Redoxon Double Action 1000 mg/10 mg Effervescent Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ascorbic acid; Zinc citrate trihydrate

Tilgjengelig fra:

Bayer Limited

ATC-kode:

A11GB

INN (International Name):

Ascorbic acid; Zinc citrate trihydrate

Dosering :

1000/10mg milligram(s)

Legemiddelform:

Effervescent tablet

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Ascorbic acid (vitamin C), combinations

Autorisasjon status:

Not marketed

Autorisasjon dato:

2001-11-02

Informasjon til brukeren

BCH22023
Package Leaflet: Information for the User
Redoxon Double Action 1000 mg/10 mg Effervescent Tablets
Vitamin C & Zinc
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Redoxon Double Action
carefully to get the best results from them. 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 possible side effects not listed in this
leaflet (see section 4). You must
contact a doctor if you do not feel better or if you feel worse.
WHAT IS IN THIS LEAFLET:
1. What Redoxon Double Action is and what is it used for
2. What you need to know before you take Redoxon Double Action
3. How to take Redoxon Double Action
4. Possible side effects
5. How to store Redoxon Double Action
6. Contents of the pack and other information
1. WHAT REDOXON DOUBLE ACTION IS AND WHAT IS IT USED FOR
Redoxon Double Action Effervescent Tablets are a vitamin and mineral
supplement containing vitamin C
and zinc. Redoxon Double Action Effervescent Tablets are for the
treatment of vitamin C and zinc
deficiency.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REDOXON DOUBLE ACTION
DO NOT TAKE REDOXON DOUBLE ACTION:
•
if you are allergic to vitamin C or zinc or any of the other
ingredients.
•
if you suffer or suffered from kidney stones, or have high oxalic
levels in the urine.
•
if you have severe problems with your kidneys or are on dialysis.
•
if you suffer from iron overload (hemochromatosis).
WARNINGS AND PRECAUTIONS:
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING REDOXON DOUBLE ACTION
•
if you have phenylketonuria (PKU). Redoxon Double Action contains a
source of phenylalanine. This
may be harmful to people with phenylketonuria.
•
If you have been told that you have a rare genetic disease causing a
deficiency of glucose-6-
phosphate dehydrogenase.

Preparatomtale

Health Products Regulatory Authority
10 November 2022
CRN00D61K
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Redoxon Double Action 1000 mg/10 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 effervescent tablet contains:
Ascorbic acid (vitamin C) 1000 mg
Zinc (in form of 32 mg zinc citrate trihydrate) 10 mg
Excipients:
Aspartame
15 mg
Sorbitol
655 mg
Sodium
194 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet.
Light orange round tablet with bevelled edges and flat faces.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of vitamin C and zinc deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years: 1 effervescent tablet a day
dissolved in a glass of water (200 ml).
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the active substances or to any of the
excipients listed in section 6.1.
Patients suffering from or having a history of Nephrolitiasis must not
take this product.
Patients suffering from oxalate urolithiasis or oxaluria must not take
this product.
Patients suffering from severe renal insufficiency or renal failure
must not take the product. This includes patients on dialysis.
Patients suffering from Hemochromatosis must not take this product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients suffering from renal insufficiency should consult a physician
or healthcare professional prior to intake of large doses of
ascorbic acid (see section 4.9).
Health Products Regulatory Authority
10 November 2022
CRN00D61K
Page 2 of 7
Do not exceed the recommended doses. Acute or chronic overdose (> 2 g
/ day) increases risk of adverse effects including
formation of calcium oxalate deposits, acute tubular necrosis, and/or
renal failure (see section 4.9).
Patients suffering from glucose-6-phosphatase deficiency should not
take higher than the recommended dose. Overdose of
vitamin C in this patient population has been associated with
hemolytic anemia (see section 4.9).
Patients re