Patient Medication Information: uses, side effects, how to take - AG-Vitamine D
What is AG-Vitamine D used for?
AG-Vitamine D is used to treat and prevent vitamin D deficiency:
- to manage and prevent osteoporosis or osteoporosis caused by corticosteroid. Osteoporosis is a bone disorder Osteoporosis is a bone disorder;
- to treat unmanageable rickets (vitamin D resistant rickets). Rickets is a bone disorder in children;
- to treat genetic hypophosphatemia. Hypophosphatemia is a condition that causes low levels of phosphate in the blood;
- to treat of hypoparathyroidism, a condition that occurs when the glands in the neck don’t product enough hormones.
How does AG-Vitamine D work?
The Vitamin D (Cholecalciferol) component of AG-Vitamine D increases your body’s absorption of calcium and phosphorus from your diet. It also prevents the release of calcium and phosphate from your kidneys.
What are the ingredients in AG-Vitamine D?
Medicinal ingredients: Vitamin D3 (Cholecalciferol)
Non-medicinal ingredients: Poceau 4R FCF, gelatin, glycerin, medium-chain triglycerides, sorbitol, vanillin, water
AG-Vitamine D comes in the following dosage forms:
Softgel capsules; 10 000 IU (Red)
Do not use AG-Vitamine D if:
you have known allergy:
- to Vitamin D or any of its forms (analogues and derivatives)
- to any of the other ingredients in AG-Vitamine D
- you have high levels of calcium in your body or urine
- you have kidney stones
- you have severe kidney disease
- you have a disorder in which your small intestine cannot absorb enough of certain nutrients and fluids from foods
- you have unusual sensitivity to the harmful effects of Vitamin D (for example high levels of calcium in your body)
- you currently have high levels of Vitamin D in your body
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Vitamine D. Talk about any health conditions or problems you may have, including if you are:
pregnant or planning on becoming pregnant
- breastfeeding or planning to breastfeed
Other warnings you should know about: Treatment with AG-Vitamine D can increase your risk of certain side effects, including:
- Hypervitaminosis D. Hypervitaminosis D is a condition in which the Vitamin D levels in the body is high.
- Hypercalcemia. Hypercalcemia is a condition in which the calcium level in the body is above normal.
Monitoring and Laboratory Tests: Your doctor will monitor you for your calcium, phosphate, and magnesium levels while you are taking AG-Vitamine D.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AG-Vitamine D:
Heartburn medicines (Antacids):
- Magnesium-containing antacids. Your doctor may monitor you if you have kidney failure and you are taking these types of antacids with AG-Vitamine D.
- Aluminum-containing antacids. You should avoid taking these types of antacids with AG-Vitamine D.
- Anti-seizure medicines (such as phenytoin, phenobarbital and carbamazepine)
- Medicines used to lower cholesterol (such as cholestyramine and colestipol). You should allow as much time as possible between taking cholesterol lowering medicines and AG-Vitamine D.
- Digoxin (used to treat heart failure)
- Efavirenz (used to treat HIV)
- Orlistat (used in medications for weight loss)
- Sevelamer (used to treat high phosphorous levels)
- Mineral oil. You should allow as much time as possible between taking mineral oils and AG-Vitamine D.
- Sucralfate (used to treat ulcers). You should avoid taking this with AG-Vitamine D.
- Thiazide diuretics, also known as “water pills” (such as hydrochlorothiazide, used to treat high blood pressure)
- Danazol
Do not take AG-Vitamine D along with any other products that may contain Vitamin D unless advised by your doctor.
How to take AG-Vitamine D:
While taking AG-Vitamine D, your doctor:
- will monitor you closely
- may do additional tests to check your blood calcium, magnesium, phosphorus and urea level every two weeks or more often if needed
- send you for an x-ray every month to check the conditions of your bones
- Your doctor may also prescribe a calcium supplement depending on the type of treatment you are receiving.
Usual dose:
NOTE: AG-Vitamine D capsules is only available in 10 000 IU.
Take exactly as prescribed by your doctor. Do not change your dose on your own. Your doctor will decide when to end your treatment.
Treatment to maintain Vitamin D levels:
Take 2000 IU to 4000 IU daily until your doctor ends your treatment.
Treatment for Vitamin D resistant rickets:
Take 12 000 IU to 500 000 IU daily
Treatment for Vitamin D deficiency:
Take 5000 IU daily until your doctor ends your treatment or 50 000 IU once a week for 8 weeks.
Treatment of hypoparathyroidism:
Take 50 000 IU to 200 000 IU daily. Treatment should also include a calcium supplement.
Overdose:
| If you think you have taken too much AG-Vitamine D contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Taking too much AG-Vitamine D can cause high levels of calcium in your body (hypercalcemia). See What are possible side effects from using AG-Vitamine D?
Missed Dose:
If you miss a dose of this medication, take the next dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for the missed dose.
What are possible side effects from using AG-Vitamine D?
These are not all the possible side effects you may feel when taking AG-Vitamine D. If you experience any side effects not listed here, contact your healthcare professional.
Side effects include:
hypercalcaemia (high levels of calcium in blood):
- weakness
- feeling tired and sleepy
- headache
- loss of appetite
- dry mouth
- a metallic taste
- nausea and vomiting
- dizziness
- ringing in the ears
- unusual muscle movements
- decreased muscle tone
- itching
- rash
- skin with red spots which burn, itch or sting
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 | ||||
| COMMON | |||||
| Anemia (decreased number of red blood cells): feeling tired, lack of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||||
| Impaired growth in children (stunted, abnormal growth): abnormal size of arms or legs, lack of energy, dry skin, dry hair, feeling cold, blood in the stool, diarrhea, constipation, vomiting, nausea. | √ | ||||
| Generalized vascular calcification (hardening of the blood vessels): peripheral artery disease, stroke, high blood pressure, pain or cramping in leg muscles. | √ | ||||
| Metastatic calcification (deposition of calcium salts in normal tissue): hardening of body tissues that otherwise should be soft and malleable. | √ | ||||
| Nephrocalcinosis (calcification of the tubules of the kidney): blood in the urine, fever, chills, nausea and vomiting, sever pain in the belly area, sides of the back, groin or testicles. | √ | ||||
| Osteoporosis in adults (decrease of bone mass and density): backache, gradual loss of height, stooped posture, fractures of the spine, wrist or hip. | √ | ||||
| Pancreatitis (inflammation of the pancreas): pain in your belly that spreads to your back, or feels worse after eating, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen. | √ | ||||
| Renal dysfunction (abnormal functioning of the kidney): less than normal urination, fluid retention, swelling of the legs, ankles or feet, shortness of breath, fatigue, confusion, nausea, weakness, irregular heartbeat. | √ | ||||
| Seizures (sudden convulsions or loss of consciousness): temporary confusion, a staring spell, uncontrollable jerking movements of the arms and legs, loss of consciousness or awareness, fear, anxiety or dejà vu (a disquieting feeling of having been somewhere or done something before, even though one has not.) | √ | ||||
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 report any suspected side effects associated with the use of health products to Health Canada by: |
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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. |
Storage:
Store at room temperature between 15°C and 30°C. Protect from light.
Keep out of reach and sight of children.
If you want more information about AG-Vitamine D:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or the manufacturer’s website: www.angitapharma.ca.
This document, prepared for health professionals, can be obtained by contacting the sponsor, Angita Pharma Inc. at 450-449-9272.
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3