Patient Medication Information: uses, side effects, how to take - Sandoz Desvenlafaxine
Serious Warnings and Precautions
New or worsened emotional or behavioural problems:
- When you first start taking Sandoz Desvenlafaxine or when your dose is adjusted, you may feel worse instead of better. You may feel new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
During your treatment with Sandoz Desvenlafaxine, it is important that you and your healthcare professional talk regularly about how you are feeling. They will closely
- Sandoz Desvenlafaxine.
- You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:
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- If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for Sandoz Desvenlafaxine to work.
| Self-harm or Suicide: |
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- Antidepressants, such as Sandoz Desvenlafaxine, may increase the risk of suicidal thoughts and actions for some patients.
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What is Sandoz Desvenlafaxine used for?
Sandoz Desvenlafaxine is used in adults to relieve the symptoms of:
- Major depressive disorder (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
How does Sandoz Desvenlafaxine work?
Sandoz Desvenlafaxine belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). Sandoz Desvenlafaxine is thought to work by increasing the levels of two chemicals in the brain, serotonin and norepinephrine. This helps to relieve your symptoms of major depressive disorder.
What are the ingredients in Sandoz Desvenlafaxine?
Medicinal ingredients: Desvenlafaxine
Non-medicinal ingredients:
| Alginic acid, citric acid monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating (which consists of hypromellose, iron oxide red, polyethylene glycol, titanium dioxide, talc for 50 mg tablets and hypromellose, iron oxide red, polyethylene glycol, titanium dioxide and ferrosoferric oxide for 100 mg tablets). |
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Sandoz Desvenlafaxine comes in the following dosage forms:
Extended-release tablets: 50 mg and 100 mg desvenlafaxine.
Do not use Sandoz Desvenlafaxine if:
- you are allergic to venlafaxine, desvenlafaxine or to any other ingredients in Sandoz Desvenlafaxine.
- you are taking, or have taken in the last 14 days, a monoamine oxidase inhibitor (MAOI) such as phenelzine, tranylcypromine, moclobemide, selegiline, linezolid and methylene blue. You must wait at least 7 days after you stop taking Sandoz Desvenlafaxine before taking any MAOI.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Desvenlafaxine. Talk about any health conditions or problems you may have, including if you:
have or have a history of:
- kidney problems
- seizures (sudden and uncontrolled burst of electrical activity in the brain)
- stroke
- heart problems
- aggression
- abnormal levels of lipids (fats) in your blood
- low sodium levels in your blood
- bowel blockage or narrowing of the stomach or intestines
- have difficulty swallowing tablets whole.
- have a history or family history of mania or bipolar disorder.
- have a bleeding disorder or have been told that you have low blood platelets.
- have blood pressure problems.
are taking any medicines, especially:
- other medicines used to treat depression
- medicines used to treat psychiatric disorders
- opioids (including those used to treat pain or drug dependence)
- medicines used to treat anxiety
- medicines used to prevent blood clots (e.g., acetylsalicylic acid (ASA), blood thinners)
- non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and reduce inflammation (e.g., ibuprofen, naproxen, diclofenac, celecoxib)
- medicines used to treat migraines (e.g., triptans)
- lithium, used to treat manic episodes of bipolar disorder
- are taking any nutritional or herbal supplements, including St. John’s Wort.
- had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
- are pregnant or thinking about becoming pregnant, or if you are breast-feeding.
Other warnings you should know about:
Do NOT stop taking Sandoz Desvenlafaxine without talking to your healthcare professional first, as it may cause unwanted side effects. These include irritability, agitation, aggression, dizziness, intense feelings of depression, numbness, tingling, burning or prickling sensations, anxiety, confusion, headache, low or high energy level, ringing in the ears, seizures (sudden and uncontrolled burst of electrical activity in the brain), vision changes and high blood pressure.
Activation of mania: Some patients with bipolar disorder (also known as manic depression) may enter into a manic phase when they start taking Sandoz Desvenlafaxine. Tell your healthcare professional if you experience symptoms of mania such as excessive physical activity, overactive behaviour or thoughts, increased energy, trouble sleeping, racing thoughts, reckless behaviour, excessive happiness or irritability, talking more or faster than usual.
Angle-closure glaucoma: Sandoz Desvenlafaxine can cause an acute attack of glaucoma. Having your eyes examined before you take Sandoz Desvenlafaxine could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:
- eye pain;
- changes in vision;
- swelling or redness in or around the eye.
