Venlafaxine Mabo 150 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Retard MABO 150 mg prolonged-release hard capsules EFG

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

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

Leaflet contents

1. What Venlafaxine Retard MABO is and what it is used for
2. What you need to know before taking Venlafaxine Retard MABO
3. How to take Venlafaxine Retard MABO
4. Possible side effects
5. How to store Venlafaxine Retard MABO
6. Contents of the pack and other information

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

Venlafaxine Retard MABO contains the active substance venlafaxine.

Venlafaxine 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 suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. How antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine 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 disorder (panic attacks). Properly treating depressive and anxiety 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.

2. What you need to know before taking Venlafaxine Retard MABO

Do not take Venlafaxine Retard MABO

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken at any time within the last 14 days a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Retard MABO may cause serious, potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine Retard MABO before starting any irreversible MAOI (see also the sections “Taking Venlafaxine Retard MABO with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Venlafaxine Retard MABO

• If you are taking other medicines that, when taken together with Venlafaxine Retard MABO, could increase the risk of developing serotonin syndrome (see section “Talk to your doctor or pharmacist before taking Venlafaxine 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 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 tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”).

• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).

• If you have a history of aggressive behaviour.

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

Some medicines in the same class as Venlafaxine Retard MABO (known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (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 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. This risk may increase when you first start taking antidepressants, because these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to occur 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 treated with antidepressants.

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

It may be 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 wish to ask them to tell 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 take care of your dental hygiene.

Diabetes

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

Children and Adolescents

Venlafaxine Retard MABO should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, 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 Venlafaxine Retard MABO. In addition, long-term safety with regard to growth, maturation, and cognitive and behavioral development has not been established.

Taking Venlafaxine Retard MABO 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 Venlafaxine Retard MABO 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 Venlafaxine Retard MABO. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOI: see section “What you need to know before taking Venlafaxine Retard MABO”).

• Serotonin syndrome:

• A potentially life-threatening condition or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”) may occur with venlafaxine treatment, 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 the antibiotic linezolid (used to treat infections)

• Medicines containing moclobemide, an MAOI (used to treat depression)

• Medicines containing sibutramine (used for weight loss)

• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)

• Medicines containing dextromethorphan (used to treat cough)

• Medicines containing methadone (used for opioid addiction treatment or for treating severe pain)

• Medicines containing methylene blue (used to treat elevated methemoglobin levels in blood)

• Products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or plant-based remedy 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 suspiciousness, unclear thinking, and tendency to withdraw).

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). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

Contact 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 Venlafaxine Retard MABO 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 (for treating psychiatric conditions)
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine Retard MABO with food, drinks, and alcohol

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

Do not drink alcohol during treatment with venlafaxine. Taking it 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxine Retard MABO after discussing with your doctor the potential benefits and possible risks to the unborn child.

Ensure that your midwife and/or doctor know that you are taking Venlafaxine MABO. Similar medicines (SSRIs) taken during pregnancy 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, contact your midwife and/or doctor immediately.

If you take this medicine during pregnancy, in addition to breathing problems, another symptom your baby might have at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take Venlafaxine Retard MABO 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 Venlafaxine Retard MABO so they can advise you.

Venlafaxine Retard MABO passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss the situation with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and using machines

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

3. How to take Venlafaxine Retard MABO

Follow exactly the instructions for use of this medicine. If in doubt, 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 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 Venlafaxine Retard MABO at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard MABO 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 adjusted.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Retard MABO”).

If you take more Venlafaxine Retard MABO 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 medicine and the amount ingested.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Taking venlafaxine with other medicines).

Symptoms of a possible overdose may include palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Retard MABO

If you have missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next scheduled dose as usual. Do not take a double dose to make up for a missed dose. Do not take more than the prescribed daily amount of Venlafaxine Retard MABO in one day.

If you stop taking Venlafaxine Retard MABO

Do not stop your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Retard MABO, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking this medicine, especially if it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, unsteadiness, 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, or flu-like symptoms.

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard MABO. 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 you experience any of the following effects, stop taking Venlafaxine Retard MABO and contact 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 hives (raised areas of red or pale 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, overactive 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 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 may progress to the formation of serious blisters and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

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

• Cough, noisy breathing and difficulty breathing, which may be accompanied by an increase in temperature.
• Tar-like 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 rigidity), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of being overexcited).
• Withdrawal effects (see section “How to take Venlafaxine Retard MABO, if you stop treatment with Venlafaxine Retard MABO”). Prolonged bleeding—if you are cut or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

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, restlessness, abnormal dreams.
• Tremor, a feeling 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, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or increased 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 reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tar-like stools (bowel movements) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, 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 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, rapid or irregular heartbeat, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas).
• Itching, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs 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 increased 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 bruises or broken blood vessels (broken veins).

Frequency not known

• 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 Venlafaxine Retard MABO”).
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) (see “Pregnancy” in section 2 for more information).

Venlafaxine Retard MABO 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, Venlafaxine Retard MABO 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 Venlafaxine Retard for a long time.

Reporting of adverse effects

If you experience any adverse effect, consult 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 Venlafaxine Retard MABO

Keep out of sight and reach of children.

Do not use Venlafaxine Retard MABO after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in a dry place.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Information for the user

Composition of Venlafaxine Retard MABO 150 mg prolonged-release hard capsules

The active substance is venlafaxine. Each prolonged-release hard capsule contains 150 mg of venlafaxine as venlafaxine hydrochloride.

The other components (excipients) are:

Capsule contents: hypromellose, methacrylic acid copolymer (type B), sodium lauryl sulfate, magnesium stearate,

Coating: butylated methacrylate copolymer base 12.5%,

Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E127) and indigo carmine I (E 132)

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

Appearance of the medicinal product and contents of the container

Prolonged-release hard capsules of 150 mg, opaque deep red in colour, size 00, containing three round, biconvex, film-coated tablets, marked with "VEN" on the cap and "150" on the body.

Pack sizes for the 150 mg dose: 10, 14, 28, 30, 60 and 98 prolonged-release hard capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

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

Date of the most recent revision of this leaflet: April 2023

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