Simfaxin Er

Leaflet accompanying the packaging: information for the user

Symfaxin ER, 37.5 mg, prolonged-release hard capsules

Symfaxin ER, 75 mg, prolonged-release hard capsules

Symfaxin ER, 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 doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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 Symfaxin ER and what is it used for
• 2. Important information before taking Symfaxin ER
• 3. How to take Symfaxin ER
• 4. Possible side effects
• 5. How to store Symfaxin ER
• 6. Contents of the pack and other information

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

Symfaxin ER contains the active substance venlafaxine.
Symfaxin ER is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). These medicines are used to treat depression and other conditions, such as anxiety disorders. It is thought that in people with depression and/or anxiety, there is a lower level of serotonin and noradrenaline in the brain.
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.
Symfaxin ER is used to treat depression in adults. Symfaxin 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, it is essential that the treatment of depression and anxiety disorders is carried out properly. If the patient does not undergo treatment, their condition may not improve, it may worsen, and it will be much more difficult to treat.

2. Important information before taking Symfaxin ER

When not to take Symfaxin 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 medicines known as irreversible monoamine oxidase inhibitors (MAOIs), which are used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Symfaxin ER may cause serious or even life-threatening side effects. Before starting to take any MAOI medicine, the patient should also wait at least 7 days after stopping taking Symfaxin ER (see also section "Symfaxin ER and other medicines" and the information in that section about serotonin syndrome).

"Symfaxin ER and other medicines" and the information in that section about serotonin syndrome.

Warnings and precautions

Before starting to take Symfaxin ER, the patient should discuss it with their doctor or pharmacist:

• If the patient is taking other medicines that, when taken with Symfaxin ER, may increase the risk of developing serotonin syndrome (see section "Symfaxin 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 had high blood pressure in the past.
• If the patient has had heart disease in the past.
• If the patient has had arrhythmias in the past.
• If the patient has had seizures (epilepsy) in the past.
• If the patient has had low sodium levels in the blood (hyponatremia) in the past.
• If the patient has a tendency to bruise or bleed (a history of bleeding disorders), or if they are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If the patient is pregnant (see "Pregnancy and breastfeeding").
• If the patient or anyone in their family has had mania (a feeling of excessive excitement or euphoria) or bipolar disorder in the past.
• If the patient has had aggressive behavior in the past.

Symfaxin ER may cause a feeling of restlessness or an inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, the patient should inform their doctor.
The patient should not drink alcohol during treatment with Symfaxin ER, as it may cause extreme fatigue and loss of consciousness. Taking Symfaxin ER with alcohol and/or certain other medicines may increase the severity of 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 symptoms or behavior may worsen at the start of treatment with antidepressants, as these medicines start to work usually after 2 weeks, and sometimes later.
The risk of suicidal thoughts or self-harm is higher if:

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

If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the hospital immediately.
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 and if there are any 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, the patient should pay special attention to oral hygiene.
Diabetes
Symfaxin ER may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.
Medicines such as Symfaxin ER (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Symfaxin 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 of this class 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 Symfaxin ER to patients under 18 years of age if they consider it beneficial for them. If the doctor has prescribed Symfaxin ER to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor to discuss it. The patient should inform their doctor if any of these symptoms occur or worsen in patients under 18 years of age taking Symfaxin ER. The long-term safety of Symfaxin ER on growth, maturation, and cognitive and behavioral development in this age group has not been established.

Symfaxin ER and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
The doctor will decide whether to use Symfaxin ER with other medicines.
The patient should not start or stop taking other medicines, including those available without a prescription, herbal products, or dietary supplements, without consulting their doctor or pharmacist first.

• Monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, must not be taken with Symfaxin ER. The patient should tell their doctor if they have taken these medicines within the last 14 days (see section "Important information before taking Symfaxin 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 noradrenaline 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 (used to treat opioid dependence or severe pain);
• medicines containing methylthioninium chloride (methylene blue) (used to treat high methemoglobin levels in the blood);
• medicines containing St. John's Wort (Hypericum perforatum, herbal products 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 hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, withdrawal).

