Consumer Information for: SANDOZ 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
Sandoz Felodipine is used to treat hypertension (high blood pressure).
What it does
Sandoz Felodipine contains the ingredient called felodipine. It belongs to the group of drugs called "calcium channel blockers" or "calcium antagonists".
Sandoz Felodipine relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure.
Sandoz 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
Sandoz Felodipine should not be used if you:
- are allergic to felodipine or any of the nonmedicinal ingredients in Sandoz 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 Sandoz Felodipine.
- are breast feeding
- are age 18 or younger.
What the medicinal ingredient is
Felodipine
What the non-medicinal ingredients are
Tablet Core: hydroxypropyl-methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulphate
Coating Layer: ferric oxide (red), ferric oxide (yellow), hydroxypropyl-methylcellulose, lactose monohydrate, polyethylene glycol and titanium dioxide
What dosage form it comes in
Extended release tablets 5 mg and 10 mg felodipine
Warnings and precautions
BEFORE you use Sandoz 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 Sandoz 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 Sandoz 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 over-the-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 Sandoz Felodipine works.
Drug-Drug Interactions
Drugs that may interact with Sandoz 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 Sandoz 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 Sandoz Felodipine includes:
- Grapefruit juice may also affect treatment with Sandoz Felodipine. Do not eat grapefruit or drink grapefruit juice while on Sandoz Felodipine
- Alcohol
- Food rich in carbohydrate and fat
Drug-Herb Interactions
Herbs that may interact with Sandoz Felodipine include:
- St. John’s Wort
Proper use of this medication
Usual Dose
Adults
Take Sandoz 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 Sandoz Felodipine if it is not prescribed for you.
- Sandoz 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 Sandoz Felodipine with something you do regularly each day; for example, upon waking or at breakfast. This will help you remember each dose
- Swallow Sandoz Felodipine whole with a glass of water. Do not crush, chew, break or suck on the tablets.
- Sandoz 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. Sandoz 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).
Check with your doctor if you want to drink alcohol (including wine with your meals) while you are taking Sandoz Felodipine. Drinking alcohol while on Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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, Sandoz Felodipine, like any medication, may include side effects. Some side effects may occur when Sandoz 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 Sandoz 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 Sandoz Felodipine with your doctor and pharmacist. Do not stop taking Sandoz 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 or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek 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 Sandoz Felodipine, contact your doctor or pharmacist.
How to store
Store Sandoz Felodipine at 15-30°C. Protect from light.
Do not keep Sandoz Felodipine in the bathroom.
Keep Sandoz Felodipine out of sight and reach of children
Do not keep or use Sandoz Felodipine after the expiry date indicated on the package. 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 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
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc
Last revised: March 4, 2015
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|---|---|---|---|
| THYMOGLOBULIN | 02246805 | SANOFI-AVENTIS CANADA INC | ANTI-THYMOCYTE GLOBULIN (RABBIT) 25 MG / VIAL |