DESVENLAFAXINE NEURAXPHARM 100 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take 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 also taking or have taken within the last 14 days, any medicinal product 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) with other medicines like Desvenlafaxine may cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after you stop taking Desvenlafaxine before you take any MAOI (see also the sections "Serotonin syndrome" and "Other medicines and Desvenlafaxine Neuraxpharm").

Warnings and precautions

Tell your doctor if you have had any of the following conditions before taking Desvenlafaxine or if they appear during treatment with this medicine:

• if you or someone in your family has a history of or has had mania (a state of abnormally elevated or irritable mood) or bipolar disorder (extreme mood swings, for example, from depression to mania).
• if you have a history of aggressive behaviour.
• 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 bleed easily), or if you are pregnant (see section Pregnancy, breast-feeding and fertility), or if you are using non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid) and other medicines that may increase the risk of bleeding when used at the same time as desvenlafaxine.
• if you have a history of kidney problems.
• if you have a history of low sodium levels in the blood (hyponatraemia).
• 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 diarrhoea. Contact your doctor immediately, as you may be suffering from serotonin syndrome (a disorder that can be serious and, in rare cases, life-threatening).
• if treatment is stopped abruptly, withdrawal symptoms may appear (e.g. mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (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 group to which Desvenlafaxine belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Desvenlafaxine may cause a feeling of restlessness or inability to sit or stand still during the first few weeks of treatment. You should inform your doctor if this happens to you.

Suicidal thoughts and worsening of your depression

If you are depressed, 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. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with antidepressants.

If you have thoughts of harming or killing yourself 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, 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 behaviour.

Medicines like 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 tooth decay. Therefore, you should be careful with your oral hygiene.

Elderly patients

In some elderly patients, it cannot be ruled out that they may be more sensitive to desvenlafaxine.

Children and adolescents

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

Additionally, you should know that in patients under 18 years old, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behaviour and anger) when they take this type of medicine.

Despite this, your doctor may prescribe this medicine to patients under 18 years old when they decide that it is the best for the patient.

If your doctor has prescribed this medicine to a patient under 18 years old and you want 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 old are taking this medicine. Also, the long-term effects on safety and on growth, maturity and cognitive and behavioural development of this medicine have not yet been demonstrated.

Other medicines and Desvenlafaxine Neuraxpharm

Tell your doctor or pharmacist that you are taking, have recently taken or might 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), e.g. medicines that contain linezolid (an antibiotic used to treat infections) and methylene blue (see the section "Do not take Desvenlafaxine Neuraxpharm").
• other medicines that contain venlafaxine or desvenlafaxine (also used to treat depression).
• triptans (used for migraine).
• medicines for treating depression, e.g. tricyclic antidepressants, 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 and dependence on opiates) and pentazocine.
• medicines that contain dextromethorphan (used for cough).
• products that contain St John's Wort (also called "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).
• Also, if you are being treated by other healthcare professionals, tell 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, which can cause important changes in the functioning of the brain, muscles and digestive system due to high levels of serotonin in the body, may occur. This potentially life-threatening condition may occur when taking medicines like desvenlafaxine, particularly when taken with other medicines mentioned above.

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

Changing antidepressant

When switching treatment from one antidepressant to desvenlafaxine, 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 some substances such as phencyclidine (PCP) and amphetamines may occur in urine analysis of patients who are taking or have taken desvenlafaxine, even several days after stopping treatment.

Using 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 taking this medicine.

Pregnancy, breast-feeding and fertility

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

Your doctor or midwife should know that you are taking this medicine. When similar medicines (SSRIs) are taken during pregnancy, there is an increased risk of a serious 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 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 Desvenlafaxine Neuraxpharm 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.

If you take Desvenlafaxine in the last trimester 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 know that you are taking desvenlafaxine so that they can advise you.

Desvenlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, do not use this medicine during breast-feeding, unless your doctor specifically advises you to do so.

