Prospect: information for the patient

Desvenlafaxine Stada 50 mg prolonged-release tablets EFG

Desvenlafaxine Stada 100 mg prolonged-release tablets EFG

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to other people, 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 prospect. See section 4.

1.What is Desvenlafaxine Stada and what is it used for

2.What you need to know before starting to take Desvenlafaxine Stada

3.How to take Desvenlafaxine Stada

4.Possible adverse effects

5.Storage of Desvenlafaxine Stada

6.Contents of the pack and additional information

Desvenlafaxina Stada 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 noradrenalina (also known as norepinephrine) in the brain. It is not fully understood how antidepressants work, but they may help increase the levels of serotonin and noradrenalina in the brain. Desvenlafaxina is a treatment for adults.

Do not take Desvenlafaxina Stada:

-If you are allergic to desvenlafaxine, venlafaxine, or any of the other ingredients in 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 desvenlafaxine can cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping desvenlafaxine before taking any MAOI (see also the sections “Serotonin Syndrome” and “Other Medications”).

Warnings and Precautions

Consult your doctor if you have had any of the following conditions before starting to take desvenlafaxine or if they occur during treatment with desvenlafaxine:

-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 a heart attack.

-If you have a history of seizures (convulsions).

-If you have a history of bleeding disorders (tendency to develop bruises), or if you are pregnant (see the section Pregnancy, breastfeeding, and fertility) or using nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and other medications that may increase the risk of bleeding when used with 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 rigidity, tremors, nausea, vomiting, and diarrhea. Contact your doctor immediately, as you may be experiencing serotonin syndrome (a condition that can be severe and, in rare cases, potentially life-threatening).

-If you stop treatment abruptly, you may experience withdrawal symptoms (for example, mood changes, irritability, agitation, dizziness, anxiety, confusion, headaches, sleep disturbances, tinnitus (ringing in the ears), seizures, visual problems, and hypertension). Therefore, it is essential to gradually reduce the dose of desvenlafaxine under medical supervision whenever you and your doctor decide to discontinue treatment.

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

Thoughts of suicide and worsening of depression or anxiety disorder

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 to take 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 had previous thoughts of suicide or self-harm.

-If you are a young adult. Clinical trial data have 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 worsening, or if they are concerned about changes in your behavior.

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 adults

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

Children and adolescents

Desvenlafaxine should not be used 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, if 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 in these patients under 18 years taking desvenlafaxine. Furthermore, the long-term effects of this medication on safety, growth, maturity, and cognitive and behavioral development have not yet been demonstrated.

Use of Desvenlafaxina Stada with other medications

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 Stada”).

-other medications containing venlafaxine or desvenlafaxine (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, opioids such as tramadol, fentanyl, and its analogs, tapentadol, meperidine, methadone (also used for opioid withdrawal and dependence treatment), 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 desvenlafaxine.

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

Occasionally, a condition called serotonin syndrome or reactions similar to SNM may occur, causing significant changes in brain, muscle, and digestive system function due to high levels of serotonin in the body. This potentially life-threatening state may occur when taking medications like desvenlafaxine, 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 SNM.

Switching antidepressants

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

Taking Desvenlafaxina Stada with food, drinks, and alcohol

Desvenlafaxine tablets can be taken with or without food.

Avoid taking alcohol while using desvenlafaxine.

Pregnancy, breastfeeding, and fertility

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

If you take desvenlafaxine in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking desvenlafaxine 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 faster and turn blue. These symptoms usually start within the first 24 hours after birth. If your baby has these symptoms, contact your doctor and/or midwife immediately.

Inform your doctor before stopping treatment with desvenlafaxine during pregnancy, as you may experience a relapse of depression.

If you take desvenlafaxine during the second half of pregnancy until the end, there may be an increased risk of high blood pressure and protein in the urine (preeclampsia). There may also be an increased risk of bleeding after delivery (postpartum hemorrhage).

If you take desvenlafaxine during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms when born. These symptoms may occur shortly after birth and may require hospitalization. Symptoms may include 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.

