Faxigen Xl 150 mg

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the user

Faxigen XL 37.5 mg, prolonged-release hard capsules

Faxigen XL 75 mg, prolonged-release hard capsules

Faxigen XL 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, as 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 not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Faxigen XL and what is it used for

Faxigen XL contains the active substance venlafaxine, which is an antidepressant belonging to the group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRI). Medicines in this group are used to treat depression and other conditions, such as anxiety disorders.
Faxigen XL is used to treat depression in adults and to prevent the recurrence of depressive episodes. Faxigen XL is also used to treat the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear of social situations 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 left untreated, the patient's condition may not improve, may worsen, and become more difficult to treat.

2. Important information before taking Faxigen XL

When not to take Faxigen XL

• 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 monoamine oxidase inhibitor (MAOI) medicines, which are used to treat depression or Parkinson's disease. Taking MAOIs and Faxigen XL at the same time can cause serious or even life-threatening side effects. The patient must wait at least 7 days after stopping taking Faxigen XL before starting to take any MAOI medicine (see also sections "Serotonin syndrome" and "Faxigen XL and other medicines").

Warnings and precautions

Before starting treatment with Faxigen XL, the patient should discuss the following with their doctor or pharmacist:

• If the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Faxigen XL (see section "Faxigen XL and other medicines").
• If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eye) or if an eye specialist has informed the patient that they have an increased risk of glaucoma.
• If the patient has a history of high blood pressure or has recently had a heart attack.
• If the patient or a family member has a history of heart disease.
• If the patient has a history of heart rhythm disorders.
• If the patient has a history of seizures (epilepsy).
• If the patient has a history of low sodium levels in the blood (hyponatremia), and is also elderly and taking diuretics (water pills) or is dehydrated (e.g., due to severe diarrhea or vomiting).
• If the patient has a tendency to bruise or bleed easily (bleeding disorders in the past), or is taking other medicines that thin the blood, which may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy and breastfeeding").
• If the patient or a family member has a history of mania (feeling overly excited or euphoric) or bipolar affective disorder.
• If the patient has a history of aggressive behavior. The patient may feel aggressive, especially during the early stages of treatment with Faxigen XL, during dose changes, or after stopping treatment.
• If the patient has diabetes (the medicine may affect blood sugar levels).
• If the patient is taking weight loss medicines.

During treatment

• This medicine may cause an increase in blood pressure or cholesterol levels. The doctor may recommend regular blood pressure and cholesterol checks.
• If the patient experiences restlessness or an inability to sit or stand still, which may occur during the early stages of treatment, they should consult their doctor or pharmacist.
• If the patient is to undergo urine screening tests for certain medicines, Faxigen XL may affect the results. The patient should inform their doctor or hospital staff that they are taking this medicine.
• The capsules of Faxigen XL contain granules, the insoluble part of which is excreted and may be visible in the stool.

Do not consume alcohol during treatment with Faxigen XL, as it may cause extreme fatigue and loss of consciousness. Concurrent use with alcohol and/or certain medicines may exacerbate symptoms of depression and other conditions, such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Sometimes, people with depression and/or anxiety disorders may experience suicidal thoughts or self-harm. These thoughts may worsen after starting antidepressant treatment, as the medicine may take some time to start working, usually around 2 weeks, and sometimes later. These thoughts may also occur during dose reduction or discontinuation of Faxigen XL.
The likelihood of such thoughts is higher:

• if the patient has a history of suicidal thoughts or self-harm
• in young adults; clinical trials indicate a higher risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressants.

In case of suicidal thoughts or self-harm, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital.
It may be helpful to inform relatives or friendsabout the depression or anxiety disorder and ask them to read this leaflet. The patient may ask relatives or friends to monitor them if they notice any worsening of depression or anxiety, or if they experience disturbing changes in behavior.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This condition may increase the risk of tooth decay. Therefore, it is essential to take good care of oral hygiene.
Diabetes
Faxigen XL may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.
Sexual dysfunction
Medicines like Faxigen XL (SSRI/SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Faxigen XL should not be used in children and adolescents under 18 years of age. It is also essential to remember that in people under 18, there is a higher risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger) when using medicines in this group. Nevertheless, the doctor may decide to use this medicine in a person under 18 if they consider it to be in the patient's best interest. If the doctor prescribes this medicine to a person under 18, and the patient wants to discuss this, they should consult their doctor again.
The patient should inform their doctor if they experience any of the above symptoms during treatment with Faxigen XL. Additionally, the long-term safety of this medicine in this age group has not been established regarding its impact on growth, maturation, and intellectual and behavioral development.

Faxigen XL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription, herbal medicines, and dietary supplements.
The doctor will decide whether to use Faxigen XL with other medicines.

• Do not take venlafaxine with monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease. Inform the doctor if the patient has taken these medicines within the last 14 days (MAOIs: see section "Important information before taking Faxigen XL").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening or neuroleptic malignant syndrome (NMS)-like reaction may occur, especially when used concomitantly with other medicines (see section "Possible side effects").

Examples of such medicines include:

• triptans (used to treat migraines, e.g., sumatriptan, zolmitriptan)
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines
• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing the antibiotic linezolid (used to treat infections)
• medicines containing 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, a herbal remedy used to treat mild depression)
• medicines containing tryptophan (used to treat sleep problems and depression)
• antipsychotic medicines (used to treat diseases characterized by hearing, seeing, or feeling things that do not exist, delusions, excessive suspicion, unclear thinking, and withdrawal)

The following medicines may also interact with Faxigen XL, and the patient should use them with caution. It is particularly important to inform the doctor or pharmacist if the patient is taking medicines containing:

• medicines that inhibit certain enzymes (CYP3A4), such as:
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV infection),
• ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medicines),
• clarithromycin and telithromycin (antibiotics);
• haloperidol or risperidone (medicines used to treat mental disorders);
• metoprolol (beta-blocker used to treat high blood pressure and heart disease).

Taking Faxigen XL with food, drink, and alcohol

Faxigen XL should be taken with food (see section 3 "How to take Faxigen XL").
Do not consume alcohol during treatment with Faxigen XL. Concurrent use with alcohol may cause extreme fatigue and loss of consciousness, as well as exacerbate symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Faxigen XL should only be used after discussing the potential benefits and risks to the unborn child with the doctor.
The patient should ensure that their midwife and/or doctor are informed that they are taking Faxigen XL. Taking similar medicines (SSRIs) during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension (PPHN) in the newborn, which can cause rapid breathing and bluish skin. These symptoms usually appear within the first day of life. If they occur in the baby, the patient should immediately contact their midwife and/or doctor.
If the patient takes this medicine during pregnancy, the baby may experience withdrawal symptoms after birth, such as difficulty feeding. If the patient is concerned about these symptoms in their newborn, they should consult their doctor and/or midwife, who will be able to provide appropriate advice.
Taking Faxigen XL late in pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Faxigen XL, they should inform their doctor or midwife so that they can provide appropriate advice.
If the patient is breastfeeding, they should consult their doctor. Faxigen XL 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 discontinue Faxigen XL treatment.

Driving and using machines

The patient should not drive or operate machinery until they know how the medicine affects them, as it may affect their judgment, thinking, and ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Faxigen XL

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are unsure, they should ask their doctor or pharmacist.
The recommended initial dose for the treatment of depression, generalized anxiety disorder, and social phobia is usually 75 mg once daily. The doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg once daily for depression. For the treatment of panic disorder, the doctor will start with a lower dose (37.5 mg) and gradually increase it. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg once daily. Depending on the patient's condition, the doctor may recommend taking this medicine for several months, regularly checking the patient's condition during treatment.
Faxigen XL should be taken once daily, at approximately the same time, in the morning or evening.
The capsules should be swallowed whole with a drink of water. The capsules should not be opened, crushed, chewed, or dissolved.
Faxigen XL should be taken with food.
The patient should inform their doctor if they have liver or kidney problems, as they may need to adjust the dose of the medicine.
The patient should not stop taking Faxigen XL without consulting their doctor (see section "Stopping Faxigen XL treatment").

Use in children and adolescents

Faxigen XL is not recommended for use in children and adolescents (see section 2).

Overdose

In case of overdose, the patient should immediately consult their doctor or pharmacist.
Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see section "Faxigen XL and other medicines").
Symptoms of possible overdose may include rapid or slow heart rate, changes in heart rhythm, low blood pressure, dizziness, altered consciousness (from drowsiness to coma), blurred vision, seizures, and vomiting.

Missed dose

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and take only one dose at the usual time. The patient should not take a double dose to make up for a missed dose. The patient should not take more than the prescribed daily dose of Faxigen XL.

Stopping Faxigen XL treatment

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 Faxigen XL, they will inform the patient how to gradually reduce the dose before completely stopping treatment.
In patients who stop taking the medicine, especially when treatment is stopped abruptly or the dose is reduced too quickly, they may experience side effects such as suicidal thoughts, aggression, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, restlessness, nervousness, agitation, disorientation, ringing in the ears, or tingling, and rarely, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.
The doctor will advise the patient on how to gradually stop taking Faxigen XL. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very slowly over several months or longer. If the patient experiences any of these symptoms or other symptoms that are bothersome, 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, Faxigen XL can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Faxigen XL. The patient should immediately inform their doctor or go to the emergency department of the nearest hospital if they experience any of the following side effects:

Uncommon (may affect up to 1 in 100 people):

• swelling of the face, lips, tongue, throat, hands, or feet, and/or a swollen, itchy rash (hives), difficulty swallowing or breathing.

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

• chest pain, wheezing, difficulty swallowing or breathing
• severe skin rash, itching, or hives (red or pale rash, which may be itchy)
• severe rash that may lead to severe blistering and peeling of the skin
• symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heart rate, high body temperature, rapid changes in blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting. Serotonin syndrome in its most severe form can resemble neuroleptic malignant syndrome. Symptoms of NMS may include fever, rapid heart rate, sweating, very stiff muscles, confusion, changes in blood enzyme activity (visible in blood tests).
• infection symptoms, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• unexplained muscle pain, tenderness, or weakness. These may be symptoms of rhabdomyolysis

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

• symptoms of a condition called stress cardiomyopathy, including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat

Other side effects that the patient should tell their doctor about(the frequency of these side effects is listed below in the section "Other side effects") include:

• cough, wheezing, shortness of breath, which may be accompanied by high fever
• 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, dark urine, which may be symptoms 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 disturbances (muscle spasms or stiffness), seizures or convulsions
• psychiatric disorders, such as excessive activity and feeling unnatural excitement;
• withdrawal symptoms (see sections "How to take Faxigen XL" and "Stopping Faxigen XL treatment")
• prolonged bleeding time - in case of cuts or injuries, the wound may bleed slightly longer than usual

Very common (may affect more than 1 in 10 people):

• dizziness; headache
• nausea; dry mouth
• drowsiness
• excessive sweating (including night sweats)
• sleep disturbances (insomnia)
• constipation

Common (may affect up to 1 in 10 people):

• decreased appetite
• confusion; depersonalization (feeling of being unreal); lack of orgasm; decreased libido, agitation; nervousness; unusual dreams, psychomotor agitation
• vision disturbances, including blurred vision; dilated pupils; inability to automatically adjust the eye to view objects at different distances (accommodation)
• ringing in the ears (tinnitus)
• increased blood pressure; flushing
• yawning
• vomiting; diarrhea
• increased frequency of urination; urinary retention; difficulty urinating
• menstrual disturbances, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disturbances (men); erectile dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• increased cholesterol levels in the blood
• shortness of breath
• mild skin rash; itching
• weight gain; weight loss
• psychomotor agitation or inability to sit or stand still; tingling, taste disturbances, increased muscle tone
• rapid heartbeat; palpitations

Uncommon (may affect up to 1 in 100 people):

• excessive activity, racing thoughts, and decreased need for sleep (mania)
• hallucinations; feeling of detachment from reality; agitation; unusual orgasms; lack of feelings or emotions; feeling of excessive excitement; teeth grinding
• fainting; involuntary muscle movements; uncontrolled twitching, jerking, or writhing movements; coordination and balance disturbances
• 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
• sensitivity to sunlight; bruising (ecchymosis); hair loss; hives
• low blood pressure
• slight changes in liver enzyme activity in the blood, which may be visible in blood tests
• inability to control urination;
• stiffness, muscle spasms, and involuntary movements.

