DESVENLAFAXINE STADA 100 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you 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 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 methylene blue) with other medicines like desvenlafaxine may cause serious or life-threatening side effects. Also, you must wait at least 7 days after you stop taking desvenlafaxine before you take any MAOI (see also sections “Serotonin syndrome” and “Other medicines”).

Warnings and precautions

Tell your doctor if you have had any of the following conditions before starting to take desvenlafaxine or if they appear during treatment with desvenlafaxine:

• 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 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 if you are pregnant (see section Pregnancy, breast-feeding and fertility) 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 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 levels, 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 condition that can be serious and, in rare cases, 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 (tinnitus), seizures, visual problems and hypertension). 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 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 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 about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

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 behaviour.

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 an increased sensitivity to desvenlafaxine.

Children and adolescents

Desvenlafaxine should not normally be used in children and adolescents. Also, you should know that in patients under 18 years, there is an increased risk of side effects such as suicidal attempts, hostility (mainly aggression, confrontation and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years when they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years 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 are taking desvenlafaxine. Also, the long-term effects on safety, growth, maturity and cognitive and behavioural development of this medicine have not yet been demonstrated.

Using Desvenlafaxine Stada with other medicines

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 containing linezolid (an antibiotic used to treat infections) and methylene blue (see section “Do not take Desvenlafaxine Stada”).
• 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. opioids such as tramadol, fentanyl and its analogues, tapentadol, meperidine, methadone (also used for treatment of narcotic withdrawal and dependence) and pentazocine.
• medicines that contain dextromethorphan (used for cough).
• products that contain St John's Wort (also known as “Hypericum perforatum”, a herbal or natural 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 condition called serotonin syndrome or reactions similar to NMS that 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 section “Warnings and precautions” or possible side effects related to serotonin syndrome or reactions similar to NMS.

Switching from another antidepressant to desvenlafaxine

When switching treatment from another antidepressant to desvenlafaxine, withdrawal symptoms 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 some substances such as phencyclidine (PCP) and amphetamines may occur in urine analysis of patients taking or having 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 drinking alcohol while taking desvenlafaxine.

Pregnancy, breast-feeding and fertility

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

If you take desvenlafaxine in the final stages of pregnancy, you may have a higher risk of heavy vaginal bleeding shortly after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking desvenlafaxine so they can advise you. When similar medicines (SSRIs) are taken during pregnancy, there is a higher 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.

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

If you take desvenlafaxine during the middle to end of your pregnancy, you may have a higher risk of high blood pressure and protein in your urine (pre-eclampsia). You may also have a higher risk of bleeding after giving birth (postpartum haemorrhage).

If you take desvenlafaxine during pregnancy, tell 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.

Desvenlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, do not breast-feed while taking desvenlafaxine unless your doctor advises you to do so.

Driving and using machines

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

Desvenlafaxine Stada 100 mg contains orange yellow S (E110).

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

3. How to take Desvenlafaxine Stada

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult 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 desvenlafaxine.

Desvenlafaxine 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 tablet structure in your stools after taking desvenlafaxine.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 stools. Therefore, even though you may see the tablet structure in your stools, you will have absorbed your dose of desvenlafaxine.

If you take more Desvenlafaxine Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service. Telephone 91 562 04 20 indicating the medicine and the amount taken. It is recommended to take the medicine pack 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 the time for your next dose, skip the missed dose and take only one dose, as you would normally.

If you stop taking Desvenlafaxine Stada

Do not stop taking desvenlafaxine 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 to avoid side effects. It is known that patients experience side effects when they stop taking desvenlafaxine, especially if they have taken a high dose and for a long time. Some of these side effects are: dizziness, nausea, headache, fatigue, irritability, diarrhoea, anxiety, nightmares and excessive sweating. Therefore, the dose should be reduced slowly, and under medical supervision, in case you and your doctor decide to stop treatment with desvenlafaxine. If you experience any of these or other symptoms that bother you, consult your doctor (see section “Warnings and precautions”). In some patients, complete cessation of the medicine may require several months or even longer.

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

4. Possible Adverse Effects

Like all medicines, desvenlafaxine 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), seizures, or attacks.
• 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 Affects more than 1 in 10 patients

Common Affects between 1 and 10 in 100 patients

Uncommon Affects between 1 and 10 in 1,000 patients

Rare Affects 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: hyponatremia (decreased sodium concentration in blood).

Psychiatric Disorders

Very Common: insomnia.

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

Uncommon: distortion of self-image and reality, abnormal orgasm.

Rare: mania (state of overexcitement, feeling of euphoria or hyperirritability), hypomania (state of excitement and excessive activity), and hallucinations.

Nervous System Disorders

Very Common: headache, dizziness, somnolence.

Common: tremors, 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, 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), seizures (attacks), movement disorders (e.g., involuntary muscle movements, restlessness).

Eye Disorders

Common: blurred vision, dilated pupils.

Ear and Labyrinth Disorders

Common: ringing in the ears, sensation of vertigo.

Cardiac Disorders

Common: rapid heart rate, palpitations (sensation of rapid, irregular, or strong heartbeat).

Rare: heart problems often caused by stressful situations (Takotsubo cardiomyopathy)

Vascular Disorders

Common: high blood pressure, hot flashes.

Uncommon: low blood pressure when changing position, peripheral coldness.

Respiratory Disorders

Common: yawning.

Uncommon: nosebleeds.

Gastrointestinal Disorders

Very Common: nausea, dry mouth, constipation.

Common: diarrhea, vomiting.

Rare: acute pancreatitis (inflammation of the pancreas).

Skin and Subcutaneous Tissue Disorders

Very Common: excessive sweating.

Common: skin 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: urinary retention, difficulty urinating, protein in the urine.

Reproductive System Disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory failure.

Uncommon: ejaculation disorder, sexual dysfunction.

Frequency Not Known: abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), 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: alteration of liver tests, weight gain, weight loss, high blood pressure.

Uncommon: increased cholesterol levels in the blood, increased triglyceride values in the blood, increased prolactin hormone values in the blood.

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 prospectus. 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 Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister 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 thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Desvenlafaxina Stada

• The active ingredient is desvenlafaxine (as benzoate).

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

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

Appearance of the Product and Package Contents

Desvenlafaxina Stada 50 mg are light pink, biconvex, and round tablets, with a diameter of approximately 9.6 mm ± 0.2 mm.

Desvenlafaxina Stada 100 mg are orange-red, biconvex, and round tablets, with a diameter of approximately 10.1 mm ± 0.2 mm.

This medicine is available in blister packs and unit-dose blister packs of Aluminum-OPA/Alu/PVC and Aluminum-PVC/PE/PVdC in packages 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 Last Revision of this Prospectus:September 2024

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/.