Usual dose:

• It is important that you take PARNATE exactly as your doctor has instructed. The usual starting dose of PARNATE is one 10 mg tablet taken twice a day.
• PARNATE tablets are usually taken in the morning and again mid-afternoon. It is better if you take your tablets at the same times each day.
• You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.
• Keep taking your tablets, as instructed, until the doctor tells you to stop.
• Talk to your doctor before you stop taking your medication on your own.

Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Overdose:

If you have taken a large number of tablets all at once, go to the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your pack of tablets.

Missed dose:

If you forget to take a PARNATE tablet, do not try to make up for the dose that you missed by taking more than one dose at a time. Wait until the next dose and take your normal dose then.

Like all medications, PARNATE can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and go to the nearest hospital emergency department immediately.

The most common side effects of PARNATE are:

• sleep disturbances (insomnia)
• nausea
• dry mouth
• drowsiness
• weakness
• dizziness
• loss of appetite
• diarrhea
• constipation

PARNATE does not usually affect people's normal activities. However, some people feel drowsiness, dizziness or light headedness while taking it, in which case they should not drive or operate machinery.

Tell your doctor immediately if you notice any of the following:

• severe dizziness or fainting on standing
• fast heartbeat
• blurred vision
• sweating
• edema
• unusual bleeding or bruising
• agitation, confusion or nervousness
• muscle spasms or twitches
• difficulty passing urine
• unusual hair loss or thinning

Stop taking PARNATE and contact your doctor or go to the emergency department of your nearest hospital if the following happens:

• severe or frequent headaches, chest pain, fast or slow heartbeat, neck stiffness or soreness, sweating with initial paleness followed by flushing of the skin, enlarged pupils, nausea and vomiting.

Other rare side effects that have been reported include disorders of the liver and blood.

New or Worsened Emotional or Behavioral Problems:

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also Warnings and Precautions:.

Drug Dependence and Discontinuation Symptoms:

It is possible to become dependent on PARNATE. You may experience unwanted effects when you stop taking PARNATE. Withdrawal symptoms such as sleep disturbances, depression, confusion, agitation, hallucinations and other symptoms have been reported after stopping treatment of PARNATE. Tell your doctor as soon as possible if you have these or any other symptoms. Contact your doctor before stopping or reducing your dosage of PARNATE.

Serious Warnings and Precautions

• New or Worsened Emotional or Behavioral Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
• Hypertensive Crisis: Certain foods and drinks must be avoided during treatment with PARNATE and for two weeks after stopping treatment. This hypertensive reaction can be life-threatening, depending on the amount of tyramine that has been taken (see Interactions with This Medication:).

BEFORE you use PARNATE, tell your doctor or pharmacist:

• all your medical conditions, including a history of stroke, liver disease, blood disorders, kidney disease, heart problems, diabetes, epilepsy, or overactive thyroid gland
• if you have or have ever had recurrent or frequent headaches
• any medications (prescription or non prescription) which you are taking or have recently taken, especially any other antidepressants
• if you are pregnant, plan to become pregnant, or are breastfeeding
• if you are beyond the age of sixty
• your habits of alcohol and/or street drug consumption
• if you had any type of surgery or are planning to have surgery

Effects on Pregnancy and Newborns:

As stated above, ask your doctor or pharmacist for advice before taking any medicine including PARNATE. If you are already taking/using PARNATE and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Children and adolescents (less than 18 years of age):

Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviour in children and adolescents with depression.

Angle-Closure Glaucoma:

PARNATE may cause an acute attack of glaucoma. Having your eyes examined before you take this drug 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.

This medication is for use on the skin only.

Clean and dry the affected skin area and your hands. Some products need to be shaken before use. If so directed on the product label, shake the container well before each use. Apply a thin layer of the product to the areas of skin with acne, rosacea, or seborrhea as directed by your doctor, usually 1 to 3 times daily. Dosage is based on your medical condition and response to treatment. Follow your doctor's directions. Wash your hands with soap and water after each use.

Do not apply this product to skin that is cracked, broken, or raw because this may increase your risk of side effects.

