Alpha tocopheryl acetate 500mg5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alpha tocopheryl acetate

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

A11HA03

INN (International Name):

Alpha tocopheryl acetate

Dosage:

100mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060500; GTIN: 5024403000103

Patient Information leaflet

Vitamin E PIL UK 005
PATIENT INFORMATION LEAFLET
VITAMIN E SUSPENSION 100MG IN 1 ML
DL-ALPHA-TOCOPHERYL ACETATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes
any side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
WHAT VITAMIN E SUSPENSION IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAMIN E SUSPENSION
3. HOW TO TAKE VITAMIN E SUSPENSION
4. POSSIBLE SIDE EFFECTS
5.
HOW TO STORE VITAMIN E SUSPENSION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT VITAMIN E SUSPENSION IS AND WHAT IT IS USED FOR
DL-alpha-tocopheryl acetate, the active ingredient of Vitamin E
Suspension, is
a man-made form of vitamin E. Although the exact role of vitamin E has
not
yet been worked out, it is known to play an important part in
metabolism – the
chemical reactions that are taking place in the body all the time.
Vitamin E Suspension is used in certain illnesses which prevent the
body from
absorbing enough vitamin E from the diet. By taking extra vitamin E in
the
form of Vitamin E Suspension, the body gets all it needs. The medical
names
for these illnesses are cystic fibrosis (an inherited disorder
affecting the lungs,
pancreas and other glands), chronic cholestasis (a disease of the
liver) and
abetalipoproteinaemia (a rare inherited disease which causes a
deficiency of
fat in the blood and severely affects growth).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAMIN E SUSPENSION
DO NOT TAKE VITAMIN E SUSPENSION:
•
if you are allergic to Vitamin E or any other ingredients of Vitamin E
Suspension (listed in section 6).
•
if you have an inherited condition which can cause an intolerance to
some sugars
WARNINGS AND PRECAUTIONS
Vitamin E PIL UK 005
Talk to your doctor or pharmacist before taking Vitamin E S

Summary of Product characteristics

OBJECT 1
VITAMIN E SUSPENSION 100MG/ML
Summary of Product Characteristics Updated 05-Sep-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Vitamin E Suspension 100mg/ml
2. Qualitative and quantitative composition
Each 5ml of suspension contains 500mg of DL-alpha-tocopheryl acetate.
Excipients with known effect:
Each 5ml of suspension contains 1 g of sucrose and 400 mg of
polyethoxylated castor oil
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Suspension
4. Clinical particulars
4.1 Therapeutic indications
For the correction of Vitamin E deficiency occurring in malabsorption
disorders ie. cystic fibrosis,
chronic cholestasis and abetalipoproteinaemia.
4.2 Posology and method of administration
Route of administration: For oral use.
Adults (including the elderly)
For the treatment of malabsorption disorders the following doses
should be administered:
Cystic fibrosis
Abetalipoproteinaemia
100-200mg/day
50-100mg/kg/day
Children
For the treatment of cystic fibrosis a dose of 50mg/day should be
given to children less than 1 year and
100mg/day to children 1 year and over.
The adult dosage should be used for the treatment of
abetalipoproteinaemia (50-100mg/kg/day).
Infants with vitamin E deficiency which is secondary to chronic
cholestasis may be treated with doses of
150-200mg/kg/day.
For instructions on dilution of Vitamin E before administration, see
section 6.6.
4.3 Contraindications
Use in patients with a known hypersensitivity to Vitamin E.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
4.4 Special warnings and precautions for use
Vitamin E has been reported to increase bleeding tendency in vitamin-K
deficient patients or those taking
anticoagulant treatments, it is therefore recommended to monitor the
prothrombin time and international
normalised ratio (INR) to detect any changes in haemostasis. A
possible adjustment of the dose of
anticoagulants during and