Vigalex rapid
Poland
Table of Contents
Package leaflet: Information for the patient
Vigalex Rapid, 150 micrograms/mL, oral drops, solution
Calcifediolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:
- What Vigalex Rapid is and what it is used for
- Important information before using Vigalex Rapid
- How to use Vigalex Rapid
- Possible side effects
- How to store Vigalex Rapid
- Contents of the package and other information
1. What Vigalex Rapid is and what it is used for
Vigalex Rapid is an oral drop formulation. One drop contains 5 micrograms of the active substance – calcifediol. Calcifediol belongs to a group of medicines with vitamin D activity. It is formed in the body from cholecalciferol (vitamin D). This substance is essential for the absorption and utilization of calcium required for proper bone mineralization.
Indications
- Prevention and treatment of hypocalcaemia (low blood calcium levels), rickets and osteomalacia (bone demineralization), and other conditions associated with vitamin D deficiency occurring in chronic liver diseases;
- Prevention and treatment of hypocalcaemia, rickets and osteomalacia occurring as complications of long-term antiepileptic therapy and corticosteroid therapy (treatment with corticosteroids, i.e. adrenal cortex hormones such as hydrocortisone or prednisone);
- Prevention and treatment of uremic osteodystrophy (bone tissue disorders in severe kidney diseases);
- Idiopathic (spontaneous) and postoperative hypoparathyroidism;
- Selected cases of familial hypophosphataemic rickets (vitamin D-resistant rickets);
- Prophylaxis and treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults and children aged 11 years and older. Calcifediol should be used as a second-line treatment when cholecalciferol does not increase serum 25(OH)D levels or when an immediate increase in serum 25(OH)D is required. Note! This medicine should not be used in healthy individuals for the purpose of general dietary vitamin supplementation. Calcifediol should not be used for the prevention of rickets in healthy children.
2. Important information before using Vigalex Rapid
When not to use 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 level in blood >10.5 mg/dL) or hypercalciuria (high calcium level in urine),
- if the patient has hypoparathyroidism and adrenal cortex insufficiency,
- if the patient has hyperparathyroidism,
- if the patient suffers from kidney stones,
- if the patient has renal osteodystrophy with hyperphosphatemia (bone mineralization disorders),
- if the patient is long-term immobilized (bedridden patients),
- if the patient has certain malignant diseases,
- if the patient has been diagnosed with hypervitaminosis D (excess vitamin D in the body).
Warnings and precautions
Before starting treatment with Vigalex Rapid, discuss it with your doctor or pharmacist.
During the initial treatment period – to determine the optimal dosage – serum calcium and urinary calcium levels should be measured at least once a week, and then periodically checked.
In young children – hypersensitivity may occur even to small doses of calcifediol. An individual dose must be established by a physician to avoid overdose.
In patients concurrently treated with thiazide diuretics (e.g. hydrochlorothiazide) – due to increased risk of hypercalcemia – serum calcium levels should be systematically monitored.
Caution is advised in patients treated with cardiac glycosides, as hypercalcemia, which may occur during calcifediol administration, enhances the effect of glycosides, leading to arrhythmias.
The treating physician should exercise particular caution when using this medicine in patients:
- with atherosclerosis or impaired cardiac function,
- with hyperphosphatemia (excess phosphates in blood),
- with impaired renal function,
- suffering from sarcoidosis or other granulomatous diseases, due to increased sensitivity to vitamin D.
Patients undergoing dialysis during calcifediol treatment should be advised by the physician to take phosphate-binding agents.
Please consult your doctor, even if the above warnings concern conditions that occurred in the past.
Vigalex Rapid and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Calcifediol may enhance the toxic effects of cardiac glycosides (medicines used in heart diseases).
Large doses of calcium supplements should not be taken during calcifediol treatment.
Concomitant use of antacids containing aluminum with calcifediol may increase aluminum levels in blood.
Simultaneous use of magnesium-containing preparations may cause hypermagnesemia, especially in patients with chronic kidney disease.
Antiepileptic drugs (hydantoin, barbiturates, primidone) may reduce the effects of vitamin D by accelerating its metabolism.
Concomitant administration of calcifediol may weaken or counteract the effects of calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin used in the treatment of hypercalcemia.
Large doses of phosphate-containing preparations taken simultaneously with calcifediol increase the risk of hyperphosphatemia (excess phosphates in blood), as vitamin D enhances the absorption of phosphorus compounds.
During treatment with calcifediol, vitamin D or other vitamin D-acting medicines should not be taken due to cumulative effects and increased risk of toxicity.
Vigalex Rapid with food and drink
Administer the prescribed dose with a small amount of water, milk, or fruit juice.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Controlled studies on the use of calcifediol in pregnant women have not been conducted.
Animal studies have shown harmful effects on reproduction.
Vigalex Rapid should not be used during pregnancy.
Breastfeeding
Calcifediol passes into breast milk.
Risk to newborns/infants cannot be excluded. High maternal doses of calcifediol may lead to high levels of calcitriol in milk and may cause hypercalcemia in infants.
Vigalex Rapid should not be used during breastfeeding.
Fertility
There is no data available on the effect of monohydrate calcifediol on fertility.
Driving and operating machinery
No studies have been conducted on the effect of Vigalex Rapid on the ability to drive or operate machinery.
The medicine contains propylene glycol.
This medicine contains 1,036.85 mg of propylene glycol in each milliliter, corresponding to approximately 34.56 mg of propylene glycol per drop.
Daily doses exceeding 1 mg/kg body weight of propylene glycol should not be used in neonates (up to 4 weeks of age), and daily doses exceeding 50 mg/kg body weight should not be used in children under 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, administration to neonates under 4 weeks of age is not recommended unless absolutely necessary and no other effective product with lower propylene glycol content is available.
Before administering this 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 impaired liver or kidney function should not take this medicine without medical advice. The physician may decide to perform additional tests in such patients.
3. How to use Vigalex Rapid
This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Adults:
- depending on the condition, 50 to 75 micrograms per day, i.e. 10 to 15 drops per day;
- for prophylaxis 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 associated with antiepileptic treatment: 20 to 40 micrograms per day, i.e. 4 to 8 drops per day (0.4 to 1.8 microgram/kilogram body weight/day, average 1.0 microgram/kilogram body weight/day);
- prophylactically to prevent rickets and osteomalacia in patients treated with anticonvulsant drugs: 10 to 20 micrograms per day, i.e. 2 to 4 drops per day;
- in uremic osteodystrophy, hypophosphatemic rickets, and hypoparathyroidism: individual dosing depending on serum calcium concentration.
- for prophylaxis and treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in children aged 11 years and older: 10 micrograms per day, i.e. 2 drops per day.
The prescribed dose should be administered with a small amount of water, milk, or fruit juice. During treatment, your doctor will recommend periodic laboratory tests to monitor calcium levels in blood and urine. In patients receiving therapeutic doses, the following should be monitored periodically:
- calcium content in 24-hour urine;
- serum creatinine concentration;
- blood urea nitrogen concentration;
- serum alkaline phosphatase activity;
- serum phosphate concentration;
- calcium/creatinine ratio in urine (every 1 to 3 months throughout the treatment period).
An adequate dietary intake of calcium is essential for the therapeutic effect of calcifediol, which improves intestinal calcium absorption.
Use of a higher than recommended dose of Vigalex Rapid
If a higher than recommended dose is taken, contact a doctor immediately.
Symptoms may include high blood pressure, irregular heartbeat, abdominal pain, constipation (especially in children and elderly individuals), diarrhea, dry mouth, persistent headache, increased thirst, increased urination (especially at night), loss of appetite, metallic taste in the mouth, nausea and vomiting (especially in children and elderly individuals), and weakness. In such cases, seek medical advice as quickly as possible.
Late symptoms of overdose (occurring after a relatively long time), such as bone pain and muscle pain, cloudy urine, drowsiness, increased sensitivity of the eyes to light, and skin itching, also require immediate medical intervention.
Missed dose of Vigalex Rapid
Do not take a double dose to make up for a missed dose.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Discontinuation of Vigalex Rapid
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the adverse effects listed below is unknown (frequency cannot be estimated from the available data).
Acute or chronic overdose of vitamin D or its metabolites, including calcifediol, may cause symptoms of toxicity.
Chronic hypercalcemia caused by vitamin D may lead to generalized vascular calcification, kidney stones, and calcification of soft tissues, which may result in hypertension and renal failure. In children, growth retardation may occur. Renal or circulatory failure caused by vitamin D toxicity may lead to death.
Early symptoms of vitamin D toxicity related to hypercalcemia:
constipation, diarrhoea, dry mouth, headache, increased thirst, frequent urination, loss of appetite, metallic taste in the mouth, nausea and vomiting, fatigue and weakness.
Late symptoms of vitamin D toxicity related to hypercalcemia:
bone pain, cloudy urine, high blood pressure, photophobia (eye sensitivity to light), irregular heartbeat, skin itching, lethargy (drowsiness), muscle pain, nausea and vomiting, pancreatitis (severe abdominal pain), psychosis, mood disturbances, weight loss.
If any of these symptoms occur, seek medical advice immediately.
Other adverse effects not listed in this leaflet may occur in some individuals during treatment with Vigalex Rapid.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Vigalex Rapid
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the bottle
after EXP. The expiry date refers to the last day of the specified month.
Please pay attention to the medicine's expiry date.
There are no special storage instructions for Vigalex Rapid. After first opening of the
bottle, the medicine should be stored at a temperature below 25°C.
Shelf-life of the medicine after first opening of the bottle: 9 months.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures 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 drops contains 150 micrograms of calcifediol. 1 drop contains 5 micrograms of calcifediol.
- The other ingredient is propylene glycol.
What Vigalex Rapid looks like and contents of the pack
Vigalex Rapid is a clear, colourless solution. The medicine is a 10 mL amber glass bottle made of soda-lime-silicate glass type III, with an HDPE cap, tamper-evident ring (HDPE), and an LDPE dropper. The bottle contains 10 mL of oral drops solution. The bottle, together with the patient leaflet, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500