Details for: APO-PERINDOPRIL/AMLODIPINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02468565 | APO-PERINDOPRIL/AMLODIPINE | PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE) | 3.5 MG; 2.5 MG | TABLET | ORAL |
| 02468573 | APO-PERINDOPRIL/AMLODIPINE | PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE) | 7 MG; 5 MG | TABLET | ORAL |
| 02468581 | APO-PERINDOPRIL/AMLODIPINE | PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE) | 14 MG; 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-PERINDOPRIL/AMLODIPINE is used to treat mild to moderate high blood pressure. APO-PERINDOPRIL/AMLODIPINE should only be started in patients who are between the ages of 18 and 65.
What it does
APO-PERINDOPRIL/AMLODIPINE is a combination of two active ingredients, perindopril arginine and amlodipine.
Perindopril arginine
- Is an angiotensin converting enzyme (ACE) inhibitor.
- ACE inhibitors help relax blood vessels and lower blood pressure by preventing ACE from producing angiotensin II which causes narrowing of blood vessels.
Amlodipine
- Is a calcium channel blocker.
- It blocks the transfer of calcium into the cells of the heart and blood vessels.
- This helps the blood vessels relax and to decrease blood pressure.
This medicine does not cure your disease. It is important to continue taking APO-PERINDOPRIL/AMLODIPINE regularly even if you feel fine. Do not stop taking your medicine without the advice of your doctor.
When it should not be used
Do not take APO-PERINDOPRIL/AMLODIPINE if you:
- Are less than 18 years old.
- Are older than 65 and starting treatment.
- Are allergic (hypersensitive) to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonists, or to any non-medicinal ingredient in the formulation.
- Have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
- Are taking a drug containing the combination of sacubitril/valsartan, due to the increased risk of serious allergic reaction which causes swelling of the face or throat (angioedema) when taken with APO-PERINDOPRIL/AMLODIPINE.
- Have kidney problems.
- Are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes or kidney disease.
- Have been diagnosed with hereditary angioedema: an increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.
- Have narrowing of the mitral valve and left ventricular outflow tract obstruction (aortic stenosis, hypertrophic cardiomyopathy).
- Have heart failure.
- Are pregnant or intend to become pregnant. Taking APO-PERINDOPRIL/AMLODIPINE during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. APO-PERINDOPRIL/AMLODIPINE passes into breast milk.
- Are on dialysis or any other type of blood filtration. Depending on the machine that is used, APO-PERINDOPRIL/AMLODIPINE may not be suitable for you.
- Have kidney problems where the blood supply to your kidneys is significantly reduced (renal artery stenosis).
What the medicinal ingredient is
perindopril arginine and amlodipine.
What the non-medicinal ingredients are
colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
What dosage form it comes in
APO-PERINDOPRIL/AMLODIPINE tablets are available in 3 combinations of perindopril/ amlodipine: 3.5 mg / 2.5 mg, 7 mg / 5 mg, 14 mg / 10 mg.
Warnings and precautions
Serious Warnings and Precautions - Pregnancy
APO-PERINDOPRIL/AMLODIPINE should not be used during pregnancy. If you discover that you are pregnant while taking APO-PERINDOPRIL/AMLODIPINE, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use APO-PERINDOPRIL/AMLODIPINE talk to your doctor, nurse or pharmacist if you:
- Are allergic to any drug used to lower blood pressure.
- Have hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery which supplies the kidney with blood).
- Have heart failure.
- Have a severe increase in blood pressure (hypertensive crisis).
- Are taking a medicine that contains aliskiren used to lower high blood pressure. The combination with APO-PERINDOPRIL/AMLODIPINE is not recommended.
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in "-SARTAN".
- Have diabetes, heart, liver or kidney disease (including kidney transplantation).
- Are on dialysis.
- Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
- Are on a low-salt diet.
- Are less than 18 years old or are older than 65.
- Have systemic lupus erythematosus (SLE).
- Have a skin condition known as scleroderma or “hard skin” (thickening of the skin).
- Have recently received or are planning to get allergy shots for bee or wasp stings.
- Have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism).
Monitoring: Your physician may monitor your blood and kidney function while taking APO-PERINDOPRIL/AMLODIPINE.
Surgery: If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking APO-PERINDOPRIL/ AMLODIPINE.
Driving and using machines: Wait until you know how you feel while taking APO-PERINDOPRIL/AMLODIPINE before driving or using machines. Dizziness, headache, fatigue, nausea, weariness or fainting can occur, especially after the first dose and when the dose is increased.
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-PERINDOPRIL/AMLODIPINE:
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
- Allopurinol used to treat gout.
- Antidiabetic drugs, including insulin and oral medicines.
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products, or angiotensin receptor blockers (ARBs).
- Dextran sulphate, special intravenous fluid used to counteract life-threatening low blood pressure.
- Lithium used to treat bipolar disorder.
- Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include aspirin, ibuprofen, naproxen, and celecoxib.
- Vasodilators including nitrates (products that make the blood vessels become wider).
