Covonia Chesty Cough Mixture Mentholated

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIQUORICE LIQUID, EXTRACT, LEVOMENTHOL, SQUILL TINCTURE

Available from:

Thornton & Ross Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC code:

R05C

INN (International Name):

SQUILL TINCTURE 0.6 ml/5ml LEVOMENTHOL 4 mg/5ml LIQUORICE LIQUID EXTRACT 0.125 ml/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

SQUILL TINCTURE 0.6 ml/5ml LEVOMENTHOL 4 mg/5ml LIQUORICE LIQUID EXTRACT 0.125 ml/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-06-09

Patient Information leaflet

FRONT FACE TOP
REVERSE FACE TOP
COVONIA CHESTY COUGH
MIXTURE MENTHOLATED
(levomenthol, squill tincture,
liquorice liquid extract)
IMPORTANT INFORMATION ABOUT COVONIA CHESTY
COUGH MIXTURE
UÊÊ
This medicine relieves the symptoms of
chesty coughs and sore throats in adults, the
elderly and children over 5 years.
DO NOT USE….
UÊÊ
If you have a heart complaint.
READ THE LEAFLET BEFORE YOU USE THIS MEDICINE.
IT INCLUDES OTHER INFORMATION WHICH MIGHT BE
ESPECIALLY IMPORTANT FOR YOU.
UÊÊ
Keep this leaflet. You may need to read it
again.
UÊÊ
Ask your pharmacist if you need any more
information or advice.
UÊÊ
If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
This medicine contains liquorice and squill
which belong to a group of medicines known
as expectorants. They help remove phlegm
in people with chesty coughs. Menthol helps
relieve congestion in chesty coughs and
bronchitis.
2. BEFORE YOU USE THIS
MEDICINE DO NOT USE THE MEDICINE IF YOU OR
YOUR CHILD HAVE….
UÊÊ
An ALLERGY to any of the ingredients listed in
section 6.
UÊÊ
Any type of HEART COMPLAINT.
UÊ
ÀiÊ>˜Ê>Vœ…œˆV°
UÊ>ÛiÊLÀi>̅ˆ˜}Ê`ˆvvˆVՏ̈ið
UÊ>ÛiÊÀ>ˆÃi`Ê«ÀiÃÃÕÀiʈ˜ÊޜÕÀʅi>`°
UÊ>Ûiʅi>ÀÌ]ʏˆÛiÀʜÀʎˆ`˜iÞÊ«ÀœLi“ð TALK TO YOUR DOCTOR IF YOU OR YOUR
CHILD ARE TAKING….
UÊÊ
Carbenoxolone for a stomach ulcer.
UÊÊ
Medicines which help remove fluids from the
body (e.g. water tablets). PREGNANT OR BREASTFEEDING….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding. IMPORTANT INFORMATION ABOUT SOME
OF THE INGREDIENTS
UÊÊ
This medicine contains 7.7vol% ethanol
(alcohol), i.e. up to 600mg per 10ml dose,
equivalent to 15ml beer, or 6ml wine per dose.
>À“vՏÊvœÀÊ̅œÃiÊÃÕvviÀˆ˜}ÊvÀœ“Ê>Vœ…œˆÃ“°Ê
To be taken into account in children, pregnant
women and high-risk groups such as patie

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Covonia Mentholated Cough Mixture
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levomenthol
4.0mg/5ml
Squill Tincture
0.6ml/5ml
Liquorice Liquid Extract
0.125ml/5ml
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the symptomatic relief of productive (chesty) coughs and sore
throats.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
RECOMMENDED DOSES
Adults, the elderly and children over 12 years: One or two 5ml
spoonfuls.
Children 5-12 years: One 5ml spoonful.
DOSAGE SCHEDULE
The dose to be taken every four hours if required.
4.3.
CONTRAINDICATIONS
Contraindicated in patients with known hypersensitivity to any of the
ingredients.
Also Contraindicated in patients with cardiac disorders.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist or worsen consult your doctor.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Toxicity of squill glycosides may be increased when given in
combination with
thiazides or loop diuretics, as these may cause hypokalaemia and
hypomagnesaemia,
which may lead to cardiac arrhythmias.
When used with carbenoxolone it may produce sodium and water retention
and
hypokalaemia. and may give rise to greater toxicity of squill.
4.6.
PREGNANCY AND LACTATION
There are no adverse reports when used in recommended doses.
However, as with all medicines care should be taken when using this
product in
pregnancy and medical advice sought if necessary.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8.
UNDESIRABLE EFFECTS
No adverse effects have been reported with this product, however, a
few cases of
hypersensitivity reactions to menthol have been reported. These
include generalised
urticaria and flushing, menthol may give rise to contact dermatitis.
Liquorice may cause sodium and water retention, and hypokalaemia.
4.9.
OVERDOSE
Ingestion of large doses of the active ingredients has been reported
to cause the
following