DESVENLAFAXINE CINFA 50 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information: Summary of Product Characteristics

desvenlafaxina cinfa 50 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is desvenlafaxina cinfa and what is it used for
2. What you need to know before you take desvenlafaxina cinfa
3. How to take desvenlafaxina cinfa
4. Possible side effects
5. Storing desvenlafaxina cinfa
6. Contents of the pack and other information

1. What is desvenlafaxina cinfa and what is it used for

Desvenlafaxina 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 lower levels of serotonin and noradrenaline (also known as norepinephrine) in the brain. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and noradrenaline in the brain.

This medicine is for adult use only.

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

Do not take desvenlafaxina cinfa:

• if you are allergic to desvenlafaxine, 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 methylthioninium chloride) with other medicines like desvenlafaxine can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after stopping desvenlafaxine before taking any MAOI (see also sections “Serotonin syndrome” and “Other medicines and desvenlafaxina cinfa”).

Warnings and precautions

Tell your doctor or pharmacist before you start taking desvenlafaxina.

Tell 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 mania (a state of abnormally elevated or irritable mood) or bipolar disorder (extreme mood swings, 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 (fits).
• 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 condition that can be serious and, in rare cases, potentially life-threatening).
• if treatment is stopped abruptly, withdrawal symptoms may occur (e.g. mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, ringing in the ears and seizures). Therefore, it is important to reduce the dose of desvenlafaxine gradually and under medical supervision, whenever you and your doctor decide to stop treatment.

Some medicines of the same group as desvenlafaxina (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (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 an anxiety disorder, 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 2 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. Clinical trial data have 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 desvenlafaxine. This may increase the risk of tooth decay. Therefore, you should be careful with your oral hygiene.

Elderly patients

In some elderly patients, it may not be possible to rule out increased 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 side effects such as suicidal attempts, hostility (mainly aggression, confrontational behavior and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age when they decide it is the most suitable 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, 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 methylthioninium chloride (see section “Do not take desvenlafaxina cinfa”).
• other medicines that contain venlafaxine or desvenlafaxine (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 neuroleptic malignant syndrome (NMS)-like reactions

Rarely, a condition called serotonin syndrome or NMS-like reactions may occur, which can cause important changes in the functioning of the brain, muscles, and digestive system due to high levels of serotonin in the body. This potentially life-threatening condition may occur when taking medicines like desvenlafaxine, particularly when taken with other medicines mentioned above.

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

Switching antidepressants

When switching treatment from another antidepressant to desvenlafaxina, symptoms of withdrawal from the initial antidepressant have occurred. Your doctor may gradually reduce the dose of your initial antidepressant 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 drinking alcohol while taking 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 late stage 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 be able to advise you. When similar medicines (SSRIs) are taken during pregnancy, there may be an increased risk of a serious condition in 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.

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.

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, tell 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 taking desvenlafaxina.As the tablet travels through your gastrointestinal tract, the active substance desvenlafaxine is slowly released. The tablet structure does not dissolve and is eliminated in the stool. Therefore, even though you may see the tablet structure 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 your dose, without talking to your doctor first, even if you feel better. Your doctor will probably want to gradually reduce your 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, contact your doctor (see section “Warnings and precautions”).

If you have any further questions on 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)

Disorders of the Immune System

Uncommon: allergic reaction

Disorders of Metabolism and Nutrition

Common: loss of appetite

Rare: hyponatremia (decreased sodium concentration in blood)

Psychiatric Disorders

Very Common: insomnia

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

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)

Disorders of the Nervous System

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 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: nosebleeds

Gastrointestinal Disorders

Very Common: nausea, dry mouth, constipation

Common: vomiting, diarrhea

Rare: acute pancreatitis (inflammation of the pancreas)

Disorders of the Skin and Subcutaneous Tissue

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 the urine

Disorders of the Reproductive System

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

Medical Tests and Evaluations

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

Uncommon: increased cholesterol levels in the blood, increased triglyceride values in the blood, increased prolactin hormone values in the 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 is not listed 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 stated 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 disposed of 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 will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Desvenlafaxina Cinfa

The active ingredient is desvenlafaxina. Each tablet contains 50 mg of desvenlafaxina (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, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Packaging Contents

Light pink, round, and biconvex tablets.

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

Desvenlafaxina Cinfa is available in packs 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 the 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/86783/P_86783.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86783/P_86783.html