PATIENT INFORMATION LEAFLET

Venlafaxine Combix 75 mg tablets

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.

Contents of the leaflet

Venlafaxina Combix 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. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and noradrenaline in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxina Combix 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.

No take Venlafaxina Combix

• 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 Venlafaxina Combix may produce severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Venlafaxina Combix before taking any IMAO irreversible (see also the section "Use of Venlafaxina Combix with other medications" and the information in that section on "Serotonin syndrome").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxina Combix.

• If you are taking other medications that, taken with venlafaxine Combix, may increase the risk of developing serotonin syndrome (see section "Use of Venlafaxina Combix 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 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 (history of bleeding disorders), or if you are taking other medications that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If your cholesterol levels are high.
• If you have a history of or if someone in your family has had mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.
• Diabetes: Your blood glucose levels may be affected by venlafaxine. Therefore, your diabetes medication doses may need to be adjusted.

Venlafaxina Combix may cause restlessness or difficulty sitting or staying still. You should consult your doctor if this occurs.

Some medications in the group to which Venlafaxina Combix belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

If you are applicable to any of these states, consult your doctor before taking Venlafaxina Combix.

Do not drink alcohol during treatment with Venlafaxina Combix, 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.

Pensamientos de suicidio y empeoramiento de su depresión o trastorno de ansiedad

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This may increase when starting to take antidepressants, as these medications take time to take effect, usually two weeks, but sometimes longer.

This is more likely to happen:

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

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

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. They may ask if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Sequedad bucal

There has been a report of dry mouth in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should take care of your dental hygiene.

Uso en niños y adolescentes menores de 18 años de edad

Venlafaxina Combix should not be used normally in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, 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, the doctor who prescribes it may prescribe this medication to patients under 18 years of age when they decide it is the most convenient for the patient. If the doctor prescribes this medication to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when these patients under 18 years of age are taking Venlafaxina Combix. Additionally, the long-term effects of this medication have not yet been demonstrated in terms of safety and relative to growth, maturation, and cognitive and behavioral development.

Uso de Venlafaxina Combix con otros medicamentos

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 Venlafaxina Combix with other medications.

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

• Inhibitors of monoamine oxidase used to treat depression or Parkinson's disease should not be taken with Venlafaxina Combix. 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 Venlafaxina Combix")

• 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:

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, and 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, and increased muscle enzymes (determined by a blood test).

Inform your doctor immediately or go to the nearest hospital emergency room if you think you are experiencing serotonin syndrome.

The following medications may also interact with Venlafaxina Combix and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:

Taking Venlafaxina Combix with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxina Combix. 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 Venlafaxina Combix after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking Venlafaxina Combix. 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), making the baby breathe faster and turn blue. These symptoms usually start within 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 medication during pregnancy, other symptoms that your baby may have when born are feeding problems and breathing difficulties. 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 Combix in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxina Combix to be able to advise you.

Venlafaxina Combix 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 if you should stop breastfeeding or stop taking this medication.

Driving and operating machinery

During treatment with venlafaxine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how the treatment with this medication affects you.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 Venlafaxina Combix approximately at the same time every day, either in the morning or at night.

Venlafaxina Combix 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 Combix”).

If you take more Venlafaxina Combix than you should

Call your doctor or pharmacist immediately if you take more than the prescribed amount of Venlafaxina Combix. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can put your life at risk, especially with the simultaneous intake of certain medications and/or alcohol (see Taking Venlafaxina Combix 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 Combix

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 more than the daily dose of Venlafaxina Combix prescribed to you in a day.

If you interrupt treatment with Venlafaxina Combix

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 Combix, 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 stopping it suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as 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 flu-like symptoms.

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxina Combix. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

Like all medicines, Venlafaxina Combix can cause side effects, although not everyone will experience them.

Allergic Reactions

If any of the following occur, do not take more Venlafaxina Combix.Inform your doctor immediately, or go to the nearest hospital emergency room:

• Chest tightness, wheezing, difficulty swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, sharp sensations, sudden redness of the skin, and/or a feeling of heat
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch)
• Signs and symptoms of serotonin syndrome, which can include agitation, hallucinations, loss of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, and vomiting. In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). NMS symptoms can include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and elevated muscle enzymes (determined by blood tests).

Other side effects that you should inform your doctor are:

• Cough, wheezing, shortness of breath, and high temperature.
• Black, tarry stools or blood in stools.
• Yellow eyes or skin, itching, or dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heart rate, or high blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, numbness, movement disorders, seizures, or convulsions.
• Psychiatric problems, such as hyperactivity and euphoria (an unusual feeling of overexcitement).

