Patient Information Leaflet: Package Insert

Desvenlafaxine Alter 50 mg prolonged-release tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Desvenlafaxina Alter is an antidepressant that belongs to a group of medications called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medications is used to treat depression. People with depression may have low levels of serotonin and noradrenaline (also known as norepinephrine) in the brain. The exact way 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 Alter:

• if you are allergic to desvenlafaxina, venlafaxina, or any of the other components of this medication (listed in section 6).
• if you are also taking or have taken within the last 14 days, any medication 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) with other medications such as Desvenlafaxina may produce severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Desvenlafaxina before taking any MAOI (see also the sections “Serotonin syndrome” and “Other medications”).

Warnings and precautions

Consult your doctor if you have experienced any of the following conditions before taking Desvenlafaxina or if they appear during treatment with this medication:

• if you or a family member has a history of 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 eye pressure).
• if you have a history of hypertension or high blood pressure.
• if you have a history of heart problems or myocardial infarction.
• if you have a history of seizures (convulsions).
• if you have a history of bleeding disorders (tendency to develop petechiae), or if you are pregnant (see the section Pregnancy, breastfeeding, and fertility), or if you are using nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and other medications that may increase the risk of bleeding when used with desvenlafaxina.
• 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 rigidity, 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, potentially life-threatening).
• if stopping treatment abruptly may cause withdrawal symptoms (for example, mood changes, irritability, agitation, dizziness, anxiety, confusion, headaches, 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 discontinue treatment.

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

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may have had thoughts of harming yourself or committing suicide. These thoughts may increase when starting antidepressants, as these medications take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

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

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

You may find it helpful to tell a close family member or friend who is depressed or has an anxiety disorder, 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.

Dry mouth

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

Older adults

In some older adults, it cannot be ruled out that there may be a greater sensitivity to desvenlafaxina.

Children and adolescents

Desvenlafaxina should not be used normally in children and adolescents. Additionally, you should know that, in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes this medication may prescribe it to patients under 18 years when they decide it is the best option for the patient. If the doctor who prescribes this medication to a patient under 18 years 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 when these patients under 18 years are taking Desvenlafaxina.

Furthermore, the long-term effects of this medication on safety, growth, maturity, and cognitive and behavioral development have not yet been demonstrated.

Other medications and Desvenlafaxina Alter

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

It is especially important to inform your doctor if you are taking any of the following medications:

• monoamine oxidase inhibitors (MAOIs), for example, medications containing linezolid (an antibiotic used to treat infections) and methylene blue (see the section “Do not take Desvenlafaxina Alter”).
• other medications containing venlafaxina or desvenlafaxina (also used to treat depression).
• triptans (used for migraines).
• medications to treat depression, for example, tricyclic antidepressants, amphetamines, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin and norepinephrine reuptake inhibitors (SNRIs).
• medications containing sibutramine (used for weight loss).
• pain medications, for example, those containing tramadol, fentanyl, and its analogs, tapentadol, meperidine, methadone (also used to treat opioid withdrawal and dependence), and pentazocine.
• medications containing dextromethorphan (used for coughs).
• 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).
• medications 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)

Rarely, a condition called serotonin syndrome or reactions similar to NMS may occur, causing significant changes in brain, muscle, and digestive system function due to elevated serotonin levels in the body. This potentially life-threatening state may occur when taking medications like Desvenlafaxina, especially when taken with other medications mentioned above.

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

Switching antidepressants

When switching from another antidepressant to desvenlafaxina, withdrawal symptoms from the initial antidepressant may occur. Your doctor may reduce your dose of the initial antidepressant gradually to help minimize 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 having taken desvenlafaxina, even several days after stopping treatment.

Taking Desvenlafaxina Alter with food, drinks, and alcohol

Desvenlafaxina Alter tablets can be taken with or without food. You should avoid taking alcohol while using this medication.

Pregnancy, breastfeeding, and fertility

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

If you take desvenlafaxina in the final stages of pregnancy, there may be a higher risk

of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medication to be able to advise you. When taking similar medications (SSRIs) during pregnancy, there may be an increased risk of a severe condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe more rapidly and turn blue. These symptoms usually begin within the first 24 hours after birth. If your baby has these symptoms, contact your doctor and/or midwife immediately.

If you take Desvenlafaxina during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms when born. These symptoms may appear immediately 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.

Desvenlafaxina passes into breast milk. There is a risk of an effect on the baby. Therefore, do not use Desvenlafaxina during breastfeeding unless your doctor specifically advises you to do so.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as 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 Desvenlafaxina.

This medication 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.

Do not worry if you observe the structure of a tablet in your stool after taking Desvenlafaxina Alter.As the tablet travels along your gastrointestinal tract, the active ingredient desvenlafaxine is released slowly. The tablet structure does not dissolve and is eliminated in the stool. Therefore, despite the fact that it is possible that the tablet structure may appear in your stool, you will have absorbed your dose of desvenlafaxine.

