Detremin

Document: Detremin oral drops, solution ENG PL change

Package leaflet: Information for the user

Detremin 20,000 I.U./ml oral drops, solution

Cholecalciferol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Detremin is and what it is used for

2. What you need to know before you take Detremin

3. How to take Detremin

4. Possible side effects

How to store Detremin

6. Contents of the pack and other information

What Detremin is and what it is used for

Detremin contains cholecalciferol (vitamin D₃). It is used to treat vitamin D deficiency or insufficiency, for example in the following conditions:

rickets in infants and children
bone fragility, together with calcium and possibly also other treatment
secondary hyperparathyroidism (when low blood calcium levels lead to excessive secretion of parathyroid hormone, combined with enlargement of the parathyroid gland).

Detremin is also used as prophylaxis and treatment of vitamin D deficiency in persons with difficulties to absorb vitamin D and in persons with increased risk of fractures, e.g. elderly patients and patients treated with glucocorticoids.

What you need to know before you take Detremin

Do not take Detremin

- if you are allergic (hypersensitive) to vitamin D₃ or any of the other ingredients of Detremin (see Section 6 What Detremin contains)

- if you have hypercalcemia (too high levels of calcium in the blood)

- if you have hypervitaminosis D (too high levels of vitamin D in the blood).

Do not take Detremin together with calcium if you have severely impaired renal function.

Warnings and precautions

Do not take more Detremin than your doctor has prescribed, since overdosage may occur. Do not at the same time take other vitamin D containing products other than your doctor has prescribed.

Tell your doctor

if you have had kidney stones
if you have impaired renal function
if you have sarcoidosis (an illness with the formation of inflammatory nodules, mostly affecting the lungs) or other chronic inflammation leading to the formation of nodules.

If you have increased phosphate concentration in the blood, your doctor may prescribe a phosphate binder together with Detremin. Ask your doctor for advice.

Other medicines and Detremin

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if your are taking:

Phenytoin (against epilepsy), barbiturates (sleeping-pills or tranquillizers)
Rifampicin or isoniazid (against tuberculosis)
Cardiac glycosides
Thiazide diuretics (e.g. hydrochlorthiazide and bendroflumethiazide, medicines against high blood pressure)
Aluminium-containing pills (against heartburn)
Other vitamin D containing products
Drugs for weight reduction (e.g. orlistat and cholestyramin).

Detremin with food and drink

You should preferably take Detremin together with the major meal of the day. You can also mix the drops with food or drink to facilitate intake.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Detremin can be used during pregnancy, in case of a vitamin D deficiency.

Detremin can be used during breast-feeding. Vitamin D and its metabolites pass into breast milk. Ask your doctor or midwife if you have any questions regarding this. Overdose in infants induced by nursing has not been observed.

There are no data on the effect of Detremin on fertility. However, normal levels of vitamin D are not expected to have any adverse effects on fertility.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Detremin has no known side effects which are likely to affect the ability to drive and use machines.

How to take Detremin

Always take Detremin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose depends on the condition for which you get Detremin and your level of vitamin D in the blood. Therefore, always take the dose that has been prescribed individually for you, even if you know someone else who has been prescribed a much higher dose. The usual dose is between 1 drop and 20 drops daily or between 5 drops and 3.5 ml weekly.

You should preferably take Detremin together with the major meal of the day. Hold the bottle still and straight upside down, see the figure below: