Faxigen Xl 37,5 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, 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, please tell your doctor or pharmacist. See section 4.

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 (SNRIs). These medicines 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 anxiety disorder (fear of social or performance situations or avoidance of such 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 treatment is not started, 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 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) used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Faxigen XL can cause serious or even life-threatening side effects. You must wait at least 7 days after stopping taking Faxigen XL before starting to take any MAOI (see also "Serotonin syndrome" and "Faxigen XL with other medicines").

Warnings and precautions

Before starting treatment with Faxigen XL, 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 Faxigen XL (see "Faxigen XL with other medicines").
• If you have eye diseases, such as certain types of glaucoma (increased pressure in the eyeball) or if an ophthalmologist has informed you that you have an increased risk of glaucoma.
• If you have had high blood pressure or have recently had a heart attack.
• If you or a family member have had heart disease.
• If you have had arrhythmias.
• If you have had seizures (epilepsy).
• If you have had low sodium levels in the blood (hyponatremia), and if you are elderly and taking diuretics (water pills) or are dehydrated (e.g., due to severe diarrhea or vomiting).
• If you have a tendency to bruise or bleed (bleeding disorders in the past), or if you are taking other medicines that thin the blood, which may increase the risk of bleeding, or if you are pregnant (see "Pregnancy and breastfeeding").
• If you or a family member have had mania (feeling overly excited or elated) or bipolar affective disorder.
• If you have had aggressive behavior. You may feel aggressive, especially during the early stages of treatment with Faxigen XL, during dose changes, or after stopping treatment with Faxigen XL.
• If you have diabetes (this medicine may affect blood sugar levels).
• If you are taking weight loss medicines.

During treatment

• This medicine may cause an increase in blood pressure or cholesterol levels. Your doctor may recommend regular blood pressure and cholesterol checks.
• If you experience restlessness or an inability to sit or stand still, which may occur in the early stages of treatment, consult your doctor or pharmacist.
• If you are to undergo urine screening tests for certain medicines, Faxigen XL may affect the results. Inform your doctor or hospital staff that you 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 drink alcohol while taking Faxigen XL, as it may cause extreme drowsiness 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, in people with depression and/or anxiety disorders, suicidal thoughts or self-harm may occur. Such thoughts may worsen after starting antidepressant treatment, as these medicines start to work only after some time, usually after about 2 weeks, and sometimes later. These thoughts may also occur when reducing the dose or stopping treatment with Faxigen XL.
The likelihood of such thoughts is higher:

• if you have had suicidal thoughts or self-harm in the past
• in young adults; clinical studies have shown 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, seek medical help immediately
or go to the emergency department of the nearest hospital.
It may be helpful to inform relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask relatives or friends to monitor you and inform you if they notice that your depression or anxiety has worsened or if there are worrying changes in your 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 (so-called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
Children and adolescents
Faxigen XL should not be used in children and adolescents under 18 years of age. It should also be noted that in people under 18, there is a greater risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger) when using medicines from this group. Nevertheless, the doctor may decide to use this medicine in a person under 18 if it is in the patient's 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.
If such a patient experiences or worsens any of the above symptoms while taking Faxigen XL, they should inform their doctor. Additionally, the long-term safety of this medicine in this age group has not been established in terms of effects on growth, maturation, and intellectual and behavioral development.

Faxigen XL with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take, including those available without a prescription, herbal medicines, and dietary supplements.
Your doctor will decide whether to use Faxigen XL with other medicines.

• Do not take venlafaxine with monoamine oxidase inhibitors (IMAOs) used to treat depression and Parkinson's disease. Inform your doctor if you have taken these medicines in the last 14 days (IMAOs: see "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 taken with other medicines.

Examples of such medicines are:

• triptans (used to treat migraines, e.g., sumatriptan, zolmitriptan)
• other medicines used to treat depression, e.g., 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 methadone (used to treat opioid addiction 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 therefore, should be used with caution. It is particularly important to inform your doctor or pharmacist if you are 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 drink alcohol while taking Faxigen XL. Concurrent use with alcohol may cause extreme drowsiness and loss of consciousness, as well as exacerbate symptoms 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 child, consult your 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 your doctor.
Make sure your midwife and/or doctor are informed that you are taking Faxigen XL. Taking similar medicines (SSRIs) during pregnancy may increase the risk of a severe 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 your baby, you should contact your midwife and/or doctor immediately.
If you take this medicine during pregnancy, after birth, your baby may experience, in addition to breathing difficulties, other symptoms such as poor feeding. If you are concerned about such symptoms in your newborn, you should contact your 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, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you take Faxigen XL, you should inform your doctor or midwife so that they can provide you with appropriate advice.
If you are breastfeeding, consult your doctor. Faxigen XL passes into breast milk. There is a risk of affecting the baby. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or stop treatment with Faxigen XL.

Driving and using machines

Do not drive or operate machinery until you know how the medicine affects you, as it may affect your judgment, thinking, and ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., the medicine is considered "sodium-free".

3. How to take Faxigen XL

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Typically, the recommended starting dose for the treatment of 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 the treatment of panic disorder, your 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 anxiety disorder, and panic disorder is 225 mg once daily. Depending on your condition, your doctor may recommend taking this medicine for several months, regularly checking your condition during treatment.
Take Faxigen XL once daily, at approximately the same time, in the morning or evening.
Swallow the capsules whole with a drink of water. Do not open, crush, chew, or dissolve the capsules.
Take Faxigen XL with food.
Tell your doctor if you have liver or kidney problems, as you may need a dose adjustment.
Do not stop taking Faxigen XL without consulting your doctor (see "Stopping Faxigen XL").

Use in children and adolescents

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

Overdose

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Faxigen XL with other medicines").
Symptoms of possible overdose may include rapid or slow heartbeat, changes in heart rhythm, low blood pressure, dizziness, altered consciousness (from drowsiness to coma), blurred vision, seizures, and vomiting.

Missing a dose

If you miss a dose, take it as soon as possible. However, if it is close to the time for your next dose, 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 dose in a 24-hour period.

Stopping Faxigen XL

Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Faxigen XL, they will tell you how to gradually reduce the dose before stopping treatment completely.
In patients stopping treatment, especially when stopping abruptly or reducing the dose too quickly, side effects may occur, such as suicidal thoughts, aggression, tiredness, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, anxiety, nervousness, restlessness, confusion, ringing in the ears, or tingling, and rarely, electric shock-like sensations, weakness, seizures, or flu-like symptoms, and changes in blood pressure (which may cause headache, dizziness, ringing in the ears, etc.).
Your doctor will advise you 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 gradually over several months or even longer. If you experience any of these symptoms or other symptoms that are troublesome to you, consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Faxigen XL can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Faxigen XL. Inform your doctor immediately or go to the emergency department of the nearest hospital, if you experience:

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

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

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

• chest pain, wheezing, difficulty breathing
• 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 restlessness, hallucinations, loss of coordination, rapid heartbeat, high body temperature, rapid changes in blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting. Serotonin syndrome in its most severe form may resemble neuroleptic malignant syndrome. Symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, very stiff muscles, confusion, changes in mental status, increased muscle enzyme activity (visible in blood tests).
• symptoms of infection, 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 pain, tenderness, or weakness of muscles. 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 you should tell your doctor about(the frequency of these side effects is listed below in "Other side effects") include:

• cough, wheezing, shortness of breath, which may be accompanied by high body temperature
• black (tarry) stools or blood in stools, which may be signs of internal bleeding
• itching, yellowing of the skin or whites of the eyes, dark urine, which may be signs 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 activity and feeling unnatural excitement;
• withdrawal symptoms (see sections "How to take Faxigen XL" and "Stopping Faxigen XL")
• prolonged bleeding time - in case of cuts or injuries, the wound may bleed slightly longer than usual

Do not be concerned if, after taking this medicine, you notice small white granules or balls in your stool. The capsules of Faxigen XL contain granules (small white balls) that contain the active substance (venlafaxine). These granules are released from the capsule into

the stomach. As the granules pass through the digestive tract, venlafaxine is released slowly from
them. The "coating" of these granules is insoluble and is excreted in the stool. Therefore, even if
you notice granules in your stool, the venlafaxine dose has been absorbed.
Other side effects:

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

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

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

• decreased appetite
• confusion; depersonalization (feeling of being detached from oneself); anorgasmia; decreased libido, restlessness; nervousness; unusual dreams, psychomotor agitation
• vision disorders, 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 disorders, such as heavy bleeding or more frequent irregular bleeding; ejaculation disorders/orgasm (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
• restlessness; inability to sit or stand still; tingling; taste disorders; 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; restlessness; unusual orgasms; lack of feelings or emotions; feeling of excessive excitement; teeth grinding
• fainting; involuntary muscle movements; uncontrolled, jerky, or writhing movements
• dizziness (especially when standing up too quickly); low blood pressure
• vomiting blood, black tarry stools, or blood in stools, which may be signs of internal bleeding
• sensitivity to sunlight; bruising; 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 body temperature
• excessive water retention in the body (known as SIADH)
• severe eye pain and vision changes 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 signs of liver inflammation

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

• inappropriate milk production in the breasts
• prolonged bleeding, which may be a sign of a low platelet count, indicating an increased risk of bruising or bleeding
• unexpected bleeding, e.g., from the gums, presence of blood in urine or vomit, or unexplained bruising or bleeding

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

Faxigen XL 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. Rarely, Faxigen XL may affect platelet function, leading to an increased risk of bruising or bleeding. In this case, your 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 you experience any side effects, including those not listed in this leaflet, please tell your 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

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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
Amonium methacrylate copolymer (type B)
Sodium lauryl sulfate
Magnesium stearate
Coating:
Butyl methacrylate copolymer (basic)
[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, and 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, Greece
Mylan Hungary Kft
H-2900 Komárom,
Mylan utca 1
Hungary
Pharmathen International S.A.
Sapes Industrial Park, Block 5
69300 Rodopi, Greece
Pharma Pack Kft,
2040 Budarös
Vasut u. 13, Hungary
Viatris Santé
360 Avenue Henri Schneider
69330 Meyzieu
France
Viatris Santé
1 Rue de Turin
69007 Lyon
France
Europhartech
rue Henri Matisse
63370 Lempdes, France
To obtain more detailed information on this medicine and its authorized names in the Member States of the European Economic Area, please 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: