Faxilex

Package Leaflet: Information for the User

Faxilex 50 mg prolonged-release tablets, 100 mg prolonged-release tablets

desvenlafaxine
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Faxilex is and what it is used for
2. What you need to know before taking Faxilex
3. How to take Faxilex
4. Possible side effects
5. How to store Faxilex
6. Contents of the pack and other information

1. What Faxilex is and what it is used for

Faxilex contains the active substance desvenlafaxine (as benzoate).
Faxilex is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression. It is not fully understood how antidepressants work, but they may help increase levels of serotonin and noradrenaline in the brain. Faxilex is a treatment for adults.

2. What you should know before taking Faxilex

Do not take Faxilex

• If you are allergic to desvenlafaxine, venlafaxine, or any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking, or have taken within the last 14 days, any medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression, infections, or Parkinson’s disease. Taking an MAOI (for example, linezolid or methylene blue) together with medicines like Faxilex can cause serious and potentially life-threatening side effects. Additionally, you must wait at least 7 days after stopping Faxilex before taking any MAOI (also read section “Other medicines and Faxilex” and the information in that section on “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor if you have had any of the following conditions before taking Faxilex, or if you develop any
of them during treatment with Faxilex:

• if you or someone in your family has a history of, or has experienced mania (a state of over-excitement, feelings of euphoria, or hyper-irritability) or bipolar disorder (extreme mood swings, for example, shifting from depression to euphoria).
• if you have a history of aggressive behaviour.
• if you have eye problems, such as certain types of glaucoma (increased eye pressure).
• if you have a history of hypertension or high blood pressure.
• if you have a history of heart problems or have had a heart attack.
• if you have a history of seizures (fits), if you bruise easily or bleed easily (history of bleeding disorders), or if you are pregnant (see “Pregnancy and breastfeeding”), or if you are using non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or other medicines that may increase the risk of bleeding when used together with desvenlafaxine.
• if you have a history of kidney problems.
• if you have a history of low sodium levels in the blood (hyponatraemia).
• if you have a history of high cholesterol or if your cholesterol levels increase.
• if you experience any of the following side effects: agitation (excitability and restlessness), altered consciousness, confusion, coma, palpitations, increased blood pressure, increased body temperature, excessive sweating, lack of coordination, muscle spasms or stiffness, tremor, nausea, vomiting, or diarrhoea. Contact your doctor immediately, as you may be experiencing serotonin syndrome (a condition that can be serious and, rarely, fatal).
• if treatment is stopped abruptly, withdrawal symptoms may occur (e.g. mood swings, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (ringing in the ears), and seizures (fits)). Therefore, it is important to gradually reduce the dose of Faxilex under medical supervision whenever you and your doctor decide to discontinue treatment.

Some medicines in the group to which Faxilex belongs (called SSRIs/SNRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of
treatment.
Faxilex may cause a feeling of restlessness or inability to sit still during the first weeks of treatment. You
should inform your doctor if this happens to you.
Suicidal thoughts and worsening of your depression
If you are depressed, you may sometimes have thoughts about harming yourself or committing suicide.
These thoughts may increase when you first start taking antidepressants, as it takes time for these medicines
to take effect, usually about two weeks but sometimes longer. You are more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are young. Clinical studies have shown an increased risk of suicidal behaviour in young patients under 25 years of age with psychiatric disorders who were treated with an antidepressant. If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to let you know if they think your depression is getting worse, or if they are concerned about changes in your behaviour.

Medicines like Faxilex (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction
(see section 4). In some cases, these symptoms have continued after stopping treatment.
Dry mouth
Dry mouth has been reported in 18% of patients treated with desvenlafaxine. This may increase the risk of
dental caries. You should therefore pay particular attention to your oral hygiene.
Elderly patients
Increased sensitivity to desvenlafaxine cannot be ruled out in some elderly patients.
Other medicines and Faxilex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs), for example, medicines containing linezolid (an antibiotic used to treat infections) and methylene blue (see section “Do not take Faxilex”).
• other medicines containing venlafaxine or desvenlafaxine (may also be used to treat depression).
• triptans (used for migraine).
• medicines for depression, for example, tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• medicines containing sibutramine (used for weight loss).
• pain medicines, for example, those containing tramadol, fentanyl or its analogues, tapentadol, meperidine, methadone (also used to treat narcotic withdrawal syndrome and opioid dependence), and pentazocine.
• medicines containing dextromethorphan (used for cough).
• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression).
• products containing tryptophan (used for problems such as sleep and depression).
• medicines containing ketoconazole (an antifungal).
• Also, if you are being treated by other healthcare providers, inform them that you are taking Faxilex.