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

• low sodium levels in the blood, which may be visible in blood tests
• disorientation and confusion, often accompanied by hallucinations (delirium)
• cough, wheezing, shortness of breath, which may be accompanied by high fever
• excessive water retention in the body (known as SIADH)
• severe eye pain and vision disturbances or blurred vision
• abnormal, rapid, or irregular heartbeat, which may lead to fainting
• severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas)
• 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):

• abnormal milk production in the breasts
• prolonged bleeding, which may be a sign of low platelet count, indicating an increased risk of bruising or bleeding
• unexplained bleeding, such as bleeding from the gums, blood in the urine or vomit, or unexplained bruising or bleeding under the skin

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 Faxigen XL)
• aggression
• dizziness
• severe bleeding from the vagina, which can occur shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Faxigen XL may also cause side effects that the patient 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. Less commonly, Faxigen XL may affect platelet function, leading to an increased risk of bruising or bleeding. In this case, the doctor may recommend regular blood tests, especially during long-term treatment with Faxigen XL.

Additional side effects in children and adolescents

Although this medicine is not recommended for use in children and adolescents, in this age group, additional side effects have been observed, such as hostility, self-harm, abdominal pain, nausea, and vomiting, as well as muscle pain.

Reporting side effects

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

5. How to store Faxigen XL

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label/carton after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 use. This will help protect the environment.

6. Contents of the pack and other information

What Faxigen XL contains

The active substance is venlafaxine.
Each prolonged-release hard capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg of venlafaxine. The other ingredients are:
Hypromellose
Amoniowego metakrylanu kopolimer (type B)
Sodium lauryl sulfate
Magnesium stearate
Coating:
Butyl methacrylate copolymer (type B)
[Only for 37.5 mg dose]
Capsule:
Titanium dioxide (E 171)
Gelatin
[Only for 75 mg dose]
Capsule:
Titanium dioxide (E 171)
Iron oxide red (E 172)
Gelatin
[Only for 150 mg dose]
Capsule:
Titanium dioxide (E 171)
Erythrosine (E 127)
Indigo carmine (E 132)
Gelatin
Printing ink:
Shellac
Iron oxide black (E 172).

What Faxigen XL looks like and contents of the pack

Faxigen XL 37.5 mg
White, opaque, prolonged-release hard capsules with "VEN" printed on the cap and "37.5" on the body of the capsule.
Faxigen XL 75 mg
Opaque, pink capsules, prolonged-release, hard, with "VEN" printed on the cap and "75" on the body of the capsule.
Faxigen XL 150 mg
Opaque, scarlet capsules, prolonged-release, hard, with "VEN" printed on the cap and "150" on the body of the capsule.
Prolonged-release hard capsules of Faxigen XL are available in blister packs of 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500, and 1000 capsules, as well as in bottles containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, and 250 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Pharmathen S.A.
6 Dervenakion str.
153 51 Pallini, Attiki, Grecja
Mylan Hungary Kft
H-2900 Komárom,
Mylan utca 1
Węgry
Pharmathen International S.A.
Sapes Industrial Park, Block 5
69300 Rodopi, Grecja
Pharma Pack Kft,
2040 Budarös
Vasut u. 13, Węgry
Viatris Santé
360 Avenue Henri Schneider
69330 Meyzieu
Francja
Viatris Santé
1 Rue de Turin
69007 Lyon
Francja
Europhartech
rue Henri Matisse
63370 Lempdes, Francja
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: