Velaxin Er 37,5 mg

Leaflet attached to 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

You should carefully read the contents of the 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 doubts, you should 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 as yours.
• 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). Medicines in this group 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, when taken with Velaxin ER, may increase the risk of serotonin syndrome (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 anyone in their family has 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 while taking 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 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 Velaxin ER.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

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

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the nearest hospital emergency department.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the 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 affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.
Sexual dysfunction
Medicines like Velaxin ER (SNRIs) may cause symptoms of 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 noted that patients under 18 years of age who take medicines in 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 has prescribed Velaxin ER to a patient under 18 years of age, and there are any doubts, the doctor should be consulted again to discuss this. The doctor should be informed if any of the above symptoms occur or worsen in patients under 18 years of age taking Velaxin ER. Additionally, the long-term safety of Velaxin ER regarding its impact on growth, maturation, and cognitive and behavioral development in this age group has not been established.

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 venlafaxine treatment, 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 methylthioninium chloride (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 problems 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 reasoning, and withdrawal).

Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heart rate, 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 may include fever, rapid heart rate, sweating, muscle stiffness, disorientation, elevated muscle enzyme levels (detected in blood tests).

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

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);
• antihistamine medicines (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").
The patient should not drink alcohol while taking 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, 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 of the newborn, which causes rapid breathing and bluish discoloration. These symptoms usually occur within 24 hours of birth. 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 birth, 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 become irritable, restless, and have sleep disturbances. After stopping breastfeeding, withdrawal symptoms related to venlafaxine 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, which 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. If the patient has any doubts, they should consult their doctor or pharmacist.
Typically, the recommended initial dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. The doctor may gradually increase this dose 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 the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.
Velaxin ER should be taken once a day, 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 a dose adjustment may be necessary..
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 prescribed daily dose of Velaxin ER.

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 cessation or too rapid dose reduction, side effects may occur, 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, vision disturbances, and increased blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise 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 are bothersome to the patient, they should contact their doctor.
If the patient has any further doubts about taking this medicine, they 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 Velaxin ER treatment, 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 nearest hospital emergency department.

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 (swelling with a red or pale color, 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, 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 heart rate, sweating, muscle stiffness, disorientation, elevated muscle enzyme levels (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 may lead to 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 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 disturbances, such as rapid or irregular heartbeat, high blood pressure;
• Vision disturbances, such as blurred vision, dilated pupils;
• Nervous system disturbances, such as dizziness, tingling, coordination disturbances (muscle spasms or stiffness), seizures or convulsions;
• Psychiatric disturbances, such as excessive restlessness and feeling unnatural excitement;
• Withdrawal symptoms (see sections "How to take Velaxin ER" and "Stopping Velaxin ER treatment");
• Prolonged bleeding - in case of a cut, 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 (automatically change focus from distant to near objects);
• Ringing in the ears (tinnitus);
• Rapid heartbeat; palpitations;
• Increased blood pressure; flushing;
• Shortness of breath; yawning;
• Vomiting; diarrhea;
• Mild rash; itching;
• Increased urination frequency; 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;
• Increased cholesterol levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• Excessive excitement, racing thoughts, and reduced 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 (feces) 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 a reduced platelet count, increasing the risk of bruising or bleeding;
• Unusual milk secretion 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 venlafaxine treatment or shortly 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, occurring 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 increased 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 this 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.
Reporting side effects will help to gather more information on the safety of this 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., color change).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Velaxin ER contains

The active substance is venlafaxine.
Velaxin ER 37.5 mg: each prolonged-release capsule contains 37.5 mg of venlafaxine (corresponding to 42.42 mg of venlafaxine hydrochloride).
Velaxin ER 75 mg: each prolonged-release capsule contains 75 mg of venlafaxine (corresponding to 84.84 mg of venlafaxine hydrochloride).
Velaxin ER 150 mg: each prolonged-release capsule contains 150 mg of venlafaxine (corresponding 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 pack

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 an information leaflet.

Marketing authorization holder

PROTERAPIA Sp. 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