Consumer Information for: APO-FELODIPINE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
APO-FELODIPINE is used to treat hypertension (high blood pressure).
What it does
APO-FELODIPINE contains the ingredient called felodipine.
It belongs to the group of drugs called "calcium channel
blockers" or "calcium antagonists".
APO-FELODIPINE relaxes your blood vessels, which lets
your blood flow more easily and helps lower your blood
pressure.
APO-FELODIPINE is formulated as extended release tablets
which control the speed of the drug being delivered to the
body and ensure even effects over the day.
When it should not be used
APO-FELODIPINE should not be used if you:
- are allergic to felodipine or any of the nonmedicinal ingredients in APO-FELODIPINE tablets.
- have a known allergy to other dihydropyridines (calcium channel blockers).
- are pregnant. You should tell your doctor as soon as possible if you become pregnant while using APOFELODIPINE.
- are breast feeding.
- are age 18 or younger.
What the medicinal ingredient is
Felodipine
What the non-medicinal ingredients are
anhydrous lactose, colloidal silicon dioxide, ferric oxide red (5 mg and 10 mg tablets), ferric oxide yellow (2.5 mg and 5 mg tablets), hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
What dosage form it comes in
extended release tablets 2.5 mg, 5 mg and 10 mg felodipine
Warnings and precautions
BEFORE you use APO-FELODIPINE talk to your doctor or pharmacist if:
- you are pregnant or plan to become pregnant.
- you are breast feeding.
- you have or have had heart failure.
- you ever had heart or blood vessel disease.
- you have very low blood pressure.
- you are older than 65 years of age.
- you are allergic to "non-medicinal" substances like food products, preservatives, or dyes, which may be present in APO-FELODIPINE tablets (See ‘WHAT THE NONMEDICINAL INGREDIENTS ARE”).
- you have ever had a bad, unusual or allergic reaction to "felodipine".
This medicine contains lactose. Tell your doctor if you have
an intolerance to some sugars.
A few patients report mild tenderness or swelling of their
gums while taking felodipine. This effect can be prevented or
reversed with good dental care. Brush your teeth carefully
and often with a soft toothbrush, and use dental floss daily.
Massaging your gums regularly with a soft toothbrush will
also help. If your gums do become tender, red or swollen, be
sure to tell your doctor or dentist.
Interactions with this medication
Tell your doctor or pharmacist about any medicines you are
taking or have recently taken, including prescription
medications (the ones your doctor writes for you), and overthe-
counter medications like cold or allergy medication, or
natural health products (herbal medicines). If you visit more
than one doctor make sure that each knows about all the
medicines you are taking. Certain medicines or alcohol or
food may affect the way APO-FELODIPINE works.
Drug-Drug Interactions
Drugs that may interact with APO-FELODIPINE include:
- certain anti-ulcer drugs (cimetidine)
- antibiotics (erythromycin, clarithromycin)
- antimycotics (itraconazole, ketoconazole),
- sleeping pills (barbiturates)
- drugs used to prevent epilepsy (phenytoin, carbamazepine).
- tacrolimus. Treatment with APO-FELODIPINE may affect the level of tacrolimus (a medicine given to prevent the body from rejecting a transplanted organ, e.g. kidney or liver) in your blood.
Drug-Food Interactions
Food that may interact with APO-FELODIPINE includes:
- Grapefruit juice may also affect treatment with APOFELODIPINE. Do not eat grapefruit or drink grapefruit juice while on APO-FELODIPINE.
- Alcohol
- Food rich in carbohydrate and fat
Drug-Herb Interactions
Herbs that may interact with APO-FELODIPINE include:
- St. John’s Wort
Proper use of this medication
Usual Dose
Adults
Take APO-FELODIPINE exactly as your doctor tells you. Do not miss doses or take extra doses, unless your doctor tells you. If you are not clear about the directions, ask your doctor or pharmacist. Do not take any APO-FELODIPINE if it is not prescribed for you.