The subjective and objective symptoms of serotonin syndrome may include: 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 (NMS). The symptoms of NMS may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in blood tests),

In case of suspected serotonin syndrome, the patient should immediately tell their doctor or go to the hospital.

If the patient is taking medicines that may affect heart rhythm, they should tell their doctor. Examples of such medicines include:

• anti-arrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat arrhythmias);
• antipsychotic medicines, such as thioridazine (see above - serotonin syndrome);
• medicines used to treat bacterial infections, such as erythromycin or moxifloxacin;
• antihistamine medicines (used to treat allergies).

The following medicines may also interact with Symfaxin ER, and the patient should use them with caution. It is especially important to inform the doctor or pharmacist 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 Symfaxin ER with food, drink, and alcohol

Symfaxin ER should be taken with food (see section 3 "How to take Symfaxin ER").
The patient should not drink alcohol during treatment with Symfaxin ER. Taking Symfaxin ER with alcohol may cause extreme fatigue and loss of consciousness, as well as worsening of 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 baby, they should consult their doctor or pharmacist before taking this medicine. Symfaxin ER should only be used after discussing the potential benefits and risks to the unborn child with the doctor.
The patient should inform their doctor and/or midwife if they are taking Symfaxin ER. Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in children and/or infants, called persistent pulmonary hypertension of the newborn (PPHN), 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 contact the midwife and/or doctor immediately.
If the patient took this medicine during pregnancy, the newborn may experience difficulties with breathing or other symptoms, such as poor sucking. 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.
Taking Symfaxin ER at the end of pregnancy may increase the risk of severe bleeding from the uterus, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Symfaxin ER, they should inform their doctor or midwife so that they can provide appropriate advice.
Symfaxin ER passes into breast milk. There is a risk of affecting the child. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop Symfaxin ER treatment.

Driving and using machines

The patient should not drive or operate machinery until they know how Symfaxin ER affects them.

Symfaxin ER, 150 mg contains orange yellow S (E110)

Symfaxin ER, 150 mg contains orange yellow S (E110), which may cause allergic reactions.

3. How to take Symfaxin 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.
Typically, the recommended initial 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.
Symfaxin 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 opened, crushed, chewed, or dissolved.
Symfaxin ER should be taken with food.
The patient should inform their doctor about any 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 section "Stopping Symfaxin ER treatment").

Taking a higher dose of Symfaxin ER than recommended

In case of taking a higher dose of Symfaxin ER than recommended, the patient should immediately contact their doctor or pharmacist.
Overdose may be life-threatening, especially when taken with alcohol and/or certain other medicines (see section "Symfaxin ER and 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 Symfaxin ER

In case of missing a dose, the patient should take it as soon as possible. However, if it is almost time for the next dose, the patient 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 Symfaxin ER prescribed by their doctor in one day.

Stopping Symfaxin ER treatment

The patient should not stop treatment or reduce the dose of Symfaxin ER without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop taking Symfaxin ER, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients who stop taking the medicine, especially after sudden discontinuation or too rapid dose reduction, side effects may occur, such as fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or feeling of electric shock, weakness, sweating, seizures, or flu-like symptoms.
The doctor will advise how to gradually stop taking Symfaxin ER. If any of the above symptoms or other symptoms that are troublesome for the patient occur, they should consult 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, Symfaxin ER can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Symfaxin ER and contact their doctor immediately or go to the 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 breathing, which may be accompanied by a high temperature,
• severe skin rash, itching, or hives (red or pale rash, which may be accompanied by itching),
• symptoms of serotonin syndrome, which may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

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

• cough, wheezing, and shortness of breath, which may be accompanied by a high temperature,
• black (tar-like) stools or blood in the stool, which may be a sign of internal bleeding,
• itching, yellowing of the skin or whites of the eyes, or dark urine, which may be signs of liver inflammation,
• heart rhythm disorders, such as rapid or irregular heartbeat, elevated blood pressure,
• vision 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 a feeling of unnatural excitement,
• withdrawal symptoms (see sections "How to take Symfaxin ER" and "Stopping Symfaxin ER treatment"),
• prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

The coating of the minitablets is insoluble and is excreted in the stool. Therefore, it may be visible in the stool. The patient should not be concerned if they see small, insoluble parts of the capsule in their stool after taking Symfaxin ER. The dose of venlafaxine 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,
• disorientation, feeling of detachment (or separation) from oneself, lack of orgasm, decreased libido, agitation, nervousness, unusual dreams,
• tremors, feeling of restlessness or an inability 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, flushing,
• shortness of breath, yawning,
• vomiting, diarrhea,
• mild rash, itching,
• increased frequency of urination, urinary retention, difficulty urinating,
• irregular menstrual periods, i.e., heavy bleeding or more frequent irregular bleeding; ejaculation disorders / 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 decreased need for sleep (mania),
• hallucinations, feeling of detachment (or separation) from reality, orgasm disorders, apathy, feeling of excessive excitement, teeth grinding,
• fainting, uncontrolled muscle movements, coordination and balance disorders,
• 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 a sign of internal bleeding,
• increased sensitivity to light, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, muscle spasms, and uncontrolled muscle movements,
• minor 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 a high temperature,
• disorientation and confusion, often with accompanying hallucinations (delirium),
• excessive water retention in the body (known as inappropriate antidiuretic hormone secretion, SIADH),
• decreased sodium levels in the blood,
• severe eye pain and decreased vision 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 signs of liver inflammation.

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

• prolonged bleeding, which may be a sign of a decreased platelet count, indicating an increased risk of bruising or bleeding,
• unusual milk production in women,
• unexpected bleeding, e.g., bleeding from the gums, 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 Symfaxin ER"),
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy and breastfeeding" in section 2.
• aggressive behavior,
• dizziness.

Symfaxin ER may sometimes cause side effects that the patient is not aware of, such as increased blood pressure or abnormal heart rhythm; minor changes in liver enzyme activity, sodium levels, or cholesterol levels in the blood.
In rare cases, Symfaxin ER may affect platelet function, increasing the risk of bruising or bleeding. Therefore, the doctor may recommend a blood test from time to time, especially during long-term treatment with Symfaxin 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, tel.: +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 marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Symfaxin ER

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging and blister after: EXP.
The expiry date refers to the last day of the month stated.
The medicine should be stored in its original packaging to protect it from moisture.
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 pack and other information

What Symfaxin ER contains

• The active substance of Symfaxin ER is venlafaxine.
• The other ingredients are:

Symfaxin ER, 37.5 mg, prolonged-release hard capsules
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Body of the capsule:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red ink for printing
Cap of the capsule:
Black iron oxide (E 172)
Red iron oxide (E 172)
Yellow iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red ink for printing
Symfaxin ER, 75 mg, prolonged-release hard capsules
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Body and cap of the capsule:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red ink for printing
Symfaxin ER, 150 mg, prolonged-release hard capsules
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Body and cap of the capsule:
Brilliant blue FCF (E 133)
Allura red AC (E 129)
Orange yellow S (E 110)
Titanium dioxide (E 171)
Gelatin
White ink for printing

What Symfaxin ER looks like and contents of the pack

Symfaxin ER, 37.5 mg, prolonged-release hard capsules
Hard, non-transparent, grey-orange gelatin capsules with a thick and thin red ring on the body and a thick and thin red ring on the cap. The capsule contains 3 white or off-white, round, biconvex, film-coated minitablets.
Symfaxin ER, 75 mg, prolonged-release hard capsules
Hard, non-transparent, orange-orange gelatin capsules with a thick and thin red ring on the body and a thick and thin red ring on the cap. The capsule contains 6 white or off-white, round, biconvex, film-coated minitablets.
Symfaxin ER, 150 mg, prolonged-release hard capsules
Hard, non-transparent, dark orange-dark orange gelatin capsules with a thick and thin white ring on the body and a thick and thin white ring on the cap. The capsule contains 12 white or off-white, round, biconvex, film-coated minitablets.
Symfaxin ER, 37.5 mg: 10, 28, and 30 capsules.
Symfaxin ER, 75 mg and 150 mg: 14, 28, and 30 capsules.
The capsules are packaged in blisters. The blisters are packaged in cardboard boxes.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

PL: Symfaxin ER
Date of last revision of the leaflet:May 2025