Riva-Alprazolam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RIVA-ALPRAZOLAM has been prescribed to you by your doctor to relieve your symptoms of the following conditions:

• Generalized anxiety disorder (excessive anxiety or

  worry)

• Panic disorder (repeated, unexpected panic attacks

  of extreme fear and worry about these attacks)

What it does:

RIVA-ALPRAZOLAM contains the active ingredient alprazolam, which belongs to a group of medicines known as benzodiazepines. RIVA-ALPRAZOLAM has sedative properties which help in the treatment of anxiety and panic.

When it should not be used:

Do not take RIVA-ALPRAZOLAM if you:

• are allergic to the group of medicines known as

  benzodiazepines (examples: clonazepam, chlordiazepoxide, diazepam, or flurazepam).

• are allergic to RIVA-ALPRAZOLAM or any of the

  ingredients listed in the section “What the nonmedicinal ingredients are”.

• have acute narrow angle glaucoma, a condition

  associated with increased pressure in the eye that may cause loss of sight.

• have myasthenia gravis, a chronic disease

  characterized by weakness of the skeletal muscles.

• have a liver condition.
• have lung disease or breathing problems.

• have a sleep disorder that causes pauses in breathing

  or shallow breathing while sleeping (sleep apnea).

  • are taking ketoconazole (eg., Nizoral) or itraconazole (eg., Sporanox), medicines used to treat fungal infections.

RIVA-ALPRAZOLAM should not be used in patients under 18 years of age.

What the medicinal ingredient is:

alprazolam

What the nonmedicinal ingredients are:

All tablets contain Lactose, Microcystalline Cellulose, Povidone K-30, Colloidal Silicon Dioxide and Magnesium Stearate. In addition, the 0.5 mg tablets contain FD&C yellow #6 Aluminum lake and the 1 mg tablets contain FD&C Blue # 2 Aluminum lake

What dosage forms it comes in:

RIVA-ALPRAZOLAM (alprazolam) is available in:

0.25 mg, White colored, oval shape biconvex tablet one side debossed by ‘N’ on the left side and by ‘A’ on the right side of score line and other side debossed with ‘0.25’,

0.5 mg, Orange colored, oval shape biconvex tablet one side debossed by ‘N’ on the left side and by ‘A’ on the right side of score line and other side debossed with ‘0.5’,

1 mg, Blue colored, oval shape biconvex tablet one side debossed by ‘N’ on the left side and by ‘A’ on the right side of score line and other side debossed with ‘1.0’ and

2 mg, White to off white oblong shaped multi scored debossed ‘2’ on one side and plain on other side. The 2 mg tablets-scored (3 scores) and can be broken into 4 equal parts of 0.5 mg each.

Serious Warnings and Precautions

Taking RIVA-ALPRAZOLAM with opioid medicines can cause sever drowsiness, breathing problems, coma, and death.

BEFORE you use RIVA-ALPRAZOLAM talk to your doctor or pharmacist if you:

• have a lung, liver or kidney condition.
• have a history of alcohol or drug abuse
• have a history of depression and/or suicide attempts.
• are pregnant, think you may be pregnant, or are planning to become pregnant.
• are breast feeding.

WARNINGS AND PRECAUTIONS

Product Monograph – Riva-Alprazolam Page 36 of 39

• regularly drink alcohol.
• have lactose intolerance.

Mental alertness

RIVA-ALPRAZOLAM can cause drowsiness and affect your ability to be alert. You should not perform activities that require mental alertness such as driving or operating machinery until you know how this drug will affect you. This effect of RIVA-ALPRAZOLAM may be made worse if you take alcoholic drinks. If your doctor has increased your dose or if you have changed the timings of when you take your medication this may also change how the drug affects you.

Risk of falls, memory loss

There have been reports of falls and fractures in people who take benzodiazepenes such as RIVA-ALPRAZOLAM. Memory loss has also been reported. These have occurred in people taking the usual doses.

Worsening of side effects with alcohol and other drugs RIVA-ALPRAZOLAM may have more pronounced sedative effects when taken with alcohol or other drugs that can make you sleep, such as: narcotic pain relievers, sleeping pills, antihistamines, medications to control seizures, antidepressants or antipsychotics. Do not take RIVA-ALPRAZOLAM if you drink alcohol. Do not use RIVA-ALPRAZOLAM with these other medications without first discussing with your doctor.

Withdrawal symptoms

Always contact your doctor before stopping or reducing your dosage of RIVA-ALPRAZOLAM. Suddenly stopping treatment or a large decrease in dose can cause withdrawal symptoms. This can happen with drugs of this type even when taking for only a few weeks.

Symptoms of withdrawal may include mild symptoms, such as a feeling of dissatisfaction, restlessness or trouble sleeping.

In severe cases of withdrawal, symptoms may include irritability, nervousness, insomnia, agitation, diarrhea, stomach pains, vomiting, sweating, shaking, numbness and tingling of the extremities, hallucinations (seeing or hearing things that are not there), being unusually sensitive to light, noise and physical contact and seizures.

Therefore, always follow the treatment as prescribed by your doctor.

