Consumer Information for: APO PREDNISONE TAB 50MG
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-PREDNISONE is used to treat a many conditions. These include allergy and inflammation.
What it does
APO-PREDNISONE is a corticosteroid. It decreases the body’s reaction to some diseases and reduces inflammation.
When it should not be used
Do not use APO-PREDNISONE if:
- You have a systemic fungal infection
- You have a viral disease (such as measles, chickenpox and herpes simplex of the eye)
- You receive a type of vaccine called a live, or live/attenuated vaccine
- You have stomach or gut problems (ulcer, ulcerative colitis, diverticulitis)
- You have a bacterial or viral disease that is not being treated with antiinfectives
- You are allergic to prednisone or any other corticosteroid medicine or any of the ingredients in the APO-PREDNISONE tablet.
What the medicinal ingredient is
Prednisone
What the non-medicinal ingredients are
croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose
What dosage form it comes in
APO-PREDNISONE is available in the following dosage forms: Tablets1 mg, 5 mg and 50 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-PREDNISONE. Talk about any health conditions or problems you may have, including if you:
- Have an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm); If you or your child is exposed to measles or chickenpox during treatment with APO-PREDNISONE, contact you doctor immediately.
- Have a bleeding or blood clotting problem
- Have brittle bones (osteoporosis)
- Have high blood pressure
- Have seizures (convulsions) or other neurological problems
- Have a thyroid problem (hypothyroidism)
- Have muscle pain or weakness (such as myasthenia gravis)
- Have skin cancer (Kaposi’s sarcoma), or a tumor of the adrenal glands
- Have heart problems such as heart failure
- Have certain eye diseases such as glaucoma, cataracts; herpes infection, or any problems with the retina
- Have kidney disease
- Have liver disease such as cirrhosis
- Have certain mental or mood conditions (such as depression)
- Have low potassium or calcium
- Have Cushing’s disease
- Have a weak immune response
- Have high blood sugar
- Are pregnant or are trying to become pregnant
- Are breastfeeding or planning to breast feed
Other warnings you should know about:
- Before you have any operation, tell your doctor or dentist that you are taking APO-PREDNISONE
- Corticosteroids can affect growth in children
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with APO-PREDNISONE:
- Grapefruit or grapefruit juice
- Drugs to treat glaucoma and epilepsy (such as acetazolamide)
- Drugs to ‘thin’ the blood (anticoagulant such as warfarin, coumadin)
- Drugs to treat myasthenia gravis (such as distigmine and neostigmine)
- Antibiotics (such as erythromycin, clarithromycin and troleandomycin, rifampicin and rifabutin)
- Aspirin and non-steroidal anti-inflammatory drugs (such as ibuprofen)
- Drugs to treat inflammatory conditions (such as methylprednisolone)
- Drugs to treat epilepsy (such as barbiturates and phenytoin)
- Drugs for antifungal infections (such as ketoconazole)
- Cyclosporine
- Drugs for heart problems or high blood pressure (such as digoxin and diltiazem)
- Drugs to treat high cholesterol (cholestyramine)
- Water pills (diuretics)
- Drugs to treat HIV infections (such as indinavir or ritonavir)
- Hormones (such as estrogen and growth hormone)
- Drugs to treat diabetes
- Drugs to treat tuberculosis
- Vaccines
Other interactions you should know about:
If you are taking APO-PREDNISONE you may have a suppressed reaction to skin tests.
Proper use of this medication
How to take APO-PREDNISONE:
APO-PREDNISONE tables should be taken orally, with water.
This dosage form is not suitable for children less than 6 years old.
Usual Dose
Take APO-PREDNISONE tablets exactly as directed by your doctor. When your condition has improved, your doctor will reduce your dose gradually. APO-PREDNISONE should not be stopped abruptly. Do not stop taking APO-PREDNISONE without talking to your doctor.
Overdose
If you think you have taken too much APO-PREDNISONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Side effects and what to do about them
These are not all the possible side effects you may have when taking APO-PREDNISONE. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- increased appetite, weight gain, bloating, change in taste, abnormal fat deposits
- nausea, vomiting, diarrhea, abdominal pain, indigestion
- hiccups
- Thinning hair, unusual hair growth
- Feeling of general discomfort or uneasiness
- dizziness, forgetfulness, confusion, tired, irritated, euphoria (intense feelings of well-being, elation, happiness, excitement and joy)
- change in strength and reflexes
- rounder face
- increased sweating
- headache
- increased or decreased motility and number of sperm
Skin Problems:
- thin, fragile, dry, or itchy
- tingling, tickling, prickling or burning
- spots containing blood or caused by broken blood vessels
- lightening or darkening of an area of skin
- rash
- acne or an area of pus that is red, warm, and swollen (abscess)
| Symptom / effect | Talk to your healthcare professional only if severe | Talk to your healthcare professional in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Heart failure: Shortness of breath, fatigue, weakness, dizziness, irregular heart beat | ✔ | ||
| Fluid retention, swelling | ✔ | ||
| High blood pressure: Symptoms of which are headaches or feeling unwell | ✔ | ||
| Muscle weakness | ✔ | ||
| Stomach ulcers (burst or bleeding ulcers): Stomach pain, blood in stools and/or vomiting blood | ✔ | ||
| Wounds that are slow to heal | ✔ | ||
| Convulsions | ✔ | ||
| Psychological disorders: Feeling depressed including thinking about suicide, feeling anxious, difficulty sleeping, having delusions and/or hallucinations | ✔ | ||
| Irregular menstrual periods | ✔ | ||
| Diabetes: Frequent urination, thirst, hunger | ✔ | ||
| Cramps and spasms | ✔ | ||
| Visual problems, failing eyesight | ✔ | ||
| Reactivation of tuberculosis: Coughing blood or pain in the chest | ✔ | ||
| Infections: Raised temperature and feeling unwell | ✔ | ||
| Bone/joint pain | ✔ | ||
| Bone thinning (osteoporosis) | ✔ | ||
| Allergic reactions: rash, hives, swelling of the face, lips, tongue or throat. Difficulty swallowing or breathing. | ✔ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
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 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
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.
How to store
Store at room temperature (15 to 30°C).
Keep out of reach and sight of children.
More information
If you want more information about APO-PREDNISONE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the Apotex’s website at http://www.apotex.ca/products, or by calling DISpedia, Apotex’s Drug Information Service at 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9
Last Revised: May 28, 2015
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|---|---|---|---|
| SANDOZ ENTACAPONE | 02380005 | SANDOZ CANADA INCORPORATED | ENTACAPONE 200 MG |