Concavit drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexpanthenol; Pyridoxine hydrochloride; Nicotinamide; Riboflavin sodium phosphate; Thiamine hydrochloride; Vitamin A; Ergocalciferol; Ascorbic acid; Sodium ascorbate

Available from:

Wallace Manufacturing Chemists Ltd

INN (International Name):

Dexpanthenol; Pyridoxine hydrochloride; Nicotinamide; Riboflavin sodium phosphate; Thiamine hydrochloride; Vitamin A; Ergocalciferol; Ascorbic acid; Sodium ascorbate

Dosage:

4mg/1ml ; 2mg/1ml ; 25mg/1ml ; 2mg/1ml ; 4mg/1ml ; 10000unit/1ml ; 1000unit/1ml ; 38.7mg/1ml ; 68.88mg/1ml

Pharmaceutical form:

Oral drops

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09100000; GTIN: 05034593017706

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., Wallace House, 51-53 Stert Street, Abingdon,
Oxfordshire OX14 3JF, United Kingdom and the drops are
manufactured by Thorpe Laboratories Ltd., Enterprise Road,
Mablethorpe, LincolnshireLN12 1LH, England.
Product Licence number: PL 00400/5010R
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 are taking. If
you are taking any of the medicines listed then consult your
pharmacist or doctor.

Contraceptive pills may increase levels of Vitamin A.

Agents such as Bile Acid Resins e.g. C

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Concavit Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Each 0.5 ml contains: - _
Vitamin A BP
5000.00 in
Calciferol BP
500.00 iu
Ascorbic Acid BP
19.35 mg
Sodium Ascorbate USP
34.44 mg
Thiamine Hydrochloride BP
2.00 mg
Ribofiavine
1.00 mg
(as Ribofiavine 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
4.
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, and children -0.5 ml per day.
The Elderly – no specific dose recommendation.
4.3
CONTRA-INDICATIONS
•
Oral administration in the treatment of deficiency state in
malabsorption
syndromes.
•
Hypersensitivity to any of the ingredients.
•
History of hypervitaminoses A or D.
•
Sarcoidosis
•
Hypercalcaemia
•
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 a doctor or antenatal clinic.
4.4
SPECIAL WARNINGS AND SPECIAL 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 exceed the stated dose.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
•
Contraceptive pills raise plasma levels of Vitamin A.
•
Agents such as bile acid resins, e.g. cholestyramine and colestipol
impair
the absorption of fats including the Vitamins A and D.
•
As both Vitamin