Dobupal Retard 75 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dobupal Retard 75 mg prolonged-release hard capsules

venlafaxine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Package leaflet contents:

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

2. What you need to know before taking Dobupal Retard

3. How to take Dobupal Retard

4. Possible side effects

5. Storage of Dobupal Retard

6. Contents of the pack and other information

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

Dobupal Retard is an antidepressant that belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The way antidepressants work is not fully understood, but they may help increase 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 resolve 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 to 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 medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Dobupal Retard may cause serious, even potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping Dobupal Retard before taking any MAOI (see also section “Using other medicines” 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 taking other medicines that, when taken together with Dobupal Retard, could increase the risk of developing serotonin syndrome (see section “Taking Dobupal 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 informed that your heart rhythm is abnormal.
• If you have a history of seizures (fits).
• 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 taking 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 a member of your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behavior.

Dobupal Retard may cause a feeling of restlessness or an inability to sit or stand still during the first weeks of treatment. You should consult your doctor if this occurs.

Some medicines in the same class as Dobupal Retard (called SSRIs/SNRIs) can cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Dobupal Retard, as it may cause extreme drowsiness and unconsciousness. Taking it together with certain medicines 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 anxiety disorders, you may sometimes experience thoughts of harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work, usually about two weeks, although sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Dobupal Retard.

You are more likely to experience this if:

• You have previously had thoughts of suicide or of harming yourself.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants.

If at any time you experience thoughts of harming yourself or committing suicide, contact your doctor immediately or go directly to a hospital.

You may find it helpful to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is getting worse, or if they are concerned 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 (caries). Therefore, you should pay careful attention to 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 normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is the most appropriate option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Dobupal Retard. Furthermore, the long-term safety regarding growth, maturation, and cognitive and behavioral development has not been established.

Taking Dobupal Retard with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Your doctor must decide whether you can take Dobupal Retard with other medicines.

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

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Dobupal 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 starting to take Dobupal Retard”)

• Serotonin syndrome:

A potentially life-threatening condition, or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Adverse Effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of such medicines include:

• triptans (used for migraine)
• other medicines to treat depression, for example, SNRIs, SSRIs, 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 moclobemide, an MAOI (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) (used to treat severe pain)
• medicines containing dextromethorphan (used to treat cough)
• medicines containing methadone (used for opioid addiction treatment or for treatment of severe pain)
• medicines containing methylene blue (used to treat elevated levels of methemoglobin in blood)
• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)
• products containing tryptophan (used for conditions such as sleep disorders and depression)
• antipsychotics (used to treat a disorder with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, unclear thinking, and tendency to withdraw socially)

Signs and symptoms of serotonin syndrome may include a combination of the following:

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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by 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 affect your heart rhythm.

Some examples of these medicines include:

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

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (used to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme drowsiness and unconsciousness, and may 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Dobupal Retard after discussing with your doctor the potential benefits and potential risks to the unborn child.

If you take Dobupal Retard in the late stages 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 be aware that you are taking Dobupal Retard so they can advise you appropriately. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing difficulties, another symptom your baby may have at birth is feeding problems. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to advise you.

Dobupal Retard passes into breast milk. There is a risk of adverse effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

Do not drive or operate tools or machinery until you know how this medicine affects you.

3. How to take Dobupal Retard

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase your dose and, if necessary, further increase it 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 at night. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Dobupal Retard should be taken with food.

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

Do not stop taking this medicine 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 at telephone number 91 562 04 20, indicating the medication and the amount taken.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Taking Dobupal Retard with other medicines). Symptoms of a possible overdose may include rapid heartbeat, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Dobupal 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 a single dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily amount of Dobupal Retard prescribed to you in one day.

If you interrupt treatment with Dobupal Retard

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Dobupal Retard, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when patients discontinue this medicine, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Dobupal Retard. This process may take several weeks or months. In some patients, discontinuation may need to be carried out very gradually over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If any of the following effects occur, stop taking Dobupal Retard immediately and inform your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest tightness, noisy breathing, 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, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by 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 may progress to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

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

Other adverse effects about which you should inform your doctor (the frequency of these adverse effects are included in the list below, “Other adverse effects that may occur”):

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Tar-colored stools or blood in stools.
• Itching, yellowing of the 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 disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take Dobupal Retard, If you stop taking Dobupal Retard”).
• Prolonged bleeding: if you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice white beads or small granules in your stools after taking this medicine. Inside the Dobupal Retard capsules are spheroids (small white beads) that contain the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is excreted in the stools. Therefore, even though you may see spheroids in your 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, anorgasmia, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a sensation of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhoea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities such as increased or irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or weight loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts and decreased need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overstimulated, teeth grinding.
• Fainting, involuntary muscle movements, disturbance in coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces) or blood in the stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle rigidity, spasms and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

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

• Seizures or fits.
• Cough, noisy breathing and shortness of breath which may be accompanied by a high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased levels of sodium in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal, fast 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, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs of liver inflammation (hepatitis).

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

• Prolonged bleeding, which may be due to a low number of platelets in the blood leading to an increased risk of bruising or bleeding.
• Abnormal production of breast milk.
• 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 thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2, “What you need to know before taking Dobupal Retard”).
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Dobupal Retard sometimes causes unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; slight 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 wish to carry out occasional blood tests, particularly if you have been taking Dobupal Retard for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dobupal Retard 75 mg prolonged-release hard capsules

The active substance is venlafaxine. Each capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components (excipients) are: microcrystalline cellulose, ethyl cellulose, and hydroxypropyl methylcellulose; Capsule components: iron oxide red (E-172), iron oxide yellow (E-172), titanium dioxide (E-171), and gelatin.

Appearance of the product and contents of the pack

Prolonged-release hard capsule.

The capsules are hard gelatin capsules containing white or almost white, peach-colored, opaque spheroids approximately 1 mm in diameter.

Dobupal Retard 75 mg is presented in packs containing 30 prolonged-release capsules.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturing Responsible Party

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

This medicinal product was authorized in the EEA Member States under the following names:

Spain: Dobupal Retard 75 mg prolonged-release hard capsules

Date of latest review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/