Dependence

Benzodiazepines such as RIVA-ALPRAZOLAM have caused dependence (addiction) and withdrawal symptoms can occur when treatment is stopped suddenly. The risk of dependence (addiction) increases with higher doses and longer duration of treatment, or after suddenly stopping treatment.

Pregnancy

Some benzodiazepines have been linked to birth defects when taken during the early months of pregnancy. Babies born to mothers who have taken benzodiazepines during the last weeks of pregnancy or during labour have been known to have overly relaxed muscles and breathing problems, and may also have withdrawal symptoms after birth.

Do not take this medicine if you are pregnant (or think you may be pregnant), unless advised by your doctor. Consult with your doctor before taking RIVA-ALPRAZOLAM if you are planning to become pregnant.

Breast feeding

RIVA-ALPRAZOLAM may pass into breast milk. Therefore, if you are breast feeding, this medicine should be avoided.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food store without a prescription.

RIVA-ALPRAZOLAM may have more pronounced side effects when taken with alcohol or other drugs that affect the central nervous system. Do not drink alcohol while taking RIVA-ALPRAZOLAM. Do not use RIVA-ALPRAZOLAM with the following other medicines without first discussing with your doctor:

• narcotic pain relievers (opioids, e.g., morphine, codeine)

  (see Serious Warnings and Precautions box)

• sleeping pills
• antihistamines (medicines used for relief of allergy symptoms)
• anticonvulsants (medications used to control seizures)
• antidepressants (medicines used to treat anxiety or depression)
• antipsychotics (medicines used to treat mental illnesses such as schizophrenia)

Product Monograph – Riva-Alprazolam Page 37 of 39 RIVA-ALPRAZOLAM should not be taken with ketoconazole or itraconazole (medicines used to treat fungal infections) because these medicines can cause an increase in the amount of RIVA-ALPRAZOLAM in your blood and can enhance side effects.

Other medicines that can affect the amount of RIVA-ALPRAZOLAM in your blood include cimetidine, fluvoxamine, carbamazepine, HIV protease inhibitors, and birth control pills.

Talk to your doctor if you are using RIVA-ALPRAZOLAM with digoxin, as RIVA-ALPRAZOLAM may affect the amount of digoxin in your blood.

Always tell your doctor about any other medicines you are taking or plan to take

PROPER USE OF THIS MEDICATION

Always take the tablets exactly as your doctor tells you to. Your doctor will prescribe a suitable dose for you. The dose your doctor prescribes will depend on your illness and how you respond to the medicine. The table below shows the different doses that your doctor may prescribe according to your illness.

The total daily dose should be taken as advised by your doctor.

Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.

Your doctor will advise you when to stop taking the medicine. Your doctor will slowly decrease the dosage as sudden discontinuation of treatment can cause the appearance of withdrawal symptoms.

Because elderly patients can be more sensitive to the effects of RIVA-ALPRAZOLAM, lower doses may be prescribed.

Overdose:

Contact your doctor, regional Poison Control Centre or pharmacist immediately if you suspect you have taken an overdose or someone else accidentally takes your RIVA-ALPRAZOLAM. If you are unable to contact them, go to a hospital emergency department for medical help, even though you may not feel sick. Show the doctor your bottle of tablets.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications RIVA-ALPRAZOLAM can cause some side effects. For most patients, these side effects are likely to be minor and temporary as your body adjusts to the medicine. However, some may be serious. Consult your doctor or pharmacist as soon as you can if you do not feel well while taking RIVA-ALPRAZOLAM

The most common side effects are:

• Feeling drowsy or tired, especially at the start of treatment.
• Dizziness
• Loss of some balance and coordination
• Memory problems
• Constipation
• Slurred speech

Less common possible side effects are:

• Agitation
• Changes in sex drive (increased or decreased)
• Changes in weight (gain or loss)
• Increased appetite
• Difficulty urinating
• Bladder control problems

In rare cases, RIVA-ALPRAZOLAM can affect liver function, and disorders such as hepatitis or liver failure may occur. Your doctor will monitor your blood for effects of RIVA-ALPRAZOLAM on your liver.

Elderly patients may be especially susceptible to side effects. Excessive drowsiness or loss of balance may increase the risk of falls and fractures in elderly patients.

All patients should be cautious about performing hazardous activities that require complete mental alertness, such as operating machinery or driving a car.

Withdrawal-related side effects:

If treatment is stopped suddenly or there is a large decrease in dose, symptoms of withdrawal may occur, including: restlessness and trouble sleeping. In severe cases of withdrawal, symptoms may include: irritability, nervousness, trouble sleeping, diarrhea, stomach pains, vomiting, sweating, tremors, numbness and tingling of the extremities, hallucinations (seeing or hearing things that are not there), being unusually sensitive to light, noise and physical contact and seizures.

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This is not a complete of side effects. For any unexpected effects while taking RIVA-ALPRAZOLAM, contact your doctor or pharmacist.

HOW TO STORE IT

RIVA-ALPRAZOLAM should be stored in tight, light-resistant containers at controlled room temperature (15°C to 30°C).

Keep out of the reach of children.

Blainville, J7C-3V4

Tel: 1-800-363-7988

www.labriva.com

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

Product Monograph – Riva-Alprazolam Page 39 of 39 Date of Revision: June 29, 2018