Withdrawal effects (see section “How to take Venlafaxina Combix, If you stop taking Venlafaxina Combix”).

• Prolonged bleeding - if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Complete list of side effects

Very common (affects more than 1 in 10 patients)

• Dizziness; headache;
• Nausea; dry mouth.
• Sweating (including night sweats).
  

Common (affects between 1 and 10 in 100 patients)

• Loss of appetite.
• Confusion; feeling detached (or disconnected) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Drowsiness.
• Tremor; numbness; increased muscle tone.
• Visual disturbances, including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Palpitations.
• Increased blood pressure; hot flushes.
• Yawning.
• Vomiting; constipation; diarrhea.
• Increased frequency of urination; difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding; abnormal ejaculation/orgasm (men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

Uncommon (affects between 1 and 10 in 1,000 patients)

• Hallucinations; feeling detached (or disconnected) from reality; agitation; abnormal orgasm (women); lack of feelings or emotions; feeling overexcited.
• Grinding of the teeth.
• A feeling of restlessness or inability to sit or stay still; fainting; involuntary muscle movements; alteration of coordination and balance; altered sense of taste.
• Rapid heart rate; feeling dizzy (especially when standing up too quickly).
• Vomiting blood, black, tarry stools, or blood in stools, which can be a sign of internal bleeding.
• Generalized swelling of the skin, especially the face, mouth, tongue, throat, or hands and feet, and/or raised, itchy rash (urticaria); sensitivity to sunlight; bruises;
• severe skin rash; hair loss.
• Inability to urinate.
• Weight gain or loss.

Rare (affects between 1 and 10 in 10,000 patients)

• Seizures or convulsions.
• Inability to control urination.
• Hyperactivity, rapid thoughts, and decreased need for sleep (mania).
  

Unknown frequency

• Reduced platelet count in the blood, which can increase the risk of bleeding or bruising; bleeding gums, blood in urine or vomit, or unexpected bruising or broken blood vessels, which can increase the risk of infection.
• Swelling of the face or tongue, shortness of breath, or difficulty breathing, often with skin rash (this can be a severe allergic reaction).
• Excessive water intake (SIADH).
• Decreased sodium levels in the blood.
• Suicidal thoughts and behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. “Before taking Venlafaxina Combix”).
• Disorientation and confusion, often accompanied by hallucinations (delirium); aggression.
• High temperature with rigid muscles, confusion, or agitation, and sweating, or if you experience involuntary, jerky muscle movements that you cannot control, these can be symptoms of severe conditions known as neuroleptic malignant syndrome: euphoric sensations, drowsiness, rapid, sustained eye movements, clumsiness, restlessness, feeling drunk, sweating, or rigid muscles, which are symptoms of serotonin syndrome; rigidity; spasms, and involuntary muscle movements.

• Severe eye pain and reduced or blurred vision.

• Dizziness.
• Abnormal blood pressure; irregular heart rate, rapid, or irregular, which can lead to fainting.
• Cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with increased white blood cells (eosinophilic pneumonia).
• Severe back or abdominal pain (which can 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 (hepatitis), mild changes in liver enzyme levels.
• Severe skin rash that can lead to blisters and severe skin peeling; itching; mild skin rash.
• Unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).
• Abnormal milk production.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Venlafaxina Combix can sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rate; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Venlafaxina Combix can reduce the function of platelets in the blood, which can increase the risk of bleeding or bruising. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Combix for a long time.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Combix

The active ingredient is venlafaxine. Each tablet contains 84.84 mg of hydrochloride of venlafaxine equivalent to 75 mg of venlafaxine.

The other components (excipients) are: microcrystalline cellulose (E460i), lactose monohydrate, sodium glycinate starch, magnesium stearate (E470b), yellow iron oxide (E172), and brown iron oxide (E172).

Appearance of Venlafaxina Combix and content of the container

Venlafaxina Combix 75 mg is presented in the form of oblong beige tablets, speckled, scored on one side and smooth on the other.

Venlafaxina Combix 75 mg is presented in containers containing 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Combino Pharm S.L.

Fructuós Gelabert 6-8

08970 Sant Joan Despí

Barcelona

SPAIN

Ó

Combino Pharm (Malta) Ltd.

HF 60, Hal Far Industrial Estate

BBG07 Hal Far

MALTA

Ó

ZYDUS FRANCE

Zac Les Hautes Pätures

Parc d´Activités des Pleupliers

25 rue des Pleupliers

92000 Nanterre (France)

Ó

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet has been approved in May 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/