Sandoz Amphetamine XR: Uses, Side Effects and Dosage

Serious warnings and precautions box

What SANDOZ AMPHETAMINE XR is used for:

SANDOZ AMPHETAMINE XR is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children (6 to 12 years), adolescents (13 to 17 years) and adults. It may be a part of an overall treatment for ADHD. The healthcare professional may also recommend counselling or other therapy.

How SANDOZ AMPHETAMINE XR works:

SANDOZ AMPHETAMINE XR belongs to a group of medicines called central nervous system stimulants. SANDOZ AMPHETAMINE XR is believed to act on certain parts of the brain to help increase your attention and concentration. This includes the ability to follow directions, finish tasks, and reduce rash and uncontrolled behaviour. SANDOZ AMPHETAMINE XR also contains the medicinal ingredient, amphetamine, which is released immediately after taking the medicine and later during the day to keep improving the symptoms of ADHD throughout the day.

The ingredients in SANDOZ AMPHETAMINE XR are:

Medicinal ingredients: Amphetamine aspartate monohydrate, amphetamine sulfate, d-amphetamine saccharate, and d-amphetamine sulfate.

Non-medicinal ingredients: Edible inks, FD&C Blue #2 (5 mg, 10 mg, and 15 mg capsules), hydroxypropyl methylcellulose, kosher gelatin, methacrylic acid copolymer, opadry beige, red iron oxide (20 mg, 25 mg, and 30 mg capsules), starch, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (20 mg, 25 mg, and 30 mg capsules).

SANDOZ AMPHETAMINE XR comes in the following dosage forms:

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg of mixed salts amphetamines (i.e., amphetamine aspartate monohydrate, amphetamine sulfate, d-amphetamine saccharate, and d-amphetamine sulfate).

The use of SANDOZ AMPHETAMINE XR can lead to drug dependence. SANDOZ AMPHETAMINE XR may also lead to the abuse and misuse of the drug.

Misusing SANDOZ AMPHETAMINE XR may cause serious heart problems and even sudden death.

Do not use SANDOZ AMPHETAMINE XR if:

• you are allergic to amphetamines or any of the nonmedicinal ingredients in the formulation or its container.
• you are sensitive to, allergic to or had a reaction to other stimulant medicines.
• you have a condition that hardens the arteries.
• you have symptoms of heart disease.
• you have moderate to severe high blood pressure.
• you have a condition that causes anxious and distressful feelings.
• you have glaucoma, an eye disease.
• you have hyperthyroidism (a condition that causes the thyroid gland to make too much of a hormone).
• you have a history of drug abuse.
• you are taking or have taken medications from the group called monoamine oxidase inhibitors (MAOI) within the last 14 days.
• you are breastfeeding or plan to breastfeed. SANDOZ AMPHETAMINE XR passes into breast milk.
• you 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 healthcare professional before you take SANDOZ AMPHETAMINE XR. Talk about any health conditions or problems you may have, including if you:

• have structural heart abnormalities, cardiomyopathy, serious heart rhythm (heartbeat) abnormalities or other serious heart problems.
• have a family history of sudden cardiac death or death related to heart problems.
• have mild high blood pressure.
• are involved in any physical exercises that are tiring on the body.
• take other medicines for the treatment of ADHD.
• have motion tics, verbal tics or Tourette’s syndrome (See Serious side effects and what to do about them below).
• have family with motion tics, verbal tics, or Tourette’s syndrome.
• have a history of seizures (convulsions, epilepsy).
• have had an abnormal brain wave test when using an Electroencephalogram (EEG).

• have symptoms of:

  • Raynaud’s phenomenon (a condition that causes fingers and toes feeling numb, tingling and changing colour when cold).
  • Thromboangitis obliterans (that causes pain in hands and feet).
• have any kidney related problems as your healthcare professional may reduce the dose.

• have a history of drug abuse or alcoholism.

