20,000 IU / ml oral drops, solution 
cholecalciferol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Detremin is and what it is used for 
2. What you need to know before you use Determine 
3. How to use Determine 
4. Possible side effects 
5. How to store Determine 
6. Contents of the packaging and other information 

1. What Detremin is and what it is used for

Determine contains cholecalciferol (vitamin D 3 ). It is used to treat vitamin D deficiency in, for example, the following conditions:

  • osteoporosis; then in combination with calcium and other treatment
  • secondary hyperparathyroidism (when low levels of calcium in the blood lead to excessive secretion of parathyroid hormones along with enlargement of the parathyroid gland).

Determine is also used to prevent and treat vitamin D deficiency in people who have difficulty absorbing vitamin D.

Cholecalciferol contained in Detremin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Determine

Do not use Determine

  • if you are allergic to vitamin D 3  or any of the other ingredients of this medicine (see section 6)
  • if you have hypercalcemia (too high levels of calcium in the blood)
  • if you have hypervitaminosis D (too high levels of vitamin D in your blood).

Do not take Detremin with calcium if you have severe kidney function.

Warnings and cautions

Do not take more Detremin than the dose prescribed by your doctor, as it may lead to overdose. When using Detremin, do not use other products that contain vitamin D at the same time, in addition to those prescribed by your doctor.

Tell your doctor, pharmacist, or nurse before taking Detremin:

  • if you have had kidney stones
  • if you have impaired kidney function
  • if you have sarcoidosis (an inflammatory connective tissue disease that mainly affects the lungs) or any other chronic disease that leads to inflammation of the connective tissue.

If you have increased levels of phosphate in your blood, your doctor may prescribe a drug that binds phosphate along with Detremin. Ask your doctor for advice.

Other medicines and Detremin

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

  • phenytoin (for epilepsy ), barbiturates (sleeping pills or sedatives)
  • rifampicin or isoniazid (for tuberculosis )
  • cardiac glycosides
  • diuretics type diuretics (such as hydrochlorothiazide and bendroflumethiazide, drugs for high blood pressure )
  • tablets containing aluminum (against heartburn)
  • other products containing vitamin D.
  • weight loss drugs (eg orlistat and cholestyramine).

Detremin with food and drink

Detremin can be taken independently of meals. To make it easier to take the drops, you can mix them with food or drink.

Pregnancy, breastfeeding, 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 vitamin D deficiency.

Detremin can be used during breast-feeding. Vitamin D and its breakdown products are transferred to breast milk. Contact your doctor or midwife if you have any questions about this.

There is no information on the effect of Detremin on fertility. However, normal levels of vitamin D are not expected to hurt fertility.

Driving and using machines

The effect on the ability to drive or use machines has not been studied. Detremin has no known side effects that are thought to affect the ability to drive or use machines.

3. How to use Detremin

Always use Detremin exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The dose you receive depends on why you are receiving Detremin and on the level of vitamin D in your blood. It is therefore important that you always take the dose that your doctor has prescribed for you, even if you know someone else who has been prescribed a much higher dose. The usual dose is between 1 drop and 5 drops daily or between 7 drops and 35 drops a week. If you have difficulty taking vitamin D, your doctor may prescribe a higher dose, up to 12 drops daily or 84 drops weekly. Follow your doctor’s instructions. 

Detremin can be taken independently of meals. Slowly turn the bottle straight up and down to allow air to enter the bottle. See the picture below:

Hold the bottle still, straight up and down.  It may take about 10 seconds for the first drop.  The subsequent drops come slightly faster.

It may take a few seconds for the first drop to come. The subsequent drops come slightly faster. Feel free to take the drops with the help of a spoon. Make sure you swallow the full dose one.

If you use Detremin for a long time, your doctor may want to take regular blood tests to check that the treatment is working as well as possible.

If you take more Detremin than you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Detremin

Skip the missed dose one and then take the following dose as usual. 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 observed after consuming products containing vitamin D 3 : too high levels of calcium in the blood and urine, constipation, flatulence, nausea, abdominal pain, diarrhea and hypersensitivity reactions such as itching , rash or hives .

5. How to store Detremin

  • Store the dropper bottle in the outer carton. Sensitive to light.
  • Keep out of sight and reach of children.
  • The contents of the bottle should be used within 6 months of first opening the bottle.
  • Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. respectively “EXP”. The expiration date is the last day of the specified month.
  • Do not use Detremin if you notice that the contents of the bottle are cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cholecalciferol (vitamin D 3 ). 1 ml of solution (approximately 25 drops) contains 0.5 mg of cholecalciferol, equivalent to 20,000 IU of vitamin D 3 .
  • 1 drop contains 20 micrograms of cholecalciferol, equivalent to 800 IU of vitamin 3.
  • The other ingredients are medium-chain triglycerides.

What the medicine looks like and the contents of the pack

Detremin is a clear, slightly yellowish, viscous solution. Each carton contains a brown glass bottle with a colorless drip insert and white screw cap. The bottle contains 3.6 ml solution (90 drops of 800 IU vitamin D 3 ) or 10 ml solution (250 drops of 800 IU vitamin D 3 ).

Marketing Authorization Holder and Manufacturer

Holder of approval for sale: 
Renapharma AB 
Riddargatan 16 
114 51 Stockholm 
Tel: 018 7001140 
e-mail: info@renapharma.se

Manufacturer

NextPharma SAS, 17 route de Meulan, 78520 Limay, France

This medicine is authorized in the European Economic Area under the names: 
Denmark, Finland, Norway: Detremin

Muhammad Nadeem

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