VITAGAMMA

VITAGAMMA Vitamin D3 1.000 I.E. Tabletten

Important notes (mandatory information)

Vitagamma Vitamin D3 1000 I.U. Tablets. Active ingredient: Colecalciferol dry concentrate. Areas of application: for the prevention of rickets, for the prevention of a recognisable risk of vitamin D deficiency in otherwise healthy individuals without absorption disorders (disorders of vitamin D absorption in the intestine), for the supportive treatment of osteoporosis and for the prevention of rickets in premature babies.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitagamma Vitamin D3 1000 I.U. Tablets
Active ingredient: Colecalciferol dry concentrate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

This package leaflet contains

1. WHAT ARE VITAGAMMA VITAMIN D3 1000 I.U. TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAGAMMA VITAMIN D3 1000 I.U. TABLETS?
3. HOW SHOULD VITAGAMMA VITAMIN D3 1000 I.U. TABLETS BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VITAGAMMA VITAMIN D3 1000 I.U. TABLETS BE STORED?
6. CONTENTS OF THE PACK AND FURTHER INFORMATION

1. WHAT ARE VITAGAMMA VITAMIN D3 1000 I.U. TABLETS AND WHAT ARE THEY USED FOR?

Vitagamma Vitamin D3 1000 I.U. Tablets is a vitamin supplement.

Areas of application:

• For the prevention of rickets.
• For the prevention of a recognisable risk of vitamin D deficiency in otherwise healthy individuals without absorption disorders (disorders of vitamin D absorption in the intestine).
• For the supportive treatment of osteoporosis.
• For the prevention of rickets in premature babies.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAGAMMA VITAMIN D3 1000 I.U. TABLETS?

Vitagamma Vitamin D3 1000 I.U. Tablets must not be taken:

• if you are allergic to colecalciferol, soya, peanuts or any of the other ingredients of this medicine listed in section 6.
• in the case of hypercalcaemia (elevated calcium concentration in the blood) and/or hypercalciuria (elevated calcium concentration in the urine).

Vitagamma Vitamin D3 1000 I.U. Tablets should not be taken in the case of pseudohypoparathyroidism (disorder of parathyroid hormone balance), as the vitamin D requirement may be reduced due to the intermittently normal vitamin D sensitivity, with the risk of long-term overdosing. More easily controllable active ingredients with vitamin D activity are available for this purpose.

Warnings and precautions:

• in the case of a tendency to form calcium-containing kidney stones.
• in patients with impaired excretion of calcium and phosphate via the kidneys, when treated with benzothiadiazine derivatives (medicines to promote urine excretion) and in immobilised patients (risk of hypercalcaemia (elevated calcium concentration in the blood) and hypercalciuria (elevated calcium concentration in the urine)). In these patients, the calcium levels in the blood and urine should be monitored.
• in patients suffering from sarcoidosis, as there is a risk of increased conversion of vitamin D into its active form. In these patients, the calcium levels in the blood and urine should be monitored.

If other vitamin D-containing medicines are prescribed, the dose of vitamin D from Vitagamma Vitamin D3 1000 I.U. Tablets must be taken into account. Additional administration of vitamin D or calcium should only take place under medical supervision. In such cases, the calcium levels in the blood and urine must be monitored (see above). In patients with impaired kidney function who are treated with Vitagamma Vitamin D3 1000 I.U. Tablets, the effect on calcium and phosphate balance should be monitored.

Daily doses over 500 I.U./d

During long-term treatment with Vitagamma Vitamin D3 1000 I.U. Tablets, the calcium levels in the blood and urine should be monitored regularly and kidney function should be checked by measuring serum creatinine. This check is particularly important in elderly patients and when treated at the same time with cardiac glycosides (medicines to promote the function of the heart muscle) or diuretics (medicines to promote urine excretion). In the case of hypercalcaemia (elevated calcium concentration in the blood) or signs of impaired kidney function, the dose must be reduced or the treatment interrupted. It is advisable to reduce the dose or interrupt the treatment if the calcium content in the urine exceeds 7.5 mmol/ 24 hours (300 mg/24 hours). Please talk to your doctor or pharmacist before taking Vitagamma Vitamin D3 1000 I.U. Tablets.

Taking Vitagamma Vitamin D3 1000 I.U. Tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Which other medicines affect the effect of Vitagamma Vitamin D3 1000 I.U. Tablets?
Phenytoin (medicine to treat epilepsy) or barbiturates (medicines to treat epilepsy and sleep disorders as well as for anaesthesia) can impair the effect of vitamin D. Thiazide diuretics (medicines to promote urine excretion) can lead to hypercalcaemia (elevated calcium concentration in the blood) by reducing calcium excretion via the kidneys. The calcium levels in the blood and urine should therefore be monitored during long-term treatment. The simultaneous administration of glucocorticoids (medicines to treat certain allergic diseases) can impair the effect of vitamin D.

How do Vitagamma Vitamin D3 1000 I.U. Tablets affect the effect of other medicines?
The risk of an adverse effect when taking cardiac glycosides (medicines to promote the function of the heart muscle) can increase as a result of an increase in the calcium levels in the blood during treatment with vitamin D (risk of cardiac arrhythmias). Patients should be monitored with regard to ECG and calcium levels in the blood and urine.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Daily doses up to 500 I.U./d

No risks are known in the specified dose range to date. Long-lasting overdosing of vitamin D must be prevented during pregnancy, as the resulting hypercalcaemia (elevated calcium concentration in the blood) can lead to physical and mental disability as well as congenital heart and eye diseases in the child.

Daily doses over 500 I.U./d

During pregnancy, Vitagamma Vitamin D3 1000 I.U. Tablets should only be taken after strict indication and only dosed as is absolutely necessary to remedy the deficiency. Overdosing of vitamin D during pregnancy must be prevented, as long-lasting hypercalcaemia (elevated calcium concentration in the blood) can lead to physical and mental disability as well as congenital heart and eye diseases in the child.

Vitamin D and its metabolites pass into breast milk. Overdosing in the infant has not been observed in this way.

Driving and operating machinery

There is no indication that Vitagamma Vitamin D3 1000 I.U. Tablets have an effect on the ability to drive and concentrate.

Vitagamma Vitamin D3 1000 I.U. Tablets contain sucrose

Please only take Vitagamma Vitamin D3 1000 I.U. Tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD VITAGAMMA VITAMIN D3 1000 I.U. TABLETS BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• For the prevention of rickets, V4 tablet Vitagamma Vitamin D3 1000 I.U. daily (corresponding to 0.0125 mg or 500 I.U. vitamin D3).
• For the prevention of a recognisable risk of vitamin D deficiency in otherwise healthy individuals without absorption disorders, V2 tablet Vitagamma Vitamin D3 1000 I.U. daily (corresponding to 0.0125 mg or 500 I.U. vitamin D3)
• For the supportive treatment of osteoporosis, 1 tablet Vitagamma Vitamin D3 1000 I.U. daily (corresponding to 0.025 mg or 1000 I.U. vitamin D3).
• For the prevention of rickets in premature babies, 1 tablet Vitagamma Vitamin D3 1000 I.U. daily (corresponding to 0.025 mg or 1000 I.U. vitamin D3) is recommended.

Method of administration

The tablet can be divided into equal doses.

Infants and toddlers

Vitagamma Vitamin D3 1000 I.U. Tablets should be used with particular caution in infants and toddlers, as they may not be able to swallow the tablets and could choke. It is recommended to crush the tablets as directed and mix them with water or use drops or emulsions instead. Divide the tablet into the smallest possible pieces, crush it as finely as possible with the back of a spoon and mix it with a little water on a teaspoon. This creates a suspension (mixture of parts of the tablet and water). This is best given to the child directly into the mouth during a meal. Adding the suspended tablet to a bottle or food meal for infants is not recommended, as complete intake cannot be guaranteed in this way. If the tablets are nevertheless to be administered in food, they should only be added after boiling. When using fortified food, the vitamin D content it contains must be taken into account.

Adults

Take the tablets with sufficient liquid.

Duration of use

Please ask your doctor about the necessary duration of use!

