Patient Medication Information: uses, side effects, how to take - Ran-Amlodipine
ABOUT THIS MEDICATION
What the medication is used for:
RAN-AMLODIPINEhas been prescribed to you for:
The treatment of high blood pressure
(hypertension), or
The management of a type of chest pain called
angina.
RAN-AMLODIPINEcan be used by itself or with other medicines to treat these conditions.
What it does:
RAN-AMLODIPINEis a type of medicine known as a calcium channel blocker (CCB).
RAN-AMLODIPINErelaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure.
RAN-AMLODIPINEcontrols 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 RAN-AMLODIPINEif you:
Are allergic to amlodipine (the active ingredient
in RAN-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).
What the medicinal ingredient is:
Amlodipine besylate
What the nonmedicinal ingredients are:
colloidal silicon dioxide, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
What dosage forms it comes in:
Tablets 2.5 mg amlodipine
WARNINGS AND PRECAUTIONS
BEFORE you use RAN-AMLODIPINEtalk 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.
RAN-AMLODIPINEshould not be used during pregnancy unless your doctor tells you otherwise.
- Are breast-feeding. Do not breast-feed while taking RAN-AMLODIPINE.
- Are older than 65 years.
RAN-AMLODIPINEmay occasionally cause low blood pressure (hypotension). Your blood pressure should be carefully monitored, especially if you have had a stroke or take other drugs to lower your blood pressure.
If you takeRAN-AMLODIPINEtogether 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 beta-blocker, your dose should be decreased slowly, as recommended by your doctor, before stopping it completely.
RAN-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 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 RAN-AMLODIPINEinclude:
- Cyclosporin
- Erythromycin, an antibiotic
- Diltiazem
Azoleantifungals (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)
Drug-Herb interaction:
- St-John Wort
Drug-Food interaction:
Do not eat grapefruit or drink grapefruit juice while on RAN-AMLODIPINE.
PROPER USE OF THIS MEDICATION
Take RAN-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 RAN-Amlodipineis 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:
If you think you have taken too much RAN-AMLODIPINE contactyour doctor, nurse pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.
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
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptoms / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug andseek immediate emergenc y medical help. | ||||
| Only if severe | In all cases | |||||
| Common | Flushing: Hot or warm feeling in your face | ✓ | ||||
Edema: Swelling of your legs or ankles | ✓ | |||||
| Uncommon | Arrythmia : Rapid, slow or irregular heartbeat | ✓ | ||||
| Increased frequency, severity, duration of angina: Pressing or squeezing pain in your chest | ✓ | |||||
Heart Attack: Pain, fullness |
| ✓ | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
Symptoms / effect and/or squeezing of the chest, jaw painand/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,f ainiting, lightheade dness May occur when you go from lying or sitting to standing up | Talk with your doctor, nurse or pharmacist | Stop taking drug andseek immediate emergenc y medical help. | ||||
| Only if severe | In all cases | |||||
| ✓ | ||||||
| ✓ | ||||||
| ✓ | ||||||
| Unknown | Extrapyra midal symptoms : Muscle | ✓ | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptoms / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug andseek immediate emergenc y medical help. | ||||
| Only if severe | In all cases | |||||
stiffness, body spasms, upward eye rolling, exaggerati on of reflexes, drooling, difficulty moving how and when we want. | ||||||
This is not a complete list of side effects. For any unexpected effects while taking RAN-AMLODIPINE, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Keep RAN-AMLODIPINEout of the reach and sight of children. Store RAN-AMLODIPINETablets at room temperature (between 15-300C). Protect RAN-AMLODIPINEfrom light.
ReportingSide 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 to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E Ottawa, ON K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are availableatMedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Contact your health professional if you need information about how to manage you side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about RAN-AMLODIPINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by contacting Ranbaxy Pharmaceuticals Canada Inc. at 1-866-840-1340.
Pharmaceuticals Canada Inc.