Desvenlafaxine Normon 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desvenlafaxine Normon 50 mg prolonged-release tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Desvenlafaxine Normon is an antidepressant that belongs to a group of medicines known as 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. The exact way antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Desvenlafaxine is a treatment for adults.

2. What you need to know before starting to take Desvenlafaxine Normon

Do not take Desvenlafaxine Normon:

• if you are allergic to desvenlafaxine, to venlafaxine, or to 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 medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression, infections, or Parkinson’s disease. Taking an MAOI (for example linezolid or methylene blue) together with other medicines such as desvenlafaxine may cause serious, and potentially life-threatening, adverse 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”).

Warnings and precautions

Consult your doctor if you have previously experienced any of the following conditions before starting desvenlafaxine, or if any of these occur during treatment with desvenlafaxine:

• if you or a family member 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 (fits).
• if you have a history of bleeding disorders (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breastfeeding and fertility), or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other medications 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 (restlessness and excitability), 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, in rare cases, potentially 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), seizures, visual disturbances, and high blood pressure). 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 (known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may occasionally 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 about 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 treated with antidepressants.

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

It may be helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they notice your depression or anxiety worsening, 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 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

Desvenlafaxine is not normally recommended for use in children and adolescents. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal behavior, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the treating physician may prescribe this medicine to patients under 18 years of age if they decide it is in the patient's best interest. If your physician has prescribed this medication to a patient under 18 years of age and you wish to discuss this decision, please consult your physician again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking desvenlafaxine.

Furthermore, the long-term effects of this medication on safety, as well as on growth, puberty, and cognitive and behavioral development, have not yet been established.

Other medicines and Desvenlafaxine Normon

Inform 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 Normon”).
• other medicines containing venlafaxine or desvenlafaxine (also used in the treatment of depression).
• triptans (used for migraine).
• medicines to treat depression, for example tricyclic antidepressants, amphetamines, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• medicines containing sibutramine (used for weight loss).
• medicines for pain, for example opioids such as those containing tramadol, fentanyl and its analogues, 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 called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression).
• products containing tryptophan (used for conditions such as sleep and depression).
• medicines containing ketoconazole (an antifungal).
• also, if you are being treated by other healthcare professionals, inform them that you are taking desvenlafaxine.

Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions

Rarely, a condition called serotonin syndrome or NMS-like reactions may occur, which can cause significant changes in brain, muscle, and gastrointestinal function due to elevated 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 NMS-like reactions.

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 screening tests of patients who are taking or have recently taken desvenlafaxine, even several days after discontinuation of treatment.

Taking Desvenlafaxine Normon with food, drinks, and alcohol

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

Pregnancy, breastfeeding and fertility

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

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 or midwife should be aware that you are taking desvenlafaxine so they can advise you appropriately. 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 appear blue. These symptoms usually begin within the first 24 hours after birth. If your baby shows these symptoms, contact your doctor and/or midwife immediately.

Inform your doctor before stopping treatment with desvenlafaxine during pregnancy, as you may experience a relapse of depression.

If you take desvenlafaxine from the middle of pregnancy until term, it may increase the risk of high blood pressure and protein in the urine (pre-eclampsia). It may also increase the risk of bleeding after delivery (postpartum haemorrhage).

If you take desvenlafaxine during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms at birth. These symptoms may occur immediately after delivery and may require hospitalisation. Symptoms may include difficulty breastfeeding or breathing problems. If your baby has these or other symptoms at birth and you are concerned, contact your doctor and/or midwife.

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

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.

3. How to take Desvenlafaxine Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 desvenlafaxine.

Desvenlafaxine 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.

Do not be alarmed if you notice the shell of a tablet in your faeces after taking desvenlafaxine. As the tablet passes through your gastrointestinal tract, the active ingredient desvenlafaxine is slowly released. The tablet shell does not dissolve and is eliminated in the faeces. Therefore, even though the tablet shell may appear in your faeces, you will have absorbed your dose of desvenlafaxine.

If you take more Desvenlafaxine Normon than you should

Contact your doctor or pharmacist immediately if you take more desvenlafaxine than prescribed by your doctor.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Tel. 91 562 04 20.

If you forget to take Desvenlafaxine Normon

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 one dose as usual. Do not take a double dose to make up for the missed dose.

