Apo-Desvenlafaxine

Desvenlafaxine.

Each extended-release film-coated tablet contains 50 mg or 100 mg desvenlafaxine (as base).
Excipients/Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, euroxide red iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, red iron oxide (for 100 mg), yellow iron oxide (for 50 mg).

APO-DESVENLAFAXINE belongs to a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). It is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

APO-DESVENLAFAXINE is indicated for the symptomatic relief of major depressive disorder in adults.

Always take APO-DESVENLAFAXINE exactly as told by the health professional. Check with the health professional if there are any questions.
APO-DESVENLAFAXINE is for oral use.
APO-DESVENLAFAXINE should be taken at approximately the same time each day with or without food. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved as it is time-released.
APO-DESVENLAFAXINE is prepared as a matrix tablet that slowly releases the medicine inside the body. Something that looks like a tablet may be noticed in the stool, but it is an empty matrix. Seeing the empty matrix is not a cause for concern. There is no need to take an extra tablet. The active medication has already been absorbed by the time the matrix is seen.
Do not stop taking APO-DESVENLAFAXINE without talking to the doctor.
Usual dose: The usual dose is 50 mg taken once daily. The doctor may increase the dose if needed. The maximum recommended dose should not exceed 100 mg/day.
Missed dose: If a dose is missed, take it as soon as it is remembered. However, if it is almost time for the next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten tablet.
Before stopping APO-DESVENLAFAXINE: Do not stop taking or change the dose of APO-DESVENLAFAXINE without first discussing this with the health professional. The health professional may want to slowly decrease the dose of APO-DESVENLAFAXINE to help avoid side effects. Some patients, who suddenly stop taking desvenlafaxine after more than 1 week of therapy, have felt dizzy, sick (nausea), had a headache or experienced irritability, insomnia, diarrhea, anxiety, abnormal dreams, fatigue, sweating. These symptoms are usually not serious and disappear within a few days, but if symptoms that are troublesome occur, ask the doctor for advice.

If too much APO-DESVENLAFAXINE has been taken, contact the healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. Take the medicines to show the doctor.

Do not use APO-DESVENLAFAXINE if: allergic (hypersensitive) to desvenlafaxine, venlafaxine or any of the other ingredients in APO-DESVENLAFAXINE; taking or have taken, within the last 14 days, another medicine known as monoamine oxidase inhibitor (MAOI) including linezolid, an antibiotic, and methylene blue, a dye used in certain surgeries; taking other drugs that contain venlafaxine or desvenlafaxine; taking any prescription or non-prescription medicines, including nutritional or herbal supplements, without checking with the doctor first (see Precautions and Interactions).
Taking a MAOI together with many prescription medicines, including APO-DESVENLAFAXINE, can cause serious or even life-threatening side effects. Also, wait at least 7 days after taking APO-DESVENLAFAXINE is stopped before taking any MAOI. (See Interactions.)

