Faxolet Er

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the user

Faxolet ER, 37.5 mg, prolonged-release hard capsules

Faxolet ER, 75 mg, prolonged-release hard capsules

Faxolet ER, 150 mg, prolonged-release hard capsules

(venlafaxine)

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

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

Table of contents of the leaflet:

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

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

Faxolet ER contains the active substance venlafaxine.
Faxolet 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.
Faxolet ER is used to treat depression in adults. Faxolet ER is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia, 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 treatment is not started, the patient's condition may not improve and may worsen, making it more difficult to treat.

2. Important information before taking Faxolet ER

When not to take Faxolet 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 Faxolet ER may cause severe or life-threatening side effects. Before starting to take any MAOI, the patient should wait at least 7 days after stopping Faxolet ER (see also "Faxolet ER and other medicines" and the information in this section on serotonin syndrome).

Warnings and precautions

Before starting treatment with Faxolet ER, the patient should discuss it with their doctor or pharmacist.

• If the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Faxolet ER (see "Faxolet 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 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 in the past), or if they are taking 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 or bipolar disorder (feeling overly excited or euphoric).
• If the patient has a history of aggressive behavior.

Faxolet 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.
Medicines like Faxolet ER (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

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 usually start working after 2 weeks, sometimes later. Such thoughts may also occur when the dose is reduced or when treatment with Faxolet ER is stopped.
Suicidal thoughts are more likely to occur 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 adults under 25 with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the emergency room immediately.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read the 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 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, special attention should be paid to oral hygiene.
Diabetes
Faxolet ER may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.

Children and adolescents

Faxolet 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 expressions of anger). However, the doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial.
If the doctor has prescribed this medicine to a patient under 18 years of age, in case of any doubts, the patient should discuss it with their doctor again. The doctor should be informed if any of the above symptoms occur or worsen in patients under 18 years of age taking Faxolet ER. So far, no long-term safety data are available on the effects on growth, maturation, and development of cognitive and behavioral functions in this age group.

Faxolet 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 Faxolet ER with other medicines.
The patient should not start or stop taking other medicines, including over-the-counter medicines, herbal or natural remedies, without first consulting their doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease cannot be taken with Faxolet ER. The patient should tell their doctor if they have taken these medicines within the last 14 days (MAOIs; see "Important information before taking Faxolet ER").
• Serotonin syndrome:During treatment with venlafaxine, serotonin syndrome may occur, a potentially life-threatening condition, or malignant neuroleptic syndrome (see section "Possible side effects"), especially when taken with other medicines. Examples of such medicines:
• triptans (substances used to treat migraine headaches)
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), norepinephrine and serotonin 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 buprenorphine or 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, a natural, herbal remedy used to treat mild depression)
• medicines containing tryptophan (used for sleep problems and depression).
• Antipsychotic medicines (used to treat diseases with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear reasoning, withdrawal).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. The symptoms of malignant neuroleptic syndrome may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in a blood test).

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

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

• 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 Faxolet ER and should be used 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 Faxolet ER with food, drink, and alcohol

Faxolet ER should be taken with food (see section 3 "How to take Faxolet ER")
The patient should avoid drinking alcohol during treatment with Faxolet ER.

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.
Faxolet ER should only be used after discussing the potential benefits and potential risks to the unborn child with the doctor.
The patient should ensure that their midwife and/or doctor are informed about their use of Faxolet ER. Taking similar medicines (SSRIs) during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension (PPHN) in the newborn, causing the baby to breathe rapidly and turn blue. These symptoms usually appear within the first day of life. If they occur in the baby, the patient should contact their midwife and/or doctor immediately.
If the patient takes this medicine during pregnancy, after birth, the baby may experience, in addition to breathing difficulties, other symptoms such as difficulty feeding. If the patient notices such symptoms in their newborn and is concerned, they should contact their doctor and/or midwife, who will be able to provide appropriate advice.
Taking Faxolet ER at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Faxolet ER, they should inform their doctor or midwife so that they can provide appropriate advice.
Venlafaxine passes into breast milk. There is a risk of affecting the baby.
Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

The patient should not drive or operate machinery until they know how the medicine affects them.

