Thorens 25,000units/2.5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colecalciferol

Available from:

Galen Ltd

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

10000unit/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5016298417326 5016298427332

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
THORENS 25 000 I.U. /2.5 ML ORAL SOLUTION
CHOLECALCIFEROL (VITAMIN D
3
)
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 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 or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What THORENS is and what it is used for
2.
What you need to know before you use THORENS
3.
How to use THORENS
4.
Possible side effects
5.
How to store THORENS
6.
Contents of the pack and other information
1.
WHAT THORENS IS AND WHAT IT IS USED FOR
THORENS oral solution contains cholecalciferol (vitamin D
3
). Vitamin D
3
, can be found in
some foods and is also produced by the body when skin is exposed to
sunlight. Vitamin D
3
helps
the
kidneys
and intestine
absorb
calcium
and
it helps
build
bones. Vitamin
D
3
deficiency is the predominant cause of rickets (defective
mineralization of bones in children)
and osteomalacia (inadequate mineralization of bones in adults).
THORENS oral solution is used:
•
to prevent rickets in children (defective mineralization of bones
predominantly due to
vitamin D
3
deficiency) and osteomalacia in adults (inadequate mineralization of
bones
predominantly due to vitamin D
3
deficiency).
•
to prevent rickets in preterm newborns.
•
to prevent vitamin D
3
deficiency in children and adults when a risk of deficiency is
identified.
•
to prevent vitamin D
3
deficiency in children and adults with problems in absorbing
food (malabsorption) defined by doctor.
•
to treat rickets in children and osteomalacia in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THO

Summary of Product characteristics

OBJECT 1
THORENS 25 000 I.U. /2.5 ML ORAL SOLUTION
Summary of Product Characteristics Updated 01-Sep-2015 | Galen Limited
1. Name of the medicinal product
THORENS 25 000 I.U. /2.5 ml oral solution
2. Qualitative and quantitative composition
A single-dose bottle of 2.5 ml oral solution contains: 25 000 I.U.
cholecalciferol (vitamin D
3
), equivalent
to 0.625 mg.
1 ml oral solution contains 10 000 I.U. cholecalciferol (vitamin D
3
), equivalent to 0.25 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution in single dose container
Clear and colourless to greenish-yellow oily solution without visible
solid particles and/or precipitate
4. Clinical particulars
4.1 Therapeutic indications
• Prophylaxis of rickets and osteomalacia in children and adults
• Prophylaxis of rickets in preterm newborns
• Prophylaxis of vitamin D deficiency in children and adults with an
identified risk
• Prophylaxis of vitamin D deficiency in children and adults with
malabsorption
• Treatment of rickets and osteomalacia in children and adults
4.2 Posology and method of administration
Posology
• Paediatric posology
- prevention of deficiency 0-1 years 25000 IU (1 bottle) every 8 weeks
- prevention of deficiency 1-18 years 25000 IU (1 bottle) every 6
weeks
- treatment of deficiency 0-18 years 25000 IU (1 bottle) once every 2
weeks for 6 weeks (followed by
maintenance therapy of 400-1000 IU/day)
• Pregnancy and breastfeeding
- The high strength formulation is not recommended
• Adult
- prevention of vitamin D
3
deficiency 25000 IU/month (1 bottle), higher doses may be required in
certain
situations, see below
- as an adjunct to specific therapy for osteoporosis: 25000 IU/month
(1 bottle)
- treatment of vitamin D
3
deficiency (<25 ng/ml) 50000 IU/week (2 bottles) for 6-8 weeks,
followed by
maintenance therapy (1400-2000 IU/day may be required; follow-up
25(OH)D measurements should be
made approximately three to four months after initiating maintenance
therapy to confirm that the target
level has