VENLAFAXINE RETARD MABO 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard MABO 75 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Venlafaxine Retard MABO and what is it 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 norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or have anxiety disorders have lower levels of serotonin and noradrenaline in the brain. The way that SNRIs work is not fully understood but they may help to 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). Treating depression and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Venlafaxine Retard MABO

• If you are allergic to venlafaxine or 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 medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI with Venlafaxine Retard MABO can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine Retard MABO before you take any irreversible MAOI (see also sections “Taking Venlafaxine Retard MABO with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking Venlafaxine Retard MABO

• If you are taking other medicines that, when taken with Venlafaxine Retard MABO, may increase the risk of developing serotonin syndrome (see section “Consult 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 you have an irregular heart rhythm.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).

• If you have a tendency to develop bruises or have a tendency to bleed easily (a 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 overexcited or elated).
• If you have a history of aggressive behaviour.

Venlafaxine Retard MABO may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Some medicines of the same group as Venlafaxine Retard MABO (called SSRIs/ SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Do not drink alcohol while you are taking venlafaxine, as it may increase the risk of side effects. Taking venlafaxine with certain other medicines, and/or with alcohol, may increase the risk of side effects, including those that affect the heart and blood vessels. The combination of venlafaxine with certain other medicines may also increase the risk of bleeding.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you can sometimes have thoughts of harming or killing yourself. These thoughts may be more likely to occur when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer.

You are more likely to have these thoughts if:

• You have previously had thoughts about killing or harming yourself.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Dry mouth

Dry mouth has been reported in approximately 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should pay attention to your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlafaxine Retard MABO. As a result, the doses of your diabetes medicines may need to be adjusted.

Children and Adolescents

Venlafaxine Retard MABO should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 when it is in their best interests. If your doctor has prescribed this medicine to a patient under 18 and you want to discuss this, please contact your doctor. You should inform your doctor if any of the above symptoms occur or worsen when patients under 18 are taking Venlafaxine Retard MABO. Furthermore, the long-term safety of Venlafaxine Retard MABO in relation to growth, maturation, and cognitive and behavioural development in this age group has not been demonstrated.

Taking Venlafaxine Retard MABO with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Your doctor will decide whether you can take Venlafaxine Retard MABO with other medicines.

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

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease should not be taken with Venlafaxine Retard MABO. 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 you take Venlafaxine Retard MABO”).

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

Examples of these medicines include:

• Triptans (used to treat migraine)
• Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines that contain the antibiotic linezolid (used to treat infections)
• Medicines that contain moclobemide, an MAOI (used to treat depression)
• Medicines that contain sibutramine (used for weight loss)

Medicines that contain tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)

• Medicines that contain dextromethorphan (used to treat coughs)
• Medicines that contain methadone (used for treating opioid addiction or for chronic pain management)
• Medicines that contain methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products that contain St John’s Wort (also known as Hypericum perforatum, a herbal remedy used for mild depression)
• Products that contain 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 are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a tendency to withdraw from social contact).

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

restlessness, hallucinations, loss of coordination, rapid heart beat, increased body temperature, changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

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

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

Tell your doctor if you are taking medicines that may affect the heart rhythm.

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms)
• 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 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 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 while you are taking venlafaxine. Drinking alcohol while taking venlafaxine may cause drowsiness or unconsciousness and may worsen the side effects of venlafaxine, including those that affect the heart and blood vessels.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Venlafaxine Retard MABO after discussing the potential benefits and risks with your doctor.

Make sure that your midwife and/or doctor know you are taking Venlafaxine MABO. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

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

If you take Venlafaxine Retard MABO during the last trimester of your pregnancy, there is a risk that your baby may experience withdrawal symptoms or have a higher risk of vaginal bleeding after birth, 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 an effect on the baby. Therefore, you should discuss the case with your doctor, and he/she will decide whether you should stop breast-feeding or stop Venlafaxine Retard MABO.

Driving and using machines

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

3. How to take Venlafaxine Retard MABO

Follow exactly the instructions of your doctor or pharmacist. In case of 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, up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you on 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 should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard MABO should be taken with food.

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

Do not stop taking this medicine without talking to 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 intake, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

The symptoms of a possible overdose may include rapid heart beat, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, fits or seizures, and vomiting.

If you forget to take Venlafaxine Retard MABO

If you miss a dose, take it as soon as you remember. However, if it is already the 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 a forgotten dose. Do not take more than the daily dose of Venlafaxine Retard MABO that has been prescribed to you in a day.

If you stop taking Venlafaxine Retard MABO

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks that you no longer need Venlafaxine Retard MABO, he/she may ask you to reduce the dose gradually before stopping treatment altogether. It is known that side effects occur when people stop using this medicine, especially when it is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, loss of balance, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, fits, or flu-like symptoms.

Your doctor will advise you how to gradually stop taking Venlafaxine Retard MABO. If you experience any of these or other symptoms that are troublesome for you, consult your doctor for advice.

If you have any other 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 all people suffer from them.

If any of the following effects occur, do not take more Venlafaxina Retard MABO.

Tell your doctor immediately, or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest tightness, breathing noise, difficulty swallowing, or breathing.
• Severe skin rash, itching, or hives (elevated areas of 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, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

• Cough, breathing noise, and difficulty breathing that may be accompanied by an increased temperature.
• Tarry stools (deposits) or blood in stools.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nerve problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), convulsions, or seizures.
• 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.

Other adverse effects that may occur

Very common(may affect more than 1 in 10 people)

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common(may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit still, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination frequency, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon(may affect up to 1 in 100 people)

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

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

• Seizures or convulsions.
• Cough, breathing noise, and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which can lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation.

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 bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of bruising or broken blood vessels (broken veins).

Frequency not known

• Suicidal ideation and suicidal behavior, cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after discontinuing treatment (see section 2. “What you need to know before taking Venlafaxina Retard MABO”).
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), (see “Pregnancy” in section 2 for more information).

Venlafaxina Retard MABO sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxina Retard MABO may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking Venlafaxina Retard MABO for a long time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlafaxina Retard MABO

Keep out of sight and reach of children.

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

Do not store above 30°C

Store in a dry place.

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

6. Additional information

Composition of Venlafaxina Retard MABO 75 mg prolonged-release hard capsules

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

The other ingredients (excipients) are:

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

Coating: butylated methacrylic acid copolymer 12.5%,

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

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

Appearance of the product and packaging contents

Prolonged-release hard capsules of 75 mg, opaque flesh-colored, size 0, containing two round, biconvex, 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 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

1. Coslada

Madrid

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 last revision of this leaflet: April 2023

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