If you take more Desvenlafaxina Alter than you should

Immediately contact your doctor or pharmacist if you take more Desvenlafaxina than your doctor has prescribed.

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

If you forgot to take Desvenlafaxina Alter

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 treatment with Desvenlafaxina Alter

Do not stop taking Desvenlafaxina, or change the dose, without your doctor's indication, even if you feel better. Your doctor prefers to gradually reduce the dose of Desvenlafaxina to avoid adverse effects. It is known that patients experience adverse effects when they stop taking this medication, especially if they have taken a high dose and for a prolonged period. Some of these adverse effects are: dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares, and excessive sweating. Therefore, the dose should be reduced gradually whenever possible, and under medical supervision, if you and your doctor decide to interrupt treatment with Desvenlafaxina.

If you experience any of these or other symptoms that bother you, consult your doctor (see the "Warnings and precautions" section).

If you have any other doubts about the use of this medication, ask 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 symptoms, 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 blurred 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.

Side effect list

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 frequent: affects more than 1 in 10 patients

Frequent: affects between 1 and 10 in 100 patients

Rare: affects between 1 and 10 in 1,000 patients

Rare: affects between 1 and 10 in 10,000 patients

Unknown frequency: (cannot be estimated from available data)

Immune system disorders

Rare: allergic reaction

Metabolism and nutrition disorders

Frequent: loss of appetite

Rare: hyponatremia (decreased sodium concentration in blood)

Psychiatric disorders

Very frequent: insomnia

Frequent: withdrawal syndrome, anxiety, nervousness, rare dreams, irritability, decreased libido, absence of orgasm

Rare: distorted self-image and reality, abnormal orgasm

Rare: mania (state of overexcitement, feeling of euphoria or hyperirritability), hypomania (state of excessive excitement and activity), and hallucinations

Nervous system disorders

Very frequent: dizziness, headache, somnolence

Frequent:shakiness, numbness and tingling, attention deficit, altered sense of taste

Rare: loss of consciousness, abnormal movements (dyskinesia)

Rare:serotonin syndrome (characterized by symptoms such as agitation, altered consciousness, confusion, coma, palpitations, increased blood pressure, elevated body temperature, excessive sweating, lack of coordination, muscle spasms or rigidity, shakiness, nausea, vomiting, and diarrhea), seizures (convulsions), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye disorders

Frequent: dilated pupils, blurred vision

Ear disorders

Frequent: ringing, sensation of vertigo

Cardiac disorders

Frequent: rapid heart rate, palpitations (sensation of rapid, irregular, or strong heartbeat)

Vascular disorders

Frequent: high blood pressure, hot flashes

Rare: peripheral coldness, low blood pressure upon changing position

Respiratory disorders

Frequent: yawning

Rare: nasal bleeding

Gastrointestinal disorders

Very frequent: nausea, dry mouth, constipation

Frequent: vomiting, diarrhea

Rare: acute pancreatitis (inflammation of the pancreas)

Skin and subcutaneous tissue disorders

Very frequent: excessive sweating

Frequent: skin rash

Rare: total or partial hair loss

Rare:Stevens-Johnson syndrome (erythema multiforme, a hypersensitivity reaction affecting the skin and mucous membranes), swelling under the skin, light sensitivity

Musculoskeletal disorders

Frequent: muscle stiffness

Renal and urinary disorders

Rare: difficulty urinating, urinary retention, proteinuria

Reproductive system disorders

Frequent: erectile dysfunction, delayed ejaculation, ejaculatory insufficiency

Rare: sexual dysfunction, ejaculation disorder

Unknown frequency: excessive postpartum vaginal bleeding (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information

General disorders

Frequent: fatigue, weakness, chills, feeling of unease

Medical tests and evaluations

Frequent:abnormal liver function tests, weight gain, weight loss, blood pressure

Rare: increased cholesterol levels in blood, increased triglyceride levels in blood, increased prolactin levels in blood

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 the Spanish 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 (EXP) that appears on the packaging and blister, after EXP. 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your 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 Alter

• The active ingredient is desvenlafaxine (as desvenlafaxine benzoate).

• Each tablet contains 50 mg of desvenlafaxine (as desvenlafaxine benzoate).

• The other components are: hypromellose, microcrystalline cellulose, talc, stearic acid, magnesium stearate, and anhydrous colloidal silica.

The coating film of the 50 mg tablets contains: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, and iron oxides yellow and red (E172).

Appearance of the product and content of the packaging

Clear pink, biconvex, round tablet. The tablet dimensions are 9.6 ± 0.2 mm.

Desvenlafaxina Alter 50 mg is available in a pack of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia (Malta)

Last review date of this leaflet: March 2022

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/