Velaxin Er 150 mg

Leaflet accompanying the packaging: information for the user

Velaxin ER 37.5 mg, prolonged-release hard capsules

Velaxin ER 75 mg, prolonged-release hard capsules

Velaxin ER 150 mg, prolonged-release hard capsules

Venlafaxine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Velaxin ER and what is it used for

Velaxin ER contains the active substance venlafaxine. Velaxin ER is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are used to treat depression and other conditions such as anxiety disorders. It is believed that in people with depression and/or anxiety, there is a lower concentration of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration of serotonin and norepinephrine in the brain. Velaxin ER is used to treat depression in adults. Velaxin ER 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 disorder (panic attacks). For the patient to feel better, treatment of depression and anxiety disorders should be carried out properly. If the patient does not undergo treatment, their condition may not improve, may worsen, and will be much more difficult to treat.

2. Important information before taking Velaxin ER

When not to take Velaxin ER

• if the patient is allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking or has taken within the last 14 days any irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Velaxin ER may cause serious or life-threatening side effects.

Also, before starting to take any irreversible MAOI, the patient should wait at least 7 days after stopping Velaxin ER (see also "Velaxin ER and other medicines").

Warnings and precautions

Before starting Velaxin ER, the patient should discuss the following with their doctor or pharmacist:

• if the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Velaxin ER (see "Velaxin ER and other medicines");
• if the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball);
• if the patient has a history of high blood pressure;
• if the patient has a history of heart disease;
• if the patient has a history of heart rhythm disorders;
• if the patient has a history of seizures (epilepsy);
• if the patient has a history of decreased sodium levels in the blood (hyponatremia);
• if the patient has a tendency to bruise or bleed (bleeding disorders), or if they are taking other medicines that may increase the risk of bleeding, such as warfarin (used as an anticoagulant), or if the patient is pregnant (see "Pregnancy and breastfeeding");
• if the patient or any of their family members have a history of mania (feeling excessively excited or euphoric) or bipolar disorder;
• if the patient has a history of aggressive behavior.

Velaxin ER may cause feelings of restlessness or inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, the patient should inform their doctor. Do not drink alcohol during treatment with Velaxin ER, as it may cause extreme fatigue and loss of consciousness. Concurrent use with alcohol and/or certain medicines may exacerbate symptoms of depression and other conditions, such as anxiety disorders. Suicidal thoughts and worsening of depression or anxiety disorders People 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 usually start working after 2 weeks, sometimes later. These thoughts may also occur when reducing the dose or stopping Velaxin ER. The occurrence of suicidal thoughts is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who are being treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the emergency room. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform the doctor if they notice that depression or anxiety has worsened or if there are worrying changes in behavior. Dry mouth Dry mouth was reported by 10% of patients treated with venlafaxine. It may increase the risk of tooth decay. Therefore, special attention should be paid to oral hygiene. Diabetes Velaxin ER may change blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines. Sexual dysfunction Medicines like Velaxin ER (SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment. Children and adolescents Velaxin ER should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age who take medicines from this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe Velaxin ER to patients under 18 years of age if they consider it beneficial. If the doctor prescribes Velaxin ER to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor to discuss this. The patient should inform their doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Velaxin ER. There is also no evidence of long-term safety regarding the impact on growth, maturation, and development of cognitive and behavioral functions in this age group.

Velaxin ER and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor will decide whether to use Velaxin ER with other medicines. The patient should not start or stop taking other medicines, including over-the-counter medicines, herbal or plant-based medicines, without first talking to their doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Velaxin ER.The patient should tell their doctor if they have taken these medicines within the last 14 days (MAOIs: see "Important information before taking Velaxin ER").
• Serotonin syndrome: During treatment with venlafaxine, a life-threatening or neuroleptic malignant syndrome-like reaction may occur, especially when taken with other medicines. 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 moclobemide, an MAO inhibitor (used to treat depression);
• medicines containing sibutramine (used for weight loss);
• medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain);
• medicines containing dextromethorphan (used to treat cough);
• medicines containing methadone or buprenorphine (used to treat opioid dependence 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 plant-based medicines, used to treat mild depression);
• medicines containing tryptophan (used for sleep disorders and depression);
• antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, and withdrawal).

Subjective and objective symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, hyperactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Its subjective and objective symptoms include fever, rapid heart rate, sweating, muscle stiffness, disorientation, elevated enzyme levels in the muscles (detected in blood tests).

In case of suspected serotonin syndrome, the patient should immediately contact their doctor or go to the emergency room.

If the patient is taking medicines that may affect heart rhythm, they should tell their doctor. 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 above - serotonin syndrome);
• antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections);
• antihistamines (used to treat allergies).

The following medicines may also interact with Velaxin ER, and the patient should use them with caution. It is especially important to inform the doctor if the patient is 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).

