Ephedrine 1% nasal drops

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ephedrine hydrochloride

Saatavilla:

A A H Pharmaceuticals Ltd

ATC-koodi:

R01AA03

INN (Kansainvälinen yleisnimi):

Ephedrine hydrochloride

Annos:

10mg/1ml

Lääkemuoto:

Nasal drops

Antoreitti:

Nasal

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 12020200

Pakkausseloste

FRONT FACE TOP
REVERSE FACE TOP
_Data Matrix:_ 22562009 VERIFIED
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
557112
11911
Addition of reporting of side
effects statement
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
557112
11911
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
22562009
210 x 148mm flat (27 x 148mm folded)
2
05.02.2015
Process Black
Keyline (Does not print)
Ephedrine Nasal Drops 1% w/v
Helvetica
EPHEDRINE NASAL DROPS
1% W/V
(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 MEDICINE IF YOU
HAVE….
• Taken MAOIS (MONOAMINE OXIDASE
INHIBITORS) for depression in the last two weeks.
• Taken BETA-BLOCKERS for your HEART OR BLOOD
PRESSURE.
• AN ALLERGY to any of the ingredients listed in
section 6.
• A HEART CONDITION, HIGH BLOOD PRESSURE or
POOR CIRCULATION.
• An OVERACTIVE THYROID GLA

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ephedrine Nasal Drops 1.0%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine Hydrochloride BP 1.0% W/V
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.
CONTRA-INDICATIONS
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: do not share the drops with anyone.
10ml pack states: di