Desvenlafaxine Neuraxpharm 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desvenlafaxine Neuraxpharm 50 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Desvenlafaxine Neuraxpharm contains the active substance desvenlafaxine (as benzoate).

This medicine 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.

The way antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline in the brain.

Desvenlafaxine is a treatment for adults.

2. What you need to know before taking Desvenlafaxine Neuraxpharm

Do not take Desvenlafaxine Neuraxpharm:

• if you are allergic to desvenlafaxine, venlafaxine, or any of the other ingredients of this medicine (listed in section 6).
• if you are currently taking or have taken within the last 14 days a medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression, infections, or Parkinson’s disease. Taking an MAOI (e.g., linezolid or methylene blue) together with medicines such as Desvenlafaxine may cause serious or even potentially fatal side effects. In addition, you must wait at least 7 days after stopping Desvenlafaxine before starting any MAOI (see also the sections “Serotonin syndrome” and “Other medicines and Desvenlafaxine Neuraxpharm”).

Warnings and precautions

Talk to your doctor if you have previously experienced any of the following conditions or if any of these occur during treatment with this medicine:

• if you or a family member has a history of or has had mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or bipolar disorder (extreme mood swings, for example, shifting 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 hypertension or high blood pressure.
• 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 bleed easily), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility), or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or other medicines that may increase the risk of bleeding when used together 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 disorder that can be serious and, rarely, fatal).
• if treatment is stopped abruptly, withdrawal symptoms may occur (e.g., mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (ringing in the ears), and seizures (convulsions)). Therefore, it is important to gradually reduce the dose of Desvenlafaxine under medical supervision whenever you and your doctor decide to discontinue treatment.

Some medicines in the same class as Desvenlafaxine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Desvenlafaxine may cause a feeling of restlessness or inability to sit or remain still during the first weeks of treatment. Inform your doctor if this occurs.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.

You may be more likely to have such thoughts:

• 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 (under 25 years of age) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go directly to a hospital.

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Medicines such as desvenlafaxine (called SNRIs/SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Dry mouth

Dry mouth has been reported in 18% of patients treated with desvenlafaxine. This may increase the risk of dental caries. Therefore, you should take care with your oral hygiene.

Elderly patients

In some elderly patients, increased sensitivity to desvenlafaxine cannot be ruled out.

Children and adolescents

This medicine should not normally be used in children and adolescents under 18 years of age.

In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and anger) when taking this type of medicine.

Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is the most appropriate 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 contact your doctor again. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking this medicine. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development, have not yet been established.

Other medicines and Desvenlafaxine Neuraxpharm

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

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

• monoamine oxidase inhibitors (MAOIs), for example, medicines containing linezolid (an antibiotic used to treat infections) and methylene blue (see section “Do not take Desvenlafaxine Neuraxpharm”).
• other medicines containing venlafaxine or desvenlafaxine (also used in the treatment of depression).
• triptans (used for migraine).
• medicines for depression, for example, tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• medicines containing sibutramine (used for weight loss).
• pain medicines, for example, those containing tramadol, fentanyl and its analogs, tapentadol, meperidine, methadone (also used for treatment of narcotic withdrawal syndrome and opioid dependence), and pentazocine.
• medicines containing dextromethorphan (used for cough).
• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression).
• products containing tryptophan (used for problems such as sleep and depression).
• medicines containing ketoconazole (an antifungal).
• In addition, 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, 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 such as desvenlafaxine, particularly if taken together with other medicines mentioned above.

Refer to the section “Warnings and precautions” for possible adverse effects related to serotonin syndrome or reactions similar to NMS.

Switching antidepressants

When switching treatment from another antidepressant to desvenlafaxine, withdrawal symptoms from the initial antidepressant may occur. Your doctor may gradually reduce the dose of your initial antidepressant medication to help minimize these symptoms.

Interference with laboratory tests

False positive results for certain substances such as phencyclidine (PCP) and amphetamines may occur in urine tests of patients taking or who have recently taken desvenlafaxine, even several days after discontinuation of treatment.

Use of Desvenlafaxine Neuraxpharm with food, drinks, and alcohol

The tablets of this medicine can be taken with or without food.

You should avoid drinking alcohol while using this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor or midwife should be aware that you are taking this medicine. When similar medicines (SSRIs) are taken during pregnancy, there may be an increased risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If your baby shows these symptoms, contact your doctor and/or midwife immediately.

If you take Desvenlafaxine Neuraxpharm during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms after birth. These symptoms may appear shortly after delivery and may require hospitalization. Symptoms include difficulty feeding or breathing problems. If your baby has these or other symptoms at birth and you are concerned, contact your doctor and/or midwife.

If you take Desvenlafaxine in the late 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 and/or midwife should be aware that you are taking desvenlafaxine so they can advise you accordingly.

Desvenlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, do not use this medicine during breastfeeding unless specifically instructed by your doctor.

Driving and using machines

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

3. How to take Desvenlafaxine Neuraxpharm

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

The recommended dose is 50 mg once daily. Your doctor may increase your dose up to 100 mg once daily, or even up to a maximum of 200 mg once daily 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 this medicine.