New or Worsened Emotional or Behavioural Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better. They may experience new or worsened feelings of aggression, agitation, hostility, anxiety, impulsivity, or thoughts about suicide, self-harm or harm to others.
Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. Should this happen, consult the doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue the medication without supervision. It may be more likely to think like this if there had been previous thoughts about self-harm.
It may be helpful to tell a relative or close friend about being depressed and ask them to read the patient information leaflet. They may be asked to inform if they suspect worsening depression or anxiety, or if they are worried about changes in behaviour.
Taking APO-DESVENLAFAXINE may increase the risk of experiencing sexual problems, which may continue after APO-DESVENLAFAXINE has been discontinued. Tell the doctor if experiencing symptoms such as sexual dysfunction, ejaculation disorder (in men), ejaculation failure (in men), libido decrease or anorgasmia (difficulty reaching orgasm).
Bone Fracture Risk: Taking APO-DESVENLAFAXINE may increase the risk of breaking a bone if elderly or with osteoporosis or with other major risk factors for breaking a bone. Take extra care to avoid falls especially if dizzy or with low blood pressure.
Other Medicines and Nutritional or Herbal Supplements: Tell the doctor or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Avoid taking APO-DESVENLAFAXINE with other medicines containing venlafaxine or desvenlafaxine.
The health professional will decide if APO-DESVENLAFAXINE can be taken with other medicines.
Angle-Closure Glaucoma: APO-DESVENLAFAXINE can cause an acute attack of glaucoma. Having the eyes examined before taking APO-DESVENLAFAXINE could help identify if at risk of having angle-closure glaucoma. Seek immediate medical attention if experiencing: eye pain; changes in vision; swelling or redness in or around the eye.
Sexual Dysfunction: Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SNRIs.
Abnormal Bleeding/Haemorrhage: SNRIs may increase the risk of postpartum haemorrhage.
Other Medical Problems: Before using APO-DESVENLAFAXINE, tell the doctor or pharmacist if: taking other medicines, herbal or nutritional supplements (see as previously mentioned and Interactions); with a history of high blood pressure; with a history of heart problems; with a narrowing or blockage of the gastrointestinal tract (oesophagus, stomach, or small or large intestine); with a history of fits (seizures); with a history of low sodium levels in the blood; with a bleeding disorder or with low platelets; with a recent bone fracture or with osteoporosis or risk factors for osteoporosis; with a history of high cholesterol; with a history or family history of mania or bipolar disorder; with kidney problems; pregnant or thinking about becoming pregnant, or if breastfeeding. If any of these conditions are applicable, talk with the doctor before taking APO-DESVENLAFAXINE.
Serotonergic psychiatric drugs should not be started in a patient receiving linezolid. Wait until 24 hours after the last dose of linezolid before starting serotonergic psychiatric drugs.
Driving and Using Machines: Do not drive or operate any tools or machines until it is known how APO-DESVENLAFAXINE affects. Do not drive or operate any tools or machines if APO-DESVENLAFAXINE affects in a way that prevents from safely performing these operations. If there are any further questions on the use of this product, ask the doctor or pharmacist.
Use in Children: APO-DESVENLAFAXINE should not be used in children and adolescents under 18 years of age.

The safety of desvenlafaxine during human pregnancy has not been established. Taking APO-DESVENLAFAXINE in mid to late pregnancy may increase the risk for preeclampsia (high blood pressure and protein in the urine) and taking it near delivery may increase the risk of heavy bleeding after giving birth. Desvenlafaxine is excreted in human milk. Tell the doctor immediately if pregnancy occurs, if trying to become pregnant, or if breastfeeding. If pregnancy does occur while taking this drug, do not change the dosage without consulting the doctor.
Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SNRIs exposure within the month prior to birth.
Postmarketing reports indicate that some newborns, whose mothers took an SNRI (Serotonin Norepinephrine Reuptake Inhibitor), SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants during pregnancy, have developed complications at birth requiring prolonged hospitalization, breathing support and tube-feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.
These symptoms are consistent with either a direct adverse effect of the medication on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if the baby experiences any of these symptoms, contact the doctor as soon as possible.

Like all medications, APO-DESVENLAFAXINE can cause some side effects. Any of them may not be experienced. For most patients, these side effects are likely to be minor and temporary. However, some can be serious. Some of these side effects may be dose-related. Consult the doctor if these or other side effects are experienced, as the dose may need to be adjusted.
If an allergic reaction (including red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects are experienced, stop taking the drug and seek emergency medical attention immediately.
Frequency of Side Effects: Very common (in more than 1 in 10 patients): Nausea, Dry mouth, Dizziness, Trouble sleeping, Sweating, Headache, Drowsiness.
Common (in more than 1 in 100 patients, but in less than 1 in 10 patients): Heart pounding, Heart racing, Ringing in the ears, Vertigo, Dilated pupils, Vision blurred, Vomiting, Diarrhea, Weakness, Chills, Feeling jittery, Irritability, Weight decreased, Weight increased, Blood pressure increased, Musculoskeletal stiffness, Shaking, Disturbance in attention, Tingling sensations, Taste changes, No orgasms, Anxiety, Nervousness, Interest in sex decreased, Abnormal dreams, Ejaculation delayed (in men), Erectile dysfunction (in men), Yawning, Rash, Hot flush, Decreased appetite, Constipation, Tiredness, Drug withdrawal syndrome, Liver function tests abnormal.
Uncommon (in more than 1 in 1000 patients, but in less than 1 in 100 patients): Hypersensitivity, Blood cholesterol increased, Blood prolactin increased, Blood triglyceride increased, Fainting, Depersonalization, Nose bleeds, Drop in blood pressure when standing, Coldness in hands and feet, Loss of hair, Orgasm abnormal, Movement disorders, Difficulty emptying the bladder, Urinary hesitation, Protein in the urine, Ejaculation disorder (in men), Ejaculation failure (in men), Sexual dysfunction.
Rare (in more than 1 in 10,000 patients, but in less than 1 in 1000 patients): Seizures, Sodium levels decreased, Swelling beneath the skin (e.g. throat, face, hands), Mania, Hypomania, Convulsions, Hallucinations, Muscle contractions, Sensitivity to light.
Other Side Effect Information: These are not all the possible side effects of APO-DESVENLAFAXINE. Call the health professional right away if the side effects become serious, if any side effects not previously listed are noticed, or if there is any other concerning side effect.
Discontinuation Symptoms: Contact the doctor before stopping or reducing the dosage of APO-DESVENLAFAXINE. Symptoms such as visual impairment, high blood pressure, dizziness, nausea, headache, irritability, trouble sleeping, diarrhea, anxiety, abnormal dreams, tiredness, and sweating have been reported after stopping treatment with desvenlafaxine. Tell the doctor immediately if any of these or other symptoms are present. The doctor may adjust the dosage of APO-DESVENLAFAXINE to alleviate the symptoms.
Serious side effects and what to do about them: See table.

