Label:informationpara thepatient

Desvenlafaxine Neuraxpharm 100 mg prolonged-release tablets EFG

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

Desvenlafaxina Neuraxpharm contains the active substance desvenlafaxine (as benzoate).

This medicine is an antidepressant belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs).This group of medicines is used to treat depression.

The exact way in which antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Desvenlafaxina is a treatment for adults.

Do not take Desvenlafaxina Neuraxpharm:

• if you are allergic to desvenlafaxine, venlafaxine, or any of the other ingredients of this medicine (listed in section 6).
• if you are also 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 a MAOI (for example linezolid or methylene blue) with other medicines such as Desvenlafaxina, may cause serious or potentially life-threatening side effects. You should also wait at least 7 days after stopping Desvenlafaxina before taking any MAOI (see also the sections “Serotonin syndrome” and “Other medicines and Desvenlafaxina Neuraxpharm”).

Warnings and precautions

Consult your doctor if you have had any of the following conditions before taking Desvenlafaxina or if they occur during treatment with this medicine:

• if you or a family member has a history of or has had mania (a state of overexcitement, feeling of euphoria or irritability) or bipolar disorder (extreme mood swings, for example, from depression to euphoria).
• if you have a history of aggressive behavior.
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• if you have a history of high blood pressure or hypertension.
• if you have a history of heart problems or a heart attack.
• if you have a history of seizures (convulsions).
• if you have a history of bleeding disorders (tendency to develop bruises or bleed easily), or if you are pregnant (see section Pregnancy, breastfeeding and fertility), or if you are using non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid) and other medicines that may increase the risk of bleeding when used at the same time as desvenlafaxine.
• if you have a history of kidney problems.
• if you have a history of low sodium levels in the blood (hyponatremia).
• if you have a history of high cholesterol, or if your cholesterol levels increase.
• if you experience the following side effects: agitation (excitability and restlessness), altered consciousness, confusion, coma, palpitations, increased blood pressure, elevated body temperature, excessive sweating, lack of coordination, muscle spasms or stiffness, tremors, nausea, vomiting, and diarrhea. Contact your doctor immediately, as you may be experiencing serotonin syndrome (a disorder that can be severe and, in rare cases, fatal).
• if stopping treatment abruptly may cause withdrawal symptoms (e.g., mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (ringing in the ears), and seizures). Therefore, it is essential to reduce the dose of Desvenlafaxina gradually and under medical supervision whenever you and your doctor decide to stop treatment.

Some medicines in the group to which Desvenlafaxina belongs (called SSRIs/SNRIs) may cause sexual dysfunction side effects (see section 4). In some cases, these side effects persist after stopping treatment.

Desvenlafaxina may cause a feeling of restlessness or inability to sit or remain still during the first few weeks of treatment.You should inform your doctor if this happens.

Thoughts of suicide and worsening of your depression

If you are depressed, you may have had thoughts of harming yourself or suicide.These thoughts may increase when you start taking antidepressants, as these medicines take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

• if you have had thoughts of suicide or self-harm before.
• if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years old) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or suicide at any time,contact your doctor or go to a hospital directly.

You may find it helpful to tell a close family member or friend who is depressed, and ask them to read this leaflet. You could also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Medicines like desvenlafaxine (called SSRIs/SNRIs) may cause sexual dysfunction side effects (see section 4). In some cases, these side effects persist after stopping treatment.

Dry mouth

Dry mouth has been reported in 18% of patients treated with desvenlafaxine. This may increase the risk of tooth decay. Therefore, you should take good care of your oral hygiene.

Older patients

In some older patients, it cannot be ruled out that they may be more sensitive to desvenlafaxine.

Children and adolescents

This medicine should not be used normally in children and adolescents under 18 years old.

Furthermore, you should know that, in patients under 18 years old, there is a higher risk of side effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when taking this type of medicine.

Despite this, the doctor who prescribes this medicine may prescribe it to patients under 18 years old when they decide it is the best option for the patient.

If the doctor who prescribes this medicine has prescribed it to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old while they are taking this medicine. Additionally, the long-term effects of this medicine on safety, growth, maturity, and cognitive and behavioral development have not yet been demonstrated.

Other medicines and Desvenlafaxina Neuraxpharm

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medicine.

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 the section “Do not take Desvenlafaxina Neuraxpharm”).
• other medicines containing venlafaxine or desvenlafaxine (also used to treat depression).
• triptans (used for migraines).
• medicines to treat depression, for example, 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, for example, those containing tramadol, fentanyl, and its analogues, tapentadol, meperidine, methadone (also used to treat opioid withdrawal and dependence), and pentazocine.
• medicines containing dextromethorphan (used for cough).
• products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal remedy used to treat mild depression).
• products containing tryptophan (used for problems such as sleep and depression).
• medicines containing ketoconazole (an antifungal).
• Additionally, if you are being treated by other healthcare professionals, inform them that you are taking Desvenlafaxina.

Serotonin syndrome or reactions similar to Neuroleptic Malignant Syndrome (NMS)(NMS)

Very rarely, this medicine may cause a disorder called serotonin syndrome or reactions similar to NMS that can cause significant changes in brain, muscle, and digestive system function due to high levels of serotonin in the body. This potentially fatal state may occur when taking medicines like desvenlafaxine, especially when taken with other medicines mentioned above.

See the section “Warnings and precautions” for possible side effects related to serotonin syndrome or reactions similar to NMS.

Changing antidepressant

When switching from one antidepressant to desvenlafaxine, withdrawal symptoms from the initial antidepressant have appeared. Your doctor may reduce your initial antidepressant dose gradually to help reduce these symptoms.

Interactions with laboratory tests

Falsely positive results for substances such as phenylcylidine (PCP) and amphetamines may occur in urine tests of patients taking or who have taken desvenlafaxine, even several days after stopping treatment.

Use of Desvenlafaxina Neuraxpharm with food, drinks, and alcohol

The tablets of this medicine can be taken with or without food.

Avoid taking alcohol while using this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor or midwife should know that you are taking this medicine. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition for the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If your baby has these symptoms, contact your doctor and/or midwife immediately.

If you take Desvenlafaxina Neuraxpharm during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms when born. These symptoms may appear just after birth and may require hospitalization. Among the symptoms are difficulty breastfeeding or respiratory problems. If your baby has these or other symptoms when born and you are concerned, contact your doctor and/or midwife.

If you take Desvenlafaxina in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.

Your doctor and/or midwife should know that you are taking desvenlafaxine to be able to advise you.

Desvenlafaxine passes into breast milk. There is a risk of effect on the baby. Therefore, do not use this medicine during breastfeeding unless your doctor specifically tells you to.

Driving and operating machines

This medicine may cause dizziness, drowsiness, and blurred vision.Do not drive or operate tools or machines until you know how this medicine affects you.

Desvenlafaxina Neuraxpharm 100 mg contains Sunset Yellow FCF (E 110)

Desvenlafaxina Neuraxpharm 100 mg tablets may cause allergic reactions.

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor again.

The recommended dose is 50 mg once a day. Your doctor may increase your dose up 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, consult your doctor since you may need to take a different dose of this medication.

Desvenlafaxina Neuraxpharm should be taken orally, approximately at the same time every day. The tablets should be swallowed whole with liquid, without dividing them, crushing them, chewing them, or dissolving them.

If you take more Desvenlafaxina Neuraxpharmthan you should

Immediately contact your doctor or pharmacist if you take more of this medication than your doctor has prescribed.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desvenlafaxina Neuraxpharm

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose, as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Desvenlafaxina Neuraxpharm

Do not stop taking Desvenlafaxina, or change the dose, without your doctor's indication, even if you feel better.

If your doctor considers that you no longer need to take desvenlafaxina, you can ask them to reduce the dose gradually before interrupting treatment completely.

It is known that patients experience adverse effects when stopping this medication, especially if they have taken a high dose and for a prolonged period or when treatment is interrupted abruptly or the dose is reduced too quickly.

These adverse effects are:mood changes, agitation, sensory changes (tingling or electric shock sensation), confusion, emotional instability, insomnia, hypomania, tinnitus, seizures, dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares, and excessive sweating

Although these symptoms are generally self-limiting, severe withdrawal symptoms have been reported. Therefore, the dose should be reduced gradually whenever possible, under medical supervision, if you and your doctor decide to interrupt treatment with Desvenlafaxina. If you experience any of these or other unpleasant symptoms, consult your doctor.

If you have more questions about the use of this medication, consult your doctor or pharmacist..

Like all medications, Desvenlafaxine may cause side effects, although not everyone will experience them.

Severe side effects

If you notice any of the following signs, inform your doctor immediately or visit the nearest hospital:

• Heart problems, such as rapid heart rate, increased blood pressure, or chest pain.
• Eye problems, such as blurry vision.
• Nervous system problems, such as dizziness, numbness, and tingling, movement disorder (e.g., involuntary muscle movements, restlessness), seizures, or convulsions.
• Psychiatric problems,such as hyperactivity and euphoria.
• Medication allergy, such as skin rash, throat swelling, or breathing difficulties.

List of possible side effects

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

Very common side effects: affect more than 1 in 10 patients

• Insomnia
• Dizziness, headache
• Nausea
• Dry mouth
• Constipation
• Excessive sweating

Common side effects: affect up to 1 in 10 patients

• Loss of appetite
• Anxiety
• Nervousness
• Absence of orgasm
• Decreased libido
• Nightmares
• Drowsiness
• Tremors
• Attention deficit
• Numbness and tingling
• Alteration of taste
• Pupil dilation
• Blurred vision
• Tinnitus
• Sensation of vertigo
• Rapid heart rate
• Palpitations (sensation of rapid, irregular, or strong heartbeat)
• Headaches
• Yawning
• Vomiting
• Diarrhea
• Skin rash
• Muscle rigidity
• Erectile dysfunction
• Delayed ejaculation
• Inadequate ejaculation

• Fatigue, weakness
• Chills, nervousness
• Irritability
• High blood pressure
• Weight gain, weight loss

Rare side effects: affect up to 1 in 100 patients

• Allergic reaction
• Distortion of self-image and reality
• Abnormal orgasm
• Withdrawal syndrome
• Loss of consciousness
• Sensation of cold in the extremities
• Low blood pressure upon changing position
• Nasal bleeding
• Complete or partial hair loss
• Difficulty urinating, urinary retention, protein in urine
• Sexual dysfunction, ejaculation disorder
• Increased cholesterol levels in the blood
• Alteration of liver function tests
• Increased triglyceride levels
• Increased prolactin levels

Rare side effects: affect up to 1 in 1000 patients

• Hyponatremia (decreased sodium concentration in the blood)
• Hallucinations
• Hypomania (state of excessive excitement and activity) and mania (state of overexcitement, feeling of euphoria or hyperirritability)
• Seizures (attacks)
• Movement disorders (e.g., involuntary muscle movements, restlessness)
• Edema under the skin
• Photophobia (sensitivity to light)

Unknown frequency: cannot be estimated from available data.

• Serotonin syndrome (characterized by symptoms such as agitation (excitability and restlessness), altered consciousness, confusion
• Coma
• Palpitations
• Increased blood pressure
• Elevated body temperature
• Excessive sweating
• Coordination problems
• Muscle spasms or rigidity
• Tremors
• Nausea
• Vomiting and diarrhea
• Stevens-Johnson syndrome (multiforme rash consisting of a hypersensitivity reaction affecting the skin and mucous membranes)
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, askyour pharmacist how to dispose of the packaging and medications you no longer need.By doing so,you will help protect the environment.

Composition of Desvenlafaxina Neuraxpharm

The active ingredient is desvenlafaxine (as benzoate).

Each tablet contains 100 mg of desvenlafaxine (as benzoate).

The other components are:hypromellose (E 464), microcrystalline cellulose (E460), talc (E553b), stearic acid (E570), magnesium stearate (E470b), anhydrous colloidal silica (E551).

The coating film consists of: Poly (vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172) and yellow-orange S (E 110).

Appearance of the product and contents of the packaging

Red-orange colored, round, biconvex tablets with a diameter of 10.1 ± 0.2 mm.

Packaged in Aluminio_PVC/PE/PVdC or Aluminio_OPA/Alu/PVC blisters.

Desvenlafaxina Neuraxpharm 100 mg is available in packaging of 10, 28, 30, 50 and 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

This medicine is authorized in the EEA member states with the following names:

Germany:Desveneurax 100 mg Retardtabletten

Portugal:Faxilex

Spain:Desvenlafaxina Neuraxpharm 100 mg prolonged-release tablets EFG

Italy:Faxilex

Austria:Desveneurax 100 mg Retardtabletten

Date of the last review of this leaflet:December 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es