Patient Medication Information: uses, side effects, how to take - Vitamin D3 Oral Solution
What is Vitamin D3 Oral Solution used for?
To treat vitamin D deficiency. This is when your body does not have enough Vitamin D, which is used to build and maintain healthy bones.
How does Vitamin D3 Oral Solution work?
Vitamin D3 Oral Solution is a vitamin product containing cholecalciferol (equivalent to vitamin D3). Vitamin D can be found in some foods. It is also produced by the body when skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb calcium and it helps build bones.
What are the ingredients in Vitamin D3 Oral Solution?
Medicinal ingredient: cholecalciferol 625 mcg (25,000 IU).
Non-medicinal ingredients: polyglyceryl dioleate, olive oil, orange oil, and tocopherol acetate.
Vitamin D3 Oral Solution comes in the following dosage forms:
Oral solution, 625 mcg (25,000 IU).
Do not use Vitamin D3 Oral Solution if you:
- are allergic to vitamin D or any of the other ingredients of Vitamin D3 Oral Solution, or component of the container.
- have high levels of calcium in the blood or urine
- have disturbed parathyroid hormone metabolism
- have kidney stones
- have high levels of calcium in your kidneys
- have serious kidney problems
- have malabsorption syndrome, preventing your body from absorbing certain nutrients
- have high levels of vitamin D in the blood.
- have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body)
- are less than 18 years old
- are taking other medicines containing vitamin D
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vitamin D3 Oral Solution. Talk about any health conditions or problems you may have, including if you:
- are being treated for heart disease.
- have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body)
- are likely to be exposed to a lot of sunshine while using Vitamin D3 Oral Solution.
- are being treated for kidney disease
- cannot move around
Other warnings you should know about:
Your doctor may measure the levels of calcium in your blood or urine to make sure they are not too high while you are using Vitamin D3 Oral Solution to avoid kidney damage or disease.
The levels of Vitamin D3 in your blood need to be monitored. After the first dose, you will have monthly bloodwork.
Treatment with high-dose vitamin D is not recommended for women who are pregnant or breast-feeding.
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 Oral Solution:
- medicines that act on the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or some diuretics (“water pills”, e.g. hydrochlorothiazide). When used at the same time as Vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine.
- actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals e.g., clotrimazole and ketoconazole, medicines used to treat fungal disease. These medicines may interfere with the way your body processes vitamin D.
- Glucocorticoids (steroid hormones) which can decrease the effect of Vitamin D.
- Other medicines that contain Vitamin D
the following medicines because they can interfere with the effect or the absorption of vitaminD3: - antiepileptic medicines (anticonvulsants) such as phenytoin, barbiturates
- certain medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol)
- certain medicines for weight loss that reduce the amount of fat your body absorbs (e.g. orlistat)
- certain laxatives (such as liquid paraffin).
How to take Vitamin D3 Oral Solution:
Always take Vitamin D3 Oral Solution exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You may take Vitamin D3 Oral Solution with some water or orange juice. It is not necessary to take it on an empty stomach. This medicine has a slight taste of olive oil. Empty the contents of the ampoule onto a spoon or directly into your mouth and swallow. Make sure you take the entire dose.
Usual dose:
To treat vitamin D deficiency in adults:
First dose: take 8 ampoules (5000 mcg or 200,000 IU)
After first month: take 4 ampoules (2500 mcg or 100,000 IU) once a month for 2 months
Overdose:
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the production of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in the blood and urine as shown by lab test.
| If you think you have taken too much Vitamin D3 Oral Solution, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take a dose of Vitamin D3 Oral Solution, take the forgotten dose as soon as possible. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal.
Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using Vitamin D3 Oral Solution?
These are not all the possible side effects which you may feel when taking Vitamin D3 Oral Solution. If you experience any side effects not listed here, contact your healthcare professional.
Possible side effects may include:
- Constipation, flatulence, nausea, stomach pain, or diarrhea
- Skin rash
- Itching
- Hives
- Swelling of skin
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 | ||
| UNKNOWN | |||
| Hypercalcaemia (too much calcium in your blood): constipation, nausea, vomiting, feeling thirsty, stomach pain, confusion, feeling weak | √ | ||
| Hypercalciuria (too much calcium in your urine): blood in urine, pain when urinating, urinating frequently, stomach pain, feeling weak | √ | ||
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 | ||
|---|---|---|---|
| Angioedema (swelling of tissue under the skin): difficulty breathing; swollen face, hands, feet, and throat; Swelling of the digestive tract causing diarrhea, nausea or vomiting | √ | ||
| Laryngeal edema (swelling of the larynx): change in voice, hoarseness, constant feeling to clear the throat | √ | ||
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:
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:
Keep out of reach and sight of children.
Store between 15°C and 25°C. Do not freeze or refrigerate. Store in the original carton to protect the contents from light.
Do not use this medicine after the expiry date which is stated on the carton and label after “Exp.”. The expiry date refers to the last day of that month.
If you want more information about Vitamin D3 Oral Solution:
- 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.html); or by calling the manufacturer at 1-888-640-0116 or via email at info@galephar.com.