Faxolet ER contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Faxolet 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.
Usually, the recommended initial dose for the treatment of depression, generalized anxiety disorder, social phobia is 75 mg per day. The doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg per day in the case of depression. In the case 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 per day.
Faxolet ER should be taken once a day, at approximately the same time, either in the morning or in the evening. The capsules should be swallowed whole with a drink of water. They should not be divided, crushed, chewed, or dissolved.
Faxolet 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 Faxolet ER without consulting their doctor (see "Stopping treatment with Faxolet ER").

Taking a higher dose of Faxolet ER than recommended

In case of taking a higher dose of Faxolet ER than recommended, the patient should immediately contact their doctor.
Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures, or vomiting.

Missing a dose of Faxolet 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 a higher dose in one day than the daily dose of Faxolet ER prescribed by their doctor.

Stopping treatment with Faxolet ER

The patient should not stop treatment or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop taking Faxolet ER, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients who stop taking this medicine, especially if treatment is stopped abruptly or the dose is reduced too quickly, 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, or sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms, changes in vision, and increased blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise the patient on how to gradually stop taking Faxolet 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 if the patient experiences other symptoms that are troublesome, they should consult their doctor.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Faxolet ER can cause side effects, although not everybody gets them.
In case of experiencing any of the following side effects, the patient should stop taking Faxolet ER and contact their doctor immediately or go to the emergency room
at 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 swallowing or breathing.
• Severe skin rash, itching, or hives (a red or pale rash, often itchy).
• Symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Symptoms of malignant neuroleptic syndrome may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in a blood test).
• Symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. These may be symptoms of a blood disorder, which may increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Muscle pain of unknown origin, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

Frequency not known (frequency cannot be estimated from the available data)

• Symptoms of a disease called stress cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

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

• Cough, wheezing, shortness of breath, and high fever, which may be symptoms of pneumonia associated with an increased number of white blood cells (eosinophilic pneumonia).
• Black (tar-like) stools or blood in the stool.
• Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation.
• Heart rhythm disorders, such as rapid or irregular heartbeat, high 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 feeling of unnatural excitement.
• Withdrawal symptoms (see sections "How to take Faxolet ER" and "Stopping treatment with Faxolet ER").
• Prolonged bleeding time - in case of injury, the time it takes for bleeding to stop may be 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 of detachment (or separation) from oneself; lack of orgasm; decreased libido; agitation; nervousness; unusual dreams
• Tremors; feeling of restlessness or inability to sit or stand still; tingling; taste disorders; increased muscle tone
• Vision disorders, including blurred vision; dilated pupils; inability of the eye to accommodate (automatic change in 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 frequency of urination; inability to urinate; urinary retention
• Menstrual disorders, such as 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 activity, racing thoughts, and decreased need for sleep (mania)
• Hallucinations; feeling of detachment (or separation) from reality; agitation; orgasm disorders (women); apathy; feeling of excessive excitement; teeth grinding
• Fainting; uncontrolled muscle movements; coordination and balance disorders;
• Dizziness (especially when standing up too quickly), low blood pressure
• Vomiting blood; black (tar-like) stools or blood in the stool, which may be a sign of internal bleeding
• Increased sensitivity to light; bruising; rash; excessive hair loss
• Urinary incontinence
• Stiffness, muscle spasms, and uncontrolled muscle movements
• Mild changes in liver enzyme levels in the blood
• Weight gain; weight loss

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

• Seizures
• Cough, wheezing, shortness of breath, and high fever, which are symptoms of pneumonia associated with an increased number of white blood cells (eosinophilic pneumonia)
• Disorientation with frequent hallucinations (delirium)
• Excessive water retention in the body
• Decreased sodium levels in the blood
• Severe eye pain and vision disorders or blurred vision
• Abnormal, rapid, or irregular heartbeat, which may cause 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

