DISLAVEN RETARD 75 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Dislaven Retard 75 mg prolonged-release capsules EFG

venlafaxine

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Dislaven Retard is and what it is used for.
2. What you need to know before you take Dislaven Retard.
3. How to take Dislaven Retard.
4. Possible side effects.
   1. Storage of Dislaven Retard.
   2. Contents of the pack and further information.

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

Dislaven Retard contains the active substance venlafaxine.

Dislaven Retard 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. The way that SNRIs work is not fully understood but they may help to increase the levels of serotonin and noradrenaline in the brain.

Dislaven Retard is used to treat adults with depression. It is also used to treat adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Proper treatment of depression and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Dislaven Retard:

• 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 Dislaven Retard can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Dislaven Retard before taking any MAOI (see also section “Taking other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking Dislaven Retard:

• If you have a history of bleeding disorders or if you develop unusual bruising or bleeding, or if you are pregnant (see “Pregnancy and breast-feeding”)
• If you are taking other medicines that, when taken with Dislaven Retard, may increase the risk of developing serotonin syndrome (see section “Taking Dislaven Retard with other medicines”).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told that you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency 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).
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behaviour.

Dislaven Retard may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Some medicines of the same group as Dislaven Retard (called SSRIs/ SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Do not drink alcohol while taking Dislaven Retard, as it may cause extreme drowsiness and unconsciousness. Taking it with certain medicines or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide 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. These may be increased when first starting treatment with antidepressants, as all these medicines take time to work, usually about 2 weeks, but sometimes longer.

This is more likely to happen:

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

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

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 behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Dislaven Retard. Therefore, the dose of your diabetes medicines may need to be adjusted.

Children and adolescents

Dislaven Retard should not normally be used in the treatment of children and adolescents under 18 years. In addition, you should know that in patients under 18 years, there is an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, confrontation and irritability) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years when he decides that it is in the patient's best interest. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years are taking Dislaven Retard. In addition, long-term safety data on growth, maturation, and cognitive and behavioural development in this age group are not available.

Other medicines and Dislaven Retard

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor will decide whether you can take Dislaven Retard with other medicines.

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

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

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)
• Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants or medicines containing lithium
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, an MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine or pentazocine (used to treat severe pain)
• Medicines containing dextromethorphan (used to treat coughs)
• Medicines containing methadone (used for treating addiction to opioids or for treating severe pain)
• 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 herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or feeling things that do not exist, mistaken beliefs, unusual suspiciousness, unclear reasoning and tendency to withdraw)

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, 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, fast heart beat, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the casualty department of your nearest hospital if you think you are experiencing serotonin syndrome.

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat irregular heart beats)
• 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 medicines may also 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 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 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 while taking Dislaven Retard. Taking it with alcohol may cause extreme drowsiness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Dislaven Retard after discussing the potential benefits and risks with your doctor.

If you take Dislaven Retard during the late stage of pregnancy, there is a risk of heavy bleeding in the mother and/or baby during or after birth, especially if you have a history of bleeding disorders. Your doctor or midwife need to know that you are taking Dislaven Retard so that they can advise you.

Make sure your midwife and/or doctor know that you are taking Dislaven Retard. When similar medicines (SSRIs) are taken during pregnancy, they can increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes 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 should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to problems with breathing, another symptom your baby may have when born is problems with feeding. If your baby has these symptoms when born and you are worried, contact your doctor and/or midwife, who will be able to 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 he will decide whether you should stop breast-feeding or stop the treatment with this medicine.

Driving and using machines

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

Dislaven Retard contains sucrose

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

3. How to take Dislaven Retard

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose for depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, if necessary, up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you on 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 at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with a drink and not 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 medicine.

Do not stop taking this medicine without talking to your doctor (see section “If you stop taking Dislaven Retard”).

If you take more Dislaven Retard than you should

In case of overdose or accidental intake, contact your doctor, pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

The symptoms of a possible overdose may include fast heart beat, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Dislaven Retard

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the prescribed daily dose of Dislaven Retard in a day.

If you stop taking Dislaven Retard

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks that you no longer need Dislaven Retard, he may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects can occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, 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 taking Dislaven Retard. If you experience any of these or other symptoms that are troublesome for you, consult your doctor for advice.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

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

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or swollen rash with itching, difficulty swallowing or breathing.

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

• Chest tightness, breathing noise, difficulty swallowing or breathing.
• Severe skin rash, itching or hives (elevated areas of reddened 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 enzyme levels (determined by a blood test).
• Signs of infection, such as increased temperature, chills, shivering, headache, sweating or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which can lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort or weakness. This may be a sign of rhabdomyolysis.

Other adverse effects that you should inform your doctor aboutare (the frequency of these adverse effects is included in the list below “other adverse effects that may occur”):

• Cough, breathing noise and difficulty breathing that may be accompanied by an increased temperature.
• Tarry stools (deposits) or blood in stools.
• 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.
• Nerve problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), convulsions or seizures.
• 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 injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice small white balls or granules in your stool after taking this medicine. Inside the Dislaven Retard 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 is eliminated in the stool. Therefore, even if you see spheroids in the stool, the dose of the medicine has been absorbed.

Other adverse 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)

• Decreased appetite.
• Confusion, feeling strange, absence of orgasm, decreased libido, nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to remain seated or still, tingling, 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.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination frequency, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts and decreased need for sleep (mania).

• Hallucinations, feeling detached 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 getting up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, skin rash, abnormal hair loss.
• Inability to control urination. Stiffness, spasms and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes, sodium or cholesterol.

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

• Seizures or convulsions. Cough, breathing noise 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, 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, flu-like symptoms, 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 an increased risk of bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from the available data)

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

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

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

Reporting of adverse effects

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

5. Storage of Dislaven Retard

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. The expiration date is the last day of the month indicated.

Do not store above 30 ºC.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofDislaven Retard

The active ingredient 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 (sucrose and cornstarch without gluten), stearic acid, ethylcellulose and talc.

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

Appearance of the product and package contents

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 packages that contain 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 - 2ª planta

28023 Aravaca – Madrid

Spain

Manufacturer

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

Date of the last revision of this prospectus: September 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/