Solferol 400 IU Soft Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Windzor Pharma Ireland Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Colecalciferol

Dosage:

400 international unit(s)

Pharmaceutical form:

Capsule, soft

Therapeutic area:

Vitamin D and analogues; colecalciferol

Authorization status:

Marketed

Authorization date:

2017-10-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLFEROL 800 IU SOFT CAPSULES
SOLFEROL 1,000 IU SOFT CAPSULES
SOLFEROL 10,000 IU SOFT CAPSULES
COLECALCIFEROL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
− 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.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Solferol Capsules are and what they are used for
2. What you need to know before you take Solferol Capsules
3. How to take Solferol Capsules
4. Possible side effects
5. How to store Solferol Capsules
6. Contents of the pack and other information
1. WHAT SOLFEROL CAPSULES ARE
AND WHAT THEY ARE USED FOR
The active substance of Solferol Capsules is vitamin D
3
. Vitamin D
helps the body to absorb calcium and enhances bone formation.
This medicine is recommended in the following cases:
• For certain bone conditions, such as thinning of the bone
(osteoporosis), when it will be given to you with other
medicines.
• To prevent or treat vitamin D deficiency. Vitamin D deficiency
may occur when your diet or lifestyle does not provide you
enough vitamin D or when your body requires more vitamin D.
Solferol Capsules are used in adults, the elderly and adolescents.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SOLFEROL CAPSULES
DO NOT TAKE SOLFEROL CAPSULES:
• if you are allergic to vitamin D 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 severe kidney problems (severe renal impairment)
• if you have high levels of vitamin D in your blood
(hypervitaminosis D)
• if y

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2022
CRN00D4CK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solferol 400 IU Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
400 IU Colecalciferol (equivalent to 10 micrograms Vitamin D
3
)
Excipients with known effect:
Each capsule also contains 16.5 milligrams of sorbitol and 40.5
micrograms of allura red.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft (Capsule)
Purple coloured clear transparent round shaped gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Vitamin D deficiency in pregnant and breastfeeding women
with an identified risk.
Solferol Capsules is indicated in adults and adolescents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents_
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation.
_Pregnancy and breast-feeding_
- Prevention of deficiency: The usual dose is 400 IU/day (1 capsule)
Before starting the vitamin D therapy, the patient's dietary habits
should be carefully evaluated by the doctor and artificially
added vitamin D content of certain food types should be taken into
consideration.
Certain populations are at high risk of vitamin D deficiency, and may
require higher doses and monitoring of serum 25(OH)D:
- Breast-feeding women who choose not to give the infant a vitamin D3
supplement.
- 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 disease
and coeliac disease
- Those recently treated for vitamin D deficiency, and requiring
maintenance therapy.
_Paediatric population_
Solferol