Venlafaxine Teva-Ratiopharm 150 mg prolonged-release hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlafaxine Teva-ratiopharm 150 mg prolonged-release hard capsules

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet 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 alone and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

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

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

This medicine contains the active substance venlafaxine.

Venlafaxine is an antidepressant which belongs to a group of medicines known as 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 depression in adults. It is also a treatment for the following anxiety disorders in adults: generalised 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 improve or may worsen and become more difficult to treat.

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

Do not take Venlafaxine Retard Teva-ratiopharm

• If you are allergic to venlafaxine or to any of the other components of this medicine (listed in section 6).
• If you are currently taking or have taken within the past 14 days any medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may cause serious, and potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before starting any irreversible MAOI (see also section “Other medicines and Venlafaxine Retard Teva-ratiopharm” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

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

• If you are taking other medicines that, when combined 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 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 (hyponatraemia).
• If you tend to develop bruises easily or have a tendency to bleed easily (history of bleeding disorders), if you are taking 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 breastfeeding”).
• If you have a history of, or if a member of your family has had, mania or bipolar disorder (feeling over-excited or elated).
• If you have a history of aggressive behaviour.

This medicine 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 occurs.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness and loss of consciousness. Taking venlafaxine 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 an anxiety disorder, you may sometimes experience thoughts of harming yourself or of 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 when stopping treatment with venlafaxine.

This is more likely to happen if:

• You have previously had thoughts of harming yourself or of suicide.
• 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 who were treated with antidepressants.

If at any time you experience thoughts of harming yourself or of suicide, contact your doctor immediately 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 with your dental hygiene.

Diabetes

Your blood glucose levels may be affected by venlafaxine. Therefore, the doses of your diabetes medications may need to be adjusted.

Sexual problems

Some medicines in the group to which venlafaxine belongs (SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Spheroids in stools

Do not be concerned if you notice small granules or white beads in your faeces after taking this medicine. Inside the Venlafaxine Retard Teva-ratiopharm capsules there are spheroids (small white beads) which contain the active substance (venlafaxine). These spheroids are released from the capsule into the stomach. As they travel through the stomach and intestines, venlafaxine is slowly released. The spheroid "shell" 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 is not normally recommended for use 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 behavior, and irritability) when taking this type of medication. Nevertheless, the doctor in charge may prescribe this medicine to patients under 18 years of age if they determine it is the most appropriate option 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 contact your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine. Furthermore, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development, have not yet been established for this medicine in this age group.

Other medicines and Venlafaxine Retard Teva-ratiopharm

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

Your doctor must decide whether you can take venlafaxine together with other medicines.

Do not start or stop taking any medicine, including those sold without a prescription, natural remedies, or herbal medicines, 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 this medicine. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “Do not take Venlafaxine Retard Teva-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 to treat 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, meperidine, or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used for opioid addiction treatment or for treatment of severe pain)
• Medicines containing methylene blue (used to treat elevated levels of methemoglobin in blood)
• Medicines containing St. John’s wort (also known as Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Medicines containing tryptophan (used for conditions such as sleep disorders and depression)
• Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspiciousness, unclear thinking, and withdrawal from others)

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 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 elevated muscle enzymes (determined by blood test).

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

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 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 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 (used to treat psychiatric conditions)
• Metoprolol (a beta-blocker used to treat 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 during treatment with venlafaxine. Taking it together with alcohol may cause extreme drowsiness and loss of consciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

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. You should only take venlafaxine 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. When taken during pregnancy, similar medicines (SSRIs) 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 bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

If you take this medicine 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 so they can advise you appropriately.

If you take this medicine during pregnancy, in addition to breathing problems, other symptoms your baby may have at birth include feeding difficulties. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to advise you.

Venlafaxine passes into breast milk. There is a risk of effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue 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 Teva-ratiopharm contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Venlafaxine Retard Teva-ratiopharm

Follow exactly the instructions for use of this medicine 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 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.

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 complete swallowing of the granules (spheroids inside the capsules), the capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

This medicine 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 treatment with Venlafaxine Retard Teva-ratiopharm”).

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

If you take more of this medicine than prescribed by your doctor or in case of accidental ingestion, contact your doctor, pharmacist, or call the Poison Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

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

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

If you forget to take Venlafaxine Retard Teva-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 your usual single dose. Do not take a double dose to make up for forgotten doses. Do not take more than the daily amount of this medicine that has been prescribed to you in one day.

If you stop treatment with Venlafaxine Retard Teva-ratiopharm

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need this medicine, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when patients discontinue this medicine, especially if it is stopped suddenly or 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 this medicine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further 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 everybody gets them.

If any of the following effects occur, stop taking this medicine immediately and tell your doctor straight away 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 itchy raised rash, difficulty swallowing or breathing.

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

• Chest tightness, wheezing, difficulty swallowing or breathing
• Severe skin rash, severe itching or severe hives (raised areas of red or pale skin, often itchy)
• 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 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 raised 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 which may progress to severe blistering 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 so-called "stress cardiomyopathy", which may include chest pain, shortness of breath, dizziness, fainting, or irregular heartbeats.

Other adverse reactions you should report to your doctor are (the frequency of these adverse reactions is included in the list below "Other adverse reactions that may occur"):

• Cough, noisy breathing, difficulty breathing, which may be accompanied by elevated temperature
• Black (tarry) stools or blood in the stool
• Yellowing of the 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 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 cut yourself or sustain a wound, 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
• Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Confusion, feeling detached (or separated) from oneself, inability to reach orgasm, decreased libido, agitation, restlessness, abnormal dreams
• Tremor, a sensation 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)
• Fast heartbeat, palpitations
• Increased blood pressure, hot flushes
• Difficulty breathing, yawning
• Vomiting, diarrhea
• Mild skin rash, itching
• Increased frequency of urination, inability to urinate, difficulties in urination
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in males), 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 (or separated) from reality, abnormal orgasm, lack of feelings or emotions, feeling overstimulated; teeth grinding
• Fainting, involuntary muscle movements, disturbance in coordination and balance
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure
• Vomiting blood, tarry stools (faeces) or blood in the 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

• Excessive water intake (known as SIADH)

• Decreased levels of sodium 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 signs of liver inflammation (hepatitis)

• Disorientation and confusion often accompanied by hallucinations (delirium)

• Abnormal, fast or irregular heartbeat, which may lead to fainting

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

• Prolonged bleeding, which may be due to a low 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 unexpected bruises or broken blood vessels (broken 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
• Dizziness
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

This medicine sometimes causes unwanted 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 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, particularly if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products website: 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 and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

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

6. Contents of the pack and other information

Composition of Venlafaxine Retard Teva-ratiopharm 150 mg prolonged-release hard capsules

The active substance is venlafaxine.

Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.

The other components are:

Capsule contents: Sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose, talc.

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

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

Appearance of the product and contents of the pack

Hard gelatin capsules, with opaque brown cap and body, filled with white to beige microgranules. The capsules are printed in black ink with “VNL” on the cap and the number “150” on the body. The capsule measures approximately 24 mm x 8 mm.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party:

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Venlafaxin-AbZ 150 mg Hartkapseln, retardiert

Spain: Venlafaxina Retard Teva-ratiopharm 150 mg cápsulas de liberación prolongada

Portugal: Venlafaxina Teva

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

Detailed 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 medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/87921/P_87921.html

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