Please talk to your doctor or pharmacist if you have the impression that the effect of Vitagamma Vitamin D3 1000 I.U. Tablets is too strong or too weak.

If you have taken more Vitagamma Vitamin D3 1000 I.U. Tablets than you should

Symptoms of overdosing

Daily doses up to 500 I.U./d

Long-term overdosing of vitamin D can lead to hypercalcaemia (elevated calcium concentration in the blood) and hypercalciuria (elevated calcium concentration in the urine). In the case of significant and long-lasting exceeding of the requirement, calcification of organs can occur.

Daily doses over 500 I.U./d

Ergocalciferol (vitamin D2) and colecalciferol (vitamin D3) only have a relatively narrow therapeutic range. In adults with normal function of the parathyroid glands, the threshold for vitamin D intoxication is between 40,000 and 100,000 I.U. per day over 1 to 2 months. Infants and toddlers can react sensitively to much lower doses. Therefore, warning is given against the intake of vitamin D without medical supervision.

In the case of overdosing, in addition to an increase in phosphorus in the blood and urine, hypercalcaemia syndrome (elevated calcium concentration in the blood) occurs, later also due to this, calcium deposition in the tissues and above all in the kidneys (kidney stones and kidney calcification) and the vessels. The symptoms of intoxication are not very characteristic and manifest themselves in nausea, vomiting, initially often diarrhoea, later constipation, loss of appetite, fatigue, headaches, muscle and joint pain, muscle weakness as well as persistent drowsiness, azotaemia (elevated nitrogen concentration in the blood), increased thirst and increased urge to urinate and in the final phase dehydration. Typical laboratory findings are hypercalcaemia (elevated calcium concentration in the blood), hypercalciuria (elevated calcium concentration in the urine) as well as elevated serum levels for 25-hydroxycalciferol.

Therapeutic measures in the case of overdosing

As a first measure, the vitamin D preparation must be discontinued; normalisation of hypercalcaemia (elevated calcium concentration in the blood) as a result of vitamin D intoxication takes several weeks. Graduated according to the extent of hypercalcaemia (elevated calcium concentration in the blood), a low-calcium or calcium-free diet, ample fluid intake, increased urine excretion using the medicine furosemide as well as the administration of glucocorticoids (medicines to treat certain allergic diseases) and calcitonin (hormone to regulate calcium concentration in the blood) can be used. With sufficient kidney function, infusions with isotonic saline solution (3 - 6 l in 24 hrs.) with the addition of furosemide (medicine to increase urine excretion) as well as possibly also 15 mg/kg KG/hr. sodium edetate (medicine that binds calcium in the blood) under continuous calcium and ECG monitoring have a fairly reliable calcium-lowering effect. In the case of reduced urine excretion, on the other hand, haemodialysis treatment (blood washing) with a calcium-free dialysate is indicated. A specific antidote does not exist.

Daily doses up to 500 I.U./d

Symptoms of chronic overdosing of vitamin D can make an increase in urine excretion as well as the administration of glucocorticoids (medicines to treat certain allergic diseases) or calcitonin (hormone to regulate calcium concentration in the blood) necessary.

Daily doses over 500 I.U./d

In the case of overdosing, measures are necessary to treat the often long-lasting and potentially life-threatening hypercalcaemia (elevated calcium concentration in the blood). Please ask your doctor about the symptoms of an overdosing of vitamin D.

If you forget to take Vitagamma Vitamin D3 1000 I.U. Tablets

Do not take double the dose if you have forgotten the previous dose.

If you stop taking Vitagamma Vitamin D3 1000 I.U. Tablets

If you interrupt or prematurely discontinue treatment, your symptoms may worsen or recur. Please ask your doctor about this!

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Vitagamma Vitamin D3 1000 I.U. Tablets can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

The side effects arise as a result of overdosing. Depending on the dose and duration of treatment, severe and long-lasting hypercalcaemia (elevated calcium concentration in the blood) with its acute (cardiac arrhythmias, nausea, vomiting, psychological symptoms, disorders of consciousness) and chronic (increased urge to urinate, increased thirst, loss of appetite, weight loss, kidney stone formation, kidney calc