Pristiq 100 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pristiq 100 mg prolonged-release tablets

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

Contents of the leaflet

1. What Pristiq is and what it is used for

2. What you need to know before taking Pristiq

3. How to take Pristiq

4. Possible side effects

5. How to store Pristiq

6. Contents of the pack and other information

1. What Pristiq is and what it is used for

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

Pristiq is a treatment for adults.

2. What you need to know before taking Pristiq

Do not take Pristiq:

• 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 Pristiq may cause serious or even potentially fatal side effects. In addition, you must wait at least 7 days after stopping Pristiq before taking any MAOI (see also sections “Serotonin syndrome” and “Other medicines”).

Warnings and precautions

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

• 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, e.g., 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 develop bruises), 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 (hyponatraemia).
• 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 diarrhoea. Contact your doctor immediately, as you may be experiencing serotonin syndrome (a disorder 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 problems, and hypertension). Therefore, it is important to gradually reduce the dose of Pristiq under medical supervision whenever you and your doctor decide to discontinue treatment.

Some medicines in the same class as Pristiq (known as SSRIs/SNRIs) may cause sexual dysfunction symptoms (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 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 thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

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

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 behaviour.

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

Pristiq should not normally be used in children and adolescents. In addition, you should know 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 behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is best 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 must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Pristiq. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development have not yet been established.

Taking Pristiq with other medicines

Tell 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 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 Pristiq”).
• other medicines containing venlafaxine or desvenlafaxine (also used in the treatment of depression).
• triptans (used for migraine).
• medicines used to treat depression, e.g., tricyclic antidepressants, amphetamines, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• medicines containing sibutramine (used for weight loss).
• pain medicines, e.g., opioids such as tramadol, fentanyl and its analogues, 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 called “Hypericum perforatum”, a herbal or natural remedy used to treat mild depression).
• products containing tryptophan (used for problems such as sleep and depression).
• medicines containing ketoconazole (an antifungal).
• also, 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, 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 Pristiq, particularly when taken together with other medicines mentioned above.

See the section “Warnings and precautions” or the 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.

Interactions 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 Pristiq with food, drinks, and alcohol

Pristiq tablets may be taken with or without food.

You should avoid drinking alcohol while taking Pristiq.

Pregnancy, breastfeeding, and fertility

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

If you take Pristiq 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 Pristiq 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.

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

If you take Pristiq from the middle of pregnancy until delivery, you may have an increased risk of high blood pressure and protein in the urine (pre-eclampsia). You may also have an increased risk of bleeding after childbirth (postpartum haemorrhage).

If you take Pristiq 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 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 effects on the baby. Therefore, do not use Pristiq during breastfeeding unless specifically instructed by your doctor.

Driving and using machines

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

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

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Pristiq

Follow exactly the instructions for using this medicine 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 up 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 Pristiq.

This medicine should be taken orally, approximately at the same time each day. The tablets must be swallowed whole with liquid, without splitting, crushing, chewing, or dissolving them.

Do not be alarmed if you see the tablet structure in your faeces after taking this medicine. As the tablet passes through your gastrointestinal tract, the active ingredient desvenlafaxine is slowly released. The tablet structure does not dissolve and is eliminated in the faeces. Therefore, even though the tablet structure may appear in your faeces, you will have absorbed your dose of desvenlafaxine.

If you take more Pristiq than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than prescribed by your doctor.

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

If you forget to take Pristiq

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

If you stop taking Pristiq

Do not stop taking this medicine, or change the dose, without your doctor's instruction, even if you feel better. Your doctor will usually prefer to gradually reduce the dose of Pristiq to avoid adverse effects. Adverse effects are known to occur in patients who discontinue 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 be reduced slowly and under medical supervision if you and your doctor decide to stop treatment with Pristiq. 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 require 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, this medicine can cause adverse effects, although not everyone will experience 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 rash, swelling of the throat, or breathing difficulties.

List of possible adverse effects

The adverse effects and frequencies (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: hyponatremia (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 diarrhea), seizures (fits), movement disorders (e.g., involuntary muscle movements, restlessness)

Eye disorders

Common: blurred vision, pupil dilation

Ear disorders

Common: vertigo sensation, tinnitus

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: diarrhea, vomiting
Rare: acute pancreatitis (inflammation of the pancreas)

Skin and subcutaneous tissue disorders

Very common: excessive sweating
Common: rash
Uncommon: total or partial 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 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: 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. Storage of Pristiq

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

Do not use this medicine after the expiry date which is stated on the packaging 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. Instead, dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pristiq

The active substance is desvenlafaxine (as succinate monohydrate).

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

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), iron oxide red (E172) and sunset yellow FCF (E110).

Appearance of the product and contents of the pack

Reddish-orange, pyramid-shaped tablet with a square base, marked with a "W" on the top and "100" on the flat face.

Pristiq 100 mg is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108, Alcobendas. Madrid (Spain)

Manufacturer

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

or

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

Date of the most recent revision of this leaflet: August 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/