VENLAFAXINE RETARD TEVA-RATIOPHARM 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine RetardTeva-ratiopharm75 mg prolonged-release hard capsules

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. Pack contents and further information

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

This medicine contains the active substance venlafaxine.

Venlafaxine 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 anxious have lower levels of serotonin and norepinephrine in the brain. The way that venlafaxine works is not fully understood but it is believed 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). Treating depression and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Venlafaxine Retard Teva-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 medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI with venlafaxine can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping venlafaxine before taking any irreversible MAOI (see also the section “Other medicines and Venlafaxine Retard Teva-ratiopharm” and the information in that section about “Serotonin syndrome”).

Warnings and precautions

Consult your doctor before starting to take Venlafaxine Retard Teva-ratiopharm:

• If you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Retard Teva-ratiopharm”)
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told that you have an irregular heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or have a tendency to bleed easily (a history of bleeding disorders), if you are using other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see section “Pregnancy and breast-feeding”).
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behaviour.

This medicine 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 while you are taking venlafaxine, as it may cause excessive drowsiness or loss of consciousness. Taking venlafaxine with certain medicines or alcohol may worsen the 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 can sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during the discontinuation of treatment with venlafaxine.

This is more likely to happen:

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

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

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

Dry mouth

Dry mouth has been reported in 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. Therefore, the doses of your diabetes medicines may need to be adjusted.

Sexual problems

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

Spheroids in faeces

Do not be alarmed if you see small white balls (spheroids) in your faeces after taking this medicine. Inside the capsules of Venlafaxine Retard Teva-ratiopharm are spheroids (small white balls) that contain the active substance (venlafaxine). These spheroids release venlafaxine as they pass through the stomach and intestines. The “shell” of the spheroid remains undissolved and is eliminated in the faeces. Therefore, even though you may see spheroids in your faeces, your dose of medicine has been absorbed.

Children and adolescents

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

Other medicines and Venlafaxine Retard Teva-ratiopharm

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 with other medicines.

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson’s disease must not be taken with this medicine. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “Do not take Venlafaxine Retard Teva-ratiopharm”)
• Serotonin syndrome:

A potentially life-threatening or a reaction 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 the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, an MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat coughs)
• Medicines containing methadone (used for the treatment of opioid addiction or for the treatment of severe pain)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Medicines containing St John’s Wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression)
• Medicines containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and becoming withdrawn)

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

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

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

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

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

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat irregular heart 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 and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

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

Taking Venlafaxine Retard Teva-ratiopharm with food, drinks and alcohol

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

Do not drink alcohol while you are taking venlafaxine. Taking venlafaxine with alcohol may cause excessive drowsiness or loss of consciousness, and may worsen the symptoms of depression and other conditions, such as anxiety disorders.

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. You should only take venlafaxine after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking venlafaxine. When taken during pregnancy, medicines similar to venlafaxine (SSRIs) 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 appear bluish. 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 take this medicine during the last few months of pregnancy, there is a risk that your baby may experience withdrawal symptoms or have trouble breathing after it is born. Your doctor or midwife will be able to advise you.

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

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

Driving and using machines

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

Venlafaxine RetardTeva-ratiopharm contains sucrose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Venlafaxine Retard Teva-ratiopharm

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you on a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.

Venlafaxine Retard Teva-ratiopharm is for oral use.

Take this medicine at approximately the same time each day, either in the morning or in the evening. To ensure the complete swallowing of the pellets (spheroids inside the capsules), the capsules should be swallowed whole with fluids and not opened, crushed, chewed or dissolved.

This medicine should be taken with food.

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

Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Venlafaxine Retard Teva-ratiopharm”).

If you take more Venlafaxine Retard Teva-ratiopharm than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you have taken too much medicine, you may experience symptoms such as palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, convulsions or seizures and vomiting.

Overdose can be fatal, especially with simultaneous intake of other medicines and/or alcohol (see “Taking Venlafaxine Retard Teva-ratiopharm with other medicines”).

If you forget to take Venlafaxine Retard Teva-ratiopharm

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily dose of this medicine that has been prescribed for you in a day.

If you stop treatment with Venlafaxine Retard Teva-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 believes you no longer need this medication, they may ask you to gradually reduce the dose before completely stopping treatment. 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 this medication. This may take several weeks or months. In some patients, the discontinuation may need to occur very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further 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 suffer from them.

If any of the following effects occur, do not take this medication. 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, wheezing, difficulty swallowing or breathing
• Severe skin rash, itching, or hives (elevated areas of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, exaggerated reflexes, diarrhea, coma, nausea, and 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, elevated muscle enzymes (determined by a blood test)

• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection
• Severe rash that can lead to the formation of severe blisters and skin peeling
• 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 so-called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

• Cough, breathing noise, difficulty breathing that may be accompanied by elevated temperature
• Black stools (tarry) or blood in stools
• Yellow skin or eyes, dark urine, which may be symptoms of liver inflammation (hepatitis)

• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorder (muscle spasms and stiffness), seizures, or attacks
• Psychiatric problems, such as hyperactivity and unusual 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 yourself or get injured, 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
• Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Confusion, feeling separated (or detached) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams
• Tremor, a feeling of restlessness or inability to sit still or be quiet, tingling, altered taste, 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 frequency of urination, inability to urinate, difficulty urinating
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence)
• Weakness (asthenia), fatigue, chills
• Weight gain or loss
• Increased cholesterol

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling separated (or detached) from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited; teeth grinding
• Fainting, involuntary muscle movements, altered coordination and balance
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure
• Vomiting blood, black 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, sodium, or cholesterol

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

• Seizures or attacks
• Cough, breathing noise, and shortness of breath that may be accompanied by high temperature.

• Excessive water intake (known as SIADH)
• Decreased sodium levels in the blood
• Severe eye pain and reduced or blurred vision.
• 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 symptoms of liver inflammation (hepatitis).
• Disorientation and confusion often accompanied by hallucinations (delirium)
• Abnormal heartbeat, rapid or irregular, which can lead to fainting

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 production of breast milk
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruises 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 discontinuation of 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.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, 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 Agency's website: 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 that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

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

6. Contents of the pack and further information

Composition of Venlafaxine Retard Teva-ratiopharm 75 mgprolonged-release hard capsules

The active ingredient is venlafaxine.

Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.

The other ingredients are:

Capsule content:Sugar spheres (sucrose and cornstarch), hypromellose, ethylcellulose, talc.

Capsule shell:Red iron oxide (E172), titanium dioxide (E171), gelatin.

Printing ink:Lacquer, propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172), potassium hydroxide.

Appearance and packaging of the product

Hard gelatin capsules, with a pink opaque cap and body, filled with white to beige microgranules. The capsules are marked with black ink with "VNL" on the cap and the number "75" on the body. The capsule measures approximately 20 mm x 7 mm.

Blister packs of 10, 14, 20, 28, 30, 50, 98, 100 prolonged-release hard capsules or perforated unit dose blister of 100x1 prolonged-release hard capsules.

HDPE bottles with a screw cap: pack sizes of 30, 150 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharma S.L.U.

C/C, n. 4, Polígono Industrial Malpica

50016 Zaragoza, Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Venlafaxin-AbZ 75 mg Hartkapseln, retardiert

Spain: Venlafaxina Retard Teva-ratiopharm 75 mg prolonged-release hard capsules

Portugal: Venlafaxina Teva

Date of the last revision of this leaflet:May 2023

Detailed information about 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/87920/P_87920.html

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