Prospect: information for the user

Dislaven Retard 75 mg prolonged-release EFG capsules

venlafaxine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Dislaven Retard and for what it is used.

2.What you need to know before starting to take Dislaven Retard.

3.How to take Dislaven Retard.

4.Possible adverse effects.

1. Storage of Dislaven Retard.
2. Contents of the package and additional information.

Dislaven Retard contains the active ingredient venlafaxine.

Dislaven Retard 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.

Dislaven Retard is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). 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 Dislaven Retard:

• If you are allergic to venlafaxine or any of the other ingredients in 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 Dislaven Retard may cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Dislaven Retard before taking any IMAO (see also the section "Use of other medications" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dislaven Retard:

• If you have a history of bleeding disorders or if you develop unusual bruises […], or if you are pregnant (see "Pregnancy and breastfeeding").
• If you are taking other medications that, when taken with Dislaven Retard, may increase the risk of developing serotonin syndrome (see the section "Taking Dislaven Retard with 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 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 cardenals or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medications that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots).
• 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.

Dislaven Retard may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this occurs.

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

Do not drink alcohol during treatment with Dislaven Retard, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen 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 anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This may increase when starting to take antidepressants, as all these medications take time to take effect, usually two weeks but sometimes longer.

This is more likely to happen:

• If you have previously had 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 nearest hospital directly.

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 care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Dislaven Retard. Therefore, your diabetes medication doses may need to be adjusted.

Children and adolescents

Dislaven Retard should not be used normally in the treatment of children and adolescents under 18 years old. Additionally, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe this medication to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medication to a patient under 18 years old, and you want 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 old while taking Dislaven Retard. Furthermore, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medications and Dislaven Retard

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

Your doctor should decide if you can take Dislaven Retard with other medications.

Do not start or stop taking any medication, including those available over the counter, natural remedies, and herbal products, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's diseaseshould not be taken with Dislaven Retard. 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 Dislaven Retard").

Serotonin syndrome:

A potentially life-threatening 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)
• Other 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 IMAO (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used for severe pain)
• Medications containing dextromethorphan (used for cough)
• Medications containing methadone (used for opioid addiction treatment or for severe pain treatment)
• Medications containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's Wort (also known asHypericum perforatum, a natural 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, 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, 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 heartbeat, sweating, severe muscle rigidity, confusion, and 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.

Inform your doctor if you are taking medications that may affect your heart rhythm.

Examples of these medications include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (see also serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergies)

The following medications may interact with Dislaven Retard 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 conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking Dislaven Retard with food, drinks, and alcohol

Dislaven Retard should be taken with food (see section 3 "How to take Dislaven Retard").

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. You should only take Dislaven Retard after discussing the possible benefits and risks for the unborn child with your doctor.

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

Make sure your midwife and/or doctor know that you are taking Dislaven Retard. When taken during pregnancy, similar medications (ISRS) may increase the risk of a severe condition in babies, 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's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

Dislaven Retard 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 medication.

Driving and operating machinery

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

Dislaven Retard contains saccharose

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.

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

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, 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. If you are being treated for panic disorder, your doctor will start 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 Dislaven Retard approximately at the same time every day, either in the morning or at night. The capsules must be swallowed whole with liquid and should not be opened, crushed, chewed, or dissolved.

Dislaven Retard should be taken with food.

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

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

If you take more Dislaven Retard than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Overdose can put your life at risk, especially with the simultaneous taking of certain medications and/or alcohol (see Taking Dislaven Retard with other medications).

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

If you forgot to take Dislaven Retard

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 dose of Dislaven Retard that you have been prescribed in a day.

If you interrupt treatment with Dislaven Retard

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 Dislaven Retard, they may ask you to gradually reduce the dose 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 fatigue, dizziness, lack of stability, headache, 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 Dislaven Retard. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

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

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 agitation, hallucinations, loss of coordination, rapid heartbeat, 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). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by blood tests).
• Signs of infection, such as increased temperature, 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.
• Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

You must inform your doctor about other side effects (the frequency of these side effects is included in the list below “other side effects that may occur”):

• Cough, wheezing, and difficulty breathing, which may be accompanied by an increased temperature.
• Stool (deposits) or blood in stool.
• Itching, yellow eyes or skin, 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, numbness, movement disorders (muscle spasms and rigidity), seizures, or attacks.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Dislaven Retard, if you interrupt treatment with Dislaven Retard”).
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for the bleeding to stop.

Do not worry if you see white pellets or small granules in your stool after taking this medicine. Inside the Dislaven Retard capsules, there are spheroids (small white pellets) 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 eliminated in the stool. Therefore, although you see spheroids in the stool, the dose of the medicine has been absorbed.

Other side effects that may occur

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

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Loss of appetite.
• Confusion, feeling strange, absence of orgasm, decreased libido, 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 change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• 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, accelerated thoughts, and decreased need for sleep (mania).

• Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, stool (deposits) or blood in stool, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, skin rash, abnormal hair loss.
• Inability to control urination.Muscle rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

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

• Seizures or attacks.Cough, wheezing, and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular heartbeat, 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, leading to petechiae or bleeding.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of petechiae or vessel rupture (broken veins).

Unknown frequency (cannot be estimated with available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. “What you need to know before taking Dislaven Retard”).
• Aggression.
• Dizziness.

Prolonged vaginal bleeding after childbirth (postpartum hemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.

Dislaven Retard may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Dislaven Retard may reduce the function of platelets in the blood, which can increase the risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Dislaven Retard 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 Pharmacovigilance of Medicines for Human Use: http://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 use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines 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. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofDislaven Retard

The active principle is venlafaxine.

Each prolonged-release capsule contains 84.86 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components (excipients) are: sugar spheres 20 (saccharose and cornstarch without gluten), stearic acid, ethylcellulose, and talc.

Components of the capsule: gelatin and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Dislaven Retard 75 mg is presented in the form of hard, prolonged-release capsules. The capsules are hard gelatin that contain white or off-white spheroids of approximately
1 mm in diameter, with a white opaque cap and body.

Dislaven Retard 75 mg is presented in packaging that contains 30 hard, prolonged-release capsules.

Other presentations

Dislaven Retard 150 mg prolonged-release capsules

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca – Madrid

Spain

Responsible for Manufacturing

Valpharma International, S.P.A.

Via G. Morgagni, 2

61016 Pesaro-Urbino - Italy

or

Natrix Sciences Ltd.

HF 79, A-B Hal Far Industrial Estate-Hal Far

BBG3000 - Malta

or

Farmalider, S.A.

c/ Aragoneses, 2

28108 Alcobendas (Madrid) - Spain

Last review date of this leaflet: September 2023

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