Symfaxin er: detailed information

Package leaflet: Information for the user

Symfaxin ER, 37.5 mg, prolonged-release capsules, hard
Symfaxin ER, 75 mg, prolonged-release capsules, hard
Symfaxin ER, 150 mg, prolonged-release capsules, hard
Venlafaxinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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

What Symfaxin ER is and what it is used for
What you need to know before taking Symfaxin ER
How to take Symfaxin ER
Possible side effects
How to store Symfaxin ER
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 medicine belonging to a group of medicines called
serotonin and noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are used in the treatment of depression and other conditions such as anxiety disorders. It is believed that people experiencing depression and/or anxiety have lower levels of serotonin and noradrenaline in the brain. The exact 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 important that treatment for depression and anxiety disorders is properly managed. If treatment is not initiated, the condition may not improve, may worsen, and may become more difficult to treat.

2. Important information before taking Symfaxin ER

When not to use 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 currently taking or has taken within the last 14 days any medicine from the group of irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with Symfaxin ER may cause severe or even life-threatening adverse reactions. Before starting treatment with any MAOI, the patient must wait at least 7 days after discontinuing Symfaxin ER (see also section

"Symfaxin ER and other medicines" and information in the same section regarding serotonin syndrome).
Warnings and precautions
Before starting treatment with Symfaxin ER, discuss this with your doctor or pharmacist:

If the patient is taking other medicines that, when used together with Symfaxin ER, may increase the risk of serotonin syndrome (see section "Symfaxin ER and other medicines").
If the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eyeball).
If the patient has previously had high blood pressure.
If the patient has previously had heart diseases.
If the patient has previously had cardiac arrhythmias.
If the patient has previously had seizures (epilepsy).
If the patient has previously had low sodium levels in the blood (hyponatremia).
If the patient is prone to bruising or bleeding (a history of blood clotting disorders), or if taking other medicines that may increase the risk of bleeding, e.g. warfarin (used as an anticoagulant).
If the patient is pregnant (see "Pregnancy and breastfeeding").
If the patient or anyone in their family has previously experienced mania (feelings of excessive excitement or euphoria) or bipolar disorder.
If the patient has previously exhibited aggressive behavior.

Symfaxin ER may cause feelings of restlessness or an inability to sit still or remain motionless during the first few weeks of treatment. If such symptoms occur, inform the treating physician.
Do not consume alcohol during treatment with Symfaxin ER, as it may cause extreme fatigue and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions, such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working.
The occurrence of suicidal thoughts or self-harm ideation is more likely if:

the patient has previously had suicidal thoughts or self-harm tendencies,
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who are being treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical attention by contacting a doctor or going to the nearest hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask relatives or friends for support and request them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behavior.
Dry mouth
Dry mouth was reported in 10% of patients treated with venlafaxine. It may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.
Diabetes
Symfaxin ER may alter blood glucose levels and therefore may necessitate adjustment of the dosage of antidiabetic medicines.
Medicines such as Symfaxin ER (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Symfaxin 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 adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and manifestations of anger). Nevertheless, a doctor may prescribe Symfaxin ER to patients under 18 years of age if they consider it beneficial. If Symfaxin ER has been prescribed to a patient under 18 years of age, any doubts should be discussed again with the doctor. Inform the doctor if any of these symptoms occur or worsen in patients under 18 years of age taking Symfaxin ER. The long-term safety of effects on growth, maturation, and cognitive and behavioral development in this age group has not yet been established.
Symfaxin ER and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
The treating physician will decide whether Symfaxin ER can be used together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, herbal remedies, or plant-derived preparations, without first consulting your doctor or pharmacist.

