PHL-Indapamide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-INDAPAMIDE is used to treat mild to moderate high blood pressure. phl-INDAPAMIDE can be used by itself or with other medicines to treat that condition.

What it does:

phl-INDAPAMIDE is a diuretic often called a “water pill”. It increases urination. This lowers blood pressure. phl-INDAPAMIDE affects the kidney’s ability to reabsorb electrolytes.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking phl-INDAPAMIDE regularly even if you feel fine.

When it should not be used:

Do not take phl-INDAPAMIDE if you:

• Are allergic to indapamide or any other sulfonamide or

  to any non-medicinal ingredient in the formulation

• Have severe kidney disease

• Have severe liver disease or suffer from a condition

  called hepatic encephalopathy (a degenerative disease of the brain)

• Have low potassium levels in your blood

• Are taking drugs to treat heart rhythm disturbances

  (antiarrhythmics) that might cause severe cardiac arrhythmias

• Are breastfeeding. phl-INDAPAMIDE passes into

  breast milk

• Are pregnant. phl-INDAPAMIDE should not be used

  during pregnancy. If you become pregnant, discontinue use immediately and discuss with your doctor

• Have lactose intolerance or have hereditary galactose

  intolerance, glucose-galactose malabsorption or the Lapp lactase deficiency because phl-INDAPAMIDE contains lactose

What the medicinal ingredient is:

Indapamide

What the non-medicinal ingredients are:

1.25 mg tablets: FD&C Yellow No. 6 Aluminum Lake, Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene

Glycol, Polysorbate 80, Purified Water, Corn Starch, Talc and Titanium Dioxide

2.5 mg tablets: FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Purified Water Corn Starch, Talc and Titanium Dioxide.

What dosage forms it comes in:

Tablets of 1.25 mg and 2.5 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use phl-INDAPAMIDE talk to your doctor, nurse, or pharmacist if you:

• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating
• Have diabetes, liver or kidney disease
• Have any congenital or a family history of heart rhythm problems
• Suffer from hyperparathyroidism (dysfunctioning of the parathyroid gland)
• Have systemic lupus erythematosus (SLE)
• Are malnourished
• Are elderly
• Have coronary artery disease, heart disease or heart failure
• Had a surgery called a Sympathectomy
• Suffer from gout.

phl-INDAPAMIDE is not recommended for use in children.

You may become sensitive to the sun while taking phl-INDAPAMIDE. Exposure to sunlight should be minimized.

Athletes should be aware that phl-INDAPAMIDE contains an active ingredient, which may give a positive reaction in doping tests.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to phl-INDAPAMIDE. Dizziness, light headedness, or fainting can especially occur after the first dose or when another antihypertensive agent is added.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

• The following may interact with phl-INDAPAMIDE:

  ACTH (e.g., tetracosactide) for treatment of arthritis or inflammatory bowel disease

• Alcohol, barbiturates (sleeping pills), or narcotics

  (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.

• Allopurinol (to treat gout)
• Antibiotics such as moxifloxacin, erythromycin IV
• Antifungal medications such as amphotericin B (IV)
• Antimicrobial medications such as pentamidine
• Baclofen, a skeletal muscle relaxant
• Calcium tablets or other calcium supplements

• Cyclosporin, tacrolimus or other medications to depress

  the immune system after organ transplantation

• Drugs to treat heart rhythm disturbances (e.g., digoxin,

  quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide)

• Drugs to treat high blood pressure, including

  angiotensin converting enzyme (ACE) inhibitors

• Drugs used to treat anxiety and schizophrenia (e.g.,

  clozapine, risperidone, pimozide)

• Drugs used to treat depression, in particular selective

  serotonin reuptake inhibitors (SSRIs eg., paroxetine, sertraline, citalopram) and tricyclic antidepressants (imipramine)

• Iodinated contrast media
• Lithium used to treat bipolar disease
• Metformin, an oral medication for diabetes

• Nonsteroidal anti-inflammatory drugs (NSAIDs), such

  as ibuprofen, naproxen or celecoxib or high doses of acetylsalicylic acid (more than 3 g/day)

• Oral corticosteroids for treatment of asthma

• Potassium-sparing diuretics (e.g., amiloride,

  spironolactone, triamterene)

• Stimulant laxatives such as bisacodyl and senna

PROPER USE OF THIS MEDICATION

Take phl-INDAPAMIDE exactly as prescribed. It is recommended to take your dose at about the same time every day in the morning.

phl-INDAPAMIDE is for oral use: swallow the tablet whole with water.

Usual Adult dose:

1.25 mg tablet a day.

Maximum dose:

2.5 mg a day

Your doctor may increase the dose to a maximum of 2.5 mg daily depending on your response to treatment after 4 to 8 weeks. Recommended dose for the elderly: 1.25 mg tablet a day. This dose may be adjusted depending on your kidney function.

Overdose:

If you think you have taken too much phl-INDAPAMIDE contact your doctor, nurse, pharmacist, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Headache
• Pains in the stomach, back, chest
• Dizziness
• Fatigue, weakness
• Burning or prickling feeling in hands, arms, legs or feet
• Muscle cramps
• Vertigo
• Constipation, diarrhea, nausea, vomiting
• Cough, dry mouth
• Swelling
• Rash, itching

If any of these symptoms affects you severely, tell your doctor, nurse or pharmacist.

phl-INDAPAMIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Common

Unknown

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

HOW TO STORE

HOW TO STORE IT

Store at room temperature (15°C-30°C).

Keep out of reach and sight of children.

Medicines can be kept for a limited period only. Therefore, do not use phl-INDAPAMIDE after the date (month and year) printed after “EXP”, even if it has been stored properly. Always return old medicines to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:

• Online at www.healthcanada.gc.ca/medeffect
• By calling 1-866-234-2345 (toll free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at

www.healthcanada.gc.ca/medeffect

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.

Please consult your doctor, nurse or pharmacist with any questions or concerns you may have regarding your individual condition.

This document plus the full Product Monograph, prepared for health professionals can be obtained by contacting Pharmel Inc. at 1-888-550-6060

Pharmel Inc.

Montreal Quebec

H4P 2T4

Last revised: March 21, 2016

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