One-Alpha 1 microgram soft capsules

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Alfacalcidol

Disponibbli minn:

LTT Pharma Limited

Kodiċi ATC:

A11CC; A11CC03

INN (Isem Internazzjonali):

Alfacalcidol

Dożaġġ:

1 microgram(s)

Għamla farmaċewtika:

Capsule, soft

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Vitamin D and analogues; alfacalcidol

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2014-12-05

Fuljett ta 'informazzjoni

These are signs that there may be problems
developing with your kidneys. Kidney stones may
be forming. Kidney stones may cause a sharp
spasm or pain in one side of your lower back.
RARE POSSIBLE SIDE EFFECTS WHICH MAY AFFECT UP
TO 1 IN 1,000 PEOPLE ARE:
•
Dizziness
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2; Tel: [phone]; Fax: +353 1
6762517. Website: www.hpra.ie;
e-mail: [e-mail]. By reporting side
effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ONE-ALPHA
®
•
Keep this medicine out of the sight and reach of
children.
•
Do not store above 25°C.
•
Do not use this medicine after the expiry date
which is stated on the carton and foil blister
(EXP). The expiry date is the last day of that
month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT ONE-ALPHA
®
CONTAINS
The active substance, which treats your illness is
alfacalcidol.
One-Alpha
®
1 microgram capsule contains
1 microgram of alfacalcidol.
The other ingredients in One-Alpha® 1 microgram
capsules are: sesame oil, all-rac-α-tocopherol,
gelatin, glycerol, potassium sorbate and ferric
oxide (E172).
You can find important information about some of
the ingredients in your medicine near the end of
section 2 of this leaflet.
WHAT ONE-ALPHA
®
LOOKS LIKE AND CONTENTS OF
THE PACK
One-Alpha
®
1 microgram soft capsules are brown,
egg shaped, soft capsules.
The capsules come in blister packs of
30 soft capsules.
THE PARALLEL PRODUCT AUTHORISATION HOLDER IS:
LTT Pharma Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire,
B98 0RE, UK.
REPACKAGED BY:
Lexon (UK) Limited

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
One-Alpha 1 microgram soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1 microgram of alfacalcidol.
Excipient(s) with known effects: contains Sesame Oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft (capsule).
_Product imported from Greece._
Brown, egg-shaped soft gelatin capsule, holding 0.1g oily solution.
4 CLINICAL PARTICULARS
As per PA 0046/024/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 0046/024/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sesame oil
All-rac-
-tocopherol
Gelatin
Glycerol
Potassium sorbate
Ferric oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
Al/PVC blister foil, polyamide/Al lid containing 30 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance wi