DESVENLAFAXINE CINFA 100 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take desvenlafaxina cinfa

Do not take desvenlafaxina cinfa:

• if you are allergic to desvenlafaxina, 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 medicines known as monoamine oxidase inhibitors (MAOIs) used to treat depression, infections or Parkinson's disease. Taking an MAOI (e.g. linezolid or methylene blue) with other medicines like desvenlafaxina can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after you stop taking desvenlafaxina before you take any MAOI (see also sections "Serotonin syndrome" and "Other medicines and desvenlafaxina cinfa").

Warnings and precautions

Consult your doctor or pharmacist before starting to take desvenlafaxina.

Consult your doctor if you have had any of the following conditions before taking desvenlafaxina or if they appear during treatment with desvenlafaxina:

• if you or someone in your family has a history of or has had mania (a state of excitement, feeling of euphoria or hyperirritability) or bipolar disorder (extreme mood changes, e.g. 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 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 section Pregnancy and breastfeeding), or if you are using non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and other medicines that may increase the risk of bleeding when used at the same time as 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 stiffness, tremors, nausea, vomiting and diarrhea. Contact your doctor immediately, as you may be suffering from serotonin syndrome (a disorder that can be serious and, in rare cases, potentially life-threatening).
• if treatment is stopped abruptly, withdrawal symptoms may appear (e.g. mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, ringing in the ears (tinnitus) and seizures (convulsions)). Therefore, it is important to gradually reduce the dose of desvenlafaxina 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 symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually around two weeks, but sometimes longer.

You may be more likely to think this way:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric disorders who were treated with antidepressants.

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

You may find it helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried 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 be careful with your oral hygiene.

Elderly patients

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

Children and adolescents

Desvenlafaxina should not normally be used in children and adolescents. Additionally, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, hostility (predominantly aggression, confrontational behavior and irritability) when taking this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking desvenlafaxina.

Additionally, the long-term effects on safety and those related to growth, maturity and cognitive and behavioral development of this medicine have not yet been demonstrated.

Other medicines and desvenlafaxina cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important that you tell your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs), e.g. medicines that contain linezolid (an antibiotic used to treat infections) and methylene blue (see section "Do not take desvenlafaxina cinfa").
• other medicines that contain venlafaxine or desvenlafaxina (also used to treat depression).
• triptans (used for migraine).
• medicines for treating depression, e.g. tricyclic antidepressants, amphetamines, lithium, selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).
• medicines that contain sibutramine (used for weight loss).
• medicines for pain, e.g. those that contain tramadol, fentanyl and its analogues, tapentadol, meperidine, methadone (also used for treatment of narcotic withdrawal syndrome and opioid dependence) and pentazocine.
• medicines that contain dextromethorphan (used for cough).
• products that contain St. John's Wort (also known as Hypericum perforatum, a natural or herbal remedy used to treat mild depression).
• products that contain tryptophan (used for problems such as sleep and depression).
• medicines that contain 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 disorder called serotonin syndrome or reactions similar to NMS may occur, which can cause significant changes in brain, muscle and digestive system function due to high levels of serotonin in the body. This potentially life-threatening condition may occur when taking medicines like desvenlafaxina, particularly when taken with other medicines mentioned above.

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

Switching antidepressants

When switching treatment from another antidepressant to desvenlafaxina, symptoms of withdrawal from the initial antidepressant have appeared. Your doctor may gradually reduce the dose of your initial antidepressant medication to help decrease these symptoms.

Interactions with laboratory tests

False positives for certain substances such as phencyclidine (PCP) and amphetamines may occur in urine analysis of patients who are taking or have taken desvenlafaxina, even several days after stopping treatment.

Taking desvenlafaxina cinfa with food, drinks and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you take desvenlafaxina in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly 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 similar medicines (SSRIs) are taken during pregnancy, there may be an increased risk of a serious effect on the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If your baby has these symptoms, you should contact your doctor and/or midwife immediately.