Serotonin toxicity (also known as serotonin syndrome): Sandoz Desvenlafaxine can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take Sandoz Desvenlafaxine with certain antidepressants or migraine medications. Serotonin toxicity symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Falls and fractures: Taking Sandoz Desvenlafaxine may increase your risk of breaking a bone if you are elderly, have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls, especially if you get dizzy or have low blood pressure.
Effects on sexual function: Taking medicines like Sandoz Desvenlafaxine may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping Sandoz Desvenlafaxine treatment. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.
Pregnancy: Only take Sandoz Desvenlafaxine during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you take Sandoz Desvenlafaxine near the end of your pregnancy, you may be at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking Sandoz Desvenlafaxine, tell your healthcare professional right away.
Effects on newborns: In some cases, babies born to a mother taking Sandoz Desvenlafaxine during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they:
- have trouble breathing or feeding;
- have muscle stiffness, or floppy muscles (like a rag doll);
- have seizures (sudden and uncontrolled burst of electrical activity in the brain);
- are shaking (jitteriness);
- are constantly crying
Breast-feeding: Sandoz Desvenlafaxine can pass into breast milk and may harm a breastfed baby. Only take Sandoz Desvenlafaxine while you are breast-feeding if you and your healthcare professional have discussed the risks and have decided that you should.
Driving and using machines: Until you know how Sandoz Desvenlafaxine affects you, do not drive or operate a vehicle or potentially dangerous machinery.
Monitoring and tests: Your healthcare professional may do tests, including blood tests, before you take Sandoz Desvenlafaxine and regularly during your treatment. These tests will monitor:
- your blood pressure;
- your levels of cholesterol and triglycerides (types of fat) in your blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
Do not take Sandoz Desvenlafaxine if you:
- are taking, or have taken in the last 14 days, any MAOIs such as phenelzine, tranylcypromine, moclobemide, selegiline, linezolid and methylene blue. You must wait at least 7 days after you stop taking Sandoz Desvenlafaxine before taking any MAOI.
Before taking Sandoz Desvenlafaxine, tell your healthcare professional if you take the following medicines:
- other medicines that contain desvenlafaxine, or venlafaxine
- other antidepressants, such as other SNRIs, selective serotonin reuptake inhibitors (SSRIs) and certain tricyclic antidepressants
- medicines used to treat psychiatric disorders (antipsychotics)
amphetamines, used to treat conditions such as narcolepsy (uncontrollable urge to
- lithium, used to treat manic episodes of bipolar disorder
- opioid medicines, used to treat pain or drug dependence, such as methadone, tramadol, buprenorphine, fentanyl, tapentadol, meperidine, pentazocine
- dextromethorphan, used to relieve coughs
- triptans, used to treat migraines
- tryptophan supplements
- St. John’s Wort, a herbal remedy
| Taking Sandoz Desvenlafaxine with any of these medicines may cause serious drug interactions (e.g., serotonin toxicity). Ask your healthcare professional if you are unsure. |
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The following may also interact with Sandoz Desvenlafaxine:
- medicines used to treat anxiety
- medicines to treat fungal infections such as ketoconazole
- benzodiazepines (used to treat anxiety, seizures and insomnia) such as midazolam
- medicines that affect your electrolyte levels such as diuretics (“water pills”)
- medicines that can affect how your blood clots such as warfarin, acetylsalicylic acid (ASA), and non-steroidal anti-inflammatory drugs (NSAIDs)
- nutritional or herbal supplements
- alcohol. It is recommended to avoid drinking alcohol while taking Sandoz Desvenlafaxine.
How to take Sandoz Desvenlafaxine:
- It is very important that you take Sandoz Desvenlafaxine exactly as your healthcare professional has instructed.
- Do not change your dose without talking to your healthcare professional.
- Your healthcare professional will tell you when to stop taking Sandoz Desvenlafaxine. Always follow your healthcare professional’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
- Continue to take Sandoz Desvenlafaxine even if you do not feel better as it may take several weeks for your medicine to start working.
Take Sandoz Desvenlafaxine:
- once a day,
- at the same time each day,
with or without food.
- Swallow tablets whole with a glass of water. Do not chew, divide or crush tablets.
- The medication in Sandoz Desvenlafaxine is packed within a non-absorbable shell. This shell has been specially designed to slowly release the medicine at a constant rate over time so that the body can absorb it. The shell does not dissolve completely after all the medicine has been released, and you may sometimes notice it in your stool. Do not be concerned, this is normal.
Usual dose:
The usual dose is 50 mg once daily. Your healthcare professional may increase your dose if you need it.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Desvenlafaxine, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using Sandoz Desvenlafaxine?