Other warnings you should know about:

Pregnancy: Tell your healthcare professional if you are pregnant or plan to become pregnant. Taking SANDOZ AMPHETAMINE XR during pregnancy can cause harm to your unborn baby. If SANDOZ AMPHETAMINE XR is required during pregnancy, the risk to the unborn baby should be weighed against the benefits for the mother. Your healthcare professional can discuss these issues with you.

The following have been reported with use of medicines used to treat ADHD such as SANDOZ AMPHETAMINE XR:

Serotonin toxicity (also known as serotonin syndrome):

SANDOZ AMPHETAMINE XR 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 AMPHETAMINE XR with other serotonergic medicines, for example, 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.

Heart-related problems: The following heart related problems have been reported in people taking medications to treat ADHD, like SANDOZ AMPHETAMINE XR:

• sudden death in children, adolescents and adults 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 children and adolescents treated with medicines for ADHD. Those children and adolescents had problems with the structure of their heart or had other serious heart problems. SANDOZ AMPHETAMINE XR generally should not be used in children, adolescents or adults who have any serious heart diseases or conditions, such as:

• high blood pressure,
• problems with the structure of their heart,
• diseases that impact the muscles of their heart,
• serious problems with their heartbeat.

Tell your healthcare professional if you have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your healthcare professional may wish to check you for:

• heart problems before starting SANDOZ AMPHETAMINE XR.
• irregular blood pressure and heart rate during treatment with SANDOZ AMPHETAMINE XR.

Call your healthcare professional right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking SANDOZ AMPHETAMINE XR.

Mental (psychiatric) problems:

• New or worse thoughts or feelings related to suicide. This can include thinking about or feeling like killing yourself and suicide attempts. This may happen at any time during treatment, especially at the start or during dose changes, and also after stopping the treatment of SANDOZ AMPHETAMINE XR. Should this happen to you, talk to your healthcare professional immediately. Close observation by a healthcare professional is necessary in this situation.
• New symptoms of mania. This can include unusual excited, over-active or unrestrained behavior.
• New or worse bipolar illness. This can appear as extreme mood swings (alternating from feelings of unusual excitement, over-active or un-inhibited to feelings of depression, sadness, worthlessness or hopelessness).
• New or worse aggressive behavior, anxiety, agitation or hostility.
• New symptoms of psychosis. This includes seeing or hearing voices that are not real, believing things that are not true, or are suspicious.

These problems are more likely to occur if you have any known or unknown mental disorders. Speak to the healthcare professional if you or family have or had:

• any mental disorders,
• bipolar illness,
• depression,
• a history of suicide.

Drug abuse and dependence

• SANDOZ AMPHETAMINE XR includes the medicinal ingredient, amphetamine. Amphetamines have the potential to cause drug abuse and misuse.
• Abuse of amphetamines can lead to dependence, tolerance, social disorders and possibly serious heart problems and death.

• Long term misuse of amphetamines may cause:

  • skin diseases;
  • sleeping problems;
  • personality changes;
  • anxious and distressful feelings;
  • rash, uncontrolled behaviour;
  • psychosis;
  • schizophrenia.

• Healthcare professional supervision is needed when you stop taking SANDOZ AMPHETAMINE XR. Suddenly ending treatment when taking higher doses of SANDOZ AMPHETAMINE XR for a long period of time can cause:

  • extreme fatigue,
  • depression,
  • changes in sleep patterns.
• SANDOZ AMPHETAMINE XR should only be given under close medical supervision to patients whose condition has been properly diagnosed.

Growth in children

Stimulants are possibly believed to temporarily slow growth in children. The healthcare professional will be monitoring the child’s height and weight while they are taking SANDOZ AMPHETAMINE XR. If the child is not growing or gaining weight as the healthcare professional expects, the healthcare professional may stop SANDOZ AMPHETAMINE XR treatment.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions

Serious drug interactions with SANDOZ AMPHETAMINE XR include:

• any monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, or moclobemide as it may have serious side effects. Do not take SANDOZ AMPHETAMINE XR if you are taking or have recently taken (in the last 14 days) any MAOIs.

