Patient Medication Information: uses, side effects, how to take - Alprazolam (Jamp Pharma)

ABOUT THIS MEDICATION

What the medication is used for:

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:

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

When it should not be used:

Do not take ALPRAZOLAM if you:

are allergic to the group of medicines known as
benzodiazepines (examples: clonazepam, chlordiazepoxide, diazepam, or flurazepam).
are allergic to 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.
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:

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.

WARNINGS AND PRECAUTIONS

BEFORE you use 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.
consume alcohol.
have lactose intolerance.

Mental alertness

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.

Worsening of side effects

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 ALPRAZOLAM if you drink alcohol. Do not use ALPRAZOLAM with these other medications without first discussing with your doctor.

Withdrawal symptoms

Always contact your doctor before stopping or reducing your dosage of ALPRAZOLAM. Suddenly stopping treatment or a large decrease in dose can cause withdrawal symptoms.

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 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 labor 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 ALPRAZOLAM if you are planning to become pregnant.

Breast feeding

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.

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 ALPRAZOLAM. Do not use ALPRAZOLAM with the following other medicines without first discussing with your doctor:

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

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

Talk to your doctor if you are using Alprazolam with digoxin, as 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.

	Usual Daily Dose
Anxiety disorders	0.25 mg, two to three
	times per day.
	Maximum 3 mg/day.
Panic disorders	0.5 mg, three times per
	day. Maximum 10
	mg/day.

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

IMPORTANT: PLEA

discontinuation of treatment can cause the appearance of withdrawal symptoms. Because elderly patients can be more sensitive to the effects of alprazolam, lower doses may be prescribed.

Because elderly patients can be more sensitive to the effects of 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 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 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 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, ALPRAZOLAM can affect liver function, and disorders such as hepatitis or liver failure may occur. Your doctor will monitor your blood for effects of 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.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist right away		Seek immediate emergenc y medical assistance
		Only if severe	In all cases
	Unusual behavioural problems (aggression, rage), sudden anxiety or excitation, restlessness, agitation, irritability; hallucinations (see or hear things that are not there) or delusions, severe sleep disturbances, nightmares, inappropriate behaviour		√
	Allergic reactions (red skin, skin rashes, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath)			√
	Depression. Symptoms may include: Difficulty sleeping, changes in weight, feelings of worthlessness, guilt,		√

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY
	HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect regret, helplessness or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced libido (sex drive), and thoughts of death or suicide		Talk with your doctor or pharmacist right away		Seek immediate emergenc y medical assistance
		Only if severe	In all cases
				Hepatitis, liver failure (yellow skin and eyes, nausea, vomiting, pain in upper right abdomen, loss of appetite, dark-colored urine	√
Serious skin reactions (rash that may be severe, red skin, blistering of the lips, eyes or mouth, peeling skin)				√
Increased pressure in the eyes (change in side vision, sudden severe pain in the eye, decreased or cloudy vision, seeing rainbow-like halos around lights, eyes feeling swollen)				√

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

HOW TO STORE IT

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.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program Health Canada

Postal Locator 0701E

Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORAMTION

Alprazolam (Jamp Pharma): Uses, Side Effects and Dosage