be symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heart rate, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, numbness, movement disorder (muscle spasms and rigidity), convulsions or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxine retard Krka", "If you stop taking Venlafaxine retard Krka").
• Prolonged bleeding time: if you cut or injure yourself, bleeding may take longer than usual to stop.

Other side effects that may occur

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

• Dizziness, headache, somnolence.
• Insomnia
• Nausea, dry mouth, constipation.
• Sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Loss of appetite.
• Confusion, feeling disconnected (or detached) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically focus on distant objects.
• Tinnitus (ringing in the ears).
• Rapid heart rate, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.

• Increased frequency of urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected (or detached) from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling lightheaded, (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, black stools (tarry stools) or blood in the stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, abnormal hair loss.
• Inability to control urination.

• Rigidity, spasms, and involuntary muscle movements.

• Mild changes in liver enzyme levels.

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

• Convulsions or seizures.

• Cough, wheezing, and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• SIADH (excessive water intake).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heart rhythm, rapid or irregular heart rate, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, symptoms similar to the flu, which are symptoms of liver inflammation.

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood that leads to petechiae or bleeding.

• Abnormal milk production.

• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of petechiae or rupture of blood vessels (broken veins).

Frequency unknown (cannot be estimated from available data)

• Suicidal thoughts and behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before starting to take Venlafaxine retard Krka").
• Excessive bleeding after childbirth (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.
• Aggression.
• Dizziness.

Venlafaxine retard Krka may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Venlafaxine retard Krka may reduce the function of platelets in the blood, which increases the risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxine retard Krka for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Venlafaxine retard Krka

• The active ingredient is venlafaxine. Each prolonged-release hard capsule contains 150 mg of venlafaxine as venlafaxine hydrochloride.
• The other components are: sugar spheres (sucrose, maize starch), hydroxypropylcellulose (E463), povidone K30 (E1201), ethylcellulose, dibutyl sebacate and talc (E553B).
• The capsule components are: gelatin, iron oxide red (E172), titanium dioxide (E171) and iron oxide yellow (E172). See section 2 “Venlafaxine Retard Krka contains sucrose”.

Appearance of the product and contents of the package

Prolonged-release hard capsule.

Orange-brown capsules containing white to off-white spheres.

Package sizes:

Boxes of 10, 14, 20, 28, 30, 50, 60, 98, 100 and 112 prolonged-release hard capsules in blister packs.

HDPE child-resistant bottles with 50, 100 or 250 prolonged-release hard capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the Representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this leaflet:May 2024

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