Taking Velaxin ER with food, drink, and alcohol

Velaxin ER should be taken with food (see section 3 "How to take Velaxin ER"). Do not drink alcohol during treatment with Velaxin ER. Concurrent use with alcohol may cause extreme fatigue and loss of consciousness, as well as exacerbate symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Velaxin ER should only be used after discussing the potential benefits and risks to the unborn child with the doctor. Taking Velaxin ER at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Velaxin ER, they should inform their doctor or midwife so that they can provide appropriate advice. Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension, which causes rapid breathing and bluish discoloration. These symptoms usually occur within 24 hours of delivery. If the patient notices such symptoms in their child, they should immediately contact their midwife and/or doctor. If the patient is taking this medicine during pregnancy, after delivery, the child may experience, in addition to breathing difficulties, other symptoms such as poor feeding. If the patient is concerned about such symptoms in their newborn, they should contact their doctor and/or midwife, who will be able to provide appropriate advice. Velaxin ER passes into breast milk. There is a risk of affecting the child. The infant may be irritable, restless, and have sleep disturbances. After stopping breastfeeding, symptoms of venlafaxine withdrawal have also been reported. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop Velaxin ER treatment.

Driving and using machines

The patient should not drive or operate machinery until they know how the medicine affects them. Velaxin ER contains sodium The 37.5 mg and 75 mg Velaxin ER capsules contain less than 1 mmol (9 mg and 18 mg, respectively) of sodium per capsule, which means the medicine is essentially "sodium-free". The 150 mg Velaxin ER capsule contains 36 mg of sodium (the main component of common salt) per capsule. This corresponds to 1.8% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Velaxin ER

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg once daily. The doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg once daily in the case of depression. For the treatment of panic disorder, 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 phobia, and panic disorder is 225 mg once daily. Velaxin ER should be taken once daily, at approximately the same time, regardless of whether it is morning or evening. The capsules should be swallowed whole with a drink of water. They should not be divided, crushed, chewed, or dissolved. Velaxin ER should be taken with food. The patient should inform their doctor if they have liver or kidney problems, as it may be necessary to adjust the dose. The patient should not stop taking this medicine without consulting their doctor (see "Stopping Velaxin ER treatment").

Taking a higher dose of Velaxin ER than recommended

In case of taking a higher dose of Velaxin ER than recommended, the patient should immediately contact their doctor. Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Velaxin ER and other medicines"). Symptoms of possible overdose may include rapid heart rate, changes in consciousness (from drowsiness to coma), vision disturbances, seizures, and vomiting.

Missing a dose of Velaxin ER

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and take only one dose at the usual time. The patient should not take a double dose to make up for the missed dose. The patient should not take more than the daily dose of Velaxin ER prescribed by their doctor in a 24-hour period.

Stopping Velaxin ER treatment

The patient should not stop treatment or reduce the dose without talking to their doctor, even if they feel better. If the doctor decides that it is possible to stop Velaxin ER, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients who stop treatment, especially after sudden discontinuation or too rapid dose reduction, side effects may occur, such as suicidal thoughts, aggressive behavior, fatigue, dizziness, headache, feeling empty-headed, 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, vision disturbances, and elevated blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.). The doctor will advise the patient on how to gradually stop Velaxin ER. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very slowly over a period of several months or longer. If any of the above symptoms occur or worsen, the patient should contact their doctor. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Velaxin ER can cause side effects, although not everybody gets them. During treatment with Velaxin ER, the patient may notice small, white granules or balls in their stool. Inside the Velaxin ER capsules, there are granules or small, white balls that contain the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract, passing through its entire length, gradually releasing venlafaxine. The skeleton of the granules does not dissolve and is excreted in the stool. Therefore, even if the patient notices granules in their stool, the venlafaxine dose has been absorbed. If the patient experiences any of the following side effects, they should stop taking Velaxin ER and immediately contact their doctor or go to the emergency room.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, throat, hands, or feet, and (or) a swollen, itchy rash (hives), 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 (a red or pale rash, often accompanied by itching);
• Serotonin syndrome symptoms, which may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, hyperactivity, 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 heart rate, sweating, muscle stiffness, disorientation, elevated enzyme levels in the muscles (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, which may lead to the formation of severe blisters and skin peeling;
• Muscle pain of unknown origin, 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.