Avoid getting this medication on your eyelids or lips, or in your eyes, nose, or mouth. If you do get medication in these areas, rinse with plenty of water.

Use this medication regularly to get the most benefit from it. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Tell your doctor if your condition does not improve after a few weeks. Stop using this medication and tell your doctor right away if your condition worsens, or if you develop a rash or other serious side effects. See Side Effects section.

Mild peeling of the top layer of skin is expected. Skin irritation, redness, and scaling may also occur. If any of these effects persist or worsen, stop using this medicationand tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, sodium sulfacetamide products applied to the skin may be absorbed and may cause serious side effects. Stop using this product and tell your doctor right away if any of these rare but serious side effects occur: aching/swollen joints, rash on nose and cheeks, signs of infection (such as fever, persistent sore throat), signs of anemia(such as unusual tiredness/weakness, rapid breathing, fast heartbeat), unusual bleeding/bruising, signs of liver problems (such as dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea, vomiting), mouth sores.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Before using this product, tell your doctor or pharmacist if you are allergic to sodium sulfacetamide or sulfur; or to sulfa antibiotics (such as sulfamethoxazole); or to other ingredients listed on the product package; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

Tell your doctor if there are areas of skin near where this product will be applied that are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: skin products containing silver (such as silver sulfadiazine).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Usual dose:

• Take digoxin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Try to take digoxin at the same time every day.
• Ask your doctor to teach you how to monitor your heart rate and at what heart rate you should notify them before taking any more medication.
• Do not stop taking digoxin without talking to your doctor. Stopping suddenly could make your condition worse. Even if you feel better, you may need to keep taking this medication to help the heart work properly.
• Make sure you always have enough digoxin on hand for vacations and holidays.
• Your doctor may want to perform blood tests during treatment with digoxin to monitor the amount of medication in your body.
• This medicine has been tested in children. Dosages should be individualized as directed by your doctor.
• It may take several weeks to several months for digoxin to improve your heart function. Don't be surprised if your symptoms don't get better right away. Keep taking your digoxin as prescribed. Digoxin is used to treat heart conditions that last for a long time, so you may take digoxin the rest of your life. Call your doctor if you have any problems with the drug.
• Dosage reduction may be required in patients with renal function impairment.

Overdose:

• Seek emergency medical attention.
• Symptoms of a digoxin overdose include nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, light “halos” around objects, green or yellow vision, fatigue, irregular heartbeats, and abnormally fast or slow heartbeats.

In case of accidental drug overdose, contact a health care practitioner, hospital emergency department, or regional poison centre immediately, even if there are no symptoms.

Missed dose:

Take the missed dose up to 12 hours late. If more than 12 hours have passed, skip the missed dose and take only the next regularly scheduled dose. Do Not take a double dose of this medication. Tell your doctor if you have missed 2 or more days of TOLOXIN.

If you experience any of the following side effects, talk to your doctor if you experience:

• depression;
• decreased sex drive; or
• enlarged breasts in males.

Serious Warnings and Precautions

• Do not take other prescription, non-prescription and herbal medications without advice from your doctor.

Although digoxin has been prescribed to help some patients lose weight, it should never be used in this way. When used improperly, digoxin can cause serious problems.

BEFORE you use TOLOXIN, talk to your doctor or pharmacist if:

• You are pregnant or could become pregnant during treatment. Digoxin crosses the placenta and should not be used in pregnant women unless absolutely needed.
• You are breast-feeding. Digoxin is distributed into breast milk; caution should be used.
• You are taking any other prescription, non-prescription and herbal medication.
• You are over 65 years of age, you may be more likely to experience side effects from digoxin. You may require a dosage adjustment or special monitoring.
• You have ever had any unusual or allergic reaction to digitalis medicines.