Desvenlafaxine Neuraxpharm should be taken orally, approximately at the same time each day. The tablets must be swallowed whole with liquid and must not be divided, crushed, chewed, or dissolved.

If you take more Desvenlafaxine Neuraxpharm than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than prescribed.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desvenlafaxine Neuraxpharm

If you have missed 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 your next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Desvenlafaxine Neuraxpharm

Do not stop taking desvenlafaxine or change the dose without your doctor's instruction, even if you feel better.

If your doctor considers that you no longer need to take desvenlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely.

It is known that patients may experience adverse effects when stopping this medicine, especially if they have taken a high dose for a prolonged period, or when treatment is stopped abruptly or the dose is reduced too quickly.

These adverse effects include: mood changes, agitation, sensory disturbances (tingling or electric shock sensations), confusion, emotional lability, insomnia, hypomania, tinnitus, seizures, dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares, and excessive sweating.

Although these symptoms are generally self-limiting, cases of severe withdrawal symptoms have been reported. Therefore, the dose should be gradually reduced whenever possible, under medical supervision, if you and your doctor decide to discontinue treatment with Desvenlafaxine. If you experience any of these or other bothersome symptoms, consult your doctor.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Desvenlafaxine may cause adverse effects, although not everyone experiences them.

Serious adverse effects

If you notice any of the following signs, tell your doctor immediately or go to the nearest hospital:

• heart problems, such as rapid heartbeat, increased blood pressure, or chest pain.
• eye problems, such as blurred vision.
• nervous system problems, such as dizziness, numbness and tingling, movement disorders (e.g., involuntary muscle movements, restlessness), seizures or fits.
• psychiatric problems, such as hyperactivity and euphoria.
• drug allergy, such as skin rash, swelling of the throat, or breathing difficulties.

List of possible adverse effects

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

Very common adverse effects: affect more than 1 in 10 patients

• Insomnia
• Dizziness, headache
• Nausea
• Dry mouth
• Constipation
• Excessive sweating

Common adverse effects: affect up to 1 in 10 patients

• Loss of appetite

• Anxiety

• Restlessness

• Absence of orgasm

• Decreased libido

• Nightmares

• Drowsiness

• Tremors

• Attention deficit

• Numbness and tingling

• Disturbance of taste sensation

• Pupil dilation

• Blurred vision

• Tinnitus (ringing in the ears)

• Sensation of dizziness or vertigo

• Rapid heartbeat

• Palpitations (sensation of rapid, irregular, or strong heartbeat)

• Hot flushes

• Yawning

• Vomiting

• Diarrhea

• Skin rash

• Muscle stiffness

• Erectile dysfunction

• Delayed ejaculation

• Ejaculatory failure

• Fatigue, weakness

• Chills, restlessness

• Irritability

• High blood pressure

• Weight gain, weight loss

Uncommon adverse effects: affect up to 1 in 100 patients

• Allergic reaction
• Distortion of self-image and reality
• Abnormal orgasm
• Withdrawal syndrome
• Loss of consciousness
• Sensation of cold in the extremities
• Low blood pressure upon changing position (orthostatic hypotension)
• Nosebleeds
• Complete or partial hair loss
• Difficulty urinating, urinary retention, protein in urine
• Sexual dysfunction, ejaculation disorder
• Increased blood cholesterol levels
• Abnormal liver function tests
• Increased triglyceride levels
• Increased prolactin levels

Rare adverse effects: affect up to 1 in 1000 patients

• Hyponatremia (low sodium concentration in the blood)
• Hallucinations
• Hypomania (a state of exaggerated excitement and activity) and mania (a state of overexcitement, feelings of euphoria or hyperirritability)
• Seizures (fits)
• Movement disorders (e.g., involuntary muscle movements, restlessness)
• Swelling under the skin
• Light sensitivity

Frequency not known: cannot be estimated from available data

• Serotonin syndrome (characterized by symptoms such as 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
• Stevens-Johnson syndrome (multiform erythema, a hypersensitivity reaction affecting the skin and mucous membranes)
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desvenlafaxine Neuraxpharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desvenlafaxine Neuraxpharm

The active substance is desvenlafaxine (as benzoate).

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

The other components are: hypromellose type 2208, 100 Pa.s (E464), microcrystalline cellulose (E460), talc (E553b), stearic acid (E570), magnesium stearate (E470b), colloidal anhydrous silica (E551).

The coating film of the 50 mg tablets consists of: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxides (E172) and red iron oxide (E172).

Appearance of the product and contents of the pack

Light pink, round, biconvex tablets with a diameter of 9.6 ± 0.2 mm.

Packed in aluminium_PVC/PE/PVdC or aluminium_OPA/Alu/PVC blisters.

Desvenlafaxine Neuraxpharm 50 mg is available in packs containing 10, 20, 28, 30, 50 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

This medicinal product is authorised in the EEA Member States under the following names:

Germany: Desveneurax 50 mg Retardtabletten

Portugal: Faxilex

Spain: Desvenlafaxina Neuraxpharm 50 mg comprimidos de liberación prolongada EFG

Italy: Faxilex

Austria: Desveneurax 50 mg Retardtabletten

Date of the most recent review of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es