Patient Medication Information: uses, side effects, how to take - Ratio-Amlodipine Tablets 5mg
ABOUT THIS MEDICATION
What this medication is used for:
ratio-AMLODIPINE (amlodipine besylate) is used for
high blood pressure
ratio-AMLODIPINE (amlodipine besylate) is used for
chest pain (chronic stable angina).
What is does:
Amlodipine relaxes the blood vessels which helps to lower blood pressure and relieve chest pain.
When it should not be used:
If you have had an allergic reaction to amlodipine
besylate or to any of the non-medicinal ingredients in this product.
If you have ever had an allergic reaction to a similar type
of medicine.
If you have very low blood pressure (less than 90
mmHg).
What the medicinal ingredient is:
Amlodipine Besylate
What the important non-medicinal ingredients are:
Non-medicinal ingredients: calcium phosphate dibasic anhydride, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
What dosage form it comes in:
Tablets, 2.5 mg, 5 mg and 10 mg
WARNINGS AND PRECAUTIONS
BEFORE you use ratio-AMLODIPINE talk to your doctor or pharmacist if you have other medical problems or conditions described below:
- hypertensive crisis or heart attack
- arterial stenosis (narrowing of the heart valve)
- liver disease
- heart failure
- low blood pressure
pregnant or plan to become pregnant
- breast feeding
ratio-AMLODIPINE is not recommended in children less than 6 years of age.
ratio-AMLODIPINE should be used cautiously in the elderly.
INTERACTIONS WITH THIS MEDICATION
Always tell your doctor, nurse or pharmacist if you are taking any other medicines, either prescription, over-the-counter or herbal medicines, because taking some medicines together can be harmful.
Be sure to tell your doctor if you are taking or consuming: antifungals, benzodiazepines, beta-blockers, cyclosporine, erythromycin, flecainide, grapefruit juice, imipramine, phenobarbital, phenytoin, propafenone, quinidine, sildenafil, rifampin, terfenadine, theophylline.
PROPER USE OF THIS MEDICATION
Usual Dose:
Your dosage may be adjusted depending on your tolerance and responsiveness.
For both hypertension and angina, the recommended initial dose of ratio-AMLODIPINE (amlodipine besylate) is 5 mg once daily. Take ratio-AMLODIPINE as instructed by your doctor.
Overdose:
If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control centre immediately, even if you do not feel sick.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with all medications you may experience side effects while taking ratio-AMLODIPINE.
Some common side effects you may experience include: edema (swelling), headaches, palpitations, dizziness, flushing, sleepiness, nausea, abdominal pain, fatigue, rashes,
muscle cramps, tingling sensation, indigestion, diarrhea, flatulence, difficulty breathing, abnormal vision, general pain, and loss of strength.
Some uncommon side effects you may experience include: palpitations (irregular heart beat, rapid or slow heart beat), low blood pressure, fainting, lightheadedness, lightheadedness when standing, itching, increased sweating, dry mouth, constipation, insomnia, nervousness, ringing in the ear, decreased sense of touch, muscle weakness, pain or numbness, tremor, vertigo, anorexia, difficulty swallowing, vomiting, swollen gums, allergic reactions, back pain, malaise, chills, weight gain, painful joints, sexual dysfunction, depression, abnormal dreams, anxiety, depersonalization, nosebleeds, skin redness or rashes, skin lesions or blisters, double vision, eye irritation or pain, increased frequency of urination, irregular urination, urination at night, and thirst.
Very rare side effects include: heart failure, jaundice (yellowing of the skin), dry skin, severe skin reactions, hair loss, twitching, incoordination, muscle tension, migraine, apathy, loss of memory, stomach aches, abdominal pain, increased appetite, coughing, nasal congestion and sneezing, change of smell and taste, and dry eyes.
Consult your doctor if you experience these or other side effects.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Edema (swelling) | T | ||
| Sleepiness | T | |||
Light- headedness | T | |||
Light- headedness when standing | T | |||
| Tingling sensation | T | |||
| Abnormal vision | T | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | Palpitations | T | ||
| Low blood pressure | T | |||
| Fainting | T | |||
| Mood changes | T | |||
| Breathing Difficulty | T | |||
| Severe skin reactions (redness, blistering, rashes) | T | |||
| Muscle cramps | T | |||
| Nose bleeds | T | |||
| Eye irritation or pain | T | |||
| Very rare | Allergic reactions (swelling of the tongue and face, difficulty breathing) | T | ||
| Yellowing of the skin | T | |||
This is not a complete list of side effects. For any unexpected effects while taking ratio-AMLODIPINE contact your doctor or pharmacist.
HOW TO STORE IT
ratio-AMLODIPINE Tablets should be stored between 15 - 30°C in tightly closed light resistance containers. Protect from humidity.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your doctor or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals obtained by contacting the sponsor, ratiopharm inc., at: 1-800-337-2584