Document: Detremin oral drops, solution ENG PL change

• Detremin oral drops, solution PL
• Detremin oral drops, solution ENG PL

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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

6. Contents of the pack and other information

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.

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.

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:

It may take approximately 10 seconds to the first drop. The following drops will come slightly faster. The drops are preferably taken with a spoon. Make sure to ingest the entire dose.

If you take Detremin during a long time, your doctor may want to take blood samples regularly to ensure that the treatment is optimal for you.

If you take more Detremin than you should

If you have taken more Detremin than you should, tell your doctor. If you have taken a massive overdose you should seek medical help immediately; hospital treatment may be necessary.

If you forget to take Detremin

Leave out the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Detremin can cause side effects, although not everybody gets them.

The following symptoms have been seen after intake of products containing vitamin D₃: too high levels of calcium in the blood and urine, constipation, formation of gas, nausea, abdominal pain, diarrhoea and hypersensitivity reactions such as itching, rash or hives.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Detremin

• Keep the dropper container in the outer carton in order to protect from light.

• Keep this medicine out of the sight and reach of children.

• The content of the bottle should be used within 6 months after first opening.

• Do not use Detremin after the expiry date which is stated on the carton and the bottle, after EXP. The expiry date refers to the last day of that month.

• Do not use Detremin if you notice turbidity.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Detremin contains

• The active substance is cholecalciferol (vitamin D₃). One ml solution (approximately 40 drops) contains 0.5 mg cholecalciferol, equivalent to 20,000 I.U. vitamin D₃.

• The other ingredients are medium chain triglycerides (received from coconut oil and palm kernel oil).

What Detremin looks like and contents of the pack

Detremin is a clear, weakly yellowish, viscous solution. Each box contains one dropper container of brown glass with 10 ml solution, a colourless or white dropper and a white screw cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Renapharma AB

Kungsängsvägen 21B

SE-753 23 Uppsala, Sweden

Tel: +46 18 7001140

e-mail: info@renapharma.se

Manufacturer:

Merck KGaA, Darmstadt, Germany

or

NextPharma SAS, Limay, France

This medicinal product is authorized in the Member States of the EEA under the following names:

Denmark, Finland, Norway, Sweden: Detremin

This leaflet was last approved in 08/2016