Package Insert: Information for the User

Dobupal 37.5 mg Tablets

venlafaxine

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

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

Contents of the package andadditional information

Dobupal 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. The exact mechanism of action of antidepressants is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Dobupal is a treatment for adults with depression. Properly treating depressive disorders 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 Dobupal

• 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 Dobupal may cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Dobupal 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 Dobupal:

• If you are taking other medications that, taken with Dobupal, may increase the risk of developing serotonin syndrome (see section "Taking Dobupal 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 petechiae or tendency to bleed easily), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility), or if you are taking other medications that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Dobupal 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 Dobupal 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 Dobupal, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when starting to take antidepressants, as all these medications take time to act, usually two weeks, although sometimes more. These thoughts may also occur when your dose is reduced or during the interruption of treatment with Dobupal.

It is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric diseases treated with antidepressants.

Immediately contact your doctor or go to the nearest hospital emergency room if you have thoughts of harming yourself or committing suicide at any time.

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 worsening, 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 altered by Dobupal. Therefore, your diabetes medication doses may need to be adjusted.

Children and adolescents

Dobupal 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 thoughts, suicidal ideation, and hostility (predominantly 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 deciding what is best 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 Dobupal. Furthermore, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Taking Dobupal with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication. Your doctor must decide if you can take Dobupal with other medications.

Do not start or stop taking any medication, including those available over the counter, natural remedies, or herbal products, without checking with your doctor or pharmacist.

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

• 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 amphetamines (used for attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• Medications containing the antibiotic linezolid (used to treat infections)
• Medications containing moclobemide, an IMAO (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 to treat severe pain)
• 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 disease 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, 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, increased muscle enzymes (determined by blood analysis).

Immediately inform your doctor 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 alter 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 Dobupal 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 states)
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Dobupal with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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

If you take Dobupal 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 Dobupal so they can advise you. When taken during pregnancy, similar medications (ISRS) may increase the risk of a severe condition in newborns, 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, other symptoms that your baby may have when born are feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife, who can advise you.

Dobupal 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

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

Important information about some of the components of Dobupal

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

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

The usual recommended initial dose is 75 mg per day in divided doses, two or three times a day. Your doctor may gradually increase the dose and if necessary, even up to a maximum daily dose of 375 mg for depression.

Take Dobupal approximately at the same time every day, either in the morning or at night.

Dobupal must be taken with food.

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

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

If you take more Dobupal 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 taken.

An overdose can put your life in danger, especially with the simultaneous taking of certain medications and/or alcohol (see Taking Dobupal 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 Dobupal

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 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 Dobupal that has been prescribed to you in a day.

If you interrupt treatment with Dobupal

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 Dobupal, 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 suicidal thoughts, aggression, fatigue, dizziness, lack of stability, headaches, 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 symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Dobupal. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

If any of the following effects occur, do not take any more Dobupal.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)

• Chest tightness, breathing sounds, 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 Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

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

Unknown frequency (cannot be estimated from available data)

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

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

• Cough, breathing sounds, and difficulty breathing that may be accompanied by a fever.
• 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.
• Nerve problems: dizziness, numbness, movement disorder (muscle spasms and rigidity), convulsions or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Dobupal" "If you interrupt treatment with Dobupal").
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for the bleeding to stop.

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, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone.
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically focus on distant objects.
• Ring in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected 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, abnormal hair loss.
• Inability to control urination.
• Rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

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

• Convulsions or seizures
• Cough, breathing sounds, and difficulty breathing that may be accompanied by a fever.
• 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 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 (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, leading to an increased risk of petechiae or bleeding.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of unexpected petechiae or vessel rupture (broken veins).

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after treatment was stopped (see section 2. "What you need to know before starting to take Dobupal").

• Aggression.

• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Dobupal 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, Dobupal may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Dobupal for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use, Website: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.

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

Medications should not be disposed of through drains or in the trash.Deposit empty packaging and unused medications at the SIGRE collection pointat your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dobupal 37.5 mg tablets

The active ingredient is venlafaxine. Each tablet contains 42.42 mg of venlafaxine hydrochloride equivalent to 37.5 mg of venlafaxine base.

The other components (excipients) are: lactose, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, yellow iron oxide (E-172), and brown iron oxide (E-172).

Appearance of Dobupal and content of the packaging

Dobupal 37.5 mg is presented in the form of tablets. The tablets are circular, biplanar, with beveled edges and salmon-colored.

Dobupal 37.5 mg is presented in packaging containing 60 tablets for oral administration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Responsible for manufacturing

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 Member States of the EEA with the following names:

Spain: Dobupal 37.5 mg tablets

Date of the last review of this leaflet:May 2023

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