Venlafaxine prolonged-release Teva-Ratiopharm 225 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlafaxine Retard Teva-ratiopharm 225 mg prolonged-release hard capsules EFG

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

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, since it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

What Venlafaxine Retard Teva-ratiopharm is and what it is used for
What you need to know before taking Venlafaxine Retard Teva-ratiopharm
How to take Venlafaxine Retard Teva-ratiopharm
Possible adverse effects
How to store Venlafaxine Retard Teva-ratiopharm
Contents of the pack and other information

1. What Venlafaxine Retard Teva-ratiopharm is and what it is 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 noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. How antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine Retard 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). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Retard 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, a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlafaxine Retard ratiopharm may cause serious, potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine Retard ratiopharm before starting any MAOI (see also section “Taking Venlafaxine Retard ratiopharm with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 are prone to bruising or bleeding easily (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 a family member has had, mania or bipolar disorder (feeling overly excited or euphoric)
If you have a history of aggressive behaviour.

Venlafaxine Retard ratiopharm may cause a feeling of restlessness or an inability to sit or stand still during the first 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 drowsiness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You are more likely to experience this:

If you have previously had thoughts of suicide or self-harm
If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

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

It may be helpful to inform a close friend or family member that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to let you know if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Dry mouth

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

Diabetes

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

Sexual problems

Some medicines in the group to which Venlafaxine Retard ratiopharm belongs (called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist 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. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlafaxine Retard ratiopharm. In addition, the long-term safety regarding growth, maturation, and cognitive and behavioural development has not been established 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 need to take any other medicines.

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

Do not start or stop taking any medicine, including those sold without a prescription, herbal remedies, or plant-based products, without first checking with your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with Venlafaxine Retard ratiopharm. 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 taking Venlafaxine Retard ratiopharm”).
Serotonin syndrome:
A potentially life-threatening condition or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

Triptans (used for migraine)
Other medicines for treating depression, e.g., 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 cough)
Medicines containing methadone (used for opioid addiction treatment or for treating severe pain)
Medicines containing methylene blue (used to treat elevated 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 are not real, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw) and other dopamine antagonists such as metoclopramide (used to treat nausea and vomiting).

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, diarrhoea, coma, nausea, vomiting.

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

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

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 Venlafaxine Retard ratiopharm and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

Ketoconazole (an antifungal medicine)
Haloperidol or risperidone (for treating psychiatric conditions)
Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Inform 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 together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

In addition, alcohol may affect the coating of the tablet, which could lead to a 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 having an effect until the next scheduled dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Ensure that your midwife and/or doctor knows that you are taking Venlafaxine Retard ratiopharm. Medicines similar to this one (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

If you take Venlafaxine Retard ratiopharm in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Venlafaxine Retard ratiopharm so they can advise you accordingly.

Breastfeeding

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

Driving and using machines

Do not drive or operate tools or 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 exactly the dosing instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, further 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 Venlafaxine Retard ratiopharm at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard ratiopharm should be taken with food.

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

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking 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 immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

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

If you forget to take Venlafaxine Retard ratiopharm

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

If you stop taking Venlafaxine Retard ratiopharm

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Retard ratiopharm, they may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, especially when it is stopped suddenly or when the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard ratiopharm. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over several months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected 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 may progress to the formation of severe blisters and peeling of the skin.
Unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

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

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

Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature
Tar-like stools or blood in stools
Itching, yellowing of the eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis)
Heart problems, such as rapid or irregular heartbeat, increased blood pressure
Eye problems, such as blurred vision, dilated pupils
Nerve problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits
Psychiatric problems, such as hyperactivity and unusual feelings of over-excitement
Withdrawal effects (see section “How to take Venlafaxine Retard Teva-ratiopharm, if you stop taking Venlafaxine Retard Teva-ratiopharm”)
Prolonged bleeding; if you are cut or injured, it may take longer than normal for the bleeding to stop.

Other adverse effects that may occur

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

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Hyperactivity, racing thoughts, and reduced need for sleep (mania)
Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling over-excited, teeth grinding
Fainting, involuntary muscle movements, impaired coordination and balance
Dizziness (especially when getting up too quickly), decreased blood pressure
Vomiting blood, tar-like stools (bowel movements), or blood in stools, which may be a sign of internal bleeding
Sensitivity to sunlight, bruising, abnormal hair loss
Inability to control urination
Muscle stiffness, spasms, and involuntary movements
Slight changes in blood levels of liver enzymes

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

Seizures or fits
Cough, noisy breathing, and shortness of breath, which may be accompanied by high temperature
Disorientation and confusion, often accompanied by hallucinations (delirium)
Excessive water intake (known as SIADH)
Decreased levels of sodium in the blood
Severe eye pain and reduced or blurred vision
Abnormal, rapid, or irregular heartbeat, which may lead to fainting
Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas)
Itching, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs of liver inflammation (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 bruising or bleeding
Abnormal production of breast milk
Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of bruises or broken blood vessels (ruptured veins)

Frequency not known (cannot be estimated from available data)

Suicidal thoughts and suicidal behaviour: cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. “What you need to know before taking Venlafaxine Retard Teva-ratiopharm”).
Aggression
Vertigo
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

Venlafaxine Retard Teva-ratiopharm sometimes causes adverse effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight 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 wish to carry out occasional blood tests, especially if you have been taking Venlafaxine Retard Teva-ratiopharm for a long time.

Reporting of adverse effects

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

5. Storage of Venlafaxine Retard Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Retard ratiopharm 225 mg

The active substance is venlafaxine.

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

The other components are:

Capsule contents: 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: shellac, propylene glycol, strong ammonia solution, aluminium lake of indigo carmine (E 132).

Appearance of the product and contents of the container

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

Venlafaxine Retard ratiopharm 225 mg is available in:

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

Blister packs made of white opaque PVC/PVdC and aluminum, containing 28, 30, or 30x1 prolonged-release hard capsules.

Blister packs made of white opaque PVC/Aclar and aluminum, containing 28, 30, or 30x1 prolonged-release hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 - Madrid, Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren, Germany

Date of the most recent review of this leaflet: May 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. 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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