Vigalex Forte 2000 IU, 30 tablets

Vigalex Forte 2000 IU, 30 tablets

Best before date: 31.3.2025

Trade name:

Vigalex Forte 2000 IU, 30 tablets

Type:

Bow

Product description:

Vigalex Forte medicines contain the active substance vitamin D3 (cholecalciferol), which plays an important role in the process of bone formation, in supporting immunity and in numerous physiological processes of the body. Vitamin D3 (cholecalciferol) is produced by the body in the skin under the influence of sunlight (UV radiation), it can also be supplied to the body with food. In vitamin D deficiency, there are disorders of bone calcification (rickets) or loss of calcium from the bones (osteomalacia) and weakening of the body’s immunity.

Indications:

Vigalex Forte medications are used in:

– preventing vitamin D deficiency in children and adults,

– prevention of vitamin D deficiency in women planning a pregnancy, pregnant and breastfeeding in consultation with a doctor,

– prevention of rickets and osteomalacia in children and adults,

– supportive treatment of osteoporosis in adults.

Vigalex Forte is intended for patients aged 11 years and over with a normal body weight.

Ingredients:

One tablet contains 20 mg of cholecalciferol, powder, equivalent to 0.05 mg (2000 IU) of cholecalciferol (vitamin D3).One tablet contains 20 mg of cholecalciferol, powder, equivalent to 0.05 mg (2000 IU) of cholecalciferol (vitamin D3).

– The other ingredients are: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, pregelatinized maize starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, medium chain triglycerides, colloidal anhydrous silica, all-rac-α-tocopherol.

Use:

Always use these medicines exactly as described in this package leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not use this medicine for a long time (over 3 months) or in higher doses than recommended without medical supervision. Do not use other medicines, dietary supplements or other types of food products containing vitamin D (cholecalciferol), calcitriol or other metabolites and analogues of vitamin D at the same time without medical supervision. Dosage Children aged 6 to 10 years with normal body weight 1000 IU per day Adolescents aged 11 to 18 years with normal body weight

– prevention of vitamin D deficiency: 1000 to 2000 IU per day

– prevention of rickets and osteomalacia: 2000 IU per day

Adults with normal body weight

– prevention of vitamin D deficiency: 1000 to 2000 IU per day

– prevention of rickets and osteomalacia: 2000 IU per day

– supportive treatment of osteoporosis: 2000 to 4000 IU per day

Elderly people (over 75 years old)

– prevention of vitamin D deficiency: 2000 to 4000 IU per day

Women planning a pregnancy, pregnant and breastfeedingConsult your doctor to determine the dose of vitamin D that you should take during pregnancy. The usual recommended dose is 2000 IU per day, regardless of the season, unless your doctor recommends a different dosage. During pregnancy, women should follow the recommendations of their doctor, because their vitamin D requirements may vary depending on the body’s vitamin D reserves.Patients with renal failureThe drug should not be used in patients with renal failure without medical supervision.Patients with liver failureNo special dosage recommendations.Children under 6 years of ageIt is not recommended to administer to children under 6 years of age, due to the form of the drug (tablets).How to take the drugTake the tablet with a sufficient amount of fluid.Using a higher dose of Vigalex Forte than recommendedIf you use a higher dose of Vigalex Forte than recommended, contact your doctor. The doctor will decide on the appropriate treatment. Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in the blood), excessive thirst, polyuria and dehydration. High concentrations of calcium in the blood can cause heart disorders, kidney failure, psychosis and even coma. Laboratory tests show hypercalcemia (increased concentration of calcium in the blood), hypercalciuria (excessive excretion of calcium in the urine) and increased concentration of 25-hydroxycalciferol in the serum. Overdose requires taking measures to control the often prolonged and sometimes life-threatening hypercalcemia. Missed use of Vigalex Forte Do not take a double dose to make up for the missed dose. Discontinued use of Vigalex Forte If you have any further questions regarding the use of this medicine, contact your doctor or pharmacist.

Side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.The following side effects may occur when taking Vigalex Forte: Unknown frequency (frequency cannot be estimated based on available data):

– gastrointestinal complaints such as constipation, flatulence, nausea, abdominal pain or diarrhea;

– hypersensitivity reactions such as itching, rash or hives;

– in case of long-term use of high doses, hypercalcaemia (too high concentration of calcium in the blood) and hypercalciuria (excessive excretion of calcium in the urine) occur.

In isolated cases, deaths have been reported.Reporting side effectsIf you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Side effects can also be reported to the responsible entity. By reporting side effects, you can gather more information on the safety of the medicine.

Contraindications:

When not to use Vigalex Forte medication

– if the patient is allergic to cholecalciferol or any of the other ingredients of these medicines,

– in case of hypercalcaemia (too much calcium in the blood) or hypercalciuria (excessive excretion of calcium in the urine),

– if you have kidney stones or severe kidney failure,

– in cases of pseudohypoparathyroidism.

Warnings and precautions:

Before starting to use Vigalex Forte medication, talk to your doctor or pharmacist. Vigalex Forte medication should be used under medical supervision:

– if you are also taking other products containing vitamin D, as additional doses of vitamin D should only be taken under medical supervision,

– if you have sarcoidosis (an immune system disease that may increase the level of vitamin D in the body),

– if you have kidney problems,

– if the patient is treated with cardiac glycosides or diuretics,

– for children under 6 years of age,

– if the treatment with vitamin D is long-term (over 3 months), because in such a case the doctor should monitor the patient’s calcium level in serum and urine and check kidney function by measuring the level of creatinine in the blood.

Storage conditions:

Keep this medicine out of the sight and reach of children. Store below 30ºC. Store in the original package in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Interactions:

Vigalex Forte and other medicinesTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Antacids (used to treat hyperacidity, containing aluminium) used together with Vigalex Forte may increase the level of aluminium in the blood, increasing the risk of aluminium toxicity to the bones.Antacids containing magnesium used together with Vigalex Forte may increase the level of magnesium in the blood.Some antiepileptic, sedative or sleep-inducing medicines (containing phenytoin or barbiturates) used together with Vigalex Forte may reduce its effectiveness.Some diuretics may lead to hypercalcaemia (increased calcium levels), caused by reduced excretion of calcium by the kidneys. During long-term treatment, calcium levels in serum and urine should be monitored. Concomitant administration of glucocorticosteroids (adrenal cortex hormones) may nullify the effect of Vigalex Forte drugs. Vigalex Forte drugs may enhance the effect and toxicity of digitalis glycosides, which creates a risk of developing cardiac arrhythmias. In this case, the doctor should monitor the calcium level in the serum and urine of the patient and conduct periodic ECG tests. The simultaneous use of metabolites or analogues of vitamin D (e.g. calcitriol) and the drug Vigalex Forte is possible only on the recommendation of a doctor, only in exceptional cases, provided that the concentration of calcium in the serum is monitored. Rifampicin and isoniazid may reduce the effectiveness of Vigalex Forte drugs. Pregnancy and breast-feeding If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before using these drugs. Pregnancy The doctor should be consulted to determine the dose of vitamin D that the patient should take during pregnancy. The usually recommended dose is 2000 IU per day, regardless of the season, unless the doctor recommends a different dosage. During pregnancy, women should follow the recommendations of the treating doctor, because their need for vitamin D may vary depending on the body’s vitamin D resources. Vitamin D should not be taken in doses higher than 2000 IU per day.BreastfeedingYou should consult your doctor to determine the dose of vitamin D you should take while breastfeeding.The usual recommended dose is 2000 IU per day, regardless of the season, unless your doctor recommends a different dosage.Women who are breastfeeding should follow the recommendations of their doctor, as their vitamin D requirements may vary depending on their body’s vitamin D reserves.Doses of vitamin D higher than 2000 IU per day should not be taken without medical supervision.Driving and using machinesVigalex Forte medicines do not affect the ability to drive or use machines.Vigalex Forte medicines contain sucrose.If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these medicines.This medicine contains less than 1 mmol (23 mg) of sodium in the maximum daily dose, that is to say the medicine is considered to be “sodium-free”.

Responsible entity:

Biofarm Sp. z ooul. Wałbrzyska 1360-198 Poznań

Manufacturer:

Biofarm Sp. z ooul. Wałbrzyska 1360-198 Poznań

This is a medicine. For safety, use it according to the leaflet included in the package. Do not exceed the maximum dose of the medicine. If in doubt, consult your doctor or pharmacist.

Characteristics of the Medicinal Product