Venlafaxine Actavis

Leaflet accompanying the packaging: information for the user

Venlafaxine Actavis, 37.5 mg, prolonged-release hard capsules

Venlafaxine Actavis, 75 mg, prolonged-release hard capsules

Venlafaxine Actavis, 150 mg, prolonged-release hard capsules

Venlafaxine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Venlafaxine Actavis and what is it used for
• 2. Important information before taking Venlafaxine Actavis
• 3. How to take Venlafaxine Actavis
• 4. Possible side effects
• 5. How to store Venlafaxine Actavis
• 6. Contents of the packaging and other information

1. What is Venlafaxine Actavis and what is it used for

Venlafaxine Actavis contains the active substance venlafaxine. Venlafaxine Actavis 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. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline in the brain. Venlafaxine Actavis is used to treat depression in adults. It is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic attacks. For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out properly. If left untreated, the patient's condition may not improve, worsen, and become more difficult to treat.

2. Important information before taking Venlafaxine Actavis

When not to take Venlafaxine Actavis

• if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking, or have taken within the last 14 days, certain medicines called irreversible monoamine oxidase inhibitors (IMAOs) used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Venlafaxine Actavis can cause serious or even life-threatening side effects. Also, before starting to take any IMAO medicine, you should wait at least 7 days after stopping Venlafaxine Actavis (see also "Venlafaxine Actavis with other medicines" and the information in this section about serotonin syndrome).

Actavis (see also "Important information before taking Venlafaxine Actavis" and the information in this section about serotonin syndrome).

Warnings and precautions

Beforestarting to take Venlafaxine Actavis, you should discuss it with your doctor or pharmacist:

• if you are taking other medicines that may increase the risk of serotonin syndrome when taken with Venlafaxine Actavis (see "Venlafaxine Actavis with other medicines")
• if you have eye diseases, such as certain types of glaucoma (increased pressure in the eyeball)
• if you have had high blood pressure in the past
• if you have had heart disease in the past
• if you have had irregular heart rhythms
• if you have had seizures (epilepsy) in the past
• if you have had low sodium levels in the blood (hyponatremia) in the past
• if you have a tendency to bruise or bleed easily (bleeding disorders in the past) or if you are pregnant (see "Pregnancy and breastfeeding") or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots)
• if you or anyone in your family has had mania or bipolar disorder (excessive excitement or euphoria) in the past
• if you have had aggressive behavior in the past.

Venlafaxine Actavis may cause feelings of anxiety or inability to sit or stand still in the first few weeks of treatment. If such symptoms occur, you should inform your doctor. Do not drink alcohol while taking Venlafaxine Actavis, as it may cause extreme fatigue and loss of consciousness. Taking it with alcohol and/or certain medicines may increase the symptoms of depression and other conditions, such as anxiety disorders. Suicidal thoughts and worsening of depression or anxiety disorders Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts may worsen at the start of treatment with antidepressants, as these medicines start to work usually after 2 weeks, sometimes later. These thoughts may also occur when reducing the dose or stopping treatment with venlafaxine. The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult. Clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the emergency department of the nearest hospital. It may be helpful to inform your family or friends about your depression or anxiety disorder and ask them to read this leaflet. You may ask your family or friends for help and ask them to inform you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your behavior. Dry mouth Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay special attention to oral hygiene. Diabetes Blood sugar levels may change when taking Venlafaxine Actavis. Therefore, it may be necessary to adjust the dosage of antidiabetic medicines. Sexual dysfunction Medicines like Venlafaxine Actavis (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Children and adolescents

Venlafaxine Actavis should not normally be used in children and adolescents under 18 years of age. It should be noted that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Venlafaxine Actavis to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Venlafaxine Actavis to a patient under 18 years of age and there are any doubts, you should consult the doctor. There is a lack of available data on the long-term safety of this medicine in this age group regarding growth, maturation, and cognitive and behavioral development.

Venlafaxine Actavis with other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Your doctor will decide whether it is possible to take Venlafaxine Actavis with other medicines. Do not start or stop taking other medicines, including those available without a prescription, herbal, or dietary supplements, without consulting your doctor or pharmacist first.

• Irreversible monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease must not be taken with Venlafaxine Actavis. You should inform your doctor if you have taken these medicines in the last 14 days. (IMAO: see "Important information before taking Venlafaxine Actavis")
• Serotonin syndrome:During treatment with venlafaxine, a life-threatening or neuroleptic malignant syndrome (NMS) may occur, especially when taken with other medicines (see "Important information before taking Venlafaxine Actavis").

Examples of such medicines include:

• triptans (used to treat migraine headaches)
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), noradrenaline and serotonin reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines
• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing the antibiotic linezolid (used to treat infections)
• medicines containing the MAO inhibitor moclobemide (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• medicines containing dextromethorphan (used to treat cough)
• medicines containing methadone (used to treat opioid addiction, narcotics, or severe pain)
• medicines containing methylene blue (used to treat high methemoglobin levels in the blood)
• medicines containing St. John's Wort (Hypericum perforatum, herbal or dietary supplements used to treat mild depression)
• medicines containing tryptophan (used for sleep problems and depression)
• antipsychotic medicines (used to treat conditions with symptoms such as seeing, hearing, or feeling things that are not there, delusions, unnatural suspicion, unclear thinking, and withdrawal)

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Its symptoms include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in blood tests). If serotonin syndrome is suspected, you should immediately tell your doctor or go to the emergency department of the nearest hospital.

Venlafaxine Actavis with food, drink, and alcohol

Venlafaxine Actavis should be taken with food (see section 3 "How to take Venlafaxine Actavis"). Do not drink alcohol while taking Venlafaxine Actavis. Taking it with alcohol may cause extreme fatigue and loss of consciousness, as well as worsen the 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 plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy Venlafaxine Actavis should only be used after discussing the potential benefits and risks to the unborn child with your doctor. You should inform your doctor and/or midwife about taking Venlafaxine Actavis. Taking medicines like Venlafaxine Actavis during pregnancy may increase the risk of severe complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, you should immediately contact the midwife and/or doctor. If you take this medicine during pregnancy, after the baby is born, in addition to breathing difficulties, other symptoms may occur, such as problems with sucking. If you are concerned about such symptoms in the newborn, you should contact the doctor and/or midwife, who will be able to provide proper advice. Taking Venlafaxine Actavis at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you take Venlafaxine Actavis, you should inform your doctor or midwife so that they can provide you with proper advice. Breastfeeding Venlafaxine Actavis passes into breast milk. There is a risk of affecting the baby. Therefore, you should discuss this with your doctor, and the doctor will decide whether to stop breastfeeding or discontinue this medicine.

Driving and using machines

You should not drive or operate machinery until you know how the medicine affects you.

Venlafaxine Actavis contains sucrose

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

Venlafaxine Actavis contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

Venlafaxine Actavis 37.5 mg also contains cochineal red (E 124)

The medicine may cause allergic reactions.

Venlafaxine Actavis 75 mg and 150 mg also contain orange yellow (E 110)

The medicine may cause allergic reactions.

3. How to take Venlafaxine Actavis

This medicine should always be taken as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist. The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, social anxiety disorder is 75 mg per day. This dose may be gradually increased by your doctor if necessary, up to a maximum dose of 375 mg per day in the case of depression. In the case of panic attacks, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day. Venlafaxine Actavis should be taken once a day, at approximately the same time, regardless of whether the medicine is taken in the morning or evening. The capsules should be swallowed whole with a drink of water, without dividing, crushing, chewing, or dissolving them. Venlafaxine Actavis should be taken with food. If you have liver or kidney problems, you should inform your doctor, as it may be necessary to adjust the dose. Do not stop taking this medicine without consulting your doctor (see "Stopping Venlafaxine Actavis").

Taking a higher dose of Venlafaxine Actavis than recommended

In case of overdose, you should immediately contact your doctor or pharmacist. Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Venlafaxine Actavis with other medicines"). Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures, and vomiting.

Missing a dose of Venlafaxine Actavis

If you forget to take a dose, you should take the next capsule as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose and take only one dose at the usual time. Do not take a double dose to make up for the missed dose. Do not take more than the daily dose of Venlafaxine Actavis prescribed by your doctor in one day.

Stopping Venlafaxine Actavis

You should not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Venlafaxine Actavis, they will tell you how to gradually reduce the dose before completely stopping treatment. In patients stopping this medicine, especially when treatment is stopped abruptly or the dose is reduced too quickly, side effects may occur. Some patients may experience symptoms such as suicidal thoughts, aggressive behavior, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, confusion, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, and changes in vision and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.). Your doctor will advise you on how to gradually stop taking Venlafaxine Actavis. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over a period of months or longer. If you experience any of the above symptoms or other symptoms that are troublesome to you, you should consult your doctor. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of the following side effects, you should stop taking Venlafaxine Actavis and immediately contact your doctor or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, throat, hands, or feet, and/or a raised, itchy rash (hives), difficulty swallowing or breathing.

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

• chest pain, wheezing, difficulty swallowing or breathing
• severe skin rash, itching, or hives (red or pale rash, often itchy)
• symptoms of serotonin syndrome, such as: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in blood tests).
• infection symptoms, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be the result of a blood disorder that increases the risk of infection.
• severe rash that can lead to severe blistering and peeling of the skin
• muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

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

• Symptoms of a condition called stress cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

You should tell your doctorif you experience other side effects, such as (the frequency of these side effects is listed below in the "Other side effects" section):

• cough, wheezing, shortness of breath, which may be accompanied by high fever
• black (tarry) stools or blood in stools, which may be a sign of internal bleeding
• itching, yellowing of the skin or eyes, dark urine, which may be symptoms of liver inflammation
• heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure
• eye disorders, such as blurred vision, dilated pupils
• nervous system disorders, such as dizziness, tingling, coordination disorders (muscle spasms or stiffness), seizures, or convulsions
• psychiatric disorders, such as excessive restlessness and unnatural excitement
• withdrawal symptoms (see "How to take Venlafaxine Actavis", "Stopping Venlafaxine Actavis")
• Prolonged bleeding time - in case of a cut, the wound may bleed slightly longer than usual.

During treatment with this medicine, you may notice small, white balls or granules in your stool.

The capsules of Venlafaxine Actavis contain granules (small, white balls) that contain the active substance, venlafaxine. These granules are released from the capsule into the digestive tract. As they pass through the stomach and intestines, the venlafaxine is slowly released from them. The skeleton of the granule does not dissolve and is excreted in the stool. Therefore, if you notice granules in your stool, the dose of the medicine has been absorbed.

Other side effects

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
• feeling confused, feeling detached (or separated) from oneself, lack of orgasm, decreased libido, restlessness, nervousness, unusual dreams
• tremors, feeling anxious or unable to sit or stand still, tingling, taste disorders, increased muscle tone
• vision disorders, such as blurred vision, dilated pupils
• ringing in the ears (tinnitus)
• rapid heartbeat, palpitations
• increased blood pressure, hot flashes
• shortness of breath, yawning
• vomiting, diarrhea
• mild diarrhea, itching
• increased frequency of urination, urinary retention, difficulty urinating
• menstrual disorders, such as heavy bleeding or more frequent irregular bleeding; ejaculation disorders and orgasm disorders (men), erectile dysfunction (impotence)
• weakness (asthenia), fatigue, chills
• weight gain, weight loss
• increased cholesterol levels

Uncommon (may affect up to 1 in 100 people)

• excessive activity, racing thoughts, and reduced need for sleep (mania)
• hallucinations, feeling detached (or separated) from reality, orgasm disorders, lack of feelings or emotions, feeling overly excited, teeth grinding
• fainting, involuntary muscle movements, coordination and balance disorders
• dizziness (especially when standing up too quickly), decreased blood pressure
• blood in vomit, black (tarry) stools, or blood in stools, which may be a sign of internal bleeding
• photosensitivity, bruising, excessive hair loss
• involuntary urination
• stiffness, muscle spasms, and involuntary muscle movements
• mild changes in liver enzyme activity in the blood

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

• seizures
• cough, wheezing, shortness of breath, which may be accompanied by high fever
• disorientation with frequent hallucinations (delirium)
• excessive water intake (known as SIADH)
• low sodium levels in the blood
• severe eye pain and vision changes or blurred vision
• abnormal, rapid, or irregular heartbeat, which can lead to fainting
• severe abdominal or back pain (which may indicate severe bowel, liver, or pancreas disorders)
• itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which are symptoms of liver inflammation

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

• prolonged bleeding, which may be a sign of low platelet count, indicating an increased risk of bruising or bleeding
• unusual milk production in women
• unexpected bleeding, such as bleeding from the gums, blood in urine or vomit, or unexpected bruising or broken blood vessels (broken veins)

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

• suicidal thoughts and behaviors; during treatment with venlafaxine or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Venlafaxine Actavis")
• aggressive behavior
• vertigo of labyrinthine origin
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in the "Pregnancy and breastfeeding" subsection in section 2.

Venlafaxine Actavis may sometimes cause side effects that you are not aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in sodium, cholesterol, or liver enzyme levels in the blood. Even more rarely, Venlafaxine Actavis may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, your doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Actavis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlafaxine Actavis

The medicine should be stored out of sight and reach of children. Do not take Venlafaxine Actavis after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Venlafaxine Actavis contains

• The active substance of the medicine is venlafaxine. One capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg, 75 mg, or 150 mg of venlafaxine.
• The other ingredients of the medicine are: sucrose spheres, hydroxypropylcellulose (HPC-LM), hypromellose (6 cps), talc, hypromellose (E-15), dibutyl sebacate, oleic acid, colloidal silica anhydrous, ethylcellulose (20 cP) Capsule shell:

37.5 mg: gelatin, sodium lauryl sulfate, dyes: cochineal red (E 124), quinoline yellow (E 104), titanium dioxide (E 171) 75 mg: gelatin, sodium lauryl sulfate, dyes: orange yellow (E 110), quinoline yellow (E 104), titanium dioxide (E 171) 150 mg: gelatin, sodium lauryl sulfate, dyes: orange yellow (E 110), quinoline yellow (E 104), patent blue (E 131), titanium dioxide (E 171)

What Venlafaxine Actavis looks like and contents of the pack

Venlafaxine Actavis 37.5 mg, prolonged-release hard capsules: white to almost white pellets in a size "3" capsule with an orange cap and a transparent body. Venlafaxine Actavis 75 mg, prolonged-release hard capsules: white to almost white pellets in a size "1" capsule with a yellow cap and a transparent body. Venlafaxine Actavis 150 mg, prolonged-release hard capsules: white to almost white pellets in a size "0" capsule with a light yellow cap and a transparent body. The prolonged-release hard capsules are available in PVC/Aluminum blisters. Pack sizes: 28 capsules packaged in blisters (PVC/Aluminum). 30 capsules packaged in blisters (PVC/Aluminum).

Marketing authorization holder

Actavis Group PTC ehf. Dalshraun 1 220 Hafnarfjörður Iceland

Manufacturer

Balkanpharma – Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa Bulgaria

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00. Date of last revision of the leaflet:February 2024.