Vigalex Rapid

Package Leaflet: Information for the Patient

Vigalex Rapid, 150 micrograms/mL, Oral Drops, Solution

Calcifediol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Vigalex Rapid and what is it used for
• 2. Important information before taking Vigalex Rapid
• 3. How to take Vigalex Rapid
• 4. Possible side effects
• 5. How to store Vigalex Rapid
• 6. Contents of the pack and other information

1. What is Vigalex Rapid and what is it used for

Vigalex Rapid is an oral solution. One drop contains 5 micrograms of the active substance - calcifediol. Calcifediol belongs to a group of medicines with vitamin D activity.
It is produced in the body from cholecalciferol (vitamin D). This substance is necessary for the absorption and utilization of calcium for proper bone mineralization.

Indications

• prevention and treatment of hypocalcemia (low calcium levels in the blood), rickets, and osteomalacia (bone demineralization) and other conditions resulting from vitamin D deficiency, accompanying chronic liver diseases;
• prevention and treatment of hypocalcemia, rickets, and osteomalacia occurring as complications of long-term antiepileptic and corticosteroid therapy (treatment with corticosteroids, i.e., adrenal cortex hormones, such as hydrocortisone or prednisone);
• prevention and treatment of renal osteodystrophy (bone tissue disorder in severe kidney diseases);
• idiopathic (primary) and postoperative hypoparathyroidism;
• selected cases of familial hypophosphatemic rickets (resistant to vitamin D);
• prevention and treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults and children from 11 years of age. Calcifediol should be used as a second-line treatment when cholecalciferol does not increase 25(OH)D serum levels or when an immediate increase in 25(OH)D serum levels is required. Warning!The medicine should not be used in healthy people to simply enrich the diet with vitamins. Calcifediol should not be used to prevent rickets in healthy children.

2. Important information before taking Vigalex Rapid

When not to take Vigalex Rapid:

• if the patient is allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has hypercalcemia (calcium levels in the blood >10.5 mg/dL) or hypercalciuria (high calcium levels in the urine),
• if the patient has hypothyroidism and adrenal insufficiency,
• if the patient has hyperparathyroidism,
• if the patient has kidney stones;
• if the patient has renal osteodystrophy with hyperphosphatemia (mineralization disorders of bone tissue);
• if the patient is long-term bedridden (bedridden patients);
• if the patient has certain types of cancer;
• if the patient has been diagnosed with hypervitaminosis D (excessive amounts of vitamin D in the body).

Warnings and precautions

Before starting treatment with Vigalex Rapid, discuss it with your doctor or pharmacist.
In the initial period of treatment - to determine the optimal dosage, it is recommended to determine the calcium level in the serum and urine at least once a week, and then check it periodically.
In small children - hypersensitivity may occur even at small doses of calcifediol. It is necessary to individually determine the dose by the doctor to avoid overdose.
In patients treated simultaneously with thiazide diuretics (e.g., hydrochlorothiazide) - due to the increased risk of hypercalcemia, it is recommended to systematically check the calcium level in the blood serum.
Caution should be exercised in patients treated with digitalis glycosides, as hypercalcemia that may occur when taking calcifediol can enhance the effects of glycosides, leading to arrhythmias.
The treating doctor will exercise particular caution when using the medicine in patients:

• with atherosclerosis or heart function disorders;
• with hyperphosphatemia (excessive phosphates in the blood);
• with kidney function disorders;
• with sarcoidosis or other granulomatous diseases, due to increased sensitivity to vitamin D. Patients undergoing dialysis during calcifediol treatment should be advised by the treating doctor to take phosphate-binding agents. It is recommended to discuss with the doctor even if the above warnings concern situations that occurred in the past.

Vigalex Rapid and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
Calcifediol may enhance the toxic effects of digitalis glycosides (medicines used in heart diseases).
During calcifediol treatment, do not take large doses of calcium preparations.
Taking antacids containing aluminum simultaneously with calcifediol can increase aluminum levels in the blood.
Taking magnesium preparations simultaneously may cause hypermagnesemia, especially in patients with chronic kidney diseases.
Antiepileptic drugs (hydantoin, barbiturates, primidone) may reduce the effects of vitamin D by accelerating its metabolism.
Simultaneous administration of calcifediol may weaken or abolish the effects of calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin used in the treatment of hypercalcemia.
Large doses of phosphorus-containing preparations taken simultaneously with calcifediol increase the risk of hyperphosphatemia (excessive phosphates in the blood), as vitamin D increases phosphate absorption.
During calcifediol treatment, do not take vitamin D or other medicines with vitamin D activity, due to the summation of effects and increased risk of toxicity.

Vigalex Rapid with food and drink

The prescribed dose should be taken with a small amount of water, milk, or fruit juice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No controlled studies have been conducted on the use of calcifediol in pregnant women.
Animal studies have shown a harmful effect on reproduction.
Vigalex Rapid should not be used during pregnancy.
Breastfeeding
Calcifediol passes into breast milk.
A risk to newborns/infants cannot be excluded.
Taking high doses of calcifediol by the mother may lead to high levels of calcitriol in milk and may cause hypercalcemia in children.
Vigalex Rapid should not be used during breastfeeding.
Fertility
There are no data on the effects of calcifediol on fertility.

Driving and using machines

No studies have been conducted on the effects of Vigalex Rapid on the ability to drive and use machines.