Monoamine oxidase inhibitors used in the treatment of depression or Parkinson's disease must not be taken with Symfaxin ER. Inform your doctor if these medicines were taken within the last 14 days (see section "Important information before taking Symfaxin ER").
Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or reactions resembling neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when used concomitantly with other medicines. Examples of such medicines include:
- triptans (substances used for migraine headaches);
- other medicines used to treat depression, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium;
- 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 methylene blue (used to treat high levels of methemoglobin in the blood);
medicines containing St. John's wort (Hypericum perforatum, herbal or plant-derived preparations used to treat mild depression);
medicines containing tryptophan (used for sleep problems and depression);
antipsychotic medicines (used to treat illnesses with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, and social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, coma, nausea, and vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome.
Its subjective and objective symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, and elevated muscle enzyme levels (detected in blood tests).
If serotonin syndrome is suspected, immediately inform your doctor or go to the nearest hospital.
If the patient is taking medicines that may affect heart rhythm, inform the doctor.
Examples of such medicines:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat cardiac arrhythmias);
antipsychotics such as thioridazine (see above - serotonin syndrome);
medicines used to treat bacterial infections, such as erythromycin or moxifloxacin;
antihistamines (used to treat allergies).

The following medicines may also interact with Symfaxin ER and therefore should be used with caution. It is especially important to inform your doctor or pharmacist if the patient is taking medicines containing:

ketoconazole (an antifungal medicine);
haloperidol or risperidone (medicines used to treat psychiatric disorders);
metoprolol (a beta-blocker used to treat high blood pressure and heart diseases).

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 consume alcohol during treatment with Symfaxin ER. Concurrent use with alcohol may cause extreme fatigue and loss of consciousness and may worsen symptoms of depression and other medical conditions, such as anxiety disorders.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Symfaxin ER should only be used after discussing with the doctor the potential benefits and risks for the unborn child.
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 newborns and (or) infants called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis. These symptoms usually occur within 24 hours after birth. If such symptoms are observed in the child, contact the midwife and (or) doctor immediately.
If the patient took this medicine during pregnancy, the newborn may experience, in addition to breathing difficulties, other symptoms such as abnormal sucking. If the patient is concerned about such symptoms in the newborn, contact the doctor and (or) midwife, who will be able to provide appropriate advice.
Taking Symfaxin ER late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Symfaxin ER, she should inform her doctor or midwife so they can provide appropriate advice.
Symfaxin ER passes into human milk. There is a risk of affecting the infant. Therefore, this issue should be discussed with the doctor, who will decide whether to discontinue breastfeeding or stop treatment with Symfaxin ER.
Driving and operating machinery
Do not drive or operate machinery until the effect of Symfaxin ER on the patient's body is known.
Symfaxin ER 150 mg contains Sunset Yellow FCF (E110)
Symfaxin ER 150 mg contains Sunset Yellow FCF (E110), which may cause allergic reactions.

3. How to take Symfaxin ER

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual starting dose for the treatment of depression, generalized anxiety disorders, and social phobia is 75 mg once daily. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg daily in the treatment of depression. For panic disorder, treatment should be initiated at a lower dose (37.5 mg), which may then be gradually increased. The maximum dose for the treatment of generalized anxiety disorders, social phobia, and panic disorder is 225 mg per day.

Symfaxin ER should be taken every day at approximately the same time, regardless of whether in the morning or evening. The capsules must be swallowed whole with liquid. Do not open, crush, chew, or dissolve the capsules.

Symfaxin ER should be taken with food.

Inform your doctor if you have any liver or kidney problems, as your dose may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section "Stopping Symfaxin ER").

Taking more Symfaxin ER than prescribed

If you take more Symfaxin ER than recommended, contact your doctor or pharmacist immediately.

Overdose can be life-threatening, especially when taken together with alcohol and/or certain other medicines (see section "Symfaxin ER and other medicines").

Symptoms of overdose may include rapid heartbeat, disturbances in consciousness (from drowsiness to coma), visual disturbances, seizures, and vomiting.

Missing a dose of Symfaxin ER

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take only your next 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 in a single day.

Stopping Symfaxin ER

Do not stop taking this medicine or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that treatment with Symfaxin ER can be discontinued, they will advise you on how to gradually reduce the dose before stopping completely.

Patients discontinuing treatment, especially after abrupt cessation or too rapid dose reduction, may experience adverse effects such as fatigue, dizziness, feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling sensations or electric shock-like feelings, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually discontinue Symfaxin ER. If any of the symptoms listed above, or other bothersome symptoms, occur, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue the medicine
Symfaxin ER and contact a doctor immediately or go to the nearest
hospital:
Uncommon (may occur in fewer than 1 in 100 people):

swelling of the face, lips, tongue, throat, hands or feet, and (or) raised, itchy rash (urticaria), difficulty swallowing or breathing.

Rare (may occur in fewer than 1 in 1000 people):

chest tightness, wheezing, difficulty swallowing or breathing,
severe skin rash, itching or urticaria (red or pale raised swelling, often 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, hyperreflexia, diarrhea, drowsiness, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome
(NMS). Symptoms of NMS may include fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected
in blood tests),
signs of infection such as high fever, chills, shaking, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection,
severe rash which may lead to formation of severe blisters and skin peeling,
muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

If any of the following adverse reactions occur, contact a doctor
(the frequency of these adverse reactions is listed below
under "Other adverse reactions"):

cough, wheezing and shortness of breath, possibly accompanied by high temperature,
black (tarry) stools or blood in the stool,
itching, yellowing of the skin or whites of the eyes, or dark urine, which may be signs of liver inflammation,
heart problems such as rapid or irregular heartbeat, elevated blood pressure,
vision disturbances such as blurred vision, dilated pupils,
nervous system disorders such as dizziness, tingling sensation, movement coordination disturbances (muscle spasms or stiffness), seizures or convulsions,
psychiatric disturbances such as excessive restlessness and feelings of unnatural excitement,
withdrawal symptoms (see sections "How to take Symfaxin ER", "Stopping treatment with Symfaxin ER"),
prolonged bleeding time – in case of cuts, wounds may bleed slightly longer than usual.

The coating of the mini-tablets is insoluble and is excreted in the feces. Therefore, it may
be visible in the stool. Do not be alarmed if small, insoluble parts of the capsule are visible in the stool after taking Symfaxin ER.
The dose of venlafaxine has been absorbed.
Other adverse reactions
Very common (may occur in more than 1 in 10 people):

dizziness, headache, drowsiness,
insomnia,
nausea, dry mouth, constipation,
sweating (including night sweats).

Common (may occur in fewer than 1 in 10 people):

decreased appetite,
confusion, feeling of detachment from oneself, anorgasmia, reduced sexual drive, agitation, nervousness, unusual dreams,
tremor, feeling of anxiety or inability to sit still or remain motionless, tingling, taste disturbances, increased muscle tension,
visual disturbances, including blurred vision, dilated pupils, inability of the eye to accommodate (automatic adjustment of visual focus),
ringing in the ears (tinnitus),
rapid heartbeat, palpitations,
increased blood pressure, sudden flushing,
shortness of breath, yawning,
vomiting, diarrhea,
mild rash, itching,
increased frequency of urination, urinary retention, problems with urination,
irregular menstruation, i.e. heavy bleeding or more frequent irregular bleeding; ejaculation/orgasm disorders (men), erectile dysfunction (impotence),
weakness (asthenia), fatigue, chills,
increased body weight, decreased body weight,
increased blood cholesterol levels.

Uncommon (may occur in fewer than 1 in 100 people):

excessive agitation, racing thoughts and reduced need for sleep (mania),
hallucinations, feeling of detachment from reality, orgasm disturbances, apathy, feeling of excessive excitement, teeth grinding,
fainting, uncontrolled muscle movements, disturbances in coordination and balance,
dizziness (especially upon standing up too quickly), decreased blood pressure,
vomiting blood; black tarry stools (feces) or blood in the stool, which may indicate internal bleeding,
light sensitivity, bruising, excessive hair loss,
urinary incontinence,
stiffness, spasms and uncontrolled muscle movements,
minor changes in liver enzyme activity in blood.

