DOBUPAL RETARD 150 mg PROLONGED-RELEASE HARD CAPSULES

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What is Dobupal Retard and what is it used for
2. What you need to know before starting to take Dobupal Retard
3. How to take Dobupal Retard
4. Possible adverse effects
5. Storage of Dobupal Retard

1. Package contents and additional information

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

Dobupal 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 not fully understood how antidepressants work, but they may help increase the levels of serotonin and norepinephrine in the brain.

Dobupal 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). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not disappear or may worsen and become more difficult to treat.

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

Do not take Dobupal Retard

• 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 a medication known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Dobupal Retard can cause serious or potentially life-threatening adverse effects. Additionally, you must wait at least 7 days after stopping Dobupal Retard before taking any MAOI (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 Dobupal Retard:

• If you are using other medications that, when taken with Dobupal Retard, may increase the risk of developing serotonin syndrome (see the section "Taking Dobupal 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 history of bleeding disorders (tendency to develop bruises or tendency to bleed easily), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility), or if you are using other medications that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots).
• If you or a family member have had mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Dobupal 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 medications in the same group as Dobupal Retard (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Do not drink alcohol during treatment with Dobupal 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.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as all these medications take time to work, usually a couple of weeks, although sometimes longer. These thoughts can also occur when your dose is decreased or during the interruption of treatment with Dobupal Retard.

This is more likely to happen to you:

• If you have had previous thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of self-harm or 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 prospectus. 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 can increase the risk of tooth decay (caries). Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Dobupal Retard. Therefore, the doses of your diabetes medications may need to be adjusted.

Children and adolescents

Dobupal Retard should not normally be used 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 greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications. Despite this, your doctor may prescribe this medication to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed this medication to a patient under 18 years of age and you want to discuss this decision, 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 of age are taking Dobupal Retard. Additionally, long-term safety regarding growth, maturity, and cognitive and behavioral development has not been demonstrated.

Taking Dobupal Retard with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Your doctor must decide if you can take Dobupal Retard with other medications.

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

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Dobupal Retard. Tell your doctor if you have taken any of these medications in the last 14 days. (MAOI: see section "What you need to know before starting to take Dobupal Retard")

• Serotonin Syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section "Possible Adverse Effects") may occur with venlafaxine treatment, particularly when taken with other medications.

Examples of these medications include:

• Triptans (used for migraine)
• Other medications for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medications containing lithium
• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity)
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an MAOI (used to treat depression)
• Medications containing sibutramine (used for weight loss)
• Medications containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) (used to treat severe pain)
• Medications containing dextromethorphan (used to treat cough)
• Medications containing methadone (used to treat opioid addiction or severe pain)
• Medications containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's Wort (also called "Hypericum perforatum", a herbal remedy or plant-based product 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 suspicion, 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, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

Tell your doctor if you are taking medications that may alter your heart rhythm.

Some examples of these medications include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat altered 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 also interact with Dobupal Retard and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications containing:

• Ketoconazole (an antifungal medication)
• Haloperidol or risperidone (for treating psychiatric conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Dobupal Retard with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. You should only take Dobupal Retard after discussing the possible benefits and risks to the unborn child with your doctor.

If you take Dobupal Retard in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Dobupal Retard so they can advise you. When similar medications (SSRIs) are taken during pregnancy, they may increase the risk of a serious 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, you should immediately contact your midwife and/or doctor.

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

Dobupal Retard passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and they will decide whether you should interrupt breastfeeding or interrupt treatment with this medication.

Driving and using machines

Do not drive or operate tools or machines until you know how this medication affects you.

Dobupal Retard 150 mg contains sodium

Dobupal Retard 150 mg contains less than 23 mg of sodium (1mmol) per capsule; this is, essentially "sodium-free".

3. How to take Dobupal Retard

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

The initial recommended dose 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, 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 Dobupal Retard at approximately the same time each day, either in the morning or evening. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Dobupal 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 stop taking Dobupal Retard").

If you take more Dobupal Retard than you should

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

Overdose can put your life in danger, especially with the simultaneous intake of certain medications and/or alcohol (see "Taking Dobupal Retard with other medications"). The symptoms of a possible overdose may include rapid heartbeat, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or convulsions, and vomiting.

If you forget to take Dobupal Retard

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily dose of Dobupal Retard that has been prescribed for you in one day.

If you stop taking Dobupal Retard

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Dobupal 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 too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop taking Dobupal Retard. 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 advice.

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

4. Possible Adverse Effects

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

If any of the following effects occur, do not take more Dobupal Retard. Tell your doctor immediately, or go to the emergency department 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 enzymes (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.

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

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

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 a high 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), seizures or attacks.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Dobupal Retard, If you stop treatment with Dobupal 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 stools after taking this medicine. Inside the Dobupal 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 stools. Therefore, even if you see spheroids in the stools, 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, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, 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, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes.

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

• Seizures or attacks
• 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 heartbeat, rapid or irregular, which can 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 (hepatitis).

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 unexpected bruising or broken blood vessels (broken veins).

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

• Suicidal ideation and suicidal behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before you start taking Dobupal Retard").
• Aggression
• Dizziness
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding and fertility" in section 2 for more information.

Dobupal 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, Dobupal 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 Dobupal Retard for a long time.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that is not listed in this leaflet. 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 Dobupal Retard

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in a dry place.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dobupal Retard 150 mg prolonged-release hard capsules

The active ingredient is venlafaxine. Each capsule contains 169.7 mg of venlafaxine hydrochloride equivalent to 150 mg of venlafaxine base.

The other ingredients (excipients) are: microcrystalline cellulose, ethyl cellulose and hypromellose; Capsule components: red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), gelatin and ink (shellac lacquer, propylene glycol, sodium hydroxide, titanium dioxide and povidone).

Appearance of the Product and Package Contents

Prolonged-release hard capsule.

The capsules are hard gelatin capsules that contain white or off-white spheroids approximately 1 mm in diameter, body and cap elongated dark orange in color, opaque, with white printing.

Dobupal Retard 150 mg is available in packages containing 30 prolonged-release capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

This medicine was authorized in the EEA Member States with the following names:

Spain: Dobupal Retard 150 mg prolonged-release hard capsules

Date of the last revision of this leaflet:May 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/