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EPHEDRINE NASAL DROPS 1%

Active substance(s): EPHEDRINE HYDROCHLORIDE

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Ephedrine Nasal Drops
1% w/v
(ephedrine hydrochloride)

FRONT FACE TOP

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.

Dosage
Adults and children over 12 years

• ­­Use one or two drops in each nostril as
required not more than 4 times a day.
• This is the normal dose unless your doctor
tells you differently.
• Do not use for longer than 7 days without
talking to your doctor.

REVERSE FACE TOP

Children under 12 years

Do not give to children under 12 unless your
doctor tells you to.
DO NOT EXCEED THE STATED DOSE.
If your symptoms persist you should ask your
doctor for advice.
If you use too much
If you accidentally use too much or swallow
some, see a doctor straight away. Take the
pack with you to show which medicine you
MHRA
Header Box
have
swallowed.
Ephedrine Nasal Drops 1% w/v

Product

4. Title
Possible side effects

2. Before you use this
medicine
D
 o 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 gland.
• Overexcitability.
• Glaucoma.
• Excessive levels of adrenaline in the blood.
• Recently had an operation on your nose or
sinuses.
• Difficulty passing urine.
• Been told you have a type of tumour called a
phaeochromocytoma.
• Are already taking other medicines to
unblock your nose.
• Or are under 12 years old.
Talk to your doctor or pharmacist if

you have….

• Asthma.
• Kidney problems.
• Diabetes.
• Prostate problems.
• Or you are elderly.

• Digoxin or digitoxin for heart failure.
• Dexamethasone for relief of inflammation.
• Quinidine to treat irregular heartbeat.
• Ergotamine or methysergide for migraine
relief.
• Caffeine which may increase the effects of
ephedrine.
• Rasagiline or selegiline for Parkinson’s
disease.
• Medicines for psychotic illness.
• Theophylline for asthma.
• Thyroid hormones e.g. levothyroxine.
• Medicines or supplements to reduce your
appetite or make you more alert.
• Or if oxytocin is used to assist birth or
breastfeeding.
• If you go into hospital for an operation you
should tell the doctor and anaesthetist that
you are using Ephedrine Nasal Drops.

Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding.
Do not use the drops unless your doctor tells
you to do so. If you use the drops when
breastfeeding, your child may become irritable
and sleepless.

3. How t­­­o use this medicine

Talk to your doctor or pharmacist if
you are taking….
• Guanethidine, reserpine, methyldopa or any
other drugs for high blood pressure.
• Tricyclic antidepressants eg amitriptyline or
imipramine.

• Avoid touching the glass dropper – hold the
dropper by the bulb.
• Do not put the dropper inside your nostril.
• Put your head back and using the dropper,
place the drops into each nostril.
• Replace the dropper in the bottle after use.
• Do not share the drops
Turn over
with anyone else.
• Keep away from eyes.
22562009

• Weakness and trembling.
• Irritation, dryness or soreness in the nose.
• Inflammation of the skin.
• Sweating, flushing or goose pimples.
• Effects on the heart e.g. palpitations.
• Effects on the circulation e.g. high or low
blood pressure.
• Changes in blood sugar or potassium levels.
• Anorexia.
• Shortness of breath.
• Wide pupils in the eye.
People with difficulty in passing urine may find
that the condition gets worse.
Use of the drops for more than 7 days may
make your congestion worse and the
effectiveness of the drops will decrease
(tolerance). It may also make you want to use
the drops more often than recommended, and
you may find it difficult to stop using them
(dependence).
If you notice these or any other side effect not
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.

5. Storing this medicine

Reporting of side effects
Helvetica
If you getProcess
any Black
side effects, talk to
your doctor,
pharmacist
or
nurse.
This
includes
any possible
Keyline (Does not print)
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard

What the medicine looks like

Colours Used

Fonts Used

Like
all medicines,Leaflet
Ephedrine Nasal Drops can
Component
have side effects, although these don’t affect
Pack SizeSide effects
10mlmay be minimised by
everyone.
avoiding
prolonged
or excessive use.
IG Code
22562009
Possible side effects are:
By reporting side effects you can help provide
210 x 148mm
(27 x 148mm
folded)
Dimensions
• Anxiety,
fear (paranoia),
beingflat
irritable,

more information on the safety of this
restless
or
not
sleeping.
Proof No.
Date
05.02.2015 medicine.
2
• Seeing things (hallucinations).
• Headache.
• Feeling sick, being sick, feeling thirsty, more
or less saliva than usual in your mouth.
• Dizziness and fainting.

• Keep it out of the sight and reach of children.
• Do not store above 25°C.
• Do not allow to freeze.
• Do not use after the expiry date shown on the
carton. The expiry date refers to the last day
of that month.
• If you have any unused drops 2 months after
opening the bottle, return them to your
pharmacist.
• Medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

6. Further information
What the medicine contains

The active ingredient is:
ephedrine hydrochloride 1% w/v.
The other ingredients are: chlorobutanol,
sodium chloride, purified water.
Ephedrine Nasal Drops are a clear, colourless
liquid.
They are supplied in 10ml bottles with a
dropper.

Marketing authorisation holder and
manufacturer

Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
This leaflet was last revised in February 2015
22562009

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 557112

Data Matrix: 22562009 VERIFIED
Suf fix

CRN

11911

Reason for
Change

Addition of reporting of side
effects statement

A

Issued by
Date

MHRA/IMB
submission Yes
required

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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