Ephedrine 0.5% nasal drops

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Ephedrine hydrochloride

Dostupné s:

Alliance Healthcare (Distribution) Ltd

ATC kód:

R01AA03

INN (Mezinárodní Name):

Ephedrine hydrochloride

Dávkování:

5mg/1ml

Léková forma:

Nasal drops

Podání:

Nasal

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 12020200

Informace pro uživatele

_Data Matrix:_ 22488810 VERIFIED
FRONT FACE TOP
REVERSE FACE TOP
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
535575
11478
Update to excipient name and
addition of reporting of side
effects statement
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
10ml
22488810
210 x 148mm flat (27 x 148mm folded)
2
15.10.2014
Process Black
Keyline (Does not print)
Ephedrine Nasal Drops 0.5% w/v
Helvetica
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
535575
11478
Update to excipient name and
addition of reporting of side
effects statement
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
10ml
22488810
210 x 148mm flat (27 x 148mm folded)
2
15.10.2014
Process Black
Keyline (Does not print)
Ephedrine Nasal Drops 0.5% w/v
Helvetica
EPHEDRINE NASAL
DROPS 0.5%
(ephedrine hydrochloride)
IMPORTANT INFORMATION ABOUT EPHEDRINE NASAL
DROPS
• This medicine relieves nasal congestion in
adults and children over 12 years old.
DO NOT USE….
• For anyone under 12 years old.
• For longer than 7 days.
TALK TO YOUR DOCTOR….
• If your congestion has not cleared up after 7
days.
NOW READ THE REST OF THE LEAFLET BEFORE YOU
USE THIS MEDICINE. IT INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
Ephedrine Nasal Drops belong to a group of
medicines known as nasal decongestants. They
act to relieve congestion by constricting blood
vessels in the nose.
2. BEFORE YOU USE THIS
MEDICINE DO NOT USE THE MEDI

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ephedrine Nasal Drops B.P.C 1973 0.5%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine Hydrochloride 0.5% W/V
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal Drops.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of nasal congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nasal, by application to the mucous membranes.
RECOMMENDED DOSE
Instil one or two drops into each nostril.
DOSAGE SCHEDULE
As required, but not more than 4 times a day.
The above dose and schedule are recommended for adults, the elderly
and children
over 12 years.
4.3
CONTRAINDICATIONS
Ephedrine should not be given to patients who are being treated with
monoamine oxidase inhibitors, or within two weeks of stopping such
treatment (see section 4.5).
Ephedrine should not be taken with beta-blockers (see section 4.5)
It should be used with caution in patients receiving halogenated
anaesthetics.
Ephedrine nasal drops should not be used concomitantly with other
sympathomimetic decongestants.
It should also be avoided in patients with cardiovascular disease,
cardiac
arrhythmias, cardiomyopathy and peripheral vascular disease,_
_hypertension,
hyperthyroidism, hyperexcitability, phaeochromocytoma, closed-angle
glaucoma and urinary retention.
Ephedrine nasal drops should not be used after nasal or sinus surgery.
Excessive and/or frequent use of a nasal decongestant should be
avoided.
Children under 12 years of age.
Hypersensitivity to ephedrine or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Store below 25°C. Do not allow to freeze.
Keep all medicines away from children.
Warning: asthmatics should consult their doctor before using this
product.
Ephedrine should be used with care in the elderly and in patients with
prostatic
hypertrophy, diabetes mellitus or renal impairment.
The product should not be used for longer than 7 days. Avoid
contamination
during use. Keep away from eyes.
10ml pack label states: