Patient leaflet - Deltius 50 000 I.U./2 5 ml oral solution
1. What DELTIUS is and what it is used for
DELTIUS oral solution contains the active ingredient colecalciferol (vitamin D3). Vitamin D3, can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones. Vitamin D3 deficiency is the predominant cause of rickets (defective mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).
DELTIUS oral solution is used for initial treatment of clinically relevant vitamin D deficiency in adults.
2. What you need to know before you use DELTIUS
Do not use DELTIUS:
- if you are allergic to vitamin D3 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) or severe renal impairment;
- if you have high levels of vitamin D3 in your blood (hypervitaminosis D)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DELTIUS if you:
- are undergoing treatment with certain medicines used to treat heart disorders (eg, cardiac glycosides, such as digoxin);
- have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D3 in the body);are treated with diuretics (e.g. benzothiadiazine)
- are immobilized
- suffer from pseudohypoparathyreoidism
- are taking medicines containing vitamin D3, or eating foods or milk enriched with vitamin D3;
- are likely to be exposed to a lot of sunshine whilst using DELTIUS;
- take additional supplements containing calcium. Your doctor will monitor your blood levels of calcium to make sure they are not too high whilst you are using DELTIUS;
- have kidney damage or disease and if you have a tendency for the formation of renal stones . Your doctor may want to measure the levels of calcium in your blood or urine.
- take a daily dose of vitamin D3 exceeding 1,000 I.U. over a long period of time, your doctor should monitor the level of calcium in your blood by lab test.
Children and Adolescents
The use is not recommended in children and adolescents under 18 years of age.
Other medicines and DELTIUS
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important if you are taking:
- medicines that act on the heart or kidneys, such as cardiac glycosides (eg, digoxin) or diuretics (eg, bendroflumethiazide). When used at the same time as vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine;
- medicines containing vitamin D3 or eating food rich in vitamin D3, such as, some types of vitamin D3-enriched milk;
- actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (eg, clotrimazole and ketoconazole, medicines used to treat fungal disease). These medicines may interfere with the way your body process vitamin D3;
- medicines to treat tuberculosis e.g. rifampicin, isoniazid;
the following medicines because they can interfere with the effect or the absorption of vitamin D3:
- antiepileptic medicines (anticonvulsants), barbiturates;
- glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D3;
- medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol);
- certain medicines for weight loss that reduce the amount of fat your body absorbs (eg, orlistat);
- certain laxatives (such as liquid paraffin).
DELTIUS with food, drink and alcohol
You should take this medicine preferably together with a meal to help your body absorb the vitamin D3. You can also mix the solution with cold or lukewarm food, to help you take this medicine. For detailed information see section 3 “How to use DELTIUS ”.
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.
This high strength formulation is not recommended for use in pregnant and breastfeeding women.
Driving and using machines
There is limited information on the possible effects of this medicine on your ability to drive. However, it is not expected that it would affect your ability to drive or to operate machinery.
3. How to use DELTIUS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Shake before use.
You should take DELTIUS preferably together with a meal.
This medicine has a taste of olive oil. It can be taken on its own from the bottle or to help you take the medicine you can also mix the solution with a small amount of cold or lukewarm food immediately before use. Make sure the entire dose is taken.
Use in adults
The recommended dose is one bottle 25.000 IU/week during the first month. After first month, lower doses may be considered.
Higher doses may be required:
- 50.000 IU/week for 6 – 8 weeks.
This initial treatment may be followed by maintenance therapy, as directed by your doctor.
Your doctor will adjust the dose for you.
Paediatric population
DELTIUS 50.000 I.U. is not recommended in children and adolescents under 18 years of age.
Pregnancy and breastfeeding
DELTIUS 50.000 I.U. is not recommended.
If you take more DELTIUS than you should
If you take more medicine than prescribed, stop using this medicine and contact your doctor. If it is not possible to talk to a doctor go to the nearest hospital emergency department and take the medicine package with you.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the production of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in the blood and in urine (hypercalcaemia and hypercalciuria) shown by lab test.
If you forget to take DELTIUS
If you forget to take a dose of DELTIUS, take the forgotten dose as soon as possible. Then take the next dose at the correct time. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects may include:
Uncommon (affects less than 1 in 100 people)
- Too much calcium in your blood (hypercalcaemia)
- Too much calcium in your urine (hypercalciuria)
Rare (affects less than 1 in 1000 people)
- Skin rash
- Itching
- Hives
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store DELTIUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25° C.
Do not freeze or refrigerate.
Keep the bottle in the outer carton in order to protect from light.
Do not use this medicine if you notice the solution is cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What DELTIUS contains
The active substance is colecalciferol (vitamin D3).
One single-dose bottle contains 1.25 mg colecalciferol (vitamin D3) equivalent to 50 000 I.U.
The other ingredient is refined olive oil.
What DELTIUS looks like and contents of pack
DELTIUS 50 000 I.U. oral solution, is a clear and colourless to greenish-yellow oily solution. It is supplied in an amber glass bottle sealed with a tamper evident plastic cap.
Each pack contains 1, 2 or 4 single dose bottles containing 2.5 ml solution.
Not all pack sizes may be marketed.
Marketing authorisation holder
Galen Limited
Seagoe Industrial Estate
Craigavon
Northern Ireland
BT63 5UA
UK
Manufacturer
Abiogen Pharma S.p.A.
Via Meucci, 36 – Pisa (Italy)
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: DELTIUS 50.000 IU oral solution
France: DELTIUS 50.000 IU oral solution
Portugal: DELTIUS 50.000 IU oral solution
Spain: DELTIUS 50.000 IU oral solution
Cyprus: DELTIUS 50.000 IU oral solution
Greece: DELTIUS 50.000 IU oral solution
This leaflet was last revised in June 2020
Other sources of information
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.