VENLAFAXINE RETARD TEVA-RATIOPHARM 225 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine RetardTeva-ratiopharm225 mg prolonged-release hard capsules EFG

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

• 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 and other information

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

1. What is Venlafaxine Retard Teva-ratiopharm and what is it used for

Venlafaxine Retard Teva-ratiopharm contains the active substance venlafaxine.

Venlafaxine Retard Teva-ratiopharm 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 norepinephrine in the brain. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine 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). Proper treatment of depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve or may become more difficult to treat.

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

Do not take Venlafaxine Retard ratiopharm:

• 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 medicinal product known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Venlafaxine Retard ratiopharm can cause serious or potentially life-threatening side effects. Also, you mustwait at least 7 days after stopping Venlafaxine Retard ratiopharm before taking any MAOI (see also section “Taking Venlafaxine Retard ratiopharm with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist beforestarting treatment with Venlafaxine Retard ratiopharm:

• If you are taking other medicines that, when taken with Venlafaxine Retard ratiopharm, could increase the risk of developing serotonin syndrome (see section “Taking Venlafaxine 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 (fits)
• If you have a history of low sodium levels in the blood (hyponatremia)
• If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are pregnant (see “Pregnancy and breast-feeding”) or if you are using 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 a family member has had, mania or bipolar disorder (feeling overexcited or elated)
• If you have a history of aggressive behavior.

Venlafaxine Retard ratiopharm 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.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme tiredness and unconsciousness. Taking it with certain medicines and/or with 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 or killing yourself. These thoughts may increase when you first start taking antidepressants, because these medicines take time to work, usually around 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric conditions who were treated with antidepressants.

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

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 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 be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Venlafaxine Retard ratiopharm. Therefore, the doses of your diabetes medicines may need to be adjusted.

Sexual problems

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

Children and adolescents

Venlafaxine Retard ratiopharm should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years of age when they decide it is the most suitable 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 go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking Venlafaxine Retard ratiopharm. Also, long-term safety in relation to growth, maturity, and cognitive and behavioral development has not been demonstrated in this age group.

Taking Venlafaxine Retard ratiopharm with other medicines

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

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

Do not start or stop taking any medicines, including those that can be bought without a prescription, herbal or plant-based remedies, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Venlafaxine Retard ratiopharm. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine 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 venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating depression, for example SNRIs, SSRIs, 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 MAOI (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 coughs)
• Medicines containing methadone (used to treat opioid addiction or severe pain)
• Medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methemoglobin in the blood)
• Products containing St John's Wort (also known as “Hypericum perforatum”, a herbal 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, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a 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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

You should tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat)
• 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 ratiopharm and should be used with caution. It is especially important to tell 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 for treating high blood pressure and heart problems).

Tell your doctor if you are taking oral contraceptives.

Taking Venlafaxine Retard ratiopharm with food, drinks, and alcohol

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

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

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

Pregnancy and breast-feeding

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.

Pregnancy

You should only take Venlafaxine Retard ratiopharm after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking Venlafaxine Retard ratiopharm. 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 breathing problems, another symptom your baby may have when born is feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

If you take Venlafaxine Retard ratiopharm in the final stages of pregnancy, you may have a higher risk of heavy vaginal bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Retard ratiopharm so they can advise you.

Breast-feeding

Venlafaxine Retard ratiopharm passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and they will decide whether you should stop breast-feeding or stop taking this medicine.

Driving and using machines

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

Venlafaxine Retard ratiopharm 225 mg contains Carmoisine (E 122)

May cause allergic reactions.

3. How to take Venlafaxine Retard ratiopharm

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

The normal recommended initial dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, 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 ratiopharm approximately at the same time each 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.

Venlafaxine Retard ratiopharm should be taken with food.

If you have liver or kidney problems, talk to your doctor as it may be necessary for your dose of this medication to be different.

Do not stop taking this medication without consulting your doctor (see section "If you stop treatment with Venlafaxine Retard ratiopharm").

If you take more Venlafaxine Retard ratiopharm than you should

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

Overdose can put your life in danger, especially with the simultaneous intake of certain medications and/or alcohol (see "Taking Venlafaxine Retard ratiopharm with other medications").

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

If you forgot to take Venlafaxine Retard ratiopharm

If you have not taken 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 single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily amount of Venlafaxine Retard ratiopharm that has been prescribed for you in one day.

If you stop treatment with Venlafaxine Retard ratiopharm

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Venlafaxine 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 too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Venlafaxine Retard ratiopharm. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

If any of the following side effects occur, stop taking Venlafaxine Retard Teva-ratiopharm.Tell your doctor immediately, or go to the emergency room 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 sounds, difficulty swallowing or breathing
• Severe skin rash, itching, or hives (elevated areas of reddened 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 enzyme levels (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 that can lead to blistering and peeling of the skin
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from the 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 tell your doctor aboutare (the frequency of these side effects is included in the list below "Other side effects that may occur"):

• Cough, breathing sounds, and difficulty breathing that may be accompanied by a high temperature
• Tarry stools (deposits) or blood in stools
• Itching, yellow eyes or skin, dark urine, symptoms similar to the flu, 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), seizures or attacks
• Psychiatric problems, such as hyperactivity and unusual feeling of overexcitement
• Withdrawal effects (see section "How to take Venlafaxine Retard Teva-ratiopharm, if you stop treatment with Venlafaxine Retard Teva-ratiopharm")
• Prolonged bleeding, if you cut or injure yourself, 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)

• Decreased appetite
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams
• Tremors, a feeling of restlessness or inability to sit or stand 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 (men), 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 standing 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 attacks
• Cough, breathing sounds, 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 (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 that leads to an increased risk of bruising or bleeding
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of bruising or broken blood vessels (broken veins)

Frequency not known (cannot be estimated from the available data)

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

Venlafaxine Retard Teva-ratiopharm sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine Retard Teva-ratiopharm 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 Venlafaxine Retard Teva-ratiopharm for a long time.

Reporting side effects

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

5. Storage of Venlafaxine Retard Teva-ratiopharm

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine Retard ratiopharm 225 mg

• The active ingredient is venlafaxine.

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

• Other ingredients are:

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

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

Printing ink for the capsule: shellac, propylene glycol, strong ammonia solution, aluminum lacquer carmine (E 132).

Appearance of the product and package contents

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

Venlafaxine Retard ratiopharm 225 mg is available in:

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

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1ª planta.

Alcobendas, 28108 - Madrid

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

Date of the last revision of this leaflet: May 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (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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