These are not all the possible side effects you may have when taking Sandoz Desvenlafaxine. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Sandoz Desvenlafaxine may include:
- nausea, vomiting, diarrhea, constipation, abdominal discomfort or pain, feeling bloated (gas), dry mouth
- headache, dizziness, vertigo (feeling like you are spinning)
- chills
- lack of energy
- flu (fever, body aches, cough), stuffy nose, nosebleeds
- poor appetite, change in tastes, changes in weight
- burning or prickling sensation in the hands, arms, legs, or feet
- coldness in hands and feet
- difficulty to fall or stay asleep, sleepiness
- excessive sweating, skin rash, sensitivity to light
- abnormal dreams
- yawning
- hot flashes
- hair loss
| Serious side effects and what to do about them | |||
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| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Hypertension (high blood pressure): headache, stronger and possibly faster heartbeat, chest pain, dizziness, excessive tiredness, and blurred vision. Sometimes, the increase in blood pressure could be severe enough to require urgent medical attention | ✓ | ||
| Sexual problems: abnormal ejaculation or impotence in men, decreases in sexual desire, performance and satisfaction | ✓ | ||
| Symptoms after discontinuation or dose reduction: loss of appetite or weight, anxiety, restlessness, aggression, confusion, convulsions, coordination problems, diarrhea, dizziness, dry mouth, fatigue, headache, rapid mood swings, nausea, nightmares, tingling of the skin, sleep disturbances, sweating, ringing in the ears or vomiting | ✓ | ||
| Tachycardia (abnormally fast heartbeat): dizziness, | ✓ | ||
| light headedness, shortness of breath, racing heart | |||
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| UNCOMMON | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue, (hypotension may occur when you go from lying or sitting to standing up) | ✓ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||
| Myocardial ischemia (lack of blood flow to the heart which can lead to heart attack): sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, sudden heavy sweating | ✓ | ||
| Severe skin reactions: raised red or purple skin patches, possibly with blister or crust in the center, possibly swollen lips, mild itching or burning; skin redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, can | ✓ | ||
| be accompanied with fever, chills, headache, cough, body aches or swollen glands | |||
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| Urinary retention (inability to urinate or empty or loss of control of the bladder): pain | ✓ | ||
| RARE | |||
| Angle-closure glaucoma: blurred vision, halos around lights, eye pain and redness, nausea and vomiting, severe headache | ✓ | ||
| Hallucinations (seeing or hearing things that are not there) | ✓ | ||
| Hyponatremia (low sodium in the blood): lack of energy, confusion, muscular twitching, achy, stiff or uncoordinated muscles, seizure, coma | ✓ | ||
| New or worsened emotional or behavioural problems: agitation, feeling detached from one’s self, anger, aggression, anxiety, violent thoughts | ✓ | ||
| Mania: elevated or irritable mood, decreased need for sleep, racing thoughts | ✓ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Seizures (sudden and uncontrolled burst of electrical activity in the | ✓ | ||
| brain): confusion, staring, changes in behaviour and emotions, can occur with or without loss of consciousness, muscle twitching or other movements | |||
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| Serotonin toxicity (also known as serotonin syndrome): mental changes such as agitation, hallucinations, confusion, or other changes in mental status; coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes); restlessness, shaking, shivering, racing or fast heartbeat, high or low blood pressure, sweating or fever, nausea, vomiting, or diarrhea, muscle rigidity (stiff muscles), tremor, loss of muscle control | ✓ | ||
| Uncontrollable movements of the body or face | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Low Platelets: Bruising or unusual bleeding from the skin or other areas | ✓ | ||
| Akathisia (a type of movement disorder): a feeling of inner restlessness accompanied by mental distress and an inability to sit or stand still. | ✓ | ||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, | ✓ | ||
| swelling of the face, lips, tongue or throat | |||
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| Gastrointestinal bleeding (bleeding in the stomach or bowels): black, tarry stool, blood in the stool, vomiting blood | ✓ | ||
| Self-harm or Suicide: thoughts or actions about hurting or killing yourself | ✓ | ||
| Syndrome of inappropriate antidiuretic hormone secretion (SIADH): concentrated urine (dark in colour), feel or are sick, muscle cramps, confusion and fits (seizures) which may be due to inappropriate secretion of ADH (antidiuretic hormone) | ✓ | ||
| Urinary tract infection (infection of the urinary system, including kidneys, ureters, bladder and urethra): pain or burning sensation while urinating, frequent urination, blood in urine, pain in the lower abdomen, strong smelling urine, cloudy urine | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
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If you want more information about Sandoz Desvenlafaxine:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.