EXITAL 100 MG PROLONGED-RELEASE TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Exital 100 mg prolonged-release tablets EFG

Desvenlafaxine

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

• Keep this leaflet, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Exital is and what it is used for

Exital 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 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, a 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 medicines such as desvenlafaxine may cause serious, and potentially life-threatening, side effects. In addition, you must wait at least 7 days after stopping desvenlafaxine before starting any MAOI (see also sections “Serotonin syndrome” and “Other medicines”).

Warnings and precautions

Consult your doctor if you have previously experienced any of the following conditions before taking Desvenlafaxine, or if any of these occur during treatment with this medicine:

• if you or a family member has had or has a history of mania (a state of over-excitement, 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 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 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 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 (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), and seizures (fits)). 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 have 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 disorders treated with antidepressants.

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

It may be helpful to inform 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 should not normally be 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, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. 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. You should 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, as well as on growth, maturation, and cognitive and behavioral development, have not yet been established for this medicine.

Other medicines and Exital

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 Exital”).
• 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).
• pain medicines, for example those containing 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 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 reactions similar to NMS.

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

Use of Exital with food, drinks, and alcohol

Exital tablets may be taken with or without food. You should avoid alcohol while using this medicine.

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 aware that you are taking this medicine 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 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 has these symptoms, contact your doctor and/or midwife immediately.

If you take Desvenlafaxina 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 include difficulty feeding 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 in the baby. Therefore, do not use Desvenlafaxine during breastfeeding unless specifically instructed by your doctor.

Driving and using machines

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

Exital 100 mg prolonged-release tablets EFG contains sunset yellow FCF (E110).

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110).

3. How to take Exital

Follow exactly the instructions for use of this medicine as given by your doctor. If you are 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 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 splitting, crushing, chewing or dissolving them.

Do not be concerned if you notice the tablet shell in your faeces after taking Exital.

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 Exital 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Exital

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 your next dose as scheduled. 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 the dose without your doctor’s advice, even if you feel better. Your doctor will usually prefer to gradually reduce the dose of Desvenlafaxine to avoid adverse effects. It is known that patients may experience adverse effects when stopping this medicine, especially if they have taken 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 always be reduced gradually whenever possible 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”).

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, contact 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, swelling of the throat, or breathing difficulties.

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: 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 (low 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 and reality perception, 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: dizziness, headache, drowsiness

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 (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 diarrhea), seizures (fits), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye disorders

Common: pupil dilation, blurred vision

Ear disorders

Common: tinnitus, sensation of vertigo

Cardiac disorders

Common: rapid heartbeat, palpitations (sensation of rapid, irregular, or forceful heartbeat)

Vascular disorders

Common: high blood pressure, hot flushes

Uncommon: peripheral coldness, low blood pressure upon changing position

Respiratory disorders

Common: yawning

Uncommon: nosebleeds

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: partial or complete hair loss

Rare: Stevens-Johnson syndrome (erythema multiforme, a hypersensitivity reaction affecting the skin and mucous membranes), swelling under the skin, photosensitivity

Musculoskeletal disorders

Common: muscle stiffness

Renal and urinary disorders

Uncommon: difficulty urinating, urinary retention, protein in 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, breastfeeding and fertility” in section 2 for more information

General disorders

Common: fatigue, weakness, chills, 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 values, increased blood prolactin levels

Reporting of adverse effects

If you experience any adverse effect, talk to 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 System for Pharmacovigilance of Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point 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 container and additional information

Composition of Exital

• The active substance 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, iron oxide red (E172), and orange yellow S (E110).

Appearance of the product and contents of the package

Reddish-orange, 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 Manufacturing Responsible

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 the most recent review of this leaflet: March 2022

Detailed and up-to-date 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/