Label:Information for the Patient

Pristiq 100 mg Extended-Release Tablets

desvenlafaxine

Read this label carefully before starting to take this medication, because it contains important information for you.

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

6. Contents of the pack and additional informationl

Pristiq is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs).This group of medications is used to treat depression. People with depression may have low levels of serotonin and norepinephrine (also known as noradrenaline) in the brain.The exact way antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Pristiq is a treatment for adults.

Do not take Pristiq:

• if you are allergic to desvenlafaxine, venlafaxine, or any of the other ingredients in this medication (listed in section 6).
• if you are also taking or have taken within the last 14 days, any medication 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) with other medications like Pristiq can cause severe or potentially life-threatening side effects. Additionally, you should wait at least 7 days after stopping Pristiq before taking any MAOI (see also the sections "Serotonin syndrome" and "Other medications").

Warnings and precautions

Consult your doctor if you have had any of the following conditions before starting to take Pristiq or if they occur during treatment with Pristiq:

• if you or a family member has a history of mania (a state of overexcitement, feeling of euphoria, or irritability) or bipolar disorder (extreme mood swings, for example, from depression to euphoria).
• if you have a history of aggressive behavior.
• if you have eye problems, such as certain types of glaucoma (increased eye pressure).
• 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 ecchymoses), or if you are pregnant (see the section Pregnancy, breastfeeding, and fertility), or if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and other medications 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 rigidity, tremors, nausea, vomiting, and diarrhea. Contact your doctor immediately, as you may be experiencing serotonin syndrome (a disorder that can be severe and, in rare cases, potentially life-threatening).
• if you stop treatment abruptly, you may experience withdrawal symptoms (for example, mood changes, irritability, agitation, dizziness, anxiety, confusion, headache, sleep disturbances, tinnitus (ringing in the ears), seizures, visual disturbances, and hypertension). Therefore, it is essential to reduce the dose of Pristiq gradually and under medical supervision whenever you and your doctor decide to discontinue treatment.

Some medications in the group to which Pristiq belongs (called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may have had thoughts of harming yourself or suicidal thoughts. These thoughts may increase when starting to take antidepressants, as these medications take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

• if you have had previous thoughts of suicide or self-harm.
• if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or suicidal thoughts at any time,contact your doctor or go to the hospital directly.

It may be helpful to tell a close family member or friend who is depressed or has an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is getting worse, 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 tooth decay. Therefore, you should take good care of your oral hygiene.

Older adults

In some older adults, it cannot be ruled out that there may be a greater sensitivity to desvenlafaxine.

Children and adolescents

Pristiq should not be used in children and adolescents. Additionally, you should know that, in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal behavior, hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes your medication may prescribe Pristiq to patients under 18 years of age if they decide it is in the best interest of the patient. If the doctor who prescribes your medication has prescribed Pristiq to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in patients under 18 years of age who are taking Pristiq. Furthermore, the long-term effects of this medication on safety, growth, maturity, and cognitive and behavioral development have not yet been demonstrated.

Taking Pristiq with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

• monoamine oxidase inhibitors (MAOIs), for example, medications containing linezolid (an antibiotic used to treat infections) and methylene blue (see the section "Do not take Pristiq").
• other medications containing venlafaxine or desvenlafaxine (also used to treat depression).
• triptans (used for migraines).
• medications to treat depression, for example, tricyclic antidepressants, amphetamines, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin and norepinephrine reuptake inhibitors (SNRIs).
• medications containing sibutramine (used for weight loss).
• pain medications, for example, opioids such as tramadol, fentanyl, and its analogs, tapentadol, meperidine, methadone (also used to treat opioid withdrawal and dependence), and pentazocine.
• medications containing dextromethorphan (used for coughs).
• products containing St. John's Wort (also known as "Hypericum perforatum," a natural remedy or herbal remedy used to treat mild depression).
• products containing tryptophan (used for problems such as sleep and depression).
• medications containing ketoconazole (an antifungal).
• in addition, if you are being treated by other healthcare professionals, inform them that you are taking Pristiq.

Serotonin syndrome or reactions similar to Neuroleptic Malignant Syndrome (NMS)

Rarely, this medication can cause a disorder called serotonin syndrome or reactions similar to NMS that can cause significant changes in brain, muscle, and digestive system function due to high levels of serotonin in the body. This potentially life-threatening state can occur when taking medications like Pristiq, especially when taken with other medications mentioned above.

See the section "Warnings and precautions" or the possible side effects related to serotonin syndrome or reactions similar to NMS.

Switching antidepressants

When switching from another antidepressant to desvenlafaxine, withdrawal symptoms from the initial antidepressant have appeared. Your doctor may reduce your initial antidepressant medication dose gradually to help minimize these symptoms.

Interactions with laboratory tests

Falsely positive results for substances such as phenylcylidine (PCP) and amphetamines may occur in urine tests of patients taking or who have taken desvenlafaxine, even several days after stopping treatment.

Taking Pristiq with food, drinks, and alcohol

Pristiq tablets can be taken with or without food.

