Product Information for the Patient

Desvenlafaxine Normon 50 mg Extended-Release Tablets EFG

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, 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 you should not give it 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 product information. See section 4.

1. What isDesvenlafaxine Normonand for what it is used

2. What you need to know before starting to takeDesvenlafaxine Normon

3. How to takeDesvenlafaxine Normon

4. Possible adverse effects

5. Storage ofDesvenlafaxine Normon

6. Contents of the package and additional information

Desvenlafaxina Normon 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. The exact way that antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenalina in the brain.

Desvenlafaxina is a treatment for adults.

Do not take Desvenlafaxina Normon:

Warnings and precautions

Consult your doctor if you have experienced any of the following conditions before starting to take desvenlafaxina or if they appear during treatment with desvenlafaxina:

Some medications 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.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have thought about 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 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 may 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 they may be more sensitive to desvenlafaxina.

Children and adolescents

Desvenlafaxina should not be used in children and adolescents. Additionally, you should know that, in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal behavior, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. However, the doctor who prescribes your medication may prescribe this medication to patients under 18 years of age when they decide it is in the best interest of the patient. If the doctor who prescribes your medication has prescribed this medication to a patient under 18 years of age 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 patients under 18 years of age who 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 Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

Rarely, desvenlafaxina may produce 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 life-threatening state can 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 have appeared. Your doctor may reduce your initial antidepressant medication 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 desvenlafaxina, even several days after stopping treatment.

Taking Desvenlafaxina Normon with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 desvenlafaxina to advise you. When taking similar medications (SSRIs) during pregnancy, there may be an increased risk of a severe 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.

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

If you take desvenlafaxina during the middle of pregnancy to 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 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

Desvenlafaxina may cause dizziness, somnolence, and blurred vision. Do not drive or operate tools or machines 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 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 desvenlafaxina.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 Normon 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 the Toxicological Information Service, Tel. 91 562 04 20.

If you forgot to take Desvenlafaxina Normon

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 Normon

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, 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 "Warnings and precautions" section). In some patients, complete discontinuation of the medication may take months or even longer.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 go to 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), convulsions, or seizures.
• psychiatric problems, such as hyperactivity and euphoria.
• allergic reactions to medicines, such as rashes, swelling of the throat, or difficulty breathing.

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 commonaffects more than 1 in 10 patients

Commonaffects between 1 and 10 in 100 patients

Rareaffects between 1 and 10 in 1,000 patients

Rareaffects 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

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.

Rare: distortion of 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 common: headache, dizziness, somnolence.

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

Rare: 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), convulsions (seizures), movement disorders (e.g., involuntary muscle movements, restlessness).

Eye disorders

Common: blurred vision, dilated pupils.

Ear disorders

Common: sensation of vertigo, tinnitus.

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.

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

Respiratory disorders

Common: yawning.

Rare: nasal bleeding.

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: 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

Common: muscle stiffness.

Renal and urinary disorders

Rare: urinary retention, difficulty urinating, proteinuria.

Reproductive system disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory insufficiency.

Rare: ejaculation disorder, sexual dysfunction.

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

General disorders

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

Medical tests and evaluations

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

Rare:increased levels of cholesterol in the blood, increased levels of triglycerides in the blood, increased levels of prolactin hormone in the 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 Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desvenlafaxina Normon

The active ingredient is desvenlafaxine.

Each tablet contains 50 mg of desvenlafaxine.

The other components are: hypromellose, microcrystalline cellulose, talc, magnesium stearate, alginic acid, citric acid monohydrate, and povidone.

The coating film of the 50 mg tablets contains: hypromellose, titanium dioxide (E171), macrogol, talc, and iron oxide red (E172).

Appearance of the product and contents of the packaging

Pinkish clear tablet, diamond-shaped, biconvex with "11I" on one side and flat on the other. Approximately 12 mm in length and 9 mm in width.

Desvenlafaxina Normon 50 mg prolonged-release tablets EFG are available in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid (Spain)

Last review date of this leaflet: February 2024

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