Concavit Drops

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ASCORBIC ACID, COLECALCIFEROL, DEXPANTHENOL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN, SODIUM ASCORBATE

Available from:

Wallace Manufacturing Chemists Limited 51-53 Stert Street, Abingdon, OX14 3JF, United Kingdom

ATC code:

A11BA

INN (International Name):

ASCORBIC ACID 19.35 mg COLECALCIFEROL 500 IU DEXPANTHENOL 2 mg NICOTINAMIDE 12.5 mg PYRIDOXINE HYDROCHLORIDE 1 mg THIAMINE HYDROCHLORIDE 2 mg RETINOL PALMITATE 5000 IU RIBOFLAVIN 1 mg SODIUM ASCORBATE 34.44 mg

Pharmaceutical form:

ORAL DROPS, SOLUTION

Composition:

ASCORBIC ACID 19.35 mg COLECALCIFEROL 500 IU DEXPANTHENOL 2 mg NICOTINAMIDE 12.5 mg PYRIDOXINE HYDROCHLORIDE 1 mg THIAMINE HYDROCHLORIDE 2 mg RETINOL PALMITATE 5000 IU RIBOFLAVIN 1 mg SODIUM ASCORBATE 34.44 mg

Prescription type:

OTC

Therapeutic area:

VITAMINS

Authorization status:

Withdrawn

Authorization date:

2006-04-13

Patient Information leaflet

Concavit Drops 

Each 0.5ml contains: - 
Vitamin A BP 
5000.00 iu 
Calciferol BP 
500.00 iu 
Vitamin C 
50mg 
_(as Ascorbic Acid BP _
_19.35mg and _
_ Sodium Ascorbate USP _
_34.44mg)_ 
Thiamine Hydrochloride 
2.00 mg 
Riboflavine 1.0 
mg 
_(as Riboflavine Sodium Phosphate BP _
_1.37 mg) _
Pyridoxine Hydrochloride BP 
1.00 mg 
Nicotinamide BP 
12.50 mg  
Panthenol 2.0mg 

In addition the drops also contain Sodium Edetate, Glycerin, 
Polysorbate 80, Propylene Glycol, Hydroxybenzoates 
(Methyl, Ethyl, Propyl and Butyl), Propyl Gallate, Flavouring 
(Orange Essence & Morella Cherry Essence), Sodium 
Saccharin, Sorbitol Solution and Water. 

Concavit drops is available in packs of 15ml. 

Concavit is an oral vitamin supplement. 

The product licence holder is Wallace Manufacturing 
Chemists Ltd., 52 Queen Anne Street, London W1M 9LA, 
England and the drops are manufactured by Pharmasol Ltd., 
North Way, Walworth Industrial Estate, Andover, 
Hampshire SP10 5AZ, England. 

Concavit is intended as a multiple vitamin supplement in 
situations of special dietary need. It is not intended for
the 
correction of specific vitamin deficiencies. 

BEFORE YOU USE CONCAVIT 
Do not use Concavit to treat vitamin deficiencies caused by 
inability to absorb the vitamin(s) orally. 
Do not use Concavit if: 
•  You are hypersensitive to any of the ingredients 
•  You have a history of high levels of Vitamins A or D 
•  You have bone tumours 
•  You have elevated blood calcium levels. 
•  You have abnormal metabolic sensitivity to vitamin D 
Do not take Vitamin A supplements if you are pregnant or 
likely to become pregnant except on the advice
of your doctor 
or antenatal clinic. 

PRECAUTIONS FOR THE USE OF CONCAVIT 
Do not exceed the stated dose. 

INTERACTIONS WITH OTHER MEDICINE 
Concavit may react with other medicines you

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Concavit Drops 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_ _
_Each 0.5ml contains: - _

Vitamin A BP 
 5000.00 iu 
Calciferol BP 
 500.00 iu 
Ascorbic Acid BP 
 19.35 mg 
Sodium Ascorbate USP 
 34.44 mg 
Thiamine Hydrochloride BP 
 2.00 mg 
Riboflavine  
1.00 
mg 
(as Riboflavine Sodium Phosphate BP) 
 (1.37 mg) 
Pyridoxine Hydrochloride BP 
 1.00 mg 
Nicotinamide BP 
 12.50 mg  
d-Panthenol  
2.00 
mg 

3. PHARMACEUTICAL 
FORM 

Oral Liquid, Drops 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

As a supplement of multiple vitamins in situations of
special dietary need. Not suitable for 
the correction of specific vitamin deficiencies. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
Oral administration. 
Adults, The Elderly and children – 0.5ml per day. 

4.3. CONTRA-INDICATIONS 
ƒ  Oral administration in the treatment of deficiency state
in malabsorption syndromes. 
ƒ  Hypersensitivity to any of the ingredients. 
ƒ  History of hypervitaminoses A or D. 
ƒ  Sarcoidosis 
ƒ  Hypercalcaemia 
ƒ  Abnormal metabolic sensitivity to Vitamin D. 
ƒ  Do not take vitamin A supplements if you are pregnant or
likely to become pregnant except on 
the advice of a doctor or antenatal clinic. 

Page 2 of 4 
4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
There are serious risks of developing hypercalcaemia
when calcium salts or thiazides are co-
administered. Serum calcium, phosphate, alkaline phosphatase, liver
function tests and 
magnesium should be monitored when indicated. 

Absorption of Vitamin A is
reduced in cystic fibrosis, hepatic diseases, pancreatic 
dysfunction and in patients with intestinal infections. 

The use of Vitamin A in renal
diseases requires extreme caution. 

Do not e