In case of experiencing any of the following side effects, the patient should contacttheir doctor (the frequency of these side effects is listed below in the "Other side effects" section):

• Cough, wheezing, and shortness of breath, which may be accompanied by high fever;
• Black (tar-like) stools or blood in the stool;
• Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation;
• Heart rhythm disorders, such as rapid or irregular heartbeat, elevated blood pressure;
• Vision disturbances, such as blurred vision, dilated pupils;
• Nervous system disorders, such as dizziness, tingling, coordination disturbances (muscle spasms or stiffness), seizures or convulsions;
• Psychiatric disorders, such as excessive restlessness and feeling unnatural excitement;
• Withdrawal symptoms (see sections "How to take Velaxin ER" and "Stopping Velaxin ER treatment");
• Prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

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;
• Disorientation; 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 disturbances; increased muscle tone;
• Vision disturbances, including blurred vision; dilated pupils; inability of the eye to accommodate (automatic change of focus from distant to near objects);
• Ringing in the ears (tinnitus);
• Rapid heartbeat; palpitations;
• Elevated blood pressure; flushing;
• Shortness of breath; yawning;
• Vomiting; diarrhea;
• Mild rash; itching;
• Increased frequency of urination; urinary retention; urination problems;
• Irregular menstrual bleeding, i.e., heavy or more frequent irregular bleeding;
• Ejaculation or orgasm disorders (men); erectile dysfunction (impotence);
• Weakness (asthenia); fatigue; chills;
• Weight gain; weight loss;
• Elevated cholesterol levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• Excessive excitement, racing thoughts, and decreased need for sleep (mania);
• Hallucinations; feeling detached (or separated) from reality; orgasm disorders; apathy; feeling excessively excited; teeth grinding;
• Fainting; uncontrolled muscle movements; coordination and balance disturbances;
• Dizziness (especially when standing up too quickly); decreased blood pressure;
• Vomiting blood; black (tar-like) stools or blood in the stool, which may be signs of internal bleeding;
• Sensitivity to light; bruising; excessive hair loss;
• Urinary incontinence;
• Stiffness, muscle spasms, and uncontrolled muscle movements;
• Slight changes in liver enzyme activity in the blood.

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

• Seizures;
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever;
• Disorientation and confusion, often with accompanying hallucinations (delirium);
• Excessive water retention in the body (known as SIADH, syndrome of inappropriate antidiuretic hormone hypersecretion);
• Decreased sodium levels in the blood;
• Severe eye pain and vision disturbances or blurred vision;
• Abnormal, rapid, or irregular heartbeat, which may lead to fainting;
• Severe abdominal or back pain (which may indicate serious intestinal, liver, or pancreatic problems);
• Itching, yellowing of the skin or whites of the eyes, dark urine, or flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

Very rare (may affect less than 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 production in women;
• Unexpected bleeding, such as gum bleeding, blood in the 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 treatment with venlafaxine or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Velaxin ER");
• Aggressive behavior;
• Dizziness;
• Severe postpartum hemorrhage, which occurs shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Velaxin ER may sometimes cause side effects that the patient is not aware of, such as elevated blood pressure or abnormal heart function; slight changes in liver enzyme activity, sodium levels, or cholesterol levels in the blood. In rare cases, Velaxin ER may affect platelet function, increasing the risk of bruising or bleeding. Therefore, the doctor may recommend regular blood tests, especially during long-term treatment with Velaxin ER.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the representative of the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Velaxin ER

Do not store above 30°C. Store in the original packaging to protect from moisture. Store out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Do not use this medicine if visible signs of deterioration are observed (e.g., change in color). Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Velaxin ER contains

The active substance of Velaxin ER is venlafaxine. Velaxin ER 37.5 mg: each prolonged-release capsule contains 37.5 mg of venlafaxine (which corresponds to 42.42 mg of venlafaxine hydrochloride). Velaxin ER 75 mg: each prolonged-release capsule contains 75 mg of venlafaxine (which corresponds to 84.84 mg of venlafaxine hydrochloride). Velaxin ER 150 mg: each prolonged-release capsule contains 150 mg of venlafaxine (which corresponds to 169.68 mg of venlafaxine hydrochloride). The other ingredients are: Velaxin ER 37.5 mg Microcrystalline cellulose, sodium chloride, ethyl cellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172). Capsule shell composition: erythrosine (E 127), indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin. Velaxin ER 75 mg Microcrystalline cellulose, sodium chloride, ethyl cellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172). Capsule shell composition: red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin. Velaxin ER 150 mg Microcrystalline cellulose, sodium chloride, ethyl cellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172). Capsule shell composition: red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Velaxin ER looks like and contents of the packaging

Velaxin ER 37.5 mg Hard gelatin capsules: orange cap, colorless body. Velaxin ER 75 mg Hard gelatin capsules: red cap, colorless body. Velaxin ER 150 mg Hard gelatin capsules: red cap, colorless body. The packaging contains 28 (2 x 14) or 30 (3 x 10) prolonged-release capsules (37.5 mg, 75 mg, and 150 mg) in a PVC/PVDC/Aluminum blister pack and a cardboard box with a patient information leaflet.

Marketing authorization holder

PROTERAPIA Spółka z o.o. ul. Komitetu Obrony Robotników 45 D 02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC 1165 Budapest, Bökényföldi út 116-120. Hungary EGIS Pharmaceuticals PLC 9900 Körmend Mátyás király u. 65 Hungary

Date of last revision of the leaflet: 28.04.2023