If you stop treatment with Desvenlafaxine Normon

Do not stop taking desvenlafaxine or change the dose without first consulting your doctor, even if you feel better. Your doctor will usually recommend gradually reducing the dose of desvenlafaxine to help prevent adverse effects. It is known that patients may experience adverse effects when stopping desvenlafaxine, particularly if they have been taking a high dose for a prolonged period. Some of these adverse effects include: dizziness, nausea, headache, fatigue, irritability, diarrhoea, anxiety, nightmares, and excessive sweating. Therefore, the dose should be tapered gradually and under medical supervision if you and your doctor decide to discontinue treatment with desvenlafaxine.

If you experience any of these or other symptoms that are troublesome, consult your doctor (see section “Warnings and precautions”). In some patients, complete discontinuation of the medication may take months or even longer.

If you have any further 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 everyone will experience 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 rash, swelling of the throat, or breathing difficulties.

List of possible adverse effects

The adverse effects and frequencies (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: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 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: hyponatraemia (reduced sodium concentration in blood).

Psychiatric disorders

Very common: insomnia.
Common: withdrawal syndrome, anxiety, nervousness, unusual dreams, irritability, decreased libido, absence of orgasm.
Uncommon: distortion of self-image and reality, abnormal orgasm.
Rare: mania (a state of overexcitement, feelings of euphoria or hyperirritability), hypomania (a state of exaggerated excitement and activity), and hallucinations.

Nervous system disorders

Very common: headache, dizziness, somnolence (sleepiness).
Common: tremor, numbness and tingling, attention deficit, altered sense of taste.
Uncommon: loss of consciousness, abnormal movements (dyskinesia).
Rare: 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 diarrhoea), seizures (fits), movement disorders (e.g., involuntary muscle movements, restlessness).

Eye disorders

Common: blurred vision, pupil dilation.

Ear disorders

Common: sensation of vertigo, tinnitus (ringing in the ears).

Cardiac disorders

Common: rapid heartbeat, palpitations (sensation of rapid, irregular, or strong heartbeat).
Rare: heart problems often triggered by stressful situations (Takotsubo cardiomyopathy).

Vascular disorders

Common: high blood pressure, hot flushes.
Uncommon: low blood pressure upon changing position, peripheral coldness.

Respiratory disorders

Common: yawning.
Uncommon: nosebleeds.

Gastrointestinal disorders

Very common: nausea, dry mouth, constipation.
Common: diarrhoea, vomiting.
Rare: acute pancreatitis (inflammation of the pancreas).

Skin and subcutaneous tissue disorders

Very common: excessive sweating.
Common: rash.
Uncommon: partial or complete hair loss.
Rare: Stevens-Johnson syndrome (multiform erythema, a hypersensitivity reaction affecting the skin and mucous membranes), swelling under the skin, photosensitivity (sensitivity to light).

Musculoskeletal disorders

Common: muscle stiffness.

Renal and urinary disorders

Uncommon: urinary retention, difficulty urinating, protein in urine.

Reproductive system disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory insufficiency.
Uncommon: ejaculation disorder, sexual dysfunction.
Frequency not known: heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

General disorders

Common: fatigue, weakness, chills, feeling of restlessness.

Investigations and medical tests

Common: abnormal liver function tests, weight gain, weight loss, high blood pressure.
Uncommon: increased blood cholesterol levels, increased blood triglyceride levels, increased blood prolactin levels.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Desvenlafaxine Normon

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 refers to 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 empty containers and unused medicines at the SIGRE collection point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desvenlafaxine Normon

The active substance is desvenlafaxine.

Each tablet contains 50 mg of desvenlafaxine.

The other components are: hypromellose, microcrystalline cellulose, talc, magnesium stearate, alginic acid, citric acid monohydrate and povidone.

The coating film of the 50 mg tablets contains: hypromellose, titanium dioxide (E171), macrogol, talc and iron oxide red (E172).

Appearance of the product and contents of the pack

Light pink coloured tablet, diamond-shaped, biconvex with "11I" on one side and flat on the other. Approximately 9 mm wide and 12 mm long.

Desvenlafaxine Normon 50 mg prolonged-release tablets EFG is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid (Spain)

Date of the most recent review of this leaflet: February 2024

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