Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Consilient Health Ltd
A11CC05
Colecalciferol
2400unit/1ml
Oral drops
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5391512452056
Read all of this leaflet carefully before you start using 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, or nurse. • This medicine has been prescribed for you only. Do not pass it onto 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, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What InVita D3 is and what it is used for 2. What you need to know before you use InVita D3 3. How to use InVita D3 4. Possible side effects 5. How to store InVita D3 6. Contents of the pack and other information 1. WHAT INVITA D3 IS AND WHAT IT IS USED FOR InVita D3 oral drops contain cholecalciferol (vitamin D). Vitamin D can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb calcium and it helps build bones. InVita D3 oral drops are used: • to prevent vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D • with other medicines to treat certain bone conditions, such as thinning of the bone (osteoporosis) • to treat vitamin D deficiency that has been confirmed by laboratory tests. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INVITA D3 Do not use InVita D3 • if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6) • if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) • if you have kidney stones (renal calculi) • if you have high levels of vitamin D in your blood (hypervitaminosis D). Warnings and precautions Talk to your doctor, pharmacist or nurse before using InVita D3 if you: • are undergoing treatment with certain medicines used to treat heart disorders (e.g., cardiac glycosides, such as Read the complete document
OBJECT 1 INVITA D3 2,400 IU/ML ORAL DROPS, SOLUTION Summary of Product Characteristics Updated 17-Jun-2015 | Consilient Health Ltd 1. Name of the medicinal product InVita D3 2,400 IU/ml oral drops, solution 2. Qualitative and quantitative composition 1 ml solution (36 drops) contains 0.06 mg cholecalciferol, equivalent to 2,400 IU vitamin D3. 1 drop contains 1.67 microgram cholecalciferol, equivalent to 67 IU vitamin D3. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Clear, slightly yellow, oily liquid with an orange odour 4. Clinical particulars 4.1 Therapeutic indications - Prevention of vitamin D deficiency in infants and children - Prevention of vitamin D deficiency in pregnant and breast-feeding women 4.2 Posology and method of administration Posology 1 drop contains 67 IU vitamin D3. Paediatric posology - prevention of deficiency 0-1 years 400 IU/day (6 drops) - prevention of deficiency 1-18 years 600 IU/day (9 drops) Pregnancy and breast-feeding posology - prevention of deficiency 400 IU/day (6 drops) Special populations - patients with renal impairment: no specific adjustment is required - Other conditions: in obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D metabolism, higher doses are required for the treatment and prevention of vitamin D deficiency (2 - 3 times higher). Method of administration Patients should be advised to take InVita D3 preferably with a meal (see section 5.2 Pharmacokinetic properties - Absorption). The product should be shaken before use. InVita D3 can be taken as is or to facilitate the intake it can also be mixed with a spoonful or a small amount of cold or lukewarm food immediately prior to use. The patient should be sure to take the entire dose. In children, InVita D3 can be mixed with a small amount of children's foods, yogurt, milk, cheese or other dairy products. The parents should be warned not to mix InVita D3 into a bottle of milk or container of soft foods in case the child does no Read the complete document