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 this medicine, as it contains important information for you.

• You should keep this leaflet, so 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 for you only. 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 pack 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 norepinephrine 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 norepinephrine 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 phobia (fear or avoidance of social situations), and panic attacks (panic disorder). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly. 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 known as irreversible monoamine oxidase inhibitors (IMAOs), used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Venlafaxine Actavis may cause serious or life-threatening side effects. Also, before starting to take any IMAO medicine, you should wait at least 7 days after stopping your Venlafaxine Actavis treatment (see also "Venlafaxine Actavis with other medicines" and the information in this section about serotonin syndrome).

Actavis (see also "Venlafaxine Actavis with other medicines" and the information in this section about serotonin syndrome).

Warnings and precautions

Beforestarting treatment with 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 problems, such as certain types of glaucoma (increased pressure in the eye)
• if you have had high blood pressure in the past
• if you have had heart problems 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 severity 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 when starting antidepressant treatment, as these medicines usually start working after 2 weeks, sometimes later. These thoughts may also occur when reducing the dose or stopping venlafaxine treatment. The occurrence of suicidal thoughts is more likely if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age 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 can 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 patients under 18 years of age taking medicines of this class, they are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Venlafaxine Actavis to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Venlafaxine Actavis to a patient under 18 years of age and you have any doubts, you should consult your 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, 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 venlafaxine treatment, 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), serotonin and norepinephrine 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 levels of methemoglobin 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)

Symptoms of serotonin syndrome may include a combination of the following: 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 may 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.

You should inform your doctor if you are taking medicines that may affect your heart rhythm. Examples of such medicines include:

• antiarrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders)
• antipsychotic medicines, 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 Actavis and should be used with caution. It is especially important to inform your doctor if you are taking medicines containing:

• ketokonazole (an antifungal medicine)
• haloperidol or risperidone (medicines used to treat mental disorders)
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease)

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 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 ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Venlafaxine Actavis should only be used after discussing the potential benefits and risks with your doctor. You should inform your doctor and/or midwife about taking Venlafaxine Actavis. Taking Venlafaxine Actavis during pregnancy may increase the risk of severe complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually appear 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 appropriate 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 appropriate 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 your doctor will decide whether to stop breastfeeding or stop this treatment.

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 erythrosine (E 124)

The medicine may cause allergic reactions.

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

The medicine may cause allergic reactions.

3. How to take Venlafaxine Actavis

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, social phobia 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. For panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for generalized anxiety disorder, social phobia, 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. 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 treatment").

Taking a higher dose of Venlafaxine Actavis than recommended

If you have taken more than the recommended dose of the medicine, 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 have missed a dose, you should take the next capsule as soon as possible. However, if it is almost time for your 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 a missed dose. Do not take more than the recommended daily dose of Venlafaxine Actavis prescribed by your doctor.

Stopping Venlafaxine Actavis treatment

You should not stop taking this medicine 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. When stopping this medicine, especially if 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, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, as well as 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 these 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 any 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, which may be 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 may 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).
• symptoms of infection, 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, which may 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 known as stress cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

You should tell your doctorif you experience any 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 (tar-like) 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 feelings of unnatural excitement
• withdrawal symptoms (see sections "How to take Venlafaxine Actavis" and "Stopping Venlafaxine Actavis treatment")
• Prolonged bleeding time - in case of injury, 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.

The granules in the stool do not affect the action of the medicine.

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, agitation, nervousness, unusual dreams
• tremors, feeling restless or unable to sit or stand still, tingling, taste disorders, increased muscle tone
• vision disorders, including 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 decreased need for sleep (mania)
• hallucinations, feeling detached (or separated) from reality, orgasm disorders, lack of feelings or emotions, feeling excessively 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 (tar-like) stools, or blood in stools, which may be a sign of internal bleeding
• hypersensitivity to light, bruising, excessive hair loss
• involuntary urination
• stiffness, muscle spasms, and involuntary muscle movements
• slight 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)
• decreased sodium levels in the blood
• severe eye pain and vision disorders or blurred vision
• abnormal, rapid, or irregular heartbeat, which may lead to fainting
• severe abdominal or back pain (which may indicate severe disorders of the intestines, liver, or pancreas)
• 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 decreased platelet count, indicating an increased risk of bruising or bleeding
• unusual milk secretion in women
• unexpected bleeding, such as gum bleeding, 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 thoughts and behaviors; during venlafaxine treatment 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 vestibular origin
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in the "Pregnancy and breastfeeding" section 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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 use 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 pack 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 anhydrous silica, ethylcellulose (20 cP) Capsule shell:

37.5 mg: gelatin, sodium lauryl sulfate, dyes: erythrosine (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 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 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 transparent body. The prolonged-release hard capsules are available in PVC/Aluminum blisters. Pack sizes: 28 capsules in blisters (PVC/Aluminum). 30 capsules 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

For more information about this medicine and its authorized names in 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