Metaperex 400 IU soft capsules

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Rrr alpha-tocoferol

Inapatikana kutoka:

Kora Corporation Limited trading as Kora Healthcare

ATC kanuni:

A11HA03

INN (Jina la Kimataifa):

Rrr alpha-tocoferol

Dawa fomu:

Capsule, soft

Eneo la matibabu:

tocopherol (vit E)

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2023-01-20

Taarifa za kipeperushi

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METAPEREX 400 IU SOFT CAPSULES
RRR-α-tocopherol (Vitamin E)
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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Metaperex is and what it is used for
2.
What you need to know before you take Metaperex
3.
How to take Metaperex
4.
Possible side effects
5.
How to store Metaperex
6.
Contents of the pack and other information
1.
WHAT METAPEREX IS AND WHAT IT IS USED FOR
Metaperex contains 280 mg RRR-α-tocopherol (equivalent to 400 IU of
Vitamin E)
Metaperex is indicated in the following conditions for adults:
-
Vitamin E deficiency in patients diagnosed with ataxia with vitamin E
deficiency (AVED).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METAPEREX
_ _
DO NOT TAKE METAPEREX:
-
If you are allergic to Vitamin E or any of the other ingredients of
this medicine (listed in
section 6).
-
Metaperex 400 IU soft capsules contains soya-bean oil. If you are
allergic to peanut or soya,
do not use this medicinal product.
-
If you have Vitamin K deficiency (increased risk of bleeding).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Metaperex. In
particular, tell your doctor if:
-
You lack vitamin K (involved in the blood clotting process). If you
take doses of vitamin E above
560 mg per day (equivalent to 800 I.U), you may be more likely to
bleed for longer than usual.
-
You are being treated with blood thiners or the hormone oestrogen. A
possible adjustment of the
dose of blood thiner medication during a

Tabia za bidhaa

Health Products Regulatory Authority
20 January 2023
CRN00CCC2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metaperex 400 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains RRR-α-tocopherol 280 mg (equivalent to 400IU of
Vitamin E).
Excipient with known effect: refined soya-bean oil (146 mg per
capsule)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, soft
Yellow-brown coloured, clear oval shaped soft gelatine capsules with a
clear yellow-brown oily liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metaperex 400 IU soft capsules is indicated in the following
conditions for adults:

Vitamin E deficiency in patients diagnosed with ataxia with vitamin E
deficiency (AVED).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be adjusted to the type of disorder and the patient's
clinical condition.
One international unit (IU) of vitamin E equals the biologic activity
of 1 mg of all rac-α-tocopheryl acetate (dl-α-tocopheryl
acetate).
_ _
For adults diagnosed with AVED the following doses should be
administered:

800 IU (560 mg) vitamin E per day (2 capsules) divided into 2 doses.
Diagnosis of vitamin E deficiency should be documented and based on:

measuring the plasma α-tocopherol level (level < 5μg/mL or <11.6
μmol/L indicates vitamin E deficiency) and/or

ratio of plasma α-tocopherol to plasma lipid level (in adults; < 0.8
mg/g total lipid).
Plasma vitamin E level should be monitored monthly initially, to
ensure levels return to the normal range, thereafter at 6-month
intervals and the dose adjusted accordingly if necessary.
Method of administration
For oral use.
Vitamin E is absorbed with lipids, therefore advise patients to take
vitamin E during or after a meal to ensure optimal
absorption.
Health Products Regulatory Authority
20 January 2023
CRN00CCC2
Page 2 of 5
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.

Metap