Patient Medication Information: uses, side effects, how to take - Sandoz Alfacalcidol
What is Sandoz Alfacalcidol used for?
Sandoz Alfacalcidol is used in adult patients with chronic kidney failure to treat:
- Low calcium levels in the body (hypocalcaemia)
- Bone disease (osteodystrophy)
- A condition in which the parathyroid gland is overactive (hyperparathoidism)
How does Sandoz Alfacalcidol work?
Sandoz Alfacalcidol contains the medicinal ingredient alfacalcidol, which works similarly to vitamin D. Alfacalcidol helps your body absorb calcium from your diet.
What are the ingredients in Sandoz Alfacalcidol?
Medicinal ingredients: alfacalcidol
Nonmedicinal ingredients: Sandoz Alfacalcidol– all-rac-α-tocopherol and sesame oil;
shell composition: Gelatin [TSE-BSE Free] [COS grade, Glycerol /Glycerin, Potassium Sorbate (Powder) (E 202), Titanium dioxide (E171), Ferric oxide (Red) (E172), Ferric oxide (Black) (E172), Purified water, Medium chain Triglyceride, Sesame oil and Nitrogen
Sandoz Alfacalcidol come in the following dosage forms:
- 0.25 mcg – cream-coloured, egg-shaped capsule
- 1 mcg – brown, egg-shaped capsule
Do not use Sandoz Alfacalcidol if:
- you are allergic to any of the ingredients in Sandoz Alfacalcidol or the packaging
- you have high calcium levels in your blood (hypercalcemia)
- you know you have high phosphate levels in your blood (hyperphosphatemia)
- you took a dose of Vitamin D and overdosed
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Alfacalcidol. Talk about any health conditions or problems you may have, including if
you:
- have arteries or heart valves that are hardened and stiff (arteriosclerosis or cardiac valve sclerosis)
- are taking heart medicines called a cardiac glycoside, such as digoxin
- are taking other vitamin D medicines or similar products
- have any kidney problems, including kidney stones
- are on dialysis treatment
- have an immune system or inflammatory disease like sarcoidosis
Other warnings you should know about:
High calcium and phosphorus levels: Treatment with Sandoz Alfacalcidol can cause high calcium levels in your blood (hypercalcemia) and urine (hypercalciuria). This depends on your bone building process, how well your kidneys work, and the dose of Sandoz Alfacalcidol. High calcium levels caused by Sandoz Alfacalcidol can cause:
- Heart problems like hard and stiff arteries or heart valves, abnormal heart beats for patients taking medicines for heart problems and heart disease in patients with lung calcium deposits.
- Calcium deposits (calcification) on your arteries and veins, kidneys or eyes.
- Kidney problems.
Sandoz Alfacalcidol can also cause high phosphorus levels in your blood. Your healthcare professional might put you on a low phosphate diet and have you take other medicines to control phosphate levels. They will do blood and urine tests while you are taking Sandoz Alfacalcidol. These tests will tell your healthcare professional how your calcium and phosphate levels are.
Check-ups and testing: You will have regular visits with your healthcare professional during your treatment. They might do:
- Blood and urine tests. This will check for different levels of proteins, cholesterol, liver enzymes and other substances.
- Eye exams to check your eyes for calcium deposits.
- Diagnostic imaging like x-rays and ultrasounds to check for calcium deposits in different parts of your body.
Pregnancy and breastfeeding:
Female patients
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- You should not take Sandoz Alfacalcidol if you are pregnant. It may harm your unborn baby.
- You should not take Sandoz Alfacalcidol if you are breastfeeding. Sandoz Alfacalcidol may be present in breast milk.
Pediatrics (children less than 18 years old): Sandoz Alfacalcidol should not be used in children less than 18 years old.
Geriatrics (adults 65 years and older): Sandoz Alfacalcidol should not be used in geriatric patients.
Tell your healthcare professional about all the medicines you are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sandoz Alfacalcidol:
- medicines to treat seizures (anticonvulsants) like barbiturates, phenytoin, carbamazepine or primidone
- medicines called barbiturates that help you sleep
- medicines used to treat heart problems (cardiac glycosides) such as digoxin).
