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EPHEDRINE NASAL DROPS BPC 1973 0.5%

Active substance: EPHEDRINE HYDROCHLORIDE

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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.

Talk to your doctor or pharmacist if
you have….
• Asthma.
• Kidney problems.
• Diabetes.
• Prostate problems.
• Or you are elderly.

Reporting of side effects
If you get any side effects, talk to your doctor,
210 x 148mm flat (27 x 148mm folded)
Dimensions
pharmacist or nurse. This includes any possible
4. Proof No.
Possible 2side effects 15.10.2014 side effects not listed in this leaflet. You can
Date
also report side effects directly via the Yellow
Like all medicines, Ephedrine Nasal Drops can
Card Scheme at: www.mhra.gov.uk/yellowcard.
have side effects, although these don’t affect
everyone. Side effects may be minimised by
avoiding prolonged or excessive use.

Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
This leaflet was last revised in November 2014

By reporting side effects you can help provide
more information on the safety of this medicine.

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 535575
Suf fix

CRN

11478

Reason for
Change

Update to excipient name and
addition of reporting of side
effects statement

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Issued by
Date

MHRA/IMB
submission Yes
required

Data Matrix: 22488810 VERIFIED

22488810

Helvetica

15.10.2014
Date

Marketing authorisation holder and
manufacturer

2

If you accidentally use too much or swallow
Pack Size
some, see a doctor 10ml
straight away. Take the pack
withIG Codeshow which medicine you have
you to
22488810
swallowed.

Helvetica

If you notice these or any other side effect not
Keyline stop use and
included above,(Does not print) tell your doctor or
pharmacist. They will tell you what to do.

Ephedrine Nasal Drops are a clear, colourless
liquid.
It is supplied in 10ml bottles with a dropper.

Proof No.

Process Black

If you use too much
Component
Leaflet

What the medicine looks like

210 x 148mm flat (27 x 148mm folded)

Title

The active ingredient is: ephedrine
hydrochloride 0.5% w/v.
The other ingredients are: chlorobutanol
hemihydrate, sodium chloride, purified water.

Dimensions

If your symptoms persist you should ask your
Product
doctor for advice. Ephedrine Nasal Drops 0.5% w/v

What is in this medicine

22488810

DO MHRA Header THE STATED DOSE.
NOT EXCEED Box

6. Further information

10ml

Do not give to children under 12 unless your
doctor tells you to.

•  eep out of the sight and reach of children.
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•  o not store above 25°C.
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•  o not allow to freeze.
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•  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
I
opening the bottle, return them to your
pharmacist.
•  edicine should not be disposed of via
M
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

IG Code

Children under 12 years

5. Storing this medicine

Pack Size

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.
•  o not use for longer than 7 days without
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talking to your doctor.

Possible side effects are:
•  nxiety, fear (paranoia), being irritable,
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restless or not sleeping.
• Seeing things (hallucinations).
•  eadache.
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•  eeling sick, being sick, feeling thirsty, more
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or less saliva than usual in your mouth.
• Dizziness and fainting.
•  eakness and trembling.
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• rritation, dryness or soreness in the nose.
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• nflammation of the skin.
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• 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
Colours Used
Fonts Used
(dependence).

Keyline (Does not print)

REVERSE FACE TOP

Dosage

22488810

Process Black

•  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 with anyone else.
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• Keep away from eyes.

Turn over

Leaflet

3. How to use this medicine

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 the doctor tells
you to do so. If you use the drops when
breastfeeding, your child may become irritable
and sleepless.

Component

Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
•  eep this leaflet. You may need to read it
K
again.
•  sk your pharmacist if you need any more
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information or advice.
• f any of the side effects gets serious, or if
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you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

•  aken MAOIs (monoamine oxidase
T
inhibitors) for depression in the last two weeks.
•  aken beta-blockers for your heart or blood
T
pressure.
•  n allergy to any of the ingredients listed in
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section 6.
•  heart condition, high blood pressure or
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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.
•  een told you have a type of tumour called a
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phaeochromocytoma.
•  re already taking other medicines to
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unblock your nose.
• Or are under 12 years old.


Fonts Used

Talk to your doctor….
• f your congestion has not cleared up after 7
I
days.

 o not use the medicine if you
D
have….

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FRONT FACE TOP

Do not use….
•  or anyone under 12 years old.
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•  or longer than 7 days.
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2.  efore you use this
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medicine

Ephedrine Nasal Drops 0.5% w/v

Important information about Ephedrine Nasal
Drops
•  his medicine relieves nasal congestion in
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adults and children over 12 years old.

Product
Title

(ephedrine hydrochloride)

you are taking….

•  uanethidine, reserpine, methyldopa or any
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other drugs for high blood pressure.
•  ricyclic antidepressants eg amitriptyline or
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imipramine.
• 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.
• 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.

MHRA Header Box

Ephedrine Nasal
Drops 0.5%

Talk to your doctor or pharmacist if

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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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