Click on icon to see table/diagram/image

Do not use APO-DESVENLAFAXINE if taking or have recently taken monoamine oxidase inhibitors. Do not take APO-DESVENLAFAXINE with a MAOI or within 14 days of stopping a MAOI. Taking a MAOI together with many prescription medicines, including APO-DESVENLAFAXINE, can cause serious or even life-threatening side effects. Also, waiting at least 7 days is needed after taking APO-DESVENLAFAXINE is stopped before taking a MAOI.
Certain laboratory results may be affected by use of APO-DESVENLAFAXINE. Discuss with the doctor if any unusual lab reports are received.
Tell the doctor if taking or have recently taken any medications (prescription, non-prescription, or natural/herbal), especially: Monoamine oxidase inhibitors (MAOI) including linezolid, an antibiotic, and methylene blue, a dye used in certain surgeries; Certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen); Medicines containing venlafaxine or other medicines containing desvenlafaxine.
Serotonin syndrome or a neuroleptic malignant syndrome (NMS)-like reactions: Rare, but potentially life-threatening conditions called serotonin syndrome or NMS-like reactions can cause serious changes in how the brain, muscles and digestive system work and can happen when medicines like APO-DESVENLAFAXINE are taken, particularly when taken with certain other medications such as: medicines to treat migraine headaches known as triptans; medicines used to treat mood or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or dopamine antagonists, including antipsychotics; amphetamines; sibutramine; certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine; certain medicines used to treat cough, such as dextromethorphan; St. John's Wort; MAOIs (including linezolid, an antibiotic, and methylene blue, a dye sometimes injected before surgery to guide the surgeon); tryptophan supplements.
Before APO-DESVENLAFAXINE and any of these medicines are taken together, talk to the healthcare professional about the possibility of serotonin syndrome or NMS-like reactions. Signs and symptoms of serotonin syndrome or NMS may include a combination of the following: Agitation (excitability, restlessness), hallucinations, confusion, loss of coordination, muscle twitching or stiffness, fast heartbeat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. Get medical care right away if suspecting that serotonin syndrome is happening.
Central nervous system drugs: Caution is advised when APO-DESVENLAFAXINE is taken in combination with other centrally acting drugs or substances, including alcohol and sedative drugs (benzodiazepines, opiates, antipsychotics, phenobarbital, sedative antihistamines). Inform the doctor if taking any of these drugs. Avoid alcohol while taking APO-DESVENLAFAXINE.
Switching from other antidepressants: Side effects from discontinuing antidepressant medication have occurred when patients switched from other antidepressants, including venlafaxine, to APO-DESVENLAFAXINE. The doctor may gradually reduce the dose of the initial antidepressant medication to help to reduce these side effects.

Medicines should not be disposed of in wastewater or in household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Store below 25°C. Keep in original pack and protect from light.

Antidepressants

N06AX23 - desvenlafaxine ; Belongs to the class of other antidepressants.

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