Patient Medication Information: uses, side effects, how to take - Teva-Dextroamphetamine SR
Serious Warnings and Precautions
Drug dependence: Like other stimulants, TEVA-DEXTROAMPHETAMINE SR have the potential to be abused. This can lead to you becoming dependent on TEVA-DEXTROAMPHETAMINE SR feeling like you need to take more of it over time.
Misusing TEVA-DEXTROAMPHETAMINE SR may cause serious heart problems and even sudden death.
What is TEVA-DEXTROAMPHETAMINE SR used for?
TEVA-DEXTROAMPHETAMINE SR is used along with other therapies, in children 6 years of age or older, adolescents and adults to treat:
- narcolepsy (a type of sleep disorder). This disorder causes excessive sleepiness during the day and frequent and uncontrollable episodes of falling asleep.
- Attention Deficit Hyperactivity Disorder (ADHD). Treatment with TEVA-DEXTROAMPHETAMINE SR should be combined with other measures such as psychological counselling, educational and social measures, as part of a total treatment program.
TEVA-DEXTROAMPHETAMINE SR is not recommended for use in children under 6 years of age.
How does TEVA-DEXTROAMPHETAMINE SR work?
TEVA-DEXTROAMPHETAMINE SR belongs to a group of medicines called sympathomimetics. TEVA-DEXTROAMPHETAMINE SR works by raising the levels of chemicals in the brain called dopamine and norepinephrine. This helps to:
- increase alertness and wakefulness in patients with narcolepsy.
- increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
What are the ingredients in TEVA-DEXTROAMPHETAMINE SR?
Medicinal ingredients: dextroamphetamine sulfate
Non-medicinal ingredients: Ammonia solution, D&C yellow no. 10, FD&C red no. 40, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, opadry clear (YS-1-7006), propylene glycol, shellac, silicon dioxide, sodium lauryl sulfate, Sugar spheres, surelease, talc, titanium dioxide
In addition, the 10 mg capsule also contains dehydrated alcohol and purified water.
TEVA-DEXTROAMPHETAMINE SR comes in the following dosage forms:
Sustained-release capsules: 10 mg and 15 mg
Do not use TEVA-DEXTROAMPHETAMINE SR if you/your child:
- are allergic to dextroamphetamine sulfate or any of the other ingredients in TEVA-DEXTROAMPHETAMINE SR.
- are sensitive to, allergic to, or had a reaction to other stimulant medicines.
- have symptoms of heart disease.
- have moderate to severe high blood pressure.
- have advanced arteriosclerosis (hardened arteries).
- have hyperthyroidism (an overactive thyroid gland).
- have glaucoma (an eye disease with increased pressure in the eye).
- have a condition that causes you to feel anxious, tense, or agitated.
- have, or have a family history of, motor tics (hard to control, repeat twitching of any parts of the body), verbal tics (hard to control, repeating of sounds or words) or Tourette’s syndrome.
- are taking or have recently taken (in the past 14 days) any medications from the group of medicines called monoamine oxidase inhibitors (MAOIs).
- have a history of drug abuse.
- have a condition called pheochromocytoma (a rare tumour that usually grows in the adrenal glands, above your kidneys).
To help avoid side effects and ensure proper use, talk to your or your child’s healthcare professional before TEVA-DEXTROAMPHETAMINE SR is taken. Talk about any health conditions or problems, including if you/your child:
- take other stimulant medications.
- have structural heart abnormalities, cardiomyopathy, serious heart rhythm abnormalities or other serious heart problems.
- have mild high blood pressure.
- have a family history of sudden death or death related to heart problems.
- have a family history of an irregular heartbeat.
have or have a family history of mental health problems, including:
- psychosis
- mania
- bipolar illness
- aggression
- depression
- suicide
- have a history of seizures (convulsions, epilepsy) or have had abnormal brain wave tests (electroencephalogram; EEGs).
- do strenuous exercise or activities.
- have severe kidney problems, including if you are undergoing dialysis.
have the following rare hereditary conditions:
- Glucose-galactose malabsorption
- Fructose intolerance
- Sucrase-isomaltase deficiency
TEVA-DEXTROAMPHETAMINE SR contains sucrose (sugar spheres).
- have a history of drug dependence or alcoholism.
- are pregnant, think you might be pregnant or planning to become pregnant.
- are breast feeding or planning to breastfeed.
Other warnings you should know about:
Dependence and tolerance: Like other stimulants, TEVA-DEXTROAMPHETAMINE SR has the potential to be abused. This can lead to dependence, tolerance and severe social disorders. If you have a history of drug or alcohol abuse, talk to your healthcare professional.
During treatment, do not change your dose or stop taking TEVA-DEXTROAMPHETAMINE SR without first talking to your healthcare professional. If you find that you are craving more TEVA-DEXTROAMPHETAMINE SR than you are supposed to take, tell your healthcare professional right away.