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

Driving and operating machinery

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

Desvenlafaxina Stada 100 mg contains Sunset Yellow FCF (E110).

This medication may cause allergic reactions because it contains Sunset Yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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 as you may need to take a different dose of desvenlafaxine.

Desvenlafaxine 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 desvenlafaxine.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 Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service. Telephone 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Desvenlafaxina Stada

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 Stada

Do not stop taking desvenlafaxine, or change the dose, without your doctor's indication, even if you feel better. Your doctor prefers to gradually reduce the dose of desvenlafaxine to avoid adverse effects. It is known that patients experience adverse effects when they stop taking desvenlafaxine, 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 slowly, and under medical supervision, if you and your doctor decide to interrupt treatment with desvenlafaxine. If you experience any of these or other symptoms that bother you, consult your doctor (see the section "Warnings and precautions"). In some patients, complete discontinuation of the medication may take months or even longer.

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.

-allergic reactions to medications, 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 commonaffect more than 1 in 10 patients

Commonaffect between 1 and 10 in 100 patients

Uncommonaffect between 1 and 10 in 1,000 patients

Rareaffect between 1 and 10 in 10,000 patients

Unknown frequency (cannot be estimated from available data)

Immune system disorders

Uncommon: allergic reaction.

Metabolism and nutrition disorders

Common: loss of appetite.

Rare: hyponatremia (decreased sodium concentration in blood).

Psychiatric disorders

Very common: insomnia.

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

Uncommon: distortion of self-image and reality, abnormal orgasm.

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

Nervous system disorders

Very common: headache, dizziness, somnolence.

Common: tremors, numbness and tingling, attention deficit, alteration of taste.

Uncommon: loss of consciousness, abnormal movements (dyskinesia).

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

Eye disorders

Common: blurred vision, dilated pupils.

Ear and labyrinth disorders

Common: tinnitus, sensation of vertigo.

Cardiac disorders

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

Rare: heart problems often caused by stressful situations (Takotsubo cardiomyopathy)

Vascular disorders

Common: high blood pressure, hot flashes.

Uncommon: low blood pressure when changing position, peripheral coldness.

Respiratory disorders

Common: yawning.

Uncommon: nasal hemorrhages.

Gastrointestinal disorders

Very common: nausea, dry mouth, constipation.

Common: diarrhea, vomiting.

Rare: acute pancreatitis (inflammation of the pancreas).

Skin and subcutaneous tissue disorders

Very common: excessive sweating.

Common: skin rash.

Uncommon: total or partial hair loss.

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

Musculoskeletal disorders

Common: muscle stiffness.

Renal and urinary disorders

Uncommon: urinary retention, difficulty urinating, proteinuria.

Reproductive system and breast disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory insufficiency.

Uncommon: ejaculation disorder, sexual dysfunction.

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

General disorders

Common: fatigue, weakness, chills, feeling of restlessness.

Investigations and medical evaluations

Common: alteration of liver function tests, increased weight, weight loss, high blood pressure.

Uncommon: 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 box and on the blister pack 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 Stada

• The active ingredient is desvenlafaxine (as benzoate).

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

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

• The other components are: hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), stearic acid (E570), magnesium stearate (E470b), and anhydrous colloidal silica (E551).

The coating of Desvenlafaxina Stada 50 mg contains: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

The coating of Desvenlafaxina Stada 100 mg contains: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide (E172), and yellow-orange S (E110).

Appearance of the product and content of the packaging

Desvenlafaxina Stada 50 mg are pale pink, biconvex, and round tablets, with an approximate diameter of 9.6 mm ± 0.2 mm.

Desvenlafaxina Stada 100 mg are orange-red, biconvex, and round tablets, with an approximate diameter of 10.1 mm ± 0.2 mm.

This medication is available in blisters and single-dose blisters of Aluminio-OPA/Alu/PVC and Aluminio-PVC/PE/PVdC in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

Last review date of this leaflet: September 2024

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