EXITAL 100 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Exital 100 mg prolonged-release tablets EFG

Desvenlafaxine

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Exital is and what it is used for
2. What you need to know before you take Exital
3. How to take Exital
4. Possible side effects
5. Storing Exital
6. Package contents and further information

1. What Exital is and what it is used for

Exital 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. It is not fully understood how antidepressants work, 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 you take Exital

Do not take Exital:

• 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 potentially life-threatening side effects. Additionally, you must wait at least 7 days after stopping Desvenlafaxine before taking 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 taking Desvenlafaxine or if they appear during treatment with this medicine:

• if you or a family member have a history of mania (a state of excitement, feeling euphoric, or being hyper-irritable) or bipolar disorder (extreme mood swings, e.g., 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 high blood pressure or hypertension.
• 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 if you are pregnant (see section Pregnancy, breastfeeding, 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 (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 stiffness, tremors, nausea, vomiting, and diarrhea. Contact your doctor immediately, as you may be suffering from serotonin syndrome (a disorder that can be serious and, in rare cases, potentially life-threatening).
• if you stop treatment abruptly, you may experience withdrawal symptoms (e.g., mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (ringing in the ears), and seizures). Therefore, it is essential to reduce the dose of Desvenlafaxine gradually and under medical supervision, whenever you and your doctor decide to discontinue treatment.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have had thoughts of harming yourself or suicide. These thoughts may increase when you start taking antidepressants, as these medicines take time to work, usually a few weeks, but sometimes longer.

You may be more likely to think this way:

• If you have had previous 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 (less than 25 years of age) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of harming yourself or suicide 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 or have an anxiety disorder, and ask them to read this leaflet. You might also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried 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 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 increased sensitivity to desvenlafaxine.

Children and adolescents

Desvenlafaxine should not normally be used in children and adolescents. Additionally, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, the doctor may prescribe this medicine to patients under 18 years of age when they decide it is appropriate for the patient. If the doctor prescribes this medicine to a patient under 18 years of age and you wish 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 of age are taking Desvenlafaxine.

Furthermore, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of this medicine have not yet been established.

Other medicines and Exital

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important to 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 Exital").
• other medicines containing 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 containing sibutramine (used for weight loss).
• medicines for pain, e.g., those containing tramadol, fentanyl, and its analogs, tapentadol, meperidine, methadone (also used for treatment of narcotic withdrawal 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 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 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 antidepressants

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 minimize these symptoms.

Interactions with laboratory tests

False positives for certain substances, such as phencyclidine (PCP) and amphetamines, may occur in urine analyses of patients taking or having taken desvenlafaxine, even several days after treatment discontinuation.

Using Exital with food, drinks, and alcohol

Exital tablets can be taken with or without food. You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

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

If you take desvenlafaxine during the late stage of pregnancy, there may be an increased risk of excessive 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 this medicine to advise you accordingly. When similar medicines (SSRIs) are taken during pregnancy, there may be an increased risk of a serious effect on 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 birth. If your baby has these symptoms, you should contact your doctor and/or midwife immediately.

If you take Desvenlafaxine during pregnancy, inform your doctor and/or midwife, as your baby may experience withdrawal symptoms when born. These symptoms may appear shortly 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 use Desvenlafaxine during breastfeeding 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.

Exital 100 mg prolonged-release tablets EFG contains orange yellow S (E110).

This medicine may cause allergic reactions because it contains orange yellow S (E110).

3. How to take Exital

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, 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 to take a different dose of Desvenlafaxine.

This medicine 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 stool after taking Exital.

As the tablet travels through your gastrointestinal tract, the active substance desvenlafaxine is released slowly. The tablet structure does not dissolve and is eliminated in the stool. Therefore, although you may see the tablet structure in your stool, you will have absorbed your dose of desvenlafaxine.

If you take more Exital than you should

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

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

If you forget to take Exital

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

If you stop taking Exital

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 the dose of Desvenlafaxine to avoid side effects. It is known that patients experience side effects when they stop taking this medicine, especially if they have taken a high dose for a long time. Some of these side effects are: dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares, and excessive sweating. Therefore, the dose should be reduced slowly, whenever possible, and under medical supervision, in case you and your doctor decide to discontinue treatment with Desvenlafaxine.

If you experience any of these or other symptoms that bother you, consult your doctor (see section "Warnings and precautions").

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 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), 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: 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, vivid 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: dizziness, headache, 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), convulsions (seizures), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye disorders

Common: pupil dilation, blurred vision

Ear and labyrinth disorders

Common: tinnitus, sensation of vertigo

Cardiac disorders

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

Vascular disorders

Common: high blood pressure, hot flashes

Uncommon: peripheral coldness, low blood pressure when changing position

Respiratory disorders

Common: yawning

Uncommon: nasal hemorrhages

Gastrointestinal disorders

Very common: nausea, dry mouth, constipation

Common: vomiting, diarrhea

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: difficulty urinating, urinary retention, protein in the urine

Reproductive system disorders

Common: erectile dysfunction, delayed ejaculation, ejaculatory failure

Uncommon: sexual dysfunction, ejaculation disorder

Frequency not known: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Lactation, and Fertility" in section 2 for more information

General disorders

Common: fatigue, weakness, chills, feeling of restlessness

Investigations and medical tests

Common: altered liver tests, weight gain, weight loss, high blood pressure

Uncommon: increased cholesterol levels in blood, increased triglyceride values in blood, increased prolactin hormone values in 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 is not listed 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 Exital

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

Do not use this medicine after the expiration date that appears on the packaging and 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 away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Exital

• The active ingredient is desvenlafaxine (as desvenlafaxine benzoate).

• Each tablet contains 100 mg of desvenlafaxine (as desvenlafaxine benzoate).
• The other components are: hypromellose, microcrystalline cellulose, talc, stearic acid, magnesium stearate, anhydrous colloidal silica (E551).

The coating film of the 100 mg tablets contains: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and orange yellow S (E110).

Appearance of the Product and Package Contents

Orange-red, biconvex, round tablet. The tablet dimensions are 10.1 ± 0.2 mm.

Exital 100 mg is available in packages of 28 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia (Malta)

Date of Last Revision of this Prospectus: March 2022

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/