Patient Medication Information: uses, side effects, how to take - Vitamin D3 (Jamp Pharma)

What is Vitamin D3 used for?

Vitamin D3 is used to treat:

Vitamin D resistant rickets (a bone disease with low level of vitamin D, calcium, or phosphorus in the body).
Hypoparathyroidism (a condition where your body does not have enough chemical messenger (hormone) to manage the levels of calcium and phosphorus in your blood).

How does Vitamin D3 work?

Vitamin D3 helps:

your body get calcium and phosphorus from your diet
prevent calcium and phosphate loss from your kidneys
build and maintains strong bones and teeth

What are the ingredients in Vitamin D3?

Medicinal ingredient: Vitamin D₃(Cholecalciferol)

Non-medicinal ingredients: sodium ascorbate, all-rac-α-tocopherol, modified starch, sucrose, medium chain triglycerides, colloidal silicon dioxide, microcrystalline cellulose, polacrilin potassium, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hypromellose, diethyl phthalate, ethyl cellulose, talc, titanium dioxide, polydextrose, maltodextrin and may contain traces of methylene chloride and isopropyl alcohol.

Vitamin D3 comes in the following dosage forms:

Tablets; 10 000 Units

Do not use Vitamin D3 if you have:

known allergy:
- to vitamin D or medicines like vitamin D
- to any of the other ingredients in Vitamin D3
too much calcium in your blood or urine
kidney stones
severe kidney disease
a bowel problem where your body can't get nutrients from the food you eat.
unusual sensitivity to vitamin D poisoning (for example when you have too much calcium in your body)
too much vitamin D in your body

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vitamin D3. 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 Vitamin D3 can increase your risk of certain side effects, including:

hypervitaminosis D (too much vitamin D in your body).
hypercalcemia too much calcium in your blood).

Monitoring and Laboratory Tests: While taking Vitamin D3, your healthcare professional may check calcium, phosphate, and magnesium levels in your blood.

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 Vitamin D3:

Heartburn medicines (Antacids):
- hagnesium-containing antacids. If you have kidney problems and taking Vitamin D3 with magnesium-containing antacids, your healthcare professional may do blood tests.
- hluminum-containing antacids. Avoid taking aluminum-containing antacids with Vitamin D3.
anti-seizure medicines (such as phenytoin, phenobarbital and carbamazepine)
medicines used to lower cholesterol (such as cholestyramine and colestipol). Allow as much time as possible between taking cholesterol lowering medicines and Vitamin D3.
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. Allow as much time as possible between taking mineral oils and Vitamin D3.
Sucralfate (used to treat ulcers). Avoid taking sucralfate with Vitamin D3.
thiazide diuretics, also known as “water pills” (such as hydrochlorothiazide, used to treat high blood pressure)
danazol

Do not take Vitamin D3 along with any other products that may contain Vitamin D unless advised by your healthcare professional.

How to take Vitamin D3:

While taking Vitamin D3, your healthcare professional:

will monitor you closely
may check your blood calcium, magnesium, phosphorus and urea level every two weeks as needed
may do an x-ray every month to check your bones
may also prescribe a calcium supplement depending on the type of treatment you are receiving.

Usual dose:

Take exactly as prescribed by your healthcare professional. Do not change your dose on your own. Your healthcare professional will decide when to end your treatment.

Overdose:

If you think you, or a person you are caring for, have taken too much Vitamin D3, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Taking too much Vitamin D3 can cause high levels of calcium in your body (hypercalcemia). See What are possible side effects from using Vitamin D3?

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 Vitamin D3?

These are not all the possible side effects you may feel when taking Vitamin D3. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

itching
rash
itchy bumps on your skin (hives)
hypercalcaemia (high blood calcium). May cause:
- early symptoms such as:
  - weakness
  - feeling tired and sleepy
  - headache
  - loss of appetite
  - dry mouth
  - a metallic taste
  - nausea and vomiting
  - dizziness
  - ringing in the ears

issues with balance, coordination and speech (ataxia)

low muscle tone (hypotonia)
later and long term serious symptoms: See Serious side effects table below

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
Hypercalcaemia (too much calcium in the blood). May lead to: anemia (low number of red blood cells): tiredness, weakness and shortness of breath kidneys problems nephrocalcinosis (buildup of too much calcium in the kidneys): blood in the urine, fever and chills, severe pain in the belly area, sides of the back (flank), groin, or testicles renal dysfunction (kidneys no longer working properly): little or no urine, swelling of the legs, ankles or feet calcification (buildup of too much calcium in your body). This may cause hardening of blood vessels and soft tissues such as the heart and lungs, leading to high blood pressure…. pancreatitis (pain and swelling of the pancreas): upper belly pain, fever, rapid heartbeat, nausea and vomiting, tenderness when touching the belly seizures (fits) osteoporosis (thin, fragile bones): broken bones, pain, back pain that gets worse when standing or walking grow problems (in children)
	√

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:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

Calling toll-free at 1-866-234-2345.

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:

Blister: Store between 15-30⁰C. Protect from light.

Bottle: Store between 15-30⁰C, in a well closed container. Protect from light and moisture.

Keep out of reach and sight of children.

If you want more information about Vitamin D3:

Talk to your healthcare professional
Find the full Prescribing Information 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); the manufacturer’s website (www.jamppharma.com), or by calling 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Rx or OTC	Prescription (Rx)?
DIN	02546876
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Vitamin D3 10000 UNIT
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	A Alimentary tract and metabolism drugs A11 Vitamins A11C Vitamin A and D, incl. combinations of the two A11CC Vitamin D and analogues A11CC05 Colecalciferol
Company	JAMP PHARMA CORPORATION
Current status	Marketed
Current status date	April 30, 2024

Vitamin D3 (Jamp Pharma): Uses, Side Effects and Dosage