If you take desvenlafaxina during pregnancy, inform your doctor and/or midwife, as your baby may have withdrawal symptoms when born. These symptoms may appear soon after birth and may require hospitalization. The symptoms include difficulty feeding or breathing 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 cinfa during breastfeeding unless your doctor specifically advises you to.

Driving and using machines

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

Desvenlafaxina cinfacontains orange yellow (E-110)

This medicine may cause allergic reactions because it contains aluminum lake yellow orange (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take desvenlafaxina cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is 50 mg once a day. Your doctor may increase your dose 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 desvenlafaxina.

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

Do not worry if you see the structure of a tablet in your stool after takingdesvenlafaxina.As the tablet travels through your gastrointestinal tract, the active substance desvenlafaxina is slowly released. The tablet structure does not dissolve and is eliminated in the stool. Therefore, even if the tablet structure appears in your stool, you will have absorbed your dose of desvenlafaxina.

If you take more desvenlafaxina cinfa than you should

Contact your doctor or pharmacist immediately if you take more desvenlafaxina than your doctor has prescribed.

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

If you forget to take desvenlafaxina cinfa

If you miss 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 make up for forgotten doses.

If you stop taking desvenlafaxina cinfa

Do not stop taking desvenlafaxina, or change the dose, without talking to your doctor first, even if you feel better. Your doctor will probably want to gradually reduce the dose of desvenlafaxina to avoid side effects. It is known that patients experience side effects when they stop taking desvenlafaxina, especially if they have taken a high dose and for a long period of time. Some of these side effects are: dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares and excessive sweating. Therefore, the dose should be reduced slowly whenever possible, and under medical supervision, in case you and your doctor decide to stop treatment with desvenlafaxina.

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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse 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.
• Drug allergy, such as rash, throat swelling, or breathing difficulties.

List of Possible Adverse Effects

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

Very Common (may affect more than 1 in 10 patients)

Common (may affect up to 1 in 10 patients)

Uncommon (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 patients)

Frequency Not Known (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, strange dreams, irritability, decreased libido, absence of orgasm

Uncommon: 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 Common: dizziness, headache, somnolence

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

Uncommon: 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, tremors, nausea, vomiting, and diarrhea), convulsions (seizures), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye Disorders

Common: pupil dilation, blurred vision

Ear and Labyrinth Disorders

Common: tinnitus, sensation of vertigo

Cardiac Disorders

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

Vascular Disorders

Common: high blood pressure, hot flashes

Uncommon: peripheral coldness, low blood pressure when changing position

Respiratory Disorders

Common: yawning

Uncommon: nasal bleeding

Gastrointestinal Disorders

Very Common: nausea, dry mouth, constipation

Common: vomiting, diarrhea

Rare: acute pancreatitis (inflammation of the pancreas)

Skin and Subcutaneous Tissue Disorders

Very Common: excessive sweating

Common: 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, sensitivity to light

Musculoskeletal Disorders

Common: muscle stiffness

Renal and Urinary Disorders

Uncommon: difficulty urinating, urinary retention, protein in urine

Reproductive System Disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory failure

Uncommon: sexual dysfunction, ejaculation disorder

Frequency Not Known: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and Lactation" in section 2 for more information.

General Disorders

Common: fatigue, weakness, chills, feeling of restlessness

Investigations and Medical Evaluations

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

Uncommon: increased cholesterol levels in blood, increased triglyceride values in blood, increased prolactin hormone values in blood.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Desvenlafaxina Cinfa

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Desvenlafaxina 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 orange-yellow aluminum lacquer (E-110).

Appearance of the Product and Package Contents

Orange-red, round, and biconvex tablets.

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

Desvenlafaxina Cinfa is available in packages of 28 prolonged-release tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

PharOs MT Ltd.

HF62X, Hall Far Industrial Estate,

Birzebbugia BBG3000

Malta

Date of Last Revision of this Prospectus: April 2022

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

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

QR code to: https://cima.aemps.es/cima/dochtml/p/86782/P_86782.html