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

• Prolonged bleeding, which may be a sign of decreased platelet count, indicating an increased risk of bruising or bleeding
• Inappropriate milk secretion in women
• Unexpected bleeding, such as bleeding from the gums, blood in the urine or vomit, or unexpected appearance of bruises or broken blood vessels (broken veins)

Frequency not known (frequency cannot be estimated from the available data)

• Suicidal thoughts and behaviors; during treatment with venlafaxine, or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2, "Important information before taking Faxolet ER")
• Dizziness
• Severe postpartum hemorrhage, which occurs shortly after delivery (postpartum hemorrhage), see additional information in the "Pregnancy and breastfeeding" subsection in section 2

Faxolet ER may sometimes cause side effects that the patient may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in sodium, cholesterol, or liver enzyme levels in the blood. In rare cases, Faxolet ER may affect platelet function, increasing the risk of bruising or bleeding.
Therefore, the doctor may occasionally recommend a blood test, especially during long-term treatment with Faxolet ER.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Faxolet ER

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the blister pack and outer packaging.
The expiry date refers to the last day of the month.
The patient should not store the medicine above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Faxolet ER contains

• The active substance of the medicine is venlafaxine. One prolonged-release hard capsule contains 37.5 mg, 75 mg, or 150 mg of venlafaxine in the form of venlafaxine hydrochloride.
• Other ingredients are:

Faxolet ER, 37.5 mg, prolonged-release hard capsules
Capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: butyl methacrylate copolymer (12.5%).
Gelatin capsule: titanium dioxide (E 171), gelatin.
Ink: shellac, iron oxide black (E 172), propylene glycol.
Faxolet ER, 75 mg, prolonged-release hard capsules
Capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: butyl methacrylate copolymer (12.5%).
Gelatin capsule: titanium dioxide (E 171), iron oxide red (E 172), gelatin.
Ink: shellac, iron oxide black (E 172), propylene glycol.
Faxolet ER, 150 mg, prolonged-release hard capsules
Capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: butyl methacrylate copolymer (12.5%).
Gelatin capsule: titanium dioxide (E 171), erythrosine (E 127), indigo carmine (E 132), gelatin.
Ink: shellac, iron oxide black (E 172), propylene glycol.

What Faxolet ER looks like and contents of the pack

Faxolet ER, 37.5 mg, prolonged-release hard capsules: white, opaque gelatin capsules (size 0), containing one round, biconvex, film-coated tablet, with "VEN" printed on the cap and "37.5" on the body of the capsule.
Faxolet ER, 75 mg, prolonged-release hard capsules: pink, opaque gelatin capsules (size 0), containing two round, biconvex, film-coated tablets, with "VEN" printed on the cap and "75" on the body of the capsule.
Faxolet ER, 150 mg, prolonged-release hard capsules: scarlet, opaque gelatin capsules (size 00), containing three round, biconvex, film-coated tablets, with "VEN" printed on the cap and "150" on the body of the capsule.
Faxolet ER, 37.5 mg:
Pack contains 28 or 98 capsules.
Faxolet ER, 75 mg:
Pack contains 28 or 98 capsules.
Faxolet ER, 150 mg:
Pack contains 28 or 98 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Pharmathen S.A.
6, Dervenakion Str.
15351 Pallini, Attikis
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5
69300 Rodopi
Greece

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

Denmark: Panofen 37.5 mg, 75 mg, 150 mg depotkapsler, hårde
Greece: Velept XR 75 mg, 150 mg σκληρά καψάκια παρατεταμένες αποδέσμευσης
Spain: Venlafaxina Retard Mylan 75 mg, 150 mg cápsulas duras de liberación prolongada
Italy: Venlafaxina EG 75 mg, 150 mg capsule rigide a rilascio prolungato

Date of last revision of the leaflet: 04.2022