Prospect: information for the user

Venlafaxine Retard MABO 75 mg prolonged-release hard capsules EFG

Read this prospect carefully before starting to take the medicine.

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

1. What is Venlafaxine Retard MABO and for what it is used

2. What you need to know before starting to takeVenlafaxine Retard MABO

3. How to take Venlafaxine Retard MABO

4. Possible adverse effects

5. Storage of Venlafaxine Retard MABO

6. Contents of the package and additional information

Venlafaxina Retard MABO contains the active ingredient venlafaxine.

Venlafaxina Retard MABO is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. The exact way in which antidepressants work is not fully understood, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina Retard MABO 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 disorders (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not disappear or may worsen and become more difficult to treat.

Do not take Venlafaxina Retard MABO

• If you are allergic to venlafaxine or any of the other ingredients in this medicine (listed in section 6).
• If you are also taking or have taken in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxina Retard MABO may cause severe or potentially life-threatening side effects. You must wait at least 7 days after stopping Venlafaxina Retard MABO before taking any IMAO irreversible (see also the sections “Taking Venlafaxina Retard MABO with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxina Retard MABO

• If you are taking other medicines that may increase the risk of developing serotonin syndrome when taken with Venlafaxina Retard MABO (see the section Consult your doctor or pharmacist before starting to take Venlafaxina Retard MABO).

• 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 your heart rhythm is altered.
• If you have a history of seizures (convulsions)
• If you have a history of low sodium levels in the blood (hyponatremia).

• If you have a tendency to develop bleeding or bruising easily (a history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”).

• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

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

Some medicines in the group to which Venlafaxina Retard MABO 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 venlafaxine, as it may cause extreme fatigue and loss of consciousness. Taking it with certain medicines and/or alcohol may worsen symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or

suiciding. This may be more likely to happen when you start taking antidepressants, as these medicines take time to work, usually two weeks but sometimes longer.

You may be more likely to experience this:

• If you have had thoughts of suicide or self-harm before.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years old) with psychiatric illnesses treated with antidepressants.

If you have thoughts of harming yourself or suiciding at any time, contact your doctor or go to the hospital emergency department immediately.

You may find it helpful to tell a close friend or family member that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). You should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxina Retard MABO. Therefore, your diabetes medicines may need to be adjusted.

Children and Adolescents

Venlafaxina Retard MABO should not normally be used in the treatment of children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However,your doctorwho prescribes it may decide that it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years old, and you want to discuss this decision, please go back 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 who are taking Venlafaxina Retard MABO. Additionally, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated

Taking Venlafaxina Retard MABO with other medicines

Inform your doctor or pharmacist if you are using or have used recentlyor may need to use any other medicine.

Your doctor must decide if you can take Venlafaxina Retard MABO with other medicines.

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

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

• Serotonin syndrome:
• A potentially life-threatening stateor reactions similar to Malignant Neuroleptic Syndrome (MNS)(see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraines)
• Other medicines to treat depression, such as ISRN, ISRS, tricyclic antidepressants, or medicines containing lithium
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemida, an IMAO (used to treat depression)
• Medicines containing sibutramine (used for weight loss)

Medicines containing tramadol, fentanil, tapentadol, petidina, or pentazocina (used to treat severe pain)

• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used to treat opioid addiction or to treat severe pain)
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containingSt. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

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

restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, 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 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 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 medicines may interact with Venlafaxina Retard MABO 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 Venlafaxina Retard MABO with food, drinks, and alcohol

Venlafaxina Retard MABO should be taken with food (see section 3 “How to take Venlafaxina Retard MABO”).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxina Retard MABO after discussing the possible benefits and risks for the unborn baby with your doctor.

Make sure your midwife and/or doctor know that you are taking Venlafaxina MABO. When taken during pregnancy, similar medicines (ISRS) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you are taking this medicine 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.

If you take Venlafaxina Retard MABO in the final stages of pregnancy, there may be a higher 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 Venlafaxina Retard MABO so they can advise you.

Venlafaxina Retard MABO 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 to stop breastfeeding or stop taking this medicine.

Driving and using machines

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

Follow the exact administration instructions for this medication. If in doubt, consult your doctor or pharmacist again.

The usual recommended initial 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, further 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 Venlafaxina Retard MABO approximately at the same time every day, either in the morning or at night. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Retard MABO should 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 Venlafaxina Retard MABO").

If you take more Venlafaxina Retard MABO 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 ingested.

Overdose can put your life at risk, especially when taken with certain medications and/or alcohol (see Taking venlafaxine with other medications).

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

If you forgot to take Venlafaxina Retard MABO

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

If you interrupt treatment with Venlafaxina Retard MABO

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 Venlafaxina Retard MABO, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as fatigue, dizziness, lack of stability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electrical shock sensations, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard MABO. 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.

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 more Venlafaxina Retard MABO.

Inform your doctor immediately, or go to the nearest hospital emergency room:

Rare (may affect up to 1 in 100 people)

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

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

• Pressure in the chest, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, and vomiting.

• In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and elevated muscle enzymes (determined by blood tests).
• Signs of infection, such as fever, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Mysterious muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

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, wheezing, and difficulty breathing that may be accompanied by a fever.
• Stool (deposits) that are tar-like or contain blood.
• 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, numbness, movement disorders (muscle spasms and rigidity), seizures, or convulsions.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section “How to take Venlafaxina Retard MABO, if you interrupt treatment with Venlafaxina Retard MABO”). Prolonged bleeding, if you cut or injure yourself, may take a little longer than usual to stop bleeding.

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.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination, inability to urinate, difficulties urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Loss of consciousness, involuntary muscle movements, alteration of coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tar-like stools (deposits) or blood in stools, 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 in the blood.

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

• Seizures or convulsions.
• Cough, wheezing, and shortness of breath 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, 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, leading to petechiae or hemorrhages.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of petechiae or vessel rupture (broken veins).

Unknown frequency

• 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 Venlafaxina Retard MABO”).
• Aggression.
• Dizziness.
• Abundant vaginal bleeding after childbirth (postpartum hemorrhage), (see “Pregnancy” in section 2 for more information).

Venlafaxina Retard MABO 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 levels. Your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard MABO for a long time.

Reporting 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 Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Venlafaxina Retard MABO after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in a dry place.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Venlafaxina Retard MABO 75 mg Hard-Shell Capsules with Prolonged Release

The active ingredient is venlafaxine. Each prolonged-release hard-shell capsule contains 75 mg of venlafaxine as venlafaxine hydrochloride.

The other components (excipients) are:

Caplet content: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate,

Covering: butylated basic methacrylate copolymer 12.5%,

Capsule coating: gelatin, titanium dioxide (E 171) and iron oxide red (E 172)

Printing ink: shellac lacquer, iron oxide black (E 172) and propylene glycol (E1520)

Appearance of the product and contents of the package

Prolonged-release hard-shell capsules of 75 mg in a beige opaque color, size 0, containing two round, biconvex, and film-coated tablets, marked with VEN on the cap and 75 on the body.

Package sizes for the 75 mg dose: 10, 14, 28, 30, 60, and 98 prolonged-release hard-shell capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821. Coslada

Madrid

Responsible for manufacturing

Pharmathen International S.A.

Sapes Industrial Park

Block 5

69300 Rodopi

Greece

or

PHARMATHEN S.A.

6, Dervenakion Str

GR-15351 Pallini Attikis, Greece

or

ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY S.A.

60th km N.N.R. Athinon-Lamias

32009 Sximatari Voiotias, Greece

Last review date of this leaflet: April 2023

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