Careful supervision from your healthcare professional is needed when you stop taking TEVA-DEXTROAMPHETAMINE SR. If you suddenly stop your treatment, especially if you have been taking high doses of TEVA-DEXTROAMPHETAMINE SR for a long time, you may experience:
- extreme fatigue.
- depression.
- changes in sleep patterns.
Driving and using machines: TEVA-DEXTROAMPHETAMINE SR may hide extreme fatigue and can affect your ability to drive and use tools or machinery. You should not drive or use tools or machinery until you know how you respond to TEVA-DEXTROAMPHETAMINE SR.
Pregnancy and breastfeeding:
- Taking TEVA-DEXTROAMPHETAMINE SR during pregnancy may cause harm to your unborn baby. If TEVA-DEXTROAMPHETAMINE SR is required during pregnancy, the risks to the unborn baby will be weighed against the benefits to the mother. Your healthcare professional will discuss these risks with you. If you discover that you are pregnant while taking TEVA-DEXTROAMPHETAMINE SR, tell your healthcare professional right away.
- Dextroamphetamine sulfate can pass through your breast milk and may harm your baby. You should not breastfeed while you are taking TEVA-DEXTROAMPHETAMINE SR. You should consult with your healthcare professional to determine if you should stop breastfeeding or discontinue TEVA-DEXTROAMPHETAMINE SR.
The following have been reported with use of TEVA-DEXTROAMPHETAMINE SR and other medicines used to treat ADHD:
Growth in children: Slower growth (weight and/or height) has been reported with long-term use of stimulant medicines in children. Your child’s healthcare professional will carefully monitor their height and weight. If your child is not growing or gaining weight as expected, your child’s healthcare professional may stop their treatment.
Heart-related problems: The following heart related problems have been reported in people taking stimulant medicines, like TEVA-DEXTROAMPHETAMINE SR.
- sudden death in patients who have heart problems or heart defects.
- stroke and heart attack in adults.
- increased blood pressure and heart rate.
Sudden death has been reported in association with stimulant medicines for ADHD treatment in children with structural heart abnormalities. TEVA-DEXTROAMPHETAMINE SR generally should not be used in children, adolescents or adults with known structural heart abnormalities.
Tell your healthcare professional if you/your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your healthcare professional will check:
- you/your child for heart problems before starting TEVA-DEXTROAMPHETAMINE SR.
- you/your child blood pressure and heart rate regularly during treatment with TEVA- DEXTROAMPHETAMINE SR.
Seek immediate medical help if you/your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking TEVA-DEXTROAMPHETAMINE SR.
Mental health problems: The following mental health problems have been reported in people taking stimulant medicines, like TEVA-DEXTROAMPHETAMINE SR:
- new or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicide actions (suicide attempt, suicidal ideation and completed suicide).
- new or worse symptoms of bipolar disorder (extreme mood swings, with periods of impulsiveness or unusual excitement, switching between periods of sadness).
- new or worse aggressive behaviour or hostility.
- new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious).
These new or worse mental health symptoms may be more likely to occur if you/your child have mental health conditions that you may or may not know about. Tell your healthcare professional about any mental health problems you or your child have, or about any personal or family history of suicide, bipolar illness, or depression.
A small number of patients taking stimulant medicines may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviors may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping TEVA-DEXTROAMPHETAMINE SR.
Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your healthcare professional immediately. Close observation by a healthcare professional is necessary in this situation.
Raynaud’s phenomenon: Stimulant medicines, such as TEVA-DEXTROAMPHETAMINE SR, are associated with Raynaud’s phenomenon. During treatment with TEVA-DEXTROAMPHETAMINE SR, your healthcare professional may check for problems with the circulation in your fingers and toes, including numbness, feeling cold or pain.
Serotonin toxicity (also known as Serotonin Syndrome): Serotonin toxicity is 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 TEVA-DEXTROAMPHETAMINE SR with certain anti-depressants 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.
Tell your healthcare professional about all the medicines you/your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not take TEVA-DEXTROAMPHETAMINE SR if you:
|
|---|
The following may also interact with TEVA-DEXTROAMPHETAMINE SR:
- medicines that make your urine or digestive contents more acidic (e.g., glutamic acid hydrochloride, ascorbic acid (vitamin C), ammonium chloride, sodium acid phosphate).
- medicines that make your urine or digestive contents more alkaline (e.g., sodium bicarbonate, antacids, acetazolamide, thiazides, proton pump inhibitors, cimetidine).
- medicines used to treat high blood pressure (e.g., guanethidine, clonidine, beta blockers) or other medicines that can affect blood pressure (e.g., norepinephrine).
- other stimulant medications.
- medicines used to treat depression, such as bupropion, tricyclic antidepressants (e.g., desipramine), selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine, fluoxetine), serotonin and noradrenaline reuptake inhibitors (SNRIs), and tryptophan (an essential amino acid).
- medicines used to treat migraines (e.g., sumatriptan, rizatriptan, zolmitriptan).
