Covonia Night Time Formula

Šalis: Malta

kalba: anglų

Šaltinis: Malta Medicines Authority

Veiklioji medžiaga:

DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE

Prieinama:

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

ATC kodas:

R05DA

INN (Tarptautinis Pavadinimas):

DEXTROMETHORPHAN HYDROBROMIDE 6.65 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 10 mg/5ml

Vaisto forma:

ORAL SOLUTION

Sudėtis:

DEXTROMETHORPHAN HYDROBROMIDE 6.65 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 10 mg/5ml

Recepto tipas:

OTC

Gydymo sritis:

COUGH AND COLD PREPARATIONS

Autorizacija statusas:

Withdrawn

Leidimo data:

2006-11-01

Pakuotės lapelis

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
486062
11024
Addition of driving warnings at
the request of the MHRA
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Portrait single ply front label
150ml
22575207
90 x 50mm
2
21.05.2014
Process Black
PANTONE 2685 C
PANTONE 2725 C
PANTONE 485 C
PANTONE 7443 C
Keyline (Does not print)
Braille
Covonia Night Time Formula
Futura
Helvetica
22575207
NEW ADVICE FOR DRIVERS - SEE REVERSE
22575207
Braille Reads
c o v o n i a
n i g h t t i m e
f o r m u l a
Braille Warning! Chesapeake cannot accept responsibility for any
errors in this proof after approval by the customer.
Whilst extreme care is taken in the setting of Braille, the customer
must take the final responsibility for its accuracy.
There is no single European Braille authority and there are many
different Braille formats in existence, with country specific
characters.
This Braille is set to the Marburg Medium format unless you have
requested otherwise.
When you sign this proof you are signifying full approval of the
Braille text and specification.
Do not store above 25°C.
Protect from light.
MA HOLDER AND MANUFACTURER
Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK
PL 00240/0042 92768591909
MA055/00503
COVONIA is a registered Trade Mark.
P1
P2
92768591909
150ML
92768591909
P
TURN OVER
P3
COVONIA NIGHT TIME FORMULA is for night time relief of
the symptoms of dry coughs and congestion from colds.
SHAKE THE BOTTLE. Take the solution by mouth.
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Take 3 x 5ml spoonfuls at bedtime. Repeat after 6 hours
if required.
DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD.
DO NOT TAKE MORE MEDICINE THAN THE LABEL TELLS YOU TO.
DO NOT TAKE WITH ANY OTHER COUGH AND COLD MEDICINE.
AVOID ALCOHOLIC DRINK. THIS MEDICINE CAN LEAD TO
DEPENDENCE. THEREFORE THE TREATMENT SHOULD BE OF
SHORT DURATION.
PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS.

Prekės savybės

Page
1
of
11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Covonia Night Time Formula
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextromethorphan Hydrobromide Ph.Eur.
6.65mg/5ml dose
Diphenhydramine Hydrochloride Ph.Eur.
10.0mg/5ml dose
Excipient(s) with known effect
This
medicine
contains, per
15ml
dose:
2.7g Maltitol,
3.675g
Sorbitol,
869mg
Ethanol, 18mg Sodium benzoate, 4.14mg Sodium.
For the 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.
Page
2
of
11
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 disor