The medicine contains propylene glycol

The medicine contains 1,036.85 mg of propylene glycol in each milliliter, which corresponds to approximately 34.56 mg of propylene glycol in one drop. It is not recommended to exceed the daily dose of 1 mg/kg body weight of propylene glycol in newborns (up to 4 weeks of age) and a daily dose of 50 mg/kg body weight of propylene glycol in children up to 5 years of age. Do not use simultaneously with other medicines or preparations containing propylene glycol or alcohol.
Due to the high content of propylene glycol, it is not recommended to administer to newborns under 4 weeks of age, unless absolutely necessary, and another effective product with lower propylene glycol content is not available.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Patients with liver or kidney function disorders should not take this medicine without consulting a doctor. The doctor may decide to perform additional tests in such patients.

3. How to take Vigalex Rapid

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
Adults:

• depending on the disease, 50 to 75 micrograms per day, i.e., 10 to 15 drops per day,
• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults: 10 micrograms per day, i.e., 2 drops per day.

Use in children and adolescents

• therapeutically in chronic liver diseases and in hypocalcemia accompanying epilepsy treatment: 20 to 40 micrograms per day, i.e., 4 to 8 drops per day (0.4 to 1.8 micrograms/kilogram body weight/day, on average 1.0 microgram/kilogram body weight/day);
• preventively in the prevention of rickets and osteomalacia in patients treated with antiepileptic drugs: 10 to 20 micrograms per day, i.e., 2 to 4 drops per day;
• in renal osteodystrophy, hypophosphatemic rickets, and hypoparathyroidism: individual dosing depending on blood calcium levels.
• for the prevention and treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in children from 11 years of age: 10 micrograms per day, i.e., 2 drops per day The prescribed dose should be taken with a small amount of water, milk, or fruit juice. During treatment, the doctor will recommend laboratory tests to control calcium levels in the blood and urine. In patients treated with therapeutic doses, the following should be periodically determined:
• calcium content in daily urine;
• creatinine levels in serum;
• urea levels in blood;
• alkaline phosphatase activity in serum;
• phosphate levels in serum; the ratio of calcium/creatinine levels in urine (every 1 to 3 months during the entire treatment period) The condition for the therapeutic effect of calcifediol, which is the improvement of intestinal calcium absorption, is the proper calcium content in the diet.

Overdose of Vigalex Rapid

In case of overdose, contact your doctor.
High blood pressure, irregular heartbeat, abdominal pain, constipation (especially in children and the elderly), diarrhea, dry mouth, headache, increased thirst, frequent urination (especially at night), loss of appetite, metallic taste in the mouth, nausea and vomiting (especially in children and the elderly), weakness; in such cases, consult a doctor as soon as possible.
Delayed symptoms of overdose (occurring after a relatively long time) also require immediate medical intervention: bone pain, cloudy urine, high blood pressure, increased sensitivity of the eyes to light, irregular heartbeat, skin itching, lethargy (drowsiness), muscle pain, nausea and vomiting, and pancreatitis (severe abdominal pain), psychosis, mood disorders, weight loss.
In case of such symptoms, consult a doctor immediately.

Missed dose of Vigalex Rapid

Do not take a double dose to make up for a missed dose.
In case of doubts about taking the medicine, consult your doctor or pharmacist.

Stopping Vigalex Rapid treatment

In case of further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vigalex Rapid can cause side effects, although not everybody gets them.
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Acute or chronic overdose of vitamin D or its metabolites, including calcifediol, may cause toxicity symptoms. Chronic hypercalcemia caused by vitamin D can lead to generalized calcification of blood vessels, kidney stones, and soft tissue calcification, which can cause hypertension and kidney failure. In children, it may cause growth retardation. Kidney or cardiovascular failure caused by vitamin D toxicity can lead to death.
Early symptoms of vitamin D toxicity related to hypercalcemia:
constipation, diarrhea, dry mouth, headache, increased thirst, frequent urination, loss of appetite, metallic taste in the mouth, nausea and vomiting, and weakness; in such cases, consult a doctor as soon as possible.
Late symptoms of vitamin D toxicity related to hypercalcemia:
bone pain, cloudy urine, high blood pressure, increased sensitivity of the eyes to light, irregular heartbeat, skin itching, lethargy (drowsiness), muscle pain, nausea and vomiting, and pancreatitis (severe abdominal pain), psychosis, mood disorders, weight loss.
In case of such symptoms, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vigalex Rapid

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle label after EXP. The expiry date refers to the last day of the month.
Pay attention to the medicine's expiry date.
There are no special precautions for storing Vigalex Rapid. After opening the bottle, the medicine should be stored at a temperature below 25°C.
The shelf life of the medicine after opening the bottle: 9 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vigalex Rapid contains

• The active substance is calcifediol. 1 mL of the solution contains 150 micrograms of calcifediol. 1 drop contains 5 micrograms of calcifediol.
• The other ingredients are: propylene glycol.

What Vigalex Rapid looks like and contents of the pack

Vigalex Rapid is a clear, colorless solution.
A brown glass bottle, type III, with a HDPE screw cap, a guarantee ring (HDPE), and a dropper (LDPE) containing 10 mL of oral solution, packed in a cardboard box with a patient leaflet.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Phone: +48 61 66 51 500

Date of the last revision of the leaflet: