Prospect: information for the patient

desvenlafaxine cinfa 100 mg prolonged-release tablets EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 prospect. See section 4.

Desvenlafaxine cinfa is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression. People with depression may have low levels of serotonin and noradrenaline (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 noradrenaline in the brain.

This medicine is a treatment for adults.

Do not take desvenlafaxine cinfa:

• 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 a MAOI (for example, linezolid or methylene blue) with other medications such as desvenlafaxine can produce 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 and desvenlafaxine cinfa").

Warnings and precautions

Consult your doctor or pharmacist before starting to take desvenlafaxine.

Consult your doctor if you have had any of the following conditions before taking 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 changes, 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 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 if you are pregnant (see the section Pregnancy and breastfeeding), or if you are 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 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, 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), and seizures). 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 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 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 normally 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 ingesting this type of medication. Despite this, the doctor who prescribes your medication may prescribe this medication to patients under 18 years of age when they decide it is the best option for 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 these patients under 18 years of age who are taking desvenlafaxine.

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 desvenlafaxine cinfa

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:

• monoamine oxidase inhibitors (MAOIs), for example, medications containing linezolid (an antibiotic used to treat infections) and methylene blue (see the section "Do not take desvenlafaxine cinfa").
• 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).
• medications for pain, 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 desvenlafaxine.

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

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

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

Switching antidepressants

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

Taking desvenlafaxine cinfa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

If you take desvenlafaxine in the final stages of pregnancy, there may be a higher risk of excessive bleeding 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.

If you take desvenlafaxine 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.

Desvenlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, do not use desvenlafaxine cinfa 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 machinery until you know how this medication affects you.

Desvenlafaxine cinfa contains yellow orange (E-110).

This medication may cause allergic reactions because it contains aluminum lake FCF yellow orange (E-110).Possible reactions include asthma, especially in patients allergic to aspirin.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist 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 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 desvenlafaxine cinfa than you should

Immediately contact your doctor or pharmacist if you take more than the amount of desvenlafaxine that your doctor has prescribed.

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

If you forgot to take desvenlafaxina cinfa

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 doses.

If you interrupt treatment with desvenlafaxina cinfa

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 gradually whenever possible, 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 section “Warnings and precautions”).

If you have any other doubts 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 medications, such as rashes, swelling of the throat, or difficulty breathing.

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 frequent (may affect more than 1 in 10 patients)

Frequent (may affect up to 1 in 10 patients)

Rare (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 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: distortion of self-image and reality, abnormal orgasm

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

Nervous system disorders

Very frequent: dizziness, headache, somnolence

Frequent: tremors, attention deficit, numbness and tingling, 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

Frequent: dilated pupils, blurred vision

Ear disorders

Frequent: tinnitus, 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 when changing position

Respiratory disorders

Frequent: yawning

Rare: nasal hemorrhages

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: rash

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

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

General disorders

Frequent: fatigue, weakness, chills, feeling of restlessness

Medical tests and evaluations

Frequent: alteration of liver function tests, high blood pressure, weight gain, weight loss

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 conditions for conservation.

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 desvenlafaxine cinfa

The active ingredient is desvenlafaxine. Each tablet contains 100 mg of desvenlafaxine (as benzoate).

The other components are:

Core:hypromellose, microcrystalline cellulose, talc, stearic acid, anhydrous colloidal silica, and magnesium stearate.

Coating:polyvinyl alcohol, titanium dioxide (E-171), macrogol, talc, red iron oxide (E-172), and yellow-orange aluminum lake FCF (E-110).

Appearance of the product and content of the container

Orange-red, round, and biconvex tablets.

The tablets are packaged in OPA/AL/PVC//Aluminum and PVC/PE/PVDC//Aluminum blisters.

Desvenlafaxine cinfa is presented in containers of 28 prolonged-release tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

PharOs MT Ltd

HF62X, Hall Far Industrial Estate,

Birzebbugia BBG3000

Malta

Last review date of this leaflet: April 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86782/P_86782.html

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