Apo-Indapamide 1.25 mg Tablets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-INDAPAMIDE is used to treat mild to moderate high blood pressure.

APO-INDAPAMIDE can be used by itself or with other medicines to treat that condition.

What is does:

APO-INDAPAMIDE is a diuretic often called a “water pill”. It increases urination. This lowers blood pressure. APO-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 APO-INDAPAMIDE regularly even if you feel fine.

When it should not be used:

Do not take APO-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. APO-INDAPAMIDE passes into breast milk

• Are pregnant. APO-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 total lactase deficiency because APO-INDAPAMIDE contains lactose

What the medicinal ingredient is:

Indapamide

What the non-medicinal ingredients are:

APO-INDAPAMIDE 1.25 mg tablets:

croscarmellose sodium, hydroxyethyl cellulose, lactose, magnesium stearate, polyethylene glycol, titanium dioxide. FD&C Yellow #6 Aluminum Lake 40%, D&C Yellow #10 Aluminum Lake 14-18%.

APO-INDAPAMIDE 2.5 mg tablets:

croscarmellose sodium, hydroxyethyl cellulose, lactose, magnesium stearate, polyethylene glycol, titanium dioxide. D&C Red #30 Aluminum Lake 30%.

What dosage forms it comes in:

Tablets of 1.25 mg or 2.5 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use APO-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
• have muscle disorders including muscle pain, tenderness, weakness or cramps,

A decrease in vision or eye pain could indicate the presence of fluid accumulation in the vascular layer of the eye or an increase of pressure in your eye. These manifestations typically occur suddenly within hours to weeks following the taking of APO-INDAPAMIDE. This can lead to permanent vision loss, if not treated. If you have a history of penicillin or sulfonamide allergies, you can be at higher risk of developing these manifestations.

APO-INDAPAMIDE is not recommended for use in children. You may become sensitive to the sun while taking APO-INDAPAMIDE. Exposure to sunlight should be minimized.

Athletes should be aware that APO-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 APO-INDAPAMIDE. Dizziness, lightheadedness, 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 APO-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,

  ciprofloxacine, clarithromycin,

• Antifungal medications such as amphotericin B (IV),

  fluconazole

• Antimicrobial medications such as pentamidine
• Baclofen, a skeletal muscle relaxant
• Calcium tablets or other calcium supplements

• Ciclosporin, 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, flecainide)

• Drugs to treat high blood pressure, including

  angiotensin converting enzyme (ACE) inhibitors

• Drugs used to treat mental disorders such as anxiety

  and schizophrenia (e.g. clozapine, risperidone, pimozide, amisulpride, haloperidol, donepezil))

• Drugs used to treat depression, in particular selective

  serotonin reuptake inhibitors (SSRIs eg. paroxetine, sertraline, citalopram, escitalopram) 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

• Medicines for the treatment of cancer (e.g. vandetanib,

  oxaliplatin)

• Anaesthetics (e.g. propofol, sevoflurane)
• Anagrelide (used to reduce elevated platelet counts)

• Medicines used to treat nausea and vomiting (e.g.

  ondansetron, domperidone)

• Papaverine (used to treat gastro-intestinal problems)

• Antiparasitic medicines used to treat certain types of

  malaria (e.g. chloroquine)

• Antihistamines used to treat allergic reactions, such as

  hay fever

  • Methadone (used to treat addiction)

PROPER USE OF THIS MEDICATION

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

APO-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 APO-

INDAPAMIDE, contact your healthcare professional, 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, diarrhoea, nausea, vomiting
• Cough, dry mouth
• Swelling
• Rash, itching

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

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

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

HOW TO STORE IT

Keep out of the reach and sight of children.

Store at room temperature (15^oC-30^oC) in tightly-closed containers.

Do not use after the expiry date stated on the carton or blister.

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

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.

MORE INFORMATION

If you want more information about APO-INDAPAMIDE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: November 19, 2020