The following may also interact with SANDOZ AMPHETAMINE XR:

• medicines used to treat depression including St. John’s Wort, selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs).
• medicines used to treat migraines called triptans.
• medicines that make urine or digestive contents more acidic (e.g., guanethidine, reserpine, ascorbic acid, ammonium chloride, sodium acid phosphate).
• medicines that make urine more alkaline (e.g., acetazolamide, thiazides).
• medicines used to reduce or increase blood pressure.
• cold and allergy medicines.
• antipsychotic medicines (e.g., chlorpromazine, haloperidol).
• lithium.
• methenamine therapy.
• opioid pain medicines (e.g., meperidine, tramadol).
• seizure medicines (e.g., ethosuximide, phenobarbital, phenytoin).
• certain radioactive agents (used for diagnostic tests). This can cause false-positive test results and your healthcare professional may ask you to stop taking SANDOZ AMPHETAMINE XR for a short period before the diagnostic test.

While on SANDOZ AMPHETAMINE XR, do not start taking a new medicine or herbal remedy before checking with the healthcare professional.

You should not take the following medications with SANDOZ AMPHETAMINE XR:

• medicines that make digestive contents more alkaline (e.g., sodium bicarbonate, antacids).
• proton pump inhibitors, commonly known as PPIs (e.g., omeprazole).

How to take SANDOZ AMPHETAMINE XR:

• Take exactly as the healthcare professional tells you to take it. Do NOT take more of it than prescribed.
• Take it only by mouth, once-a-day early in the morning.
• Avoid taking SANDOZ AMPHETAMINE XR in the afternoon as it can cause to insomnia.

• You may take SANDOZ AMPHETAMINE XR by:

  • swallowing capsules whole; or
  • opening the capsule and sprinkling all the beads on applesauce. Use immediately and do not store for later use if this method is used.
• Do not crush or chew the capsule or the beads before swallowing.
• Can be taken with or without meals.
• Capsules may be swallowed whole with water

Usual dose:

Children (6 to 12 years of age): The usual starting dose is 10 mg once a day in the morning. In some cases, the starting dose can be 5 mg once a day. Do not take more than 30 mg once a day.

Adolescents (13 to 17 years of age) and Adults (18 years of age and over): The usual starting dose is 10 mg once a day in the morning. The dose may be adjusted up to the usual maximum dose of 20 mg once a day. Do not take more than 30 mg once a day.

Your healthcare professional may:

• stop your treatment of SANDOZ AMPHETAMINE XR to assess the return of symptoms,
• change the dose depending on how you respond to SANDOZ AMPHETAMINE XR.

Overdose:

If you think you, or a person you are caring for, have taken too much SANDOZ AMPHETAMINE XR, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to take your dose in the morning, wait until the next morning and carry on with the next dose at the usual time. Do not double dose.

Possible side effects from using SANDOZ AMPHETAMINE XR:

These are not all the possible side effects you may have when taking SANDOZ AMPHETAMINE XR. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of SANDOZ AMPHETAMINE XR may include:

• behavioural changes (e.g., anxiety, irritability, mood swings, and nervousness);
• chills;
• decrease or loss of appetite;
• difficulty falling asleep;
• digestive problems (e.g., constipation, diarrhea, indigestion, nausea, and vomiting);
• dizziness;
• drowsiness;
• dry mouth and thirst;
• fever;
• grinding of teeth;
• headache;
• neck pain;
• reduced sexual drive;
• sensitive to light;
• stomach ache;
• sweating;
• unpleasant taste;
• weight loss.

Serious side effects and what to do about them

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:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15°C to 30°C) in a tight, light-resistant container.

Keep out of reach and sight of children.

If you want more information about SANDOZ AMPHETAMINE XR:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database 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-