- Procainamide used to treat irregular heartbeats.
- Medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics).
- Immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus).
- Heparin (medicines used to thin blood).
- Ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma).
- Baclofen used to treat muscle stiffness in diseases such as multiple sclerosis.
- Some antibiotics such as rifampicin, erythromycin, clarithromycin.
- Antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
- Itraconazole, ketoconazole (medicines used for treatment of fungal infections).
- Alpha-blockers used for the treatment of enlarged prostate such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin).
- Corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis).
- Gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).
- Ritonavir, indinavir, nelfinavir (used to treat HIV).
- Trimethoprim (for the treatment of infections).
- Estramustine (used in cancer therapy).
- Hypericum perforatum (St John's wort, an herbal medicine used to treat depression).
- Simvastatin (a cholesterol lowering medicine).
- Anaesthetics.
- Treatment for bee and wasp allergies.
- Tetracosactide (used as a diagnostic agent in the clinic).
- Neutral endopeptidase (NEP) inhibitors. The combination with APO-PERINDOPRIL/AMLODIPINE is not recommended.
- Sirolimus, everolimus, temsirolimus and other drugs belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs).
Grapefruit juice and grapefruit should not be consumed by people who are taking APO-PERINDOPRIL/AMLODIPINE. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of APO-PERINDOPRIL/AMLODIPINE.
Proper use of this medication
Take APO-PERINDOPRIL/AMLODIPINE exactly as prescribed.
Tablets should be swallowed whole with a glass of water preferably at the same time each day, in the morning. It is recommended to take your dose before a meal.
Usual Adult dose
The initial recommended dose is one tablet of APO-PERINDOPRIL/AMLODIPINE 3.5 mg/2.5 mg once daily.
After a month of treatment, depending on how you respond to the treatment, your doctor may increase the dose to 7 mg/5 mg once a day.
If your blood pressure is not controlled after 1 month of treatment with 7 mg/5 mg dose, your doctor may prescribe the 14 mg/10 mg APO-PERINDOPRIL/AMLODIPINE tablet once daily.
One tablet of APO-PERINDOPRIL/AMLODIPINE 14 mg/10 mg once a day is the maximum recommended dose for high blood pressure.
Overdose
If you think you have taken too much APO-PERINDOPRIL/AMLODIPINE 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, take the next one at the usual time. Do not double dose.
Side effects and what to do about them
Like all medicines, APO-PERINDOPRIL/AMLODIPINE can cause side effects, although not everybody gets them.
Side effects may include:
- cough,
- swelling in the tissues of the body (oedema),
- headache,
- diarrhea,
- nausea,
- dizziness,
- tiredness,
- itching (erythema).
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| Symptom / effect | Talk with your healthcare professional Only if severe | Talk with your healthcare professional In all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, light-headedness. May occur when you go from lying or sitting to standing up. | ✔ | ||
| Palpitations: unusual fast or irregular heartbeats | ✔ | ||
| Edema: swelling of the hands, ankles or feet | ✔ | ||
| Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | ✔ | ||
| Uncommon | |||
| Angina: sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing | ✔ | ||
| Increased levels of potassium in the blood (hyperkalemia): irregular heartbeat, muscle weakness and generally feeling unwell | ✔ | ||
| Angioedema and Severe Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
| Decreased Platelet: bruising, bleeding, fatigue and weakness | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | ✔ | ||
| Cerebrovascular accident/Stroke: slurring speech, blurred vision, face drooping | ✔ | ||
| Rare | |||
| Psoriasis aggravation | ✔ | ||
| Very Rare | |||
| Inflammation of the pancreas (pancreatitis): abdominal pain that lasts and gets worse when you lie down, nausea and vomiting | ✔ | ||
| Severe skin reactions (Steven-Johnson Syndrome): intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes. | ✔ | ||
| Liver problems: abdominal pain, nausea, vomiting, loss of appetite, jaundice (yellowing of eyes and skin). | ✔ | ||
| Myocardial infarction: heart attack, chest pain | ✔ | ||
| SIADH (syndrome of inappropriate antidiuretic hormone secretion): concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits (seizures) which may be due to inappropriate secretion of ADH (antidiuretic hormone). | ✔ | ||
| Unknown | |||
| Extrapyramidal disorder: Muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want. | ✔ | ||
| Phemphigoid: formation of blister clusters over the skin | ✔ | ||
| Toxic epidermal necrolysis: intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes | ✔ | ||
| Raynaud’s phenomenon: Discoloration, numbness and pain in fingers or toes. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-PERINDOPRIL/AMLODIPINE, contact your doctor, nurse or pharmacist.
How to store
Keep out of reach and sight of children.
Store between 15°C to 30°C. Protect from light and moisture.
Do not use after the expiry date stated on the carton, blister or bottle.
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-PERINDOPRIL/AMLODIPINE:
- 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.
This leaflet was prepared by Apotex Inc., Toronto, Ontario M9L 1T9.
Last revised: November 14, 2019