FAXILEX 50 mg Extended-Release Tablet

Зміст інструкції

1. Faxilex 50 mg prolonged-release tablets, 100 mg prolonged-release tablets
   1. What is Faxilex and what is it 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

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

desvenlafaxine
Generic medicine

Read this leaflet carefully before you start taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful to them.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Faxilex and what is it used for

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

2. What you need to 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 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 (such as linezolid or methylene blue) with other medicines like Faxilex can cause serious and even potentially life-threatening side effects. You must also wait at least 7 days after stopping Faxilex before taking any MAOI (also read the section “Other medicines and Faxilex” and the information in that section about “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 them
during treatment with Faxilex:

• if you or someone in your family has a history of, or has had mania (a state of overexcitement, feeling or euphoria or irritability) or bipolar disorder (extreme mood swings, for example, switching between depression and euphoria).
• if you have a history of aggressive behaviour.
• if you have problems with your eyes, such as certain types of glaucoma (increased pressure in the eye).
• if you have a history of 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 tend to 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 and other medicines that can increase the risk of bleeding if used at the same time as desvenlafaxine.
• if you have a history of kidney problems.
• if you have a history of low levels of sodium 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 spasm or stiffness, tremor, nausea, vomiting or diarrhoea. Contact your doctor immediately, as you may have serotonin syndrome (a condition that can be serious and, in rare cases, fatal).
• if treatment is stopped suddenly, 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 stop treatment.

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

• If you have thought about harming yourself or committing suicide before.
• If you are young. Information obtained from clinical studies has shown an increased risk of suicidal behaviour in young people under 25 years of age with psychiatric disorders, who had been treated with an antidepressant. If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or goimmediately to hospital.It may help to tell a relative or close friendthat you are depressed and ask them to

worsening, or if you are worried about changes in your behaviour.
Medicines like Faxilex (so-called SSRIs/SNRIs) can cause symptoms of sexual dysfunction
(see section 4). In some cases, these symptoms have continued after stopping treatment.

Dry mouth
Dry mouth is 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
In some elderly patients, increased sensitivity to desvenlafaxine cannot be ruled out.

Other medicines and Faxilex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is particularly important to tell your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs), such as medicines containing linezolid (an antibiotic used to treat infections) and methylene blue (read the section “Do not take Faxilex”).
• other medicines containing venlafaxine or desvenlafaxine (these can also be used to treat depression).
• triptans (used for migraine).
• medicines for the treatment of depression, such as tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).
• medicines containing sibutramine (used for weight loss).
• medicines for pain, such as 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 called “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 under the care of other healthcare professionals, tell them that you are taking Faxilex.

Serotonin syndrome or reactions similar to neuroleptic malignant syndrome (NMS)
In rare cases, a condition called serotonin syndrome or reactions similar to
NMS may occur, which can cause significant changes in the way the brain, muscles and the digestive
system function due to high levels of serotonin in the body. This condition, potentially
fatal, can be caused by taking medicines like Faxilex, especially if taken with other
medicines mentioned above.
Read the section "Warnings and precautions" about possible side effects of serotonin
syndrome or reactions similar to NMS.
Switching antidepressants
When switching treatment from an antidepressant to desvenlafaxine, withdrawal symptoms from the initial antidepressant have been observed. The doctor may be able to gradually reduce the dose
of the initial antidepressant medicine to help reduce these symptoms.
Interactions with laboratory tests
False positives may be observed with certain substances such as phencyclidine (PCP) and amphetamines, in
urine tests in patients who are taking or have taken desvenlafaxine, even several days
after stopping treatment.

Faxilex with food, drinks and alcohol
The tablets of Faxilex can be taken with or without food.
You should not drink alcohol while taking Faxilex.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice 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 a
fast breathing of the newborn and a bluish colour. These symptoms usually start during the first
24 hours of the baby's life. If this happens, you should contact your midwife and/or your
doctor immediately.
If you take Faxilex during pregnancy, tell your doctor and/or midwife, as your baby may
develop withdrawal symptoms at birth. These symptoms may appear shortly after birth and
may require hospitalisation. Symptoms include difficulty breastfeeding and
breathing problems. If your baby has these or other symptoms when born and you are worried, talk
to your doctor and/or midwife.
If you take Faxilex towards the end of pregnancy there may be an increased risk of heavy
vaginal bleeding immediately after birth, especially if you have a history of bleeding disorders. Your doctor
or midwife must know that you are taking Faxilex so that they can advise you.
Desvenlafaxine is excreted in breast milk. There is a risk of an effect on the baby. Therefore, do not use
Faxilex during breastfeeding unless your doctor tells you it is necessary.

Driving and using machines
Faxilex can cause dizziness, drowsiness and blurred vision. Do not drive or use tools or machines
until you know how the medicine affects you.
100 mg:
Faxilex contains sunset yellow FCF aluminium lake (E 110).
Faxilex may cause allergic reactions.

3. How to take Faxilex

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The recommended dose is 50 mg once a day. Your doctor may increase the dose to 100 mg once a
day or even up to a maximum of 200 mg once a day if necessary.
If you have kidney problems or a history of kidney problems, tell your doctor as it may be
necessary to take a different dose of Faxilex.
Faxilex must 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 the amount prescribed
by your doctor.

If you forget to take Faxilex
If you forget to take a dose, take it as soon as you remember. However, if you are due to take the
next dose when you remember the missed dose, skip the missed dose and take one dose
as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Faxilex
Do not stop taking Faxilex or change the dose unless your doctor tells you to, even if you
feel better.
If your doctor believes you no longer need Faxilex, they may ask you to reduce the dose gradually
before stopping treatment completely. It is known that undesirable effects occur when
patients stop taking Faxilex, especially if they have taken a high dose for a long
period or when Faxilex is stopped abruptly or the dose is reduced too quickly.
These side effects include: mood swings, agitation, sensory changes (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 reduced slowly whenever possible, under medical supervision,
if you and your doctor decide to stop treatment with . If you experience any of
these or other troublesome symptoms, ask your doctor for further advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following side effects, inform 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, changes in movement (e.g. involuntary muscle movements, restlessness), convulsions or seizures.
• psychiatric problems, such as hyperactivity and euphoria.
• drug allergy, such as skin rashes, sore throat or breathing problems.

List of possible side effects
The undesirable effects and the frequency (probability of occurrence) mentioned below have been observed
in patients. In general, these side effects occurred more often during the first week
of treatment.

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

• insomnia
• dizziness, headache
• nausea
• dry mouth
• constipation
• excessive sweating Common side effects:may affect up to 1 in 10people
• loss of appetite
• anxiety
• nervousness
• lack of orgasm
• reduced libido
• nightmares
• drowsiness
• tremor
• attention deficit
• numbness and tingling
• altered sense of taste
• dilated pupils
• blurred vision
• ringing in the ears
• sense of dizziness
• fast heartbeat
• palpitations (sensation of rapid, irregular or strong heartbeat)
• hot flashes
• yawning
• vomiting, diarrhea
• skin rash
• muscle stiffness
• erectile dysfunction
• delayed ejaculation, ejaculatory insufficiency
• fatigue, weakness
• chills, nervousness
• irritability
• high blood pressure,
• weight gain, weight loss

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

• allergic reaction
• distortion of one's own image and reality
• abnormal orgasm
• withdrawal syndrome
• loss of consciousness
• cold extremities
• low blood pressure when changing position
• nosebleed
• total or partial hair loss
• difficulty urinating, urinary retention, protein in the urine
• sexual dysfunction, ejaculation disorder
• increased cholesterol levels in the blood
• changes in liver tests
• increased triglyceride levels
• increased prolactin hormone levels

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

• hyponatremia (reduced concentration of sodium in the blood)
• hallucinations
• hypomania (state of excitement and exaggerated activity) and mania (state of overexcitation, feeling of euphoria and hyperirritability)
• convulsions (seizures)
• changes in movement (e.g. involuntary muscle movements, restlessness)
• swelling under the skin
• sensitivity to light Not known: frequency cannot be estimated based on 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 spasm or rigidity
• tremor
• nausea
• vomiting or diarrhea
• Stevens-Johnson syndrome (multiforme erythema consisting of a hypersensitivity reaction affecting the skin and mucous membranes)
• heavy vaginal bleeding immediately after childbirth (postpartum hemorrhage), see section 2 Pregnancy for more information.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the pack 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 any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Faxilex contains
The active ingredient is desvenlafaxine (as benzoate)
Each tablet contains 50 mg of desvenlafaxine (as benzoate).
The other ingredients are: stearic acid (E 570), microcrystalline cellulose (E 460), hypromellose type
2208, 100 Pa.s (E 464), magnesium stearate (E 470 b), anhydrous colloidal silica (E 551), talc (E 553 b).
The coating material of the 50 mg tablets consists of: titanium dioxide (E 171),
macrogol 3350 (E 1521), poly(vinyl alcohol) (E 1203), yellow iron oxide (E 172), red iron oxide
(E172), talc (E 553b).
Each tablet contains 100 mg of desvenlafaxine (as and benzoate).
The other ingredients are: stearic acid (E570), microcrystalline cellulose (E460), hypromellose type 2208,
100 Pa.s (E 464), magnesium stearate (E470b), anhydrous colloidal silica (E551), talc (E553b).
The coating material of the 100 mg tablets consists of: titanium dioxide (E 171),
macrogol (E 1521), poly(vinyl alcohol) (E 1203), sunset yellow FCF aluminium lake (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-shaped tablet with a diameter of 9.6 ± 0.2 mm.
• 100 mg: reddish-orange, biconvex, round-shaped tablet with a diameter of 10.1 ± 0.2 mm. Blisters in aluminium-PVC/PE/PVdC or blisters in aluminium-OPA/Alu/PVC Faxilex 50 mg is supplied in blisters of 20, 28, 50, 100 tablets Faxilex 100 mg is supplied in blisters of 28, 50, 100 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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