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EPHEDRINE NASAL DROPS 1%

Active substance: EPHEDRINE HYDROCHLORIDE

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

FRONT FACE TOP

Important information about Ephedrine Nasal
Drops
•  his medicine relieves nasal congestion in
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adults and children over 12 years old.
Do not use….
•  or anyone under 12 years old.
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•  or longer than 7 days.
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Talk to your doctor….
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• f 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.
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•  eep this leaflet. You may need to read it
again.
•  sk your pharmacist if you need any more
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information or advice.
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• f 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

• ­­ se one or two drops in each nostril as
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required not more than 4 times a day.
•  his is the normal dose unless your doctor
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tells you differently.
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•  o 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
have swallowed. Box
Ephedrine Nasal Drops 1% w/v

Product

Title
4. Possible side effects

2.  efore you use this
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medicine
 o not use the medicine if you
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have….
•  aken MAOIs (monoamine oxidase
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inhibitors) for depression in the last two weeks.
• Taken beta-blockers for your heart or blood
pressure.
•  n allergy to any of the ingredients listed in
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section 6.
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•  heart condition, high blood pressure or
poor circulation.
•  n overactive thyroid gland.
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• Overexcitability.
• Glaucoma.
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•  xcessive 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.
•  re already taking other medicines to
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unblock your nose.
• Or are under 12 years old.
Talk to your doctor or pharmacist if

you have….

•  sthma.
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•  idney problems.
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•  iabetes.
•  rostate problems.
P
O
•  r you are elderly.

•  igoxin or digitoxin for heart failure.
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•  examethasone for relief of inflammation.
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•  uinidine to treat irregular heartbeat.
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•  rgotamine or methysergide for migraine
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relief.
•  affeine which may increase the effects of
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ephedrine.
•  asagiline or selegiline for Parkinson’s
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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.
•  r if oxytocin is used to assist birth or
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breastfeeding.
• f you go into hospital for an operation you
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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 t­­­ use this medicine
o


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

•  void touching the glass dropper – hold the
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dropper by the bulb.
•  o not put the dropper inside your nostril.
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•  ut your head back and using the dropper,
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place the drops into each nostril.
•  eplace the dropper in the bottle after use.
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•  o 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.
•  ffects on the heart e.g. palpitations.
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•  ffects on the circulation e.g. high or low
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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
Process side
If you get any Black effects, talk to your doctor,
pharmacist or (Does notThis includes any possible
nurse. print)
Keyline
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, Ephedrine Nasal Drops can
Component
Leaflet
have side effects, although these don’t affect
Pack Size
10ml
everyone. Side effects may be minimised by
avoiding prolonged or excessive use.
IG Code
22562009
Possible side effects are:
By reporting side effects you can help provide
210 x 148mm flat (27 x 148mm folded)
Dimensions
• Anxiety, fear (paranoia), being 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.
•  o not use after the expiry date shown on the
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carton. The expiry date refers to the last day
of that month.
• f you have any unused drops 2 months after
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opening the bottle, return them to your
pharmacist.
•  edicine should not be disposed of via
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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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