Serotonin syndrome or reactions similar to neuroleptic malignant syndrome (NMS)
Rarely, a condition called serotonin syndrome or reactions similar to NMS may occur, which can cause
significant changes in how the brain, muscles, and digestive system function due to high levels of serotonin
in the body. This potentially life-threatening condition may be caused by taking medicines like Faxilex,
especially when taken together with other medicines mentioned above.
Please read the section “Warnings and precautions” for possible side effects related to serotonin syndrome or
reactions similar to NMS.
Switching antidepressants
When switching treatment from another antidepressant to desvenlafaxine, withdrawal symptoms from the
initial antidepressant have been observed. Your doctor may be able to gradually reduce the dose of the
initial antidepressant to help reduce these symptoms.
Interactions with laboratory tests
False positive results may occur for certain substances such as phencyclidine (PCP) and amphetamines in
urine drug screening tests in patients taking or who have taken desvenlafaxine, even several days after
stopping treatment.
Faxilex with food, drinks and alcohol
Faxilex tablets may be taken with or without food.
You must not consume alcohol while taking Faxilex.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
Make sure your midwife and/or doctor know that you are taking Faxilex. When taken during pregnancy,
similar medicines (called SSRIs) may increase the risk of a serious condition in newborns called persistent
pulmonary hypertension of the newborn (PPHN). This condition causes the newborn to breathe rapidly and
appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs, contact your
midwife and/or doctor immediately.
If you take Faxilex during pregnancy, inform your doctor and/or midwife, as the baby may experience
withdrawal symptoms at birth. These symptoms may appear immediately after delivery and may require
hospitalisation. Symptoms include difficulty feeding and breathing problems. If your baby has these or any
other symptoms at birth and you are concerned, discuss this with your doctor and/or midwife.
If you take Faxilex towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding
shortly after delivery, especially if you have a history of bleeding disorders. Your doctor should be aware that
you are taking Faxilex so they can advise you accordingly.
Desvenlafaxine is excreted in breast milk. There is a risk of effects on the infant. Therefore, do not use
Faxilex during breastfeeding unless your doctor explicitly states that it is necessary.
Driving and using machines
Faxilex may cause dizziness, drowsiness, and blurred vision. Do not drive or operate tools or machinery
until you know how this medicine affects you.
100 mg:
Faxilex contains sunset yellow aluminium lake FCF (E 110).
Faxilex may cause allergic reactions.

3. How to take Faxilex

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

The recommended dose is 50 mg once daily. Your doctor may increase the dose up to 100 mg once daily, or even up to a maximum of 200 mg once daily, if necessary.

If you have kidney problems or a history of kidney problems, inform your doctor, as you may need to take a different dose of Faxilex.

Faxilex should be taken orally, approximately at the same time each day. The tablets must be swallowed whole with liquid and must not be divided, crushed, chewed, or dissolved.

If you take more Faxilex than you should
Contact your doctor or pharmacist immediately if you take more Faxilex than prescribed.

If you forget to take Faxilex
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Faxilex
Do not stop taking Faxilex or change the dose unless instructed by your doctor, even if you feel better.

If your doctor decides that you no longer need Faxilex, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects may occur when patients stop taking Faxilex, especially if they have taken a high dose for a long time, or if Faxilex is stopped suddenly or the dose is reduced too quickly.

These side effects include: mood swings, agitation, sensory disturbances (e.g. tingling or electric shock sensations), confusion, emotional lability, insomnia, hypomania, tinnitus, seizures, dizziness, nausea, headache, fatigue, irritability, diarrhoea, anxiety, nightmares, and excessive sweating.

Although these symptoms are generally self-limiting, cases of severe withdrawal symptoms have been reported. Therefore, the dose should be tapered slowly whenever possible, under medical supervision, if you and your doctor decide to discontinue treatment with Faxilex. If you experience any of these or other bothersome symptoms, seek further advice from your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
If you experience any of the following side effects, contact your doctor immediately or go to the nearest hospital:

• heart problems, such as fast heartbeat, increased blood pressure, or chest pain.
• eye problems, such as blurred vision.
• nervous system problems, such as dizziness, numbness and tingling, movement disorders (e.g. involuntary muscle movements, restlessness), seizures or fits.
• psychiatric problems, such as hyperactivity and euphoria.
• allergic reaction to medicines, such as skin rash, sore throat, or breathing problems.

