Fultium-D3 20,000unit capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colecalciferol

Available from:

Internis Pharmaceuticals Ltd

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

20000unit

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5060222940336 5060222940282

Patient Information leaflet

13307
13307
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
15's/30's
25455802
210 x 297mm
1
14.11.2017
Fultium D3 20,000IU Capsules Internis
(Swisscaps)
N/A
K
EBR
904367
14455
Amend storage conditions and
update Yellow Card Statement
Rockwell
Helvetica
8pt
8pt
12pt
8pt
Process Black + 60% tint
Keyline (Non-Printing)
POINT SIZES USED
MIN MAX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
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.
DO NOT PASS IT ON TO OTHERS. It may harm them,
even if their symptoms are the same as yours.
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
FULTIUM-D
3 20,000 IU CAPSULES
(COLECALCIFEROL)
LAXATIVES (such as paraffin oil) or a cholesterol
lowering drug called COLESTYRAMINE may reduce
the absorption of vitamin D.
ACTINOMYCIN (a medicine used to treat some forms
of cancer) and IMIDAZOLE ANTIFUNGALS (medicines
such as clotrimazole and ketoconazole used to treat
fungal diseases) as they may interfere with the
metabolism of vitamin D.
TAKING FULTIUM-D
3 WITH FOOD AND DRINK
You can take Fultium-D
3
with or without food and
drink.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or think you may be pregnant or
you are breast-feeding you should talk to your doctor
or pharmacist before you take Fultium-D
3
.
Due to their high strength, Fultium-D
3
20,000 IU
capsules are not recommended during pregnancy
and breast-feeding.
DRIVING AND USING MACHINES
Fultium-D
3
should not affect your ability to drive or
operate machinery.
Always take Fultium-D
3
exactly as your doctor has
told you.
DOSE
USE IN CHILDREN AND ADOLESCENTS
The recommended

Summary of Product characteristics

OBJECT 1
FULTIUM-D3 20,000IU CAPSULES
Summary of Product Characteristics Updated 15-Jan-2018 | Internis
Pharmaceuticals Ltd
1. Name of the medicinal product
Fultium-D
3
20,000 IU Capsules
2. Qualitative and quantitative composition
Each capsule contains:
20,000 IU Colecalciferol (equivalent to 500 micrograms vitamin D3)
For a full list of excipients see section 6.1
3. Pharmaceutical form
Capsule, soft (Capsule)
Yellow coloured translucent soft gelatin capsule
4. Clinical particulars
4.1 Therapeutic indications
The treatment and prevention of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency.
Fultium-D
3
20,000 IU Capsules are indicated for use in adults, the elderly and
adolescents.
4.2 Posology and method of administration
Posology
_Paediatric population_
- Prevention of vitamin D deficiency 12-18 years: 20,000 IU (1
capsule) every 6 weeks
- Treatment of vitamin D deficiency 12-18 years: 20 000 IU (1 capsule)
once every 2 weeks for 6 weeks
_Adults_:
- Prevention of vitamin D deficiency: 20,000 IU/month (1 capsule),
higher doses may be required in
certain situations, see below
- Treatment of vitamin D deficiency: 40,000 IU/week (2 capsules) for 7
weeks, followed by maintenance
therapy (equivalent to 1,400-2,000 IU/day, such as 2-3 capsules per
month, 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 been achieved)
Certain populations are at high risk of vitamin D deficiency, and may
require higher doses and monitoring
of serum 25(OH)D:
- Institutionalised or hospitalised individuals
- Dark skinned individuals
- Individuals with limited effective sun exposure due to protective
clothing or consistent use of sun
screens
- Obese individuals
- Patients being evaluated for osteoporosis
- Use of certain concomitant medications (e.g., anticonvulsant
medications, glucocorticoids)
- Patients with malabsorption, including inflammatory bowel dis