- APO-FELODIPINE is taken once a day. Even if your doctor has prescribed 2 tablets a day, both should be taken at the same time, unless otherwise indicated.
- Try to take APO-FELODIPINE with something you do regularly each day; for example, upon waking or at breakfast. This will help you remember each dose.
- Swallow APO-FELODIPINE whole with a glass of water. Do not crush, chew, break or suck on the tablets.
- APO-FELODIPINE should not be taken with a meal rich in fat or carbohydrates. Breakfast foods which are rich in fat and/or carbohydrates include bacon, sausage, hash brown potatoes, and sugared cereals. APO-FELODIPINE may be taken with a light meal which is low in fat and carbohydrates (i.e. two slices of toast with cheese, cereal with milk, and orange juice).
- Do not transfer APO-FELODIPINE to other pill containers.
Check with your doctor if you want to drink alcohol (including wine with your meals) while you are taking APO-FELODIPINE. Drinking alcohol while on APO-FELODIPINE may make you feel dizzier than usual. Alcohol may also cause an uncomfortable drop in blood pressure.
Remember, you may not notice any signs of high blood pressure. Therefore it is important to take APO-FELODIPINE even when you feel well. A constant amount of drug is needed in your body to control your blood pressure. Do not stop taking APO-FELODIPINE on your own.
Remember to get a new prescription from your doctor or a refill from your pharmacy a few days before all your tablets are taken.
Overdose
If you take more than the recommended number of doses of APO-FELODIPINE, you may suffer from very low blood pressure and sometimes slow heart rate. Therefore, it is very important that you take the number of doses prescribed by your doctor. If you experience symptoms such as feeling faint, light-headedness or dizziness, contact your doctor or pharmacist immediately.
Missed Dose
If you miss a dose of APO-FELODIPINE and remember within 12 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. But if it is more than 12 hours when you remember, do not take the missed dose. Just take the next dose on time.
Never take a double dose of APO-FELODIPINE to make up for missed tablets. If you are still unsure, check with your doctor or pharmacist to see what you should do.
Side effects and what to do about them
Along with its effects on controlling blood pressure, APO-FELODIPINE, like any medication, may include side effects.
Some side effects may occur when APO-FELODIPINE is first started or when the dose is increased. These side effects are usually mild and should go away as your body gets used to APO-FELODIPINE.
It is important that you keep your doctor informed of all side effects, especially if you experience any of the following for more than a week:
- swelling of the ankles;
- a racing heartbeat;
- flushing or a feeling of warmth;
- headache;
- dizziness;
- unusual tiredness
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on APO-FELODIPINE with your doctor and pharmacist. Do not stop taking APO-FELODIPINE on your own.
Other side effects have been reported in a few cases. These include too low blood pressure (hypotension) as fainting or dizziness, tingling in the hands, arms, feet or legs, stomach upset, diarrhea, nausea, vomiting, abdominal pain, the need to urinate frequently, fever, and sexual problems. Again, if any of these effects bother you, be sure to tell your doctor.
You should be certain to contact your doctor immediately if you experience anything unusual.
| 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 get immediate medical help |
|---|---|---|---|
| Common | |||
| Rash or itchiness | ✔ | ||
| Uncommon | |||
| Increased liver enzymes (symptoms like yellowing of the skin or eyes) | ✔ | ||
| Isolated cases | |||
| Allergic reactions (symptoms like swelling of the face, lips, tongue and/or throat; rash or other skin reactions; difficulty breathing) | ✔ | ||
*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking APO-FELODIPINE, contact your doctor or pharmacist.
How to store
Store APO-FELODIPINE at room temperature 15°C-30°C in a tightly closed container. Protect from light and moisture.
Keep APO-FELODIPINE out of sight and reach of children.
Do not keep or use APO-FELODIPINE after the expiry date. Unused medicines which you know you will no longer need should be carefully discarded. You may wish to seek advice from your pharmacist.
Reporting side 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 MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- 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
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
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last prepared: February 22, 2016
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