Fultium-D3 3,200unit 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:

3200unit

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5060222940268 5060222940329

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
25450703
210 x 297mm
1
14.11.2017
Fultium D3 3,200IU Capsules Internis
(Swisscaps)
Yes
H
EBR
904467
14455
Amend storage conditions and
update Yellow Card Statement
Helvetica
Rockwell
8pt
8pt
8pt
12pt
Process Black + 60% tint
Keyline (Non-Printing)
POINT SIZES USED
MIN MAX
13313
13313
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 3,200 IU CAPSULES
(COLECALCIFEROL)
GLUCOCORTICOIDS (steroid hormones such as
hydrocortisone or prednisolone). These can
decrease the effect of vitamin D
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
. Fultium-D
3
should be used during pregnancy and breast-feeding
only if recommended by your doctor.
DRIVING AND USING MACHINES
Fultium-D
3
should not affect your ability to drive or
operate machinery.
Always take Ful

Summary of Product characteristics

OBJECT 1
FULTIUM-D3 3,200IU CAPSULES
Summary of Product Characteristics Updated 15-Jan-2018 | Internis
Pharmaceuticals Ltd
1. Name of the medicinal product
Fultium-D
3
3,200 IU Capsules
2. Qualitative and quantitative composition
Each capsule contains:
3,200 IU Colecalciferol (equivalent to 80 micrograms vitamin D3)
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Capsule, soft (Capsule)
Green coloured translucent soft gelatin capsule
4. Clinical particulars
4.1 Therapeutic indications
The treatment of vitamin D deficiency.
Fultium-D
3
is indicated in adolescents, adults and the elderly.
4.2 Posology and method of administration
Posology
Vitamin D deficiency in adolescents, adults and the elderly (serum
levels <25 nmol/l (<10 ng/ml))
1 capsule (3,200 IU) daily for up to 12 weeks dependent upon the
severity of the disease and the patient's
response to treatment.
During pregnancy and breast-feeding
Treatment of vitamin D deficiency
1 capsule (3,200 IU) daily.
Fultium-D3 should not be used in children under the age of 12.
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 or conditions resulting in hypercalcaemia and/or
hypercalciuria
Severe renal impairment
4.4 Special warnings and precautions for use
Vitamin D should be used with caution in patients with impairment of
renal function and the effect on
calcium and phosphate levels should be monitored. The risk of soft
tissue calcification should be taken
into account. In patients with severe renal insufficiency, vitamin D
in the form of colecalciferol is not
metabolised normally and other forms of vitamin D should be used (see
section 4.3, contraindications).
Caution is required in patients receiving treatment for cardiovascular
disease (see Section 4.5 – cardiac
glycosides including digitalis).
Fultium-D3 should be prescribed with caution to patients suffering
from sa