Package Insert: Information for the User

Venlafaxine Extended-ReleaseTeva-ratiopharm225 mg Hard Capsules EFG

Read this package insert carefully before you start taking this medicine,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 package insert. See section 4.

Venlafaxina Retard Teva-ratiopharm contains the active ingredient venlafaxine.

Venlafaxina Retard Teva-ratiopharm 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 Teva-ratiopharm 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 depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become harder to treat.

Do not take Venlafaxina Retard ratiopharm:

• If you are allergic to venlafaxine or to any of the other ingredients of 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 ratiopharm may produce serious or potentially life-threatening side effects. In addition,you must wait at least 7 days after stopping Venlafaxina Retard ratiopharm before taking any IMAO (see also the section “Taking Venlafaxina Retard ratiopharm with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxina Retard ratiopharm:

• If you are taking other medicines that, taken with Venlafaxina Retard ratiopharm, may increase the risk of developing serotonin syndrome (see the section “Taking Venlafaxina Retard ratiopharm with other medicines”)
• 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 (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 pregnant (see “Pregnancy and breastfeeding”) or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots)
• 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.

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

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

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, because all these medicines take time to work, usually two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxine.

It is more likely to happen:

• 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 (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 relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is 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). Therefore, you should take good care of your dental hygiene.

Diabetes

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

Sexual problems

Some medicines in the group to which Venlafaxina Retard ratiopharm belongs (called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxina Retard ratiopharm should not normally be used to treat children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age, 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 of age who are taking Venlafaxina Retard ratiopharm. In addition, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated in this age group.

Taking Venlafaxina Retard ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking/using, have taken recently or may need to take/use any other medicine.

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

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

• Inhibitors of monoamine oxidase used to treat depression or Parkinson's diseaseshould not be taken with Venlafaxina Retard ratiopharm. 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 ratiopharm”).
• Serotonin syndrome:
• A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (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, for example, SSRIs, SNRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, an IMAO (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine (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 methaemoglobin in the blood)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal 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 suspicion, unclear thinking, and tendency to withdraw) and other dopamine antagonists such as metoclopramide (used to treat nausea and vomiting).

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

restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

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

You should 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 also interact with Venlafaxina Retard ratiopharm 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 (to treat psychiatric conditions)
• Metoprolol (a beta-blocker to treat high blood pressure and heart problems).

Inform your doctor if you are taking oral contraceptives.

Taking Venlafaxina Retard ratiopharm with food, drinks, and alcohol

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

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

Additionally, alcohol may affect the coating of the capsule, which may lead to a rapid release of a relatively large amount of venlafaxine, potentially causing toxicity or overdose (see “If you take more Venlafaxina Retard ratiopharm than you should”) and preventing the capsule from having an effect until the next scheduled dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should only take Venlafaxina Retard ratiopharm 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 Retard ratiopharm. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in the newborn baby, 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 that 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 ratiopharm 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 ratiopharm so they can advise you.

Breastfeeding

Venlafaxina Retard ratiopharm 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 medicine.

Driving and using machines

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

Venlafaxina Retard ratiopharm 225 mg contains Carmoisine (E 122)

It may cause allergic reactions.

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

The usual initial dose recommended 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 increase it 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 ratiopharm approximately at the same time every day, either in the morning or at night. The capsules should be swallowed whole with liquid and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Retard ratiopharm 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 ratiopharm”).

If you take more Venlafaxina Retard ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Overdose can put your life at risk, especially with the simultaneous taking of certain medications and/or alcohol (see “Taking Venlafaxina Retard ratiopharm 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 ratiopharm

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 ratiopharm that you have been prescribed in a day.

If you interrupt treatment with Venlafaxina Retard ratiopharm

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 ratiopharm, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard ratiopharm. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

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

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

If any of the following effects occur, stop taking Venlafaxina Retard Teva-ratiopharm.Inform your doctor immediately, or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people)

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

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

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

In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). MNS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased 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 may increase the risk of infection
• Severe rash that may lead to the formation of severe blisters and skin peeling
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated with available data)

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

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

• Cough, breathing sounds, and difficulty breathing that may be accompanied by a fever
• Stool (deposits) that are tar-like or blood in stool
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis)
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, numbness, movement disorders (muscle spasms and rigidity), seizures, or attacks
• Psychiatric problems, such as hyperactivity and unusual feelings of overexcitement
• Withdrawal effects (see "How to take Venlafaxina Retard Teva-ratiopharm, if you interrupt treatment with Venlafaxina Retard Teva-ratiopharm")
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for the bleeding to stop.

Other side effects that may occur

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

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

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams
• Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically focus on distant objects to near objects
• Tinnitus (ringing in the ears)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flashes
• Difficulty breathing, yawning
• Vomiting, diarrhea
• Mild skin rash, itching
• Increased frequency of 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, rapid 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 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 attacks
• Cough, breathing sounds, 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 (hepatitis).

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of petechiae or bleeding
• Abnormal milk production
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of petechiae or vessel rupture (broken veins)

Unknown frequency (cannot be estimated with available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. "What you need to know before taking Venlafaxina Retard Teva-ratiopharm").
• Aggression.
• Dizziness
• Abundant vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

Venlafaxina Retard Teva-ratiopharm 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 in the blood. Your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard Teva-ratiopharm for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard ratiopharm 225 mg

• The active ingredient is venlafaxine.

Each prolonged-release capsule contains 225 mg of venlafaxine as venlafaxine hydrochloride.

• The other components are:

Capule content:microcrystalline cellulose, povidone (K-90), talc, colloidal silicon dioxide, magnesium stearate, ethylcellulose, copovidone.

Capsule coating:gelatin, carmoisine (E 122), titanium dioxide (E171), water.

Printing ink of the capsule:shellac, propylene glycol, strong ammonia solution, aluminum lake of indigo carmine (E 132).

Appearance of the product and contents of the package

Venlafaxina Retard ratiopharm 225 mg are hard gelatin capsules, pink, opaque, with thick and thin blue radial bands on the body and cap, containing mini tablets.

Venlafaxina Retard ratiopharm 225 mg is available in:

Packages with aluminum and cold-formed aluminum blisters (OPA/Alu/PVC) containing 28, 30, 30x1 prolonged-release hard capsules.

Packages with white opaque PVC/PVdC and aluminum blisters, containing 28, 30, 30x1 prolonged-release hard capsules.

Packages with white opaque PVC/Aclar and aluminum blisters, containing 28, 30, 30x1 prolonged-release hard capsules.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1st floor.

Alcobendas, 28108 - Madrid

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

Last review date of this leaflet: May 2023

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

You can access detailed and updated information on this medicine by scanning the QR code on the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/81364/P_81364.html

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