The presence of other medical problems may affect the use of digitalis medicines. Make sure you tell your doctor if you have any other medical problems, especially:

• Electrolyte disorders (Imbalance in bodily salts)
• Heart disease
• Lung disease (severe)
• Heart rhythm problems
• Kidney disease
• Liver disease
• Thyroid disease

Drugs that may interact with TOLOXIN include:

• another medication for irregular heartbeats, such as quinidine, amiodarone, or propafenone;
• an antacid or laxative that contains aluminum, magnesium, or kaolin-pectin such as Maalox, Rolaids, Mylanta, Milk of Magnesia, and others;
• a beta-blocker such as atenolol, propranolol, acebutolol, metoprolol, labetalol or nadolol;
• a calcium channel blocker such as diltiazem, amlodipine, felodipine, nifedipine, verapamil and others;
• a cancer chemotherapy drug;
• a diuretic (water pill) such as hydrochlorothiazide, chlorothiazide, chlorthalidone, furosemide, triamterene, amiloride, spironolactone and others;
• a steroid medicine such as prednisone, methylprednisolone, prednisolone, dexamethasone, and others;
• a thyroid medication;
• amphotericin B;
• cholestyramine or colestipol;
• erythromycin or clarithromycin;
• indomethacin;
• itraconazole;
• metoclopramide (Reglan);
• rifampin;
• sulfasalazine or
• tetracycline

Herbal products that may interact with TOLOXIN (e.g. St. John's Wort).

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with digoxin or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Proctofoam-HC is for anal and rectal use only. Do not take it by mouth or by any other route. This medication may be harmful if swallowed.

Proctofoam-HC should be taken as prescribed by your doctor. Talk to your doctor if your condition worsens or is not getting any better after 7 days of treatment.

Do not use Proctofoam-HC after the expiry date which is printed on the canister. The expiry date refers to the last day of that month inclusively.

Usual dose:

One applicatorful into the anus two or three times daily and after bowel evacuation. The foam may also be placed on a pad or gauze and applied externally to relieve pain or itching.

CAUTION:

• The applicator supplied with the medication is for anal use only. Never insert canister, internal or external cap into the anus.
• Fingers or any other device should not be used to administer the foam.
• Wash your hands before and after each application.

Please read the directions for internal and external use carefully before you use Proctofoam-HC.

Directions for Internal Use:

If possible, clean and pat dry the affected area before using the product.

Ensure that internal wing-tip cap has been placed on canister.

Hold canister in an upright position and shake vigorously for 20-30 seconds.

Withdraw plunger slowly until it stops at the catch line. This is the dotted line near the top of the applicator barrel (see diagram). It is not the fill line.

Hold applicator by barrel. With index finger, hold plunger in place. Holding the canister in an upright position, place applicator tip over wing-tip cap and push down gently so that applicator is firmly attached.

Press down gently on the wings of the internal cap to release the foam. Only a short press is needed to do this. If required, repeat until foam reaches the fill line.

Remove applicator from wing-tip cap, leaving some foam on applicator tip. Hold applicator by barrel and gently insert applicator tip into the anus and then push plunger to release foam and complete treatment.

To clean, pull applicator and plunger apart and wash with warm tap water after each use. The wing-tip cap should be removed from the canister. The wing-tip cap and stem rising from the canister should be rinsed with warm tap water after each use. Ensure all parts are gently dried with a clean cloth.

Directions for External Use:

If possible, clean and pat dry the affected area before using the product.

Remove internal wing-tip cap from canister. Replace with external cap. Take special care not to crush the stem rising from the canister when changing caps.

Hold canister in an upright position and shake vigorously for 20-30 seconds.

Holding the canister in an upright position, dispense foam onto a pad or gauze by pushing gently down on external canister cap with fingers. Only a short press is needed to do this. Repeat as required.

Apply to affected area as indicated by your doctor.

To clean, the external cap should be removed from the canister. The external cap and stem rising from the canister should be rinsed with warm tap water after each use. Ensure all parts are gently dried with a clean cloth.

Overdose:

In case of drug overdose or accidental ingestion, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

In the event that a dose is missed, you should take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue the prescribed dosing schedule; do not double the next dose.

The most common side effects with the use of Proctofoam-HC include:

• itching;
• burning;
• pain upon application;
• dryness;
• irritation, thinning of the skin;
• abnormal hair growth;
• loss of skin color (hypopigmentation);
• secondary infection;
• stinging, skin swelling.

Prolonged use of Proctofoam-HC could cause systemic corticosteroid effects which may include Cushing's syndrome (weight gain, rounding of the face and/or abnormal hair growth). Other possible side effects may include increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye, increased pressure in the eye and weakening of the bones through gradual mineral loss.

You should talk to your doctor or pharmacist if you have any signs of local or systemic side effects.

Avoid Proctofoam-HC foam from getting into the eyes, nose and ears. Prolonged use of Proctofoam-HC may cause Cushing's syndrome (weight gain, rounding of the face and/or abnormal hair growth, thinning of the skin).

BEFORE you use Proctofoam-HC talk to your doctor or pharmacist if you:

• have low thyroid function;
• have severe rectal or intestinal ulcers;
• have blood clotting problem (prothrombin deficiency);
• have venous insufficiency that causes skin sore or ulcer in the lower leg (statis dermatitis and ulcers);
• have liver disease or severe liver impairment;
• have low immune system (e.g. impaired T-cell function, immunosuppressive therapy);
• are suffering or have suffered from psychotic tendencies or emotional instabilities;
• are pregnant, trying to become pregnant or breastfeeding; or
• just had an ileorectostomy.

Tell your doctor, pharmacist or healthcare professional if you are taking any other drugs, including prescription, non-prescription or natural health products, as well as herbal and alternative medicines since drug interactions can affect how Proctofoam-HC works and may increase the risk of side effects.

Drugs that may interact with Proctofoam-HC include:

• drugs to treat Alzheimer's disease;
• blood thinning drugs (such as warfarin);
• drugs for high blood sugar (diabetes);
• drugs for tuberculosis;
• water pills (diuretics);
• drugs affecting hepatic microsomal enzymes [including HIV medicines, some macrolide antibiotics, drugs to treat fungal infections, and some medications used to treat hypertension and angina (e.g. calcium channel blockers)];
• products containing benzoyl peroxide as these products may reduce numbing effect of pramoxine hydrochloride;
• hormones (such as estrogen);
• nonsteroidal anti-inflammatory agents such as ibuprofen and aspirin;
• vaccines.

PROGLYCEM usually begins to work within 1 hour, and its effects can last up to 8 hours.

Your blood sugar will need to be checked often, and your urine may also need to be tested for ketones. Call your doctor at once if you have abnormal test results. You may need other blood tests at your doctor's office.

PROGLYCEM is only part of a treatment program that may also include diet. Follow your doctor's instructions very closely.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

If your condition does not improve after taking PROGLYCEM for 2 to 3 weeks, stop taking PROGLYCEM and talk to your doctor.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include extreme thirst or very dry mouth, fruity breath odor, stomach pain, vomiting, increased urination, confusion, and high ketones in the urine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• breathing problems in an infant or newborn treated with PROGLYCEM;
• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• a light-headed feeling, like you might pass out; or
• signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Common side effects may include:

• pounding heartbeats or fluttering in your chest;
• swelling in your hands, ankles, or feet;
• fine hair growth on the face, arms, and back (especially in women or children);
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation; or
• decreased sense of taste.

You should not take this medicine to treat occasional low blood sugar caused by diet.

You should not take this medicine if you are allergic to PROGLYCEM or to certain heart or blood pressure medicines such as hydrochlorothiazide (HCTZ), HydroDiuril, Hyzaar, Lopressor HCT, Vaseretic, Zestoretic, and others.

You should not take PROGLYCEM to treat occasional low blood sugar caused by diet.

To make sure PROGLYCEM is safe for you, tell your doctor if you have:

• congestive heart failure;
• high blood pressure;
• kidney disease;
• gout; or
• low levels of potassium in your blood (hypokalemia).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether PROGLYCEM passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not use other medications unless your doctor tells you to.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• a diuretic (water pill); or
• a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with PROGLYCEM, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.