- medicines used to treat high blood pressure like thiazide diuretics
- medicines that help your body get rid of water ("water pills" or diuretics)
- medicines such as cholestyramine, used to lower cholesterol levels, or to help stop some types of diarrhea or itching
- medicines for heartburn (antacids) and stomach ulcers that contain magnesium or aluminum hydroxide or sucralfate
- mineral oil used as a laxative
- medicines that contain calcium
- medicines that contain vitamin D or related ingredient (you should not take these medicines while you are taking Sandoz Alfacalcidol)
How to take Sandoz Alfacalcidol:
- Take Sandoz Alfacalcidol whole.
Take with or without food and or drink.
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Do not stop taking Sandoz Alfacalcidol without first checking with your healthcare professional.
- Your healthcare professional will send you for blood tests to see if your dose needs to be changed or stopped. They may also have you take other medicines and a special diet to help improve your health.
Usual dose:
- Your healthcare professional will decide your dose of Sandoz Alfacalcidol based on your health.
- Sandoz Alfacalcidol is usually taken once daily.
Overdose:
- If overdose is discovered within a short time: Your healthcare professional will have you vomit or pump your stomach. This will prevent more absorption by your stomach.
If you think you, or a person you are caring for, have taken too much Sandoz Alfacalcidol, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
- If the medicine has passed through your stomach, your healthcare professional might give you mineral oil. This will help remove the medicine by a bowel movement.
- Your healthcare professional might stop your doses of extra calcium and put you on a low calcium diet if you have an overdose.
Missed dose:
If a dose is forgotten, take it as soon as possible. If it is almost time for the next dose, do not double the dose.
What are possible side effects from using Sandoz Alfacalcidol?
These are not all the possible side effects you may have when taking Sandoz Alfacalcidol. If you experience any side effects not listed here, tell your healthcare professional.
- nausea, vomiting,
- constipation,
- diarrhea,
- loss of appetite,
- weight loss,
- abdominal pain,
- dry mouth
- feeling weak, sleepy, dizzy
- itching, rash
- headache,
- sweating,
- runny nose,
- lower sex drive,
- feeling hot
Sandoz Alfacalcidol can cause abnormal blood and / or urine tests. Your healthcare professional will decide when to perform these tests and will interpret the results. These tests will tell your healthcare professional how Sandoz Alfacalcidol is affecting your blood, heart, liver, pancreas, kidneys, and muscles.
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 | |||
| Nausea/vomiting | ✓ | ||
| Feeling weak, sleepy | ✓ | ||
| Vertigo (a sense of spinning dizziness) | ✓ | ||
| Heart Problems (disorders affecting your heart muscle, valves or rhythm): Chest | ✓ | ||
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 | ||
| pain, or chest discomfort, high blood pressure, irregular heart rhythm (fast or slow), shortness of breath, fainting, swelling of the legs, ankles and feet, weakness, slow pulse, palpitations, dizziness | |||
| Hypertensions (high blood pressure) severe headache, feeling tired and confused, vision problems, chest pain, difficulty breathing, feeling a pounding in your chest, neck or ears. | ✓ | ||
| Severe, new and/or unusual bone, joint and/or muscle pain | ✓ | ||
| Metallic taste | ✓ | ||
| Excessive thirst and/or urination, needing to wake up and urinate at night | ✓ | ||
| Eye disorders: Eye inflammation associated with eye pain, eye swelling, eye redness, sensitivity to light, fear of light, decreased vision | ✓ | ||
| Pancreatitis (swelling of the pancreas): upper abdominal pain, fever, rapid pulse, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Calcification (hardening of soft tissues, blood vessels, kidneys or eyes); chest pain, high blood pressure | ✓ | ||
| Kidney problems including kidney stones: severe pain in side and back, pain during urination, unusual | ✓ | ||
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 | |
| appearance of urine, nausea and vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | ||
| Psychosis (mental health problems): loss of contact with reality, hearing voices, agitation, anxiety, confusion, hallucinations, memory loss | ||
| ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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. |
|---|
Storing your Sandoz Alfacalcidol:
0.25 mcg Oral Capsules should be stored at room temperature (15°C to 25°C). Protect from direct sunlight.
1 mcg Oral Capsules should be stored at room temperature (15°C to 25°C). Protect from direct sunlight.
Keep out of reach and sight of children. Sandoz Alfacalcidol contains enough medication to seriously harm a child. Do not use Sandoz Alfacalcidol after the expiry date indicated on the label.
If you want more information about Sandoz Alfacalcidol:
- 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 by calling Sandoz Canada Inc. at 1-800-361-3062.
110, Rue de Lauzon, Boucherville,
Quebec J4B 1E6