Covonia night time formula oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diphenhydramine hydrochloride; Dextromethorphan hydrobromide

Available from:

Thornton & Ross Ltd

ATC code:

R05DA20

INN (International Name):

Diphenhydramine hydrochloride; Dextromethorphan hydrobromide

Dosage:

2mg/1ml ; 1.33mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03090200; GTIN: 5011309017212

Patient Information leaflet

COVONIA NIGHT TIME FORMULA

Summary of Product characteristics

OBJECT 1
COVONIA NIGHT TIME FORMULA
Summary of Product Characteristics Updated 01-Dec-2016 | Thornton &
Ross Ltd
1. Name of the medicinal product
Covonia Night Time Formula
2. Qualitative and quantitative composition
Dextromethorphan Hydrobromide Ph.Eur.
Diphenhydramine Hydrochloride Ph.Eur.
6.65mg/5ml dose
10.0mg/5ml dose
Excipients: Each 5ml contains Liquid Maltitol 1.125g, Ethanol
(alcohol) 7.3 Vol%
For full list of excipients see section 6.1
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
For the night time symptomatic relief of unproductive cough and
congestive symptoms associated with
colds.
4.2 Posology and method of administration
POSOLOGY
Adults, the Elderly and Children over 12 years
3 x 5ml spoonfuls at bedtime. Repeat after 6 hours if required.
CHILDREN UNDER 12 YEARS
Do not give to children under 12 years old.
4.3 Contraindications
Contraindicated in known hypersensitivity to any of the ingredients.
Contraindicated in persons under
treatment with monoamine oxidase inhibitors or within 2 weeks of
discontinuation of MAOI use.
Contraindicated in persons under treatment with selective serotonin
reuptake inhibitors (SSRIs)
Dextromethorphan, in common with other centrally acting antitussive
agents, should not be given to
patients in, or at risk of developing, respiratory failure.
Covonia Night Time Formula should not be used in liver dysfunction. It
should not be administered to
patients where cough is associated with asthma, or patients with
productive cough.
Diphenhydramine has been associated with acute attacks of porphyria
and is considered unsafe in
porphyric patients.
Do not give to children under 12 years old.
4.4 Special warnings and precautions for use
Because of their antimuscarinic properties antihistamines should be
used with care in conditions such as
closed angle glaucoma, urinary retention, prostatic hyperplasia or
pyeloduodenal obstruction. Caution
should also be exercised in patients with epilepsy or severe
cardiovascular disorders. Caution is neede