Driving and using machines

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

Desvenlafaxine Neuraxpharm 100 mg contains Orange Yellow (E 110)

Desvenlafaxine Neuraxpharm 100 mg tablets may cause allergic reactions.

3. How to take Desvenlafaxine Neuraxpharm

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

Desvenlafaxine Neuraxpharm 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.

If you take more Desvenlafaxine Neuraxpharmthan you should

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

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

If you forget to take Desvenlafaxine Neuraxpharm

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 you would normally.

If you stop taking Desvenlafaxine Neuraxpharm

Do not stop taking Desvenlafaxine, or change your dose, without talking to your doctor first, even if you feel better.

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

It is known that patients experience side effects when they stop taking this medicine, especially if they have taken a high dose and for a long period or when treatment is stopped abruptly or the dose is reduced too quickly.

These side effects are: mood changes, agitation, sensory changes (feeling of tingling or electric shock), confusion, emotional instability, insomnia, hypomania, ringing in the ears, seizures, dizziness, nausea, headache, fatigue, irritability, diarrhoea, anxiety, nightmares and excessive sweating.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Desvenlafaxina can produce 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 skin 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 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
• Nervousness
• Orgasm absence
• Decreased libido
• Nightmares
• Somnolence
• Tremors
• Attention deficit
• Numbness and tingling
• Altered sense of taste
• Pupil dilation
• Blurred vision
• Tinnitus
• Vertigo sensation
• Rapid heart rate
• Palpitations (sensation of rapid, irregular, or strong heartbeat)
• Hot flashes
• Vomiting
• Diarrhea
• Skin rash
• Muscle stiffness
• Erectile dysfunction
• Delayed ejaculation
• Ejaculation failure

• Fatigue, weakness
• Chills, nervousness
• 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
• Cold sensation in the extremities
• Low blood pressure when changing position
• Nasal bleeding
• Total or partial hair loss
• Difficulty urinating, urinary retention, protein in the urine
• Sexual dysfunction, ejaculation disorder
• Increased cholesterol levels in the blood
• Liver test alterations
• Increased triglyceride values
• Increased prolactin hormone values

Rare Adverse Effects: affect up to 1 in 1000 patients

• Hyponatremia (decreased sodium concentration in blood)
• Hallucinations
• Hypomania (state of excitement and exaggerated activity) and mania (state of overexcitement, feeling of euphoria, or hyperirritability)
• Seizures (attacks)
• 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 stiffness
• Tremors
• Nausea
• Vomiting and diarrhea
• Stevens-Johnson syndrome (erythema multiforme consisting of a hypersensitivity reaction affecting the skin and mucous membranes)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information

Reporting 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Desvenlafaxina Neuraxpharm

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 via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Desvenlafaxina Neuraxpharm

The active ingredient is desvenlafaxine (as benzoate).

Each tablet contains 100 mg of desvenlafaxine (as benzoate).

The other components are: hypromellose (E 464), microcrystalline cellulose (E460), talc (E553b), stearic acid (E570), magnesium stearate (E470b), anhydrous colloidal silica (E551).

The coating film consists of: Poly (vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172), and orange yellow S (E 110).

Appearance of the Product and Package Contents

Orange-red, round, biconvex tablet with a diameter of 10.1 ± 0.2 mm.

Packaged in Aluminum_PVC/PE/PVdC or Aluminum_OPA/Alu/PVC blisters.

Desvenlafaxina Neuraxpharm 100 mg is available in packages of 10, 28, 30, 50, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicine is authorized in EEA member states with the following names:

Germany: Desveneurax 100 mg Retardtabletten

Portugal: Faxilex

Spain: Desvenlafaxina Neuraxpharm 100 mg prolonged-release tablets EFG

Italy: Faxilex

Austria: Desveneurax 100 mg Retardtabletten

Date of the Last Revision of this Leaflet:December 2021

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