Fultium-D3 800unit 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:

800unit

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5060222940206 5060222940251

Patient Information leaflet

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
30's/90's
25465502
210 x 297mm
1
14.11.2017
Fultium D3 800IU Capsules Internis
Swisscaps
Yes
E
EBR
904371
14455
Amend storage conditions and
update Yellow Card Statement
Rockwell
Helvetica
10pt
8pt
11pt
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.
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
.
Fultium-D
3
should be used during pregnancy and
breast-feeding only if recommended by your doctor.
25465502
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
30's/90's
25465502
210 x 297mm
1
14.11.2017
Fultium D3 800IU Capsules Internis
Swisscaps
Yes
E
EBR
904371
14455
Amend storage conditions and
update Yellow Card Statement
Rockwell
Helvetica
10pt
8pt
11pt
8pt
Process Black + 60% tint
Keyline (Non-Printing)
POINT SIZES USED
MIN MAX
USE IN PREGNANCY AND BREAST-FEEDING
TO TREAT VITAMIN D DEFICIENCY: Your doctor will
usually prescribe 1 - 5 capsules daily for up to 12
weeks, followed by a long term maintenance dose.
LONG TERM MAINTENANCE AND TO PREVENT VITAMIN D
DEFICIENCY: Your

Summary of Product characteristics

OBJECT 1
FULTIUM-D3 800IU CAPSULES
Summary of Product Characteristics Updated 15-Jan-2018 | Internis
Pharmaceuticals Ltd
1. Name of the medicinal product
Fultium-D
3
800 IU Capsules
2. Qualitative and quantitative composition
Each capsule contains:
800IU Colecalciferol (equivalent to 20 micrograms vitamin D3)
For a full list of excipients see section 6.1
3. Pharmaceutical form
Capsule, soft (Capsule)
Blue translucent Capsule
4. Clinical particulars
4.1 Therapeutic indications
The prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of
vitamin D insufficiency.
Fultium-D
3
is indicated in adults, the elderly and adolescents.
4.2 Posology and method of administration
Posology
Vitamin D deficiency in adults and the elderly (serum levels <25
nmol/l (<10 ng/ml))
1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the
severity of the disease and the
patient's response to treatment.
Vitamin D insufficiency in adults and the elderly (serum levels 25 –
50 nmol/l (10-20 ng/mL))
AND
long term maintenance therapy following treatment of deficiency in
adults and the elderly
AND
Prevention of vitamin D deficiency
1-2 Capsules (800-1600 IU) daily
Vitamin D deficiency or insufficiency in children over 12 years – 1
capsule daily depending on the
severity of the disease and the patient's response to treatment.
Should only be given under medical
supervision.
As an adjunct to specific therapy for osteoporosis
1 capsule daily
During pregnancy and breast-feeding
Treatment of vitamin D deficiency
1 – 5 capsules (800 – 4000 IU) daily.
Long term maintenance therapy following treatment of deficiency
1 – 2 capsules (800 – 1600 IU) daily.
Fultium-D3 should not be used in children under 12 years
Method of administration
Oral
The capsules should be swallowed whole (not chewed) with water
4.3 Contraindications
Hypersensitivity to vitamin D or any of the excipients in the product
Hypervitaminosis D
Nephrolithiasis
Diseases o