- medicines used to treat psychiatric disorders, such as schizophrenia (e.g., chlorpromazine, haloperidol) and bipolar disorder (e.g., lithium carbonate).
- opioid medicines, used to relieve pain (e.g., fentanyl, tramadol, tapentadol, meperidine and methadone).
- terbinafine, used to treat fungal infections.
- quinidine, used to treat an irregular heartbeat.
- cold and allergy medicines.
- St. John’s Wort, a herbal remedy.
While on TEVA-DEXTROAMPHETAMINE SR do not start taking a new medicine or herbal remedy before checking with your healthcare professional.
How to take TEVA-DEXTROAMPHETAMINE SR:
- If you are taking TEVA-DEXTROAMPHETAMINE SR, take it once-a-day.
- Avoid taking TEVA-DEXTROAMPHETAMINE SR late in the evening as it can cause insomnia.
Usual dose:
Take TEVA-DEXTROAMPHETAMINE SR exactly as prescribed by your/your child’s healthcare professional. Do NOT change your dose or stop taking TEVA-DEXTROAMPHETAMINE SR without first discussing with your/your child’s healthcare professional.
Your/your child’s healthcare professional may gradually adjust the dose until it is right for you/your child. Follow their instructions carefully.
To treat narcolepsy
- Children (6 to 12 years of age): the usual starting dose is 5 mg per day.
- Adolescents (12 to 17 years of age) and adults: the usual starting dose is 10 mg per day.
To treat ADHD
- Children 6 years of age or older, adolescents and adults: The usual starting dose is 5 mg once a day or twice a day.
From time to time, your/your child’s healthcare professional may interrupt your/your child’s treatment to check your/your child’s ADHD symptoms while you/your child are not taking the medicine.
Overdose:
| If you think you, or a person you are caring for, have taken too much TEVA-DEXTROAMPHETAMINE SR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you missed a dose, take it as soon as you remember. Then continue with your next scheduled dose as usual. Do not take a late evening dose. Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using TEVA-DEXTROAMPHETAMINE SR?
These are not all the possible side effects you may have when taking TEVA-DEXTROAMPHETAMINE SR. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- dry mouth, unpleasant taste
- loss of appetite, weight loss
- diarrhea, constipation
- itchy skin, lace-like pattern of darkened skin, skin discolouration
- dizziness
- headache
- difficulty falling or staying asleep
- problems with your teeth
- bladder problems
- muscle spasm, shaking (tremors), uncontrolled and involuntary movements (dyskinesia)
- screaming
- feeling irritable, restless, uneasy or overexcited
- changes in sex drive, inability to get or keep an erection
- nosebleeds
- bruising
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Anxiety | ✓ | ||
| New tics: hard to control motion tics (repeat twitching of any parts of the body) or verbal tics (repeating of sounds or words) | ✓ | ||
| Palpitations (fast-beating, fluttering or pounding heart) | ✓ | ||
| Slowing of growth (height and weight) in children | ✓ | ||
| UNCOMMON | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, swelling of the face, lips, tongue or throat, hives or rash | ✓ | ||
| Aggressive Behaviour or Hostility | ✓ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive). If you have a history of depression, your depression may become worse. | ✓ | ||
| New or worsening mental health problems: paranoia, delusions, hallucinations (seeing, feeling or hearing things that are not there), mania (feeling unusually excited, over-active, or inhibited) | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Vision problems: changes in vision or blurry vision | ✓ | ||
| RARE | |||
| Serotonin Toxicity (also known as Serotonin Syndrome): feeling of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (above 38°C), rigid muscles | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Cardiomyopathy (signs of heart muscle disease): breathlessness or swelling of the legs | ✓ | ||
| Cerebrovascular disorders (problems with the blood vessels in the brain, stroke): severe headaches, weakness or paralysis of any body part, or problems with coordination, vision, speaking, finding words or with your memory | ✓ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or fast or uneven heartbeat | ✓ | ||
| Intestinal ischemia (blood flow to your intestines decreases due to a narrowed or blocked blood vessel): sudden or worsening abdominal pain (usually severe), urgent need to have a bowel movement, frequent, forceful bowel movements, nausea, vomiting, diarrhea, blood in your stool, confusion in older adults | ✓ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain in the chest, jaw, left arm, between the shoulder blades or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||
| Raynaud’s Phenomenon (episodes of reduced blood flow): cold feeling in fingers and toes (and sometimes nose, lips and ears), prickly or stinging feeling, change in skin colour to white then blue | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | ✓ | ||
| Suicidal Behaviour: thoughts or actions about hurting or killing yourself | ✓ | ||
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:
TEVA-DEXTROAMPHETAMINE SR should be stored at 15-30°C.
Do not take your medicine after the expiry date shown on the bottle.
Keep out of reach and sight of children.
If you want more information about TEVA-DEXTROAMPHETAMINE SR:
- 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-
- -product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.