Patient Medication Information: uses, side effects, how to take - Plendil
What is Plendil used for?
Plendil is used in adults to treat hypertension (high blood pressure).
It can be used together with other medicines that treat hypertension such as thiazide diuretics or beta-blockers.
How does Plendil work?
Plendil belongs to a group of medicines called “calcium channel blockers”. It helps to relax and widen blood vessels, improving blood flow and lowering blood pressure.
What are the ingredients in Plendil?
Medicinal ingredient: felodipine.
Non-medicinal ingredients: aluminum silicate, carnauba wax, hydrogen peroxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, iron oxide red-brown (5 mg or 10 mg tablets), lactose anhydrous, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, and titanium dioxide.
Plendil comes in the following dosage forms:
Extended release tablets: 2.5 mg, 5 mg, and 10 mg of felodipine.
Do not use Plendil if:
- you are allergic to felodipine or any of the other ingredients in Plendil.
- you allergic to other dihydropyridines (medicines used to treat hypertension and angina).
you are pregnant, plan to become pregnant, or are able to become pregnant. You should tell your healthcare professional as soon as possible if you become pregnant while using Plendil.
- you are breast-feeding or plan to breast-feed.
- you are age 18 or younger.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Plendil. Talk about any health conditions or problems you may have, including if you:
- have heart or blood vessel problems.
- have liver problems.
- have gum problems (e.g., gingivitis or periodontitis).
- have problems digesting certain milk sugars (e.g., galactose intolerance or glucose-galactose malabsorption). Plendil capsules contain lactose, a milk sugar. If you are unsure ask your healthcare professional.
Other warnings you should know about:
Driving and using machines: Plendil can lower your blood pressure and affect your vision. Before you drive or do tasks that require special attention, wait until you know how you respond to Plendil.
- Hypotension (low blood pressure): Plendil may occasionally cause low blood pressure. Your healthcare professional will monitor your blood pressure, especially when you first start taking Plendil or if you are older than 65 years of age.
- Oral hygiene: Plendil can cause mild tenderness or swelling of the gums. 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, tell your healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
Do not take Plendil if you are already taking medications known as “strong inhibitors of CYP3A4”. These include:
- clarithromycin and erythromycin, medicines used to treat bacterial infections.
- “azole” drugs, medicines used to treat fungal infections (e.g., ketoconazole and itraconazole).
- ritonavir, a medicine used to treat human immunodeficiency virus (HIV).
Taking Plendil with any of these medicines may cause serious drug interactions. If you are unsure if you are taking any of these medicines, ask your healthcare professional.
The following may also interact with Plendil:
- alcohol, including alcohol containing products.
- antiarrhythmics, medicines used to treat or prevent irregular heartbeats (e.g., quinidine, flecainide and propafenone ).
- other antibacterials, medicines used to treat bacterial infections (e.g., erythromycin and rifampin ).
- medicines used to prevent the body from rejecting a transplanted organ, including the kidney or liver (e.g., cyclosporine and tacrolimus ).
- warfarin, a medicine used to prevent blood clotting.
- beta-blockers, medicines used to treat high blood pressure (e.g., metoprolol).
- digoxin, a medicine used to treat heart failure and certain heartbeats problems.
- benzodiazepines, medicines used to treat anxiety, insomnia, and seizures.
- theophylline, a medicine used to relieve symptoms of asthma.
- cimetidine, a medicine used to treat stomach ulcers and reduce stomach acid.
- anticonvulsants, medicines used to prevent epilepsy or seizures (e.g., phenytoin, carbamazepine and phenobarbital).
- antidepressants, medicines used to treat depression (e.g., imipramine).
- terfenadine, a medicine used to treat allergies.
- St. John’s Wort, a herbal medicine used to treat depression.
- grapefruit juice.
How to take Plendil:
- Take exactly as directed by your healthcare professional. If you are unsure, ask your healthcare professional.
- Swallow the Plendil tablets whole with a glass of water. Do not crush or chew on the tablets.
Avoid taking Plendil 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. Plendil 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).
- To help remember each dose, try to take Plendil with something you do regularly each day. For example, upon waking or at breakfast.
- Check with your healthcare professional if you want to drink alcohol (including wine with your meals) while you are taking Plendil. Drinking alcohol while on Plendil may make you feel dizzier than usual. Alcohol may also cause an uncomfortable drop in blood pressure.
- Do not eat grapefruit or drink grapefruit juice while on Plendil.
- It is important to take Plendil even when you feel well. A constant amount of drug is needed in your body to control your blood pressure.
Usual dose:
Your healthcare professional will decide the right dose of Plendil for you. This will be depend on your health, age, and how you respond to Plendil.
The usual dose is 2.5 mg to 10 mg once a day. Even if your healthcare professional has prescribed 2 tablets a day, both should be taken at the same time, unless otherwise indicated. Do not adjust or stop your dose without first consulting your healthcare professional.
Overdose:
An overdose with Plendil may cause the following:
- feeling faint,
- feeling light-headed,
- feeling dizzy,
- very low blood pressure,
- slow heart rate.
If you think you, or a person you are caring for, have taken too much Plendil, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
- If you miss a dose of Plendil and remember within 12 hours, take the missed dose as soon as possible. Then go back to your regular schedule.
- If you miss a dose of Plendil and it has been more than 12 hours when you remember, do not take the missed dose. Just take the next dose at your regular scheduled time.
Never take a double dose of Plendil to make up for missed tablets. If you are still unsure, check with your healthcare professional to see what you should do.
What are possible side effects from using Plendil?
These are not all the possible side effects you may have when taking Plendil. If you experience any side effects not listed here, tell your healthcare professional.
The side effects of Plendil may include:
- cold or flu-like symptoms;
- constipation;
- cough;
- dizziness;
- feeling of pins and needles;
- feeling tired;
- flushing or warm sensation;
- headache;
- joint stiffness;
- muscle cramps or pain;
- upset stomach, nausea, or indigestion.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Peripheral edema (swelling of the limbs): swelling in the legs, ankles or feet, feeling of heaviness, or skin appears tight or shiny. | X | ||
| COMMON | |||
| Bradycardia or tachycardia (abnormally slow or fast heart beat) | X | ||
| Gastrointestinal (GI) problems: abdominal pain, diarrhea, vomiting, dry mouth, passing gas, acid reflux, fatigue, fever, itchiness, light-coloured stool, or yellowing of the skin or whites of eyes. | X | ||
| Gum problems: swollen gums, gum tenderness and soreness, discomfort in the mouth, problems with oral hygiene, bleeding guns, bad breath, or overgrowth or receding gums. | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up). | X | ||
| Skin reactions: itchiness, dry skin, redness, rashes, blisters, raised red bumps, red spots, swelling, or increased sensitivity to sunlight. | X | ||
| Visual disturbances | X | ||
| UNCOMMON | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, pale complexion, shortness of breath, or weakness. | X | ||
| Angioedema with breathing problems (swelling of tissue under the skin and difficulty breathing): difficulty breathing, swollen face, hands, feet, genitals tongue, or throat, diarrhea, nausea, or vomiting. | X | ||
| Heart problems: chest pain, chest pressure, shortness of breath, sweating, nausea, dizziness, fatigue, palpitations, irregular heartbeat, light-headedness, or fainting. | X | ||
| RARE | |||
| Allergic reaction: difficulty swallowing, difficulty breathing, wheezing, drop in blood pressure, nausea, vomiting, hives, rash, or swelling of the face, lips, tongue or throat. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store Plendil tablets at room temperature between 15°C to 30°C. To protect your Plendil tablets, keep them in the original blister packaging.
Keep out of reach and sight of children.
If you want more information about Plendil:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html) or by calling the manufacturer at 1-833-905-2937.