List of possible side effects
The side effects and their frequency (likelihood of occurrence) listed below have been observed in patients. In general, these side effects occurred more frequently during the first week of treatment.

Very common side effects: may affect more than 1 in 10 people

• insomnia
• dizziness, headache
• nausea
• dry mouth
• constipation
• excessive sweating

Common side effects: may affect up to 1 in 10 people

• loss of appetite
• anxiety
• nervousness
• inability to achieve orgasm
• reduced libido
• nightmares
• drowsiness
• tremor
• attention deficit
• numbness and tingling
• altered sense of taste
• dilated pupils
• blurred vision
• ringing in the ears
• sensation of dizziness
• fast heartbeat
• palpitations (awareness of rapid, irregular, or strong heartbeat)
• hot flushes
• yawning
• vomiting, diarrhoea
• skin rash
• muscle stiffness
• erectile dysfunction
• delayed ejaculation, ejaculatory failure
• fatigue, weakness
• chills, nervousness
• irritability
• high blood pressure
• weight gain, weight loss

Uncommon side effects: may affect up to 1 in 100 people

• allergic reaction
• distortion of self-image and reality
• abnormal orgasm
• withdrawal syndrome
• loss of consciousness
• cold extremities
• drop in blood pressure upon changing position
• nosebleeds
• complete or partial hair loss
• difficulty urinating, urinary retention, protein in urine
• sexual dysfunction, ejaculation disorder
• increased cholesterol levels in the blood
• changes in liver function tests
• increased triglyceride levels
• increased prolactin hormone levels

Rare side effects: may affect up to 1 in 1,000 people

• hyponatraemia (reduced sodium concentration in the blood)
• hallucinations
• hypomania (state of exaggerated excitement and activity) and mania (state of over-excitement, feeling of euphoria and hyper-irritability)
• seizures (fits)
• changes in movement (e.g. involuntary muscle movements, restlessness)
• swelling under the skin
• light sensitivity

Not known: frequency cannot be estimated from the available data

• Serotonin syndrome (characterized by symptoms such as agitation (excitability and restlessness), altered consciousness
• confusion
• coma
• palpitations
• increased blood pressure
• increased body temperature
• excessive sweating
• lack of coordination
• muscle spasms or stiffness
• tremor
• nausea
• vomiting or diarrhoea
• Stevens-Johnson syndrome (multiform erythema, a hypersensitivity reaction affecting the skin and mucous membranes)
• severe vaginal bleeding immediately after childbirth (postpartum haemorrhage). See Pregnancy in section 2 for more information.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Faxilex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Faxilex contains
The active substance is desvenlafaxine (as benzoate).
Each tablet contains 50 mg of desvenlafaxine (as benzoate).
The other components are: stearic acid (E 570), microcrystalline cellulose (E 460), hypromellose type 2208, 100 Pa.s (E 464), magnesium stearate (E 470 b), colloidal anhydrous silica (E 551), talc (E 553 b).
The coating material for the 50 mg tablets consists of: titanium dioxide (E 171), macrogol 3350 (E 1521), poly(vinyl alcohol) (E 1203), iron oxide yellow (E 172), iron oxide red (E 172), talc (E 553b).

Each tablet contains 100 mg of desvenlafaxine (as benzoate).
The other components are: stearic acid (E570), microcrystalline cellulose (E460), hypromellose type 2208, 100 Pa.s (E 464), magnesium stearate (E470b), colloidal anhydrous silica (E551), talc (E553b).
The coating material for the 100 mg tablets consists of: titanium dioxide (E 171), macrogol (E 1521), poly(vinyl alcohol) (E 1203), sunset yellow aluminium lake FCF (E 110), iron oxide red (E 172), talc (E 553b).

Description of the appearance of Faxilex and contents of the pack

• 50 mg: light pink, biconvex, round tablet with a diameter of 9.6 ± 0.2 mm.
• 100 mg: reddish-orange, biconvex, round tablet with a diameter of 10.1 ± 0.2 mm.

Aluminum-PVC/PE/PVdC or aluminum-OPA/Alu/PVC blisters.
Faxilex 50 mg is supplied in blister packs of 20, 28, 50, and 100 tablets.
Faxilex 100 mg is supplied in blister packs of 28, 50, and 100 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno (AP)
Italy

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000,
Malta

This summary of product characteristics was last approved on: