SYMFAXIN 150 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
   1. Symfaxin ER, 75 mg, prolonged-release hard capsules
   2. Symfaxin ER, 150 mg, prolonged-release hard capsules
   3. You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.
   4. Contents of the leaflet
2. What Symfaxin ER is and what it is used for
3. Important information before taking Symfaxin ER
   1. When not to take Symfaxin ER:
   2. Warnings and precautions
   3. Children and adolescents
   4. Symfaxin ER with other medicines
   5. If you suspect serotonin syndrome, you should contact your doctor or go to the hospital immediately.
   6. Taking Symfaxin ER with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Symfaxin ER, 150 mg contains orange yellow S (E110)
4. How to take Symfaxin ER
   1. Taking more Symfaxin ER than prescribed
   2. Missing a dose of Symfaxin ER
   3. Stopping Symfaxin ER treatment
5. Possible side effects
   1. Uncommon (may affect up to 1 in 100 people):
   2. Rare (may affect up to 1 in 1,000 people):
   3. The capsule shell is insoluble and is eliminated in the feces. Therefore, it may be visible in the stool. You should not be concerned if you see small, insoluble parts of the capsule in your stool after taking Symfaxin ER. The venlafaxine dose
   4. Other side effects
   5. Very common (may affect more than 1 in 10 people):
   6. Common (may affect up to 1 in 10 people):
   7. Uncommon (may affect up to 1 in 100 people):
   8. Rare (may affect up to 1 in 1,000 people):
   9. Very rare (may affect up to 1 in 10,000 people):
   10. Frequency not known (cannot be estimated from the available data):
   11. Reporting side effects
6. How to store Symfaxin ER
7. Contents of the pack and other information
   1. What Symfaxin ER contains
   2. What Symfaxin ER looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

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 this medicine, as it contains important information for you.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

• 1. What Symfaxin ER is and what it is 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 Symfaxin ER is and what it is 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 used to treat the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (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 correctly. 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 Symfaxin ER

When not to take Symfaxin ER:

• 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, any medicines known as irreversible monoamine oxidase inhibitors (IMAOs), which are used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Symfaxin ER may cause serious or even life-threatening side effects. Before starting any MAOI, you should wait at least 7 days after stopping your Symfaxin ER treatment (see also section "Symfaxin ER with other medicines" and the information in that section about serotonin syndrome).

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

Warnings and precautions

Before starting treatment with Symfaxin ER, 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 Symfaxin ER (see section "Symfaxin ER 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 rhythm disorders in the past.
• 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 (a history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If you are pregnant (see "Pregnancy and breastfeeding").
• If you or anyone in your family has had mania (a feeling of excessive excitement or euphoria) or bipolar disorder in the past.
• If you have 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, you should inform your doctor.
Do 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 risk of side effects, such as worsening 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:

• you have had suicidal thoughts or self-harm in the past,
• you are a young adult; clinical trial data indicate an increased risk of suicidal behavior in young adults with psychiatric disorders treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.
It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask your relatives or friends to tell you if they notice that your depression or anxiety has worsened and if you have any disturbing changes in your behavior.
Dry mouth
Dry mouth was reported by 10% of patients treated with venlafaxine. It may increase the risk of tooth decay. Therefore, you 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 your antidiabetic medicines.
Medicines like 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 suicide attempts, suicidal thoughts, and hostility (especially aggression, rebelliousness, and anger). However, your doctor may prescribe Symfaxin ER to patients under 18 years of age if they consider it to be beneficial. If your doctor has prescribed Symfaxin ER to a patient under 18 years of age, and you have any concerns, you should discuss them with your doctor. You should inform your 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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Your doctor will decide whether you can take Symfaxin ER with other medicines.
Do not start or stop taking other medicines, including those available without a prescription, herbal products, or dietary supplements, without consulting your doctor or pharmacist first.

• Irreversible monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, must not be taken with Symfaxin ER. Tell your doctor if you have taken these medicines in the last 14 days (see section "Important information before taking Symfaxin ER").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or neuroleptic malignant syndrome (NMS)-like reactions 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 the MAO inhibitor moclobemide (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 methylene blue (used to treat high levels of methemoglobin 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 suspiciousness, unclear thinking, and withdrawal).

The 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, 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 heart rate, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in blood tests),

If you suspect serotonin syndrome, you should contact your doctor or go to the hospital immediately.

If you are taking medicines that may affect your heart rhythm, you should tell your 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);
• 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 you should use them with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• ketokonazole (an antifungal medicine);
• haloperidol or risperidone (medicines used to treat psychiatric 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").
Do 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 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 baby, ask your doctor or pharmacist for advice before taking this medicine. Symfaxin ER should only be used after discussing the potential benefits and risks to the unborn child with your doctor.
You should inform your doctor and/or midwife if you 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 you notice such symptoms in your child, you should contact the midwife and/or doctor immediately.
If you have taken this medicine during pregnancy, your newborn baby may experience withdrawal symptoms, such as difficulty feeding, which you should discuss with your doctor and/or midwife.
Taking Symfaxin ER at the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Symfaxin ER, you should inform your doctor or midwife so that they can provide you with appropriate advice.
Symfaxin ER passes into breast milk. There is a risk to the baby. You should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop Symfaxin ER treatment.

Driving and using machines

Do not drive or operate machinery until you know how Symfaxin ER affects you.

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 your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended starting dose for depression, generalized anxiety disorder, and social anxiety disorder is 75 mg once daily. Your doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg once daily for 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 anxiety disorder, 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. Do not open them, crush them, chew them, or dissolve them.
Symfaxin ER should be taken with food.
You should inform your doctor about any liver or kidney problems, as it may be necessary to adjust the dose.
Do not stop taking this medicine without consulting your doctor (see section "Stopping Symfaxin ER treatment").

Taking more Symfaxin ER than prescribed

If you have taken more Symfaxin ER than prescribed, you should contact your doctor or pharmacist immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section "Symfaxin ER with other medicines").
Symptoms of possible overdose may include rapid heart rate, changes in consciousness (from drowsiness to coma), visual disturbances, seizures, and vomiting.

Missing a dose of Symfaxin ER

If you miss a dose, you should take it 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 prescribed daily dose of Symfaxin ER.

Stopping Symfaxin ER treatment

Do not stop taking this medicine without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Symfaxin ER, they will tell you how to gradually reduce the dose before stopping treatment completely. When stopping treatment, especially after sudden discontinuation or too rapid dose reduction, you may experience side effects, such as fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling, or electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually stop taking Symfaxin ER. If you experience any of these symptoms or other symptoms that are bothersome 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.
If you experience any of the following side effects, you should stop taking Symfaxin ER and contact your doctor or go to the hospital immediately:

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 (a red or pale raised rash, which may be itchy),
• symptoms of serotonin syndrome, which may include: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

If you experience any of the following side effects, you should contact your doctor:

• cough, wheezing, and shortness of breath, which may be accompanied by a high temperature,
• black (tar-like) stools or blood in stools, 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, high blood pressure,
• vision disturbances, such as blurred vision, dilated pupils,
• nervous system disorders, such as dizziness, tingling, coordination problems (muscle spasms or stiffness), seizures or convulsions,
• psychiatric disorders, such as excessive restlessness and 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 capsule shell is insoluble and is eliminated in the feces. Therefore, it may be visible in the stool. You should not be concerned if you see small, insoluble parts of the capsule in your stool after taking Symfaxin ER. The venlafaxine dose

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, excitement, nervousness, unusual dreams,
• tremors, feeling of restlessness or inability to sit or stand still, tingling, taste disturbances, increased muscle tone,
• vision disturbances, 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, urination problems,
• irregular menstrual periods, i.e., heavy or more frequent irregular bleeding; ejaculation or orgasm disorders (men), erectile dysfunction (impotence),
• weakness, 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 problems,
• dizziness (especially when standing up too quickly), decreased blood pressure,
• vomiting blood; black (tar-like) stools or blood in stools, 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,
• 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 a high temperature,
• disorientation and confusion, often with accompanying hallucinations (delirium),
• inappropriate secretion of antidiuretic hormone (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 may be signs 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, increasing the risk of bruising or bleeding,
• unusual milk secretion in women,
• unexpected bleeding, such as 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 venlafaxine treatment or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Symfaxin ER"),
• severe postpartum hemorrhage (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.
• aggressive behavior,
• dizziness.

Symfaxin ER may also cause side effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight 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, your doctor may recommend regular blood tests, especially during long-term treatment with Symfaxin ER.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. 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 Warszawa, 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, you can help provide more information on the safety of this medicine.

5. How to store Symfaxin ER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Symfaxin ER contains

• The active substance is venlafaxine.
• The other ingredients are:

Symfaxin ER, 37.5 mg, prolonged-release hard capsules
Core of the capsule:
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
Core of the capsule:
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
Core of the capsule:
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 pellets.
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 pellets.
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 pellets.
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 Warszawa

Importer

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

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