Desvenlafaxine Stada 100 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desvenlafaxine Stada 50 mg prolonged-release tablets EFG

Desvenlafaxine Stada 100 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. 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 Stada is and what it is used for
2. What you need to know before taking Desvenlafaxine Stada
3. How to take Desvenlafaxine Stada
4. Possible side effects
5. How to store Desvenlafaxine Stada
6. Contents of the pack and other information

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

Desvenlafaxine Stada 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 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 Stada

Do not take Desvenlafaxine Stada:

• 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 like desvenlafaxine may cause serious, potentially life-threatening adverse effects. Additionally, you must wait at least 7 days after stopping desvenlafaxine before starting any MAOI (also see sections “Serotonin syndrome” and “Other medicines”).

Warnings and precautions

Consult your doctor if you have previously experienced any of the following conditions, or if any of these occur while taking desvenlafaxine:

• if you or a family member has a history of or has experienced mania (a state of over-excitation, feelings of euphoria, or extreme irritability) or bipolar disorder (extreme mood swings, such as 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 bruise easily), 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 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 any of 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 experiencing serotonin syndrome (a condition 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 hypertension). 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 may persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from 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 experience such thoughts:

• If you have previously had suicidal thoughts or thoughts of 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 illnesses 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 or have an anxiety disorder, 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.

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 used 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 suicide attempts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be the most appropriate treatment. 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. Inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking desvenlafaxine. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development have not yet been established.

Taking Desvenlafaxine Stada with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 Stada”).
• other medicines containing venlafaxine or desvenlafaxine (also used in the treatment of depression).
• triptans (used for migraine).
• medicines used 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).
• pain medicines, for example opioids such as 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).
• Additionally, 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 condition 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 desvenlafaxine, particularly if taken together with other medicines mentioned above.

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

Switching from another antidepressant

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 stopping treatment.

Taking Desvenlafaxine Stada with food, drinks, and alcohol

Desvenlafaxine tablets can be taken with or without food.

You should avoid alcohol while taking desvenlafaxine.

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.

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 informed that you are taking desvenlafaxine so they can advise you. 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 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 desvenlafaxine during pregnancy, as you may experience a relapse of depression.

If you take desvenlafaxine from the middle of pregnancy until delivery, there may be an increased risk of high blood pressure and protein in the urine (preeclampsia). There may also be an increased risk of bleeding after childbirth (postpartum hemorrhage).

If you take desvenlafaxine during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms after birth. These symptoms may appear immediately after delivery and may require hospitalization. Symptoms may include difficulty feeding or breathing problems. If your baby shows 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 effects on the baby. Therefore, do not use desvenlafaxine during breastfeeding unless specifically instructed by your doctor.

Driving and using machines

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

Desvenlafaxine Stada 100 mg contains sunset yellow FCF (E110).

This medicine can cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Desvenlafaxine Stada

• Take Desvenlafaxine Stada exactly as prescribed by your doctor.
• Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet.
• You can take this medicine with or without food.
• Try to take your dose at approximately the same time each day, as this will help you to remember it.
• Continue taking Desvenlafaxine Stada for as long as your doctor recommends. Do not stop taking it without consulting your doctor, even if you feel better, as your symptoms may return.
• If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

The recommended dose is 50 mg once daily. Your doctor may increase your dose 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 a different dose of desvenlafaxine.

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

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

If you take more Desvenlafaxine Stada 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 your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Desvenlafaxine Stada

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 your next scheduled dose as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Desvenlafaxine Stada

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 avoid the occurrence of adverse effects. It is known that patients may experience adverse effects when stopping desvenlafaxine, especially 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 reduced slowly and 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 (see section “Warnings and precautions”). In some patients, complete discontinuation of the medicine 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, 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, throat swelling, or difficulty breathing.

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: affect more than 1 in 10 patients
Common: affect between 1 and 10 in 100 patients
Uncommon: affect between 1 and 10 in 1,000 patients
Rare: affect between 1 and 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.
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 and labyrinth disorders

Common: tinnitus, sensation of vertigo.

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: skin 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.

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 failure.
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.

Medical tests and evaluations

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 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Desvenlafaxine Stada

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

Do not use this medicine after the expiry date stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Desvenlafaxine Stada

• The active substance is desvenlafaxine (as benzoate).

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

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

• The other components are: hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), stearic acid (E570), magnesium stearate (E470b) and anhydrous colloidal silica (E551).

The coating film of Desvenlafaxine Stada 50 mg contains: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).

The coating film of Desvenlafaxine Stada 100 mg contains: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide (E172) and orange-yellow S (E110).

Nature and contents of the container

Desvenlafaxine Stada 50 mg are light pink, biconvex, round tablets with an approximate diameter of 9.6 mm ± 0.2 mm.

Desvenlafaxine Stada 100 mg are reddish-orange, biconvex, round tablets with an approximate diameter of 10.1 mm ± 0.2 mm.

This medicinal product is available in aluminum-OPA/Alu/PVC and aluminum-PVC/PE/PVdC blisters and unit-dose blisters in pack sizes of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

Date of the most recent revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.