Avoid taking alcohol while using Pristiq.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

If you take Pristiq in the final stages 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 know that you are taking Pristiq so they can advise you.When taken during pregnancy, similar medications (SSRIs) may increase the risk of a severe condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If your baby has these symptoms, contact your doctor and/or midwife immediately.

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

If you take Pristiq during the middle of pregnancy until the end, 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 delivery (postpartum hemorrhage).

If you take Pristiq 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. Among the symptoms are difficulty breastfeeding or respiratory 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 Pristiq during breastfeeding unless your doctor specifically advises you to do so.

Driving and operating machinery

Pristiq may cause dizziness, somnolence, and blurred vision. Do not drive or operate tools or machinery until you know how this medication affects you.

This medication may cause allergic reactions because it contains Yellow No. 5 (E110).

It may cause asthma, especially in patients allergic to aspirin.

Follow exactly the administration instructions of this medication 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 up 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 since you may need to take a different dose of Pristiq.

This medication should be taken orally, approximately at the same time every day. The tablets should be swallowed whole with liquid, without dividing them, crushing them, chewing them, or dissolving them.

Do not worry if you observe the structure of a tablet in your stool after taking this medication.As the tablet travels along your gastrointestinal tract, the active ingredient desvenlafaxine is released slowly. The tablet structure does not dissolve and is eliminated in the stool. Therefore, despite the fact that the tablet structure may appear in your stool, you will have absorbed your dose of desvenlafaxine.

If you take more Pristiq than you should

Immediately contact your doctor or pharmacist if you take more of this medication than your doctor prescribed.

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

If you forgot to take Pristiq

If you have not taken 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 compensate for the missed dose.

If you interrupt treatment with Pristiq

Do not stop taking this medication, or change the dose, without your doctor's indication, even if you feel better. Your doctor prefers to gradually reduce the dose of Pristiq to avoid adverse effects. It is known that patients experience adverse effects when they stop taking this medication, especially if they have taken a high dose and for a prolonged period. Some of these adverse effects are: dizziness, nausea, headache, fatigue, irritability, diarrhea, anxiety, nightmares, and excessive sweating. Therefore, the dose should be reduced slowly, and under medical supervision, if you and your doctor decide to interrupt treatment with Pristiq. If you experience any of these or other symptoms that bother you, consult your doctor (see the "Warnings and precautions" section). In some patients, complete discontinuation of the medication may take months or even longer.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side 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 convulsions.
• psychiatric problems,such as hyperactivity and euphoria.
• allergic reactions to medications, such as rashes, throat swelling, or breathing difficulties.

List of possible side effects

The side effects and frequency (probability of occurrence) mentioned below have been observed in patients. In general, these side effects occurred more frequently during the first week of treatment.

Very commonaffect more than 1 in 10 patients

Commonaffect between 1 and 10 in 100 patients

Uncommonaffect between 1 and 10 in 1,000 patients

Rareaffect between 1 and 10 in 10,000 patients

Unknown frequency (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, rare 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) andhallucinations

Nervous system disorders

Very common:headache,dizziness, somnolence

Common:tremors, numbness and tingling, attention deficit, alteration of taste

Uncommon:loss of consciousness, abnormal movements (dyskinesia)

Rare:serotonin syndrome (characterized by symptoms such as agitation (excitability and restlessness), alteration of 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 (convulsions), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye disorders

Common:blurred vision,enlarged pupils

Ear disorders

Common: sensation of vertigo, ringing in the ears

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:yawns

Uncommon:nasal bleeding

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:rash

Uncommon: complete or partial hair loss

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

Musculoskeletal disorders

Common:muscle stiffness

Renal and urinary disorders

Uncommon:urinary retention,difficulty urinating, protein in urine

Reproductive system and breast disorders

Common:erectile dysfunction, delayed ejaculation, ejaculatory insufficiency

Uncommon:ejaculation disorder, sexual dysfunction

Unknown frequency:excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information

General disorders

Common:fatigue, weakness, chills, feeling of unease

Investigations

Common: alteration of liver function tests, increased weight, weight loss, high blood pressure

Uncommon:increased levels of cholesterol in the blood, increased levels of triglycerides in the blood, increased levels of prolactin hormone in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pristiq

The active ingredient is desvenlafaxine (as monohydrate succinate).

Each tablet contains 100 mg of desvenlafaxine (as monohydrate succinate).

The other components (excipients) are: hypromellose, microcrystalline cellulose, talc, and magnesium stearate.

The coating film of the 100 mg tablets is Opadry II 85F94527, which contains: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc (E553b), red iron oxide (E172), and yellow-orange S (E110).

Appearance of the product and content of the packaging

Orange-red tablet, pyramid-shaped with a square base, with a "W" on top and a "100" on the flat face.

Pristiq 100 mg is available in packaging of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108, Alcobendas. Madrid (Spain)

Responsible for manufacturing

Pfizer Ireland Pharmaceuticals Unlimited Company, Newbridge, County Kildare (Ireland).

or

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

Last review date of this leaflet:August 2023

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