Details for: AMLODIPINE
Company: ALTAMED PHARMA
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02490781 | AMLODIPINE | AMLODIPINE (AMLODIPINE BESYLATE) | 2.5 MG | TABLET | ORAL |
| 02490803 | AMLODIPINE | AMLODIPINE (AMLODIPINE BESYLATE) | 5 MG | TABLET | ORAL |
| 02490811 | AMLODIPINE | AMLODIPINE (AMLODIPINE BESYLATE) | 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
Amlodipine has been prescribed to you for:
- The treatment of high blood pressure (hypertension), or
- The management of a type of chest pain called angina. Amlodipine can be used by itself or with other medicines to treat these conditions.
What it does
Amlodipine besylate is a type of medicine known as a
calcium channel blocker (CCB).
Amlodipine besylate relaxes your blood vessels, which
lets your blood flow more easily and helps lower your
blood pressure.
Amlodipine besylate controls chest pain by improving the
supply of blood and oxygen to the heart and by reducing
its workload.
When it should not be used
Do not use Amlodipine if you:
- Are allergic to amlodipine (the active ingredient in Amlodipine), or to the inactive ingredients listed under “What the nonmedicinal ingredients are” below.
- Have ever had an allergic reaction to a similar type of drug.
- Have very low blood pressure (less than 90 mmHg systolic).
- Are breast-feeding. Do NOT breast-feed while taking Amlodipine.
What the medicinal ingredient is
Amlodipine besylate
What the non-medicinal ingredients are
Magnesium stearate, microcrystalline cellulose, sodium starch glycolate and trisodium citrate.
What dosage form it comes in
Tablets 2.5 mg, 5 mg and 10 mg amlodipine (as amlodipine besylate).
Warnings and precautions
BEFORE you use Amlodipine talk to your doctor, nurse or pharmacist if you:
- Ever had heart or blood vessel diseases.
- Have aortic stenosis (narrowing of a valve of your heart).
- Have liver or kidney problems.
- Are pregnant, or plan to become pregnant. Amlodipine should not be used during pregnancy unless your doctor tells you otherwise.
- Are older than 65 years.
If you take Amlodipine together with a drug known as beta-blockers (e.g. acebutolol, atenolol, metoprolol, nadolol), do not suddenly stop using the beta-blocker. If your doctor advises you to discontinue use of the betablocker, your dose should be decreased slowly, as recommended by your doctor, before stopping it completely.
Amlodipine is not recommended for use in children less than 6 years of age.
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. Also, mention if you drink
alcoholic beverages.
Drug-Drug interaction:
Drugs that may interact with amlodipine besylate include:
- Cyclosporin
- Clarithromycin, Erythromycin (antibiotics)
- Diltiazem
- Azole antifungals (e.g. ketoconazole, itraconazole)
- HIV protease inhibitors (e.g. ritonavir)
- Beta-blockers
- Sildenafil (VIAGRA)
- Statin drugs used to treat high cholesterol (e.g. Simvastatin, Atorvastatin)
- Tacrolimus (an anti-rejection drug)
- Sirolimus, temsirolimus, everolimus
- St-John Wort
Proper use of this medication
Take Amlodipine exactly as prescribed by your doctor, nurse or pharmacist. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not stop taking your medication without having first informed your doctor.
Usual Dose
For both high blood pressure and chest pain, the
recommended initial dose of Amlodipine is 5 mg once
daily. If necessary, your doctor may increase your dose to
a maximum dose of 10 mg once daily.
Use in Patients with liver disease:
The starting dose is 2.5 mg once daily and can be
gradually increased by your doctor.
Use in Children (6-17 years old):
The recommended dose is 2.5 mg to 5 mg once daily.
Overdose
One or more of the following signs may occur in an overdose: Low blood pressure and rapid heartbeat.
Missed Dose
If you miss a dose, take it as soon as you remember. If it has been more than 12 hours since you missed your last dose, skip the missed dose and continue with the next dose at your regular time. Do not take double doses.
Side effects and what to do about them
Side effects include:
- Headaches
- Tiredness, extreme sleepiness
- Stomach pain, nausea
- Dizziness
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate emergency medical help |
|---|---|---|---|
| Common | |||
| Flushing: Hot or warm feeling in your face | ✔ | ||
| Edema: Swelling of your legs or ankles | ✔ | ||
| Uncommon | |||
| Arrhythmia: Rapid, slow or irregular heartbeat | ✔ | ||
| Increased frequency, severity, duration of angina: pressing or squeezing pain in your chest) or heart attack | ✔ | ||
| Heart Attack: Pain, fullness and/or squeezing of the chest, jaw pain and/or arm pain, shortness of breath | ✔ | ||
| Liver Disorder: Yellowing of the skin or eye, dark urine, abdominal pain nausea, vomiting, loss of appetite | ✔ | ||
| Allergic Reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing | ✔ | ||
| Low Blood Pressure: Dizziness, fainting, lightheadednes s May occur when you go from lying or sitting to standing up | ✔ | ||
| Unknown | |||
| Extrapyramid al symptoms: Muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Amlodipine, contact your doctor, nurse or pharmacist.
How to store
Keep Amlodipine out of the reach and sight of children. Store Amlodipine at room temperature (between 15- 30ºC). Protect Amlodipine from light.
Reporting 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 three 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 MedEffectTM 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 information
If you want more information about Amlodipine:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Altamed Pharma at 1-877- 352-7314
This leaflet was prepared by:
Altamed Pharma
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec
H4R 3E8
Tel: 1-877-352-7314
Last revised: July 23, 2019