Vigantoletten 500

Package leaflet: Information for the user

Vigantoletten 500
12.5 micrograms (500 IU) tablets
(Cholecalciferolum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, you should contact your doctor.

Contents of the leaflet:

1. What Vigantoletten 500 is and what it is used for
2. Important information before taking Vigantoletten 500
3. How to take Vigantoletten 500
4. Possible side effects
5. How to store Vigantoletten 500
6. Contents of the pack and other information

1. What Vigantoletten 500 is and what it is used for

Vigantoletten 500 contains the active substance vitamin D (cholecalciferol), which is important for bone formation.
Vitamin D (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation, and may also be supplied to the body through diet.
In vitamin D deficiency, impaired bone mineralization occurs (rickets) or calcium loss from bones (osteomalacia).
Vigantoletten 500 is used for:

• prevention of rickets and osteomalacia in children and adults,
• prevention of disorders associated with risk of vitamin D deficiency in children and adults,
• prevention of vitamin D deficiency in children and adults,
• adjunctive treatment in osteoporosis in adults.

2. Information before using Vigantoletten 500

When not to use Vigantoletten 500

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in case of hypercalcaemia (excessively high calcium levels in the blood) or hypercalciuria (excessive excretion of calcium in urine),
• if the patient has kidney stones or severe renal insufficiency,
• in case of pseudohypoparathyroidism.

Warnings and precautions
Before starting to use Vigantoletten 500, consult a doctor or pharmacist,
as Vigantoletten 500 should be used under medical supervision:

• if the patient is also taking other medicines containing vitamin D, because additional doses of vitamin D should only be taken under medical supervision,
• if the patient has sarcoidosis (an immune system disorder that may increase vitamin D levels in the body),
• if the patient has impaired kidney function,
• if the patient is being treated with cardiac glycosides or diuretics,
• in newborns, infants and young children,
• if vitamin D treatment is long-term, as in such cases the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Other medicines and Vigantoletten 500
Inform your doctor or pharmacist about all medicines the patient is currently taking
or has recently taken, as well as any medicines the patient plans to take.
Antacids used to treat acidity and containing aluminium, when taken together with Vigantoletten 500,
may increase aluminium levels in the blood, increasing the risk of aluminium's toxic effects on bones.
Antacids containing magnesium, when used simultaneously with Vigantoletten 500,
may increase magnesium levels in the blood.
Certain antiepileptic, sedative or hypnotic drugs (containing phenytoin
or barbiturates), when used concurrently with Vigantoletten 500,
may reduce its effectiveness.
Some diuretics may lead to hypercalcaemia (elevated calcium levels) caused by reduced calcium excretion by the kidneys. During prolonged treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (synthetic corticosteroid hormones) may counteract the effect of Vigantoletten 500.
Vigantoletten 500 may enhance the action and toxicity of cardiac glycosides, increasing the risk of cardiac arrhythmias. In such cases, the doctor should monitor serum and urinary calcium levels and perform periodic ECG examinations.
Concurrent use of vitamin D metabolites or analogues (e.g. calcitriol) and Vigantoletten 500
is possible only on a doctor's prescription and only in exceptional cases, provided that serum calcium levels are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigantoletten 500.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy,
consult a doctor before using this medicine.

Pregnancy
Vigantoletten 500 may be used during pregnancy only on a doctor's advice.
Vitamin D overdose should be avoided during pregnancy, as it may lead to delayed physical and mental development, heart defects, and retinal disorders (retinopathy) in the child.

Breastfeeding
Consult a doctor before using this medicine.

Driving and operating machinery
Vigantoletten 500 has no influence on the ability to drive motor vehicles or operate machinery.

Vigantoletten 500 contains sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vigantoletten 500

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor.
Dosage
Children
One tablet per day (corresponding to 0.0125 mg or 500 IU of vitamin D).
Adults (including elderly people)
Two 500 IU tablets per day (corresponding to 0.025 mg or 1000 IU of vitamin D).
This medicinal product should not be used long-term or in doses higher than recommended without medical supervision.
Adjunctive treatment of osteoporosis in adults
Four tablets per day (corresponding to 0.050 mg or 2000 IU of vitamin D).
This medicinal product should not be used long-term, or at a dose of 2000 IU per day or higher, without medical supervision.
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 simultaneously.
Newborns, infants, and young children
Vigantoletten should only be used in newborns, infants, and young children under medical supervision. The recommended dose should not be exceeded.
Inform your doctor if the child is receiving food fortified with vitamin D.
Method of administration
Newborns, infants, and young children
The tablet should be dissolved in water on a teaspoon and the aqueous suspension administered directly into the child's mouth, preferably during a meal. Before administration, ensure that the tablet has completely dissolved.
It is not recommended to add the prepared aqueous suspension to the contents of a baby bottle (for newborns or infants) or to other food, as this cannot guarantee that the full dose of medicine is taken.
However, if Vigantoletten tablets must be given with food (liquid), the food (milk) must be boiled beforehand.
Adults
Take the tablet with a sufficient amount of liquid.
Use of a higher than recommended dose of Vigantoletten 500
If a higher than recommended dose of Vigantoletten 500 has been taken, contact your doctor. The doctor will decide on appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhoea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in blood), excessive thirst, polyuria, and dehydration. With high calcium levels in blood, disturbances in heart function, kidney failure, psychosis, and even coma may occur.
Laboratory findings include hypercalcemia (increased calcium concentration in blood), hypercalciuria (excessive excretion of calcium in urine), and increased serum concentration of 25-hydroxycholecalciferol. Overdose requires measures to control hypercalcemia, which may be prolonged and sometimes life-threatening.
Missed dose of Vigantoletten 500
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Gastrointestinal disorders such as constipation, bloating, nausea, abdominal pain or diarrhoea.
Hypersensitivity reactions such as itching, rash or urticaria.
Prolonged use of high doses may lead to hypercalcaemia (excess calcium in the blood) and hypercalciuria (excessive excretion of calcium in urine). In isolated cases, fatal outcomes have been reported.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Vigantoletten 500

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vigantoletten 500 contains

• The active substance is cholecalciferol (cholecalciferol, powder containing: cholecalciferol, D,L-α-tocopherol, medium-chain triglycerides, modified starch, sodium ascorbate, sucrose, anhydrous colloidal silica).
• Other ingredients are: mannitol, microcrystalline cellulose, anhydrous colloidal silica, maize starch, sodium carboxymethyl starch (type C), talc, magnesium stearate.

What Vigantoletten 500 looks like and contents of the pack
30 or 90 tablets
Al/PVC blisters in a cardboard box.
Marketing Authorisation Holder:
P&G Health Germany GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany
Manufacturer:
P&G Health Austria GmbH & CO. OG
Hösslgasse 20
9800 Spittal/Drau
Austria