Rare (may occur in fewer than 1 in 1000 people):

convulsions,
cough, wheezing and shortness of breath, possibly accompanied by high temperature,
confusion and disorientation, often with accompanying hallucinations (delirium),
excessive fluid retention in the body (known as syndrome of inappropriate antidiuretic hormone secretion, SIADH),
decreased sodium concentration in blood,
severe eye pain and worsening 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 occur in fewer than 1 in 10,000 people):

prolonged bleeding, which may be a sign of reduced platelet count, indicating increased risk of bruising or bleeding,
unusual milk production in women,
unexpected bleeding, e.g. bleeding from gums, blood in urine or vomit, appearance of unexpected bruises or ruptured blood vessels (broken veins).

Frequency not known (cannot be estimated from available data):

suicidal thoughts and behaviors – during venlafaxine treatment or shortly after treatment discontinuation, cases of suicidal thoughts and behaviors have been reported (see section 2 "Important information before taking Symfaxin ER"),
severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2,
aggressive behavior,
dizziness.

Symfaxin ER may sometimes cause adverse reactions of which the patient may be unaware, such as increased blood pressure or abnormal heart function; minor changes in liver enzyme activity, blood sodium or cholesterol levels. In even rarer cases, Symfaxin ER may impair platelet function, increasing the risk of petechiae or bleeding. Therefore, the doctor may recommend periodic blood tests, especially during long-term treatment with Symfaxin ER.
Reporting adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Symfaxin ER

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

6. Contents of the pack and other information

What the medicine Symfaxin ER contains

The active substance is venlafaxine.
The other ingredients are:

Symfaxin ER, 37.5 mg, prolonged-release capsules, hard
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Capsule body:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red printing ink
Capsule cap:
Black iron oxide (E 172)
Red iron oxide (E 172)
Yellow iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red printing ink

Symfaxin ER, 75 mg, prolonged-release capsules, hard
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Capsule body and cap:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Red printing ink

Symfaxin ER, 150 mg, prolonged-release capsules, hard
Contents of the capsule (core):
Microcrystalline cellulose
Povidone K 90
Talc
Colloidal anhydrous silica
Magnesium stearate
Coating:
Ethylcellulose
Copovidone
Capsule body and cap:
Brilliant Blue FCF (E 133)
Allura Red AC (E 129)
Orange Yellow FCF (E 110)
Titanium dioxide (E 171)
Gelatin
White printing ink

What Symfaxin ER looks like and contents of the pack
Symfaxin ER, 37.5 mg prolonged-release capsules, hard
Hard, opaque gelatin capsules, light grey and peach in colour, with a thick and thin ring of red ink around the body and a thick and thin ring of red ink around the cap. The capsule contains 3 white or whitish, round, biconvex coated mini-tablets.

Symfaxin ER, 75 mg prolonged-release capsules, hard
Hard, opaque gelatin capsules, peach and peach in colour, with a thick and thin ring of red ink around the body and a thick and thin ring of red ink around the cap. The capsule contains 6 white or whitish, round, biconvex coated mini-tablets.

Symfaxin ER, 150 mg prolonged-release capsules, hard
Hard, opaque gelatin capsules, dark orange and dark orange in colour, with a thick and thin ring of white ink around the body and a thick and thin ring of white ink around the cap. The capsule contains 12 white or whitish, round, biconvex coated mini-tablets.

Symfaxin ER, 37.5 mg: 10, 28 and 30 capsules.
Symfaxin ER, 75 mg and 150 mg: 14, 28, 30 capsules.

The capsules are packed in blisters. Blisters are packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